UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-K
T
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the
fiscal year ended December 31, 2009
or
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the
transition period from ____________ to ____________.
Commission
File Number: 0-19961
ORTHOFIX
INTERNATIONAL N.V.
(Exact
name of registrant as specified in its charter)
Netherlands Antilles
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N/A
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(State
or other jurisdiction of incorporation or organization)
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(I.R.S.
Employer Identification No.)
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7 Abraham de Veerstraat
Curaçao
Netherlands Antilles
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N/A
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(Address
of principal executive offices)
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(Zip
Code)
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(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
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Common
Stock, $0.10 par value
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Nasdaq
Global Select Market
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(Title
of Class)
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(Name
of Exchange on Which Registered)
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Securities registered pursuant
to Section 12(g) of the Act
:
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None
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Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.
Yes
¨
No
T
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes
¨
No
T
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
at least the past 90 days.
Yes
T
No
¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).
Yes
¨
No
¨
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K.
¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “accelerated filer,” “large
accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange
Act. (Check one):
Large
Accelerated filer
¨
Accelerated
filer
T
Non-accelerated
filer
¨
(Do not
check if a smaller reporting company) Smaller reporting company
¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act). Yes
¨
No
T
The
aggregate market value of registrant’s common stock held by non-affiliates,
based upon the closing price of the common stock on the last business day of the
registrant’s most recently completed second fiscal quarter, June 30, 2009, as
reported by the Nasdaq Global Select Market, was approximately $418
million.
As of
February 26, 2010, 17,509,333 shares of common stock were issued and
outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
Certain
sections of the registrant's Definitive Proxy Statement to be filed with the
Commission in connection with the 2010 Annual General Meeting of Shareholders
are incorporated by reference in Part III of this Form 10-K.
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Forward-Looking
Statements
This Form
10-K contains forward-looking statements within the meaning of Section 21E of
the Securities Exchange Act of 1934, as amended, relating to our business and
financial outlook, which are based on our current beliefs, assumptions,
expectations, estimates, forecasts and projections. In some cases,
you can identify forward-looking statements by terminology such as “may,”
“will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,”
“projects,” “intends,” “predicts,” “potential” or “continue” or other comparable
terminology. These forward-looking statements are not guarantees of
our future performance and involve risks, uncertainties, estimates and
assumptions that are difficult to predict. Therefore, our actual
outcomes and results may differ materially from those expressed in these
forward-looking statements. You should not place undue reliance on
any of these forward-looking statements. Further, any forward-looking
statement speaks only as of the date on which it is made, and we undertake no
obligation to update any such statement, or the risk factors described in Item
1A under the heading “Risk Factors,” to reflect new information, the occurrence
of future events or circumstances or otherwise.
Factors
that could cause or contribute to such differences may include, but are not
limited to, risks relating to the expected sales of its products, including
recently launched products, unanticipated expenditures, changing relationships
with customers, suppliers, strategic partners and lenders, changes to and the
interpretation of governmental regulations, ongoing governmental investigations
of our businesses which could result in civil or criminal liability or findings
of violations of law (as further described in the “Legal Proceedings” sections
of this Form 10-K and in our quarterly reports on Form 10-Q), risks
relating to the protection of intellectual property, changes to the
reimbursement policies of third parties, the impact of competitive products,
changes to the competitive environment, the acceptance of new products in the
market, conditions of the orthopedic industry, credit markets and the economy,
corporate development and market development activities, including acquisitions
or divestitures, unexpected costs or operating unit performance related to
recent acquisitions, and other risks described in Item 1A under the heading
“Risk Factors” in this Form 10-K.
In
this Form 10-K, the terms “we”, “us”, “our”, “Orthofix” and “our Company” refer
to the combined operations of all of Orthofix International N.V. and its
respective consolidated subsidiaries and affiliates, unless the context requires
otherwise.
Company
Overview
We are a
diversified orthopedic products company offering a broad line of surgical and
non-surgical products for the Spine, Orthopedics, Sports Medicine and Vascular
market sectors. Our products are designed to address the lifelong bone-and-joint
health needs of patients of all ages, helping them achieve a more active and
mobile lifestyle. We design, develop, manufacture, market and
distribute medical equipment used principally by musculoskeletal medical
specialists for orthopedic applications. Our main products are invasive and
minimally invasive spinal implant products and related human cellular and tissue
based products (“HCT/P products”), non-invasive bone growth stimulation products
used to enhance the success rate of spinal fusions and to treat non-union
fractures, external and internal fixation devices used in fracture treatment,
limb lengthening and bone reconstruction, and bracing products used for ligament
injury prevention, pain management and protection of surgical repair to promote
faster healing. Our products also include a device for enhancing
venous circulation, cold therapy, bone cement and devices for removal of bone
cement used to fix artificial implants and airway management products used in
anesthesia applications.
We have
administrative and training facilities in the United States (“U.S.”) and Italy
and manufacturing facilities in the U.S., the United Kingdom, Italy and
Mexico. We directly distribute our products in the U.S., the United
Kingdom, Italy, Germany, Switzerland, Austria, France, Belgium, Mexico, Brazil
and Puerto Rico. In several other markets we distribute our products
through independent distributors.
Orthofix
International N.V. is a limited liability company, organized under the laws of
the Netherlands Antilles on October 19, 1987. Our principal executive
offices are located at 7 Abraham de Veerstraat, Curaçao, Netherlands Antilles,
telephone number: 599-9-465-8525. Our filings with the Securities and
Exchange Commission (the “SEC”), including our Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Annual Proxy
Statement on Schedule 14A and amendments to those reports, are available free of
charge on our website as soon as reasonably practicable after they are filed
with, or furnished to, the SEC. Information on our website or
connected to our website is not incorporated by reference into this Form
10-K. Our Internet website is located at
http://www.orthofix.com
. Our
SEC filings are also available on the SEC Internet website as part of the IDEA
database (
http://www.sec.gov
).
2009
and 2010 Business Highlights
Product
Portfolio Highlights
We
continued to expand our products with several new product developments and
acquisitions. We also continued to expand our global distribution of
our broad product portfolios.
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·
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We
began the full market release of Trinity® Evolution™ in collaboration with
Musculoskeletal Transplant Foundation (“MTF”). Trinity®
Evolution™ is a stem cell-based bone growth matrix designed to advance the
surgical use of allografts by providing characteristics similar to an
allograft in spinal and orthopedic
procedures.
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·
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In
2009, we began the full market release of three of our new products:
PILLAR™ SA spine interbody device, Firebird™ Spinal Fixation System, and
Ascent® LE Posterior Occipital Cervico-Thoracic (“POCT”)
system.
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·
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We
expanded our line of Breg FUSION® function knee braces with the
introduction of the new Lateral OA Brace. The new Lateral OA
Brace is designed to improve comfort and reduce arthritis
pain.
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·
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We
launched Vectra™ Premium Air Walker Boots which are an innovative new line
of foot and ankle products designed to improve comfort and promote
healing.
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We
entered into a license and product development agreement with Stout
Medical Group, LP for the development and marketing of a new expandable
vertebral body replacement and corpectomy device. The initial
term of the agreement is 15 years and gives us exclusive global licensing
rights to the new device which is expected to be introduced during the
second half of 2010.
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·
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In
October 2009, we transitioned out of our agreement to distribute the
Laryngeal Mask product in Italy. We will transition out of our
agreement to distribute the Laryngeal Mask product in the United Kingdom
in June 2010.
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Global
Distribution Highlights
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·
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We
committed $2.0 million in funding to MTF in conjunction with its plans to
significantly increase the production capacity of Trinity® Evolution™, the
new adult stem cell-based bone growth allograft the Company developed with
MTF and launched on July 1, 2009.
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·
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Our
subsidiary, Orthofix Inc., was awarded accreditation status by the
Accreditation Commission for Health Care, Inc. for the provision of
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
services. This demonstrates our commitment to maintain a higher
level of competency and strive for excellence in our products, services,
and customer satisfaction.
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·
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We
entered into a five year agreement with the MBA Group to expand
distribution of the Company’s spinal implant and biologic devices in the
United Kingdom.
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·
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We
entered into an expanded three-year supply agreement with Novation where
under the terms of the agreement, Breg will continue to supply Novation
with its comprehensive lines of functional, osteoarthritic (“OA”),
patellofemoral and postoperative knee braces. Additionally,
under this new agreement Breg will also provide the Voluntary Hospitals of
America (“VHA”), University Health System Consortium (“UHC”), and Provista
member hospitals with its bracing products for the upper and lower
extremities, including shoulder bracing, walkers, and ankle
bracing.
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Business
Highlights
Key Management Changes –
We
made several key management changes recently. In 2009, we appointed
Kevin L. Unger to the position of President of Orthofix Spinal Implants and Eric
Brown to the position of President, Spine Stimulation. In addition,
Bradley R. Mason transitioned from the position of Group President, North
America and into the role as Strategic Advisor to the Company during
2009.. Also in 2009, we announced Michael Mainelli has joined our
Board of Directors.
Consolidation and Reorganization of
Businesses –
During 2009, we continued our plan to consolidate and
reorganize our spine business which will combine the current operations of our
Spine Implants business in New Jersey and Massachusetts into our Texas facility
which currently houses our spine stimulation and U.S. orthopedics
operations. This initiative is part of our effort to increase our
operating efficiency and reduce expenses.
Deleveraging the Balance Sheet
– We continue to focus on reducing the balance on our credit
facility. In 2009, we made principal payments of approximately $28.3
million on our credit facility, of which, $25.0 million were voluntary
prepayments and made in advance of the scheduled maturity date.
The outstanding credit
facility balance was $252.4 million and $280.7 million at December 31, 2009 and
2008, respectively. Our leverage ratio, as defined in the credit
facility was 2.6 at December 31, 2009.
Business
Strategy
Our
business strategy is to offer innovative products to the Spine, Orthopedics,
Sports Medicine, and Vascular market sectors that reduce both patient suffering
and healthcare costs. Our strategy for growth and profitability
includes the following initiatives by market sector:
Spine:
Provide a portfolio of
non-invasive and implantable products that allow physicians to successfully
treat a variety of spinal conditions. Our main tactics and objectives
are:
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Increase
revenues with market penetration of spine
stimulation;
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Continue
new product introductions of spinal implants and biologics with a focus on
building a strong foundation of competitive core fusion products to ensure
that our product portfolio addresses all aspects of spinal fusion therapy
including degenerative disc disease, deformity and tumor/trauma market
segments;
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·
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Improve
gross margins on spinal implants and biologic products with the efficient
use of research and development resources, increasing operating leverage
with original equipment manufacturer (“OEM”) vendors, and the continued
ramp up and introduction of Trinity® Evolution™;
and
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·
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Decrease
sales and marketing and general and administrative expenses with the
previously mentioned consolidation and reorganization
plan.
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Orthopedics:
Provide a
portfolio of non-invasive and implantable products that allow physicians to
successfully treat a variety of Orthopedic conditions ranging from trauma to
deformity correction. Our main tactics and objectives
are:
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·
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Continue
new product introductions;
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Maintain
focus on sales of internal fixation, external fixation along with
deformity correction devices by expanding sales into the U.S., Latin
America, Europe, and Asia;
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Optimize
product offerings within each of our geographic
markets;
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Focus
on sales of long-bone stimulation and biologics in
U.S.;
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Continue
the ramp up and introduction of Trinity® Evolution™;
and
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·
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Decrease
sales and marketing and general and administrative expenses with the
previously mentioned consolidation and reorganization
plan.
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Sports Medicine:
Provide a
portfolio of non-invasive products that allow physicians and clinicians to treat
a variety of Orthopedic conditions in order to minimize pain and restore
mobility to their patients. Our main tactics and objectives
are:
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Leverage
strong distribution channels with well-established distributor
partners;
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·
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Leverage
strong market share in high growth areas such as Osteoarthritis knee
bracing and cold therapy; and
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Launch
innovative products and services into new and existing market
segments.
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Other
Financial and Business Initiatives:
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·
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Reduce
operating losses and improve cash flow at Spinal Implants and
Biologics;
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Continue
deleveraging the balance sheet;
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Continue
to expand applications for our products by utilizing synergies among our
core technologies;
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Continue
to enhance physician relationships through extensive product education and
training programs; and
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·
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Continue
to strengthen contracting and reimbursement
relationships.
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Business
Segments and Market Sectors
Our
business is divided into four reportable segments: Domestic, Spinal
Implants and Biologics, Breg, and International. Domestic consists of
operations of our subsidiary Orthofix Inc., which uses both direct and
distributor sales representatives to sell Spine and Orthopedic products to
hospitals, doctors, and other healthcare providers in the U.S.
market. Spinal Implants and Biologics consists of Blackstone Medical,
Inc., and its two subsidiaries, Blackstone GmbH and Goldstone
GmbH. Spinal Implants and Biologics specializes in the design,
development and marketing of spinal implant and related HCT/P products. Spinal
Implants and Biologics distributes its products through a network of domestic
and international distributors, sales representatives and
affiliates. Breg designs, manufactures, and distributes orthopedic
products for post-operative reconstruction and rehabilitative patient use and
sells those Sports Medicine products through a network of domestic and
international distributors, sales representatives, and
affiliates. International consists of locations in Europe, Mexico,
Brazil, and Puerto Rico, as well as independent distributors outside the
U.S. International uses both direct and distributor sales
representatives to sell Spine, Orthopedics, Sports Medicine, Vascular, and Other
products to hospitals, doctors and other healthcare providers.
Business
Segment:
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Year ended December 31,
(US$ in thousands)
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Percent of Total Net
Sales
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Percent of Total Net
Sales
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Percent of Total Net
Sales
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|
Domestic
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$
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210,703
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38
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%
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$
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188,807
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|
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36
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%
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$
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166,727
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|
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34
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%
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Spinal
Implants and Biologics
|
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118,680
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22
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%
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108,966
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21
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%
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115,914
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24
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%
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Breg
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92,188
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17
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%
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89,478
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17
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%
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83,397
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|
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17
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%
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International
|
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124,064
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23
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%
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132,424
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|
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26
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%
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124,285
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25
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%
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Total
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$
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545,635
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|
|
|
100
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%
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|
$
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519,675
|
|
|
|
100
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%
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$
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490,323
|
|
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|
100
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%
|
Additional
financial information regarding our business segments can be found in Part II,
Item 7 under the heading “Management’s Discussion and Analysis of Financial
Condition and Results of Operations”, as well as in Part II, Item 8 under the
heading “Financial Statements and Supplementary Data”.
We
maintain our books and records by business segment; however, we use market
sectors to describe our business. The Company’s segment information
is prepared on the same basis that the Company’s management reviews the
financial information for operational decision making
purposes. Market sectors, which categorize our revenues by types of
products, describe the nature of our business more clearly than our business
segments.
Our
market sectors are Spine, Orthopedics, Sports Medicine, Vascular, and
Other.
Market
Sector:
|
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Year ended December 31,
(US$ in thousands)
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
Percent of Total Net
Sales
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|
|
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Percent of Total Net
Sales
|
|
|
|
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Percent of Total Net
Sales
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|
Spine
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|
$
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279,425
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|
|
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51
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%
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$
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252,239
|
|
|
|
49
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%
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$
|
243,165
|
|
|
|
49
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%
|
Orthopedics
|
|
|
131,310
|
|
|
|
24
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%
|
|
|
129,106
|
|
|
|
25
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%
|
|
|
111,932
|
|
|
|
23
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%
|
Sports
Medicine
|
|
|
96,366
|
|
|
|
18
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%
|
|
|
94,528
|
|
|
|
18
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%
|
|
|
87,540
|
|
|
|
18
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%
|
Vascular
|
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|
18,710
|
|
|
|
3
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%
|
|
|
17,890
|
|
|
|
3
|
%
|
|
|
19,866
|
|
|
|
4
|
%
|
Other
|
|
|
19,824
|
|
|
|
4
|
%
|
|
|
25,912
|
|
|
|
5
|
%
|
|
|
27,820
|
|
|
|
6
|
%
|
Total
|
|
$
|
545,635
|
|
|
|
100
|
%
|
|
$
|
519,675
|
|
|
|
100
|
%
|
|
$
|
490,323
|
|
|
|
100
|
%
|
Additional
financial information regarding our business segments can be found in Part II,
Item 7 under the heading “Management’s Discussion and Analysis of Financial
Condition and Results of Operations”, as well as in Part II, Item 8 under the
heading “Financial Statements and Supplementary Data”.
Products
Our
revenues are generally derived from the sales of products in four market
sectors, Spine (51%), Orthopedics (24%), Sports Medicine (18%) and Vascular
(3%), which together accounted for 96% of our total net sales in
2009. Sales of Other products, including airway management products
for use during anesthesia, woman’s care and other products, accounted for 4% of
our total net sales in 2009.
The
following table identifies our principal products by trade name and describes
their primary applications:
Product
|
|
Primary Application
|
Spine Products
|
|
|
Cervical-Stim
®
|
|
Pulsed
electromagnetic field (“PEMF”) non-invasive cervical spine bone growth
stimulator
|
|
|
|
Spinal-Stim
®
|
|
PEMF
non-invasive lumbar spine bone growth stimulator
|
|
|
|
Alloquent
®
Allografts
|
|
Interbody
devices made of cortical bone that are designed to restore the space that
has been lost between two or more vertebrae due to a degenerated
disc
|
|
|
|
Trinity
®
Evolution™ Viable Cryopreserved Cellular Bone
Matrix
|
|
An
adult stem cell-based bone growth matrix used during surgery that is
designed to enhance the success of a spinal fusion
procedure
|
|
|
|
3
Degree™ / Reliant™ Anterior Cervical Plating Systems
|
|
Plating
systems implanted during anterior cervical spine fusion
procedures
|
|
|
|
Hallmark
®
Anterior Cervical Plate System
|
|
A
cervical plating system implanted during anterior cervical spine fusion
procedures
|
|
|
|
Ascent
®
LE Posterior Occipital Cervico-Thoracic (“POCT”) System
|
|
A
system of pedicle screws and rods implanted during a posterior spinal
fusion procedure involving the stabilization of several degenerated or
deformed cervical vertebrae
|
|
|
|
NewBridge
®
Laminoplasty Fixation System
|
|
A
device implanted during a posterior surgical procedure designed to expand
the cervical vertebrae and relieve pressure on the spinal
canal
|
|
|
|
Construx
®
Mini Polyetheretherketones (“PEEK”) Vertebral Body Replacement (“VBR”)
System
|
|
Smaller,
unibody versions of the Construx PEEK VBR System, implanted during the
replacement of degenerated or deformed spinal vertebrae
|
|
|
|
Construx
®
PEEK VBR System
|
|
A
modular device implanted during the replacement of degenerated or deformed
spinal vertebrae to provide additional anterior support
|
|
|
|
NGage
®
Surgical Mesh System
|
|
A
modular metallic interbody implant placed between two vertebrae designed
to restore disc space and increase stability that has been lost due to
degeneration or deformity
|
Product
|
|
Primary Application
|
Spine Products (continued)
|
|
|
PILLAR™
PL & TL PEEK VBR System
|
|
Interbody
devices for Posterior Lumbar Interbody Fusion (“PLIF”) and Trans-laminar
Lumbar Interbody Fusion (“TLIF”) procedures
|
|
|
|
PILLAR™
AL PEEK Partial VBR System
|
|
An
intervertebral body fusion device for Anterior Lumbar Interbody Fusion
(“ALIF”) procedures
|
|
|
|
PILLAR™
SA PEEK Spacer System
|
|
An
intervertebral body fusion device that incorporates screw fixation to
optimize implant stability
|
|
|
|
Firebird™
Spinal Fixation System
|
|
A
system of rods, crossbars and modular pedicle screws designed to be
implanted during a minimally invasive posterior lumbar spine fusion
procedure
|
|
|
|
ProView™
Minimal Access Portal (“MAP”) System
|
|
An
instrument system for minimally invasive posterior lumbar spinal fusion,
including tubular and expandable retractors, a percutaneous screw delivery
system and the ONYX™ System for Disc removal and interbody space
preparation
|
|
|
|
Unity
®
Lumbosacral Fixation System
|
|
A
plating system implanted during anterior lumbar spine fusion
procedures
|
|
|
|
Orthopedic Products
|
|
|
Fixation
|
|
External
fixation and internal fixation, including the Sheffield Ring,
limb-lengthening systems, DAF, ProCallus
®
,
XCaliber™, Contours VPS
®
, VeroNail
®
,
Centronail
®
,
PREFIX
TM
,
and Gotfried PC.C.P
®
|
|
|
|
Physio-Stim
®
|
|
PEMF
long bone non-invasive bone growth stimulator
|
|
|
|
Trinity
®
Evolution™ Viable Cryopreserved Cellular Bone
Matrix
|
|
An
adult stem cell-based bone growth matrix used during surgery that is
designed to facilitate bone fusion
|
|
|
|
Eight-Plate
Guided Growth System
®
|
|
Treatment
for the bowed legs or knock knees of children
|
|
|
|
ISKD
®
|
|
Internal
limb-lengthening device
|
|
|
|
Limb
Reconstruction System (“LRS”) and LRS ADVanced
|
|
External
fixation for lengthenings and corrections of deformity
|
|
|
|
TrueLok
TM
|
|
Ring
fixation system for limb lengthening and deformity
correction
|
|
|
|
Origen™
DBM with Bioactive Glass
|
|
A
bone void filler
|
|
|
|
Cemex
®
|
|
Bone
cement
|
|
|
|
OSCAR
|
|
Ultrasonic
bone cement removal
|
Product
|
|
Primary Application
|
Sports Medicine Products
|
|
|
Breg
®
Bracing
|
|
Bracing
products which are designed to provide support and protection of limbs,
extremities and back during healing and rehabilitation
|
|
|
|
Polar
Care
®
and KODIAK
®
|
|
Cold
therapy products that are designed to reduce swelling, pain and accelerate
the rehabilitation process
|
|
|
|
Vision
TM
Inventory Management System
|
|
Web
based inventory system customized to enable efficient management of
orthopedic devices in physician office and remote inventory
locations
|
|
|
|
Vascular Products
|
|
|
A-V
Impulse System
®
|
|
Enhancement
of venous circulation, used principally after orthopedic procedures to
prevent deep vein thrombosis
|
|
|
|
Non-Orthopedic Products
|
|
|
Laryngeal
Mask
|
|
Maintenance
of airway during anesthesia
|
|
|
|
Other
|
|
Several
non-orthopedic products for which various Orthofix subsidiaries hold
distribution rights
|
We have
proprietary rights in all of the above products with the exception of the
Laryngeal Mask, Cemex
®
,
ISKD
®
, and
Eight-Plate Guided Growth System
®
. We
have the exclusive distribution rights for the Cemex
®
in
Italy, for the Laryngeal Mask in the United Kingdom and Ireland through June
2010, and for the ISKD
®
,
Eight-Plate
Guided Growth System
®
and
Contour VPS
®
worldwide.
We have
numerous trademarked products and services including but not limited to the
following: Orthofix
®
,
Blackstone
®
,
Breg
®
,
Spinal-Stim
®
,
Cervical-Stim
®
,
Origen™ DBM, 3 Degree™, Reliant™, Hallmark
®
,
Firebird™, Ascent
®
,
Construx
®
,
Unity
®
,
Ngage
®
,
Newbridge
®
,
Trinity
®
Evolution™, PILLAR™, Alloquent
®
,
ProView™, ProCallus
®
,
XCaliber™, VeroNail
®
,
Centronail
®
,
PREFIX
TM
,
Gotfried PC.C.P
®
,
Physio-Stim
®
,
TrueLok™, Polar Care
®
, and
Fusion
®
.
Spine
Spine
product sales represented 51% of our total net sales in 2009.
Neck and
back pain is a common health problem for many people throughout the world and
often requires surgical or non-surgical intervention for
improvement. Neck and back problems are usually of a degenerative
nature and are generally more prevalent among the older
population. As the population ages, we believe physicians will see an
increasing number of patients with degenerative spine issues who wish to have a
better quality of life than that experienced by previous
generations. Treatment options for spine disorders are expected to
expand to fill the existing gap between conservative pain management and
invasive surgical options, such as spine fusion.
We
believe that our Spine products are positioned to address the needs of spine
patients at many points along the continuum of care, offering non-operative,
pre-operative, operative and post-operative products. Our
products currently address the cervical fusion segment as well as the lumbar
fusion segment which is the largest sub-segment of the spine
market.
Our
Spinal Implants and Biologics division offers a wide array of spinal implants
used during surgical procedures intended to treat a variety of spine
conditions. Many of these surgeries are fusion procedures in the
cervical, thoracic and lumbar spine that utilize Spinal Implants and Biologics’
metal plates, rods and screws, interbody spacers, or vertebral body replacement
devices, and HCT/P, as well as interbody spacers to promote bone
growth.
Additionally,
bone growth stimulators used in spinal applications are designed to enhance the
success rate of certain spinal fusions by stimulating the body’s own natural
healing mechanism post-surgically. These non-invasive portable
devices are intended to be used as part of a home treatment program prescribed
by a physician.
Spinal
Implants
The human
spine is made up of 33 interlocking vertebrae that protect the spinal cord and
provide structural support for the body. The top seven vertebrae make
up the cervical spine, which bears the weight of the skull and provides the
highest range of motion. The next 17 mobile vertebrae encompass the
thoracic and lumbar, or thoracolumbar, sections of the spine. The
thoracic spine (12 vertebrae) helps to protect the organs of the chest cavity by
attaching to the rib cage, and is the least mobile segment of the
spine. The lumbar spine (five vertebrae) carries the greatest portion
of the body’s weight, allowing a degree of flexion, extension and rotation thus
handling the majority of the bending movement. Additionally
five fused vertebrae make up the sacrum (part of the pelvis) and four vertebrae
make up the final part of the spine, the coccyx.
Spinal
bending and rotation are accomplished through the vertebral discs located
between each vertebra. Each disc is made up of a tough fibrous
exterior, called the annulus, which surrounds a soft core called the nucleus.
Excess pressure, deformities, injury or disease can lead to a variety of
conditions affecting the vertebrae and discs that may ultimately require medical
intervention in order to relieve patient pain and restore stability in the
spine.
Spinal
fusion is the permanent union of two or more vertebrae to immobilize and
stabilize the affected portion of the spine. Most fusion surgeries
involve the placement of a bone graft between the affected vertebrae, which is
typically held in place by metal implants that also provide stability to the
spine until the desired growth of new bone can complete the fusion
process. These implants typically consist of some combination of
rods, screws and plates that are designed to remain in the patient even after
the fusion has occurred.
Most
fusion procedures performed on the lumbar area of the spine are done from the
posterior, or back, while the majority of cervical fusions are performed from
the anterior, or front, of the body. However, the growing use of mesh
cages and other interbody devices has resulted in the increasing use of an
anterior, or frontal, approach to many lumbar surgeries. Interbody
devices are small hollow implants typically made of either bone, metal or a
thermoplastic compound called Polyetheretherketones (“PEEK”) that are placed
between the affected vertebrae to restore the space lost by the degenerated
disc. The hollow spaces within these interbody devices are typically
packed with some form of bone grafting material designed to accelerate the
formation of new bone around the graft which ultimately results in the desired
fusion.
Spinal
Implants and Biologics provides a wide array of implants designed for use
primarily in cervical, thoracic and lumbar fusion surgeries. These
implants are made of metal, bone, or PEEK. Additionally, Spinal
Implants and Biologics’ product portfolio includes a unique adult stem
cell-based HCT/P bone grafting product called Trinity
®
Evolution™.
The
majority of implants offered by Spinal Implants and Biologics are made of
titanium metal. This includes the 3 Degree™, Reliant™ and
Hallmark
®
cervical plates. Additionally, the Spinal Fixation System (“SFS”),
the Firebird™ Spinal Fixation Systems, the Ascent
®
and
Ascent® LE POCT Systems are sets of rods, crossbars and screws which are
implanted during posterior fusion procedures. The Firebird™ Modular
and pre-assembled Spinal Fixation System are designed to be used in either open
or minimally-invasive posterior lumbar fusion procedures with Spinal Implants
and Biologics’ ProView™ MAP System. The Company also offers specialty
plates that are used in less common procedures, and as such, are not
manufactured by many device makers. These specialty plates include
the Newbridge
®
Laminoplasty Fixation System that is designed to expand the cervical vertebrae
and relieve pressure on the spinal canal, as well as the Unity
®
plate
which is used in anterior lumbar fusion procedures.
Spinal
Implants and Biologics also offers a variety of devices made of PEEK, including
vertebral body replacements and interbody devices. Vertebral body
replacements are designed to replace a patient’s degenerated or deformed
vertebrae. On the other hand, interbody devices, or cages, are
designed to replace a damaged disc, restoring the space that had been lost
between two vertebrae. Spinal Implants and Biologics also offers the
NGage
®
Surgical Mesh System made of titanium metal.
Spinal
Implants and Biologics is also a distributor of HCT/P products including
interbody implants made of human cadaveric bone that have been harvested from
donors and carved by a machine into a desired shape, and a unique adult stem
cell-based product that is intended to enhance a patient’s ability to quickly
grow new bone around a spinal fusion site. This product contains live
adult stem cells harvested from human cadaveric donors and is intended to be a
safer, simpler alternative to an autograft, which is commonly performed in
connection with a spine fusion procedure. An autograft involves a
separate surgical incision in the patient’s hip area in order to harvest the
patient’s own bone to be used during the fusion procedure. An
autograft procedure adds risk of an additional surgical procedure and related
patient discomfort in conjunction with the spinal fusion.
Spinal
Bone Growth Stimulators
Separate
from Spinal Implants and Biologics, we offer two spinal bone growth stimulation
devices, Spinal-Stim® and Cervical-Stim®, through our subsidiary, Orthofix
Inc. Our stimulation products use a PEMF technology designed to
enhance the growth of bone tissue following surgery and are placed externally
over the site to be healed. Clinical data shows our PEMF signal
enhances the body’s enzyme activities, induces mineralization, encourages new
vascular penetration and results in a process that generates new bone growth at
the spinal fusion site. We have sponsored independent research at the
Cleveland Clinic, where scientists conducted animal and cellular studies to
identify the influence of our PEMF signals on bone cells.
From this effort, a
total of six studies have been published in peer-reviewed
journals. Among other insights, the studies illustrate the positive
effects of PEMF on bone loss, callus formation, and
collagen. Furthermore, we believe that characterization and
visualization of the Orthofix PEMF waveform is paving the way for signal
optimization for a variety of applications and indications.
Spinal-Stim
®
is a
non-invasive spinal fusion stimulator system commercially available in the
U.S. Spinal-Stim
®
is
designed for the treatment of the lower thoracic and lumbar regions of the
spine. Some spine fusion patients are at greater risk of not
generating new bone around the damaged vertebrae after the
operation. These patients typically have one or more risk factors
such as smoking, obesity or diabetes, or their surgery involves the revision of
a previously attempted fusion procedure that failed, or the fusion of multiple
levels of vertebrae in one procedure. For these patients,
post-surgical bone growth stimulation using Spinal-Stim
®
has
been shown to increase the probability of fusion, without the need for
additional surgery. According to internal sales data, more than
288,000 patients have been treated using Spinal-Stim
®
since
the product was introduced in 1990. The device uses proprietary
technology and a wavelength to generate a PEMF signal. Our approval
from the U.S. Food and Drug Administration (“FDA”) to market Spinal-Stim
®
commercially is for both failed fusions and healing enhancement as an adjunct to
initial spinal fusion surgery.
On
December 28, 2004, we received approval from the FDA to market our
Cervical-Stim
®
bone
growth stimulator for use as an adjunct to cervical (upper) spine fusion in
certain high-risk patients.
Orthopedics
Orthopedics
products represented 24% of our total net sales in 2009.
The
medical devices offered in the Company’s Orthopedics market sector are used for
two primary purposes: bone fracture management and bone deformity
correction.
Bone
Fracture Management
Fixation
Our
fracture management products consist of fixation devices designed to stabilize a
broken bone until it can heal, as well as non-invasive post-surgical bone growth
stimulation devices designed to accelerate the body’s formation of new
bone. Our fixation products come in two main types: external devices
and internal devices. With these devices, we can treat both simple
and complex fracture patterns.
External
Fixation
External
fixation devices are used to stabilize fractures from outside the skin with
minimal invasion into the body. These fixation devices use screws
that are inserted into the bone on either side of the fracture site, to which
the fixator body is attached externally. The bone segments are
aligned by manipulating the external device using patented ball joints and, when
aligned, are locked in place for stabilization. We believe that
external fixation allows micromovement at the fracture site, which is beneficial
to the formation of new bone. External fixation may also be used as
temporary devices in complex trauma cases to stabilize the fracture prior to
treating it definitively. We believe that external fixation is among
the most minimally invasive and least complex surgical options for fracture
management.
External
devices are designed in large part to be used for the same types of conditions
that can be treated by internal fixation devices. The difference is
that the external fixator is a monolateral or circular device attached with
screws to the fractured bone from outside the skin of the arm or
leg. The choice of whether to use an internal or external fixation
device is driven in large part by physician preference although it may also be
related to the fracture complexity and anatomical location. Some
patients, however, favor internal fixation devices for aesthetic
reasons.
An
example of one of our external fixation devices is the XCaliber™ fixator, which
is made from a lightweight radiolucent material and provided in three
configurations to cover long bone fractures, fractures near joints and ankle
fractures. The radiolucency of XCaliber™ fixators allows X-rays to
pass through the device and provides the surgeon with improved X-ray
visualization of the fracture and alignment. In addition, these three
configurations cover a broad range of fractures with very little
inventory. The XCaliber™ fixators are provided pre-assembled in
sterile kits to decrease time in the operating room.
Our
proprietary XCaliber™ bone screws are designed to be compatible with our
external fixators and reduce inventory for our customers. Some of
these screws are covered with hydroxyapatite, a mineral component of bone that
reduces superficial inflammation of soft tissue and improves bone
grip. Other screws in this proprietary line do not include the
hydroxyapatite coating, but offer different advantages such as patented thread
designs for better adherence in hard or poor quality bone. We believe
we have a full line of bone screws to meet the demands of the
market.
Another
example of an external fixation device designed for the rapid stabilization of
complex fractures is PREFIX
TM
. PREFIX
TM
offers free pin placement in any desired plane to rapidly create a solid
stabilization using radiolucent components. We believe the
PREFIX
TM
fixator provides the necessary temporary stabilization to allow the surgeon to
reduce the fracture, move the patient or attend to more urgent
matters.
Internal
Fixation
Internal
fixation devices come in various sizes, depending on the bone which requires
treatment, and consist of either long rods, commonly referred to as nails, or
plates that are attached with the use of screws. A nail is inserted
into the medullary canal of a fractured long bone of the human arms and legs,
i.e., humerus, femur and tibia. Alternatively, a plate is attached by
screws to an area such as a broken wrist or hip. Examples of our
internal fixation devices include:
|
·
|
The
Centronail
®
is a new nailing system designed to stabilize fractures in the femur,
tibia, supracondylar and humerus. We believe that it has all
the attributes of the Orthofix Nailing System but has additional
advantages: it is made of titanium, has improved mechanical distal
targeting and instrumentation and a design which requires significantly
reduced inventory.
|
|
·
|
The
VeroNail
®
marks Orthofix’s entry into the intramedullary hip nailing
market. For use in hip fractures, it provides a
minimally-invasive screw and nail design intended to reduce surgical
trauma and allow patients to begin walking again shortly after the
operation. It uses a dual screw configuration that we believe
provides more stability than previous single screw
designs.
|
|
·
|
The
Gotfried Percutaneous Compression Plating or Gotfried PC.C.P
®
System is a method of stabilization and fixation for hip-fracture surgery
developed by Y. Gotfried, M.D. that we believe is minimally
invasive. Traditional hip-fracture surgery can require a
5-inch-long incision down the thigh, but the Gotfried PC.C.P
®
System involves two smaller incisions, each less than one inch
long. The Gotfried PC.C.P
®
System then allows a surgeon to work around most muscles and tendons
rather than cutting through them. We believe that major
benefits of this new approach to hip-fracture surgery include (1) a
significant reduction of complications due to a less traumatic operative
procedure; (2) reduced blood loss and less pain (important benefits for
the typically fragile and usually elderly patient population, who often
have other medical problems); (3) faster recovery, with patients often
being able to bear weight a few days after the operation; and (4) improved
post-operative results.
|
Bone
Growth Stimulation
Our
Physio-Stim
®
bone
growth stimulator products use PEMF technology similar to that described
previously in the discussion of our spine stimulators. The primary
difference is that the Physio-Stim
®
physical configuration is designed for use on bones found in areas other than
the spine.
A bone’s
regenerative power results in most fractures healing naturally within a few
months. In certain situations, however, fractures do not heal or heal
slowly, resulting in “non-unions.” Traditionally, orthopedists have
treated such fracture conditions surgically, often by means of a bone graft with
fracture fixation devices, such as bone plates, screws or intramedullary
rods. These are examples of “invasive” treatments. Our
patented bone growth stimulators are designed to use a low level of PEMF signals
to activate the body’s natural healing process. The stimulation
products that we currently market are external and apply bone growth stimulation
without implantation or other surgical procedures.
Our
systems offer portability, rechargeable battery operation, integrated component
design, patient monitoring capabilities and the ability to cover a large
treatment area without factory calibration for specific patient
application. According to internal sales data, more than 159,000
patients have been treated using Physio-Stim
®
for
long bone non-unions since the product was introduced.
Bone
Deformity Correction
In
addition to the treatment of bone fractures, we also design, manufacture and
distribute devices that are intended to treat congenital bone conditions, such
as limb length discrepancies, angular deformities (e.g., bowed legs in
children), or degenerative diseases, as well as conditions resulting from a
previous trauma. Examples of products offered in these areas include
the Eight-Plate Guided Growth System
®
, the
Intramedullary Skeletal Kinetic Distractor, or ISKD
®
, the
Limb Reconstruction System (“LRS”) and TrueLoK™ Ring Fixation
System.
The
ISKD
®
system is a patented, internal limb-lengthening device that uses a magnetic
sensor to monitor limb-lengthening progress on a daily
basis. ISKD
®
is an
expandable tubular device that is completely implanted inside the bone to be
lengthened. The ISKD® system is designed to lengthen the patient’s
bone gradually, and, after lengthening is completed, stabilize the lengthened
bone. ISKD
®
is an
FDA-approved intramedullary bone lengthener on the market, and we have the
exclusive worldwide distribution rights for this product.
LRS uses
callus distraction to lengthen bone in a variety of procedures. It
can be used in monofocal lengthenings and corrections of
deformity. Its multifocal procedures include bone transport,
simultaneous compression and distraction at different sites, bifocal lengthening
and correction of deformities with shortening. In 2009, recent
improvements on size, flexibility and ease of use were implemented for the
release of the LRS ADVanced.
The TrueLoK
TM
Ring Fixation System is a
surgeon-designed, lightweight external fixation system for limb lengthening and
deformity correction. Created with pre-assembled function blocks, we
believe TrueLoK
TM
is a simple, stable, versatile ring
fixation system superior to the traditional Ilizarov ring
system.
Sports
Medicine
Sports
Medicine product sales represented 18% of our total net sales in
2009.
We
believe Breg Inc., one of Orthofix’s wholly-owned subsidiaries, is a market
leader in the sale of orthopedic post-operative reconstruction and
rehabilitative products to hospitals and orthopedic offices. Breg’s
products are grouped primarily into two product categories: Breg
®
Bracing and Polar Care
®
.
Approximately 64% of
Breg’s net revenues were attributable to the sale of bracing products in 2009,
including: (1) functional braces for treatment and prevention of ligament
injuries, (2) load-shifting braces for osteoarthritic pain management, (3)
post-operative braces for protecting surgical repair and (4) foot and ankle
supports that provide an alternative to casting. Approximately 34% of
Breg’s 2009 net revenues came from the sale of cold therapy products used to
minimize the pain and swelling following knee, shoulder, elbow, ankle and back
injuries or surgery. Approximately 2% of Breg’s 2009 net revenues
came from the sale of other rehabilitative products. Breg sells its
products through a network of domestic and international independent
distributors, 15 employee sales representatives and related international
subsidiaries.
Breg
®
Bracing
We
design, manufacture and market a broad range of rigid knee bracing products,
including ligament braces, post-operative braces and osteoarthritic
braces. The rigid knee brace products are either customized braces or
standard adjustable off-the-shelf braces.
Ligament
braces are designed to provide durable support for moderate to severe knee
ligament instabilities and help stabilize the joint so that patients may
successfully complete rehabilitation and resume their daily
activities. The product line includes premium custom braces and
off-the-shelf braces designed for use in all activities. Select
premium ligament braces are also available with a patellofemoral option to
address tracking and subsequent pain of the patellofemoral joint. We
market the ligament product line under the Fusion
®
and
X2K
®
brand
names.
Post-operative
braces are designed to limit a patient’s range of motion after knee surgery and
protect the repaired ligaments and/or joints from stress and
strain. These braces are designed to promote a faster and healthier
healing process. The products within this line provide both
immobilization and/or a protected range of motion. The Breg
post-operative family of braces, featuring the patented Quick-Set hinge, offers
complete range of motion control for both flexion and extension, along with a
simple-to-use drop lock mechanism to lock the patient in full
extension. The release lock mechanism allows for easy conversion to
full range of motion. The straps, integrated through hinge bars,
offer greater support and stability. This hinge bar can be “broken
down” to accommodate later stages of rehabilitation. The Breg
T-Scope
®
is a
premium brace in the post-operative bracing market and has every feature
available offered in our post-operative knee braces, including telescoping bars,
easy application, full range of motion and a drop lock feature.
Osteoarthritic
braces are used to treat patients suffering from osteoarthritis of the
knee. Osteoarthritis (“OA”) is a form of damage to, or degeneration
of, the articular surface of a joint. This line of custom and
off-the-shelf braces is designed to shift the load going through the knee,
provide additional stability and reduce pain. In some cases, this
type of brace may serve as a cost-efficient alternative to total knee
replacement. Breg’s single upright Solus® and lateral offloader which
are based on Fusion® technology, are our newest bracing designs delivering
optimal comfort and pain relief for patients suffering from OA.
Polar Care
®
We
manufacture, market and sell a cold therapy product line, Polar Care
®
. Breg
entered the market for cold therapy products in 1991 when it introduced the
Polar Care
®
500,
a cold therapy device used to reduce swelling, minimize the need for
post-operative pain medications and generally accelerate the rehabilitation
process. Breg’s leading cold therapy offering is the KODIAK® cold
therapy system which uses Intelliflow® technology to customize treatment for
various clinical applications. Today, we believe that cold therapy is
a standard of care with physicians despite limited historical reimbursement by
insurance companies over the years.
The Polar Care
®
product uses a circulation system
designed to provide constant fluid flow rates to ensure safe and effective
treatment. The product consists of a cooler filled with ice and cold
water connected to a pad, which is applied to the affected area of the body; the
device flows cold water through the pad to provide continuous cold therapy for
the relief of pain. Breg’s cold therapy line consists of the Polar
Care
®
500, Kodiak
®
, Polar Care
®
300, Polar Cub and cold gel
packs.
Vascular
Vascular
product sales represented 3% of our total net sales in 2009.
Our
non-invasive post-surgical vascular therapy product, called the A-V Impulse
System
®
, is
primarily used on patients following orthopedic joint replacement procedures. It
is designed to reduce dangerous deep vein thrombosis, or blood clots, and
post-surgery pain and swelling by improving venous blood return and improving
arterial blood flow. For patients who cannot walk or are immobilized,
we believe that this product simulates the effect that would occur naturally
during normal walking or hand flexion with a mechanical method and without the
side effects and complications of medication.
The A-V
Impulse System
®
consists of an electronic controller attached to a special inflatable slipper or
glove, or to an inflatable bladder within a cast, which promotes the return of
blood to the veins and the inflow of blood to arteries in the patient’s arms and
legs. The device operates by intermittently impulsing veins in the
foot, calf or hand, as would occur naturally during normal walking or hand
clenching. The A-V Impulse System
®
is
distributed in the U.S. by Covidien plc. Outside the U.S., the A-V
Impulse System
®
is
sold directly by our distribution subsidiaries in the United Kingdom, Italy and
through selected distributors in the rest of the world.
Other
Products
Other
product sales represented 4% of our total net sales in 2009.
Laryngeal
Mask
The
Laryngeal Mask, a product of The Laryngeal Mask Company Limited, is an
anesthesia medical device designed to establish and maintain the patient’s
airway during an operation. We have exclusive distribution rights for
the Laryngeal Mask in the United Kingdom and Ireland through June
2010.
Other
We hold
distribution rights for several other non-orthopedic products at our
subsidiaries.
Product
Development
Our
research and development departments are responsible for new product
development. We work regularly with certain institutions referred to
below as well as with physicians and other consultants on the long-term
scientific planning and evolution of our research and development
efforts. Our primary research and development facilities are located
in Wayne, New Jersey; Verona, Italy; McKinney, Texas; Vista, California; and
Andover, United Kingdom.
We
maintain interactive relationships with spine and orthopedic centers in the
U.S., Europe, Japan and South and Central America, including research and
development centers such as the Musculoskeletal Transplant Foundation (“MTF”),
the Orthopedic Research and Education Foundation, The University of Medicine and
Dentistry of New Jersey, the National Osteoporosis Institute, the Cleveland
Clinic Foundation, Rutgers University and the University of Verona in
Italy. Several of the products that we market have been developed
through these collaborations. In addition, we regularly receive
suggestions for new products from the scientific and medical community, some of
which result in Orthofix entering into assignment or license agreements with
physicians and third-parties. We also receive a substantial number of
requests for the production of customized items, some of which have resulted in
new products. We believe that our policy of accommodating such
requests enhances our reputation in the medical community.
In 2009,
2008, and 2007 we spent $31.5 million, $30.8 million and $24.2 million,
respectively, on research and development
.
Patents,
Trade Secrets, Assignments and Licenses
We rely
on a combination of patents, trade secrets, assignment and license agreements as
well as non-disclosure agreements to protect our proprietary intellectual
property. We own numerous U.S. and foreign patents and have numerous
pending patent applications and license rights under patents held by third
parties. Our primary products are patented in major markets in which
they are sold. There can be no assurance that pending patent
applications will result in issued patents, that patents issued or assigned to
or licensed by us will not be challenged or circumvented by competitors or that
such patents will be found to be valid or sufficiently broad to protect our
technology or to provide us with any competitive advantage or
protection. Third parties might also obtain patents that would
require assignments to or licensing by us for the conduct of our
business. We rely on confidentiality agreements with key employees,
consultants and other parties to protect, in part, trade secrets and other
proprietary technology.
We obtain
assignments or licenses of varying durations for certain of our products from
third parties. We typically acquire rights under such assignments or
licenses in exchange for lump-sum payments or arrangements under which we pay to
the licensor a percentage of sales. However, while assignments or
licenses to us generally are irrevocable, there is no assurance that these
arrangements will continue to be made available to us on terms that are
acceptable to us, or at all. The terms of our license and assignment
agreements vary in length from a specified number of years to the life of
product patents or the economic life of the product. These agreements
generally provide for royalty payments and termination rights in the event of a
material breach.
Corporate
Compliance and Government Regulation
Corporate
Compliance and Ethics Program
The
Company began implementation of its enhanced compliance program, which it
branded the
Integrity
Advantage™
Program
,
in February 2008 at its
Spinal Implants and Biologics division. In June 2008, the Company
hired a Chief Compliance Officer to oversee implementation of the
Integrity Advantage™
Program
throughout the Company. It is a fundamental policy of the Company to
conduct business in accordance with the highest ethical and legal
standards.
Our
corporate compliance and ethics program is designed to promote legal compliance
and ethical business practices throughout the Company’s domestic and
international businesses.
The
Company's
Integrity
Advantage™
Program is designed to meet U.S. Sentencing Commission
Guidelines for effective organizational compliance and ethics programs and to
prevent and detect violations of applicable federal, state and local
laws. Key elements of the
Integrity Advantage™
Program
include:
|
·
|
Organizational
oversight by senior-level personnel responsible for the compliance
function within the Company;
|
|
·
|
Written
standards and procedures, including a Corporate Code of Business
Conduct;
|
|
·
|
Methods
for communicating compliance concerns, including anonymous reporting
mechanisms;
|
|
·
|
Investigation
and remediation measures to ensure prompt response to reported matters and
timely corrective action;
|
|
·
|
Compliance
education and training for employees and
agents;
|
|
·
|
Auditing
and monitoring controls to promote compliance with applicable laws and
assess program effectiveness;
|
|
·
|
Disciplinary
guidelines to enforce compliance and address
violations;
|
|
·
|
Exclusion
Lists screening of employees, agents and distributors;
and
|
|
·
|
Risk
assessment to identify areas of regulatory compliance
risk.
|
Government
Regulation
Our
research, development and clinical programs, as well as our manufacturing and
marketing operations, are subject to extensive regulation in the U.S. and other
countries. Most notably, all of our products sold in the U.S. are subject to the
Federal Food, Drug, and Cosmetic Act (the “FDCA”) as implemented and enforced by
the U.S. Food and Drug Administration (the “FDA”). The regulations
that cover our products and facilities vary widely from country to
country. The amount of time required to obtain approvals or
clearances from regulatory authorities also differs from country to
country.
Unless an
exemption applies, each medical device that we wish to commercially distribute
in the U.S. will require either premarket notification (“510(k)”) clearance or
approval of a premarket approval application (“PMA”) from the
FDA. The FDA classifies medical devices into one of three
classes. Devices deemed to pose lower risks are placed in either
class I or II, which typically requires the manufacturer to submit to the FDA a
premarket notification requesting permission to commercially distribute the
device. This process is generally known as 510(k)
clearance. Some low risk devices are exempted from this
requirement. Devices deemed by the FDA to pose the greatest risks,
such as life-sustaining, life-supporting or implantable devices, or devices
deemed not substantially equivalent to a previously cleared 510(k) device, are
placed in class III, requiring approval of a PMA.
Manufacturers
of most class II medical devices are required to obtain 510(k) clearance prior
to marketing their devices. To obtain 510(k) clearance, a company
must submit a premarket notification demonstrating that the proposed device is
“substantially equivalent” in intended use and in technological and performance
characteristics to another legally marketed 510(k)-cleared “predicate
device.” By regulation, the FDA is required to clear or deny a 510(k)
premarket notification within 90 days of submission of the application. As a
practical matter, clearance may take longer. The FDA may require
further information, including clinical data, to make a determination regarding
substantial equivalence. After a device receives 510(k) clearance,
any modification that could significantly affect its safety or effectiveness, or
that would constitute a major change in its intended use, requires a new 510(k)
clearance or could require a PMA approval. With certain
exceptions, most of our products are subject to the 510(k) clearance
process. On January 27, 2010, the FDA announced that it is requesting
comments on actions that the FDA’s Center for Devices and Radiological Health
(“CDRH”) can consider taking to strengthen the 510(k) review process conducted
by the CDRH.
Class III
medical devices are required to undergo the PMA approval process in which the
manufacturer must establish the safety and effectiveness of the device to the
FDA’s satisfaction. A PMA application must provide extensive
preclinical and clinical trial data and also information about the device and
its components regarding, among other things, device design, manufacturing and
labeling. Also during the review period, an advisory panel of experts
from outside the FDA may be convened to review and evaluate the application and
provide recommendations to the FDA as to the approvability of the
device. In addition, the FDA will typically conduct a preapproval
inspection of the manufacturing facility to ensure compliance with quality
system regulations. By statute, the FDA has 180 days to review the
PMA application, although, generally, review of the application can take between
one and three years, or longer. Once approved, a new PMA or a PMA
Supplement is required for modifications that affect the safety or effectiveness
of the device, including, for example, certain types of modifications to the
device's indication for use, manufacturing process, labeling and
design. Our bone growth stimulation products are classified as Class
III by the FDA, and have been approved for commercial distribution in the U.S.
through the PMA process. We also have under development an artificial
cervical disk product which is currently classified as FDA Class
III. Under such a classification, in order for the product to be
approved for commercial distribution in the U.S., compliance with the FDA PMA
approval process, including a human clinical trial, will be
required. We also have under development other products designed to
treat degenerative spinal disc disease but which allow greater post-surgical
mobility than standard surgical approaches involving spinal fusion
techniques. If certain of these products are classified as FDA Class
III, in order for them to be approved for commercial distribution in the U.S.,
compliance with the FDA PMA approval process, including a human clinical trial,
will be required.
In
addition, our Spinal Implants and Biologics division is a distributor of a
product for bone repair and reconstruction under the brand name Trinity
®
Evolution™ Viable Cryopreserved Cellular Bone Matrix which is an allogeneic,
cancellous, bone matrix containing viable stem cells. We believe that
Trinity
®
Evolution™ is properly classified under FDA’s Human Cell, Tissues and
Cellular and Tissue-Based Products, or HCT/P, regulatory paradigm and not as a
medical device or as a biologic or as a drug. We believe it is
regulated under Section 361 of the Public Health Service Act and C.F.R. Part
1271. Spinal Implants and Biologics also distributes certain surgical
implant products known as “allograft” products which are derived from human
tissues and which are used for bone reconstruction or repair and are surgically
implanted into the human body. We believe that these products are
properly classified by the FDA as minimally-manipulated tissue and are covered
by FDA’s “Good Tissues Practices” regulations, which cover all stages of
allograft processing. There can be no assurance that our suppliers of
the Trinity
®
Evolution™ and allograft products will continue to meet applicable regulatory
requirements or that those requirements will not be changed in ways that could
adversely affect our business. Further, there can be no assurance
that these products will continue to be made available to us or that applicable
regulatory standards will be met or remain unchanged. Moreover,
products derived from human tissue or bone are from time to time subject to
recall for certain administrative or safety reasons and we may be affected by
one or more such recalls. For a description of these risks, see Item
1A “Risk Factors.”
The
medical devices that we develop, manufacture, distribute and market are subject
to rigorous regulation by the FDA and numerous other federal, state and foreign
governmental authorities. The process of obtaining FDA clearance and
other regulatory approvals to develop and market a medical device, particularly
from the FDA, can be costly and time-consuming, and there can be no assurance
that such approvals will be granted on a timely basis, if at
all. While we believe that we have obtained all necessary clearances
and approvals for the manufacture and sale of our products and that they are in
material compliance with applicable FDA and other material regulatory
requirements, there can be no assurance that we will be able to continue such
compliance. After a device is placed on the market, numerous
regulatory requirements continue to apply. Those regulatory
requirements include: product listing and establishment registration; Quality
System Regulation (“QSR”) which require manufacturers, including third-party
manufacturers, to follow stringent design, testing, control, documentation and
other quality assurance procedures during all aspects of the manufacturing
process; labeling regulations and FDA prohibitions against the promotion of
products for uncleared, unapproved or off-label uses or indications; clearance
of product modifications that could significantly affect safety or efficacy or
that would constitute a major change in intended use of one of our cleared
devices; approval of product modifications that affect the safety or
effectiveness of one of our PMA approved devices; Medical Device Reporting
regulations, which require that manufacturers report to FDA if their device may
have caused or contributed to a death or serious injury, or has malfunctioned in
a way that would likely cause or contribute to a death or serious injury if the
malfunction of the device or a similar device were to recur; post-approval
restrictions or conditions, including post-approval study commitments;
post-market surveillance regulations, which apply when necessary to protect the
public health or to provide additional safety and effectiveness data for the
device; the FDA's recall authority, whereby it can ask, or under certain
conditions order, device manufacturers to recall from the market a product that
is in violation of governing laws and regulations; regulations pertaining to
voluntary recalls; and notices of corrections or removals.
We and
certain of our suppliers also are subject to announced and unannounced
inspections by the FDA to determine our compliance with FDA’s QSR and other
regulations. If the FDA were to find that we or certain of our
suppliers have failed to comply with applicable regulations, the agency could
institute a wide variety of enforcement actions, ranging from a public warning
letter to more severe sanctions such as: fines and civil penalties against us,
our officers, our employees or our suppliers; unanticipated expenditures to
address or defend such actions; delays in clearing or approving, or refusal to
clear or approve, our products; withdrawal or suspension of approval of our
products or those of our third-party suppliers by the FDA or other regulatory
bodies; product recall or seizure; interruption of production; operating
restrictions; injunctions; and criminal prosecution. The FDA also has
the authority to request repair, replacement or refund of the cost of any
medical device manufactured or distributed by us. Any of those
actions could have a material adverse effect on our development of new
laboratory tests, business strategy, financial condition and results of
operations.
Moreover,
governmental authorities outside the U.S. have become increasingly stringent in
their regulation of medical devices, and our products may become subject to more
rigorous regulation by non-U.S. governmental authorities in the
future. U.S. or non-U.S. government regulations may be imposed in the
future that may have a material adverse effect on our business and
operations. The European Commission (‘EC”) has harmonized national
regulations for the control of medical devices through European Medical Device
Directives with which manufacturers must comply. Under these new
regulations, manufacturing plants must have received CE certification from a
“notified body” in order to be able to sell products within the member states of
the European Union. Certification allows manufacturers to stamp the
products of certified plants with a “CE” mark. Products covered by
the EC regulations that do not bear the CE mark cannot be sold or distributed
within the European Union. We have received certification for all
currently existing manufacturing facilities and products.
Our
products may be reimbursed by third-party payors, such as government programs,
including Medicare, Medicaid, and Tricare or private insurance plans and
healthcare networks. Third-party payors may deny reimbursement if they determine
that a device provided to a patient or used in a procedure does not meet
applicable payment criteria or if the policy holder’s healthcare insurance
benefits are limited. Also, third-party payors are increasingly
challenging the prices charged for medical products and services. The
Medicare program is expected to continue to implement a new payment mechanism
for certain items of durable medical equipment, prosthetic, orthotic supplies
(“DMEPOS”) via the implementation of its competitive bidding
program. The initial implementation was terminated shortly after it
began in 2008 and the Centers for Medicare and Medicaid Services (“CMS”) are
required to and did start the rebid process in 2009 (“Round 1
Rebid”). Payment rates for certain DMEPOS items included in the Round
1 Rebid product categories, which categories do not currently include our
products, will be determined based on bid prices rather than the current
Medicare DMEPOS fee schedule.
Orthofix
Inc., a subsidiary of the Company, received accreditation status by the
Accreditation Commission for Health Care, Inc. (“ACHC”) for the services of
DMEPOS. ACHC, a private, not-for-profit corporation, which is
certified to ISO 9001:2000 standards, was developed by home care and
community-based providers to help companies improve business operations and
quality of patient care. Although accreditation is generally a
voluntary activity where healthcare organizations submit to peer review their
internal policies, processes and patient care delivery against national
standards, CMS required DMEPOS suppliers to become accredited. By
attaining accreditation, Orthofix Inc. has demonstrated its commitment to
maintain a higher level of competency and strive for excellence in its products,
services, and customer satisfaction.
Our sales
and marketing practices are also subject to a number of U.S. laws regulating
healthcare fraud and abuse such as the federal Anti-Kickback Statute and the
federal Physician Self-Referral Law (known as the “Stark Law”), the Civil False
Claims Act and the Health Insurance Portability and Accountability Act of 1996
(“HIPAA”) as well as numerous state laws regulating healthcare and
insurance. These laws are enforced by the Office of Inspector General
within the U.S. Department of Health and Human Services, the U.S. Department
of
Justice, and other
federal, state and local agencies. Among other things, these laws and
others generally: (1) prohibit the provision of anything of value in exchange
for the referral of patients for, or the purchase, order, or recommendation of,
any item or service reimbursed by a federal healthcare program, (including
Medicare and Medicaid); (2) require that claims for payment submitted to federal
healthcare programs be truthful; (3) prohibit the transmission of protected
healthcare information to persons not authorized to receive that information;
and (4) require the maintenance of certain government licenses and
permits.
In
addition, U.S. federal and state laws protect the confidentiality of certain
health information, in particular individually identifiable information such as
medical records and restrict the use and disclosure of that protected
information. At the federal level, the Department of Health and Human
Services promulgated health information privacy and security rules under
HIPAA. These rules protect health information by regulating its use
and disclosure, including for research and other purposes. Failure of
a HIPAA “covered entity” to comply with HIPAA regarding such “protected health
information” could constitute a violation of federal law, subject to civil and
criminal penalties. Covered entities include healthcare providers
(including those that sell devices or equipment) that engage in particular
electronic transactions, including, as we do, the transmission of claims to
health plans. Consequently, health information that we access,
collect, analyze, and otherwise use and/or disclose includes protected health
information that is subject to HIPAA.
As noted above, many
state laws also pertain to the confidentiality of health
information. Such laws are not necessarily preempted by HIPAA, in
particular those state laws that afford greater privacy protection to the
individual than HIPAA. These state laws typically have their own
penalty provisions, which could be applied in the event of an unlawful action
affecting health information.
Sales,
Marketing and Distribution
General
Trends
We
believe that demographic trends, principally in the form of a better informed,
more active and aging population in the major healthcare markets of the U.S.,
Western Europe and Japan, together with opportunities in emerging markets such
as the Asia-Pacific Region (including China) and Latin America, as well as our
focus on innovative products, will continue to have a positive effect on the
demand for our products.
Primary
Markets
In 2009,
Domestic accounted for 38% of total net sales, Spinal Implants and Biologics
accounted for 22% of total net sales, Breg accounted for 17% of total net sales,
and International accounted for 23% of total net sales. No single
non-governmental customer accounted for greater than 5% of total net
sales. Sales to customers were broadly distributed.
Our
products sold in the U.S. are either prescribed by medical professionals for the
care of their patients or selected by physicians, sold to hospitals, clinics,
surgery centers, independent distributors or other healthcare providers, all of
whom may be primarily reimbursed for the healthcare products provided to
patients by third-party payors, such as government programs, including Medicare
and Medicaid, private insurance plans and managed care programs. Our
products are also sold in many other countries, such as the United Kingdom,
France and Italy, which have publicly funded healthcare systems as well as
private insurance plans. See Item 1A “Risk Factors”, page 28 for a
table of estimated revenue by payor type. For additional information
about geographic areas, see Item 8 “Financial Statements and Supplementary
Data.”
Sales,
Marketing and Distributor Network
We have
established a broad distribution network comprised of direct sales
representatives and distributors. This established distribution
network provides us with a platform to introduce new products and expand sales
of existing products. We distribute our products through a sales and
marketing force of approximately 633
sales and marketing
representatives. Worldwide we also have approximately 274 independent
distributors for our products in approximately 63 countries. The
table below highlights the makeup of our sales, marketing and distribution
network at December 31, 2009.
|
|
Direct Sales
& Marketing
Headcount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
|
340
|
|
|
|
-
|
|
|
|
340
|
|
|
|
37
|
|
|
|
1
|
|
|
|
38
|
|
Spinal
Implants and Biologics
|
|
|
35
|
|
|
|
4
|
|
|
|
39
|
|
|
|
49
|
|
|
|
33
|
|
|
|
82
|
|
Breg
|
|
|
90
|
|
|
|
1
|
|
|
|
91
|
|
|
|
33
|
|
|
|
48
|
|
|
|
81
|
|
International
|
|
|
6
|
|
|
|
157
|
|
|
|
163
|
|
|
|
2
|
|
|
|
71
|
|
|
|
73
|
|
Total
|
|
|
471
|
|
|
|
162
|
|
|
|
633
|
|
|
|
121
|
|
|
|
153
|
|
|
|
274
|
|
In our
largest market, the U.S., our sales, marketing and distribution network is
separated between several distinct sales forces addressing different market
sectors. The Spine market sector is addressed primarily by a direct
sales force for spinal bone growth stimulation products and HCT/P products and a
distribution network for spinal implant products. The Orthopedic
market sector is addressed by a hybrid distribution network of predominately
direct sales supplemented by distributors. The Sports Medicine market
sector is addressed primarily by a distribution network for Breg
products.
Outside
the U.S., we employ both direct sales representatives and distributors within
our international sales subsidiaries. We also utilize independent
distributors in Europe, the Far East, the Middle East and Central and South
America in countries where we do not have subsidiaries. In order to
provide support to our independent distribution network, we have a group of
sales and marketing specialists who regularly visit independent distributors to
provide training and product support.
Marketing
and Product Education
We seek
to market our products principally to medical professionals and group purchasing
organizations (“GPOs”)
,
which are hospital organizations that buy on a large scale. We
believe there is a developing focus on selling to GPOs and large national
accounts that reflects a trend toward large scale procurement efforts in the
healthcare industry.
We
support our sales force and distributors through specialized training workshops
in which surgeons and sales specialists participate. We also produce
marketing materials, including materials outlining surgical procedures, for our
sales force and distributors in a variety of languages using printed, video and
multimedia formats. To provide additional advanced training for
surgeons, we organize monthly
,
multilingual
,
teaching seminars at our
facility in Verona, Italy, and in various locations in the U.S. and Latin
America. The Verona and U.S. product education seminars, which in
2009 were attended by over 800 surgeons and over 300 distributor representatives
and sales representatives from around the world, include a variety of lectures
from specialists as well as demonstrations and hands-on
workshops. Each year many of our sales representatives and
distributors independently conduct basic courses in product application for
local surgeons. We also provide sales training at our training
centers in McKinney, Texas, our Breg training center in Vista, California, and
in regional locations throughout the world. Additionally, we have
implemented a web-based sales training program, which provides ongoing education
for our sales representatives.
Competition
Our bone
growth stimulation products compete principally with similar products marketed
by Biomet Spine a business unit of Biomet, Inc, DJO Incorporated, and Exogen,
Inc., a subsidiary of Smith & Nephew plc. Our spinal implant and
HCT/P products, and Trinity
®
Evolution™, an HCT/P product from which we derive marketing fees, compete with
products marketed by Medtronic, Inc., De Puy, a division of Johnson and Johnson,
Synthes AG, Stryker Corp., Zimmer, Inc., Nuvasive, Biomet Spine and various
smaller public and private companies. For external and internal
fixation devices, our principal competitors include Synthes AG, Zimmer, Inc.,
Stryker Corp., Smith & Nephew plc and Biomet Orthopedics, a business unit of
Biomet, Inc. The principal non-pharmacological products competing
with our A-V Impulse System
®
are
manufactured by Huntleigh Technology PLC and Kinetic Concepts,
Inc. The principal competitors for the Breg bracing and cold therapy
products include DJO Incorporated, Biomet, Inc., Ossur Lf. and various smaller
private companies.
We
believe that we enhance our competitive position by focusing on product features
such as innovation, ease of use, versatility, cost and patient
acceptability. We attempt to avoid competing based solely on
price. Overall cost and medical effectiveness, innovation,
reliability, after-sales service and training are the most prevalent methods of
competition in the markets for our products, and we believe that we compete
effectively.
Manufacturing
and Sources of Supply
We
generally design, develop, assemble, test and package our stimulation and
orthopedic products, and subcontract the manufacture of a substantial portion of
the component parts. We design and develop our spinal implant and
Alloquent
®
Allograft HCT/P products but subcontract their manufacture and
packaging. Through subcontracting, we attempt to maintain operating
flexibility in meeting demand while focusing our resources on product
development, education and marketing as well as quality assurance
standards. In addition to designing, developing, assembling, testing
and packaging its products, Breg also manufactures a substantial portion of the
component parts used in its products. Although certain of our key raw
materials are obtained from a single source, we believe that alternate sources
for these materials are available. Further, we believe that an
adequate inventory supply is maintained to avoid product flow
interruptions. We have not experienced difficulty in obtaining the
materials necessary to meet our production schedules.
Trinity
®
Evolution™, an HCT/P product for which we have exclusive marketing rights, is an
allograft tissue form that is supplied to customers by MTF in accordance with
orders received directly from customers and from the Company. MTF
sources, processes and packages the tissue form and is the sole supplier of
Trinity
®
Evolution™ to our customers.
Our
products are currently manufactured and assembled in the U.S., Italy, the United
Kingdom, and Mexico. We believe that our plants comply in all
material respects with the requirements of the FDA and all relevant regulatory
authorities outside the United States. For a description of the laws
to which we are subject, see Item 1 – “Business – Corporate Compliance and
Government Regulation.” We actively monitor each of our
subcontractors in order to maintain manufacturing and quality standards and
product specification conformity.
Our
business is generally not seasonal in nature. However, sales
associated with products for elective procedures appear to be influenced by the
somewhat lower level of such procedures performed in the late
summer. Certain of the Breg
®
bracing products experience greater demand in the fall and winter corresponding
with high school and college football schedules and winter sports. In
addition, we do not consider the backlog of firm orders to be
material.
Capital
Expenditures
We had
tangible and intangible capital expenditures in the amount of $22.0 million,
$20.2 million and $27.2 million in 2009, 2008 and 2007, respectively,
principally for computer software and hardware, patents, licenses, plant and
equipment, tooling and molds and product instrument sets. In 2009, we
invested $22.0 million in capital expenditures of which (1) $8.1 million related
to Spinal Implants and Biologics’ instrumentation for the new Firebird™ Spinal
Fixation Systems and other systems introduced in 2009; (2) $5.9 million related
to new software applications and computer licensing within our Domestic and
International segments; and (3) $1.1 million related to the initial construction
phase of our new facility in Lewisville, TX. We currently plan to
invest approximately $29.6 million in capital expenditures during 2010 to
support the planned expansion of our business. We expect these
capital expenditures to be financed principally with cash generated from
operations.
Employees
At
December 31, 2009, we had 1,484 employees worldwide. Of these, 541
were employed at Domestic, 87 were employed at Spinal Implants and Biologics,
500 were employed at Breg and 356 were employed at International. Our
relations with our Italian employees, who numbered 124 at December 31, 2009, are
governed by the provisions of a National Collective Labor Agreement setting
forth mandatory minimum standards for labor relations in the metal mechanic
workers industry. We are not a party to any other collective
bargaining agreement. We believe that we have good relations with our
employees. Of our 1,484 employees, 633 were employed in sales and
marketing functions, 237 in general and administrative, 491 in production and
123 in research and development.
In addition to the other information
contained in the Form 10-K and the exhibits hereto, you should carefully
consider the risks described below. These risks are not the only ones
that we may face. Additional risks not presently known to us or that
we currently consider immaterial may also impair our business
operations. This Form 10-K also contains forward-looking statements
that involve risks and uncertainties. Our actual results could differ
materially from those anticipated in these forward-looking statements as a
result of certain factors, including the risks faced by us described below or
elsewhere in this Form 10-K.
The
global recession and further adverse changes in general economic or credit
market conditions could adversely impact our sales and operating
results.
The
direction and strength of the U.S. and global economy has been uncertain due to
the recent downturn in the economy and difficulties in the credit
markets. If economic growth in the U.S. and other countries continues
to remain low, or if the credit markets continue to be difficult to access, our
distributors, suppliers and other business partners could experience significant
disruptions to their businesses and operations which, in turn, could negatively
impact our business operations and financial performance. In
addition, continued weak consumer financial strength and demand could cause a
substantial reduction in the sale of our products.
Our
acquisition of Blackstone Medical Inc. could continue to present challenges for
us.
On
September 22, 2006, we completed the acquisition of Blackstone Medical Inc.
(“Blackstone”). The acquisition has presented several challenges to
our business. In 2008, we recorded several expenses from the
impairment of goodwill and intangible assets related to the Blackstone business,
including a $57.0 million impairment loss related to the Blackstone trademark, a
$126.9 million goodwill impairment loss, and a $105.7 million impairment charge
related to the distribution network and technologies at
Blackstone. We have also received several subpoenas related to the
Blackstone business, including from the U.S. Department of Health and Human
Services, Office of the Inspector General. These subpoenas and
related government investigations have required the use of significant
management time and resources.
We
continue to integrate the operations of Blackstone into our business, however,
we may not be able to successfully integrate Blackstone’s operations into our
business and achieve the benefits that we originally anticipated at the time of
the acquisition. The continued integration of Blackstone’s operations
into our business involves numerous risks, including:
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difficulties
in incorporating Blackstone’s product lines, sales personnel and marketing
operations into our business;
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the
diversion of our resources and our management’s attention from other
business concerns;
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the
loss of any key distributors;
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the
loss of any key employees; and
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the
assumption of unknown liabilities, such as the costs and expenses related
to the current inquiries by the Department of Health and Human Service
Office of Inspector General, as described in Item 3, Legal
Proceedings.
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In
addition, Blackstone’s business is subject to many of the same risks and
uncertainties that apply to our other business operations, such as risks
relating to the protection of Blackstone’s intellectual property and proprietary
rights, including patents that it owns or licenses. If Blackstone’s
intellectual property and proprietary rights are challenged, or if third parties
claim that Blackstone infringes on their proprietary rights, our business could
be adversely affected.
Failure
to overcome these risks or any other problems encountered in connection with the
acquisition of Blackstone could adversely affect our business, prospects and
financial condition. In addition, if Blackstone’s operations and
financial results do not meet our expectations, we may not realize synergies,
operating efficiencies, market position, or revenue growth we originally
anticipated from the acquisition.
We
may be subject to federal and state health care fraud and abuse laws, and could
face substantial penalties if we are determined not to have fully complied with
such laws.
Health
care fraud and abuse regulation by federal and state governments impact our
business. Health care fraud and abuse laws potentially applicable to
our operations include:
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the
Federal Health Care Programs Anti-Kickback Law, which constrains our
marketing practices, educational programs, pricing and discounting
policies, and relationships with health care practitioners and providers,
by prohibiting, among other things, soliciting, receiving, offering or
paying remuneration, in exchange for or to induce the purchase or
recommendation of an item or service reimbursable under a federal health
care program (such as the Medicare or Medicaid
programs);
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federal
false claims laws which prohibit, among other things, knowingly
presenting, or causing to be presented, claims for payment from Medicare,
Medicaid, or other federal government payers that are false or fraudulent;
and
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state
laws analogous to each of the above federal laws, such as anti-kickback
and false claims laws that may apply to items or services reimbursed by
non-governmental third party payers, including commercial
insurers.
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Due to
the breadth of some of these laws, there can be no assurance that we will not be
found to be in violation of any of such laws, and as a result we may be subject
to penalties, including civil and criminal penalties, damages, fines, the
curtailment or restructuring of our operations or the exclusion from
participation in federal or state healthcare programs. Any penalties
could adversely affect our ability to operate our business and our financial
results. Any action against us for violation of these laws, even if
we successfully defend against them, could cause us to incur significant legal
expenses and divert our management’s attention from the operation of our
business.
In
particular, as more fully described under Item 3, “Legal Proceedings”, the
Company has received subpoenas requesting information from governmental
authorities, including the U.S. Department of Health and Human Services, Office
of Inspector General, and two separate federal grand jury subpoenas, related to
our Blackstone subsidiary, which we acquired in 2006. In addition, on
or about April 10, 2009, the Company received a HIPAA subpoena issued by the
U.S. Attorney’s Office for the District of Massachusetts (the “Boston
USAO”). The Boston USAO subsequently informed the Company that it is
investigating possible criminal and civil violations of federal law related to
the Company’s promotion and marketing of its bone growth stimulator
devices. Any adverse outcome in either of these inquiries could have
a material adverse effect on our business and financial position.
In
addition, it is possible that one or more private insurers with whom we do
business may attempt to use any penalty we might be assessed or any exclusion
from federal or state healthcare program business as a basis to cease doing
business with us. If this were to occur, it could also have a
material adverse effect on our business and financial position.
Expensive
litigation and government investigations, and difficulties recouping disputed
amounts currently being held in escrow in connection with the Blackstone
acquisition, may reduce our earnings.
As more
fully described directly above and under Item 3, "Legal Proceedings", we are
named as a defendant in a number of lawsuits and have received several subpoenas
requesting information from various governmental authorities. We are
complying with the subpoenas and intend to cooperate with any related government
investigations. The outcome of these and any other lawsuits brought
against us, and these and other investigations of us, are inherently uncertain,
and adverse developments or outcomes could result in significant monetary
damages, penalties or injunctive relief against us that could significantly
reduce our earnings and cash flows. In addition, we may continue to
incur significant legal expenses in connection with these matters in the future,
which expenses could affect our future earnings.
As also
described under Item 3, “Legal Proceedings,” in connection with those lawsuits
and investigations that relate to our Blackstone subsidiary, we may have rights
to indemnification under the merger agreement for the Blackstone acquisition for
losses incurred in connection with some or all of these matters, and we have
submitted several claims for indemnification from the escrow fund established in
connection with the merger agreement. However, the representative of
the former shareholders of Blackstone has objected to many of these
indemnification claims and expressed an intent to contest them in accordance
with the terms of the merger agreement. There can be no assurance
that we will ultimately be successful in seeking indemnification in connection
with any of these matters.
In the
event certain of these matters result in significant settlement costs or
judgments against us and, as applicable, we are not able to successfully recoup
such amounts from the escrow fund, these matters could have a significant
negative effect on our operations and financial performance.
We
may not be able to successfully introduce new products to the
market.
During
2009, we introduced several new products to the market, including the Firebird™
Spinal Fixation System, the PILLAR™ SA interbody device and Trinity
®
Evolution™, among others. We intend to introduce several new
products to the market in 2010. Despite our planning, the process of
developing and introducing new products is inherently complex and uncertain and
involves risks, including the ability of such new products to satisfy customer
needs and gain broad market acceptance, which can depend on the product
achieving broad clinical acceptance, the level of third-party reimbursement and
the introduction of competing technologies.
We
contract with third-party manufacturers to produce most of our products, like
many other companies in the medical device industry. If we or any
such manufacturer fails to meet production and delivery schedules, it can have
an adverse impact on our ability to sell such products. Further,
whether we directly manufacture a product or utilize a third-party manufacturer,
shortages and spoilage of materials, labor stoppages, product recalls,
manufacturing defects and other similar events can delay production and inhibit
our ability to bring a new product to market in timely fashion. For
example, the supply of Trinity® Evolution™ is derived from human cadaveric
donors, and our ability to distribute the product depends on our supplier
continuing to have access to donated human cadaveric tissue, as well as, the
maintenance of high standards by the supplier in its processing
methodology. The supply of such donors is inherently unpredictable
and can fluctuate over time. Further, because Trinity® Evolution™ is
classified as an HCT/P product, it could from time to time be subject to recall
for safety or administrative reasons.
We
depend on our ability to protect our intellectual property and proprietary
rights, but we may not be able to maintain the confidentiality, or assure the
protection, of these assets.
Our
success depends, in large part, on our ability to protect our current and future
technologies and products and to defend our intellectual property
rights. If we fail to protect our intellectual property adequately,
competitors may manufacture and market products similar to, or that compete
directly with, ours. Numerous patents covering our technologies have
been issued to us, and we have filed, and expect to continue to file, patent
applications seeking to protect newly developed technologies and products in
various countries, including the U.S. Some patent applications in the
U.S. are maintained in secrecy until the patent is issued. Because
the publication of discoveries tends to follow their actual discovery by several
months, we may not be the first to invent, or file patent applications on any of
our discoveries. Patents may not be issued with respect to any of our
patent applications and existing or future patents issued to, or licensed by us
and may not provide adequate protection or competitive advantages for our
products. Patents that are issued may be challenged, invalidated or
circumvented by our competitors. Furthermore, our patent rights may
not prevent our competitors from developing, using or commercializing products
that are similar or functionally equivalent to our products.
We also
rely on trade secrets, unpatented proprietary expertise and continuing
technological innovation that we protect, in part, by entering into
confidentiality agreements with assignors, licensees, suppliers, employees and
consultants. These agreements may be breached and there may not be
adequate remedies in the event of a breach. Disputes may arise
concerning the ownership of intellectual property or the applicability or
enforceability of confidentiality agreements. Moreover, our trade
secrets and proprietary technology may otherwise become known or be
independently developed by our competitors. If patents are not issued
with respect to our products arising from research, we may not be able to
maintain the confidentiality of information relating to these
products. In addition, if a patent relating to any of our products
lapses or is invalidated, we may experience greater competition arising from new
market entrants.
Third
parties may claim that we infringe on their proprietary rights and may prevent
us from manufacturing and selling certain of our products.
There has
been substantial litigation in the medical device industry with respect to the
manufacture, use and sale of new products. These lawsuits relate to
the validity and infringement of patents or proprietary rights of third
parties. We may be required to defend against allegations relating to
the infringement of patent or proprietary rights of third
parties. Any such litigation could, among other things:
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require
us to incur substantial expense, even if we are successful in the
litigation;
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require
us to divert significant time and effort of our technical and management
personnel;
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result
in the loss of our rights to develop or make certain products;
and
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require
us to pay substantial monetary damages or royalties in order to license
proprietary rights from third parties or to satisfy judgments or to settle
actual or threatened litigation.
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Although
patent and intellectual property disputes within the orthopedic medical devices
industry have often been settled through assignments, licensing or similar
arrangements, costs associated with these arrangements may be substantial and
could include the long-term payment of royalties. Furthermore, the
required assignments or licenses may not be made available to us on acceptable
terms. Accordingly, an adverse determination in a judicial or
administrative proceeding or a failure to obtain necessary assignments or
licenses could prevent us from manufacturing and selling some products or
increase our costs to market these products.
Reimbursement
policies of third parties, cost containment measures and healthcare reform could
adversely affect the demand for our products and limit our ability to sell our
products.
Our
products are sold either directly by us or by independent sales representatives
to customers or to our independent distributors and purchased by hospitals,
doctors and other healthcare providers. These products may be reimbursed by
third-party payors, such as government programs, including Medicare, Medicaid
and Tricare, or private insurance plans and healthcare
networks. Third-party payors may deny reimbursement if they determine
that a device provided to a patient or used in a procedure does not meet
applicable payment criteria or if the policy holder’s healthcare insurance
benefits are limited. Also, third-party payors are increasingly
challenging the prices charged for medical products and
services. Limits put on reimbursement could make it more difficult
for people to buy our products and reduce, or possibly eliminate, the demand for
our products. In addition, should governmental authorities enact
additional legislation or adopt regulations that affect third-party coverage and
reimbursement, demand for our products and coverage by private or public
insurers may be reduced with a consequential material adverse effect on our
sales and profitability.
Third-party
payors, whether private or governmental entities, also may revise coverage or
reimbursement policies that address whether a particular product, treatment
modality, device or therapy will be subject to reimbursement and, if so, at what
level of payment.
The
Centers for Medicare and Medicaid Services (“CMS”), in its ongoing
implementation of the Medicare program has obtained a related technical
assessment of the medical study literature to determine how the literature
addresses spinal fusion surgery in the Medicare population. The
impact that this information will have on Medicare coverage policy for the
Company’s products is currently unknown, but we cannot provide assurances that
the resulting actions would not restrict Medicare coverage for our
products. It is also possible that the government’s focus on coverage
of off-label uses of the FDA-approved devices could lead to changes in coverage
policies regarding off-label uses by TriCare, Medicare and/or
Medicaid. There can be no assurance that we or our distributors will
not experience significant reimbursement problems in the future related to these
or other proceedings. Our products are sold in many countries, such
as the United Kingdom, France, and Italy, with publicly funded healthcare
systems. The ability of hospitals supported by such systems to
purchase our products is dependent, in part, upon public budgetary
constraints. Any increase in such constraints may have a material
adverse effect on our sales and collection of accounts receivable from such
sales.
As
required by law, CMS has continued efforts to implement a competitive bidding
program for durable medical equipment paid for by the Medicare program. CMS
conducted an initial implementation of the competitive bidding program in 2008
which was terminated in that same year. CMS is required to and began the rebid
process in 2009. The implementation date of the rebid round is currently
scheduled for January 2011. The Company’s products are not yet
included in the competitive bidding process. We believe that the competitive
bidding process will principally affect products sold by our Sports Medicine
business. We cannot predict which products from any of our businesses will
ultimately be affected or when the competitive bidding process will be extended
to our businesses. The competitive bidding process is projected to be expanded
further in 2011, yet final decisions concerning which products and areas will be
affected have not been announced. While some of our products are designated by
the Food and Drug Administration as Class III medical devices and thus are not
included within the competitive bidding program, some of our products may be
encompassed within the program at varying times. There can be no assurance that
the implementation of the competitive bidding program will not have an adverse
impact on the sales of some of our products.
We
estimate that our revenue by payor type is:
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Third
Party Insurance
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22%
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Independent
Distributors
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19%
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U.S.
Government – Medicare, Medicaid,
TriCare
10%
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International
Public Healthcare Systems
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9%
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We and certain of our suppliers may
be subject to extensive government regulation that increases our costs and could
limit our ability to market or sell our products.
The
medical devices we manufacture and market are subject to rigorous regulation by
the FDA and numerous other federal, state and foreign governmental
authorities. These authorities regulate the development, approval,
classification, testing, manufacturing, labeling, marketing and sale of medical
devices. Likewise, our use and disclosure of certain categories of
health information may be subject to federal and state laws, implemented and
enforced by governmental authorities that protect health information privacy and
security. For a description of these regulations, see Item 1 –
“Business – Government Regulation.”
The
approval or clearance by governmental authorities, including the FDA in the
U.S., is generally required before any medical devices may be marketed in the
U.S. or other countries. We cannot predict whether in the future, the
U.S. or foreign governments may impose regulations that have a material adverse
effect on our business, financial condition or results of
operations. The process of obtaining FDA clearance and other
regulatory clearances or approvals to develop and market a medical device can be
costly and time-consuming, and is subject to the risk that such approvals will
not be granted on a timely basis if at all. The regulatory process
may delay or prohibit the marketing of new products and impose substantial
additional costs if the FDA lengthens review times for new
devices. The FDA has the ability to change the regulatory
classification of a cleared or approved device from a higher to a lower
regulatory classification which could materially adversely impact our ability to
market or sell our devices
.
We and
certain of our suppliers also are subject to announced and unannounced
inspections by the FDA to determine our compliance with FDA’s Quality System
Regulation (“QSR”)
and other
regulations. If the FDA were to find that we or certain of our
suppliers have failed to comply with applicable regulations, the agency could
institute a wide variety of enforcement actions, ranging from a public warning
letter to more severe sanctions such as: fines and civil penalties against us,
our officers, our employees or our suppliers; unanticipated expenditures to
address or defend such actions; delays in clearing or approving, or refusal to
clear or approve, our products; withdrawal or suspension of approval of our
products or those of our third-party suppliers by the FDA or other regulatory
bodies; product recall or seizure; interruption of production; operating
restrictions; injunctions; and criminal prosecution. The FDA also has
the authority to request repair, replacement or refund of the cost of any
medical device manufactured or distributed by us. Any of those
actions could have a material adverse effect on our development of new
laboratory tests, business strategy, financial condition and results of
operations.
Our
allograft and mesenchymal stem cell products could expose us to certain risks
which could disrupt our business.
Our
Spinal Implants and Biologics division distributes a product under the brand
name Trinity® Evolution™. Trinity® Evolution™ is derived from human
cadaveric donors, and our ability to distribute the product depends on our
supplier continuing to have access to donated human cadaveric tissue, as well
as, the maintenance of high standards by the supplier in its processing
methodology. The supply of such donors is inherently unpredictable
and can fluctuate over time. We believe that Trinity® Evolution™ is
properly classified under the FDA’s Human Cell, Tissues and Cellular and
Tissue-Based Products (“HCT/P”) regulatory paradigm and not as a medical device
or as a biologic or drug. There can be no assurance that the FDA
would agree that this category of regulatory classification applies to Trinity®
Evolution™ and the reclassification of this product from a human tissue to a
medical device could have adverse consequences for us or for the supplier of
this product and make it more difficult or expensive for us to conduct this
business by requiring premarket clearance or approval as well as compliance with
additional postmarket regulatory requirements. The success of our
Trinity® Evolution™ product will depend on these products achieving broad market
acceptance which can depend on the product achieving broad clinical acceptance,
the level of third-party reimbursement and the introduction of competing
technologies. Because Trinity® Evolution™ is classified as an HCT/P
product, it can from time to time be subject to recall for safety or
administrative reasons.
Spinal
Implants and Biologics also distributes allograft products which are also
derived from human tissue harvested from cadavers and which are used for bone
reconstruction or repair and which are surgically implanted into the human
body. We believe that these allograft products are properly
classified as HCT/P products and not as a medical device or a biologic or
drug. There can be no assurance that the FDA would agree that this
regulatory classification applies to these products and any regulatory
reclassification could have adverse consequences for us or for the suppliers of
these products and make it more difficult or expensive for us to conduct this
business by requiring premarket clearance or approval and compliance with
additional postmarket regulatory requirements. Moreover, the supply
of these products to us could be interrupted by the failure of our suppliers to
maintain high standards in performing required donor screening and infectious
disease testing of donated human tissue used in producing allograft
implants. Our allograft implant business could also be adversely
affected by shortages in the supply of donated human tissue or negative
publicity concerning methods of recovery of tissue and product liability actions
arising out of the distribution of allograft implant products.
We
may be subject to product liability claims that may not be covered by insurance
and could require us to pay substantial sums.
We are
subject to an inherent risk of, and adverse publicity associated with, product
liability and other liability claims, whether or not such claims are
valid. We maintain product liability insurance coverage in amounts
and scope that we believe is reasonable and adequate. There can be no
assurance, however, that product liability or other claims will not exceed our
insurance coverage limits or that such insurance will continue to be available
on reasonable commercially acceptable terms, or at all. A successful
product liability claim that exceeds our insurance coverage limits could require
us to pay substantial sums and could have a material adverse effect on our
financial condition.
Fluctuations
in insurance expense could adversely affect our profitability.
We hold a
number of insurance policies, including product liability insurance, directors’
and officers’ liability insurance, property insurance and workers’ compensation
insurance. If the costs of maintaining adequate insurance coverage
should increase significantly in the future, our operating results could be
materially adversely impacted.
Our
quarterly operating results may fluctuate.
Our
operating results have fluctuated significantly in the past on a quarterly
basis. Our operating results may fluctuate significantly from quarter
to quarter in the future and we may experience losses in the future depending on
a number of factors, including the extent to which our products continue to gain
or maintain market acceptance, the rate and size of expenditures incurred as we
expand our domestic and establish our international sales and distribution
networks, the timing and level of reimbursement for our products by
third-party payors, the extent to which we are subject to government regulation
or enforcement and other factors, many of which are outside our
control.
New
developments by others could make our products or technologies non-competitive
or obsolete.
The
orthopedic medical device industry in which we compete is undergoing, and is
characterized by rapid and significant technological change. We
expect competition to intensify as technological advances are
made. New technologies and products developed by other companies are
regularly introduced into the market, which may render our products or
technologies non-competitive or obsolete.
Our
ability to market products successfully depends, in part, upon the acceptance of
the products not only by consumers, but also by independent third
parties.
Our
ability to market orthopedic products successfully depends, in part, on the
acceptance of the products by independent third parties (including hospitals,
doctors, other healthcare providers and third-party payors) as well as
patients. Unanticipated side effects or unfavorable publicity
concerning any of our products could have an adverse effect on our ability to
maintain hospital approvals or achieve acceptance by prescribing physicians,
managed care providers and other retailers, customers and patients.
The
industry in which we operate is highly competitive.
The
medical devices industry is highly competitive. We compete with a
large number of companies, many of which have significantly greater financial,
manufacturing, marketing, distribution and technical resources than we
do. Many of our competitors may be able to develop products and
processes competitive with, or superior to, our own. Furthermore, we
may not be able to successfully develop or introduce new products that are less
costly or offer better performance than those of our competitors, or offer
purchasers of our products payment and other commercial terms as favorable as
those offered by our competitors. For more information regarding our
competitors, see Item 1 – “Business – Competition.”
We
depend on our senior management team.
Our
success depends upon the skill, experience and performance of members of our
senior management team, who have been critical to the management of our
operations and the implementation of our business strategy. We do not
have key man insurance on our senior management team, and the loss of one or
more key executive officers could have a material adverse effect on our
operations and development.
In
order to compete, we must attract, retain and motivate key employees, and our
failure to do so could have an adverse effect on our results of
operations.
In order
to compete, we must attract, retain and motivate executives and other key
employees, including those in managerial, technical, sales, marketing and
support positions. Hiring and retaining qualified executives, engineers,
technical staff and sales representatives are critical to our business, and
competition for experienced employees in the medical device industry can be
intense. To attract, retain and motivate qualified
employees, we utilize
stock-based incentive
awards such as employee stock options. If the value of such stock awards does
not appreciate as measured by the performance of the price of our common stock
and ceases to be viewed as a valuable benefit, our ability to attract, retain
and motivate our employees could be adversely impacted, which could negatively
affect our results of operations and/or require us to increase the amount we
expend on cash and other forms of compensation.
Termination
of our existing relationships with our independent sales representatives or
distributors could have an adverse effect on our business.
We sell
our products in many countries through independent
distributors. Generally, our independent sales representatives and
our distributors have the exclusive right to sell our products in their
respective territories and are generally prohibited from selling any products
that compete with ours. The terms of these agreements vary in length,
generally from one to ten years. Under the terms of our distribution
agreements, each party has the right to terminate in the event of a material
breach by the other party and we generally have the right to terminate if the
distributor does not meet agreed sales targets or fails to make payments on
time. Any termination of our existing relationships with independent
sales representatives or distributors could have an adverse effect on our
business unless and until commercially acceptable alternative distribution
arrangements are put in place.
We
are party to numerous contractual relationships.
We are
party to numerous contracts in the normal course of our business. We
have contractual relationships with suppliers, distributors and agents, as well
as service providers. In the aggregate, these contractual
relationships are necessary for us to operate our business. From time
to time, we amend, terminate or negotiate our contracts. We are also
periodically subject to, or make claims of breach of contract, or threaten legal
action relating to our contracts. These actions may result in
litigation. At any one time, we have a number of negotiations under
way for new or amended commercial agreements. We devote substantial
time, effort and expense to the administration and negotiation of contracts
involved in our business. However, these contracts may not continue
in effect past their current term or we may not be able to negotiate
satisfactory contracts in the future with current or new business
partners.
We
face risks related to foreign currency exchange rates.
Because
some of our revenue, operating expenses, assets and liabilities are denominated
in foreign currencies, we are subject to foreign exchange risks that could
adversely affect our operations and reported results. To the extent
that we incur expenses or earn revenue in currencies other than the U.S. dollar,
any change in the values of those foreign currencies relative to the U.S. dollar
could cause our profits to decrease or our products to be less competitive
against those of our competitors. To the extent that our current
assets denominated in foreign currency are greater or less than our current
liabilities denominated in foreign currencies, we have potential foreign
exchange exposure. We have substantial activities outside of the U.S.
that are subject to the impact of foreign exchange rates. The
fluctuations of foreign exchange rates during 2009 have had a negative impact of
$11.1 million on net sales outside of the U.S. Although we seek to
manage our foreign currency exposure by matching non-dollar revenues and
expenses, exchange rate fluctuations could have a material adverse effect on our
results of operations in the future. To minimize such exposures, we
enter into currency hedges from time to time. At December 31, 2009,
we had outstanding a currency swap to hedge a 38.3 million Euro foreign
currency exposure.
We
are subject to differing tax rates in several jurisdictions in which we
operate.
We have
subsidiaries in several countries. Certain of our subsidiaries sell
products directly to other Orthofix subsidiaries or provide marketing and
support services to other Orthofix subsidiaries. These intercompany
sales and support services involve subsidiaries operating in jurisdictions with
differing tax rates. Tax authorities in these jurisdictions may
challenge our treatment of such intercompany transactions. If we are
unsuccessful in defending our treatment of intercompany transactions, we may be
subject to additional tax liability or penalty, which could adversely affect our
profitability.
We
are subject to differing customs and import/export rules in several
jurisdictions in which we operate.
We import
and export our products to and from a number of different countries around the
world. These product movements involve subsidiaries and third-parties
operating in jurisdictions with different customs and import/export rules and
regulations. Customs authorities in such jurisdictions may challenge
our treatment of customs and import/export rules relating to product shipments
under aspects of their respective customs laws and treaties. If we
are unsuccessful in defending our treatment of customs and import/export
classifications, we may be subject to additional customs duties, fines or
penalties that could adversely affect our profitability.
Provisions
of Netherlands Antilles law may have adverse consequences to our
shareholders.
Our
corporate affairs are governed by our Articles of Association and the corporate
law of the Netherlands Antilles as laid down in Book 2 of the Civil Code
(“CCNA”). Although some of the provisions of the CCNA resemble some
of the provisions of the corporation laws of a number of states in the U.S.,
principles of law relating to such matters as the validity of corporate
procedures, the fiduciary duties of management and the rights of our
shareholders may differ from those that would apply if Orthofix were
incorporated in a jurisdiction within the U.S. For example, there is
no statutory right of appraisal under Netherlands Antilles corporate law nor is
there a right for shareholders of a Netherlands Antilles corporation to sue a
corporation derivatively. In addition, we have been advised by
Netherlands Antilles counsel that it is unlikely that (1) the courts of the
Netherlands Antilles would enforce judgments entered by U.S. courts predicated
upon the civil liability provisions of the U.S. federal securities laws and (2)
actions can be brought in the Netherlands Antilles in relation to liabilities
predicated upon the U.S. federal securities laws.
Our
business is subject to economic, political, regulatory and other risks
associated with international sales and operations.
Since we
sell our products in many different countries, our business is subject to risks
associated with conducting business internationally. Net sales
outside the U.S. represented 23% of our total net sales in 2009. We
anticipate that net sales from international operations will continue to
represent a substantial portion of our total net sales. In addition,
a number of our manufacturing facilities and suppliers are located outside the
U.S. Accordingly, our future results could be harmed by a variety of
factors, including:
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changes
in foreign currency exchange rates;
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changes
in a specific country’s or region’s political or economic
conditions;
|
|
·
|
trade
protection measures and import or export licensing requirements or other
restrictive actions by foreign
governments;
|
|
·
|
consequences
from changes in tax or customs
laws;
|
|
·
|
difficulty
in staffing and managing widespread
operations;
|
|
·
|
differing
labor regulations;
|
|
·
|
differing
protection of intellectual
property;
|
|
·
|
unexpected
changes in regulatory requirements;
and
|
|
·
|
application
of the U.S. Foreign Corrupt Practices Act (“FCPA”) and other anti-bribery
or anti-corruption laws to our
operations.
|
We
may incur costs and undertake new debt and contingent liabilities in a search
for acquisitions.
We
continue to search for viable acquisition candidates that would expand our
market sector or global presence. We also seek additional products
appropriate for current distribution channels. The search for an
acquisition of another company or product line by us could result in our
incurrence of costs from such efforts as well as the undertaking of new debt and
contingent liabilities from such searches or acquisitions. Such
costs may be incurred at any time and may vary in size depending on the scope of
the acquisition or product transactions and may have a material impact on our
results of operations.
We
may incur significant costs or retain liabilities associated with disposition
activity.
We may
from time to time sell, license, assign or otherwise dispose of or divest
assets, the stock of subsidiaries or individual products, product lines or
technologies which we determine are no longer desirable for us to own, some of
which may be material. Any such activity could result in our
incurring costs and expenses from these efforts, some of which could be
significant, as well as retaining liabilities related to the assets or
properties disposed of even though, for instance, the income generating assets
have been disposed of. These costs and expenses may be incurred at
any time and may have a material impact on our results of
operations.
Our
subsidiary Orthofix Holdings, Inc.'s senior secured bank credit facility
contains significant financial and operating restrictions, including financial
covenants that we may be unable to satisfy in the future.
When we
acquired Blackstone on September 22, 2006, one of our wholly-owned subsidiaries,
Orthofix Holdings, Inc. (“Orthofix Holdings”), entered into a senior secured
bank credit facility with a syndicate of financial institutions to finance the
transaction. Orthofix and certain of Orthofix Holdings’ direct and indirect
subsidiaries, including Orthofix Inc., Breg, and Blackstone have guaranteed the
obligations of Orthofix Holdings under the senior secured bank facility. The
senior secured bank facility provides for (1) a seven-year amortizing term loan
facility of $330.0 million of which $252.4 million and $280.7 million was
outstanding at December 31, 2009 and 2008, respectively, and (2) a six-year
revolving credit facility of $45.0 million upon which we had $44.7 million
available to be drawn as of December 31, 2009.
On
September 29, 2008, we entered into an amendment to the credit
agreement. The credit agreement, as amended, contains negative
covenants applicable to Orthofix and its subsidiaries, including restrictions on
indebtedness, liens, dividends and mergers and sales of assets. The credit
agreement also contains certain financial covenants, including a fixed charge
coverage ratio and a leverage ratio applicable to Orthofix and its subsidiaries
on a consolidated basis. A breach of any of these covenants could result in an
event of default under the credit agreement, which could permit acceleration of
the debt payments under the facility. Management believes the Company
was in compliance with these financial covenants as measured at December 31,
2009. The Company further believes that it should be able to meet
these financial covenants in future fiscal quarters, however, there can be no
assurance that it will be able to do so, and failure to do so could result in an
event of default under the credit agreement, which could have a material adverse
effect on our financial position.
The
senior secured bank credit facility requires mandatory prepayments that may have
an adverse effect on our operations and limit our ability to grow our
business.
Further,
in addition to scheduled debt payments, the credit agreement, as
amended, requires us to make mandatory prepayments with (a) the
excess cash flow (as defined in the credit agreement) of Orthofix and its
subsidiaries, in an amount equal to 50% of the excess annual cash flow beginning
with the year ending December 31, 2007, provided, however, if the leverage ratio
(as defined in the credit agreement) is less than or equal to 1.75 to 1.00, as
of the end of any fiscal year, there will be no mandatory excess cash flow
prepayments, with respect to such fiscal year, (b) 100% of the net cash proceeds
of any debt issuances by Orthofix or any of its subsidiaries or 50% of the net
cash proceeds of equity issuances by any such party, excluding the exercise of
stock options, provided, however, if the leverage ratio is less than or equal to
1.75 to 1.00 at the end of the preceding fiscal year, Orthofix Holdings shall
not be required to prepay the loans with the proceeds of any such debt or equity
issuance, (c) the net cash proceeds of asset dispositions over a minimum
threshold, or (d) unless reinvested, insurance proceeds or condemnation awards.
These mandatory prepayments could limit our ability to reinvest in our
business.
The
conditions of the U.S. and international capital and credit markets may
adversely affect our ability to draw on our current revolving credit facility or
obtain future short-term or long-term lending.
Global
market and economic conditions have been, and continue to be, disrupted and
volatile. In particular, the cost and availability of funding for
many companies has been and may continue to be adversely affected by illiquid
credit markets and wider credit spreads. These forces reached
unprecedented levels in 2008, resulting in the bankruptcy or acquisition of, or
government assistance to, several major domestic and international financial
institutions. These events have significantly diminished overall
confidence in the financial and credit markets. There can be no
assurances that recent government responses to the disruptions in the financial
and credit markets will restore consumer confidence, stabilize the markets or
increase liquidity and the availability of credit.
We
continue to maintain a six-year revolving credit facility of $45.0 million upon
which we had $44.7 million available to be drawn as of December 31,
2009. However, to the extent our business requires us to access the
credit markets in the future and we are not able to do so, including in the
event that lenders cease to lend to us, or cease to be capable of lending, for
any reason, we could experience a material and adverse impact on our financial
condition and ability to borrow additional funds. This might impair
our ability to obtain sufficient funds for working capital, capital
expenditures, acquisitions, research and development and other corporate
purposes.
The
conditions of the U.S. and international capital and credit markets may
adversely affect our interest expense under our existing credit
facility.
Our
senior bank facility provides for a seven-year amortizing term loan facility of
$330.0 million for which $252.4 million was outstanding as of December 31,
2009. Obligations under the senior secured credit facility have a
floating interest rate of the London Inter-Bank Offered Rate (“LIBOR”) plus a
margin or prime rate plus a margin. Currently, the term loan is a
$252.4 million prime rate loan plus a margin of 3.5%. In June 2008,
we entered into a three year fully amortizable interest rate swap agreement (the
“Swap”) with a notional amount of $150.0 million and an expiration date of June
30, 2011. The amount outstanding under the Swap as of December 31,
2009 was $150.0 million. Under the Swap we will pay a fixed rate of
3.73% and receive interest at floating rates based on the three month LIBOR rate
at each quarterly re-pricing date until the expiration of the
Swap. As of December 31, 2009 the interest rate on the debt related
to the Swap was 10.2%. Our overall effective interest rate, including
the impact of the Swap, as of December 31, 2009 on our senior secured debt was
8.8%. Although the Swap reduces the impact of interest rate
increases, our interest expense that we incur under our term loan could increase
if there are increases in LIBOR rates. (See Item 7A, Quantitative and
Qualitative Disclosures about Market Risk in this Form
10-K.) Further, in the event that our counterparties under the Swap
were to cease to be able to satisfy their obligations under the Swap for any
reason, our interest expense could be further increased.
Our
results of operations could vary as a result of the methods, estimates and
judgments we use in applying our accounting policies.
The
methods, estimates and judgments we use in applying our accounting policies have
a significant impact on our results of operations (see “Critical Accounting
Policies and Estimates” in Part II, Item 7 of this Form 10-K). Such methods,
estimates and judgments are, by their nature, subject to substantial risks,
uncertainties and assumptions, and factors may arise over time that leads us to
change our methods, estimates and judgments. Changes in those methods, estimates
and judgments could significantly affect our results of operations.
Goodwill and other identified
intangibles could
generate future asset impairments,
which would be recorded as operating
losses.
The
Financial Accounting Standards Board’s (“FASB”) Accounting Standards
Codification (“ASC”) Topic 350 – Intangibles – Goodwill and Other (formerly
known as Statement of Financial Accounting Standards (“SFAS”) No. 142, “Goodwill
and Other Intangible Assets”) requires that goodwill, including the goodwill
included in the carrying value of investments accounted for using the equity
method of accounting, and other intangible assets deemed to have indefinite
useful lives, such as trademarks, cease to be amortized. ASC Topic 350 requires
that goodwill and intangible assets with indefinite lives be tested at least
annually for impairment. If Orthofix finds that the carrying value of goodwill
or a certain intangible asset exceeds its fair value, it will reduce the
carrying value of the goodwill or intangible asset to the fair value, and
Orthofix will recognize an impairment loss. Any such impairment losses are
required to be recorded as non-cash operating losses.
During
the third quarter of 2008, as a result of decreasing revenues, we evaluated the
fair value of our indefinite-lived trademarks and goodwill at
Blackstone. As a result, we recorded an impairment charge of $57.0
million related to these trademarks. We determined that the carrying
amount of goodwill related to Blackstone exceeded its implied fair value, and
recognized a goodwill impairment loss of $126.9 million.
In
addition, ASC Topic 360 – Property, Plant and Equipment (formerly known as SFAS
No. 144 “Accounting for the Impairment or Disposal of Long-Lived Assets”)
requires that intangible assets with definite lives, such as Orthofix’s
developed technologies and distribution network assets, be tested for impairment
if indicators of impairment, as defined in the standard,
exist. During the third quarter of 2008, we determined that an
indicator of impairment existed with respect to the definite-lived intangible
assets at Blackstone. We compared the expected cash flows to be
generated by the definite lived intangible assets on an undiscounted basis to
the carrying value of the intangible asset. We determined the
carrying value exceeded the undiscounted cash flow and impaired the distribution
network and developed technologies at Blackstone which resulted in an impairment
charge of $105.7 million.
Certain
of the impairment tests require Orthofix to make an estimate of the fair value
of goodwill and other intangible assets, which are primarily determined using
discounted cash flow methodologies, research analyst estimates, market
comparisons and a review of recent transactions. Since a number of factors may
influence determinations of fair value of intangible assets, Orthofix is unable
to predict whether impairments of goodwill or other indefinite lived intangibles
will occur in the future.
Item
1B.
Unresolved Staff Comments
None.
Our
principal facilities are:
Facility
|
|
Location
|
|
Approx.
Square
Feet
|
|
Ownership
|
Manufacturing,
warehousing, distribution and research and development facility for Spine
and Orthopedics Products and administrative facility for the Domestic and
Spinal Implants and Biologics segments
|
|
McKinney,
TX
|
|
70,000
|
|
Leased
|
|
|
|
|
|
|
|
Tooling
and model shop for Spinal Implants and Biologics
|
|
Springfield,
MA
|
|
19,000
|
|
Leased
|
|
|
|
|
|
|
|
Research
and development office for Spinal Implants and Biologics
|
|
Wayne,
NJ
|
|
16,548
|
|
Leased
|
|
|
|
|
|
|
|
Research
and development, component manufacturing, quality control and training
facility for fixation products and sales management, distribution and
administrative facility for Italy
|
|
Verona,
Italy
|
|
38,000
|
|
Owned
|
|
|
|
|
|
|
|
International
Distribution Center for Orthofix products
|
|
Verona,
Italy
|
|
18,000
|
|
Leased
|
|
|
|
|
|
|
|
Administrative
offices for Orthofix International N.V.
|
|
Boston,
MA
|
|
7,488
|
|
Leased
|
|
|
|
|
|
|
|
Administrative
offices for Orthofix International N.V.
|
|
Huntersville,
NC
|
|
7,225
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative offices
|
|
Florham
Park, NJ
|
|
2,700
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative offices
|
|
South
Devon, England
|
|
2,500
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative offices for A-V Impulse
®
System and fixation products
|
|
Andover,
England
|
|
9,001
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative facility for United
Kingdom
|
|
Maidenhead,
England
|
|
9,000
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative facility for
Mexico
|
|
Mexico
City, Mexico
|
|
3,444
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative facility for
Brazil
|
|
Alphaville,
Brazil
|
|
4,690
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative facility for
Brazil
|
|
São
Paulo, Brazil
|
|
1,184
|
|
Leased
|
Facility
|
|
Location
|
|
Approx.
Square
Feet
|
|
Ownership
|
Sales
management, distribution and administrative facility for
France
|
|
Gentilly,
France
|
|
3,854
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative facility for
Germany
|
|
Valley,
Germany
|
|
3,000
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative facility for
Switzerland
|
|
Steinhausen,
Switzerland
|
|
1,180
|
|
Leased
|
|
|
|
|
|
|
|
Administrative,
manufacturing, warehousing, distribution and research and development
facility for Breg
|
|
Vista,
California
|
|
104,832
|
|
Leased
|
|
|
|
|
|
|
|
Manufacturing
facility for Breg products, including the A-V Impulse System
®
Impads
|
|
Mexicali,
Mexico
|
|
63,000
|
|
Leased
|
|
|
|
|
|
|
|
Sales
management, distribution and administrative facility for Puerto
Rico
|
|
Guaynabo,
Puerto Rico
|
|
4,400
|
|
Leased
|
Item
3.
Legal Proceedings
On or
about July 23, 2007, our subsidiary, Blackstone Medical Inc. (“Blackstone”)
received a subpoena issued by the Department of Health and Human Services,
Office of Inspector General, under the authority of the federal healthcare
anti-kickback and false claims statutes. The subpoena seeks documents for the
period January 1, 2000 through July 31, 2006, which is prior to Blackstone’s
acquisition by the Company. The Company believes that the subpoena concerns the
compensation of physician consultants and related matters. On September 17,
2007, the Company submitted a claim for indemnification from the escrow fund
established in connection with the agreement and plan of merger between the
Company, New Era Medical Corp. and Blackstone, dated as of August 4, 2006 (the
“Blackstone Merger Agreement”), for any losses to us resulting from this matter.
(The Company’s indemnification rights under the Blackstone Merger Agreement are
described further below). The Company was subsequently notified by legal counsel
for the former shareholders that the representative of the former shareholders
of Blackstone has objected to the indemnification claim and intends to contest
it in accordance with the terms of the Blackstone Merger Agreement.
On or
about January 7, 2008, the Company received a federal grand jury subpoena from
the U.S. Attorney’s Office for the District of Massachusetts. The subpoena seeks
documents from the Company for the period January 1, 2000 through July 15, 2007.
The Company believes that the subpoena concerns the compensation of physician
consultants and related matters, and further believes that it is associated with
the Department of Health and Human Services, Office of Inspector General’s
investigation of such matters. On September 18, 2008, the Company submitted a
claim for indemnification from the escrow fund established in connection with
the Blackstone Merger Agreement for any losses to the Company resulting from
this matter. On or about April 29, 2009, counsel for the Company received a
HIPAA subpoena issued by the U.S. Department of Justice. The subpoena seeks
documents from the Company for the period January 1, 2000 through July 15, 2007.
The Company believes that the subpoena concerns the compensation of physician
consultants and related matters, and further believes that it is associated with
the Department of Health and Human Services, Office of Inspector General’s
investigation of such matters, as well as the January 7, 2008 federal grand jury
subpoena. On or about February 25, 2010, counsel for Orthofix Inc. and
Blackstone sent to the U.S. Attorney’s Office for the District of Massachusetts
a tolling agreement (the “Tolling Agreement”) executed by Orthofix Inc.
and Blackstone, that extends an agreement tolling the statute of limitations
applicable to any criminal, civil, or administrative proceedings that the
government might later initiate. Upon execution by the U.S. Attorney's
Office for the District of Massachusetts, the Tolling Agreement will
extend the period tolling the statute of limitations to include the period
from December 1, 2008 through and including March 31, 2010.
On or
about December 5, 2008, the Company obtained a copy of a qui tam complaint filed
by Susan Hutcheson and Philip Brown against Blackstone and the Company in the
U.S. District Court for the District of Massachusetts. A qui tam action is a
civil lawsuit brought by an individual for an alleged violation of a federal
statute, in which the U.S. Department of Justice has the right to intervene and
take over the prosecution of the lawsuit at its option. On November 21, 2008,
the U.S. Department of Justice filed a notice of non-intervention in the case.
The complaint was served on Blackstone on or about March 24, 2009. Counsel for
the plaintiffs filed an amended complaint on June 4, 2009. The amended complaint
sets forth a cause of action against Blackstone under the False Claims Act for
alleged inappropriate payments and other items of value conferred on physician
consultants; Orthofix is not named as a defendant in the amended complaint. The
Company believes that this lawsuit is related to the matters described above
involving the Department of Health and Human Services, Office of the Inspector
General, and the U.S. Attorney’s Office for the District of Massachusetts, and
the U.S. Department of Justice. The Company intends to defend vigorously against
this lawsuit. On September 18, 2008, after being informed of the existence of
the lawsuit by representatives of the U.S. Department of Justice and prior to
the unsealing of the complaint (which was unsealed by the court on or about
November 24, 2008), the Company submitted a claim for indemnification from the
escrow fund established in connection with the Blackstone Merger Agreement for
any losses to us resulting from this matter.
On or
about September 27, 2007, Blackstone received a federal grand jury subpoena
issued by the U.S. Attorney’s Office for the District of Nevada (“USAO-Nevada
subpoena”). The subpoena seeks documents for the period from January 1999 to the
date of issuance of the subpoena. The Company believes that the subpoena
concerns payments or gifts made by Blackstone to certain physicians. On February
29, 2008, Blackstone received a Civil Investigative Demand (“CID”) from the
Massachusetts Attorney General’s Office, Public Protection and Advocacy Bureau,
Healthcare Division. The CID seeks documents for the period from
March 2004 through the date of issuance of the CID, and the Company believes
that the CID concerns Blackstone’s financial relationships with certain
physicians and related matters. The Ohio Attorney General’s Office,
Health Care Fraud Section has issued a criminal subpoena, dated August 8, 2008,
to Orthofix, Inc. (the “Ohio AG subpoena”). The Ohio AG subpoena seeks documents
for the period from January 1, 2000 through the date of issuance of the
subpoena. The Company believes that the Ohio AG subpoena arises from a
government investigation that concerns the compensation of physician consultants
and related matters. On September 18, 2008, the Company submitted a claim for
indemnification from the escrow fund established in connection with the
Blackstone Merger Agreement for any losses to us resulting from the USAO-Nevada
subpoena, the Massachusetts CID and the Ohio AG subpoena.
By order
entered on January 4, 2007, the U.S. District Court for the Eastern District of
Arkansas unsealed a qui tam complaint captioned Thomas v. Chan, et al.,
4:06-cv-00465-JLH, filed against Dr. Patrick Chan, Blackstone and other
defendants including another device manufacturer. The amended complaint in the
Thomas action alleges causes of action under the False Claims Act for alleged
inappropriate payments and other items of value conferred on Dr. Chan and
another provider. The Company believes that Blackstone has meritorious defenses
to the claims alleged and the Company intends to defend vigorously against this
lawsuit. On September 17, 2007, the Company submitted a claim for
indemnification from the escrow fund established in connection with the
Blackstone Merger Agreement for any losses to us resulting from this matter. The
Company was subsequently notified by legal counsel for the former shareholders
that the representative of the former shareholders of Blackstone has objected to
the indemnification claim and intends to contest it in accordance with the terms
of the Blackstone Merger Agreement.
Under the
Blackstone Merger Agreement, the former shareholders of Blackstone have agreed
to indemnify the Company for breaches of representations and warranties under
the agreement as well as certain other specified matters. These post-closing
indemnification obligations of the former Blackstone shareholders are limited to
a cumulative aggregate amount of $66.6 million. At closing, an escrow fund was
established pursuant to the terms of the Blackstone Merger Agreement to fund
timely submitted indemnification claims. The initial amount of the escrow fund
was $50.0 million. As of December 31, 2009, the escrow fund, which has
subsequently accrued interest, contained $52.0 million. The Company is also
entitled to seek direct personal recourse against certain principal shareholders
of Blackstone after all monies on deposit in the escrow fund have been paid out
or released or are the subject of pending or unresolved indemnification claims
but only for a period of six years from the closing date of the merger and only
up to an amount equal to $66.6 million less indemnification claims previously
paid.
In
addition to the foregoing claims, the Company has submitted claims for
indemnification from the escrow fund for losses that have resulted or may result
from certain civil actions filed against Blackstone as well as certain claims
against Blackstone alleging rights to payments for Blackstone stock options not
reflected in Blackstone’s corporate ledger at the time of its acquisition by the
Company, or that the shares or stock options subject to those claims were
improperly diluted by Blackstone. To date, the representative of the
former shareholders of Blackstone has not objected to approximately $1.5 million
in such claims from the escrow fund, with certain claims remaining
pending.
The
Company is unable to predict the outcome of each of the escrow claims described
above in the preceding paragraphs or to estimate the amount, if any, that may
ultimately be returned to the Company from the escrow fund and there can be no
assurance that losses to the Company from these matters will not exceed the
amount of the escrow fund. Expenses incurred by the Company relating to the
above matters are recorded as an escrow receivable in the Company’s financial
statements to the extent the Company believes, among other things, that
collection of the claims is reasonably assured. Expenditures related to such
matters for which the Company believes collection is doubtful are recognized in
earnings when incurred. As of December 31, 2009 and December 31, 2008, included
in Prepaid expenses and other current assets is approximately $12.9 million and
$8.3 million, respectively, of escrow receivable balances related to the
Blackstone matters described above. These amounts include, among other things,
attorneys’ fees and costs related to the government investigations manifested by
the subpoenas described above, the stock option-related claims described above,
and costs related to the qui-tam action described above. As described above,
some of these reimbursement claims are being contested by the representative of
the former shareholders of Blackstone. To mitigate the risk that some
reimbursement claims will not be collected, the Company records a reserve
against the escrow receivable during the period in which reimbursement claims
are recognized. During 2009, the Company received approximately $1.0
million of proceeds from the escrow fund which represented a portion of the
escrow claims that had been previously submitted by the Company.
Effective
October 29, 2007, Blackstone entered into a settlement agreement of a patent
infringement lawsuit brought by certain affiliates of Medtronic Sofamor Danek
USA Inc. In that lawsuit, the Medtronic plaintiffs had alleged that they were
the exclusive licensees of certain U.S. patents and that Blackstone’s making,
selling, offering for sale, and using its Blackstone Anterior Cervical Plate, 3º
Anterior Cervical Plate, Hallmark Anterior Cervical Plate, Reliant Cervical
Plate, Pillar PEEK and Construx Mini PEEK VBR System products within the U.S.
willfully infringed the subject patents. Blackstone denied infringement and
asserted that the patents were invalid. The settlement agreement is not expected
to have a material impact on the Company’s consolidated financial position,
results of operations or cash flows. On July 20, 2007, the Company submitted a
claim for indemnification from the escrow fund established in connection with
the Blackstone Merger Agreement for any losses to us resulting from this matter.
The Company was subsequently notified by legal counsel of the former
shareholders that the representative of the former shareholders of Blackstone
has objected to the indemnification claim and intends to contest it in
accordance with the terms of the Blackstone Merger Agreement.
On or
about April 10, 2009, the Company received a HIPAA subpoena (“HIPAA subpoena”)
issued by the U.S. Attorney’s Office for the District of Massachusetts (the
“Boston USAO”). The subpoena sought documents concerning, among other things,
the Company’s promotion and marketing of its bone growth stimulator devices. The
Boston USAO issued a supplemental subpoena in this matter dated July 23, 2009,
requiring testimony. That office later excused performance with the July 23,
2009 subpoena indefinitely. The Boston USAO also issued supplemental subpoenas
in this matter, dated September 21, 2009 and December 16, 2009, respectively,
seeking documents. The subpoenas seek documents for the period January 1, 1995
through the date of the respective subpoenas. Document production in response to
the subpoenas is ongoing. On December 21, 2009, the Boston USAO provided the
Company with grand jury subpoenas for the testimony of certain current employees
in connection with its ongoing investigation. The Company intends to cooperate
with the government’s requests. In meetings with the Company and its attorneys
regarding this matter, the Boston USAO has informed the Company that it is
investigating possible criminal and civil violations of federal law related to
the Company’s promotion and marketing of its bone growth stimulator
devices.
On or
about April 14, 2009, the Company obtained a copy of a qui tam complaint filed
by Jeffrey J. Bierman in the U.S. District Court for the District of
Massachusetts against Orthofix, Inc., the Company, and other companies that have
allegedly manufactured bone growth stimulation devices, including Orthologic
Corp., DJO Incorporated, Reable Therapeutics, Inc., the Blackstone Group, L.P.,
Biomet, Inc., EBI, L.P., EBI Holdings, Inc., EBI Medical Systems, Inc.,
Bioelectron, Inc., LBV Acquisition, Inc., and Smith & Nephew, Inc. By order
entered on March 24, 2009, the court unsealed the case. The amended complaint
alleges various causes of action under the federal False Claims Act and state
and city false claims acts premised on the contention that the defendants
improperly promoted the sale, as opposed to the rental, of bone growth
stimulation devices. The amended complaint also includes claims against the
defendants for, among other things, allegedly misleading physicians and
purportedly causing them to file false claims and for allegedly violating the
Anti-kickback Act by providing free products to physicians, waiving patients’
insurance co-payments, and providing inducements to independent sales agents to
generate business. The Company believes that this lawsuit is related to the
matter described above involving the HIPAA subpoena. The Company and Orthofix,
Inc. were served on or about September 8, 2009. The Company intends to defend
vigorously against this lawsuit.
On or
about July 2, 2009, the Company obtained a copy of a qui tam complaint filed by
Marcus Laughlin that is pending in the U.S. District Court for the District of
Massachusetts against the Company. This complaint has been consolidated with the
complaint described in the immediately preceding paragraph, and was unsealed on
June 30, 2009. The complaint alleges violations of the False Claims Act,
fraudulent billing, illegal kickbacks and wrongful termination based on
allegations that the Company promoted the sale rather than the rental of bone
growth stimulation devices, systematically overcharged for these products,
provided physicians kickbacks in the form of free units, referral fees, and
fitting fees, and that the defendant and its competitors discussed together
strategies to encourage higher government pricing for the products. The
complaint also alleges that TRICARE has been reimbursing the Company for its
Cervical Stim
®
product without approval to do so. An amended complaint alleges
conspiracy and violations of the Sherman Anti-Trust Act in connection with the
same alleged conduct. The Company was served with the complaint on or about
September 9, 2009. The Company intends to defend vigorously against
this lawsuit.
On June
18, 2008, a lawsuit against the Company was filed for unpaid royalties under an
agreement terminated by the Company in 2007. The Company has
counterclaimed for the overpayment of commissions previously paid under the
agreement. The plaintiffs are seeking approximately $3.7
million. The Company’s counterclaim exceeds this
amount. The outcome of this matter is uncertain.
Our
subsidiary, Breg, Inc., was engaged in the manufacturing and sale of local
infusion pumps for pain management from 1999 to 2008, when the product line was
divested. As between 2008 and present, numerous product liability
cases have been filed in the United States alleging that the local anesthetic,
when dispensed by such infusion pumps inside a joint, causes a rare arthritic
condition called “chondrolysis.” The Company believes that
meritorious defenses exist to these claims and Breg, Inc. intends to vigorously
defend these cases.
The
Company cannot predict the outcome of any proceedings or claims made against the
Company or its subsidiaries described in the preceding paragraphs and there can
be no assurance that the ultimate resolution of any claim will not have a
material adverse impact on our consolidated financial position, results of
operations, or cash flows.
In
addition to the foregoing, in the normal course of our business, the Company is
involved in various lawsuits from time to time and may be subject to certain
other contingencies. To the extent losses related to these
contingencies are both probable and estimable, the Company provides appropriate
amounts in the accompanying financial statements.
Item
X.
Executive Officers of the Registrant
The
following table sets forth certain information about the persons who serve as
our executive officers.
Name
|
Age
|
Position
|
Alan
W. Milinazzo
|
50
|
Chief
Executive Officer, President and Director
|
Robert
S. Vaters
|
49
|
Executive
Vice President and Chief Financial Officer
|
Michael
Simpson
|
48
|
President,
Orthopedics North America
|
Kevin
Unger
|
38
|
President,
Orthofix Spinal Implants
|
Brad
Lee
|
44
|
President,
Breg, Orthofix Sports Medicine
|
Luigi
Ferrari
|
42
|
President,
Orthofix International Orthopedic Fixation
|
Eric
Brown
|
53
|
President,
Spine Stimulation
|
Michael
M. Finegan
|
46
|
Vice
President, Corporate Development and President,
Biologics
|
Raymond
C. Kolls
|
47
|
Senior
Vice President, General Counsel and Corporate
Secretary
|
______________
Our
officers serve at the discretion of the Board of Directors. There are
no family relationships among any of our directors or executive
officers. The following is a summary of the background of each
executive officer.
Alan W.
Milinazzo.
Mr. Milinazzo joined Orthofix International N.V. in
2005 as Chief Operating Officer and succeeded to the position of Chief Executive
Officer effective as of April 1, 2006. From 2002 to 2005, Mr.
Milinazzo was Vice President of Medtronic, Inc.’s Vascular business as well as
Vice President and General Manager of Medtronic’s Coronary and Peripheral
businesses. Prior to his time with Medtronic, Mr. Milinazzo spent 12
years as an executive with Boston Scientific Corporation in numerous roles,
including Vice President of Marketing for SCIMED Europe. Mr.
Milinazzo brings more than two and a half decades of experience in the
management and marketing of medical device businesses, including positions with
Aspect Medical Systems and American Hospital Supply. He earned a
bachelor’s degree, cum laude, at Boston College in 1981.
Robert S.
Vaters.
Mr. Vaters became Executive Vice President and Chief
Financial Officer of Orthofix International N.V. on September 7,
2008. Mr. Vaters joined the Company after almost four years as a
senior executive at Inamed Corporation, where he was Executive Vice President,
Chief Financial Officer and Head of Strategy and Corporate
Development. Inamed Corporation, a global medical device company was
acquired by Allergan Inc. in March of 2006. Since 2006, Mr. Vaters
has been General Partner of a health care private equity firm, which he
co-founded, and serves on the Board of Reliable Biopharmaceutical Corporation, a
private health care company.
Michael
Simpson
. Mr. Simpson became President, Orthopedics North
America in 2008. From 2002 to 2006, Mr. Simpson was Vice President of
Operations for Orthofix Inc. In 2006, Mr. Simpson was promoted to Senior Vice
President of Global Operations and General Manager, Orthofix Inc. responsible
for world wide manufacturing and distribution. With more than 20 years of
experience in a broad spectrum of industries he has held the following
positions: Chief Operating Officer, Business Unit Vice President, Vice President
of Operations, Vice President of Sales, Plant Manager, Director of Finance and
Director of Operations. His employment history includes the following companies:
Texas Instruments, Boeing, McGaw/IVAX, Mark IV Industries, Intermec and
Unilever.
Kevin Unger.
Mr.
Unger joined Orthofix as President, Orthofix Spinal Implants in August 2009.
Prior to joining Orthofix, he held the position of Vice President and General
Manager for MedSurg Divisions at Stryker. While with Stryker, Mr. Unger held
roles with increasing responsibility in marketing and sales, during which he
built sales organizations, was head of a global marketing department and led
business development initiatives. He brings with him more than 15 years of
medical device experience, specifically in the orthopedic and minimally invasive
surgical markets. Mr. Unger attended college at Miami University (Oxford, OH)
receiving his BS in Business Administration and furthered his Pre-Med studies at
Indiana University Medical School.
Brad Lee.
Mr. Lee
became President, BREG, Orthofix Sports Medicine in July 2008. He joined
Orthofix in 2005 as Director of Business Development, and in early 2008, became
Vice President and General Manager of the BREG Sports Medicine Division. Prior
to joining the Orthofix team, Mr. Lee was Vice President of Marketing for LMA
North America.
Luigi Ferrari.
Mr.
Ferrari became President, Orthofix International Orthopedic Fixation in October
2009 and manages the Orthopedics International, MedSurg and European Spine
businesses. Previously, he was President of Orthopedics International and was
responsible for the development, manufacturing and sales of fixation systems in
international markets. From 2006 to 2008, he was Vice President of Europe and
oversaw Orthofix activities in these key geographic markets. He serves also as
General Manager of Orthofix Srl, Italy. Mr. Ferrari graduated with a
degree in Management Engineering from Politecnico di Milano University in
1992.
Eric
Brown
.
Mr.
Brown was named President, Spine Stimulation in 2009. Prior to that,
he was Senior Vice President, Sales and Marketing for Orthofix Inc. His
long-standing career with Orthofix began in 1990. He has held various sales and
marketing positions, including Region Manager, Director of Sales and Vice
President of Sales. Before joining Orthofix, Mr. Brown spent eight years at
Medtronic Neurological. He received his BS in Business Administration from
Michigan State University.
Michael M.
Finegan.
Mr. Finegan joined Orthofix International N.V. in
June 2006 as Vice President of Corporate Development. Mr. Finegan was
named President, Biologics in March 2009. Prior to joining Orthofix,
Mr. Finegan spent sixteen years as an executive with Boston Scientific in a
number of different operating and strategic roles, most recently as Vice
President of Corporate Sales. Earlier in his career, Mr. Finegan held
sales and marketing roles with Marion Laboratories and spent three years in
banking with First Union Corporation (Wachovia). Mr. Finegan earned a
BA in Economics from Wake Forest University.
Raymond C. Kolls,
J.D.
Mr. Kolls became Vice President, General Counsel and
Corporate Secretary of Orthofix International N.V. on July 1, 2004. Mr. Kolls
was named Senior Vice President, General Counsel and Corporate Secretary
effective October 1, 2006. From 2001 to 2004, Mr. Kolls was Associate
General Counsel for CSX Corporation. Mr. Kolls began his legal career
as an attorney in private practice with the law firm of Morgan, Lewis &
Bockius. Mr. Kolls will be ceasing his employment with the Company
effective as of March 31, 2010.
Item
5.
Market for Registrant’s
Common Equity, Related Stockholder Matters
and Issuer Purchases of
Equity Securities
Market
for Our Common Stock
Our
common stock is traded on the Nasdaq
®
Global Select Market under the symbol “OFIX.” The following table
shows the quarterly range of high and low sales prices for our common stock as
reported by Nasdaq
®
for
each of the two most recent fiscal years ended December 31, 2009. As
of February 26, 2010 we had 489 holders of record of our common
stock. The closing price of our common stock on February 26, 2010 was
$34.09.
|
|
High
|
|
|
Low
|
|
2008
|
|
|
|
|
|
|
First
Quarter
|
|
$
|
59.96
|
|
|
$
|
35.50
|
|
Second
Quarter
|
|
|
40.29
|
|
|
|
28.46
|
|
Third
Quarter
|
|
|
29.83
|
|
|
|
17.07
|
|
Fourth
Quarter
|
|
|
20.03
|
|
|
|
8.65
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
|
|
|
|
|
First
Quarter
|
|
$
|
19.99
|
|
|
$
|
13.43
|
|
Second
Quarter
|
|
|
27.24
|
|
|
|
16.10
|
|
Third
Quarter
|
|
|
30.47
|
|
|
|
22.03
|
|
Fourth
Quarter
|
|
|
33.49
|
|
|
|
28.43
|
|
Dividend
Policy
We have
not paid dividends to holders of our common stock in the past. We
currently intend to retain all of our consolidated earnings to finance credit
agreement obligations and to finance the continued growth of our
business. We have no present intention to pay dividends in the
foreseeable future.
In the
event that we decide to pay a dividend to holders of our common stock in the
future with dividends received from our subsidiaries, we may, based on
prevailing rates of taxation, be required to pay additional withholding and
income tax on such amounts received from our subsidiaries.
Recent
Sales of Unregistered Securities
There
were no securities sold by us during 2009 that were not registered under the
Securities Act.
Exchange
Controls
Although
there are Netherlands Antilles laws that may impose foreign exchange controls on
us and that may affect the payment of dividends, interest or other payments to
nonresident holders of our securities, including the shares of common stock, we
have been granted an exemption from such foreign exchange control regulations by
the Bank of the Netherlands Antilles. Other jurisdictions in which we
conduct operations may have various currency or exchange controls. In
addition, we are subject to the risk of changes in political conditions or
economic policies that could result in new or additional currency or exchange
controls or other restrictions being imposed on our operations. As to
our securities, Netherlands Antilles law and our Articles of Association impose
no limitations on the rights of persons who are not residents in or citizens of
the Netherlands Antilles to hold or vote such securities.
Taxation
Under the
laws of the Netherlands Antilles as currently in effect, a holder of shares of
common stock who is not a resident of, and during the taxable year has not
engaged in trade or business through a permanent establishment in, the
Netherlands Antilles will not be subject to Netherlands Antilles income tax on
dividends paid with respect to the shares of common stock or on gains realized
during that year on sale or disposal of such shares; the Netherlands Antilles
does not impose a withholding tax on dividends paid by us. There are
no gift or inheritance taxes levied by the Netherlands Antilles when, at the
time of such gift or at the time of death, the relevant holder of common shares
was not domiciled in the Netherlands Antilles. No reciprocal tax
treaty presently exists between the Netherlands Antilles and the
U.S.
Performance
Graph
The
following performance graph in this Item 5 of this Annual Report on Form 10-K is
not deemed to be “soliciting material” or to be "filed" with the SEC or subject
to Regulation 14A or 14C under the Securities Exchange Act of 1934 or to the
liabilities of Section 18 of the Securities Exchange Act of 1934, and will not
be deemed to be incorporated by reference into any filing under the Securities
Act of 1933 or the Securities Exchange Act of 1934, except to the extent we
specifically incorporate it by reference into such a filing.
The graph
below compares the five-year total return to shareholders for Orthofix common
stock with comparable return of two indexes: the NASDAQ Stock Market and NASDAQ
stocks for surgical, medical, and dental instruments and supplies.
The graph
assumes that you invested $100 in Orthofix Common Stock and in each of the
indexes on December 31, 2004. Points on the graph represent the
performance as of the last business day of each of the years
indicated.
Item
6.
Selected Financial Data
The
following selected consolidated financial data for the years ended December 31,
2009, 2008, 2007, 2006 and 2005 have been derived from our audited consolidated
financial statements. The financial data as of December 31, 2009 and
2008 and for the years ended December 31, 2009, 2008 and 2007 should be read in
conjunction with, and are qualified in their entirety by, reference to Item 7
under the heading “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” and our consolidated financial statements and notes
thereto included elsewhere in this Form 10-K. Our consolidated
financial statements have been prepared in accordance with accounting principles
generally accepted in the U.S. (“US GAAP”).
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(US$
in thousands, except margin and per share data)
|
|
Consolidated
operating results
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$
|
545,635
|
|
|
$
|
519,675
|
|
|
$
|
490,323
|
|
|
$
|
365,359
|
|
|
$
|
313,304
|
|
Gross
profit
(5)
|
|
|
407,185
|
|
|
|
367,661
|
|
|
|
361,291
|
|
|
|
271,734
|
|
|
|
229,516
|
|
Gross
profit margin
(5)
|
|
|
75
|
%
|
|
|
71
|
%
|
|
|
74
|
%
|
|
|
74
|
%
|
|
|
73
|
%
|
Total
operating income (loss)
|
|
|
63,875
|
|
|
|
(256,949
|
)
|
|
|
38,057
|
|
|
|
9,946
|
|
|
|
99,795
|
|
Net
income (loss)
(1) (2)
(3) (4)
|
|
|
24,472
|
|
|
|
(228,554
|
)
|
|
|
10,968
|
|
|
|
(7,042
|
)
|
|
|
73,402
|
|
Net
income (loss) per share of common stock (basic)
|
|
|
1.43
|
|
|
|
(13.37
|
)
|
|
|
0.66
|
|
|
|
(0.44
|
)
|
|
|
4.61
|
|
Net
income (loss) per share of common stock (diluted)
|
|
|
1.42
|
|
|
|
(13.37
|
)
|
|
|
0.64
|
|
|
|
(0.44
|
)
|
|
|
4.51
|
|
_______________
(1)
|
The
Company has not paid any dividends in any of the years
presented.
|
(2)
|
Net
loss for 2006 includes $40.0 million after tax earnings charge related to
in-process research and development costs related to the Blackstone
acquisition.
|
(3)
|
Net
income for 2007 includes $12.8 million after tax earnings charge related
to impairment of certain intangible
assets.
|
(4)
|
Net
loss for 2008 includes $237.7 million after tax charge related to
impairment of goodwill and certain intangible
assets.
|
(5)
|
Gross
profit includes effect of obsolescence provision representing 2% points
for the year ended December 31,
2008.
|
Consolidated
financial position
|
|
|
|
(at
year-end)
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(US$
in thousands, except share data)
|
|
Total
assets
|
|
$
|
590,473
|
|
|
$
|
561,215
|
|
|
$
|
885,664
|
|
|
$
|
862,285
|
|
|
$
|
473,861
|
|
Total
debt
|
|
|
254,673
|
|
|
|
282,769
|
|
|
|
306,635
|
|
|
|
315,467
|
|
|
|
15,287
|
|
Shareholders’
equity
|
|
|
240,269
|
|
|
|
202,061
|
|
|
|
433,940
|
|
|
|
392,635
|
|
|
|
368,885
|
|
Weighted
average number of shares of common stock outstanding
(basic)
|
|
|
17,119,474
|
|
|
|
17,095,416
|
|
|
|
16,638,873
|
|
|
|
16,165,540
|
|
|
|
15,913,475
|
|
Weighted
average number of shares of common stock outstanding
(diluted)
|
|
|
17,202,943
|
|
|
|
17,095,416
|
|
|
|
17,047,587
|
|
|
|
16,165,540
|
|
|
|
16,288,975
|
|
Item
7.
Management’s Discussion and Analysis of Financial
Condition and Results of Operations
The
following discussion and analysis addresses the results of our operations which
are based upon the consolidated financial statements included herein, which have
been prepared in accordance with US GAAP. This discussion should be read in
conjunction with “Forward-Looking Statements” and our consolidated financial
statements and notes thereto appearing elsewhere in this Form 10-K
.
This discussion
and analysis also addresses our liquidity and financial condition and other
matters.
General
We are a
diversified orthopedic products company offering a broad line of surgical and
non-surgical products for the Spine, Orthopedics, Sports Medicine and Vascular
market sectors. Our products are designed to address the lifelong bone-and-joint
health needs of patients of all ages, helping them achieve a more active and
mobile lifestyle. We design, develop, manufacture, market and
distribute medical equipment used principally by musculoskeletal medical
specialists for orthopedic applications. Our main products are invasive and
minimally invasive spinal implant products and related human cellular and tissue
based products (“HCT/P products”), non-invasive bone growth stimulation products
used to enhance the success rate of spinal fusions and to treat non-union
fractures, external and internal fixation devices used in fracture treatment,
limb lengthening and bone reconstruction; and bracing products used for ligament
injury prevention, pain management and protection of surgical repair to promote
faster healing. Our products also include a device for enhancing
venous circulation, cold therapy, bone cement and devices for removal of bone
cement used to fix artificial implants and airway management products used in
anesthesia applications.
In 2009,
our publicly stated financial goals were primarily related to improvements in
the operating performance of the Spinal Implants & Biologics segment,
including:
|
·
|
An
acceleration in the growth of
revenue;
|
|
·
|
An
increase of the gross profit margin;
and
|
|
·
|
A
reduction in operating expenses as a percentage of net
sales
|
The
acceleration of revenue growth was driven by the introduction of a number of key
new products in 2009, including the Trinity® Evolution™ allograft, the Firebird™
pedicle screw system, the PILLAR™ SA interbody device, and the Ascent
®
LE
posterior cervical spine system.
Our gross
profit margin increased as a result of the introduction of the key new products
indicated above, primarily Trinity® Evolution™. While we record 70%
of the sales price of Trinity® Evolution™ allograft versus recording 100% of the
sales price of the old Trinity® product, we recognize a 100% gross profit margin
from the marketing fees earned from the sales of this allograft, compared to
approximately 50% gross profit margin on our previous Trinity®
product. This is due to the fact that we are not required to purchase
inventory of Trinity® Evolution™, whereas, previously, we were required to
purchase inventory of the old Trinity® product and record the associated cost of
sales.
Our
operating expenses decreased as a percentage of net sales as we leveraged our
operating infrastructure against the increase in net sales noted
above. Additionally, we initiated a reorganization and consolidation
plan, during the fourth quarter of 2008, to reduce operating expenses by
eliminating redundancies and increasing operating efficiency. This
plan includes the consolidation of operations in our Springfield, MA and Wayne,
NJ locations into the Company’s operations in the Dallas, TX
area. For a further discussion about this reorganization and
consolidation plan, please refer to the explanation provided in our Liquidity
and Capital Resources section of this Management Discussion and
Analysis.
We have
administrative and training facilities in the U.S. and Italy and manufacturing
facilities in the U.S., the United Kingdom, Italy and Mexico. We
directly distribute our products in the U.S., the United Kingdom, Italy,
Germany, Switzerland, Austria, France, Belgium, Mexico, Brazil, and Puerto Rico.
In several of these and other markets, we also distribute our products through
independent distributors.
Our
consolidated financial statements include the financial results of the Company
and its wholly-owned and majority-owned subsidiaries and entities over which we
have control. All intercompany accounts and transactions are
eliminated in consolidation.
Our
reporting currency is the U.S. Dollar. All balance sheet accounts,
except shareholders’ equity, are translated at year-end exchange rates, and
revenue and expense items are translated at weighted average rates of exchange
prevailing during the year. Gains and losses resulting from foreign
currency transactions are included in other income (expense). Gains
and losses resulting from the translation of foreign currency financial
statements are recorded in the accumulated other comprehensive income component
of shareholders’ equity.
Our
financial condition, results of operations and cash flows are not significantly
impacted by seasonality trends. However, sales associated with
products for elective procedures appear to be influenced by the somewhat lower
level of such procedures performed in the late summer. Certain of the
Breg
®
bracing products experience greater demand in the fall and winter corresponding
with high school and college football schedules and winter sports. In
addition, we do not believe our operations will be significantly affected by
inflation. However, in the ordinary course of business, we are
exposed to the impact of changes in interest rates and foreign currency
fluctuations. Our objective is to limit the impact of such movements
on earnings and cash flows. In order to achieve this objective, we
seek to balance non-dollar denominated income and
expenditures. During the year, we have used derivative instruments to
hedge foreign currency fluctuation exposures. See Item 7A –
“Quantitative and Qualitative Disclosures About Market Risk.”
We manage
our operations as four business segments: Domestic, Spinal Implants &
Biologics, Breg, and International. Domestic consists of operations
of our subsidiary Orthofix Inc. Spinal Implants and Biologics consist
of our Blackstone subsidiary and its domestic and international
operations. Breg consists of Breg Inc.’s operations and domestic and
international distributors. International consists of operations which are
located in the rest of the world as well as independent export distribution
operations. Group Activities are comprised of the operating expenses and
identifiable assets of Orthofix International N.V. and its U.S. holding company
subsidiary, Orthofix Holdings, Inc.
Critical
Accounting Policies and Estimates
Our
discussion of operating results is based upon the consolidated financial
statements and accompanying notes to the consolidated financial statements
prepared in conformity with US GAAP. The preparation of these
statements necessarily requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amount of revenues and expenses during the reporting
period. These estimates and assumptions form the basis for the
carrying values of assets and liabilities. On an ongoing basis, we
evaluate these estimates, including those related to allowance for doubtful
accounts, sales allowances and adjustments, inventories, intangible assets and
goodwill, income taxes, derivatives and litigation and
contingencies. We base our estimates on historical experience and
various other assumptions. Actual results may differ from these
estimates. We have reviewed our critical accounting policies with the
Audit Committee of the Board of Directors.
Revenue
Recognition
Revenue
is generally recognized as income in the period in which title passes and the
products are delivered. Revenues exclude any value added or other
local taxes, intercompany sales and trade discounts. Shipping and
handling costs are included in cost of sales. Royalty revenues are
recognized when the royalty is earned.
For bone
growth stimulation and certain bracing products that are prescribed by a
physician, the Company recognizes revenue when the product is placed on or
implanted in and accepted by the patient. For domestic spinal implant
and HCT/P products, revenues are recognized when the product has been utilized
and a confirming purchase order has been received from the
hospital. For sales to commercial customers, including hospitals and
distributors, revenues are recognized at the time of shipment unless contractual
agreements specify that title passes on delivery. Revenues for
inventory delivered on consignment are recognized as the product is used by the
consignee.
In 2008,
the Company entered into an agreement with the Musculoskeletal Transplant
Foundation (“MTF”) to develop and commercialize a new stem cell-based bone
growth biologic matrix. With the development process completed in
2009, the Company and MTF operate under the terms of a separate
commercialization agreement. Under the terms of this 10-year
agreement, MTF sources the tissue, processes it to create the bone growth
matrix, and packages and delivers it in accordance with orders received directly
from customers and from the Company. The Company has exclusive global
marketing rights for the new allograft and receives a marketing fee from MTF
based on total sales. This marketing fee is recorded on a net basis
within net sales.
The
Company derives a significant amount of revenues in the U.S. from third-party
payors, including commercial insurance carriers, health maintenance
organizations, preferred provider organizations and governmental payors such as
Medicare. Amounts paid by these third-party payors are generally
based on fixed or allowable reimbursement rates. These revenues are
recorded at the expected or pre-authorized reimbursement rates, net of any
contractual allowances or adjustments. Certain billings are subject
to review by the third-party payors and may be subject to
adjustment.
Allowance
for Doubtful Accounts and Contractual Allowances
The
process for estimating the ultimate collection of accounts receivable involves
significant assumptions and judgments. Historical collection and
payor reimbursement experience is an integral part of the estimation process
related to reserves for doubtful accounts and the establishment of contractual
allowances. Accounts receivable are analyzed on a quarterly basis to
assess the adequacy of both reserves for doubtful accounts and contractual
allowances. Revisions in allowances for doubtful accounts estimates
are recorded as an adjustment to bad debt expense within sales and marketing
expenses. Revisions to contractual allowances are recorded as an
adjustment to net sales. In the judgment of management,
adequate allowances have been provided for doubtful accounts and contractual
allowances. Our estimates are periodically tested against actual
collection experience.
Inventory
Allowances
We write
down our inventory for inventory excess and obsolescence by an amount equal to
the difference between the cost of the inventory and the estimated net
realizable value based upon assumptions about future demand and market
conditions. Inventory is analyzed to assess the adequacy of inventory
excess and obsolescence provisions. Reserves in excess and
obsolescence provisions are recorded as adjustments to cost of goods
sold. If conditions or assumptions used in determining the market
value change, additional inventory adjustments in the future may be
necessary.
Goodwill
and Other Intangible Assets
In
accordance with ASC Topic 360 – Property, Plant and Equipment (formerly known as
SFAS No. 144 “Accounting for the Impairment or Disposal of Long-Lived Assets”),
intangible assets with definite lives, such as Orthofix’s developed technologies
and distribution network assets, are tested for impairment if any adverse
conditions exist or change in circumstances has occurred that would indicate
impairment or a change in the remaining useful life. If an impairment
indicator exists, the Company tests the intangible asset for
recoverability. For purposes of the recoverability test, the Company
groups its intangible assets with other assets and liabilities at the lowest
level of identifiable cash flows if the intangible asset does not generate cash
flows independent of other assets and liabilities. If the carrying
value of the intangible asset (asset group) exceeds the undiscounted cash flows
expected to result from the use and eventual disposition of the intangible asset
(asset group), the Company will write the carrying value down to the fair value
in the period identified.
The
Company generally calculates fair value of intangible assets as the present
value of estimated future cash flows the Company expects to generate from the
asset using a risk-adjusted discount rate. In determining the
estimated future cash flows associated with intangible assets, the Company uses
estimates and assumptions about future revenue contributions, cost structures
and remaining useful lives of the asset (asset group). The use of
alternative assumptions, including estimated cash flows, discount rates, and
alternative estimated remaining useful lives could result in different
calculations of impairment
The
Company tests goodwill and certain trademarks at least annually. The
Company tests more frequently if indicators are present or changes in
circumstances suggest that impairment may exist. These indicators
include, among others, declines in sales, earnings or cash flows, or the
development of a material adverse change in the business climate. The
Company assesses goodwill for impairment at the reporting unit level, which is
defined as an operating segment or one level below an operating segment,
referred to as a component. Consistent with prior years, the Company
has identified four reporting units, which are consistent with the Company’s
reporting segments; Domestic, Spinal Implants and Biologics, Breg and
International.
In
performing the annual impairment test, the Company utilizes the two-step
approach prescribed under ASC Topic 350 – Intangibles – Goodwill and Other
(formerly known as SFAS No. 142, “Goodwill and Other Intangible
Assets”). The first step requires a comparison of each reporting
unit’s carrying value to the fair value of the respective unit. If
the carrying value exceeds the fair value, a second step is performed to measure
the amount of impairment loss, if any.
Carrying
Value
In order
to calculate the respective carrying values, the Company records goodwill based
on the purchase price allocation performed at the time of
acquisition. Corporate assets and liabilities that directly relate to
a reporting unit’s operations are ascribed directly to that reporting unit.
Corporate assets and liabilities that are not directly related to a specific
reporting unit, but from which the reporting unit benefits, are allocated based
on the respective revenue contribution of each reporting unit.
Fair
Value – Income Approach
The fair
value of each reporting unit is estimated, entirely or predominantly, using an
income based approach. This income approach utilizes a discounted
cash flow (“DCF”), which estimates after-tax cash flows on a debt free basis,
discounted to present value using a risk-adjusted discount rate.
The
Company believes the DCF generally provides the most meaningful fair value as it
appropriately measures the Company’s income producing assets. The Company may
consider using a cost approach but generally believes it is not appropriate,
given the inability to replicate the value of the specific technology-based
assets within our reporting units. In circumstances when the DCF
indicator of fair value is not sufficiently conclusive to support the carrying
value of a reporting unit, or when other measures provide a more appropriate
indicator, we may consider a market approach in our determination of the
reporting unit’s fair value.
In
performing a DCF calculation, the Company is required to make assumptions about
the amount and timing of future expected cash flows, terminal value growth rates
and appropriate discount rates and in connection therewith considers the
following:
|
·
|
The
determination of expected cash flows is based on the Company’s strategic
plans and long-range planning forecasts which, to the extent reasonably
possible, reflect anticipated changes in the economy and the
industry. Revenue growth rates represent estimates based on
current and forecasted market conditions. The profit margin
assumptions are projected by each reporting unit based on historical
margins, the current cost structure and anticipated net cost
reductions.
|
|
·
|
The
terminal value growth rate is used to calculate the value of cash flows
beyond the last projected period in the DCF. This rate reflects
the Company’s estimates for stable, perpetual growth for each reporting
unit.
|
|
·
|
The
discount rates are based on the reporting unit’s risk-adjusted weighted
average cost of capital, using assumptions consistent with publicly traded
guideline companies operating within the medical device industry as well
as Company specific risk factors for each reporting
unit.
|
These
inputs represent the Company’s best estimate, however, different cash flows,
growth and discount rate assumptions could generate different fair values,
potentially impacting the Company’s impairment assessment.
Domestic,
Breg and International Reporting Units
The fair
value of the Domestic, Breg and International reporting units have been
established using a DCF method. These DCF results concluded the fair
value of the Domestic, Breg and International reporting units exceeded the
respective carrying values at December 31, 2009 and December 31,
2008. The assumptions used in the December 31, 2009 DCF results were
consistent with the DCF results used in the prior year, reflecting appropriate
adjustments for changes in the economic climate.
Spinal
Implants and Biologics Reporting Unit
During
the third quarter of 2008, the Company indentified indicators of impairment with
respect to the Spinal Implants and Biologics reporting unit, prompting an
interim impairment test. The determination of the Spinal Implants and
Biologics fair value was calculated using a combination of income and market
approaches, weighted based on guidance provided by an independent appraisal
firm. The income approach was based on a DCF model. The
market approach was based on the guideline transaction method, which derived
applicable market multiples from the prices at which comparable companies have
been acquired in the marketplace. The Company applied a weighted
average percentage of 75% - 25%, placing greater weight on the income approach,
which provided a lower fair value. This calculation resulted in a
$126.9 million impairment loss, reducing the related goodwill balance to $9.4
million as of December 31, 2008.
The
Company used a DCF to determine the fair value of the Spinal Implants and
Biologics reporting unit as of December 31, 2009. This resulted in no
significant changes to the Spinal Implants and Biologics fair value
assumptions. Accordingly, the annual impairment test as of December
31, 2009 resulted in no further impairment of the Spinal Implants and Biologics
reporting unit.
Derivatives
We manage
our exposure to fluctuations in interest rates and foreign exchange within the
consolidated financial statements according to our hedging policy. Under the
policy, we may engage in non-leveraged transactions involving various financial
derivative instruments to manage exposed positions. The policy
requires us to formally document the relationship between the hedging instrument
and hedged item, as well as its risk-management objective and strategy for
undertaking the hedge transaction. For instruments designated as a
cash flow hedge, we formally assesses (both at the hedge’s inception and on an
ongoing basis) whether the derivative that is used in the hedging transaction
has been effective in offsetting changes in the cash flows of the hedged item
and whether such derivative may be expected to remain effective in future
periods. If it is determined that a derivative is not (or has ceased
to be) effective as a hedge, we will discontinue the related hedge accounting
prospectively. Such a determination would be made when (1) the
derivative is no longer effective in offsetting changes in the cash flows of the
hedged item; (2) the derivative expires or is sold, terminated, or exercised; or
(3) management determines that designating the derivative as a hedging
instrument is no longer appropriate. Ineffective portions of changes
in the fair value of cash flow hedges are recognized in earnings.
We follow
ASC Topic 815 – Derivatives and Hedging (“ASC Topic 815”) (formerly known as
SFAS No. 133, “Accounting for Derivative Instruments and Hedging Activities”),
which requires that all derivatives be recorded as either assets or liabilities
on the balance sheet at their respective fair values. For a cash flow
hedge, the effective portion of the derivative’s change in fair value (i.e.,
gains or losses) is initially reported as a component of other comprehensive
income, net of related taxes, and subsequently reclassified into net earnings
when the hedged exposure affects net earnings.
We
utilize a cross currency swap to manage our foreign currency exposure related to
a portion of our intercompany receivable of a U.S. dollar functional currency
subsidiary that is denominated in Euro. The cross currency swap has
been accounted for as a cash flow hedge in accordance with ASC Topic
815.
Litigation
and Contingent Liabilities
From time
to time, we are parties to or targets of lawsuits, investigations and
proceedings, including product liability, personal injury, patent and
intellectual property, health and safety and employment and healthcare
regulatory matters, which are handled and defended in the ordinary course of
business. These lawsuits, investigations or proceedings could involve
a substantial number of claims and could also have an adverse impact on our
reputation and customer base. Although we maintain various liability
insurance programs for liabilities that could result from such lawsuits,
investigations or proceedings, we are self-insured for a significant portion of
such liabilities. We accrue for such claims when it is probable that
a liability has been incurred and the amount can be reasonably
estimated. The process of analyzing, assessing and establishing
reserve estimates for these types of claims involves
judgment. Changes in the facts and circumstances associated with a
claim could have a material impact on our results of operations and cash flows
in the period that reserve estimates are revised. We believe that
present insurance coverage and reserves are sufficient to cover currently
estimated exposures, but we cannot give any assurance that we will not incur
liabilities in excess of recorded reserves or our present insurance
coverage.
As part
of the total Blackstone purchase price, approximately $50.0 million was placed
into an escrow account, against which we can make claims for reimbursement for
certain defined items relating to the acquisition for which we are
indemnified. The Company has certain contingencies arising from the
acquisition that we expect will be reimbursable from the escrow account should
we have to make a payment to a third party, including legal fees incurred
related to the matter. We believe that the amount that we will be
required to pay relating to the contingencies will not exceed the amount of the
escrow account; however, there can be no assurance that the contingencies will
not exceed the amount of the escrow account.
Tax
Matters
We and
each of our subsidiaries are taxed at the rates applicable within each of their
respective jurisdictions. The composite income tax rate, tax
provisions, deferred tax assets and deferred tax liabilities will vary according
to the jurisdiction in which profits arise. Further, certain of our
subsidiaries sell products directly to our other subsidiaries or provide
administrative, marketing and support services to our other
subsidiaries. These intercompany sales and support services involve
subsidiaries operating in jurisdictions with differing tax rates. The
tax authorities in such jurisdictions may challenge our treatments under
residency criteria, transfer pricing provisions, or other aspects of their
respective tax laws, which could affect our composite tax rate and
provisions.
We
adopted the provisions of ASC Topic 740 – Income Taxes (formerly known as FASB
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes – an
interpretation of FASB Statement No. 109” (“FIN 48”)), on January 1,
2007. As such, we determine whether it is more likely than not that
our tax positions will be sustained based on the technical merits of each
position. At December 31, 2009, we have $0.4 million of unrecognized
tax benefits compared with $0.7 million of unrecognized tax benefits at December
31, 2008 and accrued interest and penalties of $0.4 million and $0.4 million at
December 31, 2009 and 2008, respectively.
Share-based
Compensation
The
Company recognizes share-based compensation in accordance with ASC Topic 718 –
Compensation – Stock Compensation (“ASC Topic 718”) (formerly known as SFAS No.
123(R) (revised 2004), “Share-Based Payment”). The fair value of
stock options is determined using the Black-Scholes valuation model. Such value
is recognized as expense over the service period net of estimated
forfeitures.
The
expected term of options granted is estimated based on a number of factors,
including the vesting term of the award, historical employee exercise behavior
for both options that are currently outstanding and options that have been
exercised or are expired, the expected volatility of the Company’s common stock
and an employee’s average length of service. The risk-free interest rate is
determined based upon a constant U.S. Treasury security rate with a contractual
life that approximates the expected term of the option
award. Management estimates expected volatility based on the
historical volatility of the Company’s stock. The compensation expense
recognized for all equity-based awards is net of estimated forfeitures.
Forfeitures are estimated based on an analysis of actual option
forfeitures.
Selected
Financial Data
The
following table presents certain items in our statements of operations as a
percent of net sales for the periods indicated:
|
|
|
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
Net
sales
|
|
|
100
|
|
|
|
100
|
|
|
|
100
|
|
Cost
of sales
|
|
|
25
|
|
|
|
29
|
|
|
|
26
|
|
Gross
profit
(1)
|
|
|
75
|
|
|
|
71
|
|
|
|
74
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
and marketing
|
|
|
40
|
|
|
|
40
|
|
|
|
38
|
|
General
and administrative
|
|
|
16
|
|
|
|
16
|
|
|
|
15
|
|
Research
and development
|
|
|
6
|
|
|
|
6
|
|
|
|
5
|
|
Amortization
of intangible assets
|
|
|
1
|
|
|
|
3
|
|
|
|
4
|
|
Impairment
of certain intangible assets
|
|
|
-
|
|
|
|
56
|
|
|
|
4
|
|
Total
operating income (loss)
|
|
|
12
|
|
|
|
(49
|
)
|
|
|
8
|
|
Net
income (loss)
(1)
|
|
|
4
|
|
|
|
(44
|
)
|
|
|
2
|
|
(1)
Includes
effect of obsolescence provision representing 2% in the year ended December 31,
2008.
Segment
and Market Sector Revenue
The
following tables display net sales by business segment and net sales by market
sector. We maintain our books and records and account for net sales,
costs of sales and expenses by business segment. We provide net sales
by market sector for information purposes only.
Business
Segment:
|
|
Year ended December 31,
(US$ in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent of Total Net
Sales
|
|
|
|
|
|
Percent of Total Net
Sales
|
|
|
|
|
|
Percent of Total Net
Sales
|
|
Domestic
|
|
$
|
210,703
|
|
|
|
38
|
%
|
|
$
|
188,807
|
|
|
|
36
|
%
|
|
$
|
166,727
|
|
|
|
34
|
%
|
Spinal
Implants and Biologics
|
|
|
118,680
|
|
|
|
22
|
%
|
|
|
108,966
|
|
|
|
21
|
%
|
|
|
115,914
|
|
|
|
24
|
%
|
Breg
|
|
|
92,188
|
|
|
|
17
|
%
|
|
|
89,478
|
|
|
|
17
|
%
|
|
|
83,397
|
|
|
|
17
|
%
|
International
|
|
|
124,064
|
|
|
|
23
|
%
|
|
|
132,424
|
|
|
|
26
|
%
|
|
|
124,285
|
|
|
|
25
|
%
|
Total
|
|
$
|
545,635
|
|
|
|
100
|
%
|
|
$
|
519,675
|
|
|
|
100
|
%
|
|
$
|
490,323
|
|
|
|
100
|
%
|
Our
revenues are derived from sales of products in the market sectors of Spine,
Orthopedics, Sports Medicine, Vascular and Other.
Market
Sector:
|
|
Year ended December 31,
(US$ in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent of Total Net
Sales
|
|
|
|
|
|
Percent of Total Net
Sales
|
|
|
|
|
|
Percent of Total Net
Sales
|
|
Spine
|
|
$
|
279,425
|
|
|
|
51
|
%
|
|
$
|
252,239
|
|
|
|
49
|
%
|
|
$
|
243,165
|
|
|
|
49
|
%
|
Orthopedics
|
|
|
131,310
|
|
|
|
24
|
%
|
|
|
129,106
|
|
|
|
25
|
%
|
|
|
111,932
|
|
|
|
23
|
%
|
Sports
Medicine
|
|
|
96,366
|
|
|
|
18
|
%
|
|
|
94,528
|
|
|
|
18
|
%
|
|
|
87,540
|
|
|
|
18
|
%
|
Vascular
|
|
|
18,710
|
|
|
|
3
|
%
|
|
|
17,890
|
|
|
|
3
|
%
|
|
|
19,866
|
|
|
|
4
|
%
|
Other
|
|
|
19,824
|
|
|
|
4
|
%
|
|
|
25,912
|
|
|
|
5
|
%
|
|
|
27,820
|
|
|
|
6
|
%
|
Total
|
|
$
|
545,635
|
|
|
|
100
|
%
|
|
$
|
519,675
|
|
|
|
100
|
%
|
|
$
|
490,323
|
|
|
|
100
|
%
|
2009
Compared to 2008
Net sales
increased 5% to $545.6 million in 2009 compared to $519.7 million in
2008. The impact of foreign currency decreased sales by $11.1 million
in 2009 when compared to 2008.
Sales
by Business Segment:
Net sales
in Domestic increased to $210.7 million in 2009 compared to $188.8 million in
2008, an increase of 12%. Domestic’s net sales represented 38% and
36% of our total net sales in 2009 and 2008, respectively. The increase in
Domestic’s net sales was partially the result of a 12% increase in sales in our
Spine market sector, which was mainly driven by increased sales of our
Spinal-Stim® and Cervical-Stim® products. The increase in Domestic’s
net sales was also attributable to a 10% increase in our Orthopedics market
sector which included a 14% increase in sales of Physio-Stim® products, an 8%
increase in sales of our external fixation products as compared to 2008 and a
36% increase in sales of our HCT/P products, specifically Trinity®
Evolution™. During the year ended December 31, 2009, Domestic
generated $1.5 million in revenues of Trinity® Evolution™.
Domestic
Sales by Market Sector:
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$
|
158,908
|
|
|
$
|
141,753
|
|
|
|
12
|
%
|
Orthopedics
|
|
|
51,795
|
|
|
|
47,054
|
|
|
|
10
|
%
|
Total
|
|
$
|
210,703
|
|
|
$
|
188,807
|
|
|
|
12
|
%
|
Net sales
in Spinal Implants & Biologics increased $9.7 million to $118.7 million
in 2009 compared to $109.0 million in 2008, an increase of 9%. Spinal
Implants & Biologics’ net sales represented 22% and 21% of our total net
sales in 2009 and 2008, respectively. The increase in sales was primarily
related to a 16% increase in our thoracolumbar product sales due to the
introduction of the new Firebird™ pedicle screw system during the second quarter
of 2009. Sales of our interbody and cervical products in 2009
increased by 4% and 10%, respectively, when compared to 2008. These
sales increases were partially offset by a 4% sales decrease in our biologics
products when compared to the same period last year as a result of our
replacement of the Trinity® product line with Trinity®
Evolution™. Although biologics sales decreased, the quantity of
product sold increased in 2009 compared to 2008 because, under the terms of the
agreement, we recognized marketing fees of 70% of the end-user sales price of
Trinity® Evolution™ compared to 100% of the end-user sales price of
Trinity®. All of Spinal Implants & Biologics’ sales are recorded
in our Spine market sector.
Net sales
in Breg increased $2.7 million to $92.2 million in 2009 compared to
$89.5 million in 2008, an increase of 3%. Breg’s net sales
represented
17%
of our total net sales
during both years ended December 31, 2009 and 2008. Net sales in Breg
would have been $93.7 million in 2009, or an increase of 5% compared to 2008,
had it not been for a reclassification of certain commissions which are
reflected as a reduction of revenue, but were originally recorded in operating
expenses. The increase in Breg’s net sales was primarily due to an 8%
increase in sales of our Breg bracing products when compared to the prior year,
primarily as a result of the sales of our new products which include spine
bracing. Further, sales of our cold therapy products increased 6% in
2009 compared to 2008 which is due to the recent introduction of our Kodiak®
cold therapy products. These increases were partially offset by a
decrease in sales of our pain therapy products as a result of the sale of
operations related to our Pain Care® line of ambulatory infusion pumps during
March 2008. All of Breg’s sales are recorded in our Sports Medicine
market sector.
Net sales
in International decreased 6% to $124.1 million in 2009 compared to $132.4
million in 2008. International’s net sales represented 23% and 26% of
our total net sales in 2009 and 2008, respectively. The impact of foreign
currency decreased International net sales by $10.9 million when compared to
2008. On a constant currency basis, Orthopedics sales in our International
segment increased 22% and 5%, respectively, in 2009 when compared to 2008.
Within the Orthopedics sector, external fixation, stimulation, and deformity
correction sales increased 7%, 20% and 23%, respectively, on a constant currency
basis, in 2009 when compared to 2008. Sales in our Vascular sector,
which consist of the A-V® Impulse System, increased 8% on a constant currency
basis, while our Other distributed products, primarily the Laryngeal Mask,
decreased 12% on a constant currency basis when compared to
2008.
International
Sales by Market Sector:
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$
|
1,837
|
|
|
$
|
1,520
|
|
|
|
21
|
%
|
|
|
22
|
%
|
Orthopedics
|
|
|
79,515
|
|
|
|
82,052
|
|
|
|
-3
|
%
|
|
|
5
|
%
|
Sports
Medicine
|
|
|
4,178
|
|
|
|
5,050
|
|
|
|
-17
|
%
|
|
|
-8
|
%
|
Vascular
|
|
|
18,710
|
|
|
|
17,890
|
|
|
|
5
|
%
|
|
|
8
|
%
|
Other
|
|
|
19,824
|
|
|
|
25,912
|
|
|
|
-23
|
%
|
|
|
-12
|
%
|
Total
|
|
$
|
124,064
|
|
|
$
|
132,424
|
|
|
|
-6
|
%
|
|
|
2
|
%
|
Sales
by Market Sector:
Sales of
our Spine products increased 11% to $279.4 million in 2009 compared to $252.2
million for 2008. Sales of our Cervical-Stim® and Spinal-Stim®
products increased 10% and 14%, respectively, in 2009 compared to
2008. In addition, sales of our Spinal Implants and Biologics
products increased 9% over the same period in the prior year primarily due to
sales in our Biologics products
which included sales from
the full market release of the Trinity® Evolution™ stem cell-based
allograft. Spine product sales were 51% and 49% of our total net
sales in the years ended December 31, 2009 and 2008, respectively.
Sales of
our Orthopedics products increased $2.2 million to $131.3 million in 2009
compared to $129.1 million in 2008. On a constant currency basis,
sales increased 7% in 2009 compared to 2008 due to increased sales of our Physio
Stim®, external fixation, and deformity correction products. Orthopedic product
sales were 24% and 25% of our total net sales for the year ended December 31,
2009 and 2008, respectively.
Sales of
our Sports Medicine products increased 2% to $96.4 million in 2009 compared to
$94.5
million in
2008. As previously mentioned, net sales of our Sports Medicine
products would have increased 4% to $97.9 million in 2009 compared to 2008 had
it not been for a revenue recognition change netting commission expenses against
gross revenues at one of our distributors. As discussed above, the
increase of $1.8 million is primarily due to sales of our Breg bracing and cold
therapy products, offset by a decrease in our pain therapy products, which
is
principally
attributable to the sale of operations relating to our Pain Care® line in March
2008. Sports Medicine product sales were 18% of our total net sales
in 2009 and 2008, respectively.
Sales of
our Vascular products, which consist of our A-V Impulse System®
,
increased 5% to $18.7 million
in 2009 compared to $17.9 million in 2008. On a constant currency
basis, sales increased 8% compared to the prior period. Vascular
product sales were 3% of our total net sales in 2009 and 2008,
respectively.
Sales of
our Other products, which include the sales of our Laryngeal Mask as well as our
Woman’s Care line, decreased 23% to $19.8 million for the year ended December
31, 2009 from $25.9 million for the year ended December 31, 2008. On
a constant currency basis, sales of our Other products decreased 12% in 2009
when compared to 2008. During 2009, we distributed the Laryngeal Mask
product in the United Kingdom and Italy. In October 2009, we
transitioned out of our agreement to distribute the Laryngeal Mask product in
Italy. We will transition out of our agreement to distribute the
Laryngeal Mask product in the United Kingdom in June 2010. Other
product sales were 4% and 5% of our total net sales in 2009 and 2008,
respectively.
Gross Profit
– Our gross
profit increased 11% to $407.2 million for the year ended December 31, 2009,
compared to $367.7 million for the year ended December 31, 2008. Gross
profit as a percent of net sales in 2009 was 74.6% compared to 70.7% in
2008. In the year ended December 31, 2008, due to reduced projections
in revenue, distributor terminations, new products, and the replacement of one
of our products with a successor product, the Company changed its estimates
regarding the inventory allowance at Spinal Implants and Biologics, primarily
based on estimated net realizable value using assumptions about future demand
and market conditions. The change in estimate resulted in an increase
in the reserve for obsolescence of approximately $10.9 million. In
addition, the Company recorded approximately $0.6 million of expense related to
Spinal Implants and Biologics instrumentation equipment, also as a result of the
replacement of one of our products with a successor product. Gross profit,
excluding the additional reserve recorded at Spinal Implants and Biologics was
73.0% for the year ended December 31, 2008. Excluding the negative
impacts in the prior year, the increase in the gross profit is primarily due to
the increased sales of higher margin stimulation products and Spinal Implants
& Biologics products. The gross margin in the year ended December
31, 2009 was unfavorably impacted by a $1.8 million increase in our inventory
reserve, which related primarily to the remaining supply of Trinity® allograft
on hand at the expiration of the Company’s distribution agreement on June 30,
2009.
Sales and Marketing Expense
–
Sales and marketing expense, which includes commissions, certain royalties and
the bad debt provision, generally increases and decreases in relation to
sales. Sales and marketing expense increased $9.0 million
,
or 4%, to $215.9
million in 2009 compared
to $206.9 million in 2008. As a percent of sales, sales and marketing
expense was 39.6% and 39.8% for 2009 and 2008, respectively. During
the year ended December 31, 2008, the Company recorded an increase in sales tax
expenses of $1.6 million resulting from an audit that covered a period of 43
months.
General and Administrative
Expense
– General and administrative expense increased $7.1 million, or
9%, in 2009 to $88.9 million compared to $81.8 million in 2008.
The increase is
primarily due to a $3.6 million restructuring charge to consolidate
substantially all of Blackstone’s operations previously conducted in Wayne, NJ
and Springfield, MA into the same facility housing its spine stimulation and
U.S. orthopedics business in the Dallas, TX area. In addition, the
Company also incurred legal and other professional services associated with a
proxy contest with one of the Company’s shareholders. The contest was
settled in a special shareholder meeting on April 2, 2009. As a
result, the Company does not anticipate incurring any expenses associated with
this matter going forward. The Company also recorded an $0.8 million
accrual during 2009 for potential royalties payable in connection with
litigation. In addition, general and administrative expenses were
also higher compared with the prior year due to infrastructure increases in some
faster growing international markets. General and administrative
expense as a percent of sales was 16.3% in 2009 compared to 15.7% in
2008.
Research and Development
Expense
– Research and development expense increased $0.6 million in 2009
to $31.5 million compared to $30.8 million in 2008. During 2009, we
incurred research and development expenses on two collaborative arrangements
with Musculoskeletal Transplant Foundation (“MTF”) and Intelligent Implant
Systems, LLC (“IIS”). We incurred approximately $3.9 million and $1.8
million in expenses as a result of our collaboration with MTF and IIS,
respectively, in 2009. As a percent of sales, research and development expense
was 5.8% in 2009 compared to 5.9% for the same period last year. We
expect to incur a milestone payment of $1.0 million to IIS in early 2010 and a
milestone payment of $0.5 million to Stout Medical Group in 2010. See
Liquidity and Capital Resources for further detail.
Amortization of Intangible
Assets
– Amortization of intangible assets decreased $10.1 million for
the year ended December 31, 2009 to $7.0 million compared to $17.1 million for
the year ended December 31, 2008. This decrease is primarily
attributed to the impairment of $105.7 million of definite-lived intangible
assets at Blackstone during 2008.
Impairment of Goodwill and Certain
Intangible Assets
– During the year ended December 31, 2008, we incurred
$289.5 million of expense related to the impairment of goodwill and certain
intangible assets. As part of our debt refinancing completed in
September 2008, five year projections were prepared for
Blackstone. These projections provided an indication of
impairment. Accordingly, an interim impairment test was performed in
accordance with ASC Topic 350 – Intangibles – Goodwill and
Other. Based on this interim test, we determined that the Blackstone
trademark, an indefinite-lived intangible asset, was impaired by $57.0
million. In addition, we determined that the carrying amount of
goodwill related to Blackstone exceeded its implied fair value, and recognized a
goodwill impairment loss of $126.9 million.
In
accordance with ASC Topic 360 – Property, Plant and Equipment, we determined
that a triggering event had occurred with respect to the definite-lived
intangible assets at Blackstone. We compared the expected cash flows
to be generated by the definite lived intangible on an undiscounted basis to the
carrying value of the intangible asset. We determined the carrying
value exceeded the undiscounted cash flow and impaired the distribution network
and technologies at Blackstone to the fair value which resulted in an impairment
charge of $105.7 million.
Gain on Sale of Pain Care®
Operations
– Gain on sale of Pain Care® operations was $1.6 million for
the year ended December 31, 2008 and represented the gain on the sale of
operations related to our Pain Care® line of ambulatory infusion pumps during
March 2008. No such gain was recorded in the same period of
2009.
Interest Expense, net
–
Interest expense, net was $24.6 million in 2009 compared to $19.7 million in
2008. Included in interest expense, net for the year ended December
31, 2009 and 2008 was interest expense of $23.5 million and $18.2 million
related to the senior secured term loan used to finance the Blackstone
acquisition. Although our overall senior secured term loan balance
has decreased when compared to the same period in the prior year, our effective
interest rate has increased which is generating the additional interest
expense.
Loss on Refinancing of Senior
Secured Term Loan
– In the year ended December 31, 2008, we incurred $5.7
million of expense related to the refinancing of the senior secured term loan
used to finance the Blackstone acquisition. This included a $3.7
million non-cash write-off of previously capitalized debt placement costs and
$2.0 million of fees associated with the amendment
.
We
anticipated that we would not remain in compliance with certain financial
covenants included in the senior secured credit facility and, consequently,
negotiated an amendment of our financial covenants, among other things, with our
lenders effective September 29, 2008.
Unrealized Non-cash Gain (Loss) on
Interest Rate Swap
– In June 2008, the Company entered into a three-year
fully amortizable interest rate swap agreement (the “Swap”) with a notional
amount of $150.0 million and an expiration date of June 30, 2011. During the
fourth quarter of 2008, the Company recognized in earnings an unrealized,
non-cash loss of approximately $(8.0) million when it was determined that the
Swap was no longer deemed highly effective. Therefore, special hedge
accounting is no longer applied and mark-to-market adjustments are required to
be reported in current earnings through the expiration of the swap in June 2011.
For the year ended December 31, 2009, the Company recorded an unrealized
non-cash gain of $1.9 million on the consolidated statements of
operations.
Other Income (Expense), net –
Other income (expense), net was ($1.1 million) in 2009 compared to ($4.7
million) in 2008. The decrease can be mainly attributed to the effect
of foreign exchange. During the year ended December 31, 2008, we recorded
foreign exchange losses of $2.7 million principally as a result of a
strengthening of the U.S. Dollar against various foreign currencies including
the Euro, Pound, Peso and Brazilian Real. Several of our foreign subsidiaries
hold trade payables or receivables in currencies (most notably the U.S. Dollar)
other than their functional (local) currency which results in foreign exchange
gains or losses when there is relative movement between those
currencies.
Income Tax Benefit
(Expense)
–
Our worldwide effective tax rate was 38.9% at December 31, 2009 as compared to a
tax benefit of 22.5% as of December 31, 2008. The 2009 effective tax
rate is impacted by a mix of earnings among tax jurisdictions, state taxes and
other items. The effective tax rate for 2008 reflected discrete items
resulting from the impairment of goodwill for which we receive no tax benefit,
the sale of operations related to our Pain Care® operations and the lapse of an
ASC Topic 740 – Income Taxes reserve item. Excluding these discrete
items, our effective tax rate for 2008 would have been 36.5%. The
increase in the effective tax rate in 2009 as compared to 2008, excluding
discrete items, primarily relates to a benefit recorded in 2008 related to the
release of tax reserves as a result of the expiration of the statute of
limitations.
Net Income (Loss)
–
Net income in 2009 was $24.5
million, or $1.43
per basic share and
$1.42 per diluted share, compared to a net loss of $(228.6) million, or $(13.37)
per basic and diluted share for 2008. The weighted average number of
basic common shares outstanding was 17,119,474 and 17,095,416 during the years
ended December 31, 2009 and 2008, respectively. The weighted average
number of diluted common shares outstanding was 17,202,943 and 17,095,416 during
the years ended December 31, 2009 and 2008, respectively.
2008
Compared to 2007
Net sales
increased 6% to $519.7 million in 2008 compared to $490.3 million in
2007. The impact of foreign currency increased sales by $4.2 million
in 2008 when compared to 2007.
Sales
by Business Segment:
Net sales
in Domestic increased to $188.8 million in 2008 compared to $166.7 million in
2007, an increase of 13%. Domestic represented 36% and 34% of our
total net sales in 2008 and 2007, respectively. The increase in
Domestic’s net sales was primarily the result of a 12% increase in sales in the
Spine market sector which was attributable to increased demand for both our
Spinal-Stim® and Cervical-Stim® products. The increase in Domestic’s net sales
was also attributable to a 17% increase in our Orthopedics market sector which
included a 15% increase in sales of Physio-Stim® products as compared to the
prior year period and an increase in sales of HCT/P products used in orthopedic
applications for which there were no comparable sales in the prior
year.
Domestic
Sales by Market Sector:
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$
|
141,753
|
|
|
$
|
126,626
|
|
|
|
12
|
%
|
Orthopedics
|
|
|
47,054
|
|
|
|
40,101
|
|
|
|
17
|
%
|
Total
|
|
$
|
188,807
|
|
|
$
|
166,727
|
|
|
|
13
|
%
|
Net sales
in Spinal Implants and Biologics decreased $6.9 million to $109.0 million in
2008 compared to $115.9 million in 2007, a decrease of 6%. Spinal
Implants and Biologics’s net sales represented 21% and 24% of our total net
sales in 2008 and 2007, respectively. During the integration of
Spinal Implants and Biologics into our business we have experienced distributor
terminations, government investigations and the replacement of one of our
products with a successor product, all of which negatively impacted our sales
during the year ended December 31, 2008. These decreases in sales
have been partially offset by the increase in sales of our HCT/P
products. All of Spinal Implants and Biologics’s sales are
recorded in our Spine market sector.
Net sales
in Breg increased $6.1 million to $89.5 million in 2008 compared to $83.4
million in 2007, an increase of 7%. Breg’s net sales represented 17%
of our total net sales during both years ended December 31, 2008 and
2007. The increase in Breg’s net sales was primarily attributable to
a 12% increase in sales of Breg bracing products primarily as a result of
increased sales of our Fusion XT™ and other new products. Further,
sales of our cold therapy products increased 16% when compared to the prior year
due to the recent launch of our new Kodiak® cold therapy products. These
increases were partially offset by a decrease in sales of our pain therapy
products as a result of the sale of operations related to our Pain Care® line of
ambulatory infusion pumps during March 2008. All of Breg’s sales are recorded in
our Sports Medicine market sector.
Net sales
in International increased 7% to $132.4 million in 2008 compared to $124.3
million in 2007. International net sales represented 26% and 25% of
our total net sales in 2008 and 2007, respectively. The impact of
foreign currency increased International sales by 3% or $4.0 million when
compared to 2007. On a constant currency basis, Spine and Orthopedics
sales in our International segment increased 140% and 9%, respectively, in 2008
when compared to 2007. Within the Orthopedics sector, external fixation,
stimulation, and deformity correction sales increased 2%, 1% and 40%,
respectively, on a constant currency basis, in 2008 when compared to
2007. Sales in our Vascular sector, which consist of the A-V® Impulse
System, decreased 10% on a constant currency basis, while our Other distributed
products, primarily the Laryngeal Mask, decreased 6% on a constant currency
basis when compared to 2007.
International
Sales by Market Sector:
|
|
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$
|
1,520
|
|
|
$
|
625
|
|
|
|
143
|
%
|
|
|
141
|
%
|
Orthopedics
|
|
|
82,052
|
|
|
|
71,831
|
|
|
|
14
|
%
|
|
|
9
|
%
|
Sports
Medicine
|
|
|
5,050
|
|
|
|
4,143
|
|
|
|
22
|
%
|
|
|
17
|
%
|
Vascular
|
|
|
17,890
|
|
|
|
19,866
|
|
|
|
-10
|
%
|
|
|
-10
|
%
|
Other
|
|
|
25,912
|
|
|
|
27,820
|
|
|
|
-7
|
%
|
|
|
-6
|
%
|
Total
|
|
$
|
132,424
|
|
|
$
|
124,285
|
|
|
|
7
|
%
|
|
|
3
|
%
|
Sales
by Market Sector:
Sales of
our Spine products grew 4% to $252.2 million in 2008 compared to $243.2 million
in 2007. The increase of $9.1 million is primarily due to a 12% increase in
sales of spinal stimulation products in the U.S. This increase was
partially offset by a decrease in sales of Spinal Implants and Biologics’
products as a result of distributor terminations, government investigations and
the replacement of one of our products with a successor product, all of which
negatively impacted our sales during the year ended December 31,
2008. Spine product sales were 49% of our total net sales in both
years ended December 31, 2008 and 2007, respectively.
Sales of
our Orthopedics products increased $17.2 million to $129.1 million in 2008
compared to $111.9 million in 2007. The increase can be mainly attributed to a
45% increase in sales of our internal fixation devices including the Eight-Plate
Guided Growth System® as well as a 6% increase in sales of our external fixation
devices. Also attributing to the sale increase was a 14% increase in
sales of our Physio-Stim® products as compared to the prior year and an increase
in sales of HCT/P products used in orthopedic applications for which there were
no comparable sales in the prior year. Orthopedic product sales were
25% and 23% of our total net sales for the years ended December 31, 2008 and
2007, respectively.
Sales of
our Sports Medicine products increased 8% to $94.5 million in 2008 compared to
$87.5 million in 2007. As discussed above, the increase of $7.0 million is
primarily due to sales of our Breg bracing products as well as our cold therapy
products, offset by a decrease in our pain therapy products, which can be mainly
attributed to the sale of operations relating to our Pain Care® line in March
2008. Sports Medicine product sales were 18% of our total net sales
for both years ended December 31, 2008 and 2007.
Sales of
our Vascular products, which consist of our A-V Impulse System®, decreased 10%
to $17.9 million in 2008, compared to $19.9 million in 2007. Vascular
product sales were 3% and 4% of our total net sales for the years ended December
31, 2008 and 2007, respectively.
Sales of
our Other products, which include the sales of our Laryngeal Mask as well as our
woman’s care line, decreased 7% to $25.9 million. Other product sales
were 5% and 6% of our total net sales for the years ended December 31, 2008 and
2007, respectively.
Gross Profit —
Our gross
profit increased 2% to $367.7 million in 2008 compared to $361.3 million in
2007. In the year ended December 31, 2008, due to reduced projections
in revenue, distributor terminations, new products, and the replacement of one
of our products with a successor product, the Company changed its estimates
regarding the inventory allowance at Spinal Implants and Biologics, primarily
based on estimated net realizable value using assumptions about future demand
and market conditions. The change in estimate resulted in an increase in the
reserve for inventory obsolescence of approximately $10.9
million. During the year ended December 31, 2007, we recorded a
charge of $2.7 million for amortization of the step-up in inventory associated
with the Blackstone acquisition. Since the step-up in the Blackstone
inventory from purchase accounting was fully amortized during 2007, no such
amortization was recorded during the year ended December 31, 2008. Gross
profit, as a percent of net sales, in 2008 was 70.7% compared to 73.7% in
2007. Gross profit, excluding the additional reserve recorded at
Blackstone, was 73.0% in the year ended December 31, 2008. The lower
margin is principally the result of changes in product and geographic
mix.
Sales and Marketing Expenses —
Sales and marketing expense, which includes commissions, royalties and
bad debt provisions generally increase and decrease in relation to
sales. Sales and marketing expense increased $19.9 million to $206.9
million in 2008 from $187.0 million in 2007. The increase is
attributed to increased expense in order to support increased sales activity,
including higher commissions on higher sales. In addition sales and
marketing expense included approximately $2.0 million of costs incurred related
to the completed exploration of the potential divestiture of our orthopedic
fixation business. Sales and marketing expense as a percent of net
sales for 2008 and 2007 were 39.8% and 38.1%, respectively.
General and Administrative Expenses
—
General and administrative expenses increased $8.9 million, or 12%, to
$81.8 million in 2008 from $72.9 million in 2007. The increase is due primarily
to approximately $4.4 million of costs incurred in connection with the Company’s
potential divestiture of certain orthopedic fixation assets and other strategic
transaction costs during the first and second quarters of 2008. The
Company also incurred approximately $3.8 million of corporate reorganization
expenses in the third and fourth quarters of 2008. General and
administrative expenses as a percent of net sales were 15.7% and 14.9% in 2008
and 2007, respectively.
Research and Development
Expenses
– Research and development expenses increased $6.6 million to
$30.8 million in 2008 compared to $24.2 million in 2007. In 2008, we
incurred $6.1 million in expenses related to the Company’s collaboration with
MTF on the development and commercialization of Trinity® Evolution™. Research
and development expenses as a percent of net sales were 5.9% in 2008 and 4.9% in
2007.
Amortization of Intangible
Assets
— Amortization of intangible assets was $17.1 million in 2008
compared to $18.2 million in 2007. This decrease can be primarily
attributed to the impairment of certain intangible assets at Blackstone in the
third quarter of 2008.
Impairment of Goodwill and Certain
Intangible Assets
– In 2008, we incurred $289.5 million of expense
related to the impairment of goodwill and certain intangible
assets. As part of our debt refinancing completed in September 2008,
five year projections were prepared for Blackstone. These projections
provided an indication of impairment. Accordingly, an interim
impairment test was performed in accordance with ASC Topic 350. Based
on this interim test, we determined that the Blackstone trademark, an
indefinite-lived intangible asset, was impaired by $57.0 million. In
addition, we determined that the carrying amount of goodwill related to
Blackstone exceeded its implied fair value, due to the recent trend of
decreasing revenues at Blackstone. We recognized a goodwill
impairment loss of $126.9 million.
In
accordance with ASC Topic 360, we determined that a triggering event had
occurred with respect to the definite-lived intangible assets at
Blackstone. We compared the expected cash flows to be generated by
the definite lived intangible on an undiscounted basis to the carrying value of
the intangible asset. We determined the carrying value exceeded the
undiscounted cash flow and impaired the distribution network and technologies at
Blackstone to the fair value which resulted in an impairment charge of $105.7
million. In 2007, as part of our annual impairment test under ASC
Topic 350, we determined that the Blackstone trademark, an indefinite-lived
intangible asset, was impaired by $21.0 million because the book value exceeded
the fair value.
Gain on Sale of Pain Care®
Operations
– Gain on sale of Pain Care® operations was $1.6 million and
represented the gain on the sale of operations related to our Pain Care® line of
ambulatory infusion pumps during March 2008. No such gain was
recorded in the same period of 2007.
Interest Expense, net
–
Interest expense, net was $19.7 million in 2008 compared to $23.7 million in
2007. Interest expense, net in 2008 and 2007 included interest
expense of $18.2 million and $22.4 million, respectively, related to the senior
secured term loan used to finance the Blackstone acquisition. This
decrease can be mainly attributed to less outstanding principal from the
comparable period in the prior year.
Unrealized Non-cash Loss on Interest
Rate Swap
– In the fourth quarter of 2008, the Company incurred an
unrealized non-cash loss of approximately $8.0 million which resulted from
changes in the fair value of the Company’s interest rate swap. Due to
declining interest rates and a LIBOR floor in our amended credit facility, the
effectiveness of the swap was no longer deemed highly effective; therefore
changes in the fair value of the swap agreement are required to be reported in
earnings through the expiration of the swap in June 2011.
Loss on Refinancing of Senior
Secured Term Loan
– In the third quarter of 2008, we incurred $5.7
million of expense related to the refinancing of the senior secured term loan
used to finance the Blackstone acquisition. This included a $3.7
million non-cash write-off of previously capitalized debt placement costs and
$2.0 million of fees associated with the amendment
.
We
anticipated that we would not remain in compliance with certain financial
covenants included in the senior secured credit facility and, consequently,
negotiated an amendment of our financial covenants, among other things, with our
lenders effective September 29, 2008. There was no comparable charge in
2007.
Other Income (Expense), net –
Other income (expense), net was an expense of $(4.7) million in 2008
compared to income of $0.4 million in 2007. The decrease can be mainly
attributed to the effect of foreign exchange. During 2008, we recorded foreign
exchange losses of $3.0 million principally as a result of a rapid strengthening
of the US Dollar against various foreign currencies including the Euro, Pound,
Peso and Brazilian Real. Several of our foreign subsidiaries hold
trade or intercompany payables or receivables in currencies (most notably the
U.S. Dollar) denominated in other than their functional (local) currency which
results in foreign exchange gains or losses when there is relative movement
between those currencies.
Income Tax Benefit (Expense)
– Our effective tax rate was a benefit of 22.5% and a benefit of 25.5%
during 2008 and 2007, respectively. The effective tax rate for 2008 reflected
discrete items resulting from the impairment of goodwill for which we receive no
tax benefit, the sale of operations related to our Pain Care® operations and the
lapse of an ASC Topic 740 – Income Taxes reserve item. Excluding
these discrete items, our effective tax rate would have been
(36.5%). The effective tax rate for 2007 included a tax credit for
research and development expense related to 2003 thru 2006. Without the benefit
for the research and development tax credits our estimated worldwide effective
tax rate for 2007 would have been (31.6%). The increase in the
effective tax rate, excluding discrete items, primarily relates to the
expiration of the Company’s intercompany deferred consideration agreement in the
first quarter of 2008.
Net Income (Loss)
–
Net loss for 2008 was $228.6
million, or ($13.37) per basic and diluted share, compared to net income of
$11.0 million, or $0.66 per basic share and $0.64 per diluted share in
2007. The weighted average number of basic common shares outstanding
was 17,095,416 and 16,638,873 during 2008 and 2007, respectively. The
weighted average number of diluted common shares outstanding was 17,095,416 and
17,047,587 during 2008 and 2007, respectively.
Liquidity
and Capital Resources
Cash and
cash equivalents at December 31, 2009 were $25.0 million, of which $11.6 million
is subject to certain restrictions under the senior secured credit agreement
described below. This compares to cash and cash equivalents of $25.6
million at December 31, 2008, of which $11.0 million was subject to certain
restrictions under the senior secured credit agreement described
below.
Net cash
provided by operating activities was $50.0 million in 2009 compared to $26.8
million in 2008, an increase of $23.2 million. Net cash provided by
operating activities is comprised of net income (loss), non-cash items
(including depreciation and amortization, provision for doubtful accounts and
inventory obsolescence, share-based compensation, deferred taxes, change in the
fair value of the interest rate swap, impairment of goodwill and certain
intangible assets, loss on refinancing of senior secured term loan and gain on
the sale of Pain Care® operations) and changes in working capital, including
changes in restricted cash. Net income increased $253.0 million to a
net income of $24.5 million in 2009 compared to net loss of $(228.6) million in
2008. Non-cash items for 2009 decreased $236.9 million to $45.7
million compared to $282.6 in 2008 primarily as a result of the impairment of
goodwill and certain intangible assets of $289.5 million in 2008 that did not
exist in 2009, a decrease in the fair value of the interest rate swap of $9.8
million, and a decrease in depreciation and amortization of $8.9 million, offset
by an increase in the change in deferred taxes of $74.7
million. Working capital accounts consumed $20.2 million of cash in
2009 compared to $27.3 million in 2008. The principal change in
working capital can be mainly attributable to an increase in the current
liabilities position of $16.0 million mainly the result of restructuring costs
previously mentioned, increases in accrued payroll, bonuses and related payroll
taxes, increased commissions to distributors and the timing of inventory
receipts. Overall performance indicators for our two primary working
capital accounts, accounts receivable and inventory, reflect days sales in
receivables of 83 days at December 31, 2009 compared to 77 days at December 31,
2008 and inventory turns of 1.6 times at December 31, 2009 compared to 1.5 times
at December 31, 2008. Also included in cash used in working capital
in 2009 were $6.1 million in costs related to matters occurring at Blackstone
prior to the acquisition and for which we are seeking reimbursement from the
applicable escrow fund.
Net cash
used in investing activities was $22.3 million in 2009 compared to $13.4 million
in 2008. During the first quarter of 2008, we sold the operations of
our Pain Care
®
line of
ambulatory infusion pumps for net proceeds of $6.0 million. During
the year ended December 31, 2009 and 2008, we invested $22.0 million and $20.2
million in capital expenditures, respectively. During the year ended
December 31, 2009, we made a loan in connection with our collaborative
arrangement with MTF for $2.0 million. In 2009, we sold our remaining
ownership in OPED AG, a German based bracing company, for net proceeds of $1.7
million. In 2008, we sold a portion of our ownership in OPED AG for
net proceeds of $0.8 million.
Net cash
used in financing activities was $29.3 million for the year ended December 31,
2009 compared to $22.8 million for the year ended December 31,
2008. During 2009, we repaid approximately $28.3 million against the
principal on our senior secured term loan compared to $17.1 million in
2008. In 2009, we borrowed $0.2 million on our line of credit through
our Italian subsidiary compared to a 2008 repayment on that same line of credit
of $6.7 million. During the year ended December 31, 2009, we used
approximately $1.1 million to purchase an additional 32% minority interest in
our Breg distributor in Germany. During the year ended December 31,
2008, we received proceeds of $1.7 million from the issuance of
51,052 shares of our
common stock upon the exercise of stock options.
On
September 22, 2006 the Company’s wholly-owned U.S. holding company subsidiary,
Orthofix Holdings, Inc. (“Orthofix Holdings”), entered into a senior secured
credit facility with a syndicate of financial institutions to finance the
acquisition of Blackstone. Certain terms of the senior secured credit
facility were amended in September 29, 2008. The senior secured
credit facility provides for (1) a seven-year amortizing term loan facility of
$330.0 million and (2) a six-year revolving credit facility of $45.0
million. As of December 31, 2009, the Company had $0.3 million of
letters of credit outstanding under the revolving credit facility and $252.4
million outstanding under the term loan facility. Obligations under
the senior secured credit facility can have a floating interest rate of the
London Inter-Bank Offered Rate (“LIBOR”) plus a margin, with a LIBOR floor of
3.0%, or prime rate plus a margin. As of December 31, 2009, the
entire term loan obligation of $252.4 million is at the prime rate plus a margin
of 3.50%.
In June
2008, we entered into a three-year fully amortizable interest rate swap
agreement (the “Swap”) with a notional amount of $150.0 million and an
expiration date of June 30, 2011. The amount outstanding under the
Swap as of December 31, 2009 was $150.0 million. Under the Swap we
will pay a fixed rate of 3.73% and receive interest at floating rates based on
the three month LIBOR rate at each quarterly re-pricing date until the
expiration of the Swap. As of December 31, 2009, the effective
interest rate on the debt related to the Swap was 10.2%. Our overall effective
interest rate, including the impact of the Swap as of December 31, 2009 on our
senior secured debt was 8.8%.
The
credit agreement contains certain financial covenants, including a fixed charge
coverage ratio and a leverage ratio applicable to Orthofix and its subsidiaries
on a consolidated basis. A breach of any of these covenants could result in an
event of default under the credit agreement, which could permit acceleration of
the debt payments under the facility. The Company was in compliance
with these financial covenants as measured at December 31, 2009. As
defined in the senior secured credit facility, our leverage ratio can not exceed
3.25 and our fixed charge ratio must be greater than or equal to 1.30 at
December 31, 2009. Our leverage and fixed charge ratios were 2.60 and
1.61, respectively, at December 31, 2009.
The
leverage ratio the Company can not exceed, as defined in the senior secured
credit facility, will be 2.85 for the first quarter of 2010, 2.75 for the second
quarter of 2010 and 2.50 thereafter. Effective January 1, 2010, the
fixed charge coverage ratio must be greater than 1.375 and it will remain at
that rate for the remaining life of the senior secured credit
facility. Based on the Company’s projected earnings, we believe that
the Company should be able to meet these financial covenants in future fiscal
quarters, however, there can be no assurance that it will be able to do so, and
failure to do so could result in an event of default under the credit agreement,
which could have a material adverse effect on our financial
position.
Each of
the domestic subsidiaries of the Company (which includes Orthofix Inc., Breg
Inc., and Blackstone) and Colgate Medical Limited and Victory Medical Limited
(wholly-owned financing subsidiaries of the Company) has guaranteed the
obligations of Orthofix Holdings under the senior secured credit
facility. The obligations of the subsidiaries under their guarantees
are secured by the pledges of their respective assets.
Certain
subsidiaries of the Company have restrictions on their ability to pay dividends
or make intercompany loan advances pursuant to the Company’s senior secured
credit facility. The net assets of Orthofix Holdings and its
subsidiaries are restricted for distributions to the parent
company. Domestic subsidiaries of the Company, as parties to the
credit agreement, have access to these net assets for operational
purposes. The amount of restricted net assets of Orthofix Holdings
and its subsidiaries as of December 31, 2009 is $143.1 million compared to
$111.3 million at December 31, 2008. In addition, the senior secured
credit facility restricts the Company and subsidiaries that are not parties to
the credit facility from access to cash held by Colgate Medical Limited and its
subsidiaries. All credit party subsidiaries have access to this cash
for operational and debt repayment purposes. The amount of restricted cash of
the Company as of December 31, 2009 is $11.6 million compared to $11.0 million
at December 31, 2008.
At
December 31, 2009, we had outstanding borrowings of $2.2 million and unused
available lines of credit of approximately 5.8 million Euro ($8.2 million)
under a line of credit established in Italy to finance the working capital of
our Italian operations. The terms of the line of credit give us the option to
borrow amounts in Italy at rates determined at the time of
borrowing.
In the
fourth quarter of 2008, as part of the Company’s strategic plan to strengthen
the business, the Company initiated a restructuring plan to improve operations
and reduce costs at Blackstone. The plan involves the consolidation
of substantially all of Blackstone’s operations previously conducted in Wayne,
NJ and Springfield, MA into the same facility housing its spine stimulation and
U.S. orthopedics business in the Dallas, TX area. The Company plans
to complete the restructuring and consolidation by the second quarter of 2010,
at which time the Company anticipates a total restructuring expense of $3.6
million. During the year ended December 31, 2009, the Company
recorded net restructuring charges of $3.6
million, which were
primarily related to severance costs and accelerated depreciation costs related
to shortening lives of assets which will be disposed. These restructuring costs
are recorded in general and administrative expense and are classified in the
Spinal Implants & Biologics segment.
The
following table presents changes in the restructuring liability, which is
included within Other Current Liabilities in the Company’s consolidated balance
sheets as of December 31, 2009 and December 31, 2008:
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2008
|
|
$
|
548
|
|
|
$
|
-
|
|
|
$
|
548
|
|
Charges
|
|
|
2,565
|
|
|
|
1,020
|
|
|
|
3,585
|
|
Cash
Payments
|
|
|
(1,287
|
)
|
|
|
-
|
|
|
|
(1,287
|
)
|
Non-cash
Items
|
|
|
-
|
|
|
|
(1,020
|
)
|
|
|
(1,020
|
)
|
Balance
at December 31, 2009
|
|
$
|
1,826
|
|
|
$
|
-
|
|
|
$
|
1,826
|
|
On July
24, 2008, we entered into an agreement with MTF to collaborate on the
development and commercialization of a new stem cell-based bone growth biologic
matrix. Under the terms of the agreement, we invested $10.0 million
to develop the new stem cell-based bone growth biologic matrix that provides the
beneficial properties of an autograft in spinal and orthopedic
surgeries. The new matrix was launched with a full market release in
the U.S. effective on July 1, 2009. Expenditures related to
collaborative arrangements are expensed to research and development based on the
terms of the related agreements. A total of $3.9 million of expenses
was recognized under the terms of the agreement and included in research and
development expense for the year ended December 31, 2009.
As
previously announced in 2008, we entered into an agreement with Intelligent
Implant Systems (“IIS”) for the acquisition and development of a next-generation
pedicle screw system for our spinal implants division. Under the
agreement, we purchased $2.5 million of intellectual property and related
technology. During the year ended December 31, 2009, IIS met their
first development milestone and under the terms of the agreement the Company
paid IIS $1.0 million. Also in 2009, the Company and IIS amended the
existing agreement and the Company paid IIS an additional $0.8 million for
partially meeting its next milestone. The Company has recorded these
payments totaling $1.8 million for the year ended December 31, 2009 as research
and development expense. IIS will continue to perform research and
development functions related to the technology and under the agreement and
amended agreement we will pay IIS an additional amount up to $2.7 million for
research and development performance milestones.
We
believe that current cash balances together with projected cash flows from
operating activities, the availability of the $44.7 million revolving credit
facility, the available Italian line of credit, and our debt capacity are
sufficient to cover anticipated working capital and capital expenditure needs
including research and development costs and research and development projects
formerly mentioned, over the near term.
Contractual
Obligations
The
following chart sets forth our contractual obligations as of December 31,
2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
2011-2013
|
|
|
|
2014-2015
|
|
|
|
|
Senior
secured term loan
|
|
$
|
252,400
|
|
|
$
|
-
|
|
|
$
|
252,400
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Estimated
interest on senior secured term loan
(1)
|
|
|
58,435
|
|
|
|
17,037
|
|
|
|
41,398
|
|
|
|
-
|
|
|
|
-
|
|
Other
borrowings
|
|
|
97
|
|
|
|
32
|
|
|
|
65
|
|
|
|
-
|
|
|
|
-
|
|
Purchase
obligations
(2)
|
|
|
2,417
|
|
|
|
1,000
|
|
|
|
1,417
|
|
|
|
-
|
|
|
|
-
|
|
Operating
leases
|
|
|
24,697
|
|
|
|
5,621
|
|
|
|
9,208
|
|
|
|
3,180
|
|
|
|
6,688
|
|
Total
|
|
$
|
338,046
|
|
|
$
|
23,690
|
|
|
$
|
304,488
|
|
|
$
|
3,180
|
|
|
$
|
6,688
|
|
|
(1)
|
Estimated
interest on senior secured term loan excludes any potential effects of the
interest rate swap agreement and assumes payments are made in accordance
with the scheduled payments as defined in the
agreement. Interest payments are estimated using rates in
effect at December 31, 2009.
|
|
(2)
|
In
addition to the unconditional purchase obligations stated above, the
Company also has inventory purchase agreements that, if terminated, would
require the Company to purchase an additional $1.1 million of
inventory.
|
We may be
required to make cash outlays related to our unrecognized tax
benefits. However, due to the uncertainty of the timing of future
cash flows associated with our unrecognized tax benefits, we are unable to make
reasonably reliable estimates of the period of cash settlement, if any, with the
respective taxing authorities. Accordingly, unrecognized tax benefits
of $0.4 million as of December 31, 2009 have been excluded from the contractual
obligations table above. For further information on unrecognized tax
benefits, see Note 14 to the consolidated financial statements included in this
Report
The
aggregate maturities of long-term debt after December 31, 2009 are as
follows: 2010 – $0, 2011 – $0, 2012 – $35.4 million, and 2013 –
$217.0 million.
In
addition to scheduled contractual payment obligations on the debt as set forth
above, our credit agreement requires us to make mandatory prepayments with (a)
the excess cash flow (as defined in the credit agreement) of Orthofix
International N.V. and its subsidiaries, in an amount equal to 50% of the excess
annual cash flow beginning with the year ending December 31, 2007, provided,
however, if the leverage ratio (as defined in the credit agreement) is less than
or equal to 1.75 to 1.00, as of the end of any fiscal year, there will be no
mandatory excess cash flow prepayment, with respect to such fiscal year, (b)
100% of the net cash proceeds of any debt issuances by Orthofix International
N.V. or any of its subsidiaries or 50% of the net cash proceeds of equity
issuances by any such party, excluding the exercise of stock options, provided,
however, if the leverage ratio is less than or equal to 1.75 to 1.00 at the end
of the preceding fiscal year, Orthofix Holdings shall not be required to prepay
the loans with the proceeds of any such debt or equity issuance in the
immediately succeeding fiscal year, (c) the net cash proceeds of asset
dispositions over a minimum threshold, or (d) unless reinvested, insurance
proceeds or condemnation awards.
Off-balance
Sheet Arrangements
As of
December 31, 2009, we did not have any off-balance sheet arrangements that have
or are reasonably likely to have a current or future effect on our financial
condition, changes in financial condition, revenues or expenses, results of
operations, cash flows, liquidity, capital expenditures or capital resources
that are material to investors.
Item
7A. Quantitative and Qualitative Disclosures About Market
Risk
We are
exposed to certain market risks as part of our ongoing business
operations. Primary exposures include changes in interest rates and
foreign currency fluctuations. These exposures can vary sales, cost of sales,
costs of operations, and the cost of financing and yields on cash and short-term
investments. We use derivative financial instruments, where
appropriate, to manage these risks. However, our risk
management policy does not allow us to hedge positions we do not hold nor do we
enter into derivative or other financial investments for trading or speculative
purposes. As of December 31, 2009, we had a currency swap in place to
minimize foreign currency exchange risk related to a 38.3 million
Euro intercompany note.
We are
exposed to interest rate risk in connection with our senior secured term loan
and borrowings under our revolving credit facility (if any), which bear interest
at floating rates based on LIBOR or the prime rate plus an applicable borrowing
margin. Therefore, interest rate changes generally do not affect the fair market
value of the debt, but do impact future earnings and cash flows, assuming other
factors are held constant. We had an interest rate swap in place as of December
31, 2009 to minimize interest rate risk related to our LIBOR-based
borrowings.
As of
December 31, 2009, we had $252.4 million of variable rate term debt represented
by borrowings under our senior secured term loan which can have a floating
interest rate of LIBOR plus a margin, with a LIBOR floor of 3.0%, or the prime
rate plus a margin. As of December 31, 2009, the entire term loan
obligation of $252.4 million is at the prime rate plus a margin of 3.50%, which
is adjusted based upon the credit rating of the Company and its
subsidiaries. In June 2008, we entered into a Swap with a notional
amount of $150.0 million and an expiration date of June 30, 2011. The
amount outstanding under the Swap as of December 31, 2009 was $150.0
million. Under the Swap we will pay a fixed rate of 3.73% and receive
interest at floating rates based on the three month LIBOR rate at each quarterly
re-pricing date until the expiration of the Swap. As of December 31,
2009, the effective interest rate on the debt related to the Swap was 10.2%. As
of December 31, 2009, our overall effective interest rate, including the impact
of the Swap, on our senior secured debt was 8.8%. Based on the balance
outstanding under the senior secured term loan combined with the Swap as of
December 31, 2009, an immediate change of one percentage point in the applicable
interest rate on the variable rate debt would cause a change in interest expense
of approximately $2.5 million on an annual basis.
Our
foreign currency exposure results from fluctuating currency exchange rates,
primarily the U.S. Dollar against the Euro, Great Britain Pound, Mexican Peso
and Brazilian Real. We are subject to cost of goods currency exposure
when we produce products in foreign currencies such as the Euro or Great Britain
Pound and sell those products in U.S. Dollars. We are subject to
transactional currency exposures when foreign subsidiaries (or the Company
itself) enter into transactions denominated in a currency other than their
functional currency. As of December 31, 2009, we had an un-hedged
intercompany receivable denominated in Euro of approximately 23.3 million ($33.4
million). We recorded a foreign currency gain during the year ended
December 31, 2009 of $0.8 million, which resulted from the strengthening of the
Euro against the U.S. dollar during the period.
We also
are subject to currency exposure from translating the results of our global
operations into the U.S. dollar at exchange rates that have fluctuated from the
beginning of the period. The U.S. dollar equivalent of international sales
denominated in foreign currencies was unfavorably impacted during the year ended
December 31, 2009 by foreign currency exchange rate fluctuations with the
strengthening of the U.S. dollar against the local foreign currency during this
period. During the year ended December 31, 2008, the U.S. dollar
equivalent of international sales denominated in foreign currencies was
favorably impacted by foreign currency exchange rate fluctuations with the
weakening of the U.S. dollar against the local foreign currency during this
period. As we continue to distribute and manufacture our products in
selected foreign countries, we expect that future sales and costs associated
with our activities in these markets will continue to be denominated in the
applicable foreign currencies, which could cause currency fluctuations to
materially impact our operating results.
Item
8.
Financial Statements and Supplementary
Data
See
“Index to Consolidated Financial Statements” on page F-1 of this Form
10-K.
Item
9
. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
None.
Item
9A.
Controls and Procedures
Disclosure
Controls and Procedures
Under the
supervision and with the participation of our management, including our Chief
Executive Officer and our Chief Financial Officer, we performed an evaluation of
the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Exchange Act Rule 13a - 15(e) or 15d – 15 (e)) as of
the end of the period covered by this report. Based upon that
evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that, as of the end of the period covered by this report, our disclosure
controls and procedures were effective.
Changes
in Internal Control over Financial Reporting
On July
1, 2009, we implemented an Enterprise Resource Planning (“ERP”) system at our
Spinal Implants and Biologics division. The ERP system, developed by
Oracle, improves and enhances internal controls over financial
reporting. This ERP system materially changes how transactions are
processed within this division.
Except
for the conversion to the ERP system, there have not been any changes in our
internal control over financial reporting during the year ended December 31,
2009 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
Our
management’s assessment regarding the Company’s internal control over financial
reporting can be found immediately prior to the financial statements in a
section entitled “Management’s Report on Internal Control over Financial
Reporting” in this Form 10-K.
Item
9B
. Other Information
Not
applicable.
Information
required by Items 10, 11, 12, 13 and 14 of Form 10-K is omitted from this annual
report and will be filed in a definitive proxy statement or by an amendment to
this annual report not later than 120 days after the end of the fiscal year
covered by this annual report.
Item
10.
Directors, Executive Officers
and Corporate
Governance
We will
provide information that is responsive to this Item 10 regarding executive
compensation in our definitive proxy statement or in an amendment to this annual
report not later than 120 days after the end of the fiscal year covered by this
annual report, in either case under the caption “Information About Directors,”
“Section 16(a) Beneficial Ownership Reporting Compliance” and others possibly
elsewhere therein. That information is incorporated in this Item 10
by reference.
Item
11.
Executive Compensation
We will
provide information that is responsive to this Item 11 regarding executive
compensation in our definitive proxy statement or in an amendment to this annual
report not later than 120 days after the end of the fiscal year covered by this
annual report, in either case under the caption “Executive Compensation,” and
possibly elsewhere therein. That information is incorporated in this
Item 11 by reference.
Item
12
.
Security Ownership of Certain Beneficial Owners and
Management
and
Related Stockholder
Matters
We will
provide information that is responsive to this Item 12 regarding ownership of
our securities by certain beneficial owners and our directors and executive
officers, as well as information with respect to our equity compensation plans,
in our definitive proxy statement or in an amendment to this annual report not
later than 120 days after the end of the fiscal year covered by this annual
report, in either case under the captions “Security Ownership of Certain
Beneficial Owners and Management and Related Stockholders” and “Equity
Compensation Plan Information,” and possibly elsewhere therein. That
information is incorporated in this Item 12 by reference.
Item
13
.
Certain Relationships and Related
Transactions
,
and Director Independence
We will
provide information that is responsive to this Item 13 regarding transactions
with related parties and director independence in our definitive proxy statement
or in an amendment to this annual report not later than 120 days after the end
of the fiscal year covered by this annual report, in either case under the
caption “Certain Relationships and Related Transactions,” and possibly elsewhere
therein. That information is incorporated in this Item 13 by
reference.
Item
14.
Principal Accountant Fees and Services
We will
provide information that is responsive to this Item 14 regarding principal
accountant fees and services in our definitive proxy statement or in an
amendment to this annual report not later than 120 days after the end of the
fiscal year covered by this annual report, in either case under the caption
“Principal Accountant Fees and Services,” and possibly elsewhere
therein. That information is incorporated in this Item 14 by
reference.
Item
15.
Exhibits and Financial Statement
Schedules
(a)
|
Documents
filed as part of report on Form
10-K
|
The
following documents are filed as part of this report on Form 10-K:
See
“Index to Consolidated Financial Statements” on page F-1 of this Form
10-K.
|
2.
|
Financial
Statement Schedules
|
See
“Index to Consolidated Financial Statements” on page F-1 of this Form
10-K.
|
|
|
3.1
|
|
Certificate
of Incorporation of the Company (filed as an exhibit to the Company’s
annual report on Form 20-F dated June 29, 2001 and incorporated herein by
reference).
|
|
|
|
3.2
|
|
Articles
of Association of the Company as amended (filed as an exhibit to the
Company's quarterly report on Form 10-Q for the quarter ended June 30,
2008 and incorporated herein by reference).
|
|
|
|
10.1
|
|
Orthofix
International N.V. Amended and Restated Stock Purchase Plan, as amended
(filed as an exhibit to the Company’s quarterly report on Form 10-Q for
the quarter ended June 30, 2009 and incorporated herein by
reference).
|
|
|
|
10.2
|
|
Orthofix
International N.V. Amended and Restated 2004 Long Term Incentive Plan
(filed as an exhibit to the Company’s quarterly report on Form 10-Q for
the quarter ended June 30, 2009 and incorporated herein by
reference).
|
|
|
|
10.3
|
|
Orthofix
International N.V. Staff Share Option Plan, as amended through April 22,
2003 (filed as an exhibit to the Company’s annual report on Form 10-K for
the fiscal year ended December 31, 2007 and incorporated herein by
reference).
|
|
|
|
10.4
|
|
Form
of Employee Non-Qualified Stock Option Agreement (post-2008 grants) (filed
as an exhibit to the Company's current report on Form 8-K filed July 7,
2009 and incorporated herein by reference).
|
|
|
|
10.5
|
|
Form
of Non-Employee Director Non-Qualified Stock Option Agreement (post-2008
grants) (filed as an exhibit to the Company's current report on Form 8-K
filed July 7, 2009 and incorporated herein by
reference).
|
|
|
|
10.6
|
|
Form
of Nonqualified Stock Option Agreement under the Orthofix International
N.V. Amended and Restated 2004 Long Term Incentive Plan (pre-2009 grants
-- vesting over 3 years) (filed as an exhibit to the Company's current
report on Form 8-K filed June 20, 2008 and incorporated herein by
reference).
|
|
|
|
10.7
|
|
Form
of Nonqualified Stock Option Agreement under the Orthofix International
N.V. Amended and Restated 2004 Long Term Incentive Plan (pre-2009 grants
-- 3 year cliff vesting) (filed as an exhibit to the Company's current
report on Form 8-K filed June 20, 2008 and incorporated herein by
reference).
|
10.8
|
|
Form
of Restricted Stock Grant Agreement under the Orthofix International N.V.
Amended and Restated 2004 Long Term Incentive Plan (vesting over 3 years)
(filed as an exhibit to the Company's current report on Form 8-K filed
June 20, 2008 and incorporated herein by reference).
|
|
|
|
10.9
|
|
Form
of Restricted Stock Grant Agreement under the Orthofix International N.V.
Amended and Restated 2004 Long Term Incentive Plan (3 year cliff vesting)
(filed as an exhibit to the Company's current report on Form 8-K filed
June 20, 2008 and incorporated herein by reference).
|
|
|
|
10.10
|
|
Amended
and Restated Orthofix Deferred Compensation Plan (filed as an exhibit to
the Company’s current report on Form 8-K filed January 7, 2009, and
incorporated herein by reference).
|
|
|
|
10.11
|
|
Acquisition
Agreement dated as of November 20, 2003, among Orthofix International
N.V., Trevor Acquisition, Inc., Breg, Inc. and Bradley R. Mason, as
shareholders’ representative (filed as an exhibit to the Company’s current
report on Form 8-K filed January 8, 2004 and incorporated herein by
reference).
|
|
|
|
10.12
|
|
Amended
and Restated Voting and Subscription Agreement dated as of December 22,
2003, among Orthofix International N.V. and the significant shareholders
of Breg, Inc. identified on the signature pages thereto (filed as an
exhibit to the Company’s current report on Form 8-K filed on January 8,
2004 and incorporated herein by reference).
|
|
|
|
10.13
|
|
Amendment
to Employment Agreement dated December 29, 2005 between Orthofix Inc. and
Charles W. Federico (filed as an exhibit to the Company’s current report
on Form 8-K filed December 30, 2005 and incorporated herein by
reference).
|
|
|
|
10.14
|
|
Form
of Indemnity Agreement (filed as an exhibit to the Company’s annual report
on Form 10-K for the fiscal year ended December 31, 2008 and incorporated
herein by reference).
|
|
|
|
10.16
|
|
Amended
and Restated Employment Agreement, dated December 6, 2007, between
Orthofix Inc. and Raymond C. Kolls (filed as an exhibit to the Company’s
annual report on Form 10-K for the fiscal year ended December 31, 2007, as
amended, and incorporated herein by reference).
|
|
|
|
10.17
|
|
Letter
Agreement, dated July 25, 2009, between Orthofix Inc. and Raymond C. Kolls
(filed as an exhibit to the Company's quarterly report on Form 10-Q for
the quarter ended September 30, 2009 and incorporated herein by
reference).
|
|
|
|
|
|
Credit
Agreement, dated as of September 22, 2006, among Orthofix Holdings, Inc.,
Orthofix International N.V., certain domestic subsidiaries of Orthofix
International N.V., Colgate Medical Limited, Victory Medical Limited,
Swiftsure Medical Limited, Orthofix UK Ltd, the several banks and other
financial institutions as may from time to time become parties thereunder,
and Wachovia Bank, National Association.
|
|
|
|
10.19
|
|
First
Amendment to Credit Agreement, dated September 29, 2008, by and among
Orthofix Holdings, Inc., Orthofix International N.V., certain domestic
subsidiaries of Orthofix International N.V., Colgate Medical Limited,
Victory Medical Limited, Swiftsure Medical Limited, Orthofix UK Ltd, and
Wachovia Bank, National Association, as administrative agent on behalf of
the Lenders under the Credit Agreement (filed as an exhibit to the
Company’s current report on Form 8-K filed September 29, 2008 and
incorporated herein by
reference).
|
10.20
|
|
Agreement
and Plan of Merger, dated as of August 4, 2006, among Orthofix
International N.V., Orthofix Holdings, Inc., New Era Medical Limited,
Blackstone Medical, Inc. and William G. Lyons, III, as Equityholders’
Representative (filed as an exhibit to the Company's current report on
Form 8-K filed August 7, 2006 and incorporated herein by
reference).
|
|
|
|
10.25
|
|
Description
of Director Fee Policy (filed as an exhibit to the Company's quarterly
report on Form 10-Q for the quarter ended March 31, 2009 and incorporated
herein by reference).
|
|
|
|
10.26
|
|
Summary
of Orthofix International N.V. Annual Incentive Program (filed as an
exhibit to the Company's quarterly report on Form 10-Q for the quarter
ended March 31, 2009 and incorporated herein by
reference).
|
|
|
|
10.27
|
|
Employment
Agreement between Orthofix Inc. and Thomas Hein dated as of April 11, 2008
(filed as an exhibit to the Company's quarterly report on Form 10-Q for
the quarter ended March 31, 2008 and incorporated herein by
reference).
|
|
|
|
10.28
|
|
Nonqualified
Stock Option Agreement under the Orthofix International N.V. Amended and
Restated 2004 Long-Term Incentive Plan, dated April 11, 2008, between
Orthofix International N.V. and Thomas Hein (filed as an exhibit to the
Company's quarterly report on Form 10-Q for the quarter ended March 31,
2008 and incorporated herein by reference).
|
|
|
|
10.29
|
|
Summary
of Consulting Arrangement between Orthofix International N.V. and Peter
Hewett (filed as an exhibit to the Company's quarterly report on Form 10-Q
for the quarter ended March 31, 2008 and incorporated herein by
reference).
|
|
|
|
10.31
|
|
Form
of Inducement Grant Nonqualified Stock Option Agreement between Orthofix
International N.V. and Robert S. Vaters (filed as an exhibit to the
current report on Form 8-K of Orthofix International N.V dated September
10, 2008 and incorporated herein by reference).
|
|
|
|
10.32+
|
|
Letter
Agreement between Orthofix Inc. and Oliver Burckhardt dated August 28,
2008 (filed as an exhibit to the Company’s quarterly report on Form 10-Q
for the quarter ended September 30, 2008 and incorporated herein by
reference).
|
|
|
|
10.33
|
|
Notice
of Termination from Orthofix Inc. to Oliver Burckhardt dated August 27,
2008 (filed as an exhibit to the Company’s quarterly report on Form 10-Q
for the quarter ended September 30, 2008 and incorporated herein by
reference).
|
|
|
|
10.34
|
|
Second
Amended and Restated Performance Accelerated Stock Options Agreement
between Orthofix International N.V. and Bradley R. Mason dated October 14,
2008 (filed as an exhibit to the Company’s current report on Form 8-K
filed October 15, 2008 and incorporated herein by
reference).
|
|
|
|
10.35
|
|
Nonqualified
Stock Option Agreement between Orthofix International N.V. and Bradley R.
Mason dated October 14, 2008 (filed as an exhibit to the Company’s current
report on Form 8-K filed October 15, 2008 and incorporated herein by
reference).
|
|
|
|
10.36
|
|
Amended
and Restated Employment Agreement, entered into and effective as of July
1, 2009, by and between Orthofix Inc. and Alan W. Milinazzo (filed as an
exhibit to the Company's current report on Form 8-K filed July 7, 2009 and
incorporated herein by
reference).
|
10.37
|
|
Amendment
No. 1 to Amended and Restated Employment Agreement, dated July 30, 2009,
by and between Orthofix Inc. and Alan W. Milinazzo (filed as an exhibit to
the Company's quarterly report on Form 10-Q for the quarter ended
September 30, 2009 and incorporated herein by
reference).
|
|
|
|
10.38
|
|
Amended
and Restated Employment Agreement, entered into and effective as of July
1, 2009, by and between Orthofix Inc. and Robert S. Vaters (filed as an
exhibit to the Company's current report on Form 8-K filed July 7, 2009 and
incorporated herein by reference).
|
|
|
|
10.39
|
|
Amendment
No. 1 to Amended and Restated Employment Agreement, dated July 30, 2009,
by and between Orthofix Inc. and Robert S. Vaters (filed as an exhibit to
the Company's quarterly report on Form 10-Q for the quarter ended
September 30, 2009 and incorporated herein by
reference).
|
|
|
|
10.40
|
|
Amended
and Restated Employment Agreement, entered into and effective as of July
1, 2009, by and between Orthofix Inc. and Bradley R. Mason (filed as an
exhibit to the Company's current report on Form 8-K filed July 7, 2009 and
incorporated herein by reference).
|
|
|
|
10.41
|
|
Amendment
No. 1 to Amended and Restated Employment Agreement, dated July 31, 2009,
by and between Orthofix Inc. and Bradley R. Mason (filed as an exhibit to
the Company's quarterly report on Form 10-Q for the quarter ended
September 30, 2009 and incorporated herein by
reference).
|
|
|
|
10.42
|
|
Amended
and Restated Employment Agreement, entered into on October 23, 2009 and
effective as of November 1, 2009, by and between Orthofix Inc. and Bradley
R. Mason (filed as an exhibit to the Company's quarterly report on Form
10-Q for the quarter ended September 30, 2009 and incorporated herein by
reference).
|
|
|
|
10.43
|
|
Amended
and Restated Employment Agreement, entered into and effective as of July
1, 2009, by and between Orthofix Inc. and Michael M. Finegan (filed as an
exhibit to the Company's current report on Form 8-K filed July 7, 2009 and
incorporated herein by reference).
|
|
|
|
10.44
|
|
Amendment
No. 1 to Amended and Restated Employment Agreement, dated August 4, 2009,
by and between Orthofix Inc. and Michael M. Finegan (filed as an exhibit
to the Company's quarterly report on Form 10-Q for the quarter ended
September 30, 2009 and incorporated herein by
reference).
|
|
|
|
10.45
|
|
Form
of Amendment to Stock Option Agreements (for Alan W. Milinazzo, Robert S.
Vaters, Bradley R. Mason, Michael M. Finegan and Michael Simpson) (filed
as an exhibit to the Company's current report on Form 8-K filed July 7,
2009 and incorporated herein by reference).
|
|
|
|
10.46
|
|
Inducement
Stock Option Agreement between Orthofix International N.V. and Kevin L.
Unger, dated August 17, 2009 (filed as an exhibit to the Company’s current
report on Form 8-K filed August 17, 2009 and incorporated herein by
reference).
|
|
|
|
10.47
|
|
Amended
and Restated Employment Agreement, entered into on September 4, 2009, by
and between Orthofix Inc. and Michael Simpson (filed as an exhibit to the
Company’s current report on Form 8-K filed September 11, 2009 and
incorporated herein by
reference).
|
|
|
Amended
and Restated Employment Agreement, entered into on July 1, 2009, by and
between Orthofix Inc. and Eric Brown.
|
|
|
|
|
|
Amended
and Restated Employment Agreement, entered into on November 16, 2009, by
and between Breg Inc. and Brad Lee.
|
|
|
|
|
|
Notice
of Termination from Orthofix Inc. to Ray Kolls dated January 29,
2010.
|
|
|
|
|
|
Matrix
Commercialization Collaboration Agreement, entered into July 24, 2008, by
and between Orthofix Holdings, Inc. and Musculoskeletal Transplant
Foundation.
|
|
|
|
|
|
List
of Subsidiaries.
|
|
|
|
|
|
Consent
of Ernst & Young LLP.
|
|
|
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Executive
Officer.
|
|
|
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Financial
Officer.
|
|
|
|
|
|
Section
1350 Certification of Chief Executive Officer.
|
|
|
|
|
|
Section
1350 Certification of Chief Financial
Officer.
|
+
Certain confidential portions of this exhibit were
omitted by means of redacting a portion of the text. This exhibit has
been filed separately with the Secretary of the Commission without redactions
pursuant to our Application Requesting Confidential Treatment under the
Securities Exchange Act of 1934.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
ORTHOFIX
INTERNATIONAL N.V.
|
|
|
|
|
|
|
|
|
Dated: March
1, 2010
|
By:
|
/s/ Alan W. Milinazzo
|
|
|
Name:
|
Alan
W. Milinazzo
|
|
|
Title:
|
Chief
Executive Officer and President
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the Registrant and in the
capacities and on the dates indicated.
Name
|
|
Title
|
Date
|
|
|
|
|
|
|
Chief
Executive Officer,
|
March
1, 2010
|
Alan
W. Milinazzo
|
|
President
and Director
|
|
|
|
|
|
|
|
Executive
Vice President and
|
March
1, 2010
|
Robert
S. Vaters
|
|
Chief
Financial Officer
|
|
|
|
|
|
|
|
Chairman
of the Board of Directors
|
March
1, 2010
|
James
F. Gero
|
|
|
|
|
|
|
|
|
|
Vice
Chairman of the Board of
|
March
1, 2010
|
Jerry
C. Benjamin
|
|
Directors
|
|
|
|
|
|
|
|
Director
|
March
1, 2010
|
Walter
von Wartburg
|
|
|
|
|
|
|
|
|
|
Director
|
March
1, 2010
|
Thomas
J. Kester
|
|
|
|
|
|
|
|
|
|
Director
|
March
1, 2010
|
Charles
W. Federico
|
|
|
|
|
|
|
|
|
|
Director
|
March
1, 2010
|
Guy
Jordan
|
|
|
|
|
|
|
|
|
|
Director
|
March
1, 2010
|
Kenneth
R. Weisshaar
|
|
|
|
|
|
|
|
|
|
Director
|
March
1, 2010
|
Maria
Sainz
|
|
|
|
|
|
|
|
|
|
Director
|
March
1, 2010
|
Michael
Mainelli
|
|
|
|
ORTHOFIX
INTERNATIONAL N.V.
Index
to Consolidated Financial Statements
|
Page
|
|
|
Index
to Consolidated Financial Statements
|
F-1
|
Statement of Management’s Responsibility for
Financial Statements
|
F-2
|
Management’s Report on Internal Control over
Financial Reporting
|
F-3
|
Report of Independent Registered Public Accounting
Firm
|
F-4
|
Consolidated Balance Sheets as of December 31,
2009 and 2008
|
F-6
|
Consolidated Statements of Operations for the
years ended December 31, 2009, 2008 and 2007
|
F-7
|
Consolidated Statements of Changes in
Shareholders’ Equity for the years ended December 31, 2009, 2008 and
2007
|
F-8
|
Consolidated Statements of Cash Flows for the
years ended December 31, 2009, 2008 and 2007
|
F-9
|
Notes
to the Consolidated Financial Statements
|
F-10
|
Schedule
1 — Condensed Financial Information of Registrant Orthofix International
N.V.
|
S-1
|
Schedule
2 — Valuation and Qualifying Accounts
|
S-5
|
All other
schedules for which provision is made in the applicable accounting regulation of
the Securities and Exchange Commission are not required under the related
instructions or are inapplicable and therefore have been
omitted.
ORTHOFIX
INTERNATIONAL N.V.
Statement
of Management’s Responsibility for Financial Statements
To the
Shareholders of Orthofix International N.V.:
Management
is responsible for the preparation of the consolidated financial statements and
related information that are presented in this report. The
consolidated financial statements, which include amounts based on management’s
estimates and judgments, have been prepared in conformity with accounting
principles generally accepted in the United States. Other financial
information in the report to shareholders is consistent with that in the
consolidated financial statements.
The
Company maintains accounting and internal control systems to provide reasonable
assurance at a reasonable cost that assets are safeguarded against loss from
unauthorized use or disposition, and that the financial records are reliable for
preparing financial statements and maintaining accountability for
assets. These systems are augmented by written policies, an
organizational structure providing division of responsibilities and careful
selection and training of qualified personnel.
The
Company engaged Ernst & Young LLP independent registered public accountants
to audit and render an opinion on the consolidated financial statements in
accordance with auditing standards of the Public Company Accounting Oversight
Board (United States). These standards include an assessment of the
systems of internal controls and test of transactions to the extent considered
necessary by them to support their opinion.
The Board
of Directors, through its Audit Committee consisting solely of outside directors
of the Company, meets periodically with management and our independent
registered public accountants to ensure that each is meeting its
responsibilities and to discuss matters concerning internal controls and
financial reporting. Ernst & Young LLP has full and free access
to the Audit Committee.
James
F. Gero
Chairman
of the Board of Directors
Alan
W. Milinazzo
President,
Chief Executive Officer and Director
Robert
S. Vaters
Executive
Vice President and Chief Financial Officer
ORTHOFIX
INTERNATIONAL N.V.
Management’s
Report on Internal Control over Financial Reporting
Management
of the Company is responsible for establishing and maintaining adequate internal
control over financial reporting (as such term is defined in Rule 13a-15f under
the Exchange Act). The Company’s internal control over financial
reporting includes those policies and procedures that (i) pertain to the
maintenance of records that, in reasonable detail, accurately and fairly reflect
the transactions and dispositions of the assets of the Company; (ii) provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the Company are
being made only in accordance with authorizations of management and directors of
the Company; and (iii) provide reasonable assurance regarding prevention or
timely detection of unauthorized acquisition, use, or disposition of the
Company’s assets that could have a material effect on the financial
statements.
Internal
control over financial reporting is designed to provide reasonable assurance to
the Company’s management and board of directors regarding the preparation of
reliable financial statements for external purposes in accordance with generally
accepted accounting principles. Internal control over financial
reporting includes self-monitoring mechanisms and actions taken to correct
deficiencies as they are identified. Because of the inherent
limitations in any internal control, no matter how well designed, misstatements
may occur and not be prevented or detected. Accordingly, even
effective internal control over financial reporting can provide only reasonable
assurance with respect to financial statement preparation. Further,
the evaluation of the effectiveness of internal control over financial reporting
was made as of a specific date, and continued effectiveness in future periods is
subject to the risks that controls may become inadequate because of changes in
conditions or that the degree of compliance with the policies and procedures may
decline.
Management
conducted an evaluation of the effectiveness of the Company’s system of internal
control over financial reporting as of December 31, 2009 based on the framework
set forth in “Internal Control – Integrated Framework” issued by the Committee
of Sponsoring Organizations of the Treadway Commission. Based on its
evaluation, management concluded that, as of December 31, 2009, the Company’s
internal control over financial reporting is effective based on the specified
criteria.
The
Company’s internal control over financial reporting has been audited by the
Company’s Independent Registered Public Accounting Firm, Ernst & Young LLP,
as stated in their reports at pages F-4 and F-5 herein.
James
F. Gero
Chairman
of the Board of Directors
Alan
W. Milinazzo
President,
Chief Executive Officer and Director
Robert
S. Vaters
Executive
Vice President and Chief Financial Officer
Report
of Independent Registered Public Accounting Firm
The
Board of Directors and Shareholders of Orthofix International N.V.
We have
audited the accompanying consolidated balance sheets of Orthofix International
N.V. as of December 31, 2009 and 2008 and the related consolidated statements of
operations, shareholders’ equity, and cash flows for each of the three years in
the period ended December 31, 2009. Our audits also included the
financial statement schedules listed in the index at Item
15(a). These financial statements and schedules are the
responsibility of the Company’s management. Our responsibility is to
express an opinion on these financial statements and schedules based on our
audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of Orthofix International
N.V. at December 31, 2009 and 2008, and the consolidated results of its
operations and its cash flows for each of the three years in the period ended
December 31, 2009 in conformity with U.S. generally accepted accounting
principles. Also, in our opinion, the related financial statement
schedules, when considered in relation to the basic consolidated financial
statements taken as a whole, present fairly in all material respects the
information set forth therein.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), Orthofix International N.V.’s internal control
over financial reporting as of December 31, 2009, based on criteria established
in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated March 1, 2010
expressed an unqualified opinion thereon.
/s/ Ernst
& Young LLP
Boston,
Massachusetts
March 1,
2010
Report
of Independent Registered Public Accounting Firm
The
Board of Directors and Shareholders of Orthofix International N.V.
We have
audited Orthofix International N.V.’s internal control over financial reporting
as of December 31, 2009 based on criteria established in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission (the COSO criteria). Orthofix International N.V.’s
management is responsible for maintaining effective internal control over
financial reporting, and for its assessment of the effectiveness of internal
control over financial reporting included in the accompanying Management’s
Report on Internal Control over Financial Reporting. Our
responsibility is to express an opinion on the Company’s internal control over
financial reporting based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
effective internal control over financial reporting was maintained in all
material respects. Our audit included obtaining an understanding of
internal control over financial reporting, assessing the risk that a material
weakness exists, testing and evaluating the design and operating effectiveness
of internal control based on the assessed risk, and performing such other
procedures as we considered necessary in the circumstances. We
believe that our audit provides a reasonable basis for our opinion.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal
control over financial reporting includes those policies and procedures that (1)
pertain to the maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of the company;
(2) provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation
of effectiveness to future periods are subject to the risk that controls may
become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
In our
opinion, Orthofix International N.V. maintained, in all material respects,
effective internal control over financial reporting as of December 31, 2009,
based on the COSO criteria.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of Orthofix
International N.V. as of December 31, 2009 and 2008, and the related
consolidated statements of operations, shareholders’ equity, and cash flows for
each of the three years in the period ended December 31, 2009 of Orthofix
International N.V. and our report dated March 1, 2010 expressed an unqualified
opinion thereon.
/s/ Ernst
& Young LLP
Boston,
Massachusetts
March 1,
2010
ORTHOFIX
INTERNATIONAL N.V.
Consolidated
Balance Sheets as of December 31, 2009 and 2008
(U.S.
Dollars, in thousands except share and per share data)
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
13,328
|
|
|
$
|
14,594
|
|
Restricted
cash
|
|
|
11,630
|
|
|
|
10,998
|
|
Trade
accounts receivable, less allowances of $7,205 and $6,473 at December 31,
2009 and 2008, respectively
|
|
|
129,777
|
|
|
|
110,720
|
|
Inventories,
net
|
|
|
94,624
|
|
|
|
91,185
|
|
Deferred
income taxes
|
|
|
20,286
|
|
|
|
17,543
|
|
Prepaid
expenses
|
|
|
4,868
|
|
|
|
6,923
|
|
Other
current assets
|
|
|
24,981
|
|
|
|
22,687
|
|
Total
current assets
|
|
|
299,494
|
|
|
|
274,650
|
|
Investments,
at cost
|
|
|
345
|
|
|
|
2,095
|
|
Property,
plant and equipment, net
|
|
|
38,694
|
|
|
|
32,660
|
|
Patents
and other intangible assets, net
|
|
|
47,628
|
|
|
|
53,546
|
|
Goodwill
|
|
|
185,175
|
|
|
|
182,581
|
|
Deferred
taxes and other long-term assets
|
|
|
19,137
|
|
|
|
15,683
|
|
Total
assets
|
|
$
|
590,473
|
|
|
$
|
561,215
|
|
Liabilities
and shareholders’ equity
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Bank
borrowings
|
|
$
|
2,209
|
|
|
$
|
1,907
|
|
Current
portion of long-term debt
|
|
|
3,332
|
|
|
|
3,329
|
|
Trade
accounts payable
|
|
|
21,821
|
|
|
|
22,179
|
|
Accounts
payable to related parties
|
|
|
1,481
|
|
|
|
1,686
|
|
Other
current liabilities
|
|
|
59,210
|
|
|
|
45,894
|
|
Total
current liabilities
|
|
|
88,053
|
|
|
|
74,995
|
|
Long-term
debt
|
|
|
249,132
|
|
|
|
277,533
|
|
Deferred
income taxes
|
|
|
6,115
|
|
|
|
4,509
|
|
Other
long-term liabilities
|
|
|
6,904
|
|
|
|
2,117
|
|
Total
liabilities
|
|
|
350,204
|
|
|
|
359,154
|
|
|
|
|
|
|
|
|
|
|
Contingencies
(Note 16)
|
|
|
|
|
|
|
|
|
Shareholders’
equity
|
|
|
|
|
|
|
|
|
Common
shares $0.10 par value; 50,000,000 shares authorized; 17,141,710
and 17,103,142 issued and outstanding as of December 31, 2009 and
2008, respectively
|
|
|
1,714
|
|
|
|
1,710
|
|
Additional
paid-in capital
|
|
|
177,246
|
|
|
|
167,818
|
|
Retained
earnings
|
|
|
54,119
|
|
|
|
29,647
|
|
Accumulated
other comprehensive income
|
|
|
7,190
|
|
|
|
2,886
|
|
Total
shareholders’ equity
|
|
|
240,269
|
|
|
|
202,061
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities and shareholders’ equity
|
|
$
|
590,473
|
|
|
$
|
561,215
|
|
The
accompanying notes form an integral part of these consolidated financial
statements.
ORTHOFIX
INTERNATIONAL N.V.
Consolidated
Statements of Operations for the years ended December 31, 2009, 2008 and
2007
(U.S.
Dollars, in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$
|
545,635
|
|
|
$
|
519,675
|
|
|
$
|
490,323
|
|
Cost
of sales
|
|
|
138,450
|
|
|
|
152,014
|
|
|
|
129,032
|
|
Gross
profit
|
|
|
407,185
|
|
|
|
367,661
|
|
|
|
361,291
|
|
Operating
expenses (income)
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
and marketing
|
|
|
215,943
|
|
|
|
206,913
|
|
|
|
186,984
|
|
General
and administrative
|
|
|
88,866
|
|
|
|
81,806
|
|
|
|
72,902
|
|
Research
and development
|
|
|
31,460
|
|
|
|
30,844
|
|
|
|
24,220
|
|
Amortization
of intangible assets
|
|
|
7,041
|
|
|
|
17,094
|
|
|
|
18,156
|
|
Impairment
of goodwill and certain intangible assets
|
|
|
–
|
|
|
|
289,523
|
|
|
|
20,972
|
|
Gain
on sale of Pain Care® operations
|
|
|
–
|
|
|
|
(1,570
|
)
|
|
|
–
|
|
|
|
|
343,310
|
|
|
|
624,610
|
|
|
|
323,234
|
|
Operating
income (loss)
|
|
|
63,875
|
|
|
|
(256,949
|
)
|
|
|
38,057
|
|
Other
income (expense), net
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
193
|
|
|
|
542
|
|
|
|
1,043
|
|
Interest
expense
|
|
|
(24,820
|
)
|
|
|
(20,216
|
)
|
|
|
(24,720
|
)
|
Unrealized
non-cash gain (loss) on interest rate swap
|
|
|
1,852
|
|
|
|
(7,975
|
)
|
|
|
–
|
|
Loss
on refinancing of senior secured term loan
|
|
|
–
|
|
|
|
(5,735
|
)
|
|
|
–
|
|
Other
income (expense), net
|
|
|
(1,079
|
)
|
|
|
(4,702
|
)
|
|
|
355
|
|
|
|
|
(23,854
|
)
|
|
|
(38,086
|
)
|
|
|
(23,322
|
)
|
Income
(loss) before income taxes
|
|
|
40,021
|
|
|
|
(295,035
|
)
|
|
|
14,735
|
|
Income
tax (expense) benefit
|
|
|
(15,549
|
)
|
|
|
66,481
|
|
|
|
(3,767
|
)
|
Net
income (loss)
|
|
$
|
24,472
|
|
|
$
|
(228,554
|
)
|
|
$
|
10,968
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per common share - basic
|
|
$
|
1.43
|
|
|
$
|
(13.37
|
)
|
|
$
|
0.66
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss) per common share - diluted
|
|
$
|
1.42
|
|
|
$
|
(13.37
|
)
|
|
$
|
0.64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares - basic
|
|
|
17,119,474
|
|
|
|
17,095,416
|
|
|
|
16,638,873
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares - diluted
|
|
|
17,202,943
|
|
|
|
17,095,416
|
|
|
|
17,047,587
|
|
The
accompanying notes form an integral part of these consolidated financial
statements.
ORTHOFIX
INTERNATIONAL N.V.
Consolidated
Statements of Changes in Shareholders’ Equity for the years ended December 31,
2009, 2008 and 2007
(U.S.
Dollars, in thousands, except share data)
|
|
Number of Common Shares
Outstanding
|
|
|
|
|
|
Additional Paid-in
Capital
|
|
|
|
|
|
Accumulated Other Comprehensive
Income
|
|
|
Total Shareholders’
Equity
|
|
At
December 31, 2006
|
|
|
16,445,859
|
|
|
$
|
1,645
|
|
|
$
|
128,297
|
|
|
$
|
248,433
|
|
|
$
|
14,260
|
|
|
$
|
392,635
|
|
Cumulative
effect adjustment for the adoption of FIN 48
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
(1,200
|
)
|
|
|
–
|
|
|
|
(1,200
|
)
|
Net
income
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
10,968
|
|
|
|
–
|
|
|
|
10,968
|
|
Other
comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
gain on derivative instrument (net of taxes of $586)
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
1,585
|
|
|
|
1,585
|
|
Translation
adjustment
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
841
|
|
|
|
841
|
|
Total
comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,194
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
benefit on exercise of stock options
|
|
|
–
|
|
|
|
–
|
|
|
|
2,145
|
|
|
|
–
|
|
|
|
–
|
|
|
|
2,145
|
|
Share-based
compensation expense
|
|
|
–
|
|
|
|
–
|
|
|
|
11,913
|
|
|
|
–
|
|
|
|
–
|
|
|
|
11,913
|
|
Common
shares issued
|
|
|
592,445
|
|
|
|
59
|
|
|
|
14,994
|
|
|
|
–
|
|
|
|
–
|
|
|
|
15,053
|
|
At
December 31, 2007
|
|
|
17,038,304
|
|
|
|
1,704
|
|
|
|
157,349
|
|
|
|
258,201
|
|
|
|
16,686
|
|
|
|
433,940
|
|
Net
loss
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
(228,554
|
)
|
|
|
–
|
|
|
|
(228,554
|
)
|
Other
comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
gain on derivative instrument (net of taxes of $609)
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
1,567
|
|
|
|
1,567
|
|
Translation
adjustment
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
(15,367
|
)
|
|
|
(15,367
|
)
|
Total
comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(242,354
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax
benefit on exercise of stock options
|
|
|
–
|
|
|
|
–
|
|
|
|
22
|
|
|
|
–
|
|
|
|
–
|
|
|
|
22
|
|
Reclassification
adjustment for tax benefit on exercise of stock options
|
|
|
–
|
|
|
|
–
|
|
|
|
(1,870
|
)
|
|
|
|
|
|
|
|
|
|
|
(1,870
|
)
|
Share-based
compensation expense
|
|
|
–
|
|
|
|
–
|
|
|
|
10,589
|
|
|
|
–
|
|
|
|
–
|
|
|
|
10,589
|
|
Common
shares issued
|
|
|
64,838
|
|
|
|
6
|
|
|
|
1,728
|
|
|
|
–
|
|
|
|
–
|
|
|
|
1,734
|
|
At
December 31, 2008
|
|
|
17,103,142
|
|
|
|
1,710
|
|
|
|
167,818
|
|
|
|
29,647
|
|
|
|
2,886
|
|
|
|
202,061
|
|
Net
income
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
24,472
|
|
|
|
–
|
|
|
|
24,472
|
|
Other
comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized
loss on derivative instrument (net of taxes of $1,050)
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
(2,702
|
)
|
|
|
(2,702
|
)
|
Translation
adjustment
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
–
|
|
|
|
7,006
|
|
|
|
7,006
|
|
Total
comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,776
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
of minority interest in subsidiary
|
|
|
–
|
|
|
|
–
|
|
|
|
(1,143
|
)
|
|
|
–
|
|
|
|
–
|
|
|
|
(1,143
|
)
|
Repurchase
of equity
|
|
|
–
|
|
|
|
–
|
|
|
|
(220
|
)
|
|
|
–
|
|
|
|
–
|
|
|
|
(220
|
)
|
Tax
benefit on exercise of stock options
|
|
|
–
|
|
|
|
–
|
|
|
|
25
|
|
|
|
–
|
|
|
|
–
|
|
|
|
25
|
|
Share-based
compensation expense
|
|
|
–
|
|
|
|
–
|
|
|
|
10,752
|
|
|
|
–
|
|
|
|
–
|
|
|
|
10,752
|
|
Common
shares issued
|
|
|
38,568
|
|
|
|
4
|
|
|
|
14
|
|
|
|
–
|
|
|
|
–
|
|
|
|
18
|
|
At
December 31, 2009
|
|
|
17,141,710
|
|
|
$
|
1,714
|
|
|
$
|
177,246
|
|
|
$
|
54,119
|
|
|
$
|
7,190
|
|
|
$
|
240,269
|
|
The
accompanying notes form an integral part of these consolidated financial
statements.
ORTHOFIX
INTERNATIONAL N.V.
Consolidated
Statements of Cash Flows for the years ended December 31, 2009, 2008 and
2007
(U.S.
Dollars, in thousands)
|
|
|
|
|
|
|
|
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
|
Net
income (loss)
|
|
$
|
24,472
|
|
|
$
|
(228,554
|
)
|
|
$
|
10,968
|
|
Adjustments
to reconcile net income (loss) to net cash provided by operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
22,344
|
|
|
|
31,279
|
|
|
|
28,531
|
|
Amortization
of debt costs
|
|
|
248
|
|
|
|
911
|
|
|
|
1,085
|
|
Provision
for doubtful accounts
|
|
|
7,335
|
|
|
|
7,261
|
|
|
|
7,326
|
|
Deferred
taxes
|
|
|
(4,409
|
)
|
|
|
(79,158
|
)
|
|
|
(12,168
|
)
|
Share-based
compensation
|
|
|
10,752
|
|
|
|
10,589
|
|
|
|
11,913
|
|
Provision
for inventory obsolescence
|
|
|
8,760
|
|
|
|
10,913
|
|
|
|
–
|
|
Loss
on refinancing of senior secured term loan
|
|
|
–
|
|
|
|
3,660
|
|
|
|
–
|
|
Impairment
of goodwill and certain intangible assets
|
|
|
–
|
|
|
|
289,523
|
|
|
|
20,972
|
|
Change
in fair value of interest rate swap
|
|
|
(1,852
|
)
|
|
|
7,975
|
|
|
|
–
|
|
Impairment
of investments held at cost
|
|
|
–
|
|
|
|
1,500
|
|
|
|
–
|
|
Amortization
of step up of fair value in inventory
|
|
|
–
|
|
|
|
493
|
|
|
|
2,718
|
|
Gain
on sale of Pain Care® operations
|
|
|
–
|
|
|
|
(1,570
|
)
|
|
|
–
|
|
Minority
interest
|
|
|
34
|
|
|
|
–
|
|
|
|
–
|
|
Other
|
|
|
2,507
|
|
|
|
(743
|
)
|
|
|
(5,816
|
)
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
cash
|
|
|
(612
|
)
|
|
|
5,444
|
|
|
|
(9,153
|
)
|
Accounts
receivable
|
|
|
(23,858
|
)
|
|
|
(13,182
|
)
|
|
|
(8,685
|
)
|
Inventories
|
|
|
(8,941
|
)
|
|
|
(13,731
|
)
|
|
|
(22,745
|
)
|
Prepaid
expenses and other current assets
|
|
|
(12
|
)
|
|
|
(5,046
|
)
|
|
|
(5,855
|
)
|
Accounts
payable
|
|
|
(1,310
|
)
|
|
|
675
|
|
|
|
303
|
|
Other
current liabilities
|
|
|
14,512
|
|
|
|
(1,469
|
)
|
|
|
2,102
|
|
Net
cash provided by operating activities
|
|
|
49,970
|
|
|
|
26,770
|
|
|
|
21,496
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital
expenditures for property, plant and equipment
|
|
|
(20,915
|
)
|
|
|
(15,600
|
)
|
|
|
(18,537
|
)
|
Capital
expenditures for intangible assets
|
|
|
(1,083
|
)
|
|
|
(4,592
|
)
|
|
|
(8,692
|
)
|
Investment
related to collaborative arrangement
|
|
|
(2,000
|
)
|
|
|
–
|
|
|
|
–
|
|
Proceeds
from sale of investments held at cost
|
|
|
1,711
|
|
|
|
769
|
|
|
|
–
|
|
Proceeds
from sale of Pain Care® operations
|
|
|
–
|
|
|
|
5,980
|
|
|
|
–
|
|
Net
cash used in investing activities
|
|
|
(22,287
|
)
|
|
|
(13,443
|
)
|
|
|
(27,229
|
)
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
proceeds from issuance of common shares
|
|
|
70
|
|
|
|
1,734
|
|
|
|
15,053
|
|
Payment
of refinancing fees and debt issuance costs
|
|
|
–
|
|
|
|
(283
|
)
|
|
|
(184
|
)
|
Repayments
of long-term debt
|
|
|
(28,323
|
)
|
|
|
(17,069
|
)
|
|
|
(17,458
|
)
|
Cash
payment for purchase of minority interest in subsidiary
|
|
|
(1,143
|
)
|
|
|
(500
|
)
|
|
|
(3,142
|
)
|
Tax
benefit on non-qualified stock options
|
|
|
25
|
|
|
|
22
|
|
|
|
2,145
|
|
Repurchase
of equity
|
|
|
(220
|
)
|
|
|
–
|
|
|
|
–
|
|
Proceeds
from (repayment of) bank borrowings, net
|
|
|
248
|
|
|
|
(6,721
|
)
|
|
|
8,131
|
|
Net
cash provided by (used in) financing activities
|
|
|
(29,343
|
)
|
|
|
(22,817
|
)
|
|
|
4,545
|
|
Effect
of exchange rates changes on cash
|
|
|
394
|
|
|
|
(980
|
)
|
|
|
371
|
|
Net
decrease in cash and cash equivalents
|
|
|
(1,266
|
)
|
|
|
(10,470
|
)
|
|
|
(817
|
)
|
Cash
and cash equivalents at the beginning of the year
|
|
|
14,594
|
|
|
|
25,064
|
|
|
|
25,881
|
|
Cash
and cash equivalents at the end of the year
|
|
$
|
13,328
|
|
|
$
|
14,594
|
|
|
$
|
25,064
|
|
Supplemental
disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid during the year for:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
26,724
|
|
|
$
|
19,311
|
|
|
$
|
27,477
|
|
Income
taxes
|
|
$
|
17,665
|
|
|
$
|
12,602
|
|
|
$
|
15,908
|
|
The accompanying
notes form an integral part of these consolidated financial
statements
.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements
Description
of business
Orthofix
International N.V. (the “Company”) is a multinational corporation principally
involved in the design, development, manufacture, marketing and distribution of
medical equipment, principally for the Orthopedics products
market. The Company is comprised of four reportable segments:
Domestic, Spinal Implants and Biologics (formerly referred to as “Blackstone”),
Breg and International. See Note 13 for a description of each
segment.
1.
|
Summary
of significant accounting policies
|
|
(a)
|
Basis
of consolidation
|
The
consolidated financial statements include the financial statements of the
Company and its wholly-owned and majority-owned subsidiaries and entities over
which the Company has control.
The
results of acquired businesses are included in the consolidated statements of
operations from the date of their acquisition. All intercompany
accounts, transactions and profits are eliminated in the consolidated financial
statements. The Company’s investments in which it does not have significant
influence or control are accounted for under the cost method of
accounting.
|
(b)
|
Foreign
currency
translation
|
Foreign
currency translation is performed in accordance with Accounting Standards
Codification (“ASC”) Topic 830 – Foreign Currency Matters (“ASC Topic 830”)
(formerly known as Statement of Financial Accounting Standards (“SFAS”) No. 52,
“Foreign Currency Translation”). All balance sheet accounts, except
shareholders’ equity, are translated at year end exchange rates and revenue and
expense items are translated at weighted average rates of exchange prevailing
during the year. Gains and losses resulting from the translation of
foreign currency are recorded in the accumulated other comprehensive income
component of shareholders’ equity. Transactional foreign currency
gains and losses, including intercompany transactions that are not long-term
investing in nature, are included in other income (expense), net and were $(0.5)
million, $(2.7) million and $0.8 million for the years ended December 31, 2009,
2008 and 2007, respectively.
Inventories
are valued at the lower of cost or estimated net realizable value, after
provision for excess or obsolete items. Cost is determined on a
weighted-average basis, which approximates the FIFO method. The
valuation of work-in-process, finished products, field inventory and consignment
inventory includes the cost of materials, labor and production. Field
inventory represents immediately saleable finished products inventory that is in
the possession of the Company’s direct sales representatives.
The
reporting currency is the United States (“U.S.”) Dollar.
In the
ordinary course of business, the Company is exposed to the impact of changes in
interest rates and foreign currency fluctuations. The Company’s
objective is to limit the impact of such movements on earnings and cash
flows. In order to achieve this objective the Company seeks to
balance its non-dollar denominated income and expenditures. During
2008, the Company executed an interest rate swap agreement to manage the cash
flow exposure generated from interest rate fluctuations. During 2009,
2008, and 2007, the Company made use of a foreign currency swap agreement
entered into in December 2006 to manage cash flow exposure generated from
foreign currency fluctuations. See Note 10 for additional
information.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Property,
plant and equipment is stated at cost less accumulated
depreciation. Plant and equipment also includes
instrumentation. Depreciation is computed on a straight-line basis
over the useful lives of the assets, except for land, which is not
depreciated. Depreciation of leasehold improvements is computed over
the shorter of the lease term or the useful life of the asset. The
useful lives are as follows:
|
Years
|
Buildings
|
25
to 33
|
Plant,
equipment
|
2
to 10
|
Instrumentation
|
3
to 4
|
Furniture
and fixtures
|
4
to 8
|
Expenditures
for maintenance and repairs and minor renewals and improvements, which do not
extend the lives of the respective assets, are expensed. All other
expenditures for renewals and improvements are capitalized. The
assets and related accumulated depreciation are adjusted for property
retirements and disposals, with the resulting gain or loss included in
operations. Fully depreciated assets remain in the accounts until
retired from service.
Patents
and other intangible assets are recorded at cost, or when acquired as a part of
a business combination, at estimated fair value. These assets
primarily include patents and other technology agreements (“developed
technologies”), certain trademarks and distribution
networks. Identifiable intangible assets which are considered
definite lived are generally amortized over their useful lives using a method of
amortization that reflects the pattern in which the economic benefit of the
intangible assets is consumed. The Company’s weighted average
amortization period for developed technologies and distribution networks is 11
and 10 years, respectively.
ASC Topic
360 – Property, Plant and Equipment (“ASC Topic 360”) (formerly known as SFAS
No. 144 “Accounting for the Impairment or Disposal of Long-Lived Assets”)
requires that intangible assets with definite lives, such as Orthofix’s
developed technologies and distribution network assets, be tested for impairment
if any adverse conditions exist or change in circumstances has occurred that
would indicate impairment or a change in the remaining useful
life. If an impairment indicator exists, the Company tests the
intangible asset for recoverability. For purposes of the
recoverability test, the Company groups its intangible assets with other assets
and liabilities at the lowest level of identifiable cash flows if the intangible
asset does not generate cash flows independent of other assets and
liabilities. If the carrying value of the intangible asset (asset
group) exceeds the undiscounted cash flows expected to result from the use and
eventual disposition of the intangible asset (asset group), the Company will
write the carrying value down to the fair value in the period
identified.
The
Company generally calculates fair value of intangible assets as the present
value of estimated future cash flows the Company expects to generate from the
asset using a risk-adjusted discount rate. In determining the
estimated future cash flows associated with intangible assets, the Company uses
estimates and assumptions about future revenue contributions, cost structures
and remaining useful lives of the asset (asset group). The use of
alternative assumptions, including estimated cash flows, discount rates, and
alternative estimated remaining useful lives could result in different
calculations of impairment
The
Company tests goodwill and certain trademarks at least annually. The
Company tests more frequently if indicators are present or changes in
circumstances suggest that impairment may exist. These indicators
include, among others, declines in sales, earnings or cash flows, or the
development of a material adverse change in the business climate. The
Company assesses goodwill for impairment at the reporting unit level, which is
defined as an operating segment or one level below an operating segment,
referred to as a component. Consistent with prior years, the Company
has identified four reporting units, which are consistent with the Company’s
reporting segments; Domestic, Spinal Implants and Biologics, Breg and
International (see Note 13 for additional information).
In
performing the annual impairment test, the Company utilizes the two-step
approach prescribed under ASC Topic 350 – Intangibles – Goodwill and Other (“ASC
Topic 350”) (formerly known as SFAS No. 142, “Goodwill and Other Intangible
Assets”). The first step requires a comparison of each reporting
unit’s carrying value to the fair value of the respective unit. If
the carrying value exceeds the fair value, a second step is performed to measure
the amount of impairment loss, if any.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Carrying
Value
In order
to calculate the respective carrying values, the Company records goodwill based
on the purchase price allocation performed at the time of
acquisition. Corporate assets and liabilities that directly relate to
a reporting unit’s operations are ascribed directly to that reporting unit.
Corporate assets and liabilities that are not directly related to a specific
reporting unit, but from which the reporting unit benefits, are allocated based
on the respective revenue contribution of each reporting unit.
Fair
Value – Income Approach
The fair
value of each reporting unit is estimated, entirely or predominantly, using an
income based approach. This income approach utilizes a discounted
cash flow (“DCF”), which estimates after-tax cash flows on a debt free basis,
discounted to present value using a risk-adjusted discount rate.
The
Company believes the DCF generally provides the most meaningful fair value as it
appropriately measures the Company’s income producing assets. The Company may
consider using a cost approach but generally believes it is not appropriate,
given the inability to replicate the value of the specific technology-based
assets within our reporting units. In circumstances when the DCF
indicator of fair value is not sufficiently conclusive to support the carrying
value of a reporting unit, or when other measures provide a more appropriate
indicator, we may consider a market approach in our determination of the
reporting unit’s fair value.
In
performing a DCF calculation, the Company is required to make assumptions about
the amount and timing of future expected cash flows, terminal value growth rates
and appropriate discount rates and in connection therewith considers the
following:
|
·
|
The
determination of expected cash flows is based on the Company’s strategic
plans and long-range planning forecasts which, to the extent reasonably
possible, reflect anticipated changes in the economy and the
industry. Revenue growth rates represent estimates based on
current and forecasted market conditions. The profit margin
assumptions are projected by each reporting unit based on historical
margins, the current cost structure and anticipated net cost
reductions.
|
|
·
|
The
terminal value growth rate is used to calculate the value of cash flows
beyond the last projected period in the DCF. This rate reflects
the Company’s estimates for stable, perpetual growth for each reporting
unit.
|
|
·
|
The
discount rates are based on the reporting unit’s risk-adjusted weighted
average cost of capital, using assumptions consistent with publicly traded
guideline companies operating within the medical device industry as well
as Company specific risk factors for each reporting
unit.
|
These
inputs represent the Company’s best estimate, however, different cash flows,
growth and discount rate assumptions could generate different fair values,
potentially impacting the Company’s impairment assessment.
Domestic,
Breg and International Reporting Units
The fair
value of the Domestic, Breg and International reporting units have been
established using a DCF method. These DCF results concluded the fair
value of the Domestic, Breg and International reporting units exceeded the
respective carrying values at December 31, 2009 and December 31,
2008. The assumptions used in the December 31, 2009 DCF results were
consistent with the DCF results used in the prior year, reflecting appropriate
adjustments for changes in the economic climate.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Spinal
Implants and Biologics Reporting Unit
During
the third quarter of 2008, the Company indentified indicators of impairment with
respect to the Spinal Implants and Biologics reporting unit, prompting an
interim impairment test. The determination of the Spinal Implants and
Biologics fair value was calculated using a combination of income and market
approaches, weighted based on guidance provided by an independent appraisal
firm. The income approach was based on a DCF model. The
market approach was based on the guideline transaction method, which derived
applicable market multiples from the prices at which comparable companies have
been acquired in the marketplace. The Company applied a weighted
average percentage of 75% - 25%, placing greater weight on the income approach,
which provided a lower fair value. This calculation resulted in a
$126.9 million impairment loss, reducing the related goodwill balance to $9.4
million as of December 31, 2008.
The
Company used a DCF to determine the fair value of the Spinal Implants and
Biologics reporting units as of December 31, 2009. This resulted in
no significant changes to the Spinal Implants and Biologics fair value
assumptions. Accordingly, the annual impairment test as of December
31, 2009 resulted in no further impairment of the Spinal Implants and Biologics
reporting unit.
|
(g)
|
Revenue
recognition and accounts receivable
|
Revenue
is generally recognized as income in the period in which title passes and the
products are delivered. Revenues exclude any value added or other
local taxes, intercompany sales and trade discounts. Shipping and
handling costs are included in cost of sales. Royalty revenues are
recognized when the royalty is earned.
For bone
growth stimulation and certain bracing products that are prescribed by a
physician, the Company recognizes revenue when the product is placed on or
implanted in and accepted by the patient. For domestic spinal implant
and human cellular and tissue based products (“HCT/P products”), revenues are
recognized when the product has been utilized and a confirming purchase order
has been received from the hospital. For sales to commercial
customers, including hospitals and distributors, revenues are recognized at the
time of shipment unless contractual agreements specify that title passes on
delivery. Revenues for inventory delivered on consignment are
recognized as the product is used by the consignee.
In 2008,
the Company entered into an agreement with the Musculoskeletal Transplant
Foundation (“MTF”) to develop and commercialize a new stem cell-based bone
growth biologic matrix. With the development process completed in
2009, the Company and MTF operate under the terms of a separate
commercialization agreement. Under the terms of this 10-year
agreement, MTF sources the tissue, processes it to create the bone growth
matrix, and packages and delivers it in accordance with orders received directly
from customers and from the Company. The Company has exclusive global
marketing rights for the new allograft and receives a marketing fee from MTF
based on total sales. This marketing fee is recorded on a net basis
within net sales.
The
Company derives a significant amount of revenues in the U.S. from third-party
payors, including commercial insurance carriers, health maintenance
organizations, preferred provider organizations and governmental payors such as
Medicare. Amounts paid by these third-party payors are generally
based on fixed or allowable reimbursement rates. These revenues are
recorded at the expected or pre-authorized reimbursement rates, net of any
contractual allowances or adjustments. Certain billings are subject
to review by the third-party payors and may be subject to
adjustment.
The
process for estimating the ultimate collection of accounts receivable involves
significant assumptions and judgments. Historical collection and
payor reimbursement experience is an integral part of the estimation process
related to reserves for doubtful accounts and the establishment of contractual
allowances. Accounts receivable are analyzed on a quarterly basis to
assess the adequacy of both reserves for doubtful accounts and contractual
allowances. Revisions in allowances for doubtful accounts estimates
are recorded as an adjustment to bad debt expense within sales and marketing
expenses. Revisions to contractual allowances are recorded as an
adjustment to net sales. In the judgment of management,
adequate allowances have been provided for doubtful accounts and contractual
allowances. Our estimates are periodically tested against actual
collection experience.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
|
(h)
|
Research
and development costs
|
Expenditures
for research and development are expensed as incurred. Expenditures
related to collaborative arrangements are expensed based on the terms of the
related agreements. On July 24, 2008, the Company entered into an
agreement with MTF to collaborate on the development and commercialization of a
new stem cell-based bone growth biologic matrix. Under the terms of
the agreement, the Company invested $10.0 million to develop the new stem
cell-based bone growth biologic matrix that provides the beneficial properties
of an autograft in spinal and orthopedic surgeries. The new matrix
was launched with a full market release in the U.S. effective on July 1,
2009. A total of $6.1 million and $3.9 million of expenses was
recognized under the terms of the agreement and are included in research and
development expense for the years ended December 31, 2009 and 2008,
respectively.
As
previously announced in 2008, the Company entered into an agreement with
Intelligent Implant Systems (“IIS”) for the acquisition and development of a
next-generation pedicle screw system for the spinal implants
division. Under the agreement the Company purchased $2.5 million of
intellectual property and related technology. During the year ended
December 31, 2009, IIS met their first development milestone and under the terms
of the agreement the Company paid IIS $1.0 million. Also in 2009, the
Company and IIS amended the existing agreement and the Company paid IIS an
additional $0.8 million for partially meeting its next milestone. The
Company has recorded these payments totaling $1.8 million for the year ended
December 31, 2009 as research and development expense. IIS will
continue to perform research and development functions related to the technology
and under the agreement and amended agreement we will pay IIS an additional
amount up to $2.7 million for research and development performance
milestones.
The
Company accounts for income taxes in accordance with ASC Topic 740 – Income
Taxes (“ASC Topic 740”). The Company is subject to income taxes in
both the United States and foreign jurisdictions, and uses estimates in
determining the provision for income taxes. The Company accounts for
income taxes using the asset and liability method for accounting and reporting
for income taxes. Under this method, deferred tax assets and
liabilities are recognized based on temporary differences between the financial
reporting and income tax bases of assets and liabilities using statutory rates.
This process requires that the Company project the current tax liability and
estimate the deferred tax assets and liabilities, including net operating loss
and tax credit carryforwards. In assessing the need for a valuation
allowance, the Company has considered the recent operating results, future
taxable income projections and all prudent and feasible tax planning
strategies.
ASC Topic
740 also provides criteria for the recognition, measurement, presentation and
disclosures of uncertain tax positions. A tax benefit from an
uncertain tax position may be recognized if it is “more likely than not” that
the position is sustainable based solely on its technical merits. The
Company recognized $1.2 million in additional tax liability, inclusive of
interest, which was accounted for as a reduction of retained earnings at the
date of implementation of January 1, 2007. As of December 31, 2008
and December 31, 2009, the Company had $1.1 million and $0.8 million,
respectively, including interest, of unrecognized tax benefits.
|
(j)
|
Net
income (loss) per common share
|
Net
income per common share is computed in accordance with ASC Topic 260 – Earnings
per Share (formerly known as SFAS No. 128, “Earnings per Share”). Net
income per common share – basic is computed using the weighted average number of
common shares outstanding during each of the respective years. Net
income per common share – diluted is computed using the weighted average number
of common and common equivalent shares outstanding during each of the respective
years using the “treasury stock” method. Common equivalent shares
represent the dilutive effect of the assumed exercise of outstanding share
options (see Note 19) and the only differences between basic and diluted shares
result solely from the assumed exercise of certain outstanding share options and
warrants. In 2008, the effect of options was not included in the
calculation because the inclusion would have been
anti-dilutive.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
|
(k)
|
Cash
and cash equivalents
|
The
Company considers all highly liquid investments with an original maturity of
three months or less at the date of purchase to be cash
equivalents.
Restricted
cash consists of cash held at certain subsidiaries, the distribution or transfer
of which to Orthofix International N.V. (the “Parent”) or other subsidiaries
that are not parties to the credit facility described in Note 9 is
restricted. The senior secured credit facility restricts the Parent
and subsidiaries that are not parties to the facilities from access to cash held
by Colgate Medical Limited and its subsidiaries. All credit party
subsidiaries have access to this cash for operational and debt repayment
purposes.
|
(m)
|
Sale
of accounts receivable
|
The
Company follows the provisions of ASC Topic 860 – Transfers and Servicing
(formerly known as SFAS No. 140, “Accounting for Transfers and Servicing of
Financial Assets and Extinguishment of Liabilities”). Trade accounts
receivables sold without recourse are removed from the balance sheet at the time
of sale. The Company generally does not require collateral on trade
receivables.
|
(n)
|
Use
of estimates in preparation of financial
statements
|
The
preparation of financial statements in conformity with accounting principles
generally accepted in the U.S. requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. On an ongoing basis, the Company evaluates its
estimates including those related to contractual allowances, doubtful accounts,
inventories, taxes and potential goodwill and intangible asset
impairment. Actual results could differ from these
estimates.
Certain
prior year amounts have been reclassified to conform to the 2009
presentation. The reclassifications have no effect on previously
reported net earnings or shareholders’ equity.
|
(p)
|
Share-based
compensation
|
The
Company recognizes share-based compensation in accordance with ASC Topic 718 –
Compensation – Stock Compensation (“ASC Topic 718”) (formerly known as SFAS No.
123(R) (revised 2004), “Share-Based Payment”). The fair value of
stock options is determined using the Black-Scholes valuation model. Such value
is recognized as expense over the service period net of estimated
forfeitures.
The
expected term of options granted is estimated based on a number of factors,
including the vesting term of the award, historical employee exercise behavior
for both options that are currently outstanding and options that have been
exercised or are expired, the expected volatility of the Company’s common stock
and an employee’s average length of service. The risk-free interest rate is
determined based upon a constant U.S. Treasury security rate with a contractual
life that approximates the expected term of the option
award. Management estimates expected volatility based on the
historical volatility of the Company’s stock. The compensation expense
recognized for all equity-based awards is net of estimated forfeitures.
Forfeitures are estimated based on an analysis of actual option
forfeitures.
The
Company expenses all advertising costs as incurred. Advertising
expense for the years ended December 31, 2009, 2008 and 2007 was $0.7 million,
$1.1 million and $1.8 million, respectively.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
|
(r)
|
Derivative
instruments
|
The
Company manages its exposure to fluctuating cash flows resulting from changes in
interest rates and foreign exchange within the consolidated financial statements
according to its hedging policy. Under the policy, the Company may engage in
non-leveraged transactions involving various financial derivative instruments to
manage exposed positions. The policy requires the Company to formally
document the relationship between the hedging instrument and hedged item, as
well as its risk-management objective and strategy for undertaking the hedge
transaction. For instruments designated as a cash flow hedge, the
Company formally assesses (both at the hedge’s inception and on an ongoing
basis) whether the derivative that is used in the hedging transaction has been
effective in offsetting changes in the cash flows of the hedged item and whether
such derivative may be expected to remain effective in future
periods. If it is determined that a derivative is not (or has ceased
to be) effective as a hedge, the Company will discontinue the related hedge
accounting prospectively. Such a determination would be made when (1)
the derivative is no longer effective in offsetting changes in the cash flows of
the hedged item; (2) the derivative expires or is sold, terminated, or
exercised; or (3) management determines that designating the derivative as a
hedging instrument is no longer appropriate. Ineffective portions of
changes in the fair value of cash flow hedges are recognized in
earnings.
The
Company follows ASC Topic 815 – Derivatives and Hedging (“ASC Topic 815”)
(formerly known as SFAS No. 133, “Accounting for Derivative Instruments and
Hedging Activities” as amended and interpreted), which requires that all
derivatives be recorded as either assets or liabilities on the balance sheet at
their respective fair values. For a cash flow hedge, the effective
portion of the derivative’s change in fair value (i.e. gains or losses) is
initially reported as a component of other comprehensive income, net of related
taxes, and subsequently reclassified into net earnings when the hedged exposure
is no longer effective.
The
Company utilizes a cross currency swap to manage its foreign currency exposure
related to a portion of the Company’s intercompany receivable of a U.S. dollar
functional currency subsidiary that is denominated in Euro. The cross
currency swap has been accounted for as a cash flow hedge in accordance with ASC
Topic 815.
See Note
10 for a description of the types of derivative instruments the Company
utilizes.
|
(s)
|
Accumulated
other comprehensive income
|
Accumulated
other comprehensive income is comprised of foreign currency translation
adjustments and the effective portion of the gain (loss) for the Company’s
cross-currency swap which is designated and accounted for as a cash flow hedge
(refer to Note 10). The components of and changes in accumulated other
comprehensive income are as follows:
|
|
Foreign Currency Translation
Adjustments
|
|
|
Fair Value of Cross -Currency
Swap
|
|
|
Accumulated Other Comprehensive
Income/(Loss)
|
|
Balance
at December 31, 2008
|
|
$
|
(211
|
)
|
|
$
|
3,097
|
|
|
$
|
2,886
|
|
Unrealized
loss on cross-currency swap, net of tax of $(1,050)
|
|
|
-
|
|
|
|
(2,702
|
)
|
|
|
(2,702
|
)
|
Foreign
currency translation adjustment
(1)
|
|
|
7,006
|
|
|
|
-
|
|
|
|
7,006
|
|
Balance
at December 31, 2009
|
|
$
|
6,795
|
|
|
$
|
395
|
|
|
$
|
7,190
|
|
(1) As
the cash remains permanently invested in the foreign subsidiaries, no deferred
taxes are recognized on the related foreign currency translation
adjustment.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
|
(t)
|
Recently
Issued Accounting Standards
|
In
January 2009, the Company adopted the Financial Accounting Standards Board
("FASB") ASC Topic 808 – Collaborative Arrangements (“ASC Topic 808”)
(formerly known as Emerging Issues Task Force (“EITF”) 07-1 “Accounting for
Collaborative Arrangements”). ASC Topic 808 provides information
related to the classification of the payments between participants, the
appropriate income statement presentation, as well as disclosures related to
certain collaborative arrangements. The adoption of ASC Topic 808 did
not have a material impact on the Company’s results of operations or financial
position, as the Company had applied this guidance since there was no prevailing
authority previously.
In
January 2009, the Company adopted ASC Topic 810 - Consolidations (“ASC Topic
810”) (formerly known as SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements, an Amendment of ARB 51”). ASC
Topic 810 establishes accounting and reporting standards pertaining to ownership
interest in subsidiaries held by parties other than the parent, the amount of
net income attributable to the parent and to the non-controlling interest,
changes in a parent’s ownership interest, and the valuation of any retained
non-controlling equity investment when a subsidiary is
deconsolidated. ASC Topic 810 also establishes disclosure
requirements that clearly identify and distinguish between the interests of the
parent and the interests of the non-controlling owners. ASC Topic 810
and its adoption changed the method in which the Company accounted for a
minority interest acquisition during the first quarter of 2009. It
also requires the excess purchase price over the minority interest liability (at
the time of the acquisition) to be recorded as a capital
transaction. The disclosure requirements of ASC Topic 810 did not
have an impact on the Company’s financial reporting as the remaining minority
interest liability is immaterial.
In May
2009, the FASB issued ASC Topic 855 – Subsequent Events (“ASC Topic 855”)
(formerly known as SFAS No. 165, “Subsequent Events”). ASC Topic 855
provides authoritative accounting literature for a topic that was previously
addressed only in auditing literature (AICPA AU Section 560, Subsequent
Events). The guidance in ASC Topic 855 is largely similar to the
current guidance in the auditing literature with some exceptions that are not
intended to result in significant changes in practice. Two
modifications to the subsequent events guidance in AU Section 560 are: 1) to
name the two types of subsequent events either as recognized subsequent events
(currently referred to in practice as Type I subsequent events) or
non-recognized subsequent events (currently referred to in practice as Type II
subsequent events) and 2) to modify the definition of subsequent events to
refer to events or transactions that occur after the balance sheet date, but
before the financial statements are issued for public entities. ASC
Topic 855 is effective for interim or annual financial periods ending after June
15, 2009. On February 24, 2010, the FASB issued Accounting Standards
Updated ("ASU") 2010-09 to amend ASC Topic 855. In preparation of the December
31, 2009 financial statements, the Company has performed all related procedures
required by ASC Topic 855.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
|
|
December 31,
|
|
|
|
|
|
|
|
|
Raw
materials
|
|
$
|
11,777
|
|
|
$
|
9,314
|
|
Work-in-process
|
|
|
6,687
|
|
|
|
8,829
|
|
Finished
products
|
|
|
59,812
|
|
|
|
57,151
|
|
Field
inventory
|
|
|
14,955
|
|
|
|
13,633
|
|
Consignment
inventory
|
|
|
25,274
|
|
|
|
23,426
|
|
|
|
|
118,505
|
|
|
|
112,353
|
|
Less
reserve for obsolescence
|
|
|
(23,881
|
)
|
|
|
(21,168
|
)
|
|
|
$
|
94,624
|
|
|
$
|
91,185
|
|
Field
inventory represents immediately saleable finished products inventory that is in
the possession of the Company’s direct sales representatives
The
Company had total investments held at cost of $0.3 million and $2.1 million as
of December 31, 2009 and 2008, respectively. In August 2008, Orthofix
entered into an agreement with Oped AG to liquidate a portion of the Company’s
investment in Oped AG. During the third quarter of 2008, the Company
received net proceeds of $0.8 million for the sale of a portion of its ownership
in OPED AG. In 2009, Orthofix modified its agreement with Oped AG and
sold 100% of its remaining investment to them in the third quarter of 2009 for
the net proceeds of $1.7 million. The Company’s investments at
December 31, 2009 reflect its ownership in Biowave Corporation, a pain therapy
company. The Company has assessed these cost investments as of
December 31, 2009 and 2008, noting no impairment in carrying value.
The
Company also has an investment in OrthoRx which was reduced to zero in
2004.
4.
|
Property,
plant and equipment
|
|
|
December
31,
|
|
|
|
|
|
|
|
|
Cost
|
|
|
|
|
|
|
Buildings
|
|
$
|
3,611
|
|
|
$
|
3,340
|
|
Plant,
equipment and instrumentation
|
|
|
94,927
|
|
|
|
76,827
|
|
Furniture
and fixtures
|
|
|
11,613
|
|
|
|
10,638
|
|
|
|
|
110,151
|
|
|
|
90,805
|
|
Accumulated
depreciation
|
|
|
(71,457
|
)
|
|
|
(58,145
|
)
|
|
|
$
|
38,694
|
|
|
$
|
32,660
|
|
Depreciation
expense for the years ended December 31, 2009, 2008 and 2007 was $15.3 million,
$14.2 million and $10.4 million, respectively.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
5.
|
Patents
and other intangible assets
|
|
|
December
31,
|
|
|
|
|
|
|
|
|
Cost
|
|
|
|
|
|
|
Patents
and developed technologies
|
|
$
|
27,961
|
|
|
$
|
25,602
|
|
Trademarks
– definite lived (subject to amortization)
|
|
|
119
|
|
|
|
105
|
|
Trademarks
– indefinite lived (not subject to amortization)
|
|
|
23,542
|
|
|
|
23,382
|
|
Distribution
networks
|
|
|
44,586
|
|
|
|
44,586
|
|
|
|
|
96,208
|
|
|
|
93,675
|
|
Accumulated
amortization
|
|
|
|
|
|
|
|
|
Patents
and developed technologies
|
|
|
(17,499
|
)
|
|
|
(13,194
|
)
|
Trademarks
– definite lived (subject to amortization)
|
|
|
(107
|
)
|
|
|
(105
|
)
|
Distribution
networks
|
|
|
(30,974
|
)
|
|
|
(26,830
|
)
|
Patents
and other intangible assets, net
|
|
$
|
47,628
|
|
|
$
|
53,546
|
|
Amortization expense for intangible
assets is estimated to be approximately $6.0 million, $5.9 million, $4.7
million, $1.6 million, $1.6 million and $4.3 million for the periods ending
December 31, 2010, 2011, 2012, 2013, 2014 and 2015 and thereafter,
respectively.
During
the third quarter of 2008, the Company determined that a test for impairment of
indefinite lived assets at Blackstone in accordance with ASC Topic 350 was
necessary due to decreasing revenues at Blackstone, among other
matters. The Company evaluated the indefinite-lived intangible assets
which included the Blackstone trademark acquired during the acquisition of
Blackstone. The impairment analysis resulted in the carrying value,
as adjusted for an impairment charge recognized in the fourth quarter of 2007,
of the trademark exceeding the fair value for which the Company recognized a
$57.0 million impairment charge included in Impairment of Goodwill and Certain
Intangible Assets in the year ended December 31, 2008.
Also,
during the third quarter of 2008, the Company determined that an impairment
indicator as described in ASC Topic 360 occurred with respect to the
definite-lived intangibles at Spinal Implants and Biologics. Due to
the impairment indicator, the Company compared the expected cash flows to be
generated by the Spinal Implants and Biologics reporting unit, which represented
the lowest level at which cash flows are specifically identifiable, on an
undiscounted basis to the carrying value of the reporting unit’s assets,
including goodwill. The Company determined the carrying value of the
Spinal Implants and Biologics reporting unit exceeded the related undiscounted
cash flows, which determination resulted in the impairment of the distribution
network and technologies at Spinal Implants and Biologics based on their fair
values. The resulting impairment charge of $105.7 million is included in
Impairment of Goodwill and Certain Intangible Assets.
During
the third quarter of 2008, due to the matters described in Note 5 above, the
Company performed an impairment analysis of the goodwill at Spinal Implants and
Biologics. The impairment analysis resulted in a goodwill impairment
charge of $126.9 million because the carrying value exceeded the implied fair
value of goodwill. For a discussion of how the Company tests to determine if
goodwill is impaired, see Note 2.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
The
following table presents the changes in the net carrying value of goodwill by
reportable segment:
|
|
|
|
|
Spinal Implants and
Biologics
|
|
|
|
|
|
|
|
|
|
|
At
December 31, 2007
|
|
$
|
31,793
|
|
|
$
|
136,240
|
|
|
$
|
101,322
|
|
|
$
|
50,583
|
|
|
$
|
319,938
|
|
Disposals
(1)
|
|
|
-
|
|
|
|
-
|
|
|
|
(2,027
|
)
|
|
|
-
|
|
|
|
(2,027
|
)
|
Purchase
of additional minority interest
(2)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(365
|
)
|
|
|
(365
|
)
|
Impairment
(3)
|
|
|
-
|
|
|
|
(126,873
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
(126,873
|
)
|
Foreign
currency
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(8,092
|
)
|
|
|
(8,092
|
)
|
At
December 31, 2008
|
|
|
31,793
|
|
|
|
9,367
|
|
|
|
99,295
|
|
|
|
42,126
|
|
|
|
182,581
|
|
Foreign
currency
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
2,594
|
|
|
|
2,594
|
|
At
December 31, 2009
|
|
$
|
31,793
|
|
|
$
|
9,367
|
|
|
$
|
99,295
|
|
|
$
|
44,720
|
|
|
$
|
185,175
|
|
(1) Sale
of operations relating to the Pain Care® business at Breg during the first
quarter of 2008.
(2) Purchase
of the remaining 38.74% of the minority interest in Mexican subsidiary and 4.00%
of the minority interest in Brazilian subsidiary.
(3) The
impairment analysis resulted in a goodwill impairment charge of $126.9 million
because the carrying value exceeded the implied fair value of
goodwill.
As of
December 31, 2009, the Company performed its annual impairment review of all its
reporting units and determined there was no additional impairment of
goodwill.
|
|
December
31,
|
|
|
|
|
|
|
|
|
Borrowings
under line of credit
|
|
$
|
2,209
|
|
|
$
|
1,907
|
|
The
weighted average interest rate on borrowings under lines of credit as of
December 31, 2009 and 2008 was 5.15% and 5.86%, respectively.
Borrowings
under the line of credit consist of borrowings in Euros. The Company
had an unused available line of credit of 5.8 million Euros ($8.2 million) and
5.2 million Euros ($7.3 million) at December 31, 2009 and 2008, respectively, in
its Italian line of credit. This line of credit provides the Company
the option to borrow amounts in Italy at rates which are determined at the time
of borrowing. This line of credit is unsecured.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
8.
|
Other
current liabilities
|
|
|
December
31,
|
|
|
|
|
|
|
|
|
Accrued
expenses
|
|
$
|
15,240
|
|
|
$
|
9,652
|
|
Salaries,
bonuses, commissions and related taxes payable
|
|
|
30,779
|
|
|
|
20,919
|
|
Interest
rate swap
|
|
|
6,123
|
|
|
|
7,975
|
|
Income
taxes payable
|
|
|
1,510
|
|
|
|
2,833
|
|
Other
payables
|
|
|
5,558
|
|
|
|
4,515
|
|
|
|
$
|
59,210
|
|
|
$
|
45,894
|
|
|
|
December
31,
|
|
|
|
|
|
|
|
|
Long-term
obligations
|
|
$
|
252,400
|
|
|
$
|
280,700
|
|
Other
loans
|
|
|
64
|
|
|
|
162
|
|
|
|
|
252,464
|
|
|
|
280,862
|
|
Less
current portion
|
|
|
(3,332
|
)
|
|
|
(3,329
|
)
|
|
|
$
|
249,132
|
|
|
$
|
277,533
|
|
On
September 22, 2006 the Company’s wholly-owned U.S. holding company subsidiary,
Orthofix Holdings, Inc. (“Orthofix Holdings”), entered into a senior secured
credit facility with a syndicate of financial institutions to finance the
acquisition of Blackstone Medical Inc. (“Blackstone”). Certain terms
of the senior secured credit facility were amended September 29,
2008. The senior secured credit facility provides for (1) a
seven-year amortizing term loan facility of $330.0 million and (2) a six-year
revolving credit facility of $45.0 million. As of December 31, 2009,
the Company had $0.3 million of letters of credit outstanding under the
revolving credit facility and $252.4 million outstanding under the term loan
facility. Obligations under the senior secured credit facility have a
floating interest rate of the London Inter-Bank Offered Rate (“LIBOR”) plus a
margin, with a LIBOR floor of 3.0%, or prime rate plus a margin. As
of December 31, 2009, the entire term loan obligation of $252.4 million is at
the prime rate plus a margin of 3.50%. The effective interest rates
on the senior secured credit facility, including the impact of an interest rate
swap (see Note 10), as of December 31, 2009 and December 31, 2008 were 8.8% and
8.4%, respectively.
Each of
the domestic subsidiaries of the Company (which includes Orthofix Inc., Breg
Inc., and Blackstone) and Colgate Medical Limited and Victory Medical Limited
(wholly-owned financing subsidiaries of the Company) has guaranteed the
obligations of Orthofix Holdings under the senior secured credit
facility. The obligations of the subsidiaries under their guarantees
are secured by the pledges of their respective assets.
Certain
subsidiaries of the Company have restrictions on their ability to pay dividends
or make intercompany loan advances pursuant to the Company’s senior secured
credit facility. The net assets of Orthofix Holdings and its
subsidiaries are restricted for distributions to the parent
company. Domestic subsidiaries of the Company, as parties to the
credit agreement, have access to these net assets for operational
purposes. The amount of restricted net assets of Orthofix Holdings
and its subsidiaries as of December 31, 2009 is $143.0 million compared to
$111.3 million at December 31, 2008. In addition, the senior secured
credit facility restricts the Company and subsidiaries that are not parties to
the credit facility from access to cash held by Colgate Medical Limited and its
subsidiaries. All credit party subsidiaries have access to this cash
for operational and debt repayment purposes.
As a
result of the Company prepaying $25.0 million of its long-term debt in 2009, the
aggregate maturities of long-term debt under contractual obligations after
December 31, 2009 are as follows: 2010 - $0, 2011 - $0, 2012 - $35.4
million, and 2013 - $217.0 million. However, the Company’s intentions
are to follow the original agreed upon payment schedule under the senior secured
credit facility and therefore, the aggregate maturities after December 31, 2009
are as follows: 2010 - $3.3 million, 2011 - $3.3 million, 2012 - $80.0 million
and 2013 - $165.8 million.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
In
conjunction with obtaining the senior secured credit facility, the Company
incurred debt issuance costs of $6.4 million which it has been amortizing over
the life of the facility. A portion of the capitalized debt issuance
costs included in other long-term assets related to the senior secured credit
facility were expensed as a result of the amendment on September 29, 2008, and
are included in the loss on refinancing of senior secured term loan for the year
ended December 31, 2008. In connection with the amendment to the
credit facility, the Company paid additional fees of $2.4 million in the year
ended December 31, 2008, of which $2.1 million are included in the loss on
refinancing of senior secured term loan.
As of December 31, 2009
and 2008, $0.2 million and $0.8 million, respectively, of debt issuance costs
which relate to the Company’s revolving credit facility are included in other
long-term assets.
10.
|
Derivative
instruments
|
In 2006,
the Company entered into a cross-currency swap agreement to manage its cash
flows related to foreign currency exposure for a portion of the Company’s
intercompany receivable of a U.S. dollar functional currency subsidiary that is
denominated in Euro. The derivative instrument, a ten-year fully
amortizable agreement with an initial notional amount of $63.0 million, is
scheduled to expire on December 30, 2016. The instrument is
designated as a cash flow hedge. The amount outstanding under the
agreement as of December 31, 2009 and December 31, 2008 was $53.5 million and
$56.7 million, respectively. Under the agreement, the Company pays
Euro and receives U.S. dollars based on scheduled cash flows in the agreement.
The Company recognized an unrealized gain (loss) on the change in fair value of
this swap arrangement of $(2.7) million and $1.6 million, net of tax, within
other comprehensive income for the year ended December 31, 2009 and December 31,
2008, respectively.
In June
2008, the Company entered into a three-year fully amortizable interest rate swap
agreement (the “Swap”) with a notional amount of $150.0 million and an
expiration date of June 30, 2011. During the second and third
quarters of 2008, the interest rate Swap was accounted for as a cash flow hedge,
and changes in its value were recorded as part of accumulated other
comprehensive income on the balance sheet. Due to declining interest
rates and a LIBOR floor in the Company's amended credit facility, the Swap was
no longer deemed highly effective. Therefore, during the fourth
quarter of 2008, the Company recognized in earnings an unrealized, non-cash loss
of approximately $8.0 million which resulted from changes in the fair value of
the Company’s interest rate Swap. Special hedge accounting is no longer applied
and fair value adjustments are expected to be reported in current earnings
through the expiration of the Swap in June 2011. For the year ended
December 31, 2009, the Company recorded an unrealized gain of $1.9
million in unrealized
non-cash gain (loss) on interest rate swap on the statement of
operations. The Swap continues to provide an economic hedge against
fluctuating interest rate exposure on the $150.0 million portion of outstanding
debt it covers, should the LIBOR interest rate rise above 3.73%.
As
required by ASC Topic 815 – Derivatives and Hedging (formerly known as SFAS No.
161 “Disclosures about Derivative Instruments and Hedging Activities”), the
tables below disclose the types of derivative instruments the Company owns, the
classifications and fair values of these instruments within the balance sheet,
and the amount of gain (loss) recognized in other comprehensive income (loss)
(“OCI”) or income (loss).
(US$ in thousands)
As of December 31,
2009
|
|
Fair value: favorable
(unfavorable)
|
|
|
|
Amount of gain (loss) recognized in
OCI
|
|
Cross-currency
swap
|
|
$
|
(4,737
|
)
|
Other
long-term liabilities
|
|
$
|
(2,702
|
)
|
Interest
rate swap
|
|
$
|
(6,123
|
)
|
Other
current liabilities
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
Cross-currency
swap
|
|
$
|
681
|
|
Other
long-term assets
|
|
$
|
1,567
|
|
Interest
rate swap
|
|
$
|
(7,975
|
)
|
Other
current liabilities
|
|
$
|
-
|
|
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
(US$
in thousands)
|
|
For the year ended
December 31,
|
|
Amount of gain (loss) recognized in income
(loss)
|
|
|
|
|
|
|
Interest
rate swap
|
|
$
|
1,852
|
|
|
$
|
(7,975
|
)
|
11.
|
Fair
value measurements
|
The
Company adopted the accounting guidance for fair value measurements on January
1, 2008. Fair value is defined as the price that would be received
for an asset or paid to transfer a liability (an exit price) in the principal or
most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Non-financial
assets and liabilities of the Company measured at fair value include any
long-lived assets or equity method investments that are impaired in a currently
reported period. The authoritative guidance also describes three
levels of inputs that may be used to measure fair value:
Level 1 –
quoted prices in active markets for identical assets and
liabilities
Level 2 –
observable inputs other than quoted prices in active markets for identical
assets and liabilities
Level 3 –
unobservable inputs in which there is little or no market data available, which
require the reporting entity to develop its own assumptions
As of
December 31, 2009, the Company held certain items that are required to be
measured at fair value on a recurring basis. These included cash
equivalents, restricted cash, accounts receivable, short-term bank borrowings,
accounts payable, long-term secured debt, an interest rate derivative contract,
and a cross currency derivative contract. Cash equivalents consist of
short-term, highly liquid, income-producing investments, all of which have
original maturities of 90 days or less, including money market
funds. Restricted cash, accounts receivable, short-term bank
borrowings and accounts payable approximate fair value due to the short-term
maturities of these instruments. The Company’s long-term secured debt
carries a floating rate of interest and therefore, the carrying value is
considered to approximate the fair value. The derivative instruments
are related to the Company’s interest rate and foreign currency
hedges.
The
Company’s interest rate derivative instrument is an over-the-counter (“OTC”)
swap contract. The inputs used to determine the fair value of this
contract are obtained in quoted public markets. Therefore, the
Company has categorized the swap contract as Level 2. The
Company also considers counterparty credit risk and its own credit risk in its
determination of all estimated fair values. The Company has
consistently applied these valuation techniques in all periods
presented.
The
Company’s cross currency derivative instrument is an OTC contract, which is not
traded on a public exchange. The fair value of the swap
contract is determined based on inputs that are readily available in public
markets or can be derived from information available in publicly quoted
markets. Therefore, the Company has categorized the swap contract as
a Level 2 derivative financial instrument. The Company also
considers counterparty credit risk and its own credit risk in its determination
of all estimated fair values. The Company has consistently applied
these valuation techniques in all periods presented.
The fair
value of the Company’s financial assets and liabilities on a recurring basis
were as follows:
|
|
Balance December 31,
2009
|
|
|
|
|
|
|
|
|
|
|
Derivative
Financial Instruments
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flow Hedges
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
rate hedge
|
|
$
|
(6,123
|
)
|
|
$
|
-
|
|
|
$
|
(6,123
|
)
|
|
$
|
-
|
|
Cross
currency hedge
|
|
$
|
(4,737
|
)
|
|
$
|
-
|
|
|
$
|
(4,737
|
)
|
|
$
|
-
|
|
(1)
See
Note 10, “Derivative Instruments”.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Leases
The
Company has entered into operating leases for facilities and
equipment. These leases are non-cancellable and typically do not
contain renewal options. Certain leases contain rent escalation
clauses for which the Company recognizes the expense on a straight-line
basis. Rent expense under the Company’s operating leases for the
years ended December 31, 2009, 2008 and 2007 was approximately $6.2 million,
$5.6 million and $5.2 million, respectively. Future minimum
lease payments under operating leases as of December 31, 2009 are as
follows:
|
|
|
|
2010
|
|
$
|
5,621
|
|
2011
|
|
|
4,363
|
|
2012
|
|
|
2,883
|
|
2013
|
|
|
1,963
|
|
2014
|
|
|
1,567
|
|
Thereafter
|
|
|
8,300
|
|
Total
|
|
$
|
24,697
|
|
In
February 2009, as part of the consolidation and reorganization of the Company’s
spine business from New Jersey and Massachusetts into the Texas facility, the
Company entered into a ten year operating lease in Lewisville,
Texas. The future minimum lease payments of $1.5 million per year for
the first five years and $1.6 million per year for the following five years are
included in the table above. This lease will commence upon the
earlier of occupancy or completion of improvements, which is expected to occur
in the second quarter of 2010.
13.
|
Business
segment information
|
The
Company’s segment information is prepared on the same basis that the Company’s
management reviews the financial information for operational decision making
purposes. The Company is comprised of the following segments:
Domestic
Domestic
(“Domestic”) consists of the operations of Orthofix Inc. within the
U.S. Domestic designs, manufactures and distributes stimulation,
orthopedic and biologics products. Domestic uses both direct and
distributor sales representatives to sell Spine and Orthopedic products to
hospitals, doctors and other healthcare providers in the U.S.
market.
Spinal
Implants and Biologics (previously referred to as “Blackstone”)
Spinal
Implants and Biologics (“Spinal Implants and Biologics”) consists of Blackstone
and its two subsidiaries, Blackstone GmbH and Goldstone GmbH. Spinal
Implants and Biologics specializes in the design, development and marketing of
spinal implant and related HCT/P products. Spinal Implants and Biologics
distributes its products through a network of domestic and international
distributors, sales representatives and affiliates.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Breg
Breg,
Inc. (“Breg”), based in Vista, California, designs, manufactures, and
distributes orthopedic products for post-operative reconstruction and
rehabilitative patient use and sells its products through a network of domestic
and international distributors, sales representatives and
affiliates.
International
International
(“International”) consists of international operations located in Europe,
Mexico, Brazil and Puerto Rico, as well as independent distributors located
outside the U.S. International uses both direct and distributor sales
representatives to sell Spine, Orthopedics, Sports Medicine, Vascular and Other
products to hospitals, doctors, and other healthcare providers.
Group
Activities
Group
activities are comprised of the operating expenses of Orthofix International
N.V. and its U.S. holding company subsidiary, Orthofix Holdings,
Inc.
The
tables below present information by reportable segment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
210,703
|
|
|
$
|
188,807
|
|
|
$
|
166,727
|
|
|
$
|
4,516
|
|
|
$
|
5,871
|
|
|
$
|
4,090
|
|
Spinal
Implants and Biologics
|
|
|
118,680
|
|
|
|
108,966
|
|
|
|
115,914
|
|
|
|
2,335
|
|
|
|
3,999
|
|
|
|
5,925
|
|
Breg
|
|
|
92,188
|
|
|
|
89,478
|
|
|
|
83,397
|
|
|
|
5,521
|
|
|
|
5,583
|
|
|
|
3,780
|
|
International
|
|
|
124,064
|
|
|
|
132,424
|
|
|
|
124,285
|
|
|
|
23,116
|
|
|
|
24,914
|
|
|
|
27,893
|
|
Total
|
|
$
|
545,635
|
|
|
$
|
519,675
|
|
|
$
|
490,323
|
|
|
$
|
35,488
|
|
|
$
|
40,367
|
|
|
$
|
41,688
|
|
Operating
Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
67,831
|
|
|
$
|
64,301
|
|
|
$
|
55,297
|
|
Spinal
Implants and Biologics
|
(1) (2)
(3)
|
|
(14,045
|
)
|
|
|
(330,755
|
)
|
|
|
(26,110
|
)
|
Breg
|
|
|
13,061
|
|
|
|
12,393
|
|
|
|
9,717
|
|
International
|
|
|
17,664
|
|
|
|
18,664
|
|
|
|
19,973
|
|
Group
Activities
|
|
|
(21,156
|
)
|
|
|
(20,812
|
)
|
|
|
(19,003
|
)
|
Eliminations
|
|
|
520
|
|
|
|
(740
|
)
|
|
|
(1,817
|
)
|
Total
|
|
$
|
63,875
|
|
|
$
|
(256,949
|
)
|
|
$
|
38,057
|
|
|
(1)
|
Includes
$5.7 million of research and development expense from collaborative
arrangements and $3.6
million of
restructuring charges for the year ended December 31,
2009.
|
|
(2)
|
Includes
impairment charges on goodwill and certain intangible assets of $289.5
million and $20.0 million during the years ended December 31, 2008 and
2007, respectively.
|
|
(3)
|
Includes
an increase in the reserve for obsolescence of $10.9 million during the
year ended December 31, 2008, due to reduced projections in revenue,
distributor terminations, new products, and the replacement of one product
with a successor product.
|
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
The
following table presents identifiable assets by segment, excluding intercompany
balances and investments in consolidated subsidiaries.
Identifiable
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
116,376
|
|
|
$
|
110,981
|
|
Spinal
Implants and Biologics
|
|
|
134,446
|
|
|
|
121,508
|
|
Breg
|
|
|
164,236
|
|
|
|
172,398
|
|
International
|
|
|
161,457
|
|
|
|
146,444
|
|
Group
activities
|
|
|
13,438
|
|
|
|
10,624
|
|
Eliminations
|
|
|
520
|
|
|
|
(740
|
)
|
Total
|
|
$
|
590,473
|
|
|
$
|
561,215
|
|
The
following table presents depreciation and amortization, income tax expense
(benefit) and other income (expense) by segment:
|
|
Depreciation and
amortization
|
|
|
Income tax
expense (benefit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
2,519
|
|
|
$
|
2,674
|
|
|
$
|
2,831
|
|
|
$
|
29,427
|
|
|
$
|
25,457
|
|
|
$
|
21,803
|
|
|
$
|
(20
|
)
|
|
$
|
(1,414
|
)
|
|
$
|
69
|
|
Spinal
Implants and Biologics
|
|
|
7,500
|
|
|
|
15,837
|
|
|
|
13,975
|
|
|
|
(12,725
|
)
|
|
|
(86,857
|
)
|
|
|
(16,186
|
)
|
|
|
179
|
|
|
|
73
|
|
|
|
475
|
|
Breg
|
|
|
6,964
|
|
|
|
7,750
|
|
|
|
8,048
|
|
|
|
3,749
|
|
|
|
2,676
|
|
|
|
1,799
|
|
|
|
(209
|
)
|
|
|
(119
|
)
|
|
|
(89
|
)
|
International
|
|
|
5,087
|
|
|
|
4,794
|
|
|
|
3,497
|
|
|
|
1,398
|
|
|
|
(222
|
)
|
|
|
(520
|
)
|
|
|
45
|
|
|
|
(7,460
|
)
|
|
|
6,178
|
|
Group
activities
|
|
|
274
|
|
|
|
224
|
|
|
|
180
|
|
|
|
(6,300
|
)
|
|
|
(7,535
|
)
|
|
|
(3,129
|
)
|
|
|
(23,849
|
)
|
|
|
(29,166
|
)
|
|
|
(29,955
|
)
|
Total
|
|
$
|
22,344
|
|
|
$
|
31,279
|
|
|
$
|
28,531
|
|
|
$
|
15,549
|
|
|
$
|
(66,481
|
)
|
|
$
|
3,767
|
|
|
$
|
(23,854
|
)
|
|
$
|
(38,086
|
)
|
|
$
|
(23,322
|
)
|
Capital
expenditures of tangible and intangible assets for each segment are as
follows:
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
4,569
|
|
|
$
|
1,813
|
|
|
$
|
2,936
|
|
Spinal
Implants and Biologics
|
|
|
9,442
|
|
|
|
10,355
|
|
|
|
15,278
|
|
Breg
|
|
|
1,898
|
|
|
|
3,071
|
|
|
|
2,706
|
|
International
|
|
|
5,975
|
|
|
|
4,757
|
|
|
|
6,309
|
|
Group
activities
|
|
|
114
|
|
|
|
196
|
|
|
|
-
|
|
Total
|
|
$
|
21,998
|
|
|
$
|
20,192
|
|
|
$
|
27,229
|
|
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Geographical
information
Analysis
of net sales by geographic destination:
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
415,356
|
|
|
$
|
381,016
|
|
|
$
|
359,007
|
|
International:
|
|
|
|
|
|
|
|
|
|
|
|
|
U.K.
|
|
|
19,407
|
|
|
|
27,465
|
|
|
|
33,109
|
|
Italy
|
|
|
19,679
|
|
|
|
26,075
|
|
|
|
25,175
|
|
Other
|
|
|
91,193
|
|
|
|
85,119
|
|
|
|
73,032
|
|
Total
international
|
|
|
130,279
|
|
|
|
138,659
|
|
|
|
131,316
|
|
Total
net sales
|
|
$
|
545,635
|
|
|
$
|
519,675
|
|
|
$
|
490,323
|
|
There are
no sales in the Netherlands Antilles.
Analysis
of property, plant and equipment and investments by geographic
area:
|
|
|
|
|
|
|
U.S.
|
|
$
|
25,245
|
|
|
$
|
21,409
|
|
Italy
|
|
|
7,567
|
|
|
|
6,540
|
|
U.K.
|
|
|
2,415
|
|
|
|
2,044
|
|
Others
|
|
|
3,812
|
|
|
|
4,762
|
|
Total
|
|
$
|
39,039
|
|
|
$
|
34,755
|
|
There are
no long-lived assets in the Netherlands Antilles.
|
|
Sales by Market Sector for the year ended December
31, 2009
|
|
|
|
|
|
|
Spinal Implants and
Biologics
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$
|
158,908
|
|
|
$
|
118,680
|
|
|
$
|
-
|
|
|
$
|
1,837
|
|
|
$
|
279,425
|
|
Orthopedics
|
|
|
51,795
|
|
|
|
-
|
|
|
|
-
|
|
|
|
79,515
|
|
|
|
131,310
|
|
Sports
Medicine
|
|
|
-
|
|
|
|
-
|
|
|
|
92,188
|
|
|
|
4,178
|
|
|
|
96,366
|
|
Vascular
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
18,710
|
|
|
|
18,710
|
|
Other
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
19,824
|
|
|
|
19,824
|
|
Total
|
|
$
|
210,703
|
|
|
$
|
118,680
|
|
|
$
|
92,188
|
|
|
$
|
124,064
|
|
|
$
|
545,635
|
|
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
|
|
Sales by Market Sector for the year ended December
31, 2008
|
|
|
|
|
|
|
Spinal Implants and
Biologics
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$
|
141,753
|
|
|
$
|
108,966
|
|
|
$
|
-
|
|
|
$
|
1,520
|
|
|
$
|
252,239
|
|
Orthopedics
|
|
|
47,054
|
|
|
|
-
|
|
|
|
-
|
|
|
|
82,052
|
|
|
|
129,106
|
|
Sports
Medicine
|
|
|
-
|
|
|
|
-
|
|
|
|
89,478
|
|
|
|
5,050
|
|
|
|
94,528
|
|
Vascular
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
17,890
|
|
|
|
17,890
|
|
Other
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
25,912
|
|
|
|
25,912
|
|
Total
|
|
$
|
188,807
|
|
|
$
|
108,966
|
|
|
$
|
89,478
|
|
|
$
|
132,424
|
|
|
$
|
519,675
|
|
|
|
Sales by Market Sector for the year ended December
31, 2007
|
|
|
|
|
|
|
Spinal Implants and
Biologics
|
|
|
|
|
|
|
|
|
|
|
Spine
|
|
$
|
126,626
|
|
|
$
|
115,914
|
|
|
$
|
-
|
|
|
$
|
625
|
|
|
$
|
243,165
|
|
Orthopedics
|
|
|
40,101
|
|
|
|
-
|
|
|
|
-
|
|
|
|
71,831
|
|
|
|
111,932
|
|
Sports
Medicine
|
|
|
-
|
|
|
|
-
|
|
|
|
83,397
|
|
|
|
4,143
|
|
|
|
87,540
|
|
Vascular
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
19,866
|
|
|
|
19,866
|
|
Other
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
27,820
|
|
|
|
27,820
|
|
Total
|
|
$
|
166,727
|
|
|
$
|
115,914
|
|
|
$
|
83,397
|
|
|
$
|
124,285
|
|
|
$
|
490,323
|
|
Income
(loss) before provision (benefit) for income taxes consisted of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
28,542
|
|
|
$
|
(304,542
|
)
|
|
$
|
551
|
|
Non-U.S.
|
|
|
11,479
|
|
|
|
9,507
|
|
|
|
14,184
|
|
|
|
$
|
40,021
|
|
|
$
|
(295,035
|
)
|
|
$
|
14,735
|
|
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
The
provision for (benefit from) income taxes in the accompanying consolidated
statements of operations consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
|
|
|
|
|
|
|
-Current
|
|
$
|
17,929
|
|
|
$
|
12,697
|
|
|
$
|
10,501
|
|
-Deferred
|
|
|
(6,698
|
)
|
|
|
(81,661
|
)
|
|
|
(10,817
|
)
|
Non-U.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
-Current
|
|
|
2,029
|
|
|
|
(53
|
)
|
|
|
2,134
|
|
-Deferred
|
|
|
2,289
|
|
|
|
2,536
|
|
|
|
1,949
|
|
Total
tax expense
|
|
$
|
15,549
|
|
|
$
|
(66,481
|
)
|
|
$
|
3,767
|
|
The tax
effects of the significant temporary differences, which comprise the deferred
tax assets and liabilities and assets, are as follows:
|
|
|
|
|
|
|
Goodwill
|
|
$
|
(1,029
|
)
|
|
$
|
(901
|
)
|
Patents,
trademarks and other intangible assets
|
|
|
(12,181
|
)
|
|
|
(12,760
|
)
|
Property,
plant and equipment
|
|
|
(4,297
|
)
|
|
|
(2,172
|
)
|
Other
current
|
|
|
(6,115
|
)
|
|
|
(4,509
|
)
|
Inventories
and related reserves
|
|
|
11,065
|
|
|
|
9,108
|
|
Accrued
compensation
|
|
|
14,296
|
|
|
|
10,669
|
|
Allowance
for doubtful accounts
|
|
|
4,306
|
|
|
|
4,254
|
|
Interest
|
|
|
12,254
|
|
|
|
9,284
|
|
Net
operating loss carryforwards
|
|
|
18,664
|
|
|
|
15,320
|
|
Other
long-term
|
|
|
6,195
|
|
|
|
7,383
|
|
Valuation
allowance
|
|
|
(17,239
|
)
|
|
|
(14,370
|
)
|
Net
deferred tax asset (liability)
|
|
$
|
25,919
|
|
|
$
|
21,306
|
|
The
valuation allowance as of December 31, 2009 and 2008 was $17.2 million and $14.4
million, respectively. The net increase in the valuation
allowance of $2.8 million during the year relates to current period foreign
losses not benefitted. The valuation allowance is attributable to net
operating loss carryforwards in certain foreign jurisdictions, the benefit for
which is dependent upon the generation of future taxable income in that
location. In assessing the realizability of deferred tax assets,
management considers whether it is more likely than not that some portion or all
of the deferred tax assets will not be realized. The ultimate
realization of deferred tax assets is dependent upon the generation of future
taxable income during the periods in which those temporary differences become
deductible. Management considers the scheduled reversal of deferred
tax liabilities, projected future taxable income and tax planning strategies in
making this assessment. Based upon the level of historical taxable
income and projections for future taxable income over the periods in which the
deferred tax assets are deductible, management believes it is more likely than
not the Company will realize the benefits of these deductible differences, net
of the existing valuation allowances at December 31, 2009.
The
Company has tax net operating loss carryforwards in various taxing jurisdictions
of approximately $67.3 million with the majority of the losses related to the
Company’s Netherlands operations expiring in various amounts in tax years
beginning in 2010. The Company has provided a valuation allowance
against a significant portion of these net operating loss carryforwards since it
does not believe that this deferred tax asset can be realized prior to
expiration.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
The rate
reconciliation presented below is based on the U.S. federal income tax rate,
rather than the parent company’s country of domicile tax
rate. Management believes, given the large proportion of taxable
income earned in the United States, such disclosure is more
meaningful.
(US$ in thousands, except
percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Statutory
U.S. federal income tax rate
|
|
$
|
14,007
|
|
|
|
35
|
%
|
|
$
|
(103,263
|
)
|
|
|
35
|
%
|
|
$
|
5,179
|
|
|
|
35
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
State
taxes, net
|
|
|
1,574
|
|
|
|
3.9
|
%
|
|
|
(4,798
|
)
|
|
|
1.6
|
%
|
|
|
317
|
|
|
|
2.1
|
%
|
Foreign
rate differential
|
|
|
(1,401
|
)
|
|
|
(3.5
|
)%
|
|
|
(1,422
|
)
|
|
|
0.5
|
%
|
|
|
(2,504
|
)
|
|
|
(17.0
|
)%
|
Valuation
allowance – foreign losses
|
|
|
2,861
|
|
|
|
7.2
|
%
|
|
|
3,031
|
|
|
|
(1.0
|
)%
|
|
|
2,665
|
|
|
|
18.0
|
%
|
Italy
step-up amortization
|
|
|
(2,573
|
)
|
|
|
(6.4
|
)%
|
|
|
(2,527
|
)
|
|
|
0.9
|
%
|
|
|
(2,115
|
)
|
|
|
(14.3
|
)%
|
Blackstone
purchased research and development
|
|
|
-
|
|
|
|
0.0
|
%
|
|
|
(165
|
)
|
|
|
0.1
|
%
|
|
|
(1,320
|
)
|
|
|
(8.9
|
)%
|
Domestic
manufacturing deduction
|
|
|
(839
|
)
|
|
|
(2.1
|
)%
|
|
|
(741
|
)
|
|
|
0.3
|
%
|
|
|
(453
|
)
|
|
|
(3.1
|
)%
|
Reserves,
net
|
|
|
172
|
|
|
|
0.4
|
%
|
|
|
(1,093
|
)
|
|
|
0.4
|
%
|
|
|
372
|
|
|
|
(2.5
|
)%
|
Goodwill
impairment
|
|
|
-
|
|
|
|
0.0
|
%
|
|
|
44,406
|
|
|
|
(15.2
|
)%
|
|
|
-
|
|
|
|
0.0
|
%
|
Permanent
items
|
|
|
935
|
|
|
|
2.4
|
%
|
|
|
900
|
|
|
|
(0.3
|
)%
|
|
|
451
|
|
|
|
3.0
|
%
|
Tax
rate changes
|
|
|
-
|
|
|
|
0.0
|
%
|
|
|
(2,320
|
)
|
|
|
0.8
|
%
|
|
|
1,266
|
|
|
|
8.6
|
%
|
Other
items, net
|
|
|
813
|
|
|
|
2.0
|
%
|
|
|
1,511
|
|
|
|
(0.6
|
)%
|
|
|
(91
|
)
|
|
|
(0.4
|
)%
|
Income
tax expense/effective rate
|
|
$
|
15,549
|
|
|
|
38.9
|
%
|
|
$
|
(66,481
|
)
|
|
|
22.5
|
%
|
|
$
|
3,767
|
|
|
|
25.5
|
%
|
The
Company’s gross unrecognized tax benefit was $0.4 million and $0.7 million for
the years ended December 31, 2009 and 2008, respectively. The Company
recognizes potential accrued interest and penalties related to unrecognized tax
benefits within its global operations in income tax expenses. The
Company had approximately $0.4 million and $0.4 million accrued for payment of
interest and penalties as of December 31, 2009 and 2008,
respectively.
The
entire amount of unrecognized tax benefits, including interest, would favorably
impact the Company’s effective tax rate if recognized. As of December
31, 2009, the Company does not expect the amount of unrecognized tax benefits to
change significantly over the next twelve months.
A
reconciliation of the gross unrecognized tax benefits (excluding interest) for
the years ended December 31, 2009 and December 31, 2008 follows:
|
|
|
|
|
|
|
Balance
as of January 1,
|
|
$
|
707
|
|
|
$
|
1,707
|
|
Additions
for current year tax positions
|
|
|
-
|
|
|
|
-
|
|
Additions
for prior year tax positions
|
|
|
338
|
|
|
|
-
|
|
Expiration
of statutes
|
|
|
-
|
|
|
|
(1,000
|
)
|
Audit
settlements
|
|
|
(603
|
)
|
|
|
-
|
|
Balance
as of December 31,
|
|
$
|
442
|
|
|
$
|
707
|
|
The
Company files a consolidated income tax return in the U.S. federal jurisdiction
and numerous consolidated and separate income tax returns in many state and
foreign jurisdictions. The statute of limitations with respect to federal tax
authorities is closed for years prior to December 31, 2006. The
statute of limitations for the various state tax filings is closed in most
instances for the years prior to December 31, 2006. There are certain
state tax statutes open for years from 1997 forward due to current
examinations. The statute of limitations with respect to the major
foreign tax filing jurisdictions is closed for years prior to December 31,
2005.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
The
Company’s intention is to reinvest the total amount of its unremitted foreign
earnings (residing outside the Netherland Antilles) in the local jurisdiction,
to the extent they are generated and available, or to repatriate the earnings
only when tax-effective. As such, the Company has not provided tax expense on
$276.1 million of the unremitted earnings of its foreign
subsidiaries. It is not practicable to determine the amounts of net
additional income tax that may be payable if such earnings were
repatriated.
The
following related party balances and transactions as of and for the three years
ended December 31, 2009, among the Company and other companies in which
directors and/or executive officers have an interest are reflected in the
consolidated financial statements. The Company buys components
related to the A-V Impulse
®
System and buys the Laryngeal Mask from companies in which a former board member
has a beneficial minority interest. OrthoPro, Inc., an independent
distributor for Breg, Inc., is owned by the son of one of the Company’s current
board members. The Company sells bracing products to OrthoRx, an
entity in which the Company has a minority interest equity ownership, accounted
for under the cost method.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
|
|
$
|
4,043
|
|
|
$
|
2,278
|
|
|
$
|
1,478
|
|
Purchases
|
|
$
|
11,901
|
|
|
$
|
12,681
|
|
|
$
|
13,207
|
|
Accounts
payable
|
|
$
|
1,481
|
|
|
$
|
1,686
|
|
|
$
|
2,189
|
|
Accounts
receivable
|
|
$
|
563
|
|
|
$
|
460
|
|
|
$
|
7
|
|
Litigation
On or
about July 23, 2007, our subsidiary, Blackstone Medical Inc. (“Blackstone”)
received a subpoena issued by the Department of Health and Human Services,
Office of Inspector General, under the authority of the federal healthcare
anti-kickback and false claims statutes. The subpoena seeks documents for the
period January 1, 2000 through July 31, 2006, which is prior to Blackstone’s
acquisition by the Company. The Company believes that the subpoena concerns the
compensation of physician consultants and related matters. On September 17,
2007, the Company submitted a claim for indemnification from the escrow fund
established in connection with the agreement and plan of merger between the
Company, New Era Medical Corp. and Blackstone, dated as of August 4, 2006 (the
“Blackstone Merger Agreement”), for any losses to us resulting from this matter.
(The Company’s indemnification rights under the Blackstone Merger Agreement are
described further below). The Company was subsequently notified by legal counsel
for the former shareholders that the representative of the former shareholders
of Blackstone has objected to the indemnification claim and intends to contest
it in accordance with the terms of the Blackstone Merger Agreement.
On or
about January 7, 2008, the Company received a federal grand jury subpoena from
the U.S. Attorney’s Office for the District of Massachusetts. The subpoena seeks
documents from the Company for the period January 1, 2000 through July 15, 2007.
The Company believes that the subpoena concerns the compensation of physician
consultants and related matters, and further believes that it is associated with
the Department of Health and Human Services, Office of Inspector General’s
investigation of such matters. On September 18, 2008, the Company submitted a
claim for indemnification from the escrow fund established in connection with
the Blackstone Merger Agreement for any losses to the Company resulting from
this matter. On or about April 29, 2009, counsel for the Company received a
HIPAA subpoena issued by the U.S. Department of Justice. The subpoena seeks
documents from the Company for the period January 1, 2000 through July 15, 2007.
The Company believes that the subpoena concerns the compensation of physician
consultants and related matters, and further believes that it is associated with
the Department of Health and Human Services, Office of Inspector General’s
investigation of such matters, as well as the January 7, 2008 federal grand jury
subpoena. On or about February 25, 2010, counsel for Orthofix Inc. and
Blackstone sent to the U.S. Attorney’s Office for the District of Massachusetts
a tolling agreement (the “Tolling Agreement”) executed by Orthofix Inc.
and Blackstone, that extends an agreement tolling the statute of limitations
applicable to any criminal, civil, or administrative proceedings that the
government might later initiate. Upon execution by the U.S. Attorney's
Office for the District of Massachusetts, the Tolling Agreement will
extend the period tolling the statute of limitations to include the period
from December 1, 2008 through and including March 31, 2010.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
On or
about December 5, 2008, the Company obtained a copy of a qui tam complaint filed
by Susan Hutcheson and Philip Brown against Blackstone and the Company in the
U.S. District Court for the District of Massachusetts. A qui tam action is a
civil lawsuit brought by an individual for an alleged violation of a federal
statute, in which the U.S. Department of Justice has the right to intervene and
take over the prosecution of the lawsuit at its option. On November 21, 2008,
the U.S. Department of Justice filed a notice of non-intervention in the case.
The complaint was served on Blackstone on or about March 24, 2009. Counsel for
the plaintiffs filed an amended complaint on June 4, 2009. The amended complaint
sets forth a cause of action against Blackstone under the False Claims Act for
alleged inappropriate payments and other items of value conferred on physician
consultants; Orthofix is not named as a defendant in the amended complaint. The
Company believes that this lawsuit is related to the matters described above
involving the Department of Health and Human Services, Office of the Inspector
General, and the U.S. Attorney’s Office for the District of Massachusetts, and
the U.S. Department of Justice. The Company intends to defend vigorously against
this lawsuit. On September 18, 2008, after being informed of the existence of
the lawsuit by representatives of the U.S. Department of Justice and prior to
the unsealing of the complaint (which was unsealed by the court on or about
November 24, 2008), the Company submitted a claim for indemnification from the
escrow fund established in connection with the Blackstone Merger Agreement for
any losses to us resulting from this matter.
On or
about September 27, 2007, Blackstone received a federal grand jury subpoena
issued by the U.S. Attorney’s Office for the District of Nevada (“USAO-Nevada
subpoena”). The subpoena seeks documents for the period from January 1999 to the
date of issuance of the subpoena. The Company believes that the subpoena
concerns payments or gifts made by Blackstone to certain physicians. On February
29, 2008, Blackstone received a Civil Investigative Demand (“CID”) from the
Massachusetts Attorney General’s Office, Public Protection and Advocacy Bureau,
Healthcare Division. The CID seeks documents for the period from
March 2004 through the date of issuance of the CID, and the Company believes
that the CID concerns Blackstone’s financial relationships with certain
physicians and related matters. The Ohio Attorney General’s Office,
Health Care Fraud Section has issued a criminal subpoena, dated August 8, 2008,
to Orthofix, Inc. (the “Ohio AG subpoena”). The Ohio AG subpoena seeks documents
for the period from January 1, 2000 through the date of issuance of the
subpoena. The Company believes that the Ohio AG subpoena arises from a
government investigation that concerns the compensation of physician consultants
and related matters. On September 18, 2008, the Company submitted a claim for
indemnification from the escrow fund established in connection with the
Blackstone Merger Agreement for any losses to us resulting from the USAO-Nevada
subpoena, the Massachusetts CID and the Ohio AG subpoena.
By order
entered on January 4, 2007, the U.S. District Court for the Eastern District of
Arkansas unsealed a qui tam complaint captioned Thomas v. Chan, et al.,
4:06-cv-00465-JLH, filed against Dr. Patrick Chan, Blackstone and other
defendants including another device manufacturer. The amended complaint in the
Thomas action alleges causes of action under the False Claims Act for alleged
inappropriate payments and other items of value conferred on Dr. Chan and
another provider. The Company believes that Blackstone has meritorious defenses
to the claims alleged and the Company intends to defend vigorously against this
lawsuit. On September 17, 2007, the Company submitted a claim for
indemnification from the escrow fund established in connection with the
Blackstone Merger Agreement for any losses to us resulting from this matter. The
Company was subsequently notified by legal counsel for the former shareholders
that the representative of the former shareholders of Blackstone has objected to
the indemnification claim and intends to contest it in accordance with the terms
of the Blackstone Merger Agreement.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Under the
Blackstone Merger Agreement, the former shareholders of Blackstone have agreed
to indemnify the Company for breaches of representations and warranties under
the agreement as well as certain other specified matters. These post-closing
indemnification obligations of the former Blackstone shareholders are limited to
a cumulative aggregate amount of $66.6 million. At closing, an escrow fund was
established pursuant to the terms of the Blackstone Merger Agreement to fund
timely submitted indemnification claims. The initial amount of the escrow fund
was $50.0 million. As of December 31, 2009, the escrow fund, which has
subsequently accrued interest, contained $52.0 million. The Company is also
entitled to seek direct personal recourse against certain principal shareholders
of Blackstone after all monies on deposit in the escrow fund have been paid out
or released or are the subject of pending or unresolved indemnification claims
but only for a period of six years from the closing date of the merger and only
up to an amount equal to $66.6 million less indemnification claims previously
paid.
In
addition to the foregoing claims, the Company has submitted claims for
indemnification from the escrow fund for losses that have resulted or may result
from certain civil actions filed against Blackstone as well as certain claims
against Blackstone alleging rights to payments for Blackstone stock options not
reflected in Blackstone’s corporate ledger at the time of its acquisition by the
Company, or that the shares or stock options subject to those claims were
improperly diluted by Blackstone. To date, the representative of the
former shareholders of Blackstone has not objected to approximately $1.5 million
in such claims from the escrow fund, with certain claims remaining
pending.
The
Company is unable to predict the outcome of each of the escrow claims described
above in the preceding paragraphs or to estimate the amount, if any, that may
ultimately be returned to the Company from the escrow fund and there can be no
assurance that losses to the Company from these matters will not exceed the
amount of the escrow fund. Expenses incurred by the Company relating to the
above matters are recorded as an escrow receivable in the Company’s financial
statements to the extent the Company believes, among other things, that
collection of the claims is reasonably assured. Expenditures related to such
matters for which the Company believes collection is doubtful are recognized in
earnings when incurred. As of December 31, 2009 and December 31, 2008, included
in Prepaid expenses and other current assets is approximately $12.9 million and
$8.3 million, respectively, of escrow receivable balances related to the
Blackstone matters described above. These amounts include, among other things,
attorneys’ fees and costs related to the government investigations manifested by
the subpoenas described above, the stock option-related claims described above,
and costs related to the qui-tam action described above. As described above,
some of these reimbursement claims are being contested by the representative of
the former shareholders of Blackstone. To mitigate the risk that some
reimbursement claims will not be collected, the Company records a reserve
against the escrow receivable during the period in which reimbursement claims
are recognized. During 2009, the Company received approximately $1.0
million of proceeds from the escrow fund which represented a portion of the
escrow claims that had been previously submitted by the Company.
Effective
October 29, 2007, Blackstone entered into a settlement agreement of a patent
infringement lawsuit brought by certain affiliates of Medtronic Sofamor Danek
USA Inc. In that lawsuit, the Medtronic plaintiffs had alleged that they were
the exclusive licensees of certain U.S. patents and that Blackstone’s making,
selling, offering for sale, and using its Blackstone Anterior Cervical Plate, 3º
Anterior Cervical Plate, Hallmark Anterior Cervical Plate, Reliant Cervical
Plate, Pillar PEEK and Construx Mini PEEK VBR System products within the U.S.
willfully infringed the subject patents. Blackstone denied infringement and
asserted that the patents were invalid. The settlement agreement is not expected
to have a material impact on the Company’s consolidated financial position,
results of operations or cash flows. On July 20, 2007, the Company submitted a
claim for indemnification from the escrow fund established in connection with
the Blackstone Merger Agreement for any losses to us resulting from this matter.
The Company was subsequently notified by legal counsel of the former
shareholders that the representative of the former shareholders of Blackstone
has objected to the indemnification claim and intends to contest it in
accordance with the terms of the Blackstone Merger Agreement.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
On or
about April 10, 2009, the Company received a HIPAA subpoena (“HIPAA subpoena”)
issued by the US Attorney’s Office for the District of Massachusetts (the
“Boston USAO”). The subpoena sought documents concerning, among other things,
the Company’s promotion and marketing of its bone growth stimulator devices. The
Boston USAO issued a supplemental subpoena in this matter dated July 23, 2009,
requiring testimony. That office later excused performance with the July 23,
2009 subpoena indefinitely. The Boston USAO also issued supplemental subpoenas
in this matter, dated September 21, 2009 and December 16, 2009, respectively,
seeking documents. The subpoenas seek documents for the period January 1, 1995
through the date of the respective subpoenas. Document production in response to
the subpoenas is ongoing. On December 21, 2009, the Boston USAO provided the
Company with grand jury subpoenas for the testimony of certain current employees
in connection with its ongoing investigation. The Company intends to cooperate
with the government’s requests. In meetings with the Company and its attorneys
regarding this matter, the Boston USAO has informed the Company that it is
investigating possible criminal and civil violations of federal law related to
the Company’s promotion and marketing of its bone growth stimulator
devices.
On or
about April 14, 2009, the Company obtained a copy of a qui tam complaint filed
by Jeffrey J. Bierman in the U.S. District Court for the District of
Massachusetts against Orthofix, Inc., the Company, and other companies that have
allegedly manufactured bone growth stimulation devices, including Orthologic
Corp., DJO Incorporated, Reable Therapeutics, Inc., the Blackstone Group, L.P.,
Biomet, Inc., EBI, L.P., EBI Holdings, Inc., EBI Medical Systems, Inc.,
Bioelectron, Inc., LBV Acquisition, Inc., and Smith & Nephew, Inc. By order
entered on March 24, 2009, the court unsealed the case. The amended complaint
alleges various causes of action under the federal False Claims Act and state
and city false claims acts premised on the contention that the defendants
improperly promoted the sale, as opposed to the rental, of bone growth
stimulation devices. The amended complaint also includes claims against the
defendants for, among other things, allegedly misleading physicians and
purportedly causing them to file false claims and for allegedly violating the
Anti-kickback Act by providing free products to physicians, waiving patients’
insurance co-payments, and providing inducements to independent sales agents to
generate business. The Company believes that this lawsuit is related to the
matter described above involving the HIPAA subpoena. The Company and Orthofix,
Inc. were served on or about September 8, 2009. The Company intends to defend
vigorously against this lawsuit.
On or
about July 2, 2009, the Company obtained a copy of a qui tam complaint filed by
Marcus Laughlin that is pending in the U.S. District Court for the District of
Massachusetts against the Company. This complaint has been consolidated with the
complaint described in the immediately preceding paragraph, and was unsealed on
June 30, 2009. The complaint alleges violations of the False Claims Act,
fraudulent billing, illegal kickbacks and wrongful termination based on
allegations that the Company promoted the sale rather than the rental of bone
growth stimulation devices, systematically overcharged for these products,
provided physicians kickbacks in the form of free units, referral fees, and
fitting fees, and that the defendant and its competitors discussed together
strategies to encourage higher government pricing for the products. The
complaint also alleges that TRICARE has been reimbursing the Company for its
Cervical Stim
®
product without approval to do so. An amended complaint alleges conspiracy and
violations of the Sherman Anti-Trust Act in connection with the same alleged
conduct. The Company was served with the complaint on or about September 9,
2009. The Company intends to defend vigorously against this
lawsuit.
On June
18, 2008, a lawsuit against the Company was filed for unpaid royalties under an
agreement terminated by the Company in 2007. The Company has
counterclaimed for the overpayment of commissions previously paid under the
agreement. The plaintiffs are seeking approximately $3.7
million. The Company’s counterclaim exceeds this
amount. The outcome of this matter is uncertain.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Our
subsidiary, Breg, Inc., was engaged in the manufacturing and sale of local
infusion pumps for pain management from 1999 to 2008, when the product line was
divested. As between 2008 and present, numerous product liability
cases have been filed in the United States alleging that the local anesthetic,
when dispensed by such infusion pumps inside a joint, causes a rare arthritic
condition called “chondrolysis.” The Company believes that
meritorious defenses exist to these claims and Breg, Inc. intends to vigorously
defend these cases.
The
Company cannot predict the outcome of any proceedings or claims made against the
Company or its subsidiaries described in the preceding paragraphs and there can
be no assurance that the ultimate resolution of any claim will not have a
material adverse impact on our consolidated financial position, results of
operations, or cash flows.
In
addition to the foregoing, in the normal course of our business, the Company is
involved in various lawsuits from time to time and may be subject to certain
other contingencies. To the extent losses related to these
contingencies are both probable and estimable, the Company provides appropriate
amounts in the accompanying financial statements.
Concentrations
of credit risk
Financial
instruments which potentially subject the Company to concentrations of credit
risk are primarily cash investments and accounts receivable. Cash
investments are primarily in money market funds deposited with major financial
center banks. Concentrations of credit risk with respect to accounts
receivable are limited due to the large number of entities comprising the
Company’s customer base. The Company performs ongoing credit
evaluations of its customers and generally does not require
collateral. Certain of these customers rely on third party healthcare
payers, such as private insurance companies and governments, to make payments to
the Company on their behalf. Accounts receivable in countries where
the government funds medical spending are primarily located in North Africa,
Middle East, South America, Asia and Europe. The Company has
considered special situations when establishing allowances for potentially
uncollectible accounts receivable in such countries as India, Egypt and
Turkey. The Company also records reserves for bad debts for all other
customers based on a variety of factors, including the length of time the
receivables are past due, the financial condition of the customer, macroeconomic
conditions and historical experiences. The Company maintains reserves
for potential credit losses and such losses have been within management’s
expectations.
The
Company sells via a direct sales force and distributors. There were
no customers that accounted for 5% or more of net sales in 2009, 2008 or
2007.
17.
|
Pensions
and deferred compensation
|
Orthofix
Inc. sponsors a defined contribution plan (the “Orthofix Inc. 401(k) Plan”)
covering substantially all full time employees. The Orthofix Inc.
401(k) Plan allows for participants to contribute up to 15% of their pre-tax
compensation, subject to certain limitations, with the Company matching 100% of
the first 2% of the employee’s base compensation and 50% of the next 4% of the
employee’s base compensation if contributed to the Orthofix Inc. 401(k)
Plan. Breg also sponsors a 401(k) plan (the “Breg 401(k)
plan”). The Breg 401(k) Plan allows for participants to contribute up
to 100% of their compensation, subject to certain limitations, with the Company
matching 100% of the first $1,000 deferred. Blackstone also sponsors
a 401(k) plan (the “Blackstone 401(k) Plan”). The Blackstone 401(k)
Plan allows for participants to contribute up to 75% of their compensation,
subject to certain limitations, with the Company matching 50% of the first 6% of
the employee’s compensation deferred. In 2010, the Blackstone 401(k)
Plan will be merged into the Orthofix Inc. 401(k) Plan. During the
years ended December 31, 2009, 2008 and 2007, expenses incurred relating to
401(k) Plans, including matching contributions, were approximately $1.9 million,
$1.8 million and $1.5 million, respectively.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
The
Company operates defined contribution pension plans for its other International
employees not described above meeting minimum service
requirements. The Company’s expenses for such pension contributions
during 2009, 2008 and 2007 were approximately $1.0 million in each
year.
Under
Italian Law, Orthofix S.r.l. accrues, on behalf of its employees, deferred
compensation, which is paid on termination of employment. Each year’s
provision for deferred compensation is based on a percentage of the employee’s
current annual remuneration plus an annual charge. Deferred
compensation is also accrued for the leaving indemnity payable to agents in case
of dismissal which is regulated by a national contract and is equal to
approximately 3.5% of total commissions earned from the Company. The
Company’s expense for deferred compensation during 2009, 2008 and 2007 was
approximately $0.6 million, $0.5 million and $0.4 million,
respectively. Deferred compensation payments of $0.6 million, $0.5
million and $0.3 million were made in 2009, 2008 and 2007,
respectively. The balance as of December 31, 2009 and 2008 of $1.7
million represents the amount which would be payable if all the employees and
agents had terminated employment at that date and is included in other long-term
liabilities.
The
Orthofix Deferred Compensation Plan (the “Plan”), administered by the Board of
Directors of Orthofix, effective January 1, 2007, and as amended and restated
effective January 1, 2009, is a plan intended to allow a select group of key
management and highly compensated employees of Orthofix to defer the receipt of
compensation that would otherwise be payable to them. The terms of
this plan are intended to comply in all respects with the provisions of Code
Section 409A and Code Section 457A. Under the Plan, employees of
Orthofix and its subsidiaries are eligible to participate if the employee is in
management or a highly compensated employee and is named by the Board of
Directors to be a participant in the Plan. All directors were
eligible to participate in the Plan, but effective January 1, 2009, they were
prohibited from further participation, unless a director performs services as an
employee attributable, for tax purposes, to any U.S. subsidiary of the
Company. An eligible employee may elect to enter into a salary
deferral commitment and/or a director’s fees deferral commitment with respect to
any plan year by submitting a participation agreement to the plan administrator
by December 31 of the calendar year immediately preceding the plan
year. Further, an eligible employee may elect to enter into a bonus
deferral commitment with respect to bonus compensation earned during any plan
year by submitting a participation agreement to the plan administrator by
December 31 of the calendar year immediately preceding the plan
year. Deferral commitments can be stated as a percentage or a flat
dollar amount as allowed by the plan administrator. A participant’s
participation agreement will remain in effect only for the immediately
succeeding plan year. Distributions are made in accordance with the
requirements of Code Section 409A.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
18.
|
Share-based
compensation plans
|
At
December 31, 2009, the Company had three stock option and award plans and one
stock purchase plan which are described below.
2004
Long Term Incentive Plan
The 2004
Long Term Incentive Plan (the “2004 LTIP Plan”) is a long term incentive plan
that was originally adopted in April 2004. The 2004 LTIP Plan was
approved by shareholders on June 29, 2004 and 2.0 million shares were reserved
for issuance under this plan (in addition to shares (i) available for future
awards as of June 29, 2004 under prior plans or (ii) that become available for
future issuance upon the expiration or forfeiture after June 29, 2004 of awards
upon prior plans). Awards generally vest on years of service with all
awards fully vesting within three years from the date of grant for employees and
either three or five years from the date of grant for non-employee
directors. Awards can be in the form of a stock option, restricted
stock, restricted share unit, performance share unit, or other award form
determined by the Board of Directors. Awards granted under the 2004
LTIP Plan expire no later than 10 years after the date of the
grant. On June 20, 2007, the Company’s shareholders approved
amendments and a restatement of the 2004 LTIP Plan, providing for the following
major changes: an increase in the number of shares available for
grant from 2.0 million shares to 2.8 million shares, a specific allowance for
grants of restricted stock awards, and a provision for fixed awards to
non-employee directors on the date of their first election to the Board and on
each subsequent re-election.
On June
19, 2008, the Company’s shareholders approved further amendments to the 2004
LTIP Plan to increase the number of shares available for grant from 2.8 million
shares to 3.1 million shares, to increase the annual grant to non-employee
directors from 3,000 shares to 5,000 shares, and to limit in the future the
number of shares that may be awarded under the plan as full value awards to
100,000 shares.
At
December 31, 2009, there were 2,948,798 options outstanding under the 2004 LTIP
Plan, of which 1,501,982 were exercisable; in addition, there were 62,161 shares
of restricted stock outstanding, none of which were vested.
Staff
Share Option Plan
The Staff
Stock Option Plan (the “Staff Plan”) is a fixed stock option plan which was
adopted in April 1992. Under the Staff Plan, the Company granted
options to its employees at the estimated fair market value of such options at
the date of grant. Options generally vest based on years of service
with all options to be fully vested within five years from date of
grant. Options granted under the Staff Plan expire ten years after
the date of grant. There are no options left to be granted under the
Staff Plan. At December 31, 2009, there were 128,825 options
outstanding and exercisable under the Staff Plan.
Performance
Accelerated Stock Option Inducement Grants
On
December 30, 2003, the Company granted inducement stock option awards to two key
executives of Breg, in conjunction with the acquisition of Breg. The
exercise price was fixed at $38.00 per share on November 20, 2003, when the
Company announced it had entered into an agreement to acquire
Breg. The inducement grants included both service-based and
performance-based vesting provisions. The inducement grants became
100% vested on the fourth anniversary of the grant date but are subject to
certain exercisability limitations. Following vesting on December 30,
2007, the original inducement grants limited the executives’ ability to exercise
specific numbers of options during the years 2008 – 2012. Prior to
the options fully vesting and as an inducement for the executives to extend the
term of their employment agreements for one year, in November 2007 the Company
entered into amended award agreements with the two executives. The
amended agreements did not change the vesting date of the options, but provided
that the options granted thereunder will only be exercisable during the fixed
period beginning January 1, 2009 and ending on December 31, 2009
.
In December 2008, in order to meet certain requirements
of Code Section 409A and the Treasury Regulations promulgated thereunder, and
fulfill the Company’s desire to extend each of the executives’ terms of
employment with the Company, the Company and the executives entered into second
amended and restated award agreements. The second amended agreements
provided for the election by the executives of respective periods during which
they can exercise options. Bradley Mason has elected to exercise
50,000 options in each of the following periods: April 1, 2010 through December
31, 2010, January 1, 2011 through December 31, 2011 and January 1, 2012 through
December 31, 2012. William Hopson has elected to exercise his 50,000
options in the period between January 1, 2011 and December 31, 2011.
Subject
to certain termination of employment provisions and notwithstanding any other
provisions of the second amended agreements, any portion of the options that are
not exercised during their respective exercise periods will not be exercisable
thereafter and will lapse and be cancelled. At December 31, 2009,
there were 200,000 options outstanding and exercisable under the inducement
grants.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Inducement
Stock Option Agreement
In the
years ended December 31, 2009 and 2008, 50,000 stock options and 150,000 stock
options, respectively, were granted pursuant to standalone inducement stock
option agreements, on terms substantially the same as grants made under the
Company’s Amended and Restated 2004 Long Term Incentive Plan. These
stock option grants vest in one-third increments annually.
Stock
Purchase Plan
The
Orthofix International N.V. Amended and Restated Stock Purchase Plan (the “Stock
Purchase Plan”) provides for the issuance of shares of the Company’s common
stock to eligible employees and directors of the Company and its subsidiaries
that elect to participate in the plan and acquire shares of common stock through
payroll deductions (including executive officers). On June 20, 2008,
the Company’s shareholders approved an amendment and restatement of the plan,
providing for the following major change: (i) to
allow officers and directors of Orthofix Inc. to
participate in the plan on the same basis as our other employees, (ii) to
provide that the Company will assume and adopt the plan, as amended, in lieu of
Orthofix Inc. acting as sponsor of the plan, (iii) to allow non-employee
directors of the Company to participate in the plan, (iv) to increase by 500,000
shares the maximum number of shares available for issuance under the plan, and
(v) to provide that the determination of the value of common stock under the
plan will be determined either on the first or last day of the plan year,
whichever date renders the lower value. These changes were generally
effective for the plan year starting January 1, 2009. In June 2009,
the Company’s shareholders approved a further amendment to the Stock Purchase
Plan to increase the number of shares available for grant from 950,000 shares to
1,400,000 shares.
During
each purchase period, eligible employees may designate between 1% and 25% of
their compensation to be deducted for the purchase of common stock under the
plan
(up to 25% for employees working in
North America, South America and Asia, and up to 15% for employees working in
Europe). For eligible directors, the designated percentage will be an
amount equal to his or her annual or other director compensation paid in cash
for the current plan year
. The purchase price of the shares
under the plan is equal to 85% of the fair market value on the first day of the
plan year (which is a calendar year, running from January 1
st
to
December 31
st
) or,
if lower, on the last day of the plan year. The aggregate number of
shares reserved for issuance under the Employee Stock Purchase Plan is
1,400,000
shares. As of
December 31, 2009, 429,688 shares had been issued under the Stock Purchase
Plan.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
Share-Based
Compensation:
As of
December 31, 2009, the unamortized compensation expense relating to options
granted and expected to be recognized was $7.6 million. This amount
is expected to be recognized over a weighted average period of 1.24
years.
The
following table shows the detail of share-based compensation by line item in the
consolidated statements of operations for the years ended December 31, 2009,
2008 and 2007 and the assumptions for each of these years:
|
|
Year
Ended December 31,
|
|
|
Year
Ended December 31,
|
|
|
Year
Ended December 31,
|
|
(US$ in thousands, except
assumptions)
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
$
|
677
|
|
|
$
|
175
|
|
|
$
|
403
|
|
Sales
and marketing
|
|
|
3,045
|
|
|
|
1,890
|
|
|
|
2,749
|
|
General
and administrative
|
|
|
6,467
|
|
|
|
7,731
|
|
|
|
7,884
|
|
Research
and development
|
|
|
563
|
|
|
|
793
|
|
|
|
877
|
|
Total
|
|
$
|
10,752
|
|
|
$
|
10,589
|
|
|
$
|
11,913
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected
term
|
|
4.00
years
|
|
|
3.92
years
|
|
|
3.94
years
|
|
Expected
volatility
|
|
|
45.0%
- 48.7
|
%
|
|
|
28.4
|
%
|
|
|
30.3
|
%
|
Risk
free interest rate
|
|
|
1.60%
- 2.57
|
%
|
|
|
1.52%
- 3.49
|
%
|
|
|
3.49%
- 5.03
|
%
|
Dividend
rate
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Weighted
average fair value of options granted during the year
|
|
$
|
9.29
|
|
|
$
|
7.51
|
|
|
$
|
15.09
|
|
The
Company has chosen to use the “short-cut method” to determine the pool of
windfall tax benefits as of the adoption of ASC Topic 718.
During
the year ended December 31, 2008, the Company granted to employees 83,434 shares
of restricted stock, which vest at various dates through December
2011. The compensation expense, which represents the fair value of
the stock measured at the market price at the date of grant, less estimated
forfeitures, is recognized on a straight-line basis over the vesting
period. Unamortized compensation expense related to restricted stock
amounted to $1.4 million at December 31, 2009. No shares of
restricted stock were granted in 2009.
Stock
Option Activity:
Summaries
of the status of the Company’s stock option plans as of December 31, 2009 and
2008 and changes during the year ended December 31, 2009 are presented
below:
|
|
|
|
|
|
|
|
|
Weighted Average Exercise
Price
|
|
Outstanding
at beginning of year
|
|
|
3,150,020
|
|
|
$
|
35.30
|
|
Granted
|
|
|
792,500
|
|
|
$
|
23.51
|
|
Exercised
|
|
|
(10,768
|
)
|
|
$
|
23.89
|
|
Forfeited
|
|
|
(454,129
|
)
|
|
$
|
39.45
|
|
Outstanding
at end of year
|
|
|
3,477,623
|
|
|
$
|
32.09
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable at end of year
|
|
|
1,880,807
|
|
|
|
|
|
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
No
options were granted during 2009 at less than market value.
Outstanding
and exercisable by price range as of December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Remaining Contractual
Life
|
|
|
Weighted Average Exercise
Price
|
|
|
|
|
|
Weighted Average Exercise
Price
|
|
$10.42
- $23.58
|
|
|
|
511,766
|
|
|
|
8.68
|
|
|
$
|
18.50
|
|
|
|
63,612
|
|
|
$
|
13.61
|
|
$24.01
- $25.01
|
|
|
|
361,100
|
|
|
|
9.09
|
|
|
$
|
24.98
|
|
|
|
20,434
|
|
|
$
|
24.84
|
|
$25.05
- $28.50
|
|
|
|
257,000
|
|
|
|
8.55
|
|
|
$
|
25.83
|
|
|
|
68,000
|
|
|
$
|
25.96
|
|
$28.95
- $28.95
|
|
|
|
538,860
|
|
|
|
8.37
|
|
|
$
|
28.95
|
|
|
|
179,631
|
|
|
$
|
28.95
|
|
$29.17
- $37.76
|
|
|
|
515,690
|
|
|
|
5.88
|
|
|
$
|
34.57
|
|
|
|
418,861
|
|
|
$
|
35.26
|
|
$38.00
- $38.11
|
|
|
|
540,224
|
|
|
|
5.49
|
|
|
$
|
38.07
|
|
|
|
540,224
|
|
|
$
|
38.07
|
|
$38.40
- $43.04
|
|
|
|
460,800
|
|
|
|
5.74
|
|
|
$
|
41.50
|
|
|
|
408,803
|
|
|
$
|
41.56
|
|
$43.26
- $50.15
|
|
|
|
282,683
|
|
|
|
7.32
|
|
|
$
|
45.46
|
|
|
|
174,908
|
|
|
$
|
45.50
|
|
$50.50
- $50.50
|
|
|
|
2,000
|
|
|
|
7.01
|
|
|
$
|
50.50
|
|
|
|
1,334
|
|
|
$
|
50.50
|
|
$50.99
- $50.99
|
|
|
|
7,500
|
|
|
|
7.04
|
|
|
$
|
50.99
|
|
|
|
5,000
|
|
|
$
|
50.99
|
|
|
|
|
|
3,477,623
|
|
|
|
7.25
|
|
|
$
|
32.09
|
|
|
|
1,880,807
|
|
|
$
|
36.66
|
|
The
weighted average remaining contractual life of exercisable options was 5.98
years at December 31,
2009. The total intrinsic value of options exercised was $67,000,
$88,000 and $14.6 million for the years ended December 31, 2009, 2008 and 2007,
respectively. The aggregate intrinsic value of options outstanding
and options exercisable as of December 31, 2009 is calculated as the difference
between the exercise price of the underlying options and the market price of the
Company’s common stock for the shares that had exercise prices that were lower
than the $30.93 closing price of the Company’s stock on December 31,
2009. The aggregate intrinsic value of options outstanding was $10.9
million, $0.5 million and $38.1 million for the years ended December 31, 2009,
2008 and 2007, respectively. The aggregate intrinsic value of options
exercisable was $1.9 million, $10,000, and $19.4 million for the years ended
December 31, 2009, 2008 and 2007, respectively.
Restricted
Stock:
A summary
of the status of our restricted stock as of December 31, 2009 and 2008 and
changes during the year ended December 31, 2009 are presented
below:
|
|
|
|
|
Weighted Average Grant Date Fair
Value
|
|
Non-vested
as of December 31, 2008
|
|
|
118,993
|
|
|
$
|
37.49
|
|
Granted
|
|
|
-
|
|
|
$
|
-
|
|
Vested
|
|
|
(42,978
|
)
|
|
$
|
37.91
|
|
Cancelled
|
|
|
(13,854
|
)
|
|
$
|
36.86
|
|
Non-vested
as of December 31, 2009
|
|
|
62,161
|
|
|
$
|
37.40
|
|
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
For each
of the three years in the period ended December 31, 2009, there were no
adjustments to net income (loss) for purposes of calculating basic and diluted
net income (loss) available to common shareholders. The following is
a reconciliation of the weighted average shares used in the basic and diluted
net income (loss) per common share computations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares-basic
|
|
|
17,119,474
|
|
|
|
17,095,416
|
|
|
|
16,638,873
|
|
Effect
of diluted securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unexercised
stock options net of treasury share repurchase
|
|
|
83,469
|
|
|
|
-
|
|
|
|
408,714
|
|
Weighted
average common share-diluted
|
|
|
17,202,943
|
|
|
|
17,095,416
|
|
|
|
17,047,587
|
|
For the
year ended December 31, 2008, the effects of all potentially dilutive options
were excluded from the computation of diluted earnings per share because the
Company had a net loss and, therefore, the effect would have been
anti-dilutive. Options to purchase shares of common stock with
exercise prices in excess of the average market price of common shares are not
included in the computation of diluted earnings per share. There were 3,220,357
outstanding options not included in the diluted earnings per share computation
for the fiscal year ended December 31, 2009, because the inclusion of these
options was anti-dilutive. There were 309,651 outstanding options not
included in the diluted earnings per share computation for the fiscal year ended
December 31, 2007, because the inclusion of these options was
anti-dilutive.
20.
|
Restructuring
charges
|
In the
fourth quarter of 2008, as part of the Company’s strategic plan to strengthen
the business, the Company initiated a restructuring plan to improve operations
and reduce costs at Blackstone. The plan involves the consolidation
of substantially all of Blackstone’s operations previously conducted in Wayne,
NJ and Springfield, MA into the same facility housing its spine stimulation and
U.S. orthopedics business in the Dallas, TX area. The Company plans
to complete the restructuring and consolidation by the second quarter of 2010,
at which time the Company anticipates a total restructuring expense of $3.6
million. During the year ended December 31, 2009, the Company
recorded net restructuring charges of $3.6
million which were
primarily related to severance costs and accelerated depreciation costs related
to shortening lives of assets which will be disposed. These
restructuring costs are recorded in general and administrative expense and are
classified in the Spinal Implants and Biologics segment.
ORTHOFIX
INTERNATIONAL N.V.
Notes
to the consolidated financial statements (cont.)
The
following table presents changes in the restructuring liability for the activity
discussed above, which is included within Other Current Liabilities in the
Company’s consolidated balance sheets as of December 31, 2009 and December 31,
2008:
|
|
|
|
|
|
|
|
|
|
Balance
at December 31, 2008
|
|
$
|
548
|
|
|
$
|
-
|
|
|
$
|
548
|
|
Charges
|
|
|
2,565
|
|
|
|
1,020
|
|
|
|
3,585
|
|
Cash
Payments
|
|
|
(1,287
|
)
|
|
|
-
|
|
|
|
(1,287
|
)
|
Non-cash
Items
|
|
|
-
|
|
|
|
(1,020
|
)
|
|
|
(1,020
|
)
|
Balance
at December 31, 2009
|
|
$
|
1,826
|
|
|
$
|
-
|
|
|
$
|
1,826
|
|
21.
|
Quarterly
financial data (unaudited)
|
(U.S.
Dollars, in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$
|
128,975
|
|
|
$
|
137,546
|
|
|
$
|
135,098
|
|
|
$
|
144,016
|
|
|
$
|
545,635
|
|
Gross
profit
|
|
|
96,168
|
|
|
|
100,637
|
|
|
|
103,113
|
|
|
|
107,267
|
|
|
|
407,185
|
|
Net
income (loss)
|
|
|
2,879
|
|
|
|
5,944
|
|
|
|
6,188
|
|
|
|
9,461
|
|
|
|
24,472
|
|
Net
income (loss) per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.17
|
|
|
$
|
0.35
|
|
|
$
|
0.36
|
|
|
$
|
0.55
|
|
|
$
|
1.43
|
|
Diluted
|
|
$
|
0.17
|
|
|
$
|
0.35
|
|
|
$
|
0.36
|
|
|
$
|
0.55
|
|
|
$
|
1.42
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales
|
|
$
|
128,032
|
|
|
$
|
130,039
|
|
|
$
|
129,301
|
|
|
$
|
132,303
|
|
|
$
|
519,675
|
|
Gross
profit
|
|
|
93,794
|
|
|
|
94,991
|
|
|
|
81,303
|
|
|
|
97,573
|
|
|
|
367,661
|
|
Net
income (loss)
|
|
|
3,606
|
|
|
|
5,808
|
|
|
|
(237,251
|
)
|
|
|
(717
|
)
|
|
|
(228,554
|
)
|
Net
income (loss) per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.21
|
|
|
$
|
0.34
|
|
|
$
|
(13.87
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(13.37
|
)
|
Diluted
|
|
$
|
0.21
|
|
|
$
|
0.34
|
|
|
$
|
(13.87
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(13.37
|
)
|
The sum
of per share earnings by quarter may not equal earnings per share for the year
due to the change in average share calculations. This is in
accordance with prescribed reporting requirements.
Orthofix
International N.V.
Schedule
1 — Condensed Financial Information of Registrant Orthofix International
N.V.
Condensed
Balance Sheets
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
403
|
|
|
$
|
623
|
|
Prepaid
expenses and other current assets
|
|
|
488
|
|
|
|
484
|
|
Total
current assets
|
|
|
891
|
|
|
|
1,107
|
|
Other
long term assets
|
|
|
279
|
|
|
|
274
|
|
Investments
in and amounts due from subsidiaries and affiliates
|
|
|
247,530
|
|
|
|
207,125
|
|
Total
assets
|
|
$
|
248,700
|
|
|
$
|
208,506
|
|
|
|
|
|
|
|
|
|
|
Liabilities
and shareholder’s equity
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
$
|
1,996
|
|
|
$
|
1,669
|
|
Long-term
liabilities
|
|
|
6,435
|
|
|
|
4,776
|
|
Shareholder’s
equity:
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
1,714
|
|
|
|
1,710
|
|
Additional
paid in capital
|
|
|
177,246
|
|
|
|
167,818
|
|
Accumulated
earnings
|
|
|
54,119
|
|
|
|
29,647
|
|
Accumulated
other comprehensive income
|
|
|
7,190
|
|
|
|
2,886
|
|
|
|
|
240,269
|
|
|
|
202,061
|
|
Total
liabilities and shareholder’s equity
|
|
$
|
248,700
|
|
|
$
|
208,506
|
|
See
accompanying notes to condensed financial statements.
Orthofix
International N.V.
Schedule
1 — Condensed Financial Information of Registrant Orthofix International
N.V.
Condensed
Statements of Operations
|
|
Year
Ended December 31,
|
|
|
Year
Ended December 31,
|
|
|
Year
Ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
(Expenses)
income:
|
|
|
|
|
|
|
|
|
|
General
and administrative
|
|
$
|
(10,444
|
)
|
|
$
|
(11,945
|
)
|
|
$
|
(10,172
|
)
|
Equity
in earnings of investments in subsidiaries and affiliates
|
|
|
36,592
|
|
|
|
(215,310
|
)
|
|
|
22,334
|
|
Other,
net
|
|
|
301
|
|
|
|
481
|
|
|
|
653
|
|
Income
(loss) before income taxes
|
|
|
26,449
|
|
|
|
(226,774
|
)
|
|
|
12,815
|
|
Income
tax expense
|
|
|
(1,977
|
)
|
|
|
(1,780
|
)
|
|
|
(1,847
|
)
|
Net
income (loss)
|
|
$
|
24,472
|
|
|
$
|
(228,554
|
)
|
|
$
|
10,968
|
|
See
accompanying notes to condensed financial statements.
Orthofix
International N.V.
Schedule
1 — Condensed Financial Information of Registrant Orthofix International
N.V.
Condensed
Statement of Cash Flows
|
|
Year
Ended December 31,
|
|
|
Year
Ended December 31,
|
|
|
Year
Ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income (loss)
|
|
$
|
24,472
|
|
|
$
|
(228,554
|
)
|
|
$
|
10,968
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
in earnings of investments in subsidiaries and affiliates
|
|
|
(36,592
|
)
|
|
|
215,310
|
|
|
|
(22,334
|
)
|
Cash
provided by (used in) other operating activities
|
|
|
3,574
|
|
|
|
2,350
|
|
|
|
(772
|
)
|
Net
cash used in operating activities
|
|
|
(8,546
|
)
|
|
|
(10,894
|
)
|
|
|
(12,138
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Distributions
and amounts received from subsidiaries
|
|
|
13,237
|
|
|
|
11,074
|
|
|
|
21,991
|
|
Capital
expenditures
|
|
|
(114
|
)
|
|
|
(196
|
)
|
|
|
-
|
|
Net
cash provided by investing activities
|
|
|
13,123
|
|
|
|
10,878
|
|
|
|
21,991
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
proceeds from issuance of common stock
|
|
|
70
|
|
|
|
1,734
|
|
|
|
17,198
|
|
Contributions
to subsidiaries and affiliates
|
|
|
(4,672
|
)
|
|
|
(11,165
|
)
|
|
|
(27,748
|
)
|
Repurchase
of equity
|
|
|
(220
|
)
|
|
|
-
|
|
|
|
-
|
|
Tax
benefit on exercise of stock options
|
|
|
25
|
|
|
|
22
|
|
|
|
-
|
|
Net
cash used in financing activities
|
|
|
(4,797
|
)
|
|
|
(9,409
|
)
|
|
|
(10,550
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
decrease in cash and cash equivalents
|
|
|
(220
|
)
|
|
|
(9,425
|
)
|
|
|
(697
|
)
|
Cash
and cash equivalents at the beginning of the year
|
|
|
623
|
|
|
|
10,048
|
|
|
|
10,745
|
|
Cash
and cash equivalents at the end of the year
|
|
$
|
403
|
|
|
$
|
623
|
|
|
$
|
10,048
|
|
See
accompanying notes to condensed financial statements.
Orthofix
International N.V.
Schedule
1 — Condensed Financial Information of Registrant Orthofix International
N.V.
Notes
to Condensed Financial Statements
1.
|
Background
and basis of presentation
|
These
condensed parent company financial statements have been prepared in accordance
with Rule 12-04, Schedule 1 of Regulation S-X, as the restricted net assets of
Orthofix Holdings, Inc. and its subsidiaries exceed 25% of the consolidated net
assets of Orthofix International N.V. and its subsidiaries (the
“Company”). This information should be read in conjunction with the
Company’s consolidated financial statements included elsewhere in this
filing.
2.
|
Restricted
net assets of subsidiaries
|
Certain
of the Company’s subsidiaries have restrictions, with an effective date of
September 22, 2006, on their ability to pay dividends or make intercompany loans
and advances pursuant to their financing arrangements. The amount of
restricted net assets the Company’s subsidiaries held at December 31, 2009 and
2008 was approximately $143.0 million and $111.3 million,
respectively. Such restrictions are on net assets of Orthofix
Holdings, Inc. and its subsidiaries.
3.
|
Commitments,
contingencies and long-term
obligations
|
For a
discussion of the Company’s commitments, contingencies and long term obligations
under its senior secured credit facility, see Note 9, Note 12 and Note 16 of the
Company’s consolidated financial statements.
4.
|
Dividends
from subsidiaries
|
Cash
dividends received by Orthofix International N.V. from its consolidated
subsidiaries accounted for by the equity method were $13.2 million, $11.1
million and $22.0 million for the years ended December 31, 2009, 2008 and 2007,
respectively.
Orthofix
International N.V.
Schedule
2 — Valuation and Qualifying Accounts
For the
years ended December 31, 2009, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
Provisions from assets to which they
apply:
|
|
Balance at beginning of
year
|
|
|
Charged to cost and
expenses
|
|
|
Charged (credited) to other
accounts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance
for doubtful accounts receivable
|
|
$
|
6,473
|
|
|
$
|
7,335
|
|
|
$
|
(70
|
)
|
|
$
|
(6,533
|
)
|
|
$
|
7,205
|
|
Inventory
provisions
|
|
|
21,168
|
|
|
|
8,760
|
|
|
|
-
|
|
|
|
(6,047
|
)
|
|
|
23,881
|
|
Deferred
tax valuation allowance
|
|
|
14,370
|
|
|
|
2,869
|
|
|
|
-
|
|
|
|
-
|
|
|
|
17,239
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance
for doubtful accounts receivable
|
|
$
|
6,441
|
|
|
$
|
7,261
|
|
|
$
|
(133
|
)
|
|
$
|
(7,096
|
)
|
|
$
|
6,473
|
|
Inventory
provisions
(1)
|
|
|
9,893
|
|
|
|
14,858
|
|
|
|
(22
|
)
|
|
|
(3,561
|
)
|
|
|
21,168
|
|
Deferred
tax valuation allowance
|
|
|
11,377
|
|
|
|
2,993
|
|
|
|
-
|
|
|
|
-
|
|
|
|
14,370
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance
for doubtful accounts receivable
|
|
$
|
6,265
|
|
|
$
|
7,431
|
|
|
$
|
44
|
|
|
$
|
(7,299
|
)
|
|
$
|
6,441
|
|
Inventory
provisions
|
|
|
7,213
|
|
|
|
3,472
|
|
|
|
52
|
|
|
|
(844
|
)
|
|
|
9,893
|
|
Deferred
tax valuation allowance
|
|
|
9,428
|
|
|
|
2,665
|
|
|
|
(716
|
)
|
|
|
-
|
|
|
|
11,377
|
|
(1) In
the year ended December 31, 2008, due to reduced projections in revenue,
distributor terminations, new products, and the replacement of one product with
a successor product, the Company changed its estimates regarding the inventory
allowance at Spinal Implants and Biologics, primarily based on estimated net
realizable value using assumptions about future demand and market
conditions. The change in estimate resulted in an increase in the
reserve for obsolescence of approximately $10.9 million.
S-5
Exhibit
10.18
$375,000,000
CREDIT
AGREEMENT
among
ORTHOFIX
HOLDINGS, INC.,
as
Borrower,
and
ORTHOFIX
INTERNATIONAL N.V.,
COLGATE
MEDICAL LIMITED,
VICTORY
MEDICAL LIMITED,
SWIFTSURE
MEDICAL LIMITED,
ORTHOFIX
UK LTD,
AND THE
DOMESTIC SUBSIDIARIES OF ORTHOFIX INTERNATIONAL N.V.,
as
Guarantors,
THE
LENDERS PARTIES HERETO,
WACHOVIA
BANK, NATIONAL ASSOCIATION,
as
Administrative Agent
and
CITICORP
NORTH AMERICA, INC.,
as
Syndication Agent
Dated as
of September 22, 2006
WACHOVIA
CAPITAL MARKETS, LLC,
and
CITIGROUP
GLOBAL MARKETS INC.,
as Joint
Lead Arrangers and Joint Bookrunners
TABLE OF
CONTENTS
|
|
Page
|
|
|
|
ARTICLE
I DEFINITIONS
|
1
|
Section
1.1
|
Defined
Terms.
|
1
|
Section
1.2
|
Other
Definitional Provisions.
|
34
|
Section
1.3
|
Accounting
Terms.
|
34
|
|
|
ARTICLE
II THE LOANS; AMOUNT AND TERMS
|
35
|
Section
2.1
|
Revolving
Loans; Revolver Increase.
|
35
|
Section
2.2
|
Term
Loan Facility; Incremental Term Loan.
|
38
|
Section
2.3
|
Letter
of Credit Subfacility.
|
41
|
Section
2.4
|
Swingline
Loan Subfacility.
|
45
|
Section
2.5
|
Fees.
|
46
|
Section
2.6
|
Commitment
Reductions.
|
47
|
Section
2.7
|
Prepayments.
|
48
|
Section
2.8
|
Lending
Offices.
|
50
|
Section
2.9
|
Default
Rate and Payment Dates.
|
50
|
Section
2.10
|
Conversion
Options.
|
51
|
Section
2.11
|
Computation
of Interest and Fees.
|
51
|
Section
2.12
|
Pro
Rata Treatment and Payments.
|
52
|
Section
2.13
|
Non-Receipt
of Funds by the Administrative Agent.
|
54
|
Section
2.14
|
Inability
to Determine Interest Rate.
|
55
|
Section
2.15
|
Illegality.
|
56
|
Section
2.16
|
Requirements
of Law.
|
56
|
Section
2.17
|
Indemnity.
|
58
|
Section
2.18
|
Taxes.
|
59
|
Section
2.19
|
Indemnification;
Nature of Issuing Lender’s Duties.
|
61
|
|
|
ARTICLE
III REPRESENTATIONS AND WARRANTIES
|
62
|
Section
3.1
|
Financial
Condition.
|
62
|
Section
3.2
|
No
Change.
|
63
|
Section
3.3
|
Corporate
Existence; Compliance with Law.
|
63
|
Section
3.4
|
Corporate
Power; Authorization; Enforceable Obligations.
|
65
|
Section
3.5
|
Status
Under Certain Statutes.
|
65
|
Section
3.6
|
Margin
Regulations.
|
65
|
Section
3.7
|
No
Legal Bar; No Default.
|
65
|
Section
3.8
|
No
Material Litigation.
|
66
|
Section
3.9
|
ERISA.
|
66
|
Section
3.10
|
Environmental
Matters.
|
67
|
Section
3.11
|
Use
of Proceeds.
|
68
|
Section
3.12
|
Subsidiaries.
|
68
|
Section
3.13
|
Ownership.
|
68
|
Section
3.14
|
Indebtedness.
|
69
|
Section
3.15
|
Taxes.
|
69
|
Section
3.16
|
Intellectual
Property.
|
69
|
Section
3.17
|
Solvency.
|
70
|
Section
3.18
|
Investments.
|
70
|
Section
3.19
|
Location
of Collateral.
|
70
|
Section
3.20
|
No
Burdensome Restrictions.
|
70
|
Section
3.21
|
Labor
Matters.
|
70
|
Section
3.22
|
Security
Documents.
|
70
|
Section
3.23
|
Accuracy
and Completeness of Information.
|
71
|
Section
3.24
|
Fraud
and Abuse.
|
71
|
Section
3.25
|
Licensing
and Accreditation.
|
72
|
Section
3.26
|
Other
Regulatory Protection.
|
72
|
Section
3.27
|
Reimbursement
from Third Party Payors.
|
72
|
Section
3.28
|
Other
Agreements.
|
73
|
Section
3.29
|
Material
Contracts.
|
73
|
Section
3.30
|
Insurance.
|
73
|
Section
3.31
|
Classification
as Senior Indebtedness.
|
73
|
Section
3.32
|
Tax
Shelter Regulations.
|
73
|
Section
3.33
|
Regulation
H.
|
74
|
Section
3.34
|
Anti-Terrorism
Laws.
|
74
|
Section
3.35
|
Compliance
with OFAC Rules and Regulations.
|
74
|
Section
3.36
|
Compliance
with FCPA.
|
74
|
|
|
ARTICLE
IV CONDITIONS PRECEDENT
|
75
|
Section
4.1
|
Conditions
to Closing Date and Initial Extensions of Credit.
|
75
|
Section
4.2
|
Conditions
to All Extensions of Credit.
|
80
|
|
|
ARTICLE
V AFFIRMATIVE COVENANTS
|
81
|
Section
5.1
|
Financial
Statements.
|
81
|
Section
5.2
|
Certificates;
Other Information.
|
82
|
Section
5.3
|
Payment
of Obligations.
|
83
|
Section
5.4
|
Conduct
of Business and Maintenance of Existence.
|
84
|
Section
5.5
|
Maintenance
of Property; Insurance.
|
84
|
Section
5.6
|
Inspection
of Property; Books and Records; Discussions.
|
85
|
Section
5.7
|
Notices.
|
85
|
Section
5.8
|
Environmental
Laws.
|
86
|
Section
5.9
|
Financial
Covenants.
|
87
|
Section
5.10
|
Additional
Subsidiary Guarantors.
|
88
|
Section
5.11
|
Compliance
with Law.
|
88
|
Section
5.12
|
Pledged
Assets.
|
89
|
Section
5.13
|
Limitations
on Colgate and Victory.
|
90
|
Section
5.14
|
Further
Assurances; Post-Closing Covenant.
|
90
|
|
|
ARTICLE
VI NEGATIVE COVENANTS
|
93
|
Section
6.1
|
Indebtedness.
|
93
|
Section
6.2
|
Liens.
|
95
|
Section
6.3
|
Nature
of Business.
|
95
|
Section
6.4
|
Consolidation,
Merger, Sale or Purchase of Assets, etc.
|
95
|
Section
6.5
|
Advances,
Investments and Loans.
|
97
|
Section
6.6
|
Transactions
with Affiliates.
|
97
|
Section
6.7
|
Ownership
of Subsidiaries; Restrictions.
|
97
|
Section
6.8
|
Fiscal
Year; Organizational Documents; Material Contracts; Subordinated
Indebtedness Documents.
|
98
|
Section
6.9
|
Limitation
on Restricted Actions.
|
98
|
Section
6.10
|
Restricted
Payments.
|
99
|
Section
6.11
|
Sale
Leasebacks.
|
100
|
Section
6.12
|
No
Further Negative Pledges.
|
100
|
Section
6.13
|
Accounts.
|
100
|
|
|
ARTICLE
VII EVENTS OF DEFAULT
|
101
|
Section
7.1
|
Events
of Default.
|
101
|
Section
7.2
|
Acceleration;
Remedies.
|
104
|
|
|
ARTICLE
VIII THE AGENT
|
104
|
Section
8.1
|
Appointment.
|
104
|
Section
8.2
|
Delegation
of Duties.
|
105
|
Section
8.3
|
Exculpatory
Provisions.
|
105
|
Section
8.4
|
Reliance
by Administrative Agent.
|
105
|
Section
8.5
|
Notice
of Default.
|
106
|
Section
8.6
|
Non-Reliance
on Administrative Agent and Other Lenders.
|
106
|
Section
8.7
|
Indemnification.
|
107
|
Section
8.8
|
Administrative
Agent in Its Individual Capacity.
|
107
|
Section
8.9
|
Successor
Administrative Agent.
|
107
|
Section
8.10
|
Other
Agents.
|
108
|
Section
8.11
|
Releases.
|
108
|
|
|
ARTICLE
IX MISCELLANEOUS
|
109
|
Section
9.1
|
Amendments,
Waivers and Release of Collateral.
|
109
|
Section
9.2
|
Notices.
|
111
|
Section
9.3
|
No
Waiver; Cumulative Remedies.
|
112
|
Section
9.4
|
Survival
of Representations and Warranties.
|
112
|
Section
9.5
|
Payment
of Expenses and Taxes.
|
113
|
Section
9.6
|
Successors
and Assigns; Participations; Purchasing Lenders.
|
114
|
Section
9.7
|
Adjustments;
Set-off.
|
117
|
Section
9.8
|
Table
of Contents and Section Headings.
|
119
|
Section
9.9
|
Counterparts.
|
119
|
Section
9.10
|
Effectiveness.
|
119
|
Section
9.11
|
Severability.
|
119
|
Section
9.12
|
Integration.
|
119
|
Section
9.13
|
Governing
Law.
|
119
|
Section
9.14
|
Consent
to Jurisdiction and Service of Process.
|
120
|
Section
9.15
|
Confidentiality.
|
120
|
Section
9.16
|
Acknowledgments.
|
121
|
Section
9.17
|
Waivers
of Jury Trial.
|
121
|
Section
9.18
|
Patriot
Act Notice.
|
122
|
Section
9.19
|
Resolution
of Drafting Ambiguities.
|
122
|
Section
9.20
|
Judgment
Currency; Payments in Dollars.
|
122
|
Section
9.21
|
Arbitration.
|
122
|
ARTICLE
X GUARANTY
|
124
|
Section
10.1
|
The
Guaranty.
|
124
|
Section
10.2
|
Bankruptcy.
|
125
|
Section
10.3
|
Nature
of Liability.
|
125
|
Section
10.4
|
Independent
Obligation.
|
125
|
Section
10.5
|
Authorization.
|
126
|
Section
10.6
|
Reliance.
|
126
|
Section
10.7
|
Waiver.
|
126
|
Section
10.8
|
Limitation
on Enforcement.
|
127
|
Section
10.9
|
Confirmation
of Payment.
|
128
|
Schedules
Schedule
1.1-1
|
Account
Designation Letter
|
Schedule
1.1-3
|
Permitted
Liens
|
Schedule
2.1(b)(i)
|
Form
of Notice of Borrowing
|
Schedule
2.1(e)
|
Form
of Revolving Note
|
Schedule
2.2(d)
|
Form
of Term Note
|
Schedule
2.4(d)
|
Form
of Swingline Note
|
Schedule
2.10
|
Form
of Notice of Conversion/Extension
|
Schedule
2.18
|
Form
of Tax Exempt Certificate
|
Schedule
3.3
|
Qui
Tam Actions
|
Schedule
3.8
|
Litigation
|
Schedule
3.12
|
Subsidiaries
|
Schedule
3.16
|
Intellectual
Property
|
Schedule
3.19(a)
|
Location
of Real Property
|
Schedule
3.19(b)
|
Location
of Collateral
|
Schedule
3.19(c)
|
Chief
Executive Offices
|
Schedule
3.19(d)
|
Mortgaged
Properties
|
Schedule
3.21
|
Labor
Matters
|
Schedule
3.29
|
Material
Contracts
|
Schedule
3.30
|
Insurance
|
Schedule
4.1-1
|
Form
of Secretary’s Certificate
|
Schedule
4.1-2
|
Form
of Solvency Certificate
|
Schedule
4.1-3
|
Form
of Lender Consent
|
Schedule
5.10
|
Form
of Joinder Agreement
|
Schedule
6.1(b)
|
Indebtedness
|
Schedule
6.4(a)
|
Permitted
Asset Sales
|
Schedule
6.5
|
Investments
|
Schedule
6.13
|
Accounts
|
Schedule
9.6(c)
|
Form
of Assignment Agreement
|
CREDIT AGREEMENT
, dated
as of September 22, 2006, among
ORTHOFIX HOLDINGS,
INC.
, a
Delaware corporation (the “
Borrower
”),
ORTHOFIX INTERNATIONAL
N.V
., a
Netherlands Antilles corporation (the “
Company
”),
COLGATE MEDICAL
LIMITED
, a
company formed under the laws of England and Wales (“
Colgate
”),
VICTORY MEDICAL
LIMITED
, a
company formed under the laws of England and Wales (“
Victory
”),
SWIFTSURE MEDICAL
LIMITED
, a
company formed under the laws of England and Wales (“
Swiftsure
”),
ORTHOFIX UK LTD
, a
company formed under the laws of England and Wales (“
UK Ltd
”), those
Domestic Subsidiaries of the Company identified as a “Guarantor” on the
signature pages hereto and such other Domestic Subsidiaries of the Company as
may from time to time become a party hereto (together with Swiftsure and UK Ltd,
each a “
Subsidiary
Guarantor
” and,
together with the Company, Colgate and Victory, the “
Guarantors
”), the
several banks and other financial institutions as may from time to time become
parties to this Agreement (collectively, the “
Lenders
”; and
individually, a “
Lender
”), and
WACHOVIA BANK, NATIONAL
ASSOCIATION
, a
national banking association, as administrative agent for the Lenders hereunder
(in such capacity, the “
Administrative
Agent
”).
W
I
T
N
E
S
S
E
T
H
:
WHEREAS
, the
Borrower has requested that the Lenders make loans and other financial
accommodations to the Borrower in the amount of up to $375,000,000, as more
particularly described herein; and
WHEREAS
, the
Lenders have agreed to make such loans and other financial accommodations to the
Borrower on the terms and conditions contained herein.
NOW, THEREFORE
, in
consideration of the premises and the mutual covenants contained herein, the
parties hereto hereby agree as follows:
ARTICLE
I
DEFINITIONS
|
Section
1
.
1
|
Defined
Terms
.
|
As used
in this Agreement, terms defined in the first paragraph of this Agreement have
the meanings therein indicated, and the following terms have the following
meanings:
“
Account Designation
Letter
” shall
mean the Account Designation Letter dated the Closing Date from the Borrower to
the Administrative Agent substantially in the form attached hereto as
Schedule
1.1-1
.
“
Acquired
Company
” shall
mean Blackstone Medical, Inc., a Massachusetts corporation.
“
Acquisition
” shall
mean the merger of New Era Medical Corp., a Massachusetts corporation and a
direct wholly-owned Subsidiary of the Borrower, with and into the Acquired
Company, with the Acquired Company being the surviving company, pursuant to the
Acquisition Documents.
“
Acquisition
Documents
” shall
mean (a) the Agreement and Plan of Merger, dated as of August 4, 2006, among the
Company, the Borrower, New Era Medical Corp, a Massachusetts corporation and a
direct wholly-owned Subsidiary of the Borrower, the Acquired Company, the
principal shareholders of the Acquired Company and William G. Lyons, III, as
equityholders’ representative and (b) all other agreements and documents
executed in connection with the Acquisition, each as amended or modified prior
to the Closing Date.
“
Additional Credit
Party
” shall
mean each Person that becomes a Guarantor by execution of a Joinder Agreement in
accordance with Section 5.10.
“
Additional Revolving
Loan
” shall
have the meaning set forth in Section 2.1.
“
Additional Term
Loan
” shall
have the meaning set forth in Section 2.2.
“
Administrative
Agent
” shall
have the meaning set forth in the first paragraph of this Agreement and any
successors in such capacity.
“
Administrative Details
Form
” shall
mean, with respect to any Lender, a document containing such Lender’s contact
information for purposes of notices provided under this Agreement and account
details for purposes of payments made to such Lender under this
Agreement.
“
Affiliate
” shall
mean as to any Person, any other Person which, directly or indirectly, is in
control of, is controlled by, or is under common control with, such Person. For
purposes of this definition, a Person shall be deemed to be “controlled by” a
Person if such Person possesses, directly or indirectly, power either (a) to
vote 10% or more of the securities having ordinary voting power for the election
of directors of such Person or (b) to direct or cause the direction of the
management and policies of such Person whether by contract or
otherwise.
“
Agent’s Fee
Letter
” shall
mean the letter agreement dated July 27, 2006 addressed to the Borrower from
Wachovia and WCM, as amended, modified, restated or supplemented from time to
time in accordance with its terms.
“
Agents
” shall
mean a collective reference to Wachovia and Citigroup North America, Inc.
“
Agreement
” or
“
Credit
Agreement
” shall
mean this Credit Agreement, as amended, restated, modified or supplemented from
time to time in accordance with its terms.
“
Alternate Base
Rate
” shall
mean, for any day, a rate per annum equal to the greater of (a) the Prime Rate
in effect on such day and (b) the Federal Funds Effective Rate in effect on such
day plus 1/2 of 1%. For purposes hereof: “
Prime
Rate
” shall
mean, at any time, the rate of interest per annum publicly announced from time
to time by Wachovia at its principal office in Charlotte, North Carolina as its
prime rate. Each change in the Prime Rate shall be effective as of the opening
of business on the day such change in the Prime Rate occurs. The parties hereto
acknowledge that the rate announced publicly by Wachovia as its Prime Rate is an
index or base rate and shall not necessarily be its lowest or best rate charged
to its customers or other banks; and “
Federal Funds Effective
Rate
” shall
mean, for any day, the weighted average of the rates on overnight federal funds
transactions with members of the Federal Reserve System arranged by federal
funds brokers, as published on the next succeeding Business Day by the Federal
Reserve Bank of New York, or, if such rate is not so published on the next
succeeding Business Day, the average of the quotations for the day of such
transactions received by the Administrative Agent from three federal funds
brokers of recognized standing selected by it. If for any reason the
Administrative Agent shall have determined (which determination shall be
conclusive in the absence of manifest error) that it is unable to ascertain the
Federal Funds Effective Rate, for any reason, including the inability or failure
of the Administrative Agent to obtain sufficient quotations in accordance with
the terms thereof, the Alternate Base Rate shall be determined without regard to
clause (b) of the first sentence of this definition, as appropriate, until the
circumstances giving rise to such inability no longer exist. Any change in the
Alternate Base Rate due to a change in the Prime Rate or the Federal Funds
Effective Rate shall be effective on the opening of business on the date of such
change.
“
Alternate Base Rate
Loans
” shall
mean Loans that bear interest at an interest rate based on the Alternate Base
Rate.
“
Applicable
Percentage
” shall
mean, for any day, the rate per annum set forth below opposite the applicable
level then in effect, it being understood that the Applicable Percentage for
(
a
)
Revolving Loans that are Alternate Base Rate Loans shall be the percentage set
forth under the column “Alternate Base Rate Margin for Revolving Loans”,
(
b
)
Revolving Loans that are LIBOR Rate Loans shall be the percentage set forth
under the column “LIBOR Rate Margin for Revolving Loans and Letter of Credit
Fee”, (
c
) the
Letter of Credit Fee shall be the percentage set forth under the column “LIBOR
Rate Margin for Revolving Loans and Letter of Credit Fee”, (
d
) Term
Loans that are Alternate Base Rate Loans shall be the percentage set forth under
the column “Alternate Base Rate Margin for Term Loans”, (
e
) Term
Loans that are LIBOR Rate Loans shall be the percentage set forth under the
column “LIBOR Rate Margin for Term Loans”, and (
f
) the
Commitment Fee shall be the percentage set forth under the column “Commitment
Fee”:
Level
|
Leverage
Ratio
|
Alternate
Base Rate Margin for Revolving Loans
|
LIBOR
Rate Margin for Revolving Loans and Letter of Credit Fee
|
Alternate
Base Rate Margin for Term Loans
|
LIBOR
Rate Margin for Term Loans
|
Commitment
Fee
|
I
|
≥
4.00 to 1.0
|
1.25%
|
2.25%
|
0.75%
|
1.75%
|
0.500%
|
II
|
≥
3.25 to 1.0 but
<
4.00 to 1.0
|
1.00%
|
2.00%
|
0.75%
|
1.75%
|
0.375%
|
III
|
≥
2.50 to 1.0 but
<
3.25 to 1.0
|
0.75%
|
1.75%
|
0.75%
|
1.75%
|
0.375%
|
IV
|
≥
1.75 to 1.0 but
<
2.50 to 1.0
|
0.50%
|
1.50%
|
0.75%
|
1.75%
|
0.250%
|
V
|
<
1.75 to 1.0
|
0.25%
|
1.25%
|
0.75%
|
1.75%
|
0.250%
|
The
Applicable Percentage shall, in each case, be determined and adjusted quarterly
on the date five (5) Business Days after the date on which the Administrative
Agent has received from the Borrower the financial information and
certifications required to be delivered to the Administrative Agent and the
Lenders in accordance with the provisions of Sections 5.1(a), (b) and
(c) and Section 5.2(b) (each, an “
Interest Determination
Date
”). Such
Applicable Percentage shall be effective from such Interest Determination Date
until the next such Interest Determination Date. The initial Applicable
Percentages shall be based on Level II
until the
first Interest Determination Date occurring after the delivery of the officer’s
compliance certificate pursuant to Section 5.2(b) for the quarter ended December
31, 2006. If the Borrower shall fail to provide the annual and quarterly
financial information and certifications in accordance with the provisions of
Sections 5.1(a), (b) and (c) and Section 5.2(b), the Applicable Percentage
from such Interest Determination Date shall, on the date five (5) Business Days
after the date by which the Borrower was so required to provide such financial
information and certifications to the Administrative Agent and the Lenders, be
based on Level I until such time as such information and certifications are
provided, whereupon the level shall be determined by the then current Leverage
Ratio.
“
Approved
Fund
” shall
mean any Fund that is administered, managed or underwritten by (
a
) a
Lender, (
b
) an
Affiliate of a Lender or (
c
) an
entity or an Affiliate of an entity that administers or manages a
Lender.
“
Arrangers
” shall
mean Wachovia Capital Markets, LLC and Citigroup Global Markets Inc., as joint
lead arrangers and joint bookrunners, together with their successors and/or
assigns.
“
Asset
Disposition
” shall
mean the disposition of any or all of the assets (including, without limitation,
the disposition to any person that is not a Credit Party or a Subsidiary of
Capital Stock of a Subsidiary or any ownership interest in a joint venture) of
the Company or any of its Subsidiaries whether by sale, lease, transfer or
otherwise. The term “Asset Disposition” shall not include (i) the sale, lease,
transfer or other disposition of assets permitted by Section 6.4(a)(i), (ii),
(iii), (iv), (v) or (vi) hereof or (ii) any Equity Issuance, including any
equity issued upon exercise of employee stock options.
“
Assignment
Agreement
” shall
mean an Assignment Agreement entered into by a Lender and an Eligible Assignee
(with the consent of any party whose consent is required by Section 9.6), and
accepted by the Administrative Agent, in substantially the form of
Schedule
9.6(c)
or any
other form approved by the Administrative Agent.
“
Bank
Products
” shall
mean any one or more of the following types of services or facilities extended
to any of the Credit Parties and their Subsidiaries by an Agent or an Affiliate
thereof, to the extent not prohibited by the terms of this Agreement:
(
a
)
Automated Clearing House (ACH) transactions and other similar money transfer
services; (
b
) cash
management, including controlled disbursement and lockbox services;
(
c
)
establishing and maintaining deposit accounts; (
d
) credit
cards or stored value cards; and (
e
) other
similar or related bank products and services.
“
Bankruptcy
Code
” shall
mean the Bankruptcy Code in Title 11 of the United States Code, as amended,
modified, succeeded or replaced from time to time.
“
Borrower
” shall
have the meaning set forth in the first paragraph of this
Agreement.
“
Borrowing
Date
” shall
mean, in respect of any Loan, the date such Loan is made.
“
Business
” shall
have the meaning set forth in Section 3.10.
“
Business
Day
” shall
mean a day other than a Saturday, Sunday or other day on which commercial banks
in Charlotte, North Carolina or New York, New York are authorized or required by
law to close;
provided
,
however
, that
when used in connection with a rate determination, borrowing or payment in
respect of a LIBOR Rate Loan, the term “Business Day” shall also exclude any day
on which banks in London, England are not open for dealings in Dollar deposits
in the London interbank market.
“
Capital
Lease
” shall
mean any lease of property, real or personal, the obligations with respect to
which are required to be capitalized on a balance sheet of the lessee in
accordance with GAAP.
“
Capital Lease
Obligations
” shall
mean the capitalized lease obligations relating to a Capital Lease determined in
accordance with GAAP.
“
Capital
Stock
” shall
mean (
a
) in the
case of a corporation, capital stock, (
b
) in the
case of an association or business entity, any and all shares, interests,
participations, rights or other equivalents (however designated) of capital
stock, (
c
) in the
case of a partnership, partnership interests (whether general or limited),
(
d
) in the
case of a limited liability company, membership interests and (
e
) any
other interest or participation that confers on a Person the right to receive a
share of the profits and losses of, or distributions of assets of, the issuing
Person.
“
Cash
Equivalents
” shall
mean (
a
)
securities issued or directly and fully guaranteed or insured by the United
States of America or any agency or instrumentality thereof (provided that the
full faith and credit of the United States of America is pledged in support
thereof) having maturities of not more than twelve months from the date of
acquisition (“
Government
Obligations
”),
(
b
) U.S.
dollar denominated (or foreign currency fully hedged) time deposits,
certificates of deposit, Eurodollar time deposits and Eurodollar certificates of
deposit of (
i
) any
United States commercial bank of recognized standing having capital and surplus
in excess of $250,000,000 or (
ii
) bank
whose short-term commercial paper rating from S&P is at least A-1 or the
equivalent thereof or from Moody’s is at least P-1 or the equivalent thereof
(any such bank being an “
Approved
Bank
”), in
each case with maturities of not more than 364 days from the date of
acquisition, (
c
)
commercial paper and variable or fixed rate notes issued by any Approved Bank
(or by the parent company thereof) or any variable rate notes issued by, or
guaranteed by any domestic corporation rated A-1 (or the equivalent thereof) or
better by S&P or P-1 (or the equivalent thereof) or better by Moody’s and
maturing within six months of the date of acquisition, (
d
)
repurchase agreements with a bank or trust company (including a Lender) or a
recognized securities dealer having capital and surplus in excess of
$500,000,000 for direct obligations issued by or fully guaranteed by the United
States of America, (
e
)
obligations of any state of the United States or any political subdivision
thereof for the payment of the principal and redemption price of and interest on
which there shall have been irrevocably deposited Government Obligations
maturing as to principal and interest at times and in amounts sufficient to
provide such payment, (
f
)
Investments, classified in accordance with GAAP as current assets of the
Borrower or its Subsidiaries, in money market investment programs registered
under the Investment Company Act of 1940, as amended, that are administered by
financial institutions that have the highest rating obtainable from either
Moody’s or S&P, and the portfolios of which are limited solely to
Investments (i) in corporate obligations having a remaining maturity of less
than two years, issued by corporations having outstanding comparable obligations
that are rated in the two highest categories of Moody’s and S&P or no lower
than the two highest long term debt ratings categories of either Moody’s or
S&P or (ii) of the character, quality and maturity described in clauses
(a)-(e) of this definition and (
g
)
money
market funds compliant with Rule 2a-7 of the Exchange Act
which
consist primarily of cash and cash equivalents set forth in clauses (a) through
(f) above.
“
CHAMPUS
” shall
mean the United States Department of Defense Civilian Health and Medical Program
of the United States.
“
Change of
Control
” shall
mean the occurrence of any of the following: (
a
) any
“person” or “group” (within the meaning of Sections 13(d) and 14(d)(2) of the
Exchange Act) becomes the “beneficial owner” (as defined in Rule l3d-3 under the
Exchange Act) of more than 30% of then outstanding Voting Stock of the Company,
measured by voting power rather than the number of shares; (
b
)
Continuing Directors shall cease for any reason to constitute a majority of the
members of the board of directors of the Company then in office, (
c
) the
Company shall cease to own, directly or indirectly through wholly-owned
Subsidiaries, all of the outstanding Capital Stock of the Borrower or, except as
result of the dissolution of Colgate or Victory pursuant to Section
6.4(a)(viii), Colgate or Victory, (
d
) Victory
or any successor parent company of the Borrower resulting from the dissolution
of Victory pursuant to Section 6.4(a)(viii) shall cease to own directly all of
the outstanding Capital Stock of the Borrower
or
(
e
) the
occurrence of a “Change of Control” (or any comparable term) under, and as
defined in, the documents evidencing or governing any Subordinated
Indebtedness
.
“
Closing
Date
” shall
mean the date of this Agreement.
“
CMS
” shall
mean the Centers for Medicare and Medicaid Services and any successor
thereto.
“
Code
” shall
mean the Internal Revenue Code of 1986, as amended, modified, succeeded or
replaced from time to time.
“
Colgate
” shall
have the meaning set forth in the first paragraph of this
Agreement.
“
Collateral
” shall
mean a collective reference to the collateral that is identified in, and at any
time will be covered by, the Security Documents and any other property or assets
of a Credit Party, whether tangible or intangible and whether real or personal,
that may from time to time secure the Credit Party Obligations.
“
Commitment
” shall
mean the Revolving Commitment, the LOC Commitment, the Swingline Commitment and
the Term Loan Commitment, individually or collectively, as
appropriate.
“
Commitment
Fee
” shall
have the meaning set forth in Section 2.5(a).
“
Commitment
Percentage
” shall
mean the Revolving Commitment Percentage and/or the Term Loan Commitment
Percentage, as appropriate.
“
Commitment
Period
” shall
mean the period from and including the Closing Date to but not including the
Revolver Maturity Date.
“
Commonly Controlled
Entity
” shall
mean an entity, whether or not incorporated, which is under common control with
the Borrower within the meaning of Section 4001(b)(1) of ERISA or is part of a
group which includes the Borrower and which is treated as a single employer
under Section 414(b) or 414(c) of the Code or, solely for purposes of Section
412 of the Code to the extent required by such section, Section 414(m) or 414(o)
of the Code.
“
Company
” shall
have the meaning set forth in the first paragraph of this
Agreement.
“
Consolidated Capital
Expenditures
” shall
mean, for any applicable period of computation, the aggregate amount (whether
paid in cash or accrued as a liability) of all capital expenditures of the
Company and its Subsidiaries on a consolidated basis for such period, as
determined in accordance with GAAP;
provided
,
however
,
Consolidated Capital Expenditures shall not include any such expenditures
(
i
) for
replacements and substitutions for capital assets or acquisitions of capital
assets, to the extent made with the proceeds of insurance in accordance with
Section 2.7(b)(ii) or (
ii
) for
replacements and substitutions for capital assets or acquisitions of capital
assets, to the extent made with proceeds from the sale, exchange or other
disposition of assets as permitted under Section 2.7(b)(iv) or Section
6.4(a)(iii).
“
Consolidated
EBITDA
” shall
mean
, for any
applicable period of computation, the sum of (
a
)
Consolidated Net Income for such period, but excluding therefrom all
extraordinary items of income or loss,
plus
(
b
) to the
extent deducted in determining Consolidated Net Income for such period, the sum
of (
i
) the
aggregate amount of depreciation and amortization charges for such period,
plus
(
ii
)
Consolidated Interest Expense for such period,
plus
(
iii
) the
aggregate amount of all income taxes reflected on the consolidated statements of
income of the Company and its Subsidiaries for such period
plus
(
iv
)
non-cash charges related to Hedging Agreements
plus
(
v
)
non-cash expenses resulting from the grant of stock options to any director,
officer or employee of any Credit Party or any Subsidiary pursuant to a written
plan or agreement
plus
(
vi
) fees
and expenses associated with Permitted Acquisitions to the extent such fees and
expenses do not exceed $8,000,000 during the term of this Agreement
plus
(
vii
) other
non-cash charges (excluding non-cash charges relating to accounts receivable and
inventories) in an aggregate amount not to exceed $8,000,000 per year
plus
(
viii
) fees
and expenses associated with the Acquisition and the closing of this Credit
Agreement in an aggregate amount not to exceed $12,500,000
plus
(
ix
) certain
one-time termination costs incurred
in
connection with the termination of the Medtronic Services Agreement in an
aggregate amount not to exceed $6,100,000
plus
(
x
)
non-cash charges with respect to the write-off of research and development
expenses and inventory step-ups related to the Acquisition and the purchase
accounting treatment thereof
minus
(
xi
)
non-cash gains related to Hedging Agreements
;
provided
,
however
,
notwithstanding the foregoing, for purposes of determining the portion of
Consolidated EBITDA attributable to the Acquired Company and its Subsidiaries
for the fiscal quarters ended December 31, 2005, March 31, 2006 and June 30,
2006, such amounts shall be $2,300,000, $2,300,000 and $2,800,000, respectively.
“
Consolidated Interest
Expense
” shall
mean, for any applicable period of computation, all interest expense of the
Company and its Subsidiaries on a consolidated basis for such period (including,
without limitation, the interest component under Capital Leases and any
synthetic lease, tax retention operating lease, off-balance sheet loan or
similar off-balance sheet financing product, but excluding interest income), as
determined in accordance with GAAP.
“
Consolidated Net
Income
” shall
mean, for any applicable period of computation, net income after taxes for such
period of the Company and its Subsidiaries on a consolidated basis, as
determined in accordance with GAAP.
“
Consolidated Working
Capital
” shall
mean, at any date, (a) the consolidated current assets of the Company and its
Subsidiaries as of such date (excluding cash and Permitted Investments and
current deferred tax assets)
minus
(b) the
consolidated current liabilities of the Company and its Subsidiaries as of such
date (excluding current liabilities in respect of Indebtedness and current
deferred tax liabilities). Consolidated Working Capital at any date may be a
positive or negative number. Consolidated Working Capital increases when it
becomes more positive or less negative and decreases when it becomes less
positive or more negative.
“
Continuing
Directors
” shall
mean, during any period of up to twenty-four (24) consecutive months commencing
after the Closing Date, individuals who at the beginning of such twenty-four
(24) month period were directors of the Company (together with any new director
whose (
a
)
election by the Company’s board of directors, (
b
)
nomination for election by the Company’s shareholders or board of directors or
(
c
)
appointment was approved by a vote of at least two-thirds of the directors then
still in office who either were directors at the beginning of such period or
whose election, nomination for election or appointment was previously so
approved).
“
Contractual
Obligation
” shall
mean, as to any Person, any provision of any security issued by such Person or
of any contract, agreement, instrument or undertaking to which such Person is a
party or by which it or any of its property is bound.
“
Copyright
Licenses
” shall
mean any agreement, written or oral, naming the Borrower or any of its
Subsidiaries which are Credit Parties as licensor and granting any right under
any Copyright including, without limitation, any thereof referred to in
Schedule
3.16
.
“
Copyrights
” shall
mean (a) all registered United States copyrights in all Works, now existing or
hereafter created or acquired, all registrations and recordings thereof, and all
applications in connection therewith (including, without limitation,
registrations, recordings and applications in the United States Copyright
Office), including, without limitation, any thereof referred to in
Schedule
3.16
, and (b)
all renewals thereof including, without limitation, any renewals referred to in
Schedule
3.16
.
“
Credit
Documents
” shall
mean this Agreement, each of the Notes, any Joinder Agreement, the LOC
Documents, the Security Documents and all other agreements, documents,
certificates and instruments delivered to the Administrative Agent or any Lender
by any Credit Party in connection therewith (excluding, however, any Hedging
Agreement).
“
Credit
Party
” shall
mean any of the Borrower or the Guarantors.
“
Credit Party
Obligations
” shall
mean, without duplication, (
a
) all of
the obligations of the Credit Parties to the Lenders (including the Issuing
Lender) and the Administrative Agent, whenever arising, under this Agreement,
the Notes or any of the other Credit Documents (including, but not limited to,
any interest accruing after the occurrence of a filing of a petition of
bankruptcy under the Bankruptcy Code with respect to any Credit Party,
regardless of whether such interest is an allowed claim under the Bankruptcy
Code),
and
(
b
) all
liabilities and obligations, whenever arising, owing from any Credit Party or
any of its Subsidiaries to any Hedging Agreement Provider arising under any
Secured Hedging Agreement permitted pursuant to
Section 6.1(f).
“
Debt
Issuance
” shall
mean the issuance of any Indebtedness for borrowed money by the Company or any
of its Subsidiaries (excluding, for purposes hereof, any Equity Issuance or any
Indebtedness of the Company and its Subsidiaries permitted to be incurred
pursuant to Section 6.1 (other than Section 6.1(h) (except to the extent
proceeds from such issuance are used to consummate a Permitted Acquisition if
permitted by such Section)).
“
Default
” shall
mean any event which would constitute an Event of Default, whether or not any
requirement for the giving of notice or the lapse of time, or both, or any other
condition with respect to such Event of Default, has been
satisfied.
“
Defaulting
Lender
” shall
mean, at any time, any Lender that, at such time (a) has failed to make a Loan
required pursuant to the term of this Credit Agreement or failed to fund a
Participation Interest in accordance with the terms hereof, (b) has failed to
pay to the Administrative Agent or any Lender an amount owed by such Lender
pursuant to the terms of this Credit Agreement, or (c) has been deemed insolvent
or has become subject to a bankruptcy or insolvency proceeding or to a receiver,
trustee or similar official.
“
Deposit Account Control
Agreement
” shall
mean an agreement, among a Credit Party, a depository institution, and the
Administrative Agent, which agreement is in a form reasonably acceptable to the
Administrative Agent and which provides the Administrative Agent with “control”
(as such term is used in Article 9 of the Uniform Commercial Code) over the
deposit account(s) described therein, as the same may be as amended, modified,
extended, restated, replaced, or supplemented from time to time.
“
Dispute
” shall
have the meaning set forth in Section 9.21.
“
Dollars
” and
“
$
” shall
mean dollars in lawful currency of the United States of America.
“
Domestic Lending
Office
” shall
mean, initially, the office of each Lender designated as such Lender’s Domestic
Lending Office in such Lender’s Administrative Details Form; and thereafter,
such other domestic office of such Lender as such Lender may from time to time
specify to the Administrative Agent and the Borrower as the office of such
Lender at which Alternate Base Rate Loans of such Lender are to be
made.
“
Domestic
Subsidiary
” shall
mean any Subsidiary that is organized and existing under the laws of the United
States or any state or commonwealth thereof or under the laws of the District of
Columbia (other than any Subsidiary domiciled in Puerto Rico).
“
Eligible
Assignee
” means
(a) a Lender, (b) an Affiliate of a Lender, (c) an Approved Fund, and (d) any
other Person (other than a natural person) approved by (i) the Administrative
Agent, (ii) in the case of any assignment of a Revolving Commitment, the Issuing
Bank, and (iii) unless an Event of Default has occurred and is continuing, the
Borrower (each such approval not to be unreasonably withheld or delayed);
provided
that
notwithstanding the foregoing, “Eligible Assignee” shall not include the
Borrower or any of the Borrower’s Affiliates or Subsidiaries.
“
Environmental
Laws
” shall
mean any and all applicable foreign, Federal, state, local or municipal laws,
rules, orders, regulations, statutes, ordinances, codes, decrees, requirements
of any Governmental Authority or other Requirement of Law (including common law)
regulating, relating to or imposing liability or standards of conduct concerning
protection of human health as such relates to exposure to Materials of
Environmental Concern or the environment, as now or may at any time be in effect
during the term of this Agreement.
“
Equity
Issuance
” shall
mean any issuance by the Company or any of its Subsidiaries to any Person that
is not a Credit Party or a Subsidiary of (a) shares of its Capital Stock,
(b) any shares of its Capital Stock pursuant to the exercise of options or
warrants (excluding employee stock options), (c) any shares of its Capital
Stock pursuant to the conversion of any debt securities to equity or
(d) warrants or options which are exercisable for shares of its Capital
Stock. The term “Equity Issuance” shall not include any Asset Disposition, Debt
Issuance, stock options, restricted stock or stock appreciation rights issued by
the Company or any of its Subsidiaries under a long-term incentive or employee
benefit plan of the Company or any successor plan, any shares of Capital Stock
issued in connection with a stock split (whether pursuant to a stock split in
the form of a stock dividend or otherwise), or any Capital Stock or stock
options issued in connection with or relating to the Acquisition.
“
ERISA
” shall
mean the Employee Retirement Income Security Act of 1974, as amended, modified,
succeeded or replaced from time to time.
“
Eurodollar Reserve
Percentage
” shall
mean for any day, the percentage (expressed as a decimal and rounded upwards, if
necessary, to the next higher 1/100th of 1%) that is in effect for such day as
prescribed by the Federal Reserve Board (or any successor) for determining the
maximum reserve requirement (including without limitation any basic,
supplemental or emergency reserves) in respect of Eurocurrency liabilities, as
defined in Regulation D of such Board as in effect from time to time, or any
similar category of liabilities for a member bank of the Federal Reserve System
in New York City.
“
Event of
Default
” shall
mean any of the events specified in Section 7.1;
provided
,
however
, with
respect to any such event, that any requirement for the giving of notice or the
lapse of time, or both, or any other condition with respect thereto, has been
satisfied.
“
Excess Cash
Flow
”
shall
mean, with respect to any fiscal year of the Company commencing with the
Company’s fiscal year ending December 31, 2007, for the Company and its
Subsidiaries on a consolidated basis, an amount equal to (
a
)
Consolidated EBITDA for such period
minus
(
b
)
Consolidated Capital Expenditures paid in cash for such period
minus
(
c
) Scheduled
Funded Debt Payments made during such period
minus
(
d
)
Consolidated Interest Expense paid in cash (excluding any Consolidated Interest
Expense associated with intercompany Indebtedness) for such period
minus
(
e
) amounts
paid in respect of federal, state, local and foreign income taxes of the Company
and its Subsidiaries with respect to such period
minus
(
f
)
increases in Consolidated Working Capital
plus
(
g
)
decreases in Consolidated Working Capital
minus
(
h
)
optional prepayments of Revolving Loans (to the extent accompanied by a
corresponding reduction of the Revolving Committed Amount) and the Term Loan
made pursuant to Section 2.7(a)
minus
(
i
) except
to the extent financed with the proceeds from the incurrence of Indebtedness or
any Equity Issuance, the amount of any cash consideration paid in connection
with any Permitted Acquisition during such period.
“
Exchange
Act
” shall
mean the Securities Exchange Act of 1934, as amended.
“
Extension of
Credit
” shall
mean, as to any Lender, the making of a Loan by such Lender or the issuance of,
or participation in, a Letter of Credit by such Lender.
“
Federal Funds Effective
Rate
” shall
have the meaning set forth in the definition of “Alternate Base
Rate”.
“
Fee
Letters
” shall
mean (
a
) the
Agent’s Fee Letter and (
b
) the
letter agreement dated July 27, 2006 addressed to the Borrower from Wachovia,
WCM and Citigroup Global Markets Inc.
“
Fixed Charge Coverage
Ratio
” shall
mean, with respect to the Company
and its
Subsidiaries on a consolidated basis for the twelve-month period ending on the
last day of any fiscal quarter of the Company
, the
ratio of (
a
)
Consolidated EBITDA for such period to (
b
) the
sum of Consolidated Interest Expense for such period
plus
Scheduled Funded Debt Payments required to be made during such period
plus
cash
taxes paid or payable during such period
plus
Consolidated Capital Expenditures for such period
plus
Restricted Payments made during such period. Notwithstanding the foregoing, for
purposes of calculating the Fixed Charge Coverage Ratio for the fiscal quarters
ending December 31, 2006, March 31, 2007 and June 30, 2007, the Fixed Charge
Coverage Ratio shall be determined by annualizing the Consolidated Interest
Expense and Scheduled Funded Debt Payments during such fiscal quarters such that
(i) for the calculation of the Fixed Charge Coverage Ratio as of December 31,
2006, the Consolidated Interest Expense and Scheduled Funded Debt Payments for
such fiscal quarter would be multiplied by four (4), (ii) for the
calculation of the Fixed Charge Coverage Ratio as of March 31, 2007, the
Consolidated Interest Expense and the Scheduled Funded Debt Payments for the two
fiscal quarter period then ending would be multiplied by two (2) and (iii)
for the calculation of the Fixed Charge Coverage Ratio as of June 30, 2007, the
Consolidated Interest Expense and the Scheduled Funded Debt Payments for the
three fiscal quarter period then ending would be multiplied by one and
one-third (1 1/3).
“
Flood Hazard
Property
” shall
have the meaning set forth in Section 5.14(d).
“
Foreign
Subsidiary
” shall
mean any Subsidiary that is not a Domestic Subsidiary, but shall not include
Victory, Colgate, Swiftsure or UK Ltd.
“
Fund
” means
any Person (other than a natural person) that is (or will be) engaged in making,
purchasing, holding or otherwise investing in commercial loans and similar
extensions of credit in the ordinary course of its business.
“
Funded
Debt
” shall
mean,
with
respect to any Person, without duplication, (a) all obligations of such Person
for borrowed money, (b) all obligations of such Person evidenced by bonds,
debentures, notes or similar instruments, or upon which interest payments are
customarily made, (c) all obligations of such Person under conditional sale or
other title retention agreements relating to property purchased by such Person
(other than customary reservations or retentions of title under agreements with
suppliers entered into in the ordinary course of business), (d) all obligations
of such Person incurred, issued or assumed as the deferred purchase price of
property or services purchased by such Person (other than trade debt incurred in
the ordinary course of business and due within six months of the incurrence
thereof) that would appear as liabilities on a balance sheet of such Person,
including, without limitation, the reasonably anticipated liability relating to
any earnout obligations whether or not included on the balance sheet of such
Person, (e) the principal portion of all obligations of such Person under
Capital Leases, (f) all obligations of such Person under Hedging Agreements to
the extent required to be accounted for as a liability under GAAP, excluding any
portion thereof which would be accounted for as interest expense under GAAP, (g)
the maximum amount of all letters of credit issued or bankers’ acceptances
facilities created for the account of such Person and, without duplication, all
drafts drawn thereunder (to the extent unreimbursed), (h) all preferred Capital
Stock or other equity interests issued by such Person and which by the terms
thereof could be (at the request of the holders thereof or otherwise) subject to
mandatory sinking fund payments, redemption or other acceleration, (i)
the
principal balance outstanding under any synthetic lease, tax retention operating
lease, off-balance sheet loan or similar off-balance sheet financing
product
, (j) all
Indebtedness of others of the type described in clauses (a) through (i) hereof
secured by (or for which the holder of such Indebtedness has an existing right,
contingent or otherwise, to be secured by) any Lien on, or payable out of the
proceeds of production from, property owned or acquired by such Person, whether
or not the obligations secured thereby have been assumed;
provided
that for
purposes of the amount of Indebtedness pursuant to this clause (j) shall equal
the lesser of (i) such Indebtedness, or (ii) the value of the property subject
to such Lien, (k) all Guaranty Obligations of such Person with respect to
Indebtedness of another Person of the type described in clauses (a) through (i)
hereof, and (l) all Indebtedness of the type described in clauses (a) through
(i) hereof of any partnership or unincorporated joint venture in which such
Person is a general partner or a joint venturer;
provided
,
however
, that
with respect to Funded Debt of the Company and its Subsidiaries, Funded Debt
shall not include (x) Subordinated Indebtedness among the Borrower and the
Guarantors to the extent such Indebtedness would be eliminated on a consolidated
basis or (y) any obligation of the Company to Medtronic in connection with the
termination of the Medtronic Services Agreement in an aggregate amount not to
exceed $6,100,000 during the term of this Agreement.
“
GAAP
” shall
mean generally accepted accounting principles in effect in the United States of
America applied on a consistent basis,
subject
,
however
, in the
case of determination of compliance with the financial covenants set out in
Section 5.9, to the provisions of Section 1.3.
“
German
Breg
” shall
mean Breg Deutschland GmbH, a German company.
“
German
Buyout
” shall
mean the purchase by Orthofix GmbH of the remaining 48% ownership interest in
German Breg pursuant to that certain deferred purchase agreement, dated as of
February 17, 2006 by and among Orthofix GmbH, Stephan Michels, Ronald Hansjorg,
Nikolaus Murges and Albert Engal.
“
Government
Acts
” shall
have the meaning set forth in Section 2.19(a).
“
Governmental
Authority
” shall
mean any nation or government, any state or other political subdivision thereof
and any entity exercising executive, legislative, judicial, regulatory or
administrative functions of or pertaining to government.
“
Guarantor
” shall
mean the Company, Colgate, Victory and
each
Subsidiary Guarantor.
“
Guaranty
” shall
mean the guaranty of the Guarantors set forth in Article X.
“
Guaranty
Obligations
” shall
mean, with respect to any Person, without duplication, any obligations of such
Person (other than endorsements in the ordinary course of business of negotiable
instruments for deposit or collection) guaranteeing or intended to guarantee any
Indebtedness of any other Person in any manner, whether direct or indirect, and
including without limitation any obligation, whether or not contingent,
(
a
) to
purchase any such Indebtedness or any property constituting security therefore,
(
b
) to
advance or provide funds or other support for the payment or purchase of any
such Indebtedness or to maintain working capital, solvency or other balance
sheet condition of such other Person (including without limitation keep well
agreements, maintenance agreements, comfort letters or similar agreements or
arrangements) for the benefit of any holder of Indebtedness of such other
Person, (
c
) to
lease or purchase Property, securities or services primarily for the purpose of
assuring the holder of such Indebtedness, or (
d
) to
otherwise assure or hold harmless the holder of such Indebtedness against loss
in respect thereof. The amount of any Guaranty Obligation hereunder shall
(subject to any limitations set forth therein) be deemed to be an amount equal
to the outstanding principal amount (or maximum principal amount, if larger) of
the Indebtedness in respect of which such Guaranty Obligation is
made.
“
Hedging Agreement
Provider
” shall
mean any Person that enters into a Secured Hedging Agreement with a Credit Party
or any of its Subsidiaries that is permitted by Section 6.1(f) to the extent
such Person is a Lender, an Affiliate of a Lender or any other Person that was a
Lender (or an Affiliate of a Lender) at the time it entered into the Secured
Hedging Agreement but has ceased to be a Lender (or whose Affiliate has ceased
to be a Lender) under the Credit Agreement; provided, in the case of a Secured
Hedging Agreement with a Person who is no longer a Lender, such Person shall be
considered a Hedging Agreement Provider only through the stated maturity date
(without extension or renewal) of such Secured Hedging Agreement.
“
Hedging
Agreements
” shall
mean, with respect to any Person, any agreements entered into to protect such
Person against fluctuations in interest rates, or currency or raw materials
values, including, without limitation, any interest rate swap, cap or collar
agreements or similar arrangements between such Person and one or more
counterparties, any foreign currency exchange agreements, currency protection
agreements, commodity purchase or option agreements or other interest or
exchange rate or commodity price hedging agreements.
“
Incremental Term
Facility
” shall
have the meaning set forth in Section 2.2.
“
Indebtedness
” shall
mean,
with
respect to any Person, without duplication, (a) all obligations of such Person
for borrowed money, (b) all obligations of such Person evidenced by bonds,
debentures, notes or similar instruments, or upon which interest payments are
customarily made, (c) all obligations of such Person under conditional sale or
other title retention agreements relating to property purchased by such Person
(other than customary reservations or retentions of title under agreements with
suppliers entered into in the ordinary course of business), (d) all obligations
of such Person issued or assumed as the deferred purchase price of property or
services purchased by such Person (other than trade debt incurred in the
ordinary course of business and due within six months of the incurrence thereof)
that would appear as liabilities on a balance sheet of such Person, including,
without limitation, the reasonably anticipated liability relating to any earnout
obligations whether or not included on the balance sheet of such Person, (e) all
obligations of such Person under take-or-pay or similar arrangements or under
commodities agreements, (f) all Indebtedness of others secured by (or for which
the holder of such Indebtedness has an existing right, contingent or otherwise,
to be secured by) any Lien on, or payable out of the proceeds of production
from, property owned or acquired by such Person, whether or not the obligations
secured thereby have been assumed, provided that for purposes of the amount of
Indebtedness pursuant to this clause (j) shall equal the lesser of (i) such
Indebtedness, or (ii) the value of the property subject to such Lien, (g) all
Guaranty Obligations of such Person with respect to Indebtedness of another
Person, (h) the principal portion of all obligations of such Person under
Capital Leases plus any accrued interest thereon, (i) all obligations of such
Person under Hedging Agreements to the extent required to be accounted for as a
liability under GAAP, excluding any portion thereof which would be accounted for
as interest expense under GAAP, (j) the maximum amount of all letters of credit
issued or bankers’ acceptances facilities created for the account of such Person
and, without duplication, all drafts drawn thereunder (to the extent
unreimbursed), (k) all preferred Capital Stock or other equity interest issued
by such Person and which by the terms thereof could be (at the request of the
holders thereof or otherwise) subject to mandatory sinking fund payments,
redemption or other acceleration, (l)
the
principal balance outstanding under any synthetic lease, tax retention operating
lease, off-balance sheet loan or similar off-balance sheet financing product
plus any accrued interest thereon
, and (m)
the Indebtedness of any partnership or unincorporated joint venture in which
such Person is a general partner or a joint venturer;
provided
,
however
, that
with respect to Indebtedness of the Company, Indebtedness shall not include any
obligation of the Company to Medtronic in connection with the termination of the
Medtronic Services Agreement in an aggregate amount not to exceed $6,100,00
during the term of this Agreement.
“
Insolvency
” shall
mean, with respect to any Multiemployer Plan, the condition that such Plan is
insolvent within the meaning of such term as used in Section 4245 of
ERISA.
“
Insolvent
” shall
mean being in a condition of Insolvency.
“
Intellectual
Property
” shall
mean, collectively,
all
Copyrights, Copyright Licenses, Patents, Patent Licenses, Trademarks and
Trademark Licenses.
“
Interest Determination
Date
” shall
have the meaning assigned thereto in the definition of “Applicable
Percentage”.
“
Interest Payment
Date
” shall
mean (a) as to any Alternate Base Rate Loan or Swingline Loan, the last Business
Day of each March, June, September and December during the term of this
Agreement and on the applicable Maturity Date, (b) as to any LIBOR Rate Loan
having an Interest Period of three months or less, the last day of such Interest
Period, (c) as to any LIBOR Rate Loan having an Interest Period longer than
three months, (
i
) each
three month anniversary of the first day of such Interest Period and
(
ii
) the
last day of such Interest Period, and (d) as to any Loan which is the subject of
a mandatory prepayment required pursuant to Section 2.7(b) hereof, the date of
such prepayment.
“
Interest
Period
” shall
mean, subject to availability, with respect to any LIBOR Rate Loan,
(
a
)
initially,
the period commencing on the Borrowing Date or conversion date, as the case may
be, with respect to such LIBOR Rate Loan and ending one, two, three, six, or
subject to the consent of all applicable Lenders, nine months thereafter, as
selected by the Borrower in the Notice of Borrowing or Notice of
Conversion/Extension given with respect thereto; and
(
b
)
thereafter,
each period commencing on the last day of the immediately preceding Interest
Period applicable to such LIBOR Rate Loan and ending one, two, three, six, or,
subject to the consent of all applicable Lenders, nine months thereafter, as
selected by the Borrower by irrevocable notice to the Administrative Agent not
less than three (3) Business Days prior to the last day of the then current
Interest Period with respect thereto;
provided
that the
foregoing provisions are subject to the following:
(
i
)
if any
Interest Period pertaining to a LIBOR Rate Loan would otherwise end on a day
that is not a Business Day, such Interest Period shall be extended to the next
succeeding Business Day unless the result of such extension would be to carry
such Interest Period into another calendar month in which event such Interest
Period shall end on the immediately preceding Business Day;
(
ii
)
any
Interest Period pertaining to a LIBOR Rate Loan that begins on the last Business
Day of a calendar month (or on a day for which there is no numerically
corresponding day in the calendar month at the end of such Interest Period)
shall end on the last Business Day of the relevant calendar month for such
Interest Period;
(
iii
)
if the
Borrower shall fail to give notice as provided above, the Borrower shall be
deemed to have selected an Alternate Base Rate Loan to replace the affected
LIBOR Rate Loan;
(
iv
)
any
Interest Period in respect of any Loan that would otherwise extend beyond the
Maturity Date for such Loan shall end on such Maturity Date;
(
v
)
with
regard to the Term Loan, no Interest Period shall extend beyond any principal
amortization payment date unless the portion of the Term Loan consisting of
Alternate Base Rate Loans together with the portion of the Term Loan consisting
of LIBOR Rate Loans with Interest Periods expiring prior to or concurrently with
the date such principal amortization payment date is due, is at least equal to
the amount of such principal amortization payment due on such date; and
(
vi
)
no more
than six (6) LIBOR Rate Loans may be in effect at any time;
provided
that,
for purposes hereof, LIBOR Rate Loans with different Interest Periods shall be
considered as separate LIBOR Rate Loans, even if they shall begin on the same
date and have the same duration, although borrowings, extensions and conversions
may, in accordance with the provisions hereof, be combined at the end of
existing Interest Periods to constitute a new LIBOR Rate Loan with a single
Interest Period.
“
Internal Control
Event
” shall
mean a material weakness in, or fraud that involves management or other
employees who have a significant role in, any Credit Party’s internal controls
over financial reporting, in each case as described in the Securities Laws, to
the extent such material weakness or fraud could reasonably be expected to cause
a Material Adverse Effect.
“
Investment
” shall
mean all investments made directly or indirectly in, to or from any Person,
whether in cash or by acquisition of shares of Capital Stock, property, assets,
indebtedness or other obligations or securities or by loan advance, capital
contribution or otherwise.
“
Issuing
Lender
” shall
mean Wachovia.
“
Issuing Lender
Fees
” shall
have the meaning set forth in Section 2.5(c).
“
Joinder
Agreement
” shall
mean a Joinder Agreement substantially in the form of
Schedule
5.10
,
executed and delivered by an Additional Credit Party in accordance with the
provisions of Section 5.10.
“
Judgment
Currency
” shall
have the meaning set forth in Section 9.20.
“
Lender
” shall
have the meaning set forth in the first paragraph of this Agreement and shall
include the Issuing Lender and the Swingline Lender.
“
Lender Commitment
Letter
” shall
mean, with respect to any Lender, the letter (or other correspondence) to such
Lender from the Administrative Agent notifying such Lender of its LOC
Commitment, Revolving Commitment Percentage and/or Term Loan Commitment
Percentage.
“
Letters of
Credit
” shall
mean any letter of credit issued by the Issuing Lender pursuant to the terms
hereof, as such Letters of Credit may be amended, modified, extended, renewed or
replaced from time to time.
“
Letter of Credit
Fee
” shall
have the meaning set forth in Section 2.5(b).
“
Leverage
Ratio
” shall
mean,
with
respect to the Company and its S
ubsidiaries
on a consolidated basis for the twelve-month period ending on the last day of
any fiscal quarter of the Company
,
the
ratio of (a) Funded Debt of the Company and its Subsidiaries on a consolidated
basis on the last day of such period to (b) Consolidated EBITDA of the Company
and its Subsidiaries for such period.
“
LIBOR
” shall
mean,
for any
LIBOR Rate Loan for any Interest Period therefore, the rate per annum (rounded
upwards, if necessary, to the nearest 1/100 of 1%) appearing on Telerate Page
3750 (or any successor page) as the London interbank offered rate for deposits
in Dollars at approximately 11:00
A.M
. (London
time) two (2) Business Days prior to the first day of such Interest Period
for a term comparable to such Interest Period. If for any reason such rate is
not available, the term “LIBOR” shall mean, for any LIBOR Rate Loan for any
Interest Period therefore, the rate per annum (rounded upwards, if necessary, to
the nearest 1/100 of 1%) appearing on Reuters Screen LIBO Page as the London
interbank offered rate for deposits in Dollars at approximately 11:00
A.M
. (London
time) two (2) Business Days prior to the first day of such Interest Period
for a term comparable to such Interest Period;
provided
,
however
, if more
than one rate is specified on Reuters Screen LIBO Page, the applicable rate
shall be the arithmetic mean of all such rates (rounded upwards, if necessary,
to the nearest 1/100 of 1%).
If, for
any reason, neither of such rates is available, then “LIBOR” shall mean the rate
per annum at which, as determined by the Administrative Agent, Dollars in an
amount comparable to the Loans then requested are being offered to leading banks
at approximately 11:00 A.M. London time, two (2) Business Days prior to the
commencement of the applicable Interest Period for settlement in immediately
available funds by leading banks in the London interbank market for a period
equal to the Interest Period selected.
“
LIBOR Lending
Office
” shall
mean, initially, the office of each Lender designated as such Lender’s LIBOR
Lending Office in such Lender’s Administrative Details Form; and thereafter,
such other office of such Lender as such Lender may from time to time specify to
the Administrative Agent and the Borrower as the office of such Lender at which
the LIBOR Rate Loans of such Lender are to be made.
“
LIBOR
Rate
” shall
mean a rate per annum (rounded upwards, if necessary, to the next higher 1/100th
of 1%) determined by the Administrative Agent pursuant to the following
formula:
LIBOR
Rate =
LIBOR
1.00 -
Eurodollar Reserve Percentage
“
LIBOR Rate
Loan
” shall
mean Loans the rate of interest applicable to which is based on the LIBOR
Rate.
“
Lien
” shall
mean any mortgage, pledge, hypothecation, assignment, deposit arrangement,
encumbrance, lien (statutory or other), charge or other security interest or any
preference, priority or other security agreement or preferential arrangement of
any kind or nature whatsoever (including, without limitation, any conditional
sale or other title retention agreement and any Capital Lease having
substantially the same economic effect as any of the foregoing).
“
Loan
” shall
mean a Revolving Loan, a Swingline Loan and/or a Term Loan, as
appropriate.
“
LOC
Commitment
” shall
mean the commitment of the Issuing Lender to issue Letters of Credit and, with
respect to each Revolving Lender, the commitment of such Revolving Lender to
purchase participation interests in the Letters of Credit up to the amount
identified as such Revolving Lender’s “LOC Commitment” on such Lender’s Lender
Commitment Letter or in the Register, as such amount may be modified in
connection with any assignment made in accordance with the provisions of Section
9.6(c) or reduced from time to time in accordance with the provisions
hereof.
“
LOC Committed
Amount
” shall
have the meaning set forth in Section 2.3(a).
“
LOC
Documents
” shall
mean, with respect to any Letter of Credit, such Letter of Credit, any
amendments thereto, any documents delivered in connection therewith, any
application therefore, and any agreements, instruments, guarantees or other
documents (whether general in application or applicable only to such Letter of
Credit) governing or providing for (
a
) the
rights and obligations of the parties concerned or (
b
) any
collateral security for such obligations.
“
LOC
Obligations
” shall
mean, at any time, the sum of (
a
) the
maximum amount which is, or at any time thereafter may become, available to be
drawn under Letters of Credit then outstanding, assuming compliance with all
requirements for drawings referred to in such Letters of Credit
plus
(
b
) the
aggregate amount of all drawings under Letters of Credit honored by the Issuing
Lender but not theretofore reimbursed.
“
Mandatory
Borrowing
” shall
have the meaning set forth in Section 2.3(e) and Section 2.4(b)(ii),
as the context may require.
“
Material Adverse
Effect
” shall
mean a material adverse effect on (a) the business, operations, property,
condition (financial or otherwise) or prospects of the Company and its
Subsidiaries taken as a whole or the Borrower and its Subsidiaries taken as a
whole, (b) the ability of the Borrower or the Borrower and the Guarantors taken
as a whole, to perform their obligations when such obligations are required to
be performed, under this Agreement, any of the Notes or any other Credit
Document or (c) the validity or enforceability of this Agreement, any of the
Notes or any of the other Credit Documents or the rights or remedies of the
Administrative Agent or the Lenders hereunder or thereunder.
“
Material
Contract
” shall
mean any contract or other arrangement, whether written or oral, to which any
Credit Party is a party as to which the breach, nonperformance, cancellation or
failure to renew by any party thereto could reasonably be expected to have a
Material Adverse Effect.
“
Material
Property
” shall
mean real and/or personal property of the Credit Parties with an aggregate fair
market value greater than or equal to $5,000,000.
“
Materials of Environmental
Concern
” shall
mean any gasoline or petroleum (including crude oil or any fraction thereof) or
petroleum products or any hazardous or toxic substances, materials or wastes,
defined or regulated as such in or under any Environmental Law, including,
without limitation, asbestos, polychlorinated biphenyls and urea-formaldehyde
insulation.
“
Maturity
Date
” shall
mean the Revolver Maturity Date and/or the Term Loan Maturity Date, as
applicable.
“
Medicaid
” shall
mean that entitlement program under Title XIX of the Social Security Act that
provides federal grants to states for medical assistance based on specific
eligibility criteria.
“
Medicaid
Certification
” shall
mean recognition by a state agency or other such entity administering a
particular state’s Medicaid program that a health care provider or supplier is
in compliance with all the conditions of participation set forth in the
appropriate state and federal Medicaid Regulations.
“
Medicaid Provider
Agreement
” shall
mean an agreement entered into between a state
agency or
other such entity administering the Medicaid program and a health care provider
or supplier under which the health care provider or supplier agrees to provide
services for Medicaid patients in accordance with the terms of the agreement and
Medicaid Regulations.
“
Medicaid
Regulations
” shall
mean, collectively, (
a
) all
federal statutes (whether set forth in Title XIX of the Social Security Act or
elsewhere) affecting the medical assistance program established by Title XIX of
the Social Security Act and any statutes succeeding thereto; (
b
) all
applicable provisions of all federal rules, regulations, manuals and orders of
all Governmental Authorities promulgated pursuant to or in connection with the
statutes described in clause (a) above and all federal administrative,
reimbursement and other guidelines of all Governmental Authorities having the
force of law promulgated pursuant to or in connection with the statutes
described in clause (a) above; (
c
) all
state statutes and plans for medical assistance enacted in connection with the
statutes and provisions described in clauses (a) and (b) above; and
(
d
) all
applicable provisions of all rules, regulations, manuals and orders of all
Governmental Authorities promulgated pursuant to or in connection with the
statutes described in clause (c) above and all state administrative,
reimbursement and other guidelines of all Governmental Authorities having the
force of law promulgated pursuant to or in connection with the statutes
described in clause (b) above, in each case as may be amended, supplemented or
otherwise modified from time to time.
“
Medical Reimbursement
Programs
” shall
mean Medicare, Medicaid and TRICARE programs and any other healthcare program
operated by or financed in whole or in part by any foreign, federal, state or
local government and any other non-government funded third party payor
programs.
“
Medicare
Certification
” shall
mean recognition by CMS or an entity under contract with CMS that the health
care provider or supplier is in compliance with all of the conditions of
participation set forth in the Medicare Regulations.
“
Medicare Provider
Agreement
” means
an agreement entered into between CMS or other such entity administering the
Medicare program on behalf of CMS, and a health care provider or supplier under
which the health care provider or supplier agrees to provide services for
Medicare patients in accordance with the terms of the agreement and Medicare
Regulations.
“
Medicare
” shall
mean that government-sponsored entitlement program under Title XVIII of the
Social Security Act that provides for a health insurance system for eligible
elderly and disabled individuals.
“
Medicare
Regulations
” shall
mean, collectively, all Federal statutes (whether set forth in Title XVIII of
the Social Security Act or elsewhere) affecting the health insurance program for
the aged and disabled established by Title XVIII of the Social Security Act and
any statutes succeeding thereto; together with all applicable provisions of all
rules, regulations, manuals and orders and administrative, reimbursement and
other guidelines having the force of law of all Governmental Authorities
(including, without limitation, the United States Department of Health and Human
Services (“
HHS
”), CMS,
the OIG, or any person succeeding to the functions of any of the foregoing)
promulgated pursuant to or in connection with any of the foregoing having the
force of law, as each may be amended, supplemented or otherwise modified from
time to time.
“
Medtronic
” shall
mean Medtronic Sofamor Danek USA, Inc., a Tennessee corporation.
“
Medtronics Services
Agreement
” shall
mean that certain Marketing Services Agreement, effective May 1, 2005 and
terminated August 10, 2006, between the Company and Medtronic.
“
Moody’s
” shall
mean Moody’s Investors Service, Inc or any successor rating agency.
“
Mortgage
Instruments
” shall
mean any mortgage, deed of trust or deed to secure debt executed by a Credit
Party in favor of the Administrative Agent pursuant to the terms of Section
5.14(d), 5.10 or 5.12, as the same may be amended, modified, restated or
supplemented from time to time.
“
Mortgage
Policy
” shall
mean an ALTA mortgagee title insurance policy issued by the Title Insurance
Company in an amount (limited to 125% of the appraised value (if an appraisal is
available) or, if no appraisal is available, then 125% of the assessed
value)
satisfactory
to the Administrative Agent, in form and substance satisfactory to the
Administrative Agent.
“
Mortgaged
Property
” shall
mean any owned or leased real property of a Credit Party with respect to which
such Credit Party executes a Mortgage Instrument in favor of the Administrative
Agent.
“
Multiemployer
Plan
” shall
mean a Plan which is a multiemployer plan as defined in Section 4001(a)(3) of
ERISA.
“
Net Cash
Proceeds
” shall
mean the aggregate cash proceeds received by (a) the Company or any of its
Subsidiaries in respect of any Asset Disposition, Debt Issuance, Recovery Event
or sale, lease, transfer or other disposition pursuant to Section 6.4(a)(iii)(B)
and (b) the Company or any of the Company’s Subsidiaries in respect of any
Equity Issuance, in each case net of (i) direct costs paid or payable as a
result thereof (including, without limitation, reasonable legal, accounting and
investment banking fees, and sales commissions), (ii) taxes paid or payable as a
result thereof and (iii) with respect to Indebtedness incurred pursuant to
Section 6.1(h), the direct costs incurred prior to or within 7 days of the
issuance of such Indebtedness and paid or payable as a result of any call spread
or simultaneous purchase and sale of call options for the same number of shares
instituted with respect to such Indebtedness in an aggregate amount up to 15% of
the gross proceeds received by the Company and its Subsidiaries from such
Indebtedness; it being understood that “Net Cash Proceeds” shall include,
without limitation, any cash received upon the sale or other disposition of any
non-cash consideration received by the Company or any of its Subsidiaries in
respect of such Asset Disposition, Equity Issuance, Debt Issuance, Recovery
Event or sale, lease, transfer or other disposition pursuant to Section
6.4(a)(iii)(B).
“
Note
” or
“
Notes
” shall
mean the Revolving Notes, the Swingline Note and/or the Term Notes,
collectively, separately or individually, as appropriate.
“
Notice of
Borrowing
” shall
have the meaning set forth in Section 2.1(b)(i).
“
Notice of
Conversion/Extension
” shall
have the meaning set forth in Section 2.10.
“
Obligations
” shall
mean, collectively, Loans and LOC Obligations.
“
OFAC
” shall
mean the U.S. Department of the Treasury’s Office of Foreign Assets
Control.
“
OIG
” shall
mean the Office of the Inspector General for the United States Department of
Health and Human Services.
“
Participant
” shall
have the meaning set forth in Section 9.6(b).
“
Participation
Interest
” shall
mean the purchase by a Revolving Lender of a participation interest in Letters
of Credit as provided in Section 2.3 and in Swingline Loans as provided in
Section 2.4.
“
Patent
License
” shall
mean any agreement, whether written or oral, providing for the grant by or to
the Borrower or any of its Subsidiaries which are Credit Parties of any right to
manufacture, use or sell any invention covered by a Patent, including, without
limitation, any thereof referred to in
Schedule
3.16
.
“
Patents
” shall
mean (a) all patents of the United States or any other country and all reissues
and extensions thereof, including, without limitation, any thereof referred to
in
Schedule 3.16
, and (b)
all applications for patents of the United States or any other country and all
divisions, continuations and continuations-in-part thereof, including, without
limitation, any thereof referred to in
Schedule
3.16
.
“
Patriot
Act
” shall
have the meaning set forth in Section 9.18.
“
PBGC
” shall
mean the Pension Benefit Guaranty Corporation established pursuant to Subtitle A
of Title IV of ERISA.
“
Permitted
Acquisition
” shall
mean any acquisition or any series of related acquisitions by any Credit Party
of the assets or a majority of the Voting Stock or equity interests of a Person
or any division, line of business or other business unit of such Person (such
Person or such division, line of business or other business unit of such Person
referred to herein as the “
Target
”), in
each case that is a type of business (or assets used in a type of business)
permitted to be engaged in by the Credit Parties pursuant to this Credit
Agreement, so long as (
a
) no
Default or Event of Default shall then exist or would exist after giving effect
thereto, (
b
) to the
extent required under this Agreement, the Administrative Agent, on behalf of the
Lenders, shall have received (or shall receive in connection with the closing of
such acquisition), a first priority perfected security interest in all property
with such exceptions as are consistent with Permitted Liens or otherwise
reasonably approved by the Administrative Agent (including, without limitation,
Capital Stock or equity interests) acquired with respect to the Target and the
Target, if a Person, shall have executed a Joinder Agreement, (
c
) such
acquisition is not a “hostile” acquisition and has been approved by the board of
directors and/or shareholders (or comparable persons or groups) of the
applicable Credit Party and the Target, (
d
) the
total consideration (including, without limitation, cash, assumed Indebtedness,
earnout payments and any other deferred payment but excluding the Capital Stock
of the applicable Credit Party) paid for the Target acquired in such acquisition
or series of related acquisitions shall not exceed $40,000,000 for any
individual acquisition (or series of related acquisitions) or $100,000,000 (of
which only $25,000,000 in the aggregate may be acquisitions or portions of
acquisitions involving assets situated outside the United States of America or
the Capital Stock of any Person organized outside the United States of America)
in the aggregate during the term of this Agreement, (
e
) to the
extent the total consideration of any Permitted Acquisition is in excess of
$15,000,000, the Target shall have earnings before interest, taxes, depreciation
and amortization in an amount greater than $0, determined on a Pro Forma Basis
for the period of twelve fiscal months most recently ended, (
f
) after
giving effect to such acquisition, there shall be at least $10,000,000 of
borrowing availability under the Revolving Committed Amount, (
g
) the
Administrative Agent shall have received a certificate from a Responsible
Officer of the Borrower certifying that, in the reasonable judgment of the
Credit Parties, the Credit Parties have conducted such financial, legal,
environmental and consulting due diligence with respect to the Target as a
substantially similarly situated prudent purchaser acquiring substantially
similar property and/or assets would customarily conduct, and (
h
) to the
extent the total consideration of any Permitted Acquisition is in excess of
$5,000,000 or the Borrower requests a Revolving Loan to fund such Permitted
Acquisition, the Borrower shall provide not less than fifteen (15) days prior to
the consummation of such Permitted Acquisition (
i
) a
reasonably detailed description of the material terms of such Permitted
Acquisition (including, without limitation, the purchase price and method and
structure of payment) and of each Target, (ii) to the extent available,
financial statements of the Target for the previous two years and year-to-date
financial statements of the Target, and (
ii
i) a
certificate, in form and substance reasonably satisfactory to the Administrative
Agent, executed by a Responsible Officer of the Borrower (A) setting forth the
best good faith estimate of the total consideration (including, without
limitation, cash, Capital Stock, assumed Indebtedness, earnout payments and any
other deferred payment) to be paid for each Target, and (B) certifying that
such Permitted Acquisition complies with the requirements of this Credit
Agreement, and (C) certifying and demonstrating that after giving effect to such
Permitted Acquisition and any borrowings in connection therewith on a Pro Forma
Basis, the Company and its Subsidiaries will be in compliance with the financial
covenants set forth in Section 5.9.
“
Permitted
Investments
” shall
mean:
(
a
)
cash and
Cash Equivalents;
(
b
)
receivables
owing to the Borrower or any of its Subsidiaries or any receivables and advances
to suppliers, in each case if created, acquired or made in the ordinary course
of business and payable or dischargeable in accordance with customary trade
terms;
(
c
)
Investments
(including, without limitation, the purchase or ownership of Capital Stock) by
any Credit Party in any other Credit Party (other than the Company) and
Subordinated Indebtedness owing by any Credit Party (other than the Company) to
any other Credit Party;
provided
that any
Investment or Subordinated Indebtedness made or issued by a Credit Party (other
than the Company) in or to Colgate or Victory shall be made or issued in
accordance with the Tax Structure Documents;
(
d
)
loans and
advances to officers, directors, employees and Affiliates that are not Credit
Parties or their Subsidiaries in the ordinary course of business in an aggregate
amount not to exceed $500,000 at any time outstanding;
(
e
)
Investments
(including debt obligations) received in connection with the bankruptcy or
reorganization of suppliers and customers and in settlement of delinquent
obligations of, and other disputes with, customers and suppliers arising in the
ordinary course of business;
(
f
)
Investments
by any Foreign Subsidiary in any Credit Party or any other Foreign Subsidiary
and Investments by the Company in any Foreign Subsidiary;
(
g
)
Investments,
acquisitions or transactions permitted under Section 6.4(b);
(
h
)
Permitted
Acquisitions;
(
i
)
Hedging
Agreements to the extent permitted pursuant to Section 6.1(f);
(
j
)
Investments
set forth on
Schedule
6.5
;
(
k
)
loans and
advances by Colgate and Victory to the Company to the extent that such loans and
advances would be permitted by Section 6.10(d), (f) or (i) if made as Restricted
Payments rather than loans and advances;
(
l
)
Investments
in German Breg pursuant to the German Buyout in an aggregate amount not to
exceed $4,000,000;
(
m
)
direct
costs referred to in clause (iii) of the definition of Net Cash Proceeds;
and
(
n
)
additional
loan advances and/or Investments of a nature not contemplated by the foregoing
clauses hereof;
provided
that
such loans, advances and/or Investments made pursuant to this clause (n) shall
not exceed an aggregate amount of $5,000,000.
“
Permitted
Liens
” shall
mean:
(
a
)
Liens
created by or otherwise existing, under or in connection with this Agreement or
the other Credit Documents in favor of the Administrative Agent and each other
Secured Party;
(
b
)
Liens
securing purchase money Indebtedness and Capital Lease Obligations to the extent
permitted under Section 6.1(c), including Liens existing on any asset at the
time of acquisition pursuant to a Permitted Acquisition (other than any such
Liens created in contemplation of such acquisition that do not secure the
purchase price);
provided
that
(
i
) any
such Lien attaches to such property concurrently with or within thirty (30)
days after the acquisition thereof and (
ii
) such
Lien attaches solely to the property so acquired in such
transaction;
(
c
)
Liens for
taxes, assessments, charges or other governmental levies not yet due or as to
which the period of grace (not to exceed 60 days), if any, related thereto has
not expired or which are being contested in good faith by appropriate
proceedings;
provided
that
adequate reserves with respect thereto are maintained on the books of the
Borrower or any of its Subsidiaries, as the case may be, in conformity with
GAAP;
(
d
)
carriers’,
warehousemen’s, mechanics’, materialmen’s, repairmen’s or other like Liens
arising in the ordinary course of business which are not overdue for a period of
more than sixty (60) days or which are being contested in good faith by
appropriate proceedings;
(
e
)
pledges
or deposits in connection with workers’ compensation, unemployment insurance and
other social security legislation and deposits securing liability to insurance
carriers under insurance or self-insurance arrangements incurred in the ordinary
course of business;
(
f
)
deposits
to secure the performance of bids, trade contracts (other than for borrowed
money), leases, statutory obligations, surety and appeal bonds, performance
bonds and other obligations of a like nature incurred in the ordinary course of
business;
(
g
)
any
extension, renewal or replacement (or successive extensions, renewals or
replacements), in whole or in part, of any Lien referred to in the foregoing
clauses;
provided
that
such extension, renewal or replacement Lien shall be limited to all or a part of
the property which secured the Lien so extended, renewed or
replaced;
(
h
)
Liens in
favor of a Hedging Agreement Provider in connection with any Secured Hedging
Agreement, but only (
i
) to the
extent such Liens are on the Collateral and are shared ratably with the
Administrative Agent and (
ii
) if such
Hedging Agreement Provider, the Administrative Agent and the Lenders shall share
the proceeds of the Collateral subject to such Liens in accordance with the
terms of Section 2.12(b);
(
i
)
Liens
existing on the Closing Date and set forth on
Schedule
1.1-3
;
provided that no such Lien shall at any time be extended to cover property or
assets other than the property or assets subject thereto on the Closing
Date;
(
j
)
easements,
rights-of-way, restrictions (including zoning restrictions), minor defects or
irregularities in title and other similar charges or encumbrances shown on any
Mortgage Policy or not, in any material respect, impairing the use of the
encumbered Property for its intended purposes;
(
k
)
Liens on
the assets of Foreign Subsidiaries securing Indebtedness of Foreign Subsidiaries
permitted by Section 6.1(e);
and
(
l
)
Liens on
equipment arising from precautionary UCC financing statements relating to the
lease of such equipment to the extent permitted by this Agreement.
“
Person
” shall
mean an individual, partnership, corporation, limited liability company,
business trust, joint stock company, trust, unincorporated association, joint
venture, Governmental Authority or other entity of whatever nature.
“
Plan
” shall
mean, at any particular time, any employee benefit plan which is covered by
Title IV of ERISA and in respect of which any Credit Party or a Commonly
Controlled Entity is (or, if such plan were terminated at such time, would under
Section 4069 of ERISA be deemed to be) an “employer” as defined in Section 3(5)
of ERISA.
“
Pledge
Agreement
” shall
mean the pledge agreement dated as of the Closing Date executed by the Credit
Parties in favor of the Administrative Agent, as amended, modified, restated or
supplemented from time to time in accordance with its terms and the terms
hereof.
“
Prime
Rate
” shall
have the meaning set forth in the definition of “Alternate Base
Rate”.
“
Pro Forma
Basis
” shall
mean,
with
respect to any transaction,
that such
transaction shall be deemed to have occurred as of the first day of the
twelve-month period ending as of the most recent month
end
ending at least twenty (20) days preceding the date of such transaction.
“
Properties
” shall
have the meaning set forth in Section 3.10(a).
“
Purchasing
Lenders
” shall
have the meaning set forth in Section 9.6(c).
“
Recovery
Event
” shall
mean the receipt by the Company and its Subsidiaries
of any
cash insurance proceeds or condemnation award payable by reason of theft, loss,
physical destruction or damage, taking or similar event with respect to any
Material Property.
“
Register
” shall
have the meaning set forth in Section 9.6(d).
“
Reorganization
” shall
mean, with respect to any Multiemployer Plan, the condition that such Plan is in
reorganization within the meaning of such term as used in Section 4241 of
ERISA.
“
Related
Fund
” shall
mean, with respect to any Lender, any fund or trust or entity that invests in
commercial bank loans in the ordinary course of business and is advised or
managed by (
a
) such
Lender, (
b
) an
Affiliate of such Lender, (
c
) any
other Lender or any Affiliate thereof or (
d
) the
same investment advisor as any Person described in clauses (a) -
(c).
“
Reportable
Event
” shall
mean any of the events set forth in Section 4043(c) of ERISA, other than those
events as to which the thirty-day notice period is waived under PBGC Reg.
§4043.
“
Required
Lenders
” shall
mean, at any time, Lenders holding in the aggregate a majority of (i) the
Commitments (and Participation Interests therein) or (ii) if the Commitments
have been terminated, the outstanding Loans and Participation Interests
(including the Participation Interests of the Issuing Lender in any Letters of
Credit and of the Swingline Lender in Swingline Loans);
provided
,
however
, that if
any Lender shall be a Defaulting Lender at such time, then there shall be
excluded from the determination of Required Lenders, Obligations (including
Participation Interests) owing to such Defaulting Lender and such Defaulting
Lender’s Commitments, or after termination of the Commitments, the principal
balance of the Obligations owing to such Defaulting Lender.
“
Requirement of
Law
” shall
mean, as to any Person, the Certificate of Incorporation and By-laws or other
organizational or governing documents of such Person, and each law, treaty, rule
or regulation or determination of an arbitrator or a court or other Governmental
Authority, in each case applicable to or binding upon such Person or any of its
Material Property or to which such Person or any of its Material Property is
subject.
“
Responsible
Officer
” shall
mean, as to (a) the Company, the President, the Chief Executive Officer, the
Chief Financial Officer and the Treasurer thereof or (b) any other Credit Party
or any Subsidiary thereof, the President, the Chief Executive Officer, the Chief
Financial Officer, the Treasurer and any other duly authorized director or
officer thereof.
“
Restricted
Payments
”
shall
mean (a) any dividend or other distribution, direct or indirect, on account of
any shares of any class of Capital Stock of any Credit Party or any of its
Subsidiaries, now or hereafter outstanding, (b) any redemption, retirement,
sinking fund or similar payment, purchase or other acquisition for value, direct
or indirect, of any shares of any class of Capital Stock of any Credit Party or
any of its Subsidiaries, now or hereafter outstanding, (c) any payment made to
retire, or to obtain the surrender of, any outstanding warrants, options or
other rights to acquire shares of any class of Capital Stock of any Credit Party
or any of its Subsidiaries, now or hereafter outstanding, (d) any payment with
respect to any earnout obligation, (e) any payment or prepayment of principal
of, premium, if any, or interest on, redemption, purchase, retirement,
defeasance, sinking fund or similar payment with respect to, any Subordinated
Indebtedness or (f) the payment by any Credit Party or any of its Subsidiaries
of any management or consulting fee to any Person or of any salary, bonus or
other form of compensation to any Person who is directly or indirectly a
significant partner, shareholder, owner or executive officer of any such Person,
to the extent such fee, salary, bonus or other form of compensation is either
not included in the corporate overhead of any Credit Party or such Subsidiary
or, to the extent such salary, bonus or other form of compensation, is
reimbursed by the Company.
“
Revolver
Increase
” shall
have the meaning set forth in Section 2.1.
“
Revolver Maturity
Date
” shall
mean September 22, 2012.
“
Revolving
Commitment
” shall
mean, with respect to each Revolving Lender, the commitment of such Revolving
Lender to make Revolving Loans in an aggregate principal amount at any time
outstanding up to the amount identified as such Revolving Lender’s “Revolving
Commitment” on such Lender’s Lender Commitment Letter or in the Register, as
such amount may be modified in connection with any assignment made in accordance
with the provisions of Section 9.6(c) or increased (in accordance with Section
2.1(f)) or reduced from time to time in accordance with the provisions
hereof.
“
Revolving Commitment
Percentage
” shall
mean, for each Revolving Lender, the percentage identified as its “Revolving
Commitment Percentage” on such Lender’s Lender Commitment Letter or in the
Register, as such percentage may be modified in connection with any assignment
made in accordance with the provisions of Section 9.6(c).
“
Revolving Committed
Amount
” shall
have the meaning set forth in Section 2.1.
“
Revolving
Lender
” shall
mean, as of any date of determination, each Lender with a Revolving Commitment
greater than $0.
“
Revolving
Loans
” shall
have the meaning set forth in Section 2.1.
“
Revolving
Note
” or
“
Revolving
Notes
” shall
mean the promissory notes of the Borrower in favor of each of the Revolving
Lenders evidencing the Revolving Loans provided pursuant to Section 2.1(e),
individually or collectively, as appropriate, as such promissory notes may be
amended, modified, supplemented, extended, renewed or replaced from time to
time.
“
S&P
” shall
mean Standard & Poor’s Ratings Service, a division of The McGraw Hill
Companies, Inc. or any successor or rating agency.
“
Sanctioned
Country
” shall
mean a country subject to a sanctions program identified on the list maintained
by OFAC and available at
http://www.treas.gov/offices/
eotffc/ofac/sanctions/index.html,
or as
otherwise published from time to time.
“
Sanctioned
Person
” shall
mean (
a
) a
Person named on the list of “Specially Designated Nationals and Blocked Persons”
maintained by OFAC available at
http://www.treas.gov/offices/eotffc/ofac/sdn/index.html,
or as
otherwise published from time to time, or (
b
)
(
i
) an
agency of the government of a Sanctioned Country, (
ii
) an
organization controlled by a Sanctioned Country, or (
iii
) a
person resident in a Sanctioned Country, to the extent subject to a sanctions
program administered by OFAC.
“
Sarbanes-Oxley
” shall
mean the Sarbanes-Oxley Act of 2002.
“
Scheduled Funded Debt
Payments
” shall
mean, as of any date of determination for the Company and its Subsidiaries, the
sum of all scheduled payments of principal on Funded Debt for the applicable
period ending on the date of determination (including the principal component of
payments due on Capital Leases during the applicable period ending on the date
of determination).
“
Secured Hedging
Agreement
” shall
mean any Hedging Agreement between a Credit Party and a Hedging Agreement
Provider, or any agreement relating to Bank Products between a Credit Party and
an Agent or Affiliate thereof, as amended, modified, restated or supplemented
from time to time in accordance with its terms.
“
Secured
Party
” shall
mean each of the Administrative Agent, the Lenders and the Hedging Agreement
Providers, together with their respective successors and assigns.
“
Securities Account Control
Agreement
” shall
mean an agreement, among a Credit Party, a securities intermediary, and the
Administrative Agent, which agreement is or in a form reasonably acceptable to
the Administrative Agent and which provides the Administrative Agent with
“control” (as such term is used in Articles 8 and 9 of the Uniform Commercial
Code) over the securities account(s) described therein, as the same may be as
amended, modified, extended, restated, replaced, or supplemented from time to
time.
“
Securities
Act
” shall
mean the Securities Act of 1933, together with any amendment thereto or
replacement thereof and any rules or regulations promulgated
thereunder.
“
Securities
Laws
” shall
mean the Securities Act, the Exchange Act, Sarbanes-Oxley and the applicable
accounting and auditing principles, rules, standards and practices promulgated,
approved or incorporated by the SEC or the Public Company Accounting Oversight
Board, as each of the foregoing may be amended and in effect on any applicable
date hereunder.
“
Security
Agreement
” shall
mean the security agreement dated as of the Closing Date executed by the Credit
Parties in favor of the Administrative Agent, as amended, modified, restated or
supplemented from time to time in accordance with its terms and the terms
hereof.
“
Security
Documents
” shall
mean the Security Agreement, the Pledge Agreement, the UK Security Documents,
the Mortgage Instruments, and such other documents executed and delivered in
connection with the grant, attachment and perfection of the Administrative
Agent’s security interests and liens arising thereunder, including, without
limitation, UCC financing statements.
“
Single Employer
Plan
” shall
mean any Plan which is not a Multiemployer Plan.
“
Social Security
Act
”
shall
mean the Social Security Act as set forth in Title 42 of the United States Code,
as amended, and any successor statute thereto, as interpreted by the rules and
regulations issued thereunder, in each case as in effect from time to time.
References to sections of the Social Security Act shall be construed also to
refer to any successor sections.
“
Solvent
” shall
mean, with respect to any Person on any date (a) the fair saleable value of such
Person’s assets, measured on a going concern basis, exceeds all probable
liabilities of such Person, including contingent liabilities and those
liabilities to be incurred pursuant to this Credit Agreement, or (b) such
Person (i) does not have unreasonably small capital in relation to the
business in which it is or proposes to be engaged, (ii) has not incurred,
or believes that it will incur after giving effect to the transactions
contemplated by this Credit Agreement, debts beyond its ability to pay such
debts as they become due, (iii) has not suspended making payments on any of its
debts unless subject to a good faith dispute or (iv) by reason of actual or
anticipated financial difficulties, has not commenced negotiations with one or
more of its creditors in order to reschedule the payment of such
indebtedness.
“
SRL
” shall
mean Orthofix SRL/DMO, an Italian corporation.
“
Subordinated
Indebtedness
” shall
mean any Indebtedness incurred by any Credit Party that is (a) specifically
subordinated in right of payment and performance to the prior payment of the
Credit Party Obligations on terms reasonably acceptable to the Administrative
Agent and (b) evidenced by promissory notes, to the extent such Indebtedness is
owed to another Credit Party, which promissory notes shall be pledged to the
Administrative Agent as Collateral for the Credit Party
Obligations.
“
Subsidiary
” shall
mean (a) as to any Person other than the Company, a corporation, partnership,
limited liability company or other entity of which shares of stock or other
ownership interests having ordinary voting power (other than stock or such other
ownership interests having such power only by reason of the happening of a
contingency) to elect a majority of the board of directors or other managers of
such corporation, partnership, limited liability company or other entity are at
the time owned, or the management of which is otherwise controlled, directly or
indirectly through one or more intermediaries, or both, by such Person, and (b)
as to the Company, a corporation, partnership, limited liability company or
other entity of which shares of stock or other ownership interest the Company
owns at the time directly or indirectly through one or more intermediaries, or
both, of greater than 50%. Unless otherwise qualified, all references to a
“Subsidiary” or to “Subsidiaries” in this Agreement shall refer to a Subsidiary
or Subsidiaries of the Company.
“
Subsidiary
Guarantor
” shall
have the meaning set forth in the first paragraph of this
Agreement.
“
Survey
” shall
mean any maps or plats of an as-built survey of the site of a Mortgaged
Property, which maps or plats and the surveys on which they are based shall be
sufficient to delete any standard printed survey exception contained in the
applicable title policy and be made in accordance with the Minimum Standard
Detail Requirements for Land Title Surveys jointly established and adopted by
the American Land Title Association and the American Congress on Surveying and
Mapping in 2005, and, without limiting the generality of the foregoing, there
shall be surveyed and shown on such maps, plats or surveys the following: (a)
the locations on such sites of all the buildings, structures and other
improvements and the established building setback lines; (b) the lines of
streets abutting the sites and width thereof; (c) all access and other easements
appurtenant to the sites necessary to use the sites; (d) all roadways, paths,
driveways, easements, encroachments and overhanging projections and similar
encumbrances affecting the site, whether recorded, apparent from a physical
inspection of the sites or otherwise known to the surveyor; (e) any
encroachments on any adjoining property by the building structures and
improvements on the sites; and (f) if the site is described as being on a filed
map, a legend relating the survey to said map.
“
Swiftsure
” shall
have the meaning set forth in the first paragraph of this
Agreement.
“
Swingline
Commitment
” shall
mean the commitment of the Swingline Lender to make Swingline Loans in an
aggregate principal amount at any time outstanding up to the Swingline Committed
Amount, and the commitment of the Revolving Lenders to purchase participation
interests in the Swingline Loans as provided in Section 2.4(b)(ii), as such
amounts may be reduced from time to time in accordance with the provisions
hereof.
“
Swingline Committed
Amount
” shall
have the meaning set forth in Section 2.4(a).
“
Swingline
Lender
” shall
mean Wachovia.
“
Swingline
Loan
” or
“
Swingline
Loans
” shall
have the meaning set forth in Section 2.4(a).
“
Swingline
Note
” shall
mean the promissory note of the Borrower in favor of the Swingline Lender
evidencing the Swingline Loans provided pursuant to Section 2.4(d), as such
promissory note may be amended, modified, supplemented, extended, renewed or
replaced from time to time.
“
Target
” shall
have the meaning set forth in the definition of “Permitted
Acquisition”.
“
Tax Structure
Documents
” shall
mean a collective reference to the following documents: (
a
) Offer
Letter dated December 30, 2003 from Colgate to UK Ltd, (
b
)
Amendment Agreement dated October 25, 2005 between Colgate and UK Ltd,
(
c
) Written
Notification of Termination and Offer of Amended Terms dated October 25, 2005
from Colgate to UK Ltd, (
d
)
Acknowledgment of Termination dated October 25, 2005 from UK Ltd to Colgate,
(
e
)
Promissory Note in the principal amount of $110,546,815 dated October 25, 2005
by UK Ltd for the benefit of Colgate, (
f
)
Debenture Receivable Sale and Purchase Agreement dated October 25, 2005 between
Colgate and Victory (“
Receivable
Sale
”),
(
g
)
1,999,999 ordinary shares of Victory issued to Colgate as consideration for
Receivable Sale, (
h
) Share
Subscription Agreement dated October 25, 2005 between the Borrower and
Swiftsure, (
i
)
Subscription Request Letter dated October 25, 2005 from Swiftsure to the
Borrower, (
j
)
Acknowledgment of Subscription Request Letter dated October 25, 2005 by the
Borrower to Swiftsure (“
Subscription Request
Letter
”),
(
k
) 999
ordinary shares of Swiftsure issued to the Borrower in connection with the
Subscription Request Letter, (
l
) Offer
Letter dated October 26, 2005 from Victory to Swiftsure, (
m
)
Guarantee dated October 26, 2005 by the Borrower for the
benefit
of Victory, (
n
) Share
Sale and Purchase Agreement
dated
October 26, 2005 between the Borrower and Swiftsure (“
Share Sale and Purchase
Agreement
”),
(
o
) Stock
Transfer Form dated October 26, 2005 relating to the Borrower’s sale of one
share of UK Ltd to Swiftsure (“
Stock Transfer
Form
”),
(
p
) one
ordinary share of UK Ltd issued to Swiftsure in connection with the Stock
Transfer Form, (
q
) one
ordinary shares of Swiftsure issued to the Borrower in connection with the Share
Sale and Purchase Agreement and (
r
) any
other agreement entered into to implement the terms and arrangements
contemplated by the foregoing documents that is reasonably acceptable to the
Administrative Agent.
“
Taxes
” shall
have the meaning set forth in Section 2.18.
“
Term Loan
” shall
have the meaning set forth in Section 2.2(a).
“
Term Loan
Commitment
” shall
mean, with respect to each Term Loan Lender, the commitment of such Term Loan
Lender to make its portion of the Term Loan in a principal amount equal to such
Term Loan Lender’s Term Loan Commitment Percentage of the Term Loan Committed
Amount (and for purposes of making determinations of Required Lenders hereunder
after the Closing Date, the principal amount outstanding on the Term
Loan).
“
Term Loan Commitment
Percentage
” shall
mean, for any Term Loan Lender, the percentage identified as its Term Loan
Commitment Percentage on such Lender’s Lender Commitment Letter, as such
percentage may be modified in connection with any Incremental Term Facility in
accordance with the provisions of Section 2.2(e) or any assignment made in
accordance with the provisions of Section 9.6(c).
“
Term Loan Committed
Amount
” shall
have the meaning set forth in Section 2.2(a).
“
Term Loan
Lender
” shall
mean, as of any date of determination, each Lender that holds a portion of the
outstanding Term Loan.
“
Term Loan Maturity
Date
” shall
mean September 22, 2013.
“
Term Note” or “Term
Notes
” shall
mean the promissory notes of the Borrower in favor of each of the Term Loan
Lenders evidencing the portion of the Term Loan provided pursuant to
Section 2.2(d), individually or collectively, as appropriate, as such
promissory notes may be amended, modified, restated, supplemented, extended,
renewed or replaced from time to time.
“
Title Insurance
Company
” shall
mean Chicago Title Insurance Company or any other title insurance company
approved by the Administrative Agent in its reasonable discretion.
“
Trademark
License
” shall
means any agreement, written or oral, providing for the grant by or to the
Borrower or any of its Subsidiaries which are Credit Parties of any right to use
any Trademark, including, without limitation, any thereof referred to in
Schedule
3.16
.
“
Trademarks
” shall
mean (a) all trademarks, trade names, corporate names, company names, business
names, fictitious business names, trade dress and service marks, logos and other
source or business identifiers, and the goodwill associated therewith, now
existing or hereafter adopted or acquired, all registrations and recordings
thereof, and all applications in connection therewith, whether in the United
States Patent and Trademark Office or in any similar office or agency of the
United States, any State thereof or any other country or any political
subdivision thereof, or otherwise, including, without limitation, any thereof
referred to in
Schedule
3.16
, and
(b) all renewals thereof, including, without limitation, any thereof
referred to in
Schedule
3.16
.
“
Tranche
” shall
mean the collective reference to LIBOR Rate Loans whose Interest Periods begin
and end on the same day. A Tranche may sometimes be referred to as a “LIBOR
Tranche”.
“
Transfer Effective
Date
” shall
have the meaning set forth in each Assignment Agreement.
“
TRICARE
” means
the United States Department of Defense healthcare program for service families
(including TRICARE Prime, TRICARE Extra and TRICARE Standard), and any successor
or predecessor thereof, including without limitation, CHAMPUS.
“
Type
” shall
mean, as to any Loan, its nature as an Alternate Base Rate Loan or LIBOR Rate
Loan, as the case may be.
“
UK Ltd
”
shall
have the meaning set forth in the first paragraph of this
Agreement.
“
UK Security
Documents
” shall
mean (
a
) that
certain pledge agreement dated as of the Closing Date executed by Colgate in
favor of the Administrative Agent with respect to the Capital Stock of Victory,
(
b
) that
certain pledge agreement dated as of the Closing Date executed by the Borrower
in favor of the Administrative Agent with respect to the Capital Stock of
Swiftsure, (
c
) that
certain pledge agreement dated as of the Closing Date executed by Swiftsure in
favor of the Administrative Agent with respect to the Capital Stock of UK Ltd,
(
d
) that
certain debenture dated as of the Closing Date executed by Colgate in favor of
the Administrative Agent, (
e
) that
certain debenture dated as of the Closing Date executed by Victory in favor of
the Administrative Agent, (
f
) that
certain debenture dated as of the Closing Date executed by Swiftsure in favor of
the Administrative Agent and (
g
) that
certain debenture dated as of the Closing Date executed by UK Ltd in favor of
the Administrative Agent, in each case as amended, modified, restated or
supplemented from time to time in accordance with its terms and the terms
hereof.
“
U.S.
” or
“
United
States
” shall
mean the United States of America.
“
Victory
” shall
have the meaning set forth in the first paragraph of this
Agreement.
“
Voting
Stock
” shall
mean, with respect to any Person, Capital Stock issued by such Person the
holders of which are ordinarily, in the absence of contingencies, entitled to
vote for the election of directors (or persons performing similar functions) of
such Person, even though the right so to vote may be or have been suspended by
the happening of such a contingency.
“
Wachovia
” shall
mean Wachovia Bank, National Association, a national banking association,
together with its successors and/or assigns.
“
WCM
” shall
mean Wachovia Capital Markets, LLC.
“
Works
” shall
mean all works which are subject to copyright protection pursuant to
Title 17 of the United States Code.
|
Section
1
.
2
|
Other Definitional
Provisions
.
|
(
a
)
Unless
otherwise specified therein, all terms defined in this Agreement shall have such
defined meanings when used in the Notes or other Credit Documents or any
certificate or other document made or delivered pursuant hereto.
(
b
)
The words
“hereof”, “herein” and “hereunder” and words of similar import when used in this
Agreement shall refer to this Agreement as a whole and not to any particular
provision of this Agreement, and Section, subsection, Schedule and Exhibit
references are to this Agreement unless otherwise specified.
(
c
)
The
meanings given to terms defined herein shall be equally applicable to both the
singular and plural forms of such terms.
|
Section
1
.
3
|
Accounting
Terms
.
|
Unless
otherwise specified herein, all accounting terms used herein shall be
interpreted, all accounting determinations hereunder shall be made, and all
financial statements required to be delivered hereunder shall be prepared in
accordance with GAAP applied on a basis consistent with the most recent audited
consolidated financial statements of the Company delivered to the Lenders;
provided
that, if
the Borrower notifies the Administrative Agent that it wishes to amend any
covenant in Section 5.9 to eliminate the effect of any change in GAAP on the
operation of such covenant (or if the Administrative Agent notifies the Borrower
that the Required Lenders wish to amend Section 5.9 for such purpose), then the
compliance with such covenant shall be determined on the basis of GAAP in effect
immediately before the relevant change in GAAP became effective, until either
such notice is withdrawn or such covenant is amended in a manner satisfactory to
the Borrower and the Required Lenders.
The
Borrower shall deliver to the Administrative Agent and each Lender at the same
time as the delivery of any annual or quarterly financial statements given in
accordance with the provisions of Section 5.1, (
a
) a
description in reasonable detail of any material change in the application of
accounting principles employed in the preparation of such financial statements
from those applied in the most recently preceding quarterly or annual financial
statements as to which no objection shall have been made in accordance with the
provisions above and (
b
) a
reasonable estimate of the effect on the financial statements on account of such
changes in application.
Notwithstanding
the above, the parties hereto acknowledge and agree that, for purposes of all
calculations made in determining compliance for any applicable period with the
financial covenants set forth in Section 5.9 (including without limitation for
purposes of the definition of “Pro Forma Basis” set forth in Section 1.1),
after consummation of any Permitted Acquisition, (
i
) income
statement items and other balance sheet items (whether positive or negative)
attributable to the Target acquired in such transaction shall be included in
such calculations to the extent relating to such applicable period, and
(
ii
)
Indebtedness of a Target that is retired in connection with a Permitted
Acquisition shall be excluded from such calculations and deemed to have been
retired as of the first day of such applicable period
, in each
case in accordance with
Regulation
S-X under the Securities Act, as amended, applicable to a Registration Statement
under such Act on Form S-1.
ARTICLE
II
THE LOANS; AMOUNT AND
TERMS
|
Section
2
.
1
|
Revolving Loans;
Revolver Increase
.
|
(
a
)
Revolving
Commitment
. During
the Commitment Period, subject to the terms and conditions hereof, each
Revolving Lender severally, but not jointly, agrees to make revolving credit
loans (“
Revolving
Loans
”) to the
Borrower from time to time in an aggregate principal amount of up to
FORTY-FIVE
MILLION
DOLLARS
($45,000,000)
(as such
aggregate maximum amount may be reduced from time to time as provided in Section
2.6, the “
Revolving Committed
Amount
”) for
the purposes hereinafter set forth;
provided
,
however
, that
(i) with regard to each Revolving Lender individually, the sum of such Revolving
Lender’s Revolving Commitment Percentage of outstanding Revolving Loans
plus
such
Revolving Lender’s Revolving Commitment Percentage of outstanding Swingline
Loans
plus
such
Revolving Lender’s Revolving Commitment Percentage of outstanding LOC
Obligations shall not exceed such Revolving Lender’s Revolving Commitment and
(ii) with regard to the Revolving Lenders collectively, the sum of the
outstanding Revolving Loans
plus
outstanding Swingline Loans
plus
outstanding LOC Obligations shall not exceed the Revolving Committed Amount.
Revolving Loans may consist of Alternate Base Rate Loans or LIBOR Rate Loans, or
a combination thereof, as the Borrower may request, and may be repaid or prepaid
and reborrowed in accordance with the provisions hereof;
provided
,
however
,
Revolving Loans made on the Closing Date or on any of the three (3)
Business Days following the Closing Date may only consist of Alternate Base Rate
Loans. LIBOR Rate Loans shall be made by each Revolving Lender at its LIBOR
Lending Office and Alternate Base Rate Loans at its Domestic Lending
Office.
(
b
)
Revolving Loan
Borrowings
.
(
i
)
Notice of
Borrowing
. The
Borrower shall request a Revolving Loan borrowing by written notice (a
“
Notice of
Borrowing
”)
substantially in the form of the notice attached as
Schedule
2.1(b)(i)
(or
telephone notice promptly confirmed by delivery to the Administrative Agent of a
Notice of Borrowing by fax or other electronic notice with confirmed receipt
from the recipient) to the Administrative Agent not later than 12:00 Noon
(Charlotte, North Carolina time) on the Business Day of the requested borrowing
in the case of Alternate Base Rate Loans, and on the third Business Day prior to
the date of the requested borrowing in the case of LIBOR Rate Loans. Each such
request for borrowing shall be irrevocable and shall specify (A) that a
Revolving Loan is requested, (B) the date of the requested borrowing (which
shall be a Business Day), (C) the aggregate principal amount to be borrowed on
such date, (D) whether the borrowing shall be comprised of Alternate Base Rate
Loans, LIBOR Rate Loans or a combination thereof, and (E) if LIBOR Rate Loans
are requested, the Interest Period(s) therefore. If the Borrower shall fail to
specify in any such Notice of Borrowing (I) an applicable Interest Period in the
case of a LIBOR Rate Loan, then such notice shall be deemed to be a request for
an Interest Period of one month, or (II) the type of Revolving Loan requested,
then such notice shall be deemed to be a request for an Alternate Base Rate Loan
hereunder. The Administrative Agent shall give notice to each Revolving Lender
promptly upon receipt of each Notice of Borrowing, of the contents thereof and
each such Revolving Lender’s share thereof.
(
ii
)
Minimum
Amounts
. Each
Revolving Loan shall be in a minimum aggregate amount of $1,000,000 and in
integral multiples of $500,000 in excess thereof (or the remaining amount of the
Revolving Committed Amount, if less).
(
iii
)
Advances
. Each
Revolving Lender will make its Revolving Commitment Percentage of each Revolving
Loan borrowing available to the Administrative Agent for the account of the
Borrower at the office of the Administrative Agent specified in Section 9.2, or
at such other office as the Administrative Agent may designate in writing, by
2:00 P.M. (Charlotte, North Carolina time) on the date specified in the
applicable Notice of Borrowing in Dollars and in funds immediately available to
the Administrative Agent. Such borrowing will then be made available to the
Borrower by the Administrative Agent by crediting the account of the Borrower
designated in the Account Designation Letter (or as otherwise agreed by the
Borrower and the Administrative Agent) with the aggregate of the amounts made
available to the Administrative Agent by the Revolving Lenders and in like funds
as received by the Administrative Agent.
(
c
)
Repayment
. The
principal amount of all Revolving Loans shall be due and payable in full on the
Revolver Maturity Date, unless accelerated sooner pursuant to
Section 7.2.
(
d
)
Interest
. Subject
to the provisions of Section 2.9, Revolving Loans shall bear interest as
follows:
(
i
)
Alternate Base Rate
Loans
. During
such periods as Revolving Loans shall be comprised of Alternate Base Rate Loans,
each such Alternate Base Rate Loan shall bear interest at a per annum rate equal
to the sum of the Alternate Base Rate
plus
the
Applicable Percentage; and
(
ii
)
LIBOR Rate
Loans
. During
such periods as Revolving Loans shall be comprised of LIBOR Rate Loans, each
such LIBOR Rate Loan shall bear interest at a per annum rate equal to the sum of
the LIBOR Rate
plus
the
Applicable Percentage.
Interest
on Revolving Loans shall be payable in arrears on each Interest Payment
Date.
(
e
)
Revolving Notes; Covenant to
Pay
. Each
Revolving Lender’s Revolving Commitment shall be evidenced by a duly executed
promissory note of the Borrower to such Revolving Lender in substantially the
form of
Schedule
2.1(e)
. The
Borrower covenants and agrees to pay the Revolving Loans in accordance with the
terms of this Agreement.
(
f
)
Revolver
Increase
. Subject
to the terms and conditions set forth herein, the Borrower shall have the right,
at any time and from time to time prior to the Revolver Maturity Date, to incur
additional Indebtedness under this Credit Agreement in the form of an increase
to the Revolving Committed Amount (each a “
Revolver
Increase
”) by an
aggregate amount of up to (
a
)
ONE HUNDRED TWENTY-FIVE MILLION
DOLLARS
($125,000,000)
less
(
b
) the sum
of (
i
) the
aggregate amount of any prior Incremental Term Facility established pursuant to
Section 2.2(e)
plus
(
ii
) the
aggregate amount of any prior Revolver Increases established pursuant to this
Section 2.1(f). The following terms and conditions shall apply to each Revolver
Increase: (
i
) the
loans made under any such Revolver Increase (each an “
Additional Revolving
Loan
”) shall
constitute Credit Party Obligations and will be secured and guaranteed with the
other Credit Party Obligations on a pari passu basis, (
ii
) the
proceeds of any Additional Revolving Loan will be used for the purposes set
forth in Section 3.11, (
iii
) the
Borrower shall execute a Revolving Note in favor of any new Lender or any
existing Lender requesting a Revolving Note whose Revolving Commitment is
created or increased, (
iv
) the
conditions to Extensions of Credit in Section 4.2 shall have been satisfied,
(
v
) the
Administrative Agent shall have received an opinion or opinions (including, if
reasonably requested by the Administrative Agent, local counsel opinions) of
counsel for the Credit Parties, addressed to the Administrative Agent and the
Lenders, in form and substance acceptable to the Administrative Agent,
(
vi
) any
such Revolver Increase shall be in a minimum principal amount of $15,000,000 or,
if less, the maximum remaining amount permitted pursuant to this Section 2.1(f),
(
vii
) if the
interest rate margin on any Revolver Increase would be more than the Applicable
Percentage for the existing Revolving Loans, the Applicable Percentage on the
existing Revolving Loans shall be increased such that the Applicable Percentage
on the existing Revolving Loans is equal to the interest rate margin on such
Revolver Increase, and (
viii
) the
Administrative Agent shall have received from the Borrower updated financial
projections for the remainder of the projection term set forth in Section 3.1(e)
and an officer’s certificate, in each case in form and substance reasonably
satisfactory to the Administrative Agent, demonstrating that, after giving
effect to any such Revolver Increase on a Pro Forma Basis, the Borrower will be
in compliance with the financial covenants set forth in Section 5.9 and no
Default or Event of Default shall exist. No existing Lender shall have any
obligation to provide all or any portion of the Revolver Increase.
The
Administrative Agent is authorized to enter into, on behalf of the Lenders, any
amendment to this Credit Agreement or any other Credit Document as may be
necessary to incorporate the terms of any new Revolver Increase
therein.
|
Section
2
.
2
|
Term Loan Facility;
Incremental Term Loan
.
|
(
a
)
Term Loan
. Subject
to the terms and conditions hereof and in reliance upon the representations and
warranties set forth herein, each Term Loan Lender severally agrees to make
available to the Borrower on the Closing Date, by transfer of funds as directed
by the Administrative Agent to the Borrower’s account set forth in the Account
Designation Letter, such Term Loan Lender’s Term Loan Commitment Percentage of a
term loan in Dollars (the “
Term Loan
”) in the
aggregate principal amount of
THREE HUNDRED THIRTY MILLION DOLLARS
($330,000,000)
(the
“
Term Loan Committed
Amount
”) for
the purposes hereinafter set forth. The Term Loan may consist of Alternate Base
Rate Loans or LIBOR Rate Loans, or a combination thereof, as the Borrower may
request;
provided
that on
the Closing Date the Term Loan shall only consist of Alternate Base Rate Loans.
Amounts repaid or prepaid on the Term Loan may not be reborrowed.
(
b
)
Repayment of Term
Loan
. The
principal outstanding amount of the Term Loan as of the Closing Date shall be
repaid in twenty-eight (28) consecutive quarterly installments as follows,
unless accelerated sooner pursuant to Section 7.2:
Principal
Amortization
Payment
Date
|
Term Loan
Principal Amortization
Payment
|
December 31,
2006
|
$825,000
|
March 31,
2007
|
$825,000
|
June
30, 2007
|
$825,000
|
September
30, 2007
|
$825,000
|
December
31, 2007
|
$825,000
|
Principal
Amortization
Payment
Date
|
Term Loan
Principal Amortization
Payment
|
March 31,
2008
|
$825,000
|
June
30, 2008
|
$825,000
|
September
30, 2008
|
$825,000
|
December 31,
2008
|
$825,000
|
March 31,
2009
|
$825,000
|
June
30, 2009
|
$825,000
|
September
30, 2009
|
$825,000
|
December 31,
2009
|
$825,000
|
March 31,
2010
|
$825,000
|
June
30, 2010
|
$825,000
|
September
30, 2010
|
$825,000
|
December 31,
2010
|
$825,000
|
March 31,
2011
|
$825,000
|
June
30, 2011
|
$825,000
|
September
30, 2011
|
$825,000
|
December 31,
2011
|
$825,000
|
March 31,
2012
|
$825,000
|
June
30, 2012
|
$825,000
|
September
30, 2012
|
$825,000
|
December 31,
2012
|
$77,550,000
|
March
31, 2013
|
$77,550,000
|
June
30, 2013
|
$77,550,000
|
Term
Loan Maturity Date
|
The
remainder of the outstanding Term
Loan
|
(
c
)
Interest on the Term
Loan
. Subject
to the provisions of Section 2.9, the Term Loan shall bear interest as
follows:
(
i
)
Alternate Base Rate
Loans
. During
such periods as the Term Loan shall be comprised of Alternate Base Rate Loans,
each such Alternate Base Rate Loan shall bear interest at a per annum rate equal
to the sum of the Alternate Base Rate
plus
the
Applicable Percentage; and
(
ii
)
LIBOR Rate
Loans
. During
such periods as the Term Loan shall be comprised of LIBOR Rate Loans, each such
LIBOR Rate Loan shall bear interest at a per annum rate equal to the sum of the
LIBOR Rate
plus
the
Applicable Percentage.
Interest
on the Term Loan shall be payable in arrears on each Interest Payment
Date.
(
d
)
Term
Notes
. Each
Term Loan Lender’s Term Loan Commitment Percentage of the Term Loan Committed
Amount shall be evidenced by a duly executed promissory note of the Borrower to
such Term Loan Lender in substantially the form of
Schedule 2.2(d)
.
(
e
)
Incremental Term
Loan
. Subject
to the terms and conditions set forth herein, the Borrower shall have the right,
at any time and from time to time prior to the Term Loan Maturity Date, to incur
additional Indebtedness under this Credit Agreement in the form of a term loan
(each an “
Incremental Term
Facility
”) by an
aggregate amount of up to (
a
)
ONE HUNDRED TWENTY-FIVE MILLION
DOLLARS
($125,000,000)
less
(
b
) the sum
of (
i
) the
aggregate amount of increases in the Revolving Committed Amount pursuant to any
Revolver Increase
plus
(
ii
) the
aggregate amount of any prior Incremental Term Facilities established pursuant
to this Section 2.2(e). The following terms and conditions shall apply to each
Incremental Term Facility: (
i
) the
loans made under any such Incremental Term Facility (each an “
Additional Term
Loan
”) shall
constitute Credit Party Obligations and will be secured and guaranteed with the
other Credit Party Obligations on a pari passu basis, (
ii
) any
such Incremental Term Facility shall have a maturity date no sooner than, and a
weighted average life to maturity no shorter than, the Term Loan Maturity Date
and the weighted average life to maturity of the Term Loans at such time,
respectively, (
iii
) any
such Incremental Term Facility shall be entitled to the same voting rights as
the existing Term Loans and shall be entitled to receive proceeds of prepayments
on a pro rata basis with the existing Term Loans, (
iv
) any
such Incremental Term Facility shall be obtained from existing Lenders or from
other banks, financial institutions or investment funds, (
v
) any
such Incremental Term Facility shall be in a minimum principal amount of
$25,000,000
and
integral multiples of $1,000,000 in excess thereof, or, if less, the maximum
remaining amount permitted pursuant to this Section 2.2(e), (
vi
) the
proceeds of any Additional Term Loan will be used for the purposes set forth in
Section 3.11, (
vii
) the
Borrower shall execute a Term Note in favor of any new Lender or any existing
Lender requesting a Term Note whose Term Loan Committed Amount is created or
increased, (
viii
) the
conditions to Extensions of Credit in Section 4.2 shall have been satisfied,
(
ix
) the
Administrative Agent shall have received an opinion or opinions (including, if
reasonably requested by the Administrative Agent, local counsel opinions) of
counsel for the Credit Parties, addressed to the Administrative Agent and the
Lenders, in form and substance reasonably acceptable to the Administrative
Agent, (
x
) if the
interest rate margin on any Incremental Term Facility would be more than 0.25%
greater than the Applicable Percentage for the existing Term Loan, the
Applicable Percentage on the existing Term Loan shall be increased such that the
Applicable Percentage on the existing Term Loan is 0.25% lower than the interest
rate margin on the Incremental Term Facility, and (
xi
) the
Administrative Agent shall have received from the Borrower updated financial
projections for the remainder of the initial projection term set forth in
Section 3.1 and an officer’s certificate, in each case in form and substance
reasonably satisfactory to the Administrative Agent, demonstrating that, after
giving effect to any such Incremental Term Facility on a Pro Forma Basis, the
Borrower will be in compliance with the financial covenants set forth in Section
5.9 and no Default or Event of Default shall exist. No existing Lender shall
have any obligation to provide all or any portion of the Incremental Term
Facility. The Administrative Agent is authorized to enter into, on behalf of the
Lenders, any amendment to this Credit Agreement or any other Credit Document as
may be necessary to incorporate the terms of any new Incremental Term Facility
therein.
|
Section
2
.
3
|
Letter of Credit
Subfacility
.
|
(
a
)
Issuance
. Subject
to the terms and conditions hereof and of the LOC Documents, if any, and any
other terms and conditions which the Issuing Lender may reasonably require,
during the Commitment Period the Issuing Lender shall issue, and the Revolving
Lenders shall participate in, Letters of Credit for the account of the Borrower
from time to time upon request in a form acceptable to the Issuing Lender;
provided
,
however
, that
(i) the aggregate amount of LOC Obligations shall not at any time exceed
SEVEN MILLION FIVE HUNDRED THOUSAND
DOLLARS ($7,500,000)
(the
“
LOC Committed
Amount
”), (ii)
the sum of outstanding Revolving Loans
plus
outstanding Swingline Loans
plus
outstanding LOC Obligations shall not at any time exceed the Revolving Committed
Amount, (iii) all Letters of Credit shall be denominated in U.S. Dollars and
(iv) Letters of Credit shall be issued for lawful corporate purposes and may be
issued as standby letters of credit, including in connection with workers’
compensation and other insurance programs. Except as otherwise expressly agreed
upon by all the Revolving Lenders, no Letter of Credit shall have an original
expiry date more than twelve (12) months from the date of issuance;
provided
,
however
, so long
as no Default or Event of Default has occurred and is continuing and subject to
the other terms and conditions to the issuance of Letters of Credit hereunder,
the expiry dates of Letters of Credit may be extended annually or periodically
from time to time at the request of the Borrower or by operation of the terms of
the applicable Letter of Credit to a date not more than twelve (12) months from
the date of extension;
provided
,
further
, that no
Letter of Credit, as originally issued or as extended, shall have an expiry date
extending beyond the Revolver Maturity Date. Each Letter of Credit shall comply
with the related LOC Documents. The issuance and expiry date of each Letter of
Credit shall be a Business Day. Any Letters of Credit issued hereunder shall be
in a minimum original face amount of $100,000. Wachovia shall be the Issuing
Lender on all Letters of Credit issued on or after the Closing Date. In the
event and to the extent that the provisions of any LOC Document shall conflict
with this Agreement, the provisions of this Agreement shall govern. The Issuing
Lender shall make any Letter of Credit issued hereunder available to the
Borrower at its office referred to in Section 9.2 or as otherwise agreed with
the Borrower in connection with such issuance.
(
b
)
Notice and
Reports
. The
request for the issuance of a Letter of Credit shall be submitted to the Issuing
Lender at least five (5) Business Days prior to the requested date of issuance.
The Issuing Lender will promptly upon request of the Administrative Agent
provide to the Administrative Agent for dissemination to the Revolving Lenders a
detailed report specifying the Letters of Credit which are then issued and
outstanding and any activity with respect thereto which may have occurred since
the date of any prior report, and including therein, among other things, the
account party, the beneficiary, the face amount, expiry date as well as any
payments or expirations which may have occurred.
(
c
)
Participations
. Each
Revolving Lender upon issuance of a Letter of Credit shall be deemed to have
purchased without recourse a risk participation from the Issuing Lender in such
Letter of Credit and the obligations arising thereunder and any collateral
relating thereto, in each case in an amount equal to its Revolving Commitment
Percentage of the obligations under such Letter of Credit and shall absolutely,
unconditionally and irrevocably assume, as primary obligor and not as surety,
and be obligated to pay to the Issuing Lender therefore and discharge when due,
its Revolving Commitment Percentage of the obligations arising under such Letter
of Credit. Without limiting the scope and nature of each Revolving Lender’s
participation in any Letter of Credit, to the extent that the Issuing Lender has
not been reimbursed as required hereunder or under any LOC Document, each such
Revolving Lender shall pay to the Issuing Lender its Revolving Commitment
Percentage of such unreimbursed drawing in same day funds on the day of
notification by the Issuing Lender of an unreimbursed drawing pursuant to the
provisions of subsection (d) hereof. The obligation of each Revolving Lender to
so reimburse the Issuing Lender shall be absolute and unconditional and shall
not be affected by the occurrence of a Default, an Event of Default or any other
occurrence or event. Any such reimbursement shall not relieve or otherwise
impair the obligation of the Borrower to reimburse the Issuing Lender under any
Letter of Credit, together with interest as hereinafter provided.
(
d
)
Reimbursement
. In the
event of any drawing under any Letter of Credit, the Issuing Lender will
promptly notify the Borrower and the Administrative Agent. The Borrower shall
reimburse the Issuing Lender on the day of drawing under any Letter of Credit
(with the proceeds of a Revolving Loan obtained hereunder or otherwise) in same
day funds as provided herein or in the LOC Documents. If
the
Borrower shall fail to reimburse the Issuing Lender as provided herein, the
unreimbursed amount of such drawing shall bear interest at a per annum rate
equal to the Alternate Base Rate
plus
the
Applicable Percentage for Revolving Loans that are Alternate Base Rate Loans
plus
two
percent (2%). Unless the Borrower shall promptly notify the Issuing Lender and
the Administrative Agent of its intent to otherwise reimburse the Issuing
Lender, the Borrower shall be deemed to have requested a Revolving Loan in the
amount of the drawing as provided in subsection (e) hereof, the proceeds of
which will be used to satisfy the reimbursement obligations. The Borrower’s
reimbursement obligations hereunder shall be absolute and unconditional under
all circumstances irrespective of any rights of set-off, counterclaim or defense
to payment the Borrower may claim or have against the Issuing Lender, the
Administrative Agent, the Lenders, the beneficiary of the Letter of Credit drawn
upon or any other Person, including without limitation any defense based on any
failure of the Borrower to receive consideration or the legality, validity,
regularity or unenforceability of the Letter of Credit. The Issuing Lender will
promptly notify the other Revolving Lenders of the amount of any unreimbursed
drawing and each Revolving Lender shall promptly pay to the Administrative Agent
for the account of the Issuing Lender in Dollars and in immediately available
funds, the amount of such Revolving Lender’s Revolving Commitment Percentage of
such unreimbursed drawing. Such payment shall be made on the day such notice is
received by such Revolving Lender from the Issuing Lender if such notice is
received at or before 2:00 P.M. (Charlotte, North Carolina time), otherwise such
payment shall be made at or before 12:00 Noon (Charlotte, North Carolina time)
on the next succeeding Business Day. If such Revolving Lender does not pay such
amount to the Issuing Lender in full upon such request, such Revolving Lender
shall, on demand, pay to the Administrative Agent for the account of the Issuing
Lender interest on the unpaid amount during the period from the date of such
drawing until such Revolving Lender pays such amount to the Issuing Lender in
full at a rate per annum equal to, if paid within two (2) Business Days of the
date of drawing, the Federal Funds Effective Rate and thereafter at a rate equal
to the Alternate Base Rate. Each Revolving Lender’s obligation to make such
payment to the Issuing Lender, and the right of the Issuing Lender to receive
the same, shall be absolute and unconditional, shall not be affected by any
circumstance whatsoever and without regard to the termination of this Agreement
or the Commitments hereunder, the existence of a Default or Event of Default or
the acceleration of the Credit Party Obligations hereunder and shall be made
without any offset, abatement, withholding or reduction whatsoever.
(
e
)
Repayment with Revolving
Loans
. On any
day on which the Borrower shall have requested, or been deemed to have
requested, a Revolving Loan to reimburse a drawing under a Letter of Credit, the
Administrative Agent shall give notice to the Revolving Lenders that a Revolving
Loan has been requested or deemed requested in connection with a drawing under a
Letter of Credit, in which case a Revolving Loan borrowing comprised entirely of
Alternate Base Rate Loans (each such borrowing, a “
Mandatory
Borrowing
”) shall
be immediately made (without giving effect to any termination of the Commitments
pursuant to Section 7.2)
pro
rata
based on
each Revolving Lender’s respective Revolving Commitment Percentage (determined
before giving effect to any termination of the Commitments pursuant to Section
7.2) and the proceeds thereof shall be paid directly to the Issuing Lender for
application to the respective LOC Obligations. Each Revolving Lender hereby
irrevocably agrees to make such Revolving Loans immediately upon any such
request or deemed request on account of each Mandatory Borrowing in the amount
and in the manner specified in the preceding sentence and on the same such date
notwithstanding
(i) the
amount of Mandatory Borrowing may not comply with the minimum amount for
borrowings of Revolving Loans otherwise required hereunder, (ii) whether any
conditions specified in Section 4.2 are then satisfied, (iii) whether a Default
or an Event of Default then exists, (iv) failure for any such request or deemed
request for Revolving Loan to be made by the time otherwise required in Section
2.1(b), (v) the date of such Mandatory Borrowing, or (vi) any reduction in
the Revolving Committed Amount after any such Letter of Credit may have been
drawn upon;
provided
,
however
, that in
the event any such Mandatory Borrowing should be less than the minimum amount
for borrowings of Revolving Loans otherwise provided in Section 2.1(b)(ii), the
Borrower shall pay to the Administrative Agent for its own account an
administrative fee of $500. In the event that any Mandatory Borrowing cannot for
any reason be made on the date otherwise required above (including, without
limitation, as a result of the commencement of a proceeding under the Bankruptcy
Code), then each such Revolving Lender hereby agrees that it shall forthwith
fund (as of the date the Mandatory Borrowing would otherwise have occurred, but
adjusted for any payments received from the Borrower on or after such date and
prior to such purchase) its Participation Interests in the LOC Obligations;
provided
,
further
, that in
the event any Revolving Lender shall fail to fund its Participation Interest on
the day the Mandatory Borrowing would otherwise have occurred, then the amount
of such Revolving Lender’s unfunded Participation Interest therein shall bear
interest payable by such Revolving Lender to the Issuing Lender upon demand, at
the rate equal to, if paid within two (2) Business Days of such date, the
Federal Funds Effective Rate, and thereafter at a rate equal to the Alternate
Base Rate.
(
f
)
Modification,
Extension
. The
issuance of any supplement, modification, amendment, renewal, or extension to
any Letter of Credit shall, for purposes hereof, be treated in all respects the
same as the issuance of a new Letter of Credit hereunder.
(
g
)
ISP98 and
UCP
. Unless
otherwise expressly agreed by the Issuing Lender and the Borrower, when a Letter
of Credit is issued, (i) the rules of the “International Standby Practices
1998,” published by the Institute of International Banking Law & Practice
(or such later version thereof as may be in effect at the time of issuance)
shall apply to each standby Letter of Credit, and (ii) the rules of The Uniform
Customs and Practice for Documentary Credits, as most recently published by the
International Chamber of Commerce (the “
UCP
”) at the
time of issuance, shall apply to each commercial Letter of Credit.
(
h
)
Conflict with LOC
Documents
. In the
event of any conflict between this Agreement and any LOC Document (including any
letter of credit application), this Agreement shall control.
(
i
)
Designation of Subsidiaries
as Account Parties
.
Notwithstanding anything to the contrary set forth in this Agreement, including
without limitation Section 2.3(a), a Letter of Credit issued hereunder may
contain a statement to the effect that such Letter of Credit is issued for the
account of a Subsidiary of the Borrower;
provided
that,
notwithstanding such statement, the Borrower shall be the actual account party
for all purposes of this Agreement for such Letter of Credit and such statement
shall not affect the Borrower’s reimbursement obligations hereunder with respect
to such Letter of Credit.
|
Section
2
.
4
|
Swingline Loan
Subfacility
.
|
(
a
)
Swingline
Commitment
. During
the Commitment Period, subject to the terms and conditions hereof, the Swingline
Lender, in its individual capacity, agrees to make certain revolving credit
loans to the Borrower (each a “
Swingline
Loan
” and,
collectively, the “
Swingline
Loans
”) for
the purposes hereinafter set forth;
provided
,
however
, (i) the
aggregate amount of Swingline Loans outstanding at any time shall not exceed
SEVEN MILLION FIVE HUNDRED THOUSAND
DOLLARS ($7,500,000
) (the
“
Swingline Committed
Amount
”), and
(ii) the sum of the outstanding Revolving Loans
plus
outstanding Swingline Loans
plus
outstanding LOC Obligations shall not exceed the Revolving Committed Amount.
Swingline Loans hereunder may be repaid and reborrowed in accordance with the
provisions hereof.
(
b
)
Swingline Loan
Borrowings
.
(
i
)
Notice of Borrowing and
Disbursement
. The
Swingline Lender will make Swingline Loans available to the Borrower by
crediting the account of the Borrower designated in the Account Designation
Letter (or as otherwise agreed between the Borrower and the Administrative
Agent) on any Business Day upon request made by the Borrower through the
delivery of a Notice of Borrowing (with appropriate modifications) (or telephone
notice promptly confirmed by delivery to the Administrative Agent and the
Swingline Lender of a Notice of Borrowing by fax or other electronic notice with
confirmed receipt from the recipient) to the Administrative Agent and the
Swingline Lender not later than 2:00 P.M. (Charlotte, North Carolina time) on
such Business Day. Swingline Loan borrowings hereunder shall be made in minimum
amounts of $100,000 and in integral amounts of $100,000 in excess
thereof.
(
ii
)
Repayment of Swingline
Loans
. Each
Swingline Loan borrowing shall be due and payable on the Revolver Maturity Date.
The Swingline Lender may, at any time, in its sole discretion, by written notice
to the Borrower and the Administrative Agent, demand repayment of its Swingline
Loans by way of a Revolving Loan borrowing, in which case the Borrower shall be
deemed to have requested a Revolving Loan borrowing comprised entirely of
Alternate Base Rate Loans in the amount of such Swingline Loans;
provided
,
however
, that,
in the following circumstances, any such demand shall also be deemed to have
been given one Business Day prior to each of (
A
) the
Revolver Maturity Date, (
B
) the
occurrence of any Event of Default described in Section 7.1(e), (
C
) upon
acceleration of the Credit Party Obligations hereunder, whether on account of an
Event of Default described in Section 7.1(e) or any other Event of Default, and
(
D
) the
exercise of remedies in accordance with the provisions of Section 7.2 hereof
(each such Revolving Loan borrowing made on account of any such deemed request
therefore as provided herein being hereinafter referred to as “
Mandatory
Borrowing
”). Each
Revolving Lender hereby irrevocably agrees to make such Revolving Loans promptly
upon any such request or deemed request on account of each Mandatory Borrowing
in the amount and in the manner specified in the preceding sentence and on the
same such date
notwithstanding
(I) the amount of Mandatory Borrowing may not comply with the minimum
amount for borrowings of Revolving Loans otherwise required hereunder,
(II) whether any conditions specified in Section 4.2 are then satisfied,
(III) whether a Default or an Event of Default then exists, (IV) failure of any
such request or deemed request for Revolving Loans to be made by the time
otherwise required in Section 2.1(b)(i), (V) the date of such Mandatory
Borrowing, or (VI) any reduction in the Revolving Committed Amount or
termination of the Revolving Commitments immediately prior to such Mandatory
Borrowing or contemporaneously therewith. In the event that any Mandatory
Borrowing cannot for any reason be made on the date otherwise required above
(including, without limitation, as a result of the commencement of a proceeding
under the Bankruptcy Code), then each Revolving Lender hereby agrees that it
shall forthwith purchase (as of the date the Mandatory Borrowing would otherwise
have occurred, but adjusted for any payments received from the Borrower on or
after such date and prior to such purchase) from the Swingline Lender such
participations in the outstanding Swingline Loans as shall be necessary to cause
each such Revolving Lender to share in such Swingline Loans ratably based upon
its respective Revolving Commitment Percentage (determined before giving effect
to any termination of the Commitments pursuant to Section 7.2);
provided
that (x)
all interest payable on the Swingline Loans shall be for the account of the
Swingline Lender until the date as of which the respective participation is
purchased, and (y) at the time any purchase of participations pursuant to
this sentence is actually made, the purchasing Revolving Lender shall be
required to pay to the Swingline Lender interest on the principal amount of such
participation purchased for each day from and including the day upon which the
Mandatory Borrowing would otherwise have occurred to but excluding the date of
payment for such participation, at the rate equal to, if paid within two (2)
Business Days of the date of the Mandatory Borrowing, the Federal Funds
Effective Rate, and thereafter at a rate equal to the Alternate Base
Rate.
(
c
)
Interest on Swingline
Loans
. Subject
to the provisions of Section 2.9, Swingline Loans shall bear interest at a per
annum rate equal to the Alternate Base Rate
plus
the
Applicable Percentage for Revolving Loans that are Alternate Base Rate Loans.
Interest on Swingline Loans shall be payable in arrears on each Interest Payment
Date.
(
d
)
Swingline Note; Covenant to
Pay
. The
Swingline Loans may be evidenced, upon such Lender’s request, by a duly executed
promissory note of the Borrower to the Swingline Lender in the original amount
of the Swingline Committed Amount and substantially in the form of
Schedule
2.4(d)
. The
Borrower covenants and agrees to pay the Swingline Loans in accordance with the
terms of this Agreement.
(
a
)
Commitment
Fee
. In
consideration of the Revolving Commitments, the Borrower agrees to pay to the
Administrative Agent for the ratable benefit of the Revolving Lenders a
commitment fee (the “
Commitment
Fee
”) in an
amount equal to the Applicable Percentage per annum on the average daily unused
amount of the Revolving Committed Amount. For purposes of computation of the
Commitment Fee, LOC Obligations shall be considered usage of the Revolving
Committed Amount but Swingline Loans shall not be considered usage of the
Revolving Committed Amount. The Commitment Fee shall be payable quarterly in
arrears on the last Business Day of each calendar quarter for the prior calendar
quarter then ending.
(
b
)
Letter of Credit
Fees
. In
consideration of the LOC Commitments, the Borrower agrees to pay to the Issuing
Lender a fee (the “
Letter of Credit
Fee
”) equal
to the Applicable Percentage per annum on the average daily maximum amount
available to be drawn under each Letter of Credit from the date of issuance to
the date of expiration. In addition to such Letter of Credit Fee, the Issuing
Lender may charge, and retain for its own account without sharing by the other
Lenders, an additional facing fee of one-eighth of one percent (0.125%) per
annum on the average daily maximum amount available to be drawn under each such
Letter of Credit issued by it. The Issuing Lender shall promptly pay over to the
Administrative Agent for the ratable benefit of the Revolving Lenders (including
the Issuing Lender) the Letter of Credit Fee. The Letter of Credit Fee shall be
payable quarterly in arrears on the last Business Day of each calendar quarter
for the prior calendar quarter then ending.
(
c
)
Issuing Lender
Fees
. In
addition to the Letter of Credit Fees payable pursuant to subsection (b) hereof,
the Borrower shall pay to the Issuing Lender for its own account without sharing
by the other Lenders the reasonable and customary charges from time to time of
the Issuing Lender with respect to the amendment, transfer, administration,
cancellation and conversion of, and drawings under, such Letters of Credit
(collectively, the “
Issuing Lender
Fees
”);
provided
such
fees shall not be duplicative of any fees charged under any LOC
Document.
(
d
)
Administrative
Fee
. The
Borrower agrees to pay to the Administrative Agent the annual administrative fee
as described in the Agent’s Fee Letter.
|
Section
2
.
6
|
Commitment
Reductions
.
|
(
a
)
Voluntary
Reductions
. The
Borrower shall have the right to terminate or permanently reduce the unused
portion of the Revolving Committed Amount at any time or from time to time upon
not less than five (5) Business Days’ prior notice to the Administrative
Agent (which shall notify the Revolving Lenders thereof as soon as practicable)
of each such termination or reduction, which notice shall specify the effective
date thereof and the amount of any such reduction which shall be in a minimum
amount of $1,000,000 or a whole multiple of $500,000 in excess thereof, or, if
less, the remaining Revolving Committed Amount, and shall be irrevocable and
effective upon receipt by the Administrative Agent;
provided
that no
such reduction or termination shall be permitted if after giving effect thereto,
and to any prepayments of the Loans made on the effective date thereof, the sum
of the outstanding Revolving Loans
plus
outstanding Swingline Loans
plus
outstanding LOC Obligations would exceed the Revolving Committed
Amount.
(
b
)
Swingline Committed
Amount
. If the
Revolving Committed Amount is reduced, pursuant to Section 2.6(a) above, below
the then current Swingline Committed Amount, the Swingline Committed Amount
shall automatically be reduced by an amount such that the Swingline Committed
Amount equals the Revolving Committed Amount.
(
c
)
Revolver Maturity
Date
. The
Revolving Commitment, the Swingline Commitment and the LOC Commitment shall
automatically terminate on the Maturity Date.
|
Section
2
.
7
|
Prepayments
.
|
(
a
)
Optional
Prepayments
. The
Borrower shall have the right to prepay Loans in whole or in part from time to
time;
provided
,
however
, that
each partial prepayment of a Revolving Loan and the Term Loan shall be in a
minimum principal amount of $1,000,000 and integral multiples of $500,000 in
excess thereof, and each partial prepayment of a Swingline Loan shall be in a
minimum principal amount of $100,000 and integral multiples of $100,000 in
excess thereof. The Borrower shall give three (3) Business Days’
irrevocable notice in the case of LIBOR Rate Loans and one Business Day’s
irrevocable notice in the case of Alternate Base Rate Loans, to the
Administrative Agent (which shall notify the Lenders thereof as soon as
practicable). To the extent the Borrower elects to prepay the Term Loan
(including, if applicable, any Additional Term Loan), amounts prepaid under this
Section shall be applied to the next four (4) scheduled amortization payments
and then pro rata to the Term Loan and any Additional Term Loan, if applicable
(ratably to the remaining principal installments thereof), and then (after the
Term Loan and any Additional Term Loan, if applicable, has been paid in full) to
the Revolving Loans as the Borrower may elect. All prepayments under this
Section 2.7(a) shall be subject to Section 2.17, but otherwise without premium
or penalty. Interest on the principal amount prepaid shall be payable on the
next occurring Interest Payment Date that would have occurred had such loan not
been prepaid or, at the request of the Administrative Agent, interest on the
principal amount prepaid shall be payable on any date that a prepayment is made
hereunder through the date of prepayment.
(
b
)
Mandatory
Prepayments
.
(
i
)
Revolving Committed
Amount
. If at
any time after the Closing Date, the sum of the outstanding Revolving Loans
plus
outstanding Swingline Loans
plus
outstanding LOC Obligations shall exceed the Revolving Committed Amount, the
Borrower immediately shall prepay the Loans and cash collateralize the
outstanding LOC Obligations in an amount sufficient to eliminate such excess
(such prepayment to be applied as set forth in clause (vi) below).
(
ii
)
Asset
Dispositions
. The
Borrower shall prepay the Loans and cash collateralize the outstanding LOC
Obligations in an aggregate amount equal to 100% of the Net Cash Proceeds
derived from Asset Dispositions during any fiscal year in excess of $500,000
(such prepayment to be applied as set forth in clause (vi) below);
provided
,
however
, that,
so long as no Default or Event of Default has occurred and is continuing, such
Net Cash Proceeds shall not be required to be so applied to the extent the
Borrower delivers to the Administrative Agent promptly following such Asset
Disposition a certificate stating that it or the Company or any Subsidiary
intends to use such Net Cash Proceeds to acquire like assets used in the
business of the Borrower and its Subsidiaries within 180 days of the receipt of
such Net Cash Proceeds, it being expressly agreed that any Net Cash Proceeds not
so reinvested shall be applied to prepay the Loans and cash collateralize the
outstanding LOC Obligations immediately thereafter (such prepayment to be
applied as set forth in clause (vi) below).
(
iii
)
Issuances
.
Immediately upon receipt by the Company or any of its Subsidiaries of proceeds
from (A) any Debt Issuance, the Borrower shall prepay the Loans and cash
collateralize the outstanding LOC Obligations in an aggregate amount equal to
100% of the Net Cash Proceeds of such Debt Issuance to the Lenders (such
prepayment to be applied as set forth in clause (vi) below) or (B) any Equity
Issuance, the Borrower shall prepay the Loans and cash collateralize the
outstanding LOC Obligations in an aggregate amount equal to 50% of the Net Cash
Proceeds of such Equity Issuance (such prepayment to be applied as set forth in
clause (vi) below)
;
provided
,
however
, if the
Leverage Ratio is less than or equal to 1.75 to 1.00 as of the end of the
preceding fiscal year of the Company, then the Borrower shall not be required to
prepay the Loans or cash collateralize the outstanding LOC Obligations with the
proceeds of any Debt Issuance or any Equity Issuance.
(
iv
)
Recovery
Event
. To the
extent of Net Cash Proceeds received in connection with a Recovery Event that
are not applied in accordance with Section 6.4(a)(iii), immediately following
the expiration of the period allowed for reinvesting of such Net Cash Proceeds
pursuant to Section 6.4(a)(iii), the Borrower shall prepay the Loans and cash
collateralize the outstanding LOC Obligations in an aggregate amount equal to
100% of such Net Cash Proceeds (such prepayment to be applied as set forth in
clause (vi) below).
(
v
)
Excess Cash
Flow
. Within
ninety (90) days after the end of each fiscal year of the Company
(commencing with the fiscal year ending December 31, 2007), the Borrower shall
prepay the Loans
and cash
collateralize the outstanding LOC Obligations
in an
amount equal to 50% of the Excess Cash Flow earned during such prior fiscal year
(such prepayments to be applied as set forth in clause (vi) below);
provided
,
however
, if the
Leverage Ratio is less than or equal to 1.75 to 1.00 as of the end of the
preceding fiscal year of the Company, then the Borrower shall not be required to
prepay the Loans or cash collateralize the outstanding LOC Obligations with
Excess Cash Flow.
(
vi
)
Application of Mandatory
Prepayments
. All
amounts required to be paid pursuant to this Section 2.7(b) shall be applied as
follows: (A) with respect to all amounts prepaid pursuant to Section 2.7(b)(i),
(1)
first
, to the
outstanding Swingline Loans, (2)
second
, to the
outstanding Revolving Loans and (3)
third
(after
all Revolving Loans have been repaid), to a cash collateral account in respect
of outstanding LOC Obligations, and (B) with respect to all amounts prepaid
pursuant to Sections 2.7(b)(ii) through (v), (1)
first
, to the
next four (4) scheduled amortization payments of the Term Loan (including,
if applicable, any Additional Term Loan) and then pro rata to the Term Loan and
any Additional Term Loan, if applicable (ratably to the remaining principal
installments thereof), (2)
second
to the
Swingline Loans (without a corresponding reduction in the Revolving Committed
Amount), (3)
third
, to the
Revolving Loans (without a corresponding reduction in the Revolving Committed
Amount) and (4)
fourth
(after
all Revolving Loans have been repaid), to a cash collateral account in respect
of outstanding LOC Obligations. Within the parameters of the applications set
forth above, prepayments shall be applied first to Alternate Base Rate Loans and
then to LIBOR Rate Loans in direct order of Interest Period maturities. Each
Lender shall receive its pro rata share (except with respect to prepayments of
Swingline Loans) of any such prepayment based on its Revolving Commitment
Percentage or Term Loan Commitment Percentage, as applicable. All prepayments
under this Section 2.7(b) shall be subject to Section 2.17 and be
accompanied by interest on the principal amount prepaid through the date of
prepayment.
(
c
)
Hedging Obligations
Unaffected
. Any
repayment or prepayment made pursuant to this Section 2.7 shall not affect the
Borrower’s obligation to continue to make payments under any Secured Hedging
Agreement, which shall remain in full force and effect notwithstanding such
repayment or prepayment, subject to the terms of such Secured Hedging
Agreement.
|
Section
2
.
8
|
Lending
Offices
.
|
LIBOR
Rate Loans shall be made by each Lender at its LIBOR Lending Office and
Alternate Base Rate Loans at its Domestic Lending Office.
|
Section
2
.
9
|
Default Rate and
Payment Dates
.
|
Upon the
occurrence, and during the continuance, of an Event of Default, the principal of
and, to the extent permitted by law, interest on the Loans and any other amounts
owing hereunder or under the other Credit Documents shall, at the discretion of
the Required Lenders, bear interest, payable on demand, at a per annum rate 2%
greater than the rate which would otherwise be applicable (or if no rate is
applicable, whether in respect of interest, fees or other amounts, then the
Alternate Base Rate
plus
the
Applicable Percentage with respect to Alternate Base Rate Loans
plus
2%).
|
Section
2
.
10
|
Conversion
Options
.
|
(
a
)
The
Borrower may, in the case of Revolving Loans and Term Loans, elect from time to
time to convert Alternate Base Rate Loans to LIBOR Rate Loans, by giving the
Administrative Agent at least three (3) Business Days’ prior irrevocable
written notice of such election substantially in the form of the notice attached
as
Schedule
2.10
(the
“
Notice of
Conversion/Extension
”). If
the date upon which an Alternate Base Rate Loan is to be converted to a LIBOR
Rate Loan is not a Business Day, then such conversion shall be made on the next
succeeding Business Day and during the period from such last day of an Interest
Period to such succeeding Business Day such Loan shall bear interest as if it
were an Alternate Base Rate Loan. All or any part of outstanding Alternate Base
Rate Loans may be converted as provided herein;
provided
that (i)
no Loan may be converted into a LIBOR Rate Loan when any Default or Event of
Default has occurred and is continuing and (ii) partial conversions shall be in
an aggregate principal amount of (
A
) in the
case of Revolving Loans, $1,000,000 or a whole multiple of $500,000 in excess
thereof and (
B
) in the
case of the Term Loan, $2,000,000 or a whole multiple of $1,000,000 in excess
thereof.
(
b
)
Any LIBOR
Rate Loans may be continued as such upon the expiration of an Interest Period
with respect thereto by compliance by the Borrower with the notice provisions
contained in Section 2.10(a);
provided
, that no
LIBOR Rate Loan may be continued as such when any Default or Event of Default
has occurred and is continuing, in which case such Loan shall be automatically
converted to an Alternate Base Rate Loan at the end of the applicable Interest
Period with respect thereto. If the Borrower shall fail to give timely notice of
an election to continue a LIBOR Rate Loan, or the continuation of LIBOR Rate
Loans is not permitted hereunder, such LIBOR Rate Loans shall be automatically
converted to Alternate Base Rate Loans at the end of the applicable Interest
Period with respect thereto.
|
Section
2
.
11
|
Computation of
Interest and Fees
.
|
(
a
)
Interest
payable hereunder with respect to Alternate Base Rate Loans based on the Prime
Rate shall be calculated on the basis of a year of 365 days (or 366 days, as
applicable) for the actual days elapsed. All other fees, interest and all other
amounts payable hereunder shall be calculated on the basis of a 360-day year for
the actual days elapsed. The Administrative Agent shall as soon as practicable
notify the Borrower and the Lenders of each determination of a LIBOR Rate on the
Business Day of the determination thereof. Any change in the interest rate on a
Loan resulting from a change in the Alternate Base Rate shall become effective
as of the opening of business on the day on which such change in the Alternate
Base Rate shall become effective. The Administrative Agent shall as soon as
practicable notify the Borrower and the Lenders of the effective date and the
amount of each such change.
(
b
)
Each
determination of an interest rate by the Administrative Agent pursuant to any
provision of this Agreement shall be conclusive and binding on the Borrower and
the Lenders in the absence of manifest error. The Administrative Agent shall, at
the request of the Borrower, deliver to the Borrower a statement showing the
computations used by the Administrative Agent in determining any interest
rate.
(
c
)
It is the
intent of the Lenders and the Credit Parties to conform to and contract in
strict compliance with applicable usury law from time to time in effect. All
agreements between the Lenders and the Credit Parties are hereby limited by the
provisions of this subsection which shall override and control all such
agreements, whether now existing or hereafter arising and whether written or
oral. In no way, nor in any event or contingency (including but not limited to
prepayment or acceleration of the maturity of any Credit Party Obligation),
shall the interest taken, reserved, contracted for, charged, or received under
this Agreement, under the Notes or otherwise, exceed the maximum nonusurious
amount permissible under applicable law. If, from any possible construction of
any of the Credit Documents or any other document, interest would otherwise be
payable in excess of the maximum nonusurious amount, any such construction shall
be subject to the provisions of this paragraph and such interest shall be
automatically reduced to the maximum nonusurious amount permitted under
applicable law, without the necessity of execution of any amendment or new
document. If any Lender shall ever receive anything of value which is
characterized as interest on the Loans under applicable law and which would,
apart from this provision, be in excess of the maximum nonusurious amount, an
amount equal to the amount which would have been excessive interest shall,
without penalty, be applied to the reduction of the principal amount owing on
the Loans and not to the payment of interest, or refunded to the Borrower or the
other payor thereof if and to the extent such amount which would have been
excessive exceeds such unpaid principal amount of the Loans. The right to demand
payment of the Loans or any other Indebtedness evidenced by any of the Credit
Documents does not include the right to receive any interest which has not
otherwise accrued on the date of such demand, and the Lenders do not intend to
charge or receive any unearned interest in the event of such demand. All
interest paid or agreed to be paid to the Lenders with respect to the Loans
shall, to the extent permitted by applicable law, be amortized, prorated,
allocated, and spread throughout the full stated term (including any renewal or
extension) of the Loans so that the amount of interest on account of such
Indebtedness does not exceed the maximum nonusurious amount permitted by
applicable law.
|
Section
2
.
12
|
Pro Rata Treatment and
Payments
.
|
(
a
)
Each
borrowing of Revolving Loans and any reduction of the Revolving Commitments
shall be made
pro
rata
according to the respective Revolving Commitment Percentages of the Revolving
Lenders. Each payment under this Agreement or any Note shall be applied, first,
to any fees then due and owing by the Borrower pursuant to Section 2.5, second,
to interest then due and owing in respect of the Notes of the Borrower and,
third, to principal then due and owing hereunder and under the Notes of the
Borrower. Each payment on account of any fees pursuant to Section 2.5 shall be
made
pro
rata
in
accordance with the respective amounts due and owing (except as to the portion
of the Letter of Credit retained by the Issuing Lender and the Issuing Lender
Fees). Each payment (other than prepayments) by the Borrower on account of
principal of and interest on the Revolving Loans and the Term Loan shall be made
pro
rata
according to the respective amounts due and owing in accordance with Section 2.7
hereof. Each optional prepayment on account of principal of the Loans shall be
applied in accordance with Section 2.7(a) and each mandatory prepayment on
account of principal of the Loans shall be applied in accordance with Section
2.7(b). All payments (including prepayments) to be made by the Borrower on
account of principal, interest and fees shall be made without defense, set-off
or counterclaim (except as provided in Section 2.18(b)) and shall be made
to the Administrative Agent for the account of the Lenders at the Administrative
Agent’s office specified in Section 9.2 in Dollars and in immediately available
funds not later than 1:00 P.M. (Charlotte, North Carolina time) on the date when
due. The Administrative Agent shall distribute such payments to the Lenders
entitled thereto promptly upon receipt in like funds as received. If any payment
hereunder (other than payments on the LIBOR Rate Loans) becomes due and payable
on a day other than a Business Day, such payment shall be extended to the next
succeeding Business Day, and, with respect to payments of principal, interest
thereon shall be payable at the then applicable rate during such extension. If
any payment on a LIBOR Rate Loan becomes due and payable on a day other than a
Business Day, the maturity thereof shall be extended to the next succeeding
Business Day unless the result of such extension would be to extend such payment
into another calendar month, in which event such payment shall be made on the
immediately preceding Business Day.
(
b
)
Allocation of Payments After
Exercise of Remedies
.
Notwithstanding any other provision of this Credit Agreement to the contrary,
upon the exercise of remedies by the Administrative Agent or the Lenders
pursuant to Section 7.2 (or after the Commitments shall automatically terminate
and the Loans and all other amounts under the Credit Documents shall
automatically become due and payable in accordance with the terms of such
Section), all amounts collected or received by the Administrative Agent or any
Lender on account of the Credit Party Obligations or any other amounts
outstanding under any of the Credit Documents or in respect of the Collateral
shall be paid over or delivered as follows:
FIRST, to
the payment of all reasonable out-of-pocket costs and expenses (including
without limitation reasonable attorneys’ fees) of the Administrative Agent in
connection with enforcing the rights of the Lenders under the Credit Documents
and any protective advances made by the Administrative Agent with respect to the
Collateral under or pursuant to the terms of the Collateral
Documents;
SECOND,
to payment of any fees owed to the Administrative Agent;
THIRD, to
the payment of all reasonable out-of-pocket costs and expenses (including
without limitation, reasonable attorneys’ fees) of each of the Lenders in
connection with enforcing its rights under the Credit Documents or otherwise
with respect to the Credit Party Obligations owing to such Lender;
FOURTH,
to the payment of all of the Credit Party Obligations consisting of accrued fees
and interest, including with respect to any Secured Hedging Agreement, any fees,
premiums and scheduled periodic payments due under such Secured Hedging
Agreement and any interest accrued thereon;
FIFTH, to
the payment of the outstanding principal amount of the Credit Party Obligations
and the payment or cash collateralization of the outstanding LOC Obligations,
and including with respect to any Secured Hedging Agreement, any breakage,
termination or other payments due under such Secured Hedging Agreement and any
interest accrued thereon;
SIXTH, to
all other Credit Party Obligations and other obligations which shall have become
due and payable under the Credit Documents or otherwise and not repaid pursuant
to clauses “FIRST” through “FIFTH” above; and
SEVENTH,
to the payment of the surplus, if any, to whoever may be lawfully entitled to
receive such surplus.
In
carrying out the foregoing, (i) amounts received shall be applied in the
numerical order provided until exhausted prior to application to the next
succeeding category; (ii) each of the Lenders and Hedging Agreement Providers
shall receive an amount equal to its pro rata share (based on the proportion
that the then outstanding Loans and outstanding LOC Obligations held by such
Lender or the outstanding obligations payable to such Hedging Agreement Provider
bears to the aggregate then outstanding Loans, outstanding LOC Obligations and
obligations payable under all Secured Hedging Agreements) of amounts available
to be applied pursuant to clauses ”THIRD”, “FOURTH”, “FIFTH” and “SIXTH”
above; and (iii) to the extent that any amounts available for distribution
pursuant to clause “FIFTH” above are attributable to the issued but undrawn
amount of outstanding Letters of Credit, such amounts shall be held by the
Administrative Agent in a cash collateral account and applied (A) first, to
reimburse the Issuing Lender from time to time for any drawings under such
Letters of Credit and (B) then, following the expiration of all Letters of
Credit, to all other obligations of the types described in clauses “FIFTH” and
“SIXTH” above in the manner provided in this Section 2.12(b). Notwithstanding
the foregoing terms of this Section 2.12(b), only Collateral proceeds and
payments under the Guaranty with respect to Secured Hedging Agreements shall be
applied to obligations under any Secured Hedging Agreement.
|
Section
2
.
13
|
Non-Receipt of Funds
by the Administrative Agent
.
|
(
a
)
Unless
the Administrative Agent shall have been notified in writing by a Lender prior
to the date a Loan is to be made by such Lender (which notice shall be effective
upon receipt), that such Lender does not intend to make the proceeds of such
Loan available to the Administrative Agent, the Administrative Agent may assume
that such Lender has made such proceeds available to the Administrative Agent on
such date, and the Administrative Agent may in reliance upon such assumption
(but shall not be required to) make available to the Borrower a corresponding
amount. If such corresponding amount is not in fact made available to the
Administrative Agent, the Administrative Agent shall be able to recover such
corresponding amount from such Lender. If such Lender does not pay such
corresponding amount forthwith upon the Administrative Agent’s demand therefor,
the Administrative Agent will promptly notify the Borrower, and the Borrower
shall immediately pay such corresponding amount to the Administrative Agent. The
Administrative Agent shall also be entitled to recover from the Lender or the
Borrower, as the case may be, interest on such corresponding amount in respect
of each day from the date such corresponding amount was made available by the
Administrative Agent to the Borrower to the date such corresponding amount is
recovered by the Administrative Agent at a per annum rate equal to (i) from the
Borrower at the applicable rate for the applicable borrowing pursuant to the
Notice of Borrowing and (ii) from a Lender at the Federal Funds Effective
Rate.
(
b
)
Unless
the Administrative Agent shall have been notified in writing by the Borrower,
prior to the date on which any payment is due from it hereunder (which notice
shall be effective upon receipt) that the Borrower does not intend to make such
payment, the Administrative Agent may assume that such Borrower has made such
payment when due, and the Administrative Agent may in reliance upon such
assumption (but shall not be required to) make available to each Lender on such
payment date an amount equal to the portion of such assumed payment to which
such Lender is entitled hereunder, and if the Borrower has not in fact made such
payment to the Administrative Agent, such Lender shall, on demand, repay to the
Administrative Agent the amount made available to such Lender. If such amount is
repaid to the Administrative Agent on a date after the date such amount was made
available to such Lender, such Lender shall pay to the Administrative Agent on
demand interest on such amount in respect of each day from the date such amount
was made available by the Administrative Agent to such Lender to the date such
amount is recovered by the Administrative Agent at a per annum rate equal to the
Federal Funds Effective Rate.
(
c
)
A
certificate of the Administrative Agent submitted to the Borrower or any Lender
with respect to any amount owing under this Section 2.13 shall be conclusive in
the absence of manifest error.
|
Section
2
.
14
|
Inability to Determine
Interest Rate
.
|
Notwithstanding
any other provision of this Agreement, if (i) the Administrative Agent shall
reasonably determine (which determination shall be conclusive and binding absent
manifest error) that, by reason of circumstances affecting the relevant market,
reasonable and adequate means do not exist for ascertaining LIBOR Rate for any
Interest Period, or (ii) the Administrative Agent or the Required Lenders shall
reasonably determine (which determination shall be conclusive and binding absent
manifest error) that LIBOR Rate does not adequately and fairly reflect the cost
to such Lenders of funding LIBOR Rate Loans that the Borrower has requested be
outstanding as a LIBOR Tranche during such Interest Period, the Administrative
Agent shall forthwith give telephone notice of such determination, confirmed in
writing, to the Borrower, and the Lenders at least two (2) Business Days
prior to the first day of such Interest Period. Unless the Borrower shall have
notified the Administrative Agent upon receipt of such telephone notice that it
wishes to rescind or modify its request regarding such LIBOR Rate Loans, any
Loans that were requested to be made as LIBOR Rate Loans shall be made as
Alternate Base Rate Loans and any Loans that were requested to be converted into
or continued as LIBOR Rate Loans shall remain as or be converted into Alternate
Base Rate Loans. Until any such notice has been withdrawn by the Administrative
Agent, no further Loans shall be made as, continued as, or converted into, LIBOR
Rate Loans for the Interest Periods so affected.
|
Section
2
.
15
|
Illegality
.
|
Notwithstanding
any other provision of this Agreement, if the adoption of or any change in any
Requirement of Law or in the interpretation, administration or application
thereof by the relevant Governmental Authority to any Lender shall make it
unlawful for such Lender or its LIBOR Lending Office to make or maintain LIBOR
Rate Loans as contemplated by this Agreement or to obtain in the interbank
eurodollar market through its LIBOR Lending Office the funds with which to make
such Loans, (a) such Lender shall promptly notify the Administrative Agent and
the Borrower thereof, (b) the commitment of such Lender hereunder to make LIBOR
Rate Loans or continue LIBOR Rate Loans as such shall forthwith be suspended
until the Administrative Agent shall give notice that the condition or situation
which gave rise to the suspension shall no longer exist, and (c) such Lender’s
Loans then outstanding as LIBOR Rate Loans, if any, shall be converted on the
last day of the Interest Period for such Loans or within such earlier period as
required by law to Alternate Base Rate Loans. The Borrower hereby agrees
promptly to pay any Lender, upon its demand, any additional amounts necessary to
compensate such Lender for actual and direct costs (but not including
anticipated profits) reasonably incurred by such Lender including, but not
limited to, any interest or fees payable by such Lender to lenders of funds
obtained by it in order to make or maintain its LIBOR Rate Loans hereunder. A
certificate as to any additional amounts payable pursuant to this Section
submitted by such Lender (which certificate shall include a description of the
basis for the computation), through the Administrative Agent, to the Borrower
shall be conclusive in the absence of manifest error. Each Lender agrees to use
reasonable efforts (including reasonable efforts to change its LIBOR Lending
Office) to avoid or to minimize any amounts which may otherwise be payable
pursuant to this Section;
provided
,
however
, that
such efforts shall not cause the imposition on such Lender of any additional
costs or legal or regulatory burdens deemed by such Lender in its reasonable
discretion to be material.
|
Section
2
.
16
|
Requirements of
Law
.
|
(
a
)
If the
adoption of or any change in any Requirement of Law (other than any change by
way of imposition or increase of reserve requirements included in the Eurodollar
Reserve Percentage) or in the interpretation, administration or application
thereof or compliance by any Lender with any request or directive (whether or
not having the force of law) from any central bank or other Governmental
Authority made subsequent to the date hereof:
(
i
)
shall
subject such Lender to any tax of any kind whatsoever with respect to any Letter
of Credit or any application relating thereto, any LIBOR Rate Loan made by it,
or change the basis of taxation of payments to such Lender in respect thereof
(except for changes in the rate of tax on the overall net income of such
Lender);
(
ii
)
shall
impose, modify or hold applicable any reserve, special deposit, compulsory loan
or similar requirement against assets held by, deposits or other liabilities in
or for the account of, advances, loans or other extensions of credit by, or any
other acquisition of funds by, any office of such Lender which is not otherwise
included in the determination of the LIBOR Rate hereunder; or
(
iii
)
shall
impose on such Lender any other condition;
and the
result of any of the foregoing is to increase the cost to such Lender of making
or maintaining LIBOR Rate Loans or the Letters of Credit or to reduce any amount
receivable hereunder or under any Note, then, in any such case, the Borrower
shall promptly pay such Lender, upon its demand, any additional amounts
necessary to compensate such Lender for such additional cost or reduced amount
receivable which such Lender reasonably deems to be material as determined by
such Lender with respect to its LIBOR Rate Loans or Letters of Credit. A
certificate as to any additional amounts payable pursuant to this Section
submitted by such Lender (which certificate shall include a description of the
basis for the computation), through the Administrative Agent, to the Borrower
shall be conclusive in the absence of manifest error. Each Lender agrees to use
reasonable efforts (including reasonable efforts to change its Domestic Lending
Office or LIBOR Lending Office, as the case may be) to avoid or to minimize any
amounts that might otherwise be payable pursuant to this paragraph of this
Section;
provided
,
however
, that
such efforts shall not cause the imposition on such Lender of any additional
costs or legal or regulatory burdens deemed by such Lender in its reasonable
discretion to be material.
(
b
)
If any
Lender shall have reasonably determined that the adoption of or any change in
any Requirement of Law regarding capital adequacy or in the interpretation or
application thereof or compliance by such Lender or any corporation controlling
such Lender with any request or directive regarding capital adequacy (whether or
not having the force of law) from any central bank or Governmental Authority
made subsequent to the date hereof does or shall have the effect of reducing the
rate of return on such Lender’s or such corporation’s capital as a consequence
of its obligations hereunder to a level below that which such Lender or such
corporation could have achieved but for such adoption, change or compliance
(taking into consideration such Lender’s or such corporation’s policies with
respect to capital adequacy) by an amount reasonably deemed by such Lender in
its reasonable discretion to be material, then from time to time, within
fifteen (15) days after demand by such Lender, the Borrower shall pay to
such Lender such additional amount as shall be certified by such Lender as being
required to compensate it for such reduction. Such a certificate as to any
additional amounts payable under this Section submitted by a Lender (which
certificate shall include a description of the basis for the computation),
through the Administrative Agent, to the Borrower shall be conclusive absent
manifest error.
(
c
)
In the
event that any Lender demands payment of costs or additional amounts pursuant to
Section 2.16 or Section 2.18 or asserts, pursuant to Section 2.15, that it is
unlawful for such Lender to make LIBOR Rate Loans, then (subject to such
Lender’s right to rescind such demand or assertion within 10 days after the
notice from the Borrower referred to below) the Borrower may, upon 20 days’
prior written notice to such Lender and the Administrative Agent, elect to cause
such Lender to assign at par its Loans and Commitments in full to one or more
Persons selected by the Borrower so long as (i) each such Person is either
another Lender or any Affiliate or Related Fund thereof or is otherwise
satisfactory to the Administrative Agent, (ii) such Lender receives payment in
full in cash of the outstanding principal amount of all Loans made by it and all
accrued and unpaid interest thereon and all other amounts due and payable to
such Lender as of the date of such assignment (including, without limitation,
amounts owing pursuant to Sections 2.16, 2.17 and 2.18), (iii) each such Lender
assignee agrees to accept such assignment and to assume all obligations of such
assigning party hereunder in accordance with Section 9.6 and (iv) the costs and
compensation paid by the Borrower under Section 2.16 or Section 2.18 shall be
reduced as a result of such assignment.
(
d
)
The
agreements in this Section 2.16 shall survive the termination of this Agreement
and payment of the Notes and all other amounts payable hereunder.
|
Section
2
.
17
|
Indemnity
.
|
The
Credit Parties hereby agree to indemnify each Lender and to hold such Lender
harmless from any funding loss or expense which such Lender may sustain or incur
as a consequence of (a) default by the Borrower in payment of the principal
amount of or interest on any Loan by such Lender in accordance with the terms
hereof, (b) default by the Borrower in accepting a borrowing after the Borrower
has given a notice in accordance with the terms hereof, (c) default by the
Borrower in making any prepayment after the Borrower has given a notice in
accordance with the terms hereof, and/or (d) the making by the Borrower of a
prepayment of a Loan, or the conversion thereof, on a day which is not the last
day of the Interest Period with respect thereto, in each case including, but not
limited to, any such loss or expense arising from interest or fees payable by
such Lender to lenders of funds obtained by it in order to maintain its Loans
hereunder. A certificate as to any additional amounts payable pursuant to this
Section submitted by any Lender, through the Administrative Agent, to the
Borrower (which certificate must be delivered to the Administrative Agent within
thirty (30) days following such default, prepayment or conversion and shall
include a description of the basis for the computation) shall be conclusive in
the absence of manifest error. The agreements in this Section shall survive
termination of this Agreement and payment of the Notes and all other amounts
payable hereunder.
(
a
)
All
payments made by the Borrower hereunder or under any Note will be, except as
provided in Section 2.18(b), made free and clear of, and without deduction or
withholding for, any present or future taxes, levies, imposts, duties, fees,
assessments or other charges of whatever nature now or hereafter imposed by any
Governmental Authority or by any political subdivision or taxing authority
thereof or therein with respect to such payments (but excluding any tax imposed
on or measured by the net income or profits of a Lender pursuant to the laws of
the jurisdiction in which it is organized or the jurisdiction in which the
principal office or applicable lending office of such Lender is located or any
subdivision thereof or therein) and all interest, penalties or additions to tax
with respect thereto (all such non-excluded taxes, levies, imposts, duties,
fees, assessments or other charges being referred to collectively as
“
Taxes
” and all
such excluded taxes referred to collectively as “
Excluded
Taxes
”). If
any Taxes are so levied or imposed, the Borrower agrees to pay the full amount
of such Taxes, and such additional amounts as may be necessary so that every
payment of all amounts due under this Agreement or under any Note, after
withholding or deduction for or on account of any Taxes, will not be less than
the amount provided for herein or in such Note. The Borrower will furnish to the
Administrative Agent as soon as practicable after the date the payment of any
Taxes is due pursuant to applicable law certified copies (to the extent
reasonably available and required by law) of tax receipts evidencing such
payment by the Borrower or such other evidence of payment reasonably
satisfactory to the Lenders. The Borrower agrees to indemnify and hold harmless
each Lender, and reimburse such Lender upon its written request (which shall
specify in reasonable detail the nature and amount of such Taxes), for the
amount of any Taxes so levied or imposed and paid by such Lender. Nothing
contained in this Section shall require a Lender to make available its tax
returns or provide any information relating to its taxes which it reasonably
deems confidential.
(
b
)
Each
Lender that is not a United States person (as such term is defined in Section
7701(a)(30) of the Code) agrees to deliver to the Borrower and the
Administrative Agent on or prior to the Closing Date, or in the case of a Lender
that is an assignee or transferee of an interest under this Agreement pursuant
to Section 9.6(c) (unless the respective Lender was already a Lender
hereunder immediately prior to such assignment or transfer), on the date of such
assignment or transfer to such Lender, (i) if the Lender is a “bank” within the
meaning of Section 881(c)(3)(A) of the Code, two accurate and complete original
signed copies of Internal Revenue Service Form W-8BEN, W-8ECI or W-8IMY with
appropriate attachments (or successor forms) certifying such Lender’s
entitlement to a complete exemption from United States withholding tax with
respect to payments to be made under this Agreement and under any Note, or (ii)
if the Lender is not a “bank” within the meaning of Section 881(c)(3)(A) of
the Code, Internal Revenue Service Form W-8BEN, W-8ECI or W-8IMY with
appropriate attachments as set forth in clause (i) above, or (x) a certificate
in substantially the form of
Schedule
2.18
(any
such certificate, a “
Tax Exempt
Certificate
”) and
(y) two accurate and complete original signed copies of Internal Revenue Service
Form W-8BEN (or successor form) certifying such Lender’s entitlement to an
exemption from United States withholding tax with respect to payments of
interest to be made under this Agreement and under any Note. Each Lender that is
a United States person as that term is defined in Section 7701(a)(30) of the
Code , other than a Lender that may be treated as an exempt recipient based on
the indicators described in Treasury Regulation Section 1.6049-4(c)(1)(ii),
hereby agrees that it shall, no later than the Closing Date or, in the case of a
Lender that is an assignee or transferee of an interest under this Agreement
pursuant Section 9.6(c), on the date of such assignment or transfer to such
Lender, deliver to the Borrower and the Administrative Agent two accurate,
complete and signed copies of Internal Revenue service Form W-9 or successor
form, certifying that such Lender is not subject to United States backup
withholding tax. In addition, each Lender agrees that it will deliver updated
versions of the foregoing, as applicable, (
A
)
whenever the previous certification has become inaccurate in any material
respect or (
B
) at any
time reasonably requested by the Borrower or the Administrative Agent, together
with such other forms as may be required in order to confirm or establish the
entitlement of such Lender to a continued exemption from or reduction in United
States withholding tax with respect to payments under this Agreement and any
Note. Notwithstanding anything to the contrary contained in Section 2.18(a), but
subject to the immediately succeeding sentence, (x) the Borrower shall be
entitled, to the extent it is required to do so by law, to deduct or withhold
Taxes imposed by the United States (or any political subdivision or taxing
authority thereof or therein) from interest, fees or other amounts payable
hereunder for the account of any Lender to the extent that such Lender has not
provided to the Borrower U.S. Internal Revenue Service Forms that establish a
complete exemption from such deduction or withholding and (y) the Borrower shall
not be obligated pursuant to Section 2.18(a) hereof to gross-up payments to be
made to a Lender in respect of Taxes imposed by the United States or to
indemnify such Lender for any withholding Taxes imposed by the United States if
(I) such Lender has not provided to the Borrower the Internal Revenue Service
Forms required to be provided to the Borrower pursuant to this Section or (II)
in the case of a payment, other than interest, to a Lender described in clause
(ii) above, to the extent that such Forms do not establish a complete exemption
from withholding of such Taxes. Notwithstanding anything to the contrary
contained in the preceding sentence or elsewhere in this Section, the Borrower
agrees to pay additional amounts and to indemnify each Lender in the manner set
forth in Section 2.18(a) (without regard to the identity of the jurisdiction
requiring the deduction or withholding) in respect of any amounts deducted or
withheld by it as described in the immediately preceding sentence as a result of
any changes after the Closing Date in any applicable law, treaty, governmental
rule, regulation, guideline or order, or in the interpretation thereof, relating
to the deducting or withholding of Taxes.
(
c
)
Each
Lender agrees to use reasonable efforts (including reasonable efforts to change
its Domestic Lending Office or LIBOR Lending Office, as the case may be) to
avoid or to minimize any amounts which might otherwise be payable pursuant to
this Section;
provided
,
however
, that
such efforts shall not cause the imposition on such Lender of any additional
costs or legal or regulatory burdens deemed by such Lender in its reasonable
discretion to be material.
(
d
)
If the
Borrower pays any additional amount pursuant to this Section with respect to a
Lender, such Lender shall use reasonable efforts to obtain a refund of tax or
credit against its tax liabilities on account of such payment;
provided
that
such Lender shall have no obligation to use such reasonable efforts if either
(i) it is in an excess foreign tax credit position or (ii) it believes in good
faith, in its sole discretion, that claiming a refund or credit would cause
adverse tax consequences to it. In the event that such Lender receives such a
refund or credit, such Lender shall pay to the Borrower an amount that such
Lender reasonably determines is equal to the net tax benefit obtained by such
Lender as a result of such payment by the Borrower. In the event that no refund
or credit is obtained with respect to the Borrower’s payments to such Lender
pursuant to this, then such Lender shall upon request provide a certification
that such Lender has not received a refund or credit for such payments. Nothing
contained in this Section shall require a Lender to disclose or detail the basis
of its calculation of the amount of any tax benefit or any other amount or the
basis of its determination referred to in the proviso to the first sentence of
this Section to the Borrower or any other party.
(
e
)
The
agreements in this Section shall survive the termination of this Agreement and
the payment of the Notes and all other amounts payable hereunder.
|
Section
2
.
19
|
Indemnification;
Nature of Issuing Lender’s Duties
.
|
(
a
)
In
addition to its other obligations under Section 2.3, each Credit Party
hereby agrees to protect, indemnify, pay and save each Issuing Lender harmless
from and against any and all claims, demands, liabilities, damages, losses,
charges, and reasonable out of pocket costs and expenses (including reasonable
attorneys’ fees) that the Issuing Lender may incur or be subject to as a
consequence, direct or indirect, of (i) the issuance of any Letter of Credit or
(ii) the failure of the Issuing Lender to honor a drawing under a Letter of
Credit as a result of any act or omission, whether rightful or wrongful, of any
present or future de jure or de facto government or governmental authority (all
such acts or omissions, herein called “
Government
Acts
”).
(
b
)
As
between the Credit Parties, the Issuing Lender and each Lender, the Credit
Parties shall assume all risks of the acts, omissions or misuse of any Letter of
Credit by the beneficiary thereof. Neither the Issuing Lender nor any Lender
shall be responsible for: (i) the form, validity, sufficiency, accuracy,
genuineness or legal effect of any document submitted by any party in connection
with the application for and issuance of any Letter of Credit, even if it should
in fact prove to be in any or all respects invalid, insufficient, inaccurate,
fraudulent or forged; (ii) the validity or sufficiency of any instrument
transferring or assigning or purporting to transfer or assign any Letter of
Credit or the rights or benefits thereunder or proceeds thereof, in whole or in
part, that may prove to be invalid or ineffective for any reason; (iii) failure
of the beneficiary of a Letter of Credit to comply fully with conditions
required in order to draw upon a Letter of Credit; (iv) errors, omissions,
interruptions or delays in transmission or delivery of any messages, by mail,
cable, telegraph, telex or otherwise, whether or not they be in cipher;
(v) errors in interpretation of technical terms; (vi) any loss or delay in
the transmission or otherwise of any document required in order to make a
drawing under a Letter of Credit or of the proceeds thereof; and (vii) any
consequences arising from causes beyond the control of the Issuing Lender or any
Lender, including, without limitation, any Government Acts. None of the above
shall affect, impair, or prevent the vesting of the Issuing Lender’s rights or
powers hereunder.
(
c
)
In
furtherance and extension and not in limitation of the specific provisions
hereinabove set forth, any action taken or omitted by the Issuing Lender or any
Lender, under or in connection with any Letter of Credit or the related
certificates, if taken or omitted in good faith, shall not put such Issuing
Lender or such Lender under any resulting liability to the Borrower. It is the
intention of the parties that this Agreement shall be construed and applied to
protect and indemnify the Issuing Lender and each Lender against any and all
risks involved in the issuance of the Letters of Credit, all of which risks are
hereby assumed by the Credit Parties, including, without limitation, any and all
risks of the acts or omissions, whether rightful or wrongful, of any
Governmental Authority. The Issuing Lender and the Lenders shall not, in any
way, be liable for any failure by the Issuing Lender or anyone else to pay any
drawing under any Letter of Credit as a result of any Government Acts or any
other cause beyond the control of the Issuing Lender and the
Lenders.
(
d
)
Nothing
in this Section 2.19 is intended to limit the reimbursement obligation of the
Borrower contained in Section 2.3(d) hereof. The obligations of the Credit
Parties under this Section 2.19 shall survive the termination of this Agreement.
No act or omissions of any current or prior beneficiary of a Letter of Credit
shall in any way affect or impair the rights of the Issuing Lender to enforce
any right, power or benefit under this Agreement.
(
e
)
Notwithstanding
anything to the contrary contained in this Section 2.19, the Credit Parties
shall have no obligation to indemnify any Issuing Lender or any Lender in
respect of any liability incurred by such Issuing Lender or such Lender arising
out of the gross negligence or willful misconduct of the Issuing Lender or such
Lender (including action not taken by an Issuing Lender), as determined by a
court of competent jurisdiction pursuant to a final non-appealable
judgment.
ARTICLE
III
REPRESENTATIONS AND
WARRANTIES
To induce
the Lenders to enter into this Agreement and to make the Extensions of Credit
herein provided for, the Company and its Subsidiaries hereby represent and
warrant to the Administrative Agent and each Lender that:
|
Section
3
.
1
|
Financial
Condition
.
|
The
Borrower has delivered to the Administrative Agent and the Lenders (a) balance
sheets and the related statements of income and of cash flows of (i) the
Company and its Subsidiaries for the fiscal years ended December 31, 2003,
December 31, 2004 and December 31, 2005 audited by Ernst & Young,
LLP
and
(ii) the Acquired Company and its Subsidiaries for the fiscal years ended
December 31, 2003, December 31, 2004 and December 31, 2005 audited
by
Carlin,
Charron & Rosen, LLP, (b) a company-prepared unaudited balance sheet and the
related statement of income and of cash flow of the Borrower for fiscal years
ended December 31, 2004 and December 31, 2005, (c) company-prepared
unaudited balance sheets and related statements of income and cash flows for the
Company, the Borrower and the Acquired Company and their respective Subsidiaries
for that portion of the fiscal year commencing on January 1, 2006 through the
month most recently ended prior to the Closing Date (
provided
that if
the Closing Date shall occur prior to the twentieth day of any month, then such
financial statements shall be provided as of the end of the month immediately
preceding the most recent month end), (d) good faith estimated (subject
only to completion of purchase price accounting and other related adjustments)
pro forma unaudited balance sheets of the Company and its Subsidiaries and the
Borrower and its Subsidiaries as of the last day of the month most recently
ended prior to the Closing Date (
provided
that if
the Closing Date shall occur prior to the twentieth day of any month, then such
financial statements shall be provided as of the end of the month immediately
preceding the most recent month end), in each case prepared giving effect to the
Acquisition and the initial Extensions of Credit made hereunder on a Pro Forma
Basis and in form and substance reasonably satisfactory to the Administrative
Agent and (e) the seven-year projections of the Company and the Borrower, in
form and substance reasonably satisfactory to the Administrative Agent. The
financial statements referred to in subsections (a)-(d) above are complete and
correct and present fairly the financial condition of the Company, the Borrower,
the Acquired Company and their respective Subsidiaries as of such dates, subject
in the case of unaudited financials to the absence of footnotes and immaterial
year end adjustments. All such financial statements and projections, including
the related schedules and notes thereto, have been prepared in accordance with
GAAP applied consistently throughout the periods involved (except as disclosed
therein).
|
Section
3
.
2
|
No
Change
.
|
Since
December 31, 2005 there has been no development or event which has had or could
reasonably be expected to have a Material Adverse Effect and no Internal Control
Event has occurred.
|
Section
3
.
3
|
Corporate Existence;
Compliance with Law
.
|
Each of
the Credit Parties (a) is duly organized, validly existing and in good standing
under the laws of the jurisdiction of its incorporation, organization or
formation, (b) has the requisite power and authority and the legal right to own
and operate all its property, to lease the property it operates as lessee and to
conduct the business in which it is currently engaged and has taken all actions
necessary to maintain all rights, privileges, licenses and franchises necessary
or required in the normal conduct of its business, except to the extent that the
failure to do so could not, individually or in the aggregate, reasonably be
expected to have a Material Adverse Effect, (c) is duly qualified to conduct
business and is in good standing under the laws of (
i
) the
jurisdiction of its organization or formation and (
ii
) each
other jurisdiction where its ownership, lease or operation of property or the
conduct of its business requires such qualification except to the extent that
the failure to so qualify or be in good standing could not, individually or in
the aggregate, reasonably be expected to have a Material Adverse Effect and (d)
is in compliance with all Requirements of Law except to the extent that the
failure to comply therewith could not, in the aggregate, reasonably be expected
to have a Material Adverse Effect. Without limiting the generality of the
foregoing, each of the Credit Parties represents that:
(
i
)
(A) To
the knowledge of any Responsible Officer of any Credit Party, there is no Credit
Party or individual employed by such Credit Party who may reasonably be expected
to have criminal culpability or to be excluded or suspended from participation
in any Medical Reimbursement Program for their corporate or individual actions
or failures to act where such culpability, exclusion and/or suspension has or
could be reasonably expected to result in a Material Adverse Effect; and (B)
there is no member of management continuing to be employed by any Credit Party
who may reasonably be expected to have individual culpability for matters under
investigation by any Governmental Authority where such culpability has or could
reasonably be expected to result in a Material Adverse Effect unless such member
of management has been, within a reasonable period of time after discovery of
such actual or potential culpability, either suspended or removed from positions
of responsibility related to those activities under challenge by the
Governmental Authority;
(
ii
)
current
billing policies, arrangements, protocols and instructions comply with expressly
stated requirements of Medical Reimbursement Programs and are administered by
properly trained personnel except where any such failure to comply could not
reasonably be expected to result in a Material Adverse Effect;
(
iii
)
current
medical director compensation arrangements and other arrangements with referring
physicians comply with state and federal self-referral and anti-kickback laws,
including without limitation 42 U.S.C. Section 1320a-7b(b)(1) - (b)(2) and 42
U.S.C. Section 1395nn, except where any such failure to comply could not
reasonably be expected to result in a Material Adverse Effect;
(
iv
)
none of
the Credit Parties is currently, nor has in the past been subject to any
federal, state, local governmental or private payor civil or criminal
inspections, investigations, inquiries or audits involving and/or related to its
activities, except for routine inspections, investigations, inquiries or audits
in the ordinary course not anticipated to result in a Material Adverse Effect;
and
(
v
)
except as
set forth on
Schedule
3.3
, no
Credit Party: (
A
) has had
a civil monetary penalty assessed against it pursuant to 42 U.S.C. §1320a 7a,
(
B
) has
been excluded from participation in a Federal Health Care Program (as that term
is defined in 42 U.S.C. §1320a 7b), (
C
) has
been convicted (as that term is defined in 42 C.F.R. §1001.2) of any of those
offenses described in 42 U.S.C. §1320a 7b or 18 U.S.C. §§669, 1035, 1347, 1518,
or (
D
) to the
knowledge of any Responsible Officer, has been involved or named in a U.S.
Attorney complaint made or any other action taken pursuant to the False Claims
Act under 31 U.S.C. §§3729 3731 or qui tam action brought pursuant to 31 U.S.C.
§3729 et seq.
|
Section
3
.
4
|
Corporate Power;
Authorization; Enforceable Obligations
.
|
Each of
the Credit Parties has full power and authority and the legal right to make,
deliver and perform the Credit Documents to which it is party and has taken all
necessary limited liability company or corporate or other action to authorize
the execution, delivery and performance by it of the Credit Documents to which
it is party. No consent or authorization of, filing with, notice to or other act
by or in respect of, any Governmental Authority or any other Person is required
in connection with the borrowings hereunder or with the execution, delivery or
performance of any Credit Document by the Credit Parties (other than those which
have been obtained) or with the validity or enforceability of any Credit
Document against the Credit Parties (except such filings as are necessary in
connection with the perfection of the Liens created by such Credit Documents).
This Credit Agreement has been, and each other Credit Document when delivered
hereunder will have been, duly executed and delivered on behalf of each of the
Credit Parties party thereto. Each Credit Document to which it is a party
constitutes a legal, valid and binding obligation of each of the Credit Parties,
enforceable against such Credit Party in accordance with its terms, except as
enforceability may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting the enforcement of
creditors’ rights generally and by general equitable principles (whether
enforcement is sought by proceedings in equity or at law).
|
Section
3
.
5
|
Status Under Certain
Statutes
.
|
No Credit
Party is (i) required to be registered as an “investment company”, or
“controlled” by a Person that is required to be registered as an “investment
company”, under the Investment Company Act of 1940, as amended, or (ii) subject
to regulation under any federal or state statute or regulation limiting its
ability to incur the Credit Party Obligations.
|
Section
3
.
6
|
Margin
Regulations
.
|
No part
of the proceeds of any Loan hereunder will be used directly or indirectly for
any purpose which does not comply with the provisions of Regulation T, U or X of
the Board of Governors of the Federal Reserve System as now and from time to
time hereafter in effect. The Company and its Subsidiaries taken as a group do
not own “margin stock” except as identified in the financial statements referred
to in Section 3.1 and the aggregate value of all “margin stock” owned by the
Company and its Subsidiaries taken as a group does not exceed 25% of the value
of their assets.
|
Section
3
.
7
|
No Legal Bar; No
Default
.
|
The
execution, delivery and performance of the Credit Documents, the borrowings
thereunder and the use of the proceeds of the Loans (
a
) will
not violate any Requirement of Law in any material respect or any material
Contractual Obligation of any Credit Party (except those as to which waivers or
consents have been obtained), (
b
) will
not conflict with, result in a breach of or constitute a default under the
articles of incorporation, bylaws, articles of organization, operating agreement
or other organization documents of the Credit Parties or any Material Contract
to which such Person is a party or by which any of its properties may be bound
or any material approval or material consent from any Governmental Authority
relating to such Person, and (
c
) will
not result in, or require, the creation or imposition of any Lien on any Credit
Party’s properties or revenues pursuant to any Requirement of Law or Contractual
Obligation other than the Liens arising under or contemplated in connection with
the Credit Documents or Permitted Liens. No Credit Party is in default under or
with respect to any of its material Contractual Obligations in any material
respect. No Default or Event of Default has occurred and is
continuing.
|
Section
3
.
8
|
No Material
Litigation
.
|
As of the
Closing Date, set forth on
Schedule
3.8
is a
description of any material litigation, investigation, claim, criminal
prosecution, civil investigative demand, criminal or civil fine and penalty, or
other proceeding of or before any arbitrator or Governmental Authority
(including but not limited to those regulatory agencies responsible for
licensing, accrediting or issuing Medicare or Medicaid certifications) that is
pending or, to the best knowledge of any Responsible Officer, threatened by or
against the Company or any of its Subsidiaries or against any of its or their
respective properties or revenues. No litigation, investigation, claim, criminal
prosecution, civil investigative demand, imposition of criminal or civil fines
and penalties, or any other proceeding of or before any arbitrator or
Governmental Authority (including but not limited to those regulatory agencies
responsible for licensing, accrediting or issuing Medicare or Medicaid
certifications) is pending or, to the best knowledge of any Responsible Officer,
threatened by or against the Company or any of its Subsidiaries or against any
of its or their respective properties or revenues (a) with respect to the Credit
Documents or any Loan or any of the transactions contemplated hereby, or (b)
which could reasonably be expected to be adversely determined and if so
adversely determined could reasonably be expected to have, individually or in
the aggregate, a Material Adverse Effect.
No
Reportable Event that could reasonably be expected to result in a Material
Adverse Effect, and no “accumulated funding deficiency” (within the meaning of
Section 412 of the Code or Section 302 of ERISA), has occurred during the
five-year period prior to the date on which this representation is made or
deemed made with respect to any Single Employer Plan. Each Single Employer Plan
has complied in all material respects with the applicable provisions of ERISA
and the Code. No termination of a Single Employer Plan has occurred resulting in
any liability that has remained underfunded. No Lien in favor of a Single
Employer Plan or in favor of the PBGC with respect to a Single Employer Plan has
arisen, during the five-year period prior to the date on which this
representation is made or deemed made with respect to any Single Employer Plan
(other than a Lien with respect to a liability which has been satisfied in
full). The present value of all accrued benefits under each Single Employer Plan
(based on those assumptions used to fund such Plans) did not, as of the last
annual valuation date prior to the date on which this representation is made or
deemed made, exceed the value of the assets of such Plan allocable to such
accrued benefits, except to the extent that such underfunding could not
reasonably be expected to result in a Material Adverse Effect. Neither any
Credit Party nor any Commonly Controlled Entity has any outstanding liability
for a complete or partial withdrawal from a Multiemployer Plan, except to the
extent such liability could not reasonably be expected to result in a Material
Adverse Effect.
|
Section
3
.
10
|
Environmental
Matters
.
|
Except as
could not reasonably be expected to have a Material Adverse Effect:
(
a
)
The
facilities and properties owned, leased or operated by the Company or any of its
Subsidiaries (the “
Properties
”) do not
contain any Materials of Environmental Concern in amounts or concentrations that
constitute a violation of or a liability under, any Environmental
Law.
(
b
)
The
Properties, all operations of the Company and/or its Subsidiaries at the
Properties, and the business operated by the Company or any of its Subsidiaries
(the “
Business
”) are in
compliance, and have in the last two years been in compliance, with all
applicable Environmental Laws.
(
c
)
Neither
the Company nor any of its Subsidiaries has received any written notice of
violation, alleged violation, non-compliance, liability or potential liability
regarding environmental matters or compliance with Environmental Laws with
regard to any of the Properties or the Business, nor does any Responsible
Officer of the Company or any of its Subsidiaries have knowledge that any such
notice will be received or is being threatened.
(
d
)
Materials
of Environmental Concern have not been transported or disposed of from the
Properties by the Company or any of its Subsidiaries in violation of any
Environmental Law, and neither the Company nor any of its Subsidiaries has
received any written notice of any liability or potential liability for any
Materials of Environmental Concern transported or disposed of from the
Properties by the Company or any of its Subsidiaries. Materials of Environmental
Concern have not been generated, treated, stored or disposed of by the Company
or any of its Subsidiaries at, on or under any of the Properties in violation of
any applicable Environmental Law, and neither the Company nor any of its
Subsidiaries is liable for any Materials of Environmental Concern that have been
generated, treated, stored or disposed of at, on or under any of the
Properties.
(
e
)
No
judicial proceeding or governmental or administrative action is pending or, to
the knowledge of any Responsible Officer, threatened, under any Environmental
Law to which the Company or any Subsidiary is or, with respect to any threatened
proceeding or action, is reasonably expected to become a party with respect to
the Properties or the Business, nor are there any governmental consent decrees,
consent orders or administrative orders with respect to which the Company or any
of its Subsidiaries is a party, or other administrative or judicial requirements
applicable to the Company or any of its Subsidiaries outstanding under any
Environmental Law with respect to the Properties or the Business.
(
f
)
There has
been no release of Materials of Environmental Concern by the Company or any of
its Subsidiaries or for which the Company or any of its Subsidiaries is liable
at or from the Properties, or arising from or related to the operations of the
Company or any of its Subsidiaries in connection with the Properties or
otherwise in connection with the Business, in violation of, or in amounts or in
a manner that give rise to liability, under Environmental Laws, except for any
such release that has been remediated in accordance with applicable
Environmental Laws.
|
Section
3
.
11
|
Use of
Proceeds
.
|
The
proceeds of the Extensions of Credit shall be used solely by the Borrower to
(
i
) finance
a portion of the Acquisition, (
ii
) pay any
fees and expenses in connection with the Acquisition, (
iii
) pay any
fees and expenses owing to the Lenders and the Administrative Agent in
connection with this Agreement and the other Credit Documents (including those
under the Fee Letters), (
iv
)
refinance certain existing indebtedness of the Company and its Subsidiaries, and
(
v
) provide
for working capital, capital expenditures and other general corporate purposes
of the Borrower and its Subsidiaries, including, without limitation, Permitted
Acquisitions.
|
Section
3
.
12
|
Subsidiaries
.
|
Set forth
on
Schedule
3.12
is a
complete and accurate list of all direct and indirect Subsidiaries of the
Company as of the Closing Date. Information on the attached Schedule includes
jurisdiction of incorporation or organization; the number of shares of each
class of Capital Stock or other equity interests outstanding; the number and
percentage of outstanding shares of each class of Capital Stock held by each
shareholder; and the number and effect, if exercised, of all outstanding
options, warrants, rights of conversion or purchase and similar rights. The
outstanding Capital Stock and other equity interests of all such Subsidiaries is
validly issued, fully paid and non-assessable and is owned, free and clear of
all Liens (other than those arising under or contemplated in connection with the
Credit Documents). There are no outstanding subscriptions, options, warrants,
calls, rights or other agreements or commitments (other than stock options
granted to employees or directors, directors’ qualifying shares or arrangements
with respect to the purchase of the remaining ownership interest in German Breg
as contemplated in the German Buyout) of any nature relating to any Capital
Stock of the Company or any Subsidiary, except as contemplated in connection
with the Credit Documents.
|
Section
3
.
13
|
Ownership
.
|
Each of
the Company and its Subsidiaries is the owner of, and has good and insurable
title (in the case of real property) to or an indefeasible leasehold interest
in, all of its respective assets and none of such assets are subject to any Lien
on such party’s interest other than Permitted Liens. Each Credit Party and its
Subsidiaries enjoys peaceful and undisturbed possession under all of its leases
and all such leases are valid and subsisting and in full force and effect.
|
Section
3
.
14
|
Indebtedness
.
|
Except as
otherwise permitted under Section 6.1, the Company and its Subsidiaries have no
Indebtedness.
Each of
the Company and its Subsidiaries has filed, or caused to be filed, all tax
returns required to be filed and paid (a) all amounts of taxes shown thereon to
be due (including interest and penalties) and (b) all other taxes, fees,
assessments and other governmental charges (including mortgage recording taxes,
documentary stamp taxes and intangibles taxes) owing by it, except for such
taxes (i) that are not yet delinquent or (ii) that are being contested in good
faith and by proper proceedings, and against which adequate reserves are being
maintained in accordance with GAAP. Neither the Company nor any of its
Subsidiaries are aware as of the Closing Date of any proposed tax assessments
against it or any of its Subsidiaries that, individually or in the aggregate,
could reasonably be expected to have a Material Adverse Effect.
|
Section
3
.
16
|
Intellectual
Property
.
|
To the
knowledge of any Responsible Officer, each of the Company and its Subsidiaries
owns, or has the legal right to use, all material Intellectual Property
necessary for each of them to conduct its business as currently conducted. Set
forth on
Schedule
3.16
is a
list of all material Intellectual Property (excluding unregistered trademarks to
the extent not used or not reasonably identifiable by the Credit Parties) owned
by the Credit Parties or that any Credit Party has the right to use (excluding
standard “off the shelf” licensed software used in the ordinary course of
business). To the knowledge of any Responsible Officer, except pursuant to a
license agreement disclosed in
Schedule
3.16
hereto,
or as otherwise disclosed in
Schedule
3.16
hereto,
(a) the Credit Parties have the right to use the Intellectual Property disclosed
in
Schedule
3.16
hereto
in perpetuity and without payment of royalties, and (b) all registrations with
and applications to Governmental Authorities in respect of such Intellectual
Property are valid or subsisting and in full force and effect and are not
subject to the payment of any taxes or maintenance fees or the taking of any
interest therein, held by the Company or any of its Subsidiaries to maintain
their validity or effectiveness in any material respects. To the knowledge of
any Responsible Officer, neither the Company nor any of its Subsidiaries is in
default (or with the giving of notice or lapse of time or both, would be in
default) under any license to use any material Intellectual Property; other than
as noted on
Schedule
3.16
, no
claim has been asserted in writing and is pending by any Person, in any material
respects, seeking to restrict or deny the use of any material Intellectual
Property or the validity or effectiveness of any such Intellectual Property, nor
does any Responsible Officer know of any such claim; and, to the knowledge of
any Responsible Officer, the use of any material Intellectual Property by the
Company or any of its Subsidiaries does not infringe on the rights of any
Person.
Schedule
3.16
may be
updated from time to time by the Borrower to include new Intellectual Property
by giving written notice thereof to the Administrative Agent.
|
Section
3
.
17
|
Solvency
.
|
Each of
the Credit Parties is Solvent.
|
Section
3
.
18
|
Investments
.
|
All
Investments of each of the Company and its Subsidiaries are Permitted
Investments.
|
Section
3
.
19
|
Location of
Collateral
.
|
Set forth
on
Schedule
3.19(a)
is a
list of the domestic real Properties (whether owned or leased) of the Credit
Parties as of the Closing Date with street address, county and state where
located. Set forth on
Schedule
3.19(b)
is a
list of all locations where any domestic tangible personal property of the
Credit Parties with a fair market value in excess of $250,000 is located as of
the Closing Date (other than trade show booths and related assets and tangible
personal property in transit, held by sales representatives or on consignment
with third parties), including county and state where located. Set forth on
Schedule
3.19(c)
is the
state of incorporation or organization, chief executive office, the principal
place of business, the tax identification number and organization identification
number of each of the Credit Parties as of the Closing Date. Set forth on
Schedule
3.19(d)
is a
list of all Mortgaged Properties as of the Closing Date.
|
Section
3
.
20
|
No Burdensome
Restrictions
.
|
Neither
the Company nor any of its Subsidiaries is a party to any agreement or
instrument or subject to any other obligation or any charter or corporate
restriction or any provision of any applicable law, rule or regulation that,
individually or in the aggregate, could reasonably be expected to have a
Material Adverse Effect.
|
Section
3
.
21
|
Labor
Matters
.
|
Except as
otherwise set forth in
Schedule
3.21
hereto,
as of the Closing Date, (a) there are no collective bargaining agreements or
Multiemployer Plans covering the employees of the Company or any of its
Subsidiaries, (b) neither the Company nor any of its Subsidiaries has suffered
any material strikes, walkouts, work stoppages or other material labor
difficulty within the last five years, (c) no Responsible Officer of the Company
or any of its Subsidiaries has knowledge of any material potential or pending
strike, walkout or work stoppage and (d) no material unfair labor practice
complaint is pending or, to the best knowledge of any Responsible Officer,
threatened against the Company or any of its Subsidiaries before any
Governmental Authority.
|
Section
3
.
22
|
Security
Documents
.
|
The
Security Documents create (or will create upon the execution and delivery
thereof) valid security interests in, and Liens on, the Collateral purported to
be covered thereby, which security interests and Liens are currently (or will be
upon the execution and delivery of the Security Documents and upon the filing of
appropriate financing statements, the recordation of the applicable Mortgage
Instruments, the filing of appropriate notices with the United States Patent and
Trademark Office and the United States Copyright Office, in each case in favor
of the Administrative Agent, on behalf of the Lenders) perfected security
interests and Liens, prior to all other Liens other than Permitted Liens that
would be prior to the Liens in favor of the Administrative Agent as a matter of
law.
|
Section
3
.
23
|
Accuracy and
Completeness of Information
.
|
All
factual written information (other than written financial projections)
heretofore, contemporaneously or hereafter furnished by or on behalf of any
Credit Party or any of its Subsidiaries to the Administrative Agent or any
Lender for purposes of or in connection with this Agreement or any other Credit
Document, or any transaction contemplated hereby or thereby, is or will be true
and accurate in all material respects and not incomplete by omitting to state
any material fact necessary to make such information not misleading. The written
financial projections concerning the Company and its Subsidiaries heretofore,
contemporaneously or hereafter furnished by or on behalf of any Credit Party or
any of its Subsidiaries to the Administrative Agent or any Lender for purposes
of or in connection with this Agreement or any other Credit Document, or any
transaction contemplated hereby or thereby, have been and will be prepared in
good faith based upon assumptions that the Credit Parties believe to be
reasonable at the time of such preparation. There is no fact now known to the
Borrower, any other Credit Party or any of their Subsidiaries which has, or
could reasonably be expected to have, a Material Adverse Effect, which fact has
not been set forth herein, in the financial statements of the Company and its
Subsidiaries furnished to the Administrative Agent and/or the Lenders, or in any
opinion or other written statement made or furnished by any Credit Party to the
Administrative Agent and/or the Lenders.
|
Section
3
.
24
|
Fraud and
Abuse
.
|
To the
knowledge of any Responsible Officer, neither the Company and its Subsidiaries
nor any of their officers or directors, have engaged in any activities which are
prohibited under federal Medicare and Medicaid statutes, 42 U.S.C. §1320a-7b, or
42 U.S.C. §1395nn or the regulations promulgated pursuant to such statutes or
related state or local statutes or regulations, or which are prohibited by
binding rules of professional conduct, including but not limited to the
following: (a) knowingly and willfully making or causing to be made a false
statement or representation of a material fact in any applications for any
benefit or payment; (b) knowingly and willfully making or causing to be
made any false statement or representation of a material fact for use in
determining rights to any benefit or payment; (c) failing to disclose knowledge
by a claimant of the occurrence of any event affecting the initial or continued
right to any benefit or payment on its own behalf or on behalf of another with
the intent to secure such benefit or payment fraudulently; (d) knowingly and
willfully soliciting or receiving any remuneration (including any kickback,
bribe or rebate), directly or indirectly, overtly or covertly, in cash or in
kind or offering to pay such remuneration (i) in return for referring an
individual to a Person for the furnishing or arranging for the furnishing of any
item or service for which payment may be made in whole or in part by Medicare,
Medicaid or other applicable third party payors, or (ii) in return for
purchasing, leasing or ordering or arranging for or recommending the purchasing,
leasing or ordering of any good, facility, service, or item for which payment
may be made in whole or in part by Medicare, Medicaid or other applicable third
party payors, except in each case for any such prohibited activity that could
not reasonably be expected to result in a Material Adverse Effect.
|
Section
3
.
25
|
Licensing and
Accreditation
.
|
Each of
the Company and its Subsidiaries has, to the extent applicable: (
a
)
obtained and maintains in good standing all required licenses; (
b
) to the
extent prudent and customary in the industry in which it is engaged, obtained
and maintains accreditation from all generally recognized accrediting agencies;
(
c
)
obtained and maintains Medicaid Certification and Medicare Certification; and
(
d
) entered
into and maintains in good standing its Medicare Provider Agreement and its
Medicaid Provider Agreement, except in each case to the extent the absence of
such license, accreditation, certification or good standing could not reasonably
be expected to have a Material Adverse Effect. All such required licenses are in
full force and effect on the date hereof and have not been revoked or suspended
or otherwise limited, except in each case to the extent such revocation,
suspension or other limitation could not reasonably be expected to have a
Material Adverse Effect.
|
Section
3
.
26
|
Other Regulatory
Protection
.
|
Each of
the Company and its Subsidiaries represent that it does not manufacture
pharmaceutical products and is in compliance with all applicable rules,
regulations and other requirements of the Food and Drug Administration
(“
FDA
”), the
Federal Trade Commission (“
FTC
”), the
Occupational Safety and Health Administration (“
OSHA
”), the
Consumer Product Safety Commission, the United States Customs Service and the
United States Postal Service and other state or federal regulatory authorities
or jurisdictions in which the Company or any of its Subsidiaries do business or
distribute and market products, except to the extent that any such
noncompliance, individually or in the aggregate, could not reasonably be
expected to have a Material Adverse Effect. Neither the FDA, the FTC, OSHA, the
Consumer Product Safety Commission, nor any other such regulatory authority has
requested (or, to the knowledge of any Responsible Officer, are considering
requesting) any product recalls or other enforcement actions that (a) if not
complied with, individually or in the aggregate, could reasonably be expected to
result in a Material Adverse Effect and (b) with which the Company and its
Subsidiaries have not complied within the time period allowed.
|
Section
3
.
27
|
Reimbursement from
Third Party Payors
.
|
The
accounts receivable of the Company and its Subsidiaries have been and will
continue to be adjusted to reflect the reimbursement policies (both those most
recently published in writing as well as those not in writing which have been
verbally communicated) of third party payors such as Medicare, Medicaid, Blue
Cross/Blue Shield, private insurance companies, health maintenance
organizations, preferred provider organizations, alternative delivery systems,
managed care systems, government contacting agencies and other third party
payors. In particular, accounts receivable relating to third party payors do not
and shall not exceed amounts any obligee is entered to receive under any
capitation arrangement, fee schedule, discount formula, cost-based reimbursement
or other adjustment or limitation to its usual charges.
|
Section
3
.
28
|
Other
Agreements
.
|
No Credit
Party is in default in the performance, observance or fulfillment of any of the
obligations, covenants or conditions contained in (
a
) any
Medicaid Provider Agreement, Medicare Provider Agreement or other agreement or
instrument to which such Person is a party, which default has resulted in, or if
not remedied within any applicable grace period could result in, the revocation,
termination, cancellation or material suspension of Medicaid Certification or
Medicare Certification of any such Person or (
b
) any
other agreement or instrument to which any such Person is a party, which
default, individually or in the aggregate, has, or if not remedied within any
applicable grace period could reasonably be expected to have, a Material Adverse
Effect.
|
Section
3
.
29
|
Material
Contracts
.
|
Schedule
3.29
sets
forth a true and correct and complete list of all Material Contracts currently
in effect. All of the Material Contracts are in full force and effect and no
material defaults exist thereunder.
|
Section
3
.
30
|
Insurance
.
|
The
insurance coverage of the
Credit
Parties and, with respect to the general insurance coverage of the Company and
its Subsidiaries, the Foreign Subsidiaries
is
outlined as to carrier, policy number, expiration date, type and amount on
Schedule
3.30
and such
insurance coverage complies with the requirements set forth in Section
5.5(b).
|
Section
3
.
31
|
Classification as
Senior Indebtedness
.
|
The
Credit Party Obligations constitute “Senior Indebtedness” under and as may be
defined in any agreement governing any outstanding Subordinated Indebtedness and
the subordination provisions set forth in each such agreement are legally valid
and enforceable against the parties thereto.
|
Section
3
.
32
|
Tax Shelter
Regulations
.
|
The
Borrower does not intend to treat the Loans or Letters of Credit
and
related transactions
as being
a “reportable transaction” (within the meaning of Treasury Regulation
Section 1.6011-4). In the event the Borrower determines to take any action
inconsistent with such intention, it will promptly notify the Administrative
Agent thereof. If the Borrower so notifies the Administrative Agent, the
Borrower acknowledges that one or more of the Lenders may treat its Loans and/or
Letters of Credit as part of a transaction that is subject to Treasury
Regulation Section 301.6112-1, and such Lender or Lenders, as applicable, will
maintain the lists and other records required by such treasury
regulation.
|
Section
3
.
33
|
Regulation
H
.
|
No
Mortgaged Property is a Flood Hazard Property.
|
Section
3
.
34
|
Anti-Terrorism
Laws
.
|
Neither
any Credit Party nor any of its Subsidiaries is an “enemy” or an “ally of the
enemy” within the meaning of Section 2 of the Trading with the Enemy Act of the
United States of America (50 U.S.C. App. §§ 1
et seq
.), as
amended. Neither any Credit Party nor any or its Subsidiaries is in violation of
(a) the Trading with the Enemy Act, as amended, (b) any of the foreign assets
control regulations of the United States Treasury Department (31 CFR, Subtitle
B, Chapter V, as amended) or any enabling legislation or executive order
relating thereto or (c) the Patriot Act. None of the Credit Parties (i) is a
blocked person described in Section 1 of the Executive Order Number 13224
(Anti-Terrorism Order) or (ii) to the knowledge of any Responsible Officer,
engages in any dealings or transactions, or is otherwise associated, with any
such blocked person.
|
Section
3
.
35
|
Compliance with OFAC
Rules and Regulations
.
|
None of
the Credit Parties or their Subsidiaries or, to the knowledge of any Responsible
Officer, their respective Affiliates (a) is a Sanctioned Person,
(b) has more than 15% of its assets in Sanctioned Countries, or
(c) derives more than 15% of its operating income from investments in, or
transactions with Sanctioned Persons or Sanctioned Countries. No part of the
proceeds of any Extension of Credit hereunder will be used directly or
indirectly to fund any operations in, finance any investments or activities in
or make any payments to, a Sanctioned Person or a Sanctioned
Country.
|
Section
3
.
36
|
Compliance with
FCPA
.
|
Each of
the Credit Parties and their Subsidiaries is in compliance with the Foreign
Corrupt Practices Act, 15 U.S.C. §§ 78dd-1,
et seq.
, and, to
the knowledge of any Responsible Officer, any foreign counterpart thereto. None
of the Credit Parties or their Subsidiaries has made a payment, offering, or
promise to pay, or authorized the payment of, money or anything of value
(a) in order to assist in obtaining or retaining business for or with, or
directing business to, any foreign official, foreign political party, party
official or candidate for foreign political office, (b) to a foreign
official, foreign political party or party official or any candidate for foreign
political office, and (c) with the intent to induce the recipient to misuse
his or her official position to direct business wrongfully to such Credit Party
or its Subsidiary or to any other Person, in violation of the Foreign Corrupt
Practices Act, 15 U.S.C. §§ 78dd-1,
et seq.
ARTICLE
IV
CONDITIONS
PRECEDENT
|
Section
4
.
1
|
Conditions to Closing
Date and Initial Extensions of Credit
.
|
This
Agreement shall become effective upon, and the obligation of each Lender to make
the initial Revolving Loans and the Term Loans on the Closing Date is subject
to, the satisfaction of the following conditions precedent:
(
a
)
Execution of
Agreements
. The
Administrative Agent shall have received (
i
)
counterparts of this Agreement from each party hereto, (
ii
) for the
account of each applicable Lender, a Revolving Note and a Term Note from the
Borrower, (
iii
) for the
account of each Swingline Lender, the Swingline Note from the Borrower,
(
iv
)
counterparts of the Security Agreement, and the Pledge Agreement, each Mortgage
Instrument and the other Security Documents from each Credit Party party thereto
and (
v
)
executed consents, in the form of
Schedule
4.1-3
from
each Lender authorizing the Administrative Agent to enter this Credit Agreement
on their behalf, in each case conforming to the requirements of this Agreement
and executed by a duly authorized officer of each party thereto, and in each
case in form and substance reasonably satisfactory to the Administrative Agent.
(
b
)
Authority
Documents
. The
Administrative Agent shall have received the following:
(
i
)
Articles of
Incorporation/Organizational Documents
. Copies
of the articles of incorporation, certificate of incorporation or other
organizational documents, as applicable, of each Credit Party, certified (other
than with respect to the Company, Colgate, Victory, Swiftsure and UK Ltd) to be
true and complete as of a recent date by the appropriate Governmental Authority
of the jurisdiction of its incorporation or organization, as the case may
be.
(
ii
)
Resolutions
. Copies
of resolutions of the board of directors (or comparable group and, where
applicable, the shareholders or members) of each Credit Party approving and
adopting the Credit Documents, the transactions contemplated therein and
authorizing execution and delivery thereof, certified by a secretary or
assistant secretary of such Credit Party (pursuant to a secretary’s certificate
in substantially the form of
Schedule
4.1-1
attached
hereto) as of the Closing Date to be true and correct and in force and effect as
of such date.
(
iii
)
Bylaws/Operating
Agreement
. A copy
of the bylaws, memorandum and articles of association, limited liability company
agreement or comparable operating agreement of each Credit Party (other than the
Company) certified by a secretary or assistant secretary of such Credit Party
(pursuant to a secretary’s certificate in substantially the form of
Schedule
4.1-1
attached
hereto) as of the Closing Date to be true and correct and in force and effect as
of such date.
(
iv
)
Good
Standing
. Copies
of certificates of good standing, existence or its equivalent (to the extent
applicable) with respect to the each Credit Party certified as of a recent date
by the appropriate Governmental Authorities of the jurisdiction of incorporation
or organization and each other jurisdiction in which the failure to so qualify
and be in good standing could reasonably be expected to have a Material Adverse
Effect on the business or operations of such Credit Party in such
state.
(
v
)
Incumbency
. An
incumbency certificate of Responsible Officers of each Credit Party authorized
to execute the Credit Documents on such Credit Party’s behalf certified by a
secretary or assistant secretary (pursuant to a secretary’s certificate in
substantially the form of
Schedule
4.1-1
attached
hereto) to be true and correct as of the Closing Date.
(
c
)
Legal Opinions of
Counsel
.
The
Administrative Agent shall have received (
i
)
opinions of legal counsel (including local counsel to the extent required by the
Administrative Agent) for the Credit Parties, dated the Closing Date and
addressed to the Administrative Agent and the Lenders, which opinions shall
include, without limitation, a “no conflicts” opinion with respect to corporate
instruments and Material Contracts of the Credit Parties on the Closing Date
after giving effect to the transactions contemplated herein, (
ii
) an
opinion from STvB Advocaten (Caracao) N.V. as to, inter alia, the due
authorization, execution and delivery of the Credit Documents to which the
Company is a party, and (
iii
) an
opinion from Berwin Leighton Paisner LLP as to, inter alia, enforceability of
the UK Security Documents and the due authorization, execution and delivery of
the Credit Documents to which Colgate, Victory, Swiftsure or UK Ltd is a party,
such opinions to be in form and substance reasonably satisfactory to the
Administrative Agent.
(
d
)
Reliance
. The
Administrative Agent shall have received a copy of each opinion, agreement, and
other material document required to be delivered pursuant to the Acquisition
Documents and the transactions contemplated in connection therewith, together
with evidence that the Administrative Agent and the Lenders have been authorized
to rely on each such opinion to the extent counsel providing each such opinion
has agreed to such reliance, all in form and substance reasonably satisfactory
to the Administrative Agent.
(
e
)
Personal Property
Collateral
. The
Administrative Agent shall have received, in form and substance reasonably
satisfactory to the Administrative Agent:
(
i
)
a
perfection certificate setting forth the state or jurisdiction of incorporation
or organization of each Credit Party and each jurisdiction where any Collateral
of such Credit Party with a fair market value in excess of $100,000 is located
or where the chief executive office of such Credit Party is located, copies of
Lien searches in jurisdictions as required by the Administrative Agent, and
copies of the financing statements on file in such jurisdictions and evidence
that no Liens exist other than Permitted Liens;
(
ii
)
UCC
financing statements for each appropriate jurisdiction as is necessary, in the
Administrative Agent’s reasonable discretion, to perfect the Administrative
Agent’s security interest in the Collateral; and
(
iii
)
duly
executed consents as are necessary, in the Administrative Agent’s sole
discretion, to perfect the Lenders’ security interest in the Collateral.
(
f
)
[Reserved]
(
g
)
Liability, Casualty and
Business Interruption Insurance
. The
Administrative Agent shall have received copies of insurance policies (including
a Marsh Inc. report) or certificates of insurance evidencing liability and
casualty insurance meeting the requirements set forth herein or in the Security
Documents and business interruption insurance satisfactory to the Administrative
Agent. The Administrative Agent shall be named as loss payee or mortgagee, as
its interest may appear, and/or additional insured with respect to any such
insurance providing coverage in respect of any Collateral, and the respective
Credit Party shall use commercially reasonable efforts to obtain from each
provider of any such insurance an agreement that such provider, by endorsement
upon the policy or policies issued by it or by independent instruments furnished
to the Administrative Agent, will give the Administrative Agent thirty (30) days
prior written notice before any such policy or policies shall be altered or
canceled.
(
h
)
Fees
. The
Administrative Agent and the Lenders shall have received (
i
) all
fees, if any, owing pursuant to the Fee Letters and Section 2.5 and
(
ii
)
evidence that the aggregate amount of fees and expenses payable in connection
with the consummation of the Acquisition by the Company and its Subsidiaries
(excluding those fees identified in the foregoing subsection (i)) did not exceed
$12,500,000.
(
i
)
Litigation
. Except
as set forth on
Schedule
3.8
, there
shall not exist any material litigation, investigation, claim, criminal
prosecution, civil investigative demand, imposition of criminal or civil fines
and penalties, or any other proceeding of or before any arbitrator or
Governmental Authority (including but not limited to those regulatory agencies
responsible for licensing, accrediting or issuing Medicare or Medicaid
certifications) affecting or relating to any of the Company or its Subsidiaries,
this Agreement and the other Credit Documents, that has not been settled,
dismissed, vacated, discharged or terminated prior to the Closing
Date.
(
j
)
Solvency
Certificate
. The
Administrative Agent shall have received an officer’s certificate prepared by
the chief financial officer of the Company as to the financial condition,
solvency and related matters of each Credit Party, in each case after giving
effect to the Acquisition and the initial borrowings under the Credit Documents,
in substantially the form of
Schedule
4.1-2
hereto.
(
k
)
Account Designation
Letter
. The
Administrative Agent shall have received the executed Account Designation Letter
in the form of
Schedule
1.1-1
hereto.
(
l
)
Corporate
Structure
. The
corporate, capital and ownership structure of the Company and its Subsidiaries
after giving effect to the Acquisition shall be as described in
Schedule
3.12
, and
shall otherwise be reasonably satisfactory to the Administrative Agent. The
Administrative Agent shall be satisfied with the management of the Company and
its Subsidiaries after giving effect to the Acquisition.
(
m
)
Acquisition
Documents
. The
Administrative Agent shall have reviewed and approved to its reasonable
satisfaction all of the Acquisition
Documents
(other than the Agreement and Plan of Merger referred to in the definition of
“Acquisition Documents” and all related schedules and exhibits, which have been
approved) and there shall not have been any material modification, amendment,
supplement or waiver to the
Acquisition
Documents
subsequent to August 4, 2006 without the prior written consent of the
Administrative Agent. The Acquisition
shall
have been consummated substantially in accordance with the terms of the
Acquisition
Documents
(without waiver of any material conditions precedent to the obligations of any
party thereto without the consent of the Administrative Agent).
T
he
Administrative Agent shall have received a copy, certified by an officer of the
Borrower as true and complete, of each Acquisition
Document
as originally executed and delivered, together with all exhibits and schedules
thereto.
(
n
)
Consents
. The
Administrative Agent shall have received evidence that all governmental,
shareholder, board of director and material third party consents and approvals
that the Borrower can obtain using its commercially reasonable efforts and that
are necessary in connection with the financings, the Acquisition and other
transactions contemplated hereby have been obtained and all applicable waiting
periods have expired without any action being taken by any authority that could
restrain, prevent or impose any material adverse conditions on such transactions
or that could seek or threaten any of such transactions.
(
o
)
Compliance with
Laws
. The
financings and other transactions contemplated hereby shall be in compliance
with all applicable Requirements of Law (including all applicable securities and
banking laws, rules and regulations).
(
p
)
Bankruptcy
. There
shall be no bankruptcy or insolvency proceedings with respect to any Credit
Party or any of its Subsidiaries.
(
q
)
Material Adverse
Effect
. No
material adverse change shall have occurred or could reasonably be expected to
occur since December 31, 2005 in the business, properties, prospects,
operations, regulatory environment or condition (financial or otherwise) of
either the Company, the Borrower and its Subsidiaries, taken as a whole or the
Acquired Company and its Subsidiaries, taken as a whole.
(
r
)
Minimum Consolidated
EBITDA
. The
Administrative Agent shall have received evidence satisfactory thereto provided
by the Company that the Consolidated EBITDA for the twelve-month period ending
on the last day of the most recent fiscal quarter for which financial statements
of the Company and its Subsidiaries are available, calculated on a Pro Forma
Basis, is no less than $79,000,000.
(
s
)
Leverage
Ratio
. The
Leverage Ratio (determined using Funded Debt of the Company and its Subsidiaries
as of the Closing Date and pro forma Consolidated EBITDA of the Company and its
Subsidiaries for the twelve-month period
ending on
the last day
of the
most recent fiscal quarter for which financial statements of the Company and its
Subsidiaries are available), calculated on a Pro Forma Basis as of the Closing
Date, shall not exceed 4.25 to 1.0.
(
t
)
Financial
Statements
. The
Administrative Agent shall have received copies of the financial statements and
projections referred to in Section 3.1 hereof, each in form and substance
satisfactory to it.
(
u
)
Termination of Existing
Indebtedness; Approval of Intercompany Indebtedness
. All
existing Indebtedness for borrowed money of the Company, the Borrower, the
Acquired Company and their respective Subsidiaries in excess of $5,000,000 in
the aggregate, other than Indebtedness incurred by SRL as set forth on
Schedule
6.1(b)
, shall
have been repaid in full and terminated and all Liens relating thereto shall
have been terminated. The Administrative Agent shall have reviewed and approved
in its sole discretion all loan documentation with respect to any intercompany
Indebtedness of the Credit Parties and the Administrative Agent shall have
received a copy, certified by a Responsible Officer of the Borrower as true and
complete, of each such document, as originally executed and delivered, together
with all exhibits, schedules, amendments and modifications thereto.
(
v
)
Officer’s
Certificates
. The
Administrative Agent shall have received a certificate executed by a Responsible
Officer of the Borrower as of the Closing Date stating that (i) immediately
after giving effect to this Credit Agreement (including the initial Extensions
of Credit hereunder), the other Credit Documents and the Acquisition Documents
and all the transactions contemplated therein to occur on such date, (A) no
Default or Event of Default exists, (B) all representations and warranties
contained herein and in the other Credit Documents are true and correct in all
material respects, and (C) the Credit Parties are in compliance with each of the
financial covenants set forth in Section 5.9 and demonstrating compliance with
such financial covenants.
(
w
)
Credit
Rating
. The
Borrower shall have obtained a senior secured credit rating from Moody’s and
from S&P.
(
x
)
Patriot Act
Certificate
. The
Administrative Agent shall have received a certificate satisfactory thereto, for
benefit of itself and the Lenders, provided by the Borrower that sets forth
information required by the Patriot Act (as defined in Section 9.18) including,
without limitation, the identity of each Credit Party, the name and address of
each Credit Party and other information that will allow the Administrative Agent
or any Lender, as applicable, to identify each Credit Party in accordance with
the Patriot Act.
(
y
)
Additional
Matters
. All
other documents and legal matters in connection with the transactions
contemplated by this Agreement shall be reasonably satisfactory in form and
substance to the Administrative Agent and its counsel.
|
Section
4
.
2
|
Conditions to All
Extensions of Credit
.
|
The
obligation of each Lender to make any Extension of Credit hereunder is subject
to the satisfaction of the following conditions precedent on the date of making
such Extension of Credit:
(
a
)
Representations and
Warranties
. The
representations and warranties made by the Credit Parties herein, in the
Security Documents or which are contained in any certificate furnished at any
time under or in connection herewith shall be true and correct on and as of the
date of such Extension of Credit as if made on and as of such date (other than
any such representations or warranties that, by their terms, refer to a specific
date other than the date of such Extension of Credit, in which case, as of such
specific date).
(
b
)
No Default or Event of
Default
. No
Default or Event of Default shall have occurred and be continuing on such date
or after giving effect to the Extension of Credit to be made on such date unless
such Default or Event of Default shall have been waived in accordance with this
Agreement.
(
c
)
Compliance with
Commitments
.
Immediately after giving effect to the making of any such Extension of Credit
(and the application of the proceeds thereof), (i) the sum of outstanding
Revolving Loans
plus
outstanding Swingline Loans
plus
outstanding LOC Obligations shall not exceed the Revolving Committed Amount,
(ii) the outstanding LOC Obligations shall not exceed the LOC Committed Amount
and (iii) the Swingline Loans shall not exceed the Swingline Committed
Amount.
(
d
)
Additional Conditions to
Extensions of Credit
. If such
Extension of Credit is made pursuant to Sections 2.1, 2.2, 2.3 or 2.4, all
conditions set forth in such Section shall have been satisfied.
Each
request for an Extension of Credit and each acceptance by the Borrower of any
such Extension of Credit shall be deemed to constitute a representation and
warranty by the Borrower as of the date of such Extension of Credit that the
applicable conditions in paragraphs (a) through (d) of this Section have been
satisfied.
ARTICLE
V
AFFIRMATIVE
COVENANTS
The
Credit Parties hereby covenant and agree that on the Closing Date, and
thereafter for so long as this Agreement is in effect and until the Commitments
have terminated, no Note shall remain outstanding and unpaid and the Credit
Party Obligations, together with interest, Commitment Fees and all other amounts
owing to the Administrative Agent or any Lender hereunder, shall have been paid
in full, the Credit Parties shall:
|
Section
5
.
1
|
Financial
Statements
.
|
Furnish
to the Administrative Agent (which shall transmit or make available the same to
the Lenders as soon as practicable):
(
a
)
Annual Financial
Statements
. As soon
as available, but in any event within ninety (90) days after the end of
each fiscal year of the Company commencing with the fiscal year ended December
31, 2006 (or, with respect to the comparative information required below,
commencing with the fiscal year ended December 31, 2006), a copy of the
consolidated and consolidating balance sheet of the Company and its consolidated
Subsidiaries as at the end of such fiscal year and the related consolidated and
consolidating statements of income and retained earnings and of cash flows of
the Company and its consolidated Subsidiaries for such year, audited (with
respect to the consolidated statements only) by a firm of independent certified
public accountants of, as appropriate, nationally or internationally recognized
standing reasonably acceptable to the Administrative Agent, setting forth in
comparative form consolidated and consolidating
figures
for the preceding fiscal year, reported on without a “going concern” or like
qualification or exception, or qualification indicating that the scope of the
audit was inadequate to permit such independent certified public accountants to
certify such financial statements without such qualification;
(
b
)
Annual Unaudited Financial
Statements
. As soon
as available, but in any event within ninety (90) days after the end of
each fiscal year of the Company commencing with the fiscal year ended December
31, 2006 (or, with respect to the comparative information required below,
commencing with the fiscal year ended December 31, 2006), a copy of the
consolidated and consolidating balance sheet of the Borrower and its
consolidated Subsidiaries as at the end of such fiscal year and the related
consolidated and consolidating statements of income and retained earnings and of
cash flows of the Borrower and its consolidated Subsidiaries for such year,
setting forth in comparative form consolidated and consolidating
figures
for the preceding fiscal year.
(
c
)
Quarterly Financial
Statements
. (i) As
soon as available and in any event within (A) forty-five (45) days after the end
of each of the first three fiscal quarters of the Company and (B) ninety (90)
days after the end of the fourth fiscal quarter of the Company, a
company-prepared consolidated and consolidating balance sheet of the Borrower
and its consolidated Subsidiaries as at the end of such period and related
company-prepared consolidated and consolidating
statements
of income and retained earnings and of cash flows for the Borrower and its
consolidated Subsidiaries for such quarterly period and for the portion of the
fiscal year ending with such period, in each case setting forth in comparative
form consolidated and consolidating
figures
for the corresponding period or periods of the preceding fiscal year (subject to
normal recurring year-end audit adjustments) and (ii) as soon as available and
in any event within (A) forty-five (45) days after the end of each of the first
three fiscal quarters of the Company and (B) ninety (90) days after the end of
the fourth fiscal quarter of the Company, a company-prepared consolidated and
consolidating balance sheet of the Company and its consolidated Subsidiaries as
at the end of such period and related company-prepared consolidated and
consolidating
statements
of income and retained earnings and of cash flows for the Company and its
consolidated Subsidiaries for such quarterly period and for the portion of the
fiscal year ending with such period, in each case setting forth in comparative
form consolidated and consolidating
figures
for the corresponding period or periods of the preceding fiscal year (subject to
normal recurring year-end audit adjustments) and to the extent not disclosed in
the Company’s Form 10-Q, management discussion and analysis of operating results
inclusive of operating metrics in comparative form; and
(
d
)
Annual Budget
Plan
. As soon
as available, but in any event within sixty (60) days after the end of each
fiscal year, a copy of the detailed annual budget or plan of the Company for the
next fiscal year on a quarterly basis, in form and detail reasonably acceptable
to the Administrative Agent, together with a summary of the material assumptions
made in the preparation of such annual budget or plan;
all such
financial statements to be complete and correct in all material respects
(subject, in the case of interim statements, to normal recurring year-end audit
adjustments) and to be prepared in reasonable detail and, in the case of the
annual and quarterly financial statements provided in accordance with
subsections (a), (b) and (c) above, in accordance with GAAP applied consistently
throughout the periods reflected therein and further accompanied by a
description of, and an estimation of the effect on the financial statements on
account of a change, if any, in the application of accounting principles as
provided in Section 1.3.
|
Section
5
.
2
|
Certificates; Other
Information
.
|
Furnish
to the Administrative Agent (which shall transmit or make available the same to
the Lenders as soon as practicable):
(
a
)
concurrently
with the delivery of the financial statements referred to in Section 5.1(a)
above, certificates of the independent certified public accountants of the
Company reporting on such financial statements stating that in making the
examination necessary therefore no knowledge was obtained of any Default or
Event of Default under Section 5.9, except as specified in such
certificate;
(
b
)
concurrently
with the delivery of the financial statements referred to in Sections 5.1(a),
5.1(b) and 5.1(c) above, a certificate of a Responsible Officer of the Borrower
stating that, to the best of such Responsible Officer’s knowledge, during such
period each of the Credit Parties observed or performed all of its covenants and
other agreements, and satisfied every condition, contained in this Agreement to
be observed, performed or satisfied by it, and that such Responsible Officer has
obtained no knowledge of any Default or Event of Default except as specified in
such certificate and such certificate shall include the calculations in
reasonable detail required to indicate compliance with Section 5.9 as of the
last day of such period;
(
c
)
within
ten (10) days after the same are sent, copies of all reports (other than those
otherwise provided pursuant to Section 5.1 and those which are of a promotional
nature) and other financial information which the Company sends to its members
and equity holders, and within ten (10) days after the same are filed, copies of
all financial statements and non-confidential reports which the Company may make
to or file with the Securities and Exchange Commission or any successor or
analogous Governmental Authority;
(
d
)
within
ninety (90) days after the end of each fiscal year of the Company, a certificate
containing information regarding the amount of all Asset Dispositions, Debt
Issuances, and Equity Issuances that were made during the prior fiscal year and
amounts received in connection with any Recovery Event during the prior fiscal
year;
(
e
)
promptly
upon receipt thereof, a copy of any other report or “management letter”
submitted or presented by independent accountants to any Credit Party
or any of
the Borrower’s Subsidiaries
in
connection with any annual, interim or special audit of the books of such Person
regarding material matters of the Company and its Subsidiaries, taken as a
whole;
(
f
)
promptly,
copies of all material notices from or material requests to the FDA, FTC, and
OSHA (each, as defined in Section 3.26); and
(
g
)
promptly,
such additional financial and other information as the Administrative Agent, on
behalf of any Lender, may from time to time reasonably request.
|
Section
5
.
3
|
Payment of
Obligations
.
|
Pay,
discharge or otherwise satisfy at or before maturity or before they become
delinquent, as the case may be, all its taxes (Federal, state, local and any
other taxes) and all its other obligations and liabilities of whatever nature
and any additional costs that are imposed as a result of any failure to so pay,
discharge or otherwise satisfy such obligations and liabilities, except
(a) when the amount or validity of such obligations, liabilities and costs
is currently being contested in good faith by appropriate proceedings and
reserves, if applicable, in conformity with GAAP with respect thereto have been
provided on the books of any Credit Party, as the case may be or (b) where
any such failure to pay, discharge or satisfy could not reasonably be expected
to have a Material Adverse Effect.
|
Section
5
.
4
|
Conduct of Business
and Maintenance of Existence
.
|
Continue
to (a) engage in business of the same general type as now conducted by it on the
Closing Date and preserve, renew and keep in full force and effect its corporate
existence and take all reasonable action to maintain all rights, privileges and
franchises necessary or that the applicable Credit Party reasonably deems
desirable in the normal conduct of its business;
provided
that any
Credit Party or any Subsidiary thereof may reorganize in Delaware or in another
U.S. jurisdiction acceptable to the Required Lenders so long as the
Administrative Agent receives prior written notice thereof and all actions
required to continue the perfection of the Administrative Agent’s Liens on the
Collateral are taken; and
provided
,
further
, the
Company may consummate the Acquisition and any other merger, consolidation,
purchase, lease or acquisition permitted under Section 6.4 or liquidate or
dissolve any Subsidiary that has no assets or that has sold, disposed of or
otherwise transferred all of its assets to the Borrower or a Subsidiary
Guarantor, and (b) comply with all Contractual Obligations and Requirements of
Law applicable to it except to the extent that failure to comply therewith,
individually or in the aggregate, could not reasonably be expected to have a
Material Adverse Effect.
|
Section
5
.
5
|
Maintenance of
Property; Insurance
.
|
(
a
)
Keep all
Material Property useful and necessary in its business in good working order and
condition (ordinary wear and tear, damage by casualty and obsolescence
excepted);
(
b
)
Maintain
with financially sound and reputable insurance companies insurance on all its
Material Property (including without limitation its material tangible
Collateral) in at least such amounts (or such greater amounts to the extent any
coverage amount maintained by the Credit Parties is significantly lower than the
coverage amount maintained by companies engaged in the same or a similar
business in the same general area) and against at least such risks as are
maintained by the Credit Parties as of the Closing Date and any other material
risks as are usually insured against in the same general area by companies
engaged in the same or a similar business; and furnish to the Administrative
Agent, upon written request, full information as to the insurance carried. The
Administrative Agent shall be named as loss payee or mortgagee, as its interest
may appear, (or additional insured in the case of liability coverage) with
respect to any such insurance providing coverage in respect of any Collateral,
and each provider of any such insurance shall agree, by endorsement upon the
policy or policies issued by it or by independent instruments furnished to the
Administrative Agent, that it will give the Administrative Agent thirty (30)
days prior written notice before any such policy or policies shall be altered or
canceled, and that no act or default of any Credit Party or any Subsidiary of
the Company or any other Person shall affect the rights of the Administrative
Agent or the Lenders under such policy or policies
;
and
(
c
)
In case
of any material loss, damage to or destruction of the Collateral of any Credit
Party or any part thereof, such Credit Party shall promptly give written notice
thereof to the Administrative Agent generally describing the nature and extent
of such damage or destruction. In case of any material loss, damage to or
destruction of the Collateral of any Credit Party or any part thereof, such
Credit Party, whether or not the insurance proceeds, if any, received on account
of such damage or destruction shall be sufficient for that purpose, at such
Credit Party’s cost and expense, will promptly repair or replace the Collateral
of such Credit Party so lost, damaged or destroyed.
|
Section
5
.
6
|
Inspection of
Property; Books and Records; Discussions
.
|
Keep
proper books and records of account in which full, true and correct entries in
conformity with GAAP and all Requirements of Law shall be made of all dealings
and transactions in relation to its businesses and activities; and permit,
during regular business hours and upon reasonable notice by the Administrative
Agent or any Lender, the Administrative Agent or any Lender to visit and inspect
any of its properties and examine and make abstracts from any of its books and
records (other than materials protected by the attorney-client privilege and
materials which any Credit Party may not disclose without violation of a
confidentiality obligation binding upon it) once a fiscal quarter or upon the
occurrence and during the continuance of a Default or an Event of Default, and
to discuss the business, operations, properties and financial and other
condition of the Credit Parties and their Subsidiaries with officers and
employees of the Credit Parties and their Subsidiaries and with its independent
certified public accountants. The forgoing, with respect to the Lenders, shall
be at such Lender’s expense and, with respect to the Administrative Agent, shall
be at the Borrower’s expense.
Give
notice in writing to the Administrative Agent (which shall promptly transmit
such notice to each Lender) of:
(
a
)
promptly,
but in any event within two (2) Business Days after any Responsible Officer of a
Credit Party knows thereof, the occurrence of any Default or Event of
Default;
(
b
)
promptly,
any default or event of default under any Contractual Obligation of any Credit
Party or any of its Subsidiaries which, individually or in the aggregate, could
reasonably be expected to have a Material Adverse Effect or could reasonably be
expected to result in a monetary payment in excess of $10,000,000;
(
c
)
promptly,
any litigation, or any investigation or proceeding known to any Credit Party (i)
affecting any Credit Party or any of its Subsidiaries which, if adversely
determined, individually or in the aggregate, could reasonably be expected to
have a Material Adverse Effect or could reasonably be expected to result in a
monetary judgment in excess of $5,000,000 or (ii) affecting or with respect
to this Agreement or any other Credit Document;
(
d
)
as soon
as possible and in any event within thirty (30) days after any Responsible
Officer of a Credit Party knows or has reason to know thereof: (i) the
occurrence of any material Reportable Event with respect to any Single Employer
Plan, a failure to make any required contribution to a Single Employer Plan, the
creation of any Lien in favor of a Single Employer Plan or in favor of the PBGC
with respect to a Single Employer Plan (other than a Permitted Lien) or any
withdrawal from, or the termination, Reorganization or Insolvency of, any
Multiemployer Plan, which could reasonably be expected to result in any material
liability for any Credit Party, or (ii) the institution of proceedings or the
taking of any other action by the PBGC or any Credit Party or any Commonly
Controlled Entity or any Multiemployer Plan with respect to the withdrawal from,
or the terminating, Reorganization or Insolvency of, any Plan, which could
reasonably be expected to result in any material liability for any Credit Party;
(
e
)
promptly,
of the institution of any investigation or proceeding against any Credit Party
to suspend, revoke or terminate or which may result in the termination of any
Medicaid Provider Agreement, Medicaid Certification, Medicare Provider
Agreement, Medicare Certification or exclusion from any Medical Reimbursement
Program;
(
f
)
promptly,
after any Credit Party becomes involved in a pending civil or criminal
investigation, criminal action or civil proposed debarment, exclusion or other
sanctioning action related to any Federal or state healthcare program;
(
g
)
promptly,
any other development or event which, individually or in the aggregate, could
reasonably be expected to have a Material Adverse Effect;
(
h
)
promptly,
any intention by the Borrower to treat the Loans and/or Letters of Credit and
related transactions as being a “reportable transaction” (within the meaning of
Treasury Regulation Section 1.6011-4), a duly completed copy of IRS Form 8886 or
any successor form; and
(
i
)
promptly,
the Company or any of its Subsidiaries (i) entering into a collective bargaining
agreement or Multiemployer Plan covering the employees of the Company or any of
its Subsidiaries, (ii) suffering any material strike, walkout, work stoppage or
other material labor difficulty or (iii) becoming aware of any material unfair
labor practice complaint against the Company or any of its Subsidiaries before
any Governmental Authority.
Each
notice pursuant to this Section shall be accompanied by a statement of a
Responsible Officer of the Borrower setting forth details of the occurrence
referred to therein and stating what action the Borrower proposes to take with
respect thereto. In the case of any notice of a Default or Event of Default, the
Borrower shall specify that such notice is a Default or Event of Default notice
on the face thereof.
|
Section
5
.
8
|
Environmental
Laws
.
|
(
a
)
Comply in
all material respects with, and ensure compliance in all material respects by
all tenants and subtenants, if any, with, all applicable Environmental Laws and
obtain and comply in all material respects with and maintain, and ensure that
all tenants and subtenants obtain and comply in all material respects with and
maintain, any and all licenses, approvals, notifications, registrations or
permits required by applicable Environmental Laws except to the extent that
failure to do so, individually or in the aggregate, could not reasonably be
expected to have a Material Adverse Effect;
(
b
)
Conduct
and complete all investigations, studies, sampling and testing, and all
remedial, removal and other actions required under Environmental Laws and
promptly comply in all material respects with all lawful orders and directives
of all Governmental Authorities regarding Environmental Laws except to the
extent that the same are being contested in good faith by appropriate
proceedings and the pendency of such proceedings could not reasonably be
expected to have a Material Adverse Effect; and
(
c
)
Defend,
indemnify and hold harmless the Administrative Agent and the Lenders, and their
respective employees, agents, officers and directors and affiliates, from and
against any and all claims, demands, penalties, fines, liabilities, settlements,
damages, costs and expenses of whatever kind or nature known or unknown,
contingent or otherwise, arising out of, or in any way relating to the violation
of, noncompliance with or liability under, any Environmental Law applicable to
the operations of any Credit Party or any of the Company’s Subsidiaries or the
Properties, or any orders, requirements or demands of Governmental Authorities
related thereto, including, without limitation, reasonable attorney’s and
consultant’s fees, investigation and laboratory fees, response costs, court
costs and litigation expenses, except to the extent that any of the foregoing
arise out of the gross negligence or willful misconduct of the Person seeking
indemnification or any of its employees, agents, officers and directors and
affiliates. The agreements in this paragraph shall survive repayment of the
Notes and all other amounts payable hereunder.
|
Section
5
.
9
|
Financial
Covenants
.
|
Commencing
on the day immediately following the Closing Date and for so long as this
Agreement shall remain in effect, each of the Credit Parties shall, and shall
cause each of its Subsidiaries to, comply with the following financial
covenants:
(
a
)
Leverage
Ratio
. The
Leverage Ratio, as of the last day of each fiscal quarter of the Company
occurring during the periods indicated below, shall be less than or equal to the
following:
Period
|
Ratio
|
Closing
Date through June 30, 2007
|
4.25
to 1.0
|
July
1, 2007 through December 31, 2007
|
4.00
to 1.0
|
January
1, 2008 through June 30, 2008
|
3.75
to 1.0
|
July
1, 2008 through December 31, 2008
|
3.50
to 1.0
|
January
1, 2009 through June 30, 2009
|
3.25
to 1.0
|
July
1, 2009 through December 31, 2009
|
3.00
to 1.0
|
January
1, 2010 through June 30, 2010
|
2.75
to 1.0
|
July
1, 2010 and thereafter
|
2.50
to 1.0
|
(
b
)
Fixed Charge Coverage
Ratio
. The
Fixed Charge Coverage Ratio, as of the last day of each fiscal quarter of the
Company occurring during the periods indicated below, shall be greater than or
equal to the following:
Period
|
Ratio
|
October
1, 2006 through December 31, 2008
|
1.250
to 1.0
|
January
1, 2009 through December 31, 2009
|
1.300
to 1.0
|
January
1, 2010 and thereafter
|
1.375
to 1.0
|
Notwithstanding
the above, the parties hereto acknowledge and agree that, for purposes of all
calculations made in determining compliance for any applicable period with the
financial covenants set forth in this Section, (i) after consummation of
any Permitted Acquisition, (A) income statement items and other balance
sheet items (whether positive or negative) attributable to the Target acquired
in such transaction shall be included in such calculations to the extent
relating to such applicable period, subject to adjustments mutually acceptable
to the Borrower and the Administrative Agent, and (B) Indebtedness of a
Target which is retired in connection with a Permitted Acquisition shall be
excluded from such calculations and deemed to have been retired as of the first
day of such applicable period and (ii) after any Asset Disposition
permitted by Section
6.4(a)(ix)
,
(A) income statement items, cash flow statement items and other balance
sheet items (whether positive or negative) attributable to the property or
assets disposed of shall be excluded in such calculations to the extent relating
to such applicable period, subject to adjustments mutually acceptable to the
Borrower and the Administrative Agent and (B) Indebtedness that is repaid
with the proceeds of such Asset Disposition shall be excluded from such
calculations and deemed to have been repaid as of the first day of such
applicable period
.
|
Section
5
.
10
|
Additional Subsidiary
Guarantors
.
|
The
Company will cause each of its Domestic Subsidiaries, whether newly formed,
after acquired or otherwise existing, to promptly become a Guarantor hereunder
by way of execution of a Joinder Agreement. The guaranty obligations of any such
Additional Credit Party shall be secured by, among other things, the property
and assets of such Additional Credit Party and such Domestic Subsidiary shall
execute and deliver to the Administrative Agent such Security Documents, legal
opinions and related documents as the Administrative Agent may reasonably
request with respect to such property and assets.
|
Section
5
.
11
|
Compliance with
Law
.
|
The
Credit Parties will, and will cause each of its Subsidiaries to, (a) comply with
all expressly stated laws, rules, regulations, orders, restrictions and valid
requirements imposed by all Governmental Authorities and regulatory authorities
applicable to it, its property and assets and the conduct of its business if
noncompliance with any such law, rule, regulation, order, restriction or
requirement, including without limitation Titles XVIII and XIX of the Social
Security Act, Medicare Regulations and Medicaid Regulations, individually or in
the aggregate, could reasonably be expected to have a Material Adverse Effect,
and
(b)
obtain and maintain all licenses, permits, certifications and approvals of all
applicable Governmental Authorities as are required for the conduct of its
business as currently conducted and herein contemplated, including without
limitation professional licenses, appropriate Medicaid Certifications and
Medicare Certifications, if failure to do so could reasonably be expected to
have, individually or in the aggregate, a Material Adverse Effect. Specifically,
but without limiting the foregoing, and except where any such failure to comply,
individually or in the aggregate, could not reasonably be expected to have a
Material Adverse Effect: (x) billing policies, arrangements, protocols and
instructions will comply with reimbursement requirements under Medicare,
Medicaid and other Medical Reimbursement Programs and will be administered by
properly trained personnel; and (y) medical director compensation arrangements
and other arrangements with referring physicians will comply with applicable
state and federal self-referral and anti-kickback laws, including without
limitation 42 U.S.C. Section 1320a-7b(b)(1) - (b)(2) and 42 U.S.C. Section
1395nn.
|
Section
5
.
12
|
Pledged
Assets
.
|
(
a
)
The
Company will, and will cause each of its Subsidiaries to, cause (i) 100% of the
outstanding Capital Stock of each of Victory, the Borrower and the Subsidiary
Guarantors and (ii) 65% (to the extent the pledge of a greater percentage would
be unlawful or would cause any materially adverse tax consequences to the
Borrower or any Guarantor) of the voting Capital Stock and 100% of the
non-voting Capital Stock of each first-tier Foreign Subsidiary of the Borrower
and the Subsidiary Guarantors, in each case to be subject at all times to a
first priority, perfected Lien in favor of the Administrative Agent pursuant to
the terms and conditions of the Security Documents or such other security
documents as the Administrative Agent shall reasonably request.
(
b
)
If,
subsequent to the Closing Date, any Credit Party shall acquire any securities,
instruments (except checks), chattel paper or other personal property required
for perfection to be delivered to the Administrative Agent as Collateral
hereunder or under any of the Security Documents, such Credit Party shall
promptly (and in any event within three (3) Business Days) after such
acquisition notify the Administrative Agent of same;
provided
that
property the value of which, individually, is less than $500,000 and, in the
aggregate, is less than $1,000,000 in any twelve-month period, shall not be
required to be delivered until such time that all such property shall exceed
$1,000,000 in the aggregate in any twelve-month period. Each of the Credit
Parties shall take such action at its own expense as may be necessary or
otherwise requested by the Administrative Agent (including, without limitation,
any of the actions described in Sections 4.1(e) and 5.13(b) hereof) to ensure
that the Administrative Agent has a first priority perfected Lien to secure the
Credit Party Obligations in (i) all personal property Collateral of Colgate,
Victory, the Borrower and Subsidiary Guarantors and all tangible personal
property Collateral of the Company located in the United States and (ii) to the
extent required by the Administrative Agent or the Required Lenders in its or
their sole reasonable discretion, all real property owned by the Credit Parties
located in the United States, subject in each case only to Permitted Liens.
(
c
)
If,
subsequent to the Closing Date, a Credit Party leases a warehouse, plant or
other real property material to such Person’s business and located within the
United States, such Credit Party shall (i) promptly notify the Administrative
Agent of such lease, (ii) to the extent required by the Administrative Agent and
to the extent consented to by the relevant landlord or not prohibited under the
lease, promptly deliver to the Administrative Agent such Mortgage Instruments,
title reports, Mortgage Policies, Surveys, environmental site assessment
reports, legal opinions and other documentation as the Administrative Agent may
reasonably require and (iii) use its reasonable best efforts to deliver to the
Administrative Agent such estoppel letters, consents and waivers from the
landlord on such real property as may be required by the Administrative Agent;
provided
, that
the Credit Party shall not be required to expend any significant amount of money
to obtain such estoppel letters, consents and waivers.
|
Section
5
.
13
|
Limitations on Colgate
and Victory
.
|
Neither
Colgate nor Victory shall have any Indebtedness or operations other than (a) its
Guaranty, (b) intercompany Subordinated Indebtedness or Investments permitted
hereunder, (c) operations as contemplated by the Tax Structure Documents, (d)
operations relating to the holding of the Capital Stock of its Subsidiaries and
(e) operations related to satisfying its obligations as a Credit
Party.
|
Section
5
.
14
|
Further
Assurances
; Post-Closing
Covenant
.
|
(
a
)
Further
Assurances
. Upon
the reasonable request of the Administrative Agent, promptly perform or cause to
be performed any and all acts and execute or cause to be executed any and all
documents for filing under the provisions of the Uniform Commercial Code or any
other Requirement of Law which are necessary or advisable to maintain in favor
of the Administrative Agent, for the benefit of the Secured Parties, Liens on
the Collateral that are duly perfected in accordance with the requirements of,
or the obligations of the Credit Parties under, the Credit Documents and all
applicable Requirements of Law.
(
b
)
Deposit Account Control
Agreements
. Within
sixty (60) days after the Closing Date (or such extended period of time as
agreed to by the Administrative Agent), the Administrative Agent shall have
received, in form and substance reasonably satisfactory to the Administrative
Agent, Deposit Account Control Agreements and Securities Account Control
Agreements with respect to each account required to be subject to such agreement
pursuant to Section 6.13.
(
c
)
Notice of Grant of
Security
. Within
fifteen (15) Business Days after the Closing Date (or such extended period of
time as agreed to by the Administrative Agent), the Administrative Agent shall
have received, in form and substance reasonably satisfactory to the
Administrative Agent, (
i
)
evidence that a notice of a grant of security was served upon Bank of America,
N.A. with respect to each account of Colgate, Victory Swiftsure and UK Ltd
located in the United Kingdom and (
ii
) an
acknowledgement from Bank of America, N.A. as to the existence of such security,
to the extent such acknowledgement can be obtained using commercially reasonable
efforts.
(
d
)
Real Property
Collateral
. Within
sixty (60) days after the Closing Date (or such extended period of time as
agreed to by the Administrative Agent), the Administrative Agent shall have
received, in form and substance reasonably satisfactory to the Administrative
Agent:
(
i
)
fully
executed and notarized Mortgage Instruments encumbering the owned or, to the
extent not prohibited by the applicable lease or consented to by the applicable
landlord, leasehold interest in the Mortgaged Properties owned or leased by each
Credit Party and set forth on
Schedule
3.19(d)
;
(
ii
)
a title
report in respect of each of the Mortgaged Properties;
(
iii
)
with
respect to each Mortgaged Property, ALTA Mortgage Policies issued by the Title
Insurance Company, assuring the Administrative Agent that each of the Mortgage
Instruments creates a valid and enforceable first priority mortgage lien on the
applicable Mortgaged Property, free and clear of all defects and encumbrances
except Permitted Liens, which Mortgage Policies shall provide for affirmative
insurance and such reinsurance as the Administrative Agent may reasonably
request, all of the foregoing in form and substance reasonably satisfactory to
the Administrative Agent;
(
iv
)
evidence
as to (A) whether any Mortgaged Property is in an area designated by the Federal
Emergency Management Agency as having special flood or mud slide hazards (a
“
Flood Hazard
Property
”) and
(B) if any Mortgaged Property is a Flood Hazard Property, (1) whether the
community in which such Mortgaged Property is located is participating in the
National Flood Insurance Program, (2) the Borrower’s or the applicable Credit
Party’s written acknowledgment of receipt of written notification from the
Administrative Agent (y) as to the fact that such Mortgaged Property is a Flood
Hazard Property and (z) as to whether the community in which each such Flood
Hazard Property is located is participating in the National Flood Insurance
Program and (3) copies of insurance policies or certificates of insurance of the
Borrower and its Subsidiaries evidencing flood insurance reasonably satisfactory
to the Administrative Agent and naming the Administrative Agent as loss payee on
behalf of the Lenders;
(
v
)
to the
extent available, surveys of the sites of the Mortgaged Properties certified to
the Administrative Agent and the Title Insurance Company in a manner reasonably
satisfactory to them, dated a date satisfactory to each of the Administrative
Agent and the Title Insurance Company by an independent professional licensed
land surveyor reasonably satisfactory to each of the Administrative Agent and
the Title Insurance Company;
(
vi
)
reasonably
satisfactory Phase I environmental site assessment reports (or other
environmental reports acceptable to the Administrative Agent) with respect to
each of the Mortgaged Properties, together with (to the extent required by the
Administrative Agent) reliance letters with respect to such reports in favor of
the Lenders;
(
vii
)
opinions
of counsel to the Borrower or the applicable Credit Party for each jurisdiction
in which the Mortgaged Properties are located; and
(
viii
)
in the
case of the Properties located in
McKinney,
Texas, Vista, California, Huntersville, North Carolina, Springfield,
Massachusetts, and Wayne, New Jersey, such estoppel letters, consents and
waivers from the landlords on such Properties as the Administrative Agent may
reasonably require;
provided
, that
the Credit Parties shall not be required (A) to obtain any such consent to the
extent the applicable landlord refuses to execute such consent after the Credit
Parties have used their commercially reasonable efforts to obtain such consent
or (B) to expend any significant amount of money to obtain such
consents.
(
e
)
Stock Certificate and
Power
. Within
thirty (30) days after the Closing Date (or such extended period of time as
agreed to by the Administrative Agent), the Administrative Agent shall have
received the stock certificate evidencing the interest owned by Orthofix Inc. in
Innovative Spinal Technologies and a duly executed in blank undated stock or
transfer power with respect thereto.
(
f
)
Opinion
. Within
thirty (30) days after the Closing Date (or such extended period of time as
agreed to by the Administrative Agent), the Administrative Agent shall have
received an opinion, in form and substance reasonably satisfactory to the
Administrative Agent, that the Capital Stock of each of the Credit Parties
organized under the laws of Delaware is duly authorized, validly issued, fully
paid, non-assessable and owned of record by such Credit Party.
(
g
)
Intellectual
Property
. Within
thirty (30) days after the Closing Date (or such extended period of time as
agreed to by the Administrative Agent), the Administrative Agent shall have
received evidence that all chain of title issues have been resolved with the
United States Patent and Trademark Office and all third party security interests
with respect to the Intellectual Property of the Credit Parties have been
released of record with the United States Patent and Trademark Office;
provided
that any
Indebtedness associated with such security interests shall have been paid in
full and terminated on or prior to the Closing Date.
ARTICLE
VI
NEGATIVE
COVENANTS
The
Credit Parties hereby covenant and agree that on the Closing Date, and
thereafter for so long as this Agreement is in effect and until the Commitments
have terminated, no Note remains outstanding and unpaid and the Credit Party
Obligations, together with interest, Commitment Fee and all other amounts owing
to the Administrative Agent or any Lender hereunder, are paid in full that:
|
Section
6
.
1
|
Indebtedness
.
|
No Credit
Party will, nor will it permit any Subsidiary to, contract, create, incur,
assume or permit to exist any Indebtedness, except:
(
a
)
Indebtedness
arising or existing under this Agreement and the other Credit
Documents;
(
b
)
Indebtedness
of the Company and its Subsidiaries existing as of the Closing Date as
referenced in the financial statements referenced in Section 3.1 or the
liquidity section of the management discussion and analysis (and set out more
specifically in
Schedule
6.1(b)
hereto)
and renewals, refinancings or extensions thereof in a principal amount not in
excess of that outstanding as of the date of such renewal, refinancing or
extension;
provided
that the
Credit Parties party to the intercompany notes set forth on
Schedule
6.1(b)
hereby
agree that the intercompany Indebtedness evidenced by such intercompany notes
shall be subordinated to the Credit Party Obligations and that the Credit Party
Obligations shall be paid in full prior to any payments being made on such
intercompany notes, except as permitted by Section 6.10;
(
c
)
Indebtedness
of the Borrower and its Subsidiaries incurred after the Closing Date consisting
of Capital Leases or Indebtedness incurred to provide all or a portion of the
purchase price or cost of construction of an asset (or assumed or acquired by
the Borrower and its Subsidiaries in connection with a Permitted Acquisition);
provided
that (i)
such Indebtedness to the extent resulting from Capital Leases or as a result of
the purchase price or cost of construction when incurred shall not exceed the
purchase price or cost of construction of such asset; (ii) no such Indebtedness
shall be refinanced for a principal amount in excess of the principal balance
outstanding thereon at the time of such refinancing; and (iii) the total amount
of all such Indebtedness shall not exceed $10,000,000 at any time
outstanding;
(
d
)
Unsecured
intercompany Subordinated Indebtedness (
i
) owing
by a Credit Party (other than, subject to clause (iv) below, the Company) to
another Credit Party;
provided
that any
Subordinated Indebtedness issued by a Credit Party (other than the Company) to
Colgate or Victory shall be issued in accordance with the Tax Structure
Documents, (
ii
) among
the Company and Foreign Subsidiaries, (
iii
) among
Foreign Subsidiaries and other Foreign Subsidiaries or (
iv
) owing
by the Company to Colgate or Victory to the extent that such Subordinated
Indebtedness would be permitted by Section 6.10(d), (f) or (i) if made as a
Restricted Payment rather than the issuance of Subordinated
Indebtedness;
(
e
)
Indebtedness
of Foreign Subsidiaries in an aggregate amount not to exceed $10,000,000 at any
time outstanding;
(
f
)
Indebtedness
and obligations owing under Secured Hedging Agreements and other Hedging
Agreements entered into in order to manage existing or anticipated interest rate
or exchange rate risks and not for speculative purposes;
(
g
)
Indebtedness
and obligations of the Borrower and its Subsidiaries owing under documentary
letters of credit for the purchase of goods or other merchandise (but not under
standby, direct pay or other letters of credit except for the Letters of Credit
hereunder) generally;
(
h
)
(
i
)
Indebtedness of the Company or any of its Subsidiaries the proceeds of which are
used to prepay the Term Loan in accordance with Section 2.7 or used to fund
Permitted Acquisitions so long as such Indebtedness is (and all Guaranty
Obligations with respect to such Indebtedness are) unsecured and subordinated in
right and time of payment (subject to the terms of Section 6.10(h)) and priority
to the Credit Party Obligations pursuant to subordination provisions that are
reasonably satisfactory to the Administrative Agent and (
ii
)
Indebtedness of the Company or any of its Subsidiaries the proceeds of which are
used to prepay the Term Loan in accordance with Section 2.7 so long as such
Indebtedness is (and all Guaranty Obligations with respect to such Indebtedness
are) unsecured;
provided
, in each
case that (
A
) the
covenants and events of default of such Indebtedness are, taken as a whole,
materially less restrictive than those contained in this Agreement (and shall
not include any covenant or event of default more restrictive than those
contained in this Agreement), (
B
) both
immediately prior and after giving effect thereto, (1) no Default or Event of
Default shall exist or result therefrom and (2) the Company shall be in
compliance with the financial covenants set forth in Section 5.9, such
compliance immediately after giving effect thereto determined with regard to
calculations made on a Pro Forma Basis for the fiscal quarter most recently
ended, and the Administrative Agent shall have received a certificate of a
Responsible Officer of the Borrower to such effect, and (
C
) such
Indebtedness matures, and does not require any scheduled amortization or other
scheduled or mandatory payments of principal or first scheduled put right prior
to, the date which is at least 120 days after the later of the Term Loan
Maturity Date and the maturity date of any Incremental Term Facility, other than
(1) redemptions made at the option of the holders of such Indebtedness upon a
change in control of the issuer in circumstances that would also constitute a
Change of Control under this Agreement (
provided
that any
such redemption cannot be made fewer than thirty (30) days after such change in
control and that any such redemption is fully subordinated to the indefeasible
payment in full of all Credit Party Obligations), (2) mandatory prepayments
required as a result of asset dispositions if such Indebtedness allows the
issuer to satisfy such mandatory prepayment requirement by prepayment of Loans
under this Agreement or other senior obligations of the issuer or reinvestment
of the asset disposition proceeds within a specified period of time and (3)
payments permitted by Section 6.10(h)(ii);
(
i
)
Guaranty
Obligations in respect of Indebtedness of the Company and its Subsidiaries to
the extent such Indebtedness is permitted to exist or be incurred pursuant to
this Section 6.1; and
(
j
)
other
unsecured Indebtedness of the Company and its Subsidiaries which does not exceed
$10,000,000
in the
aggregate at any time outstanding.
No Credit
Party will, nor will it permit any of its Subsidiaries to, contract, create,
incur, assume or permit to exist any Lien with respect to any of its property or
assets of any kind (whether real or personal, tangible or intangible), whether
now owned or hereafter acquired, except for Permitted Liens. Notwithstanding the
foregoing, if a Credit Party shall grant a Lien on any of its assets in
violation of this Section, then it shall be deemed to have simultaneously
granted an equal and ratable Lien on any such assets in favor of the
Administrative Agent for the ratable benefit of the Lenders and the Hedging
Agreement Providers, to the extent such Lien has not already been granted to the
Administrative Agent.
|
Section
6
.
3
|
Nature of
Business
.
|
Each of
the Credit Parties will not, nor will any Credit Party permit any Subsidiary to,
alter the character of its business or any business activities reasonably
related thereto in any material respect from that conducted as of the Closing
Date;
provided
that the
foregoing shall not apply to the cessation of business activities that the
applicable Credit Party or Subsidiary reasonably believes should no longer be
conducted by such Credit Party or Subsidiary.
|
Section
6
.
4
|
Consolidation, Merger,
Sale or Purchase of Assets, etc
.
|
Each of
the Credit Parties will not, nor will the Credit Parties permit any Subsidiary
to,
(
a
)
dissolve,
liquidate or wind up its affairs, sell, transfer, lease or otherwise dispose of
its property or assets or agree to do so at a future time except the following,
shall be expressly permitted:
(
i
)
the sale,
transfer, lease or other disposition of inventory and materials in the ordinary
course of business;
(
ii
)
the sale,
transfer or other disposition of cash and Cash Equivalents;
(
iii
)
(A) the
disposition of property or assets as a direct result of a Recovery Event or (B)
the sale, lease, transfer or other disposition of machinery, parts and equipment
no longer used or useful in the conduct of the business of the Borrower or any
of its Subsidiaries, so long as the Net Cash Proceeds from such dispositions,
sales, leases or transfers pursuant to clause (A) or (B) are used to replace
such machinery, parts and equipment or to purchase or otherwise acquire new
assets or property within 180 days of receipt of the Net Cash Proceeds or, with
respect to dispositions pursuant to clause (A), such Net Cash Proceeds are used
to prepay Loans and cash collateralize outstanding LOC Obligations in accordance
with the terms of Section 2.7(b)(iv);
provided
that,
upon the occurrence and during the continuance of a Default or an Event of
Default, the Credit Parties and their Subsidiaries shall not have the right to
reinvest such Net Cash Proceeds;
(
iv
)
the sale,
lease or transfer of property or assets between or among (
A
) the
Borrower and the Subsidiary Guarantors;
provided
that any
sale, lease or transfer of property or assets to Swiftsure and UK Ltd shall be
limited to sales or transfers of property or assets in accordance with the Tax
Structure Documents, or (
B
) the
Foreign Subsidiaries of the Company and other Foreign Subsidiaries of the
Company;
(
v
)
the
termination of any Hedging Agreement permitted pursuant to Section 6.1(f);
(
vi
)
the
factoring or disposition of receivables by SRL in connection with the
Indebtedness of SRL set forth on
Schedule
6.1(b)
;
(
vii
)
the sale
of any assets set forth on
Schedule
6.4(a)
;
provided
that the
Net Cash Proceeds from any such sale shall be applied to the Loans and the
outstanding LOC Obligations in accordance with the terms of Section 2.7(b)(ii)
(excluding any reinvestment right contained in such Section);
(
viii
)
the
liquidation or dissolution of (
A
) any
Domestic Subsidiary of the Company that has no assets or that has sold, disposed
of or otherwise transferred all of its assets to the Borrower or a Subsidiary
Guarantor, (
B
) any
Foreign Subsidiary of the Company that has no assets or that has sold, disposed
of or otherwise transferred all of its assets to the Borrower or a Subsidiary
Guarantor or another Foreign Subsidiary or (
C
)
Colgate, Victory, Swiftsure or UK Ltd if it has no assets or has sold, disposed
of or otherwise transferred all of its assets to the Borrower or a Subsidiary
Guarantor;
provided
that
Victory shall not be liquidated or dissolved unless the Administrative Agent
receives a first priority, perfected security interest in 100% of the Capital
Stock of the Borrower from the parent company of the Borrower after giving
effect to such liquidation or dissolution on terms satisfactory to the
Administrative Agent; and
(
ix
)
the sale,
lease, transfer or other disposition of property or assets not to exceed
$3,000,000 in the aggregate in any fiscal year;
provided
, that,
in the case of clauses (i), (ii), (iii), (vii) and (ix) above, at least 75% of
the consideration received therefore by the Borrower or any other Credit Party
is in the form of cash or Cash Equivalents;
provided
,
further
, that
with respect to sales, transfers, leases or other dispositions of assets
permitted hereunder only, the Administrative Agent shall without the consent of
the Required Lenders, release its Liens relating to the particular assets sold,
transferred, leased or otherwise disposed of; or
(
b
)
(
i
)
purchase, lease or otherwise acquire (in a single transaction or a series of
related transactions) the property or assets of any Person (other than
purchases, leases or other acquisitions of inventory, leases, materials,
property and equipment in the ordinary course of business, except as otherwise
limited or prohibited herein) or (
ii
) enter
into any transaction of merger or consolidation, except for (A) consummation of
the Acquisition, (B) investments or acquisitions permitted pursuant to Section
6.5, and (C) the merger or consolidation of (I) a Credit Party (other than the
Company, Colgate or Victory) with and into another Credit Party (other than the
Company, Colgate or Victory
);
provided
that
(y)
if the
Borrower is a party thereto, the Borrower will be the surviving
corporation
and (z)
the Administrative Agent’s Liens with respect to the Collateral of each Credit
Party involved in such merger or consolidation shall remain continuously
perfected
; and
(II) a Foreign Subsidiary into another Foreign Subsidiary.
|
Section
6
.
5
|
Advances, Investments
and Loans
.
|
No Credit
Party will, nor will it permit any Subsidiary to, make any Investment except for
Permitted Investments.
|
Section
6
.
6
|
Transactions with
Affiliates
.
|
Except as
permitted in subsections (c), (d), (e), (f) or (k) of the definition of
Permitted Investments, no Credit Party will, nor will it permit any Subsidiary
to, enter into any transaction or series of transactions, whether or not in the
ordinary course of business, with any officer, director, shareholder or
Affiliate other than on terms and conditions substantially as favorable as would
be obtainable in a comparable arm’s-length transaction with a Person other than
an officer, director, shareholder or Affiliate.
|
Section
6
.
7
|
Ownership of
Subsidiaries; Restrictions
.
|
Neither
Colgate, Victory, the Borrower, nor any Subsidiary Guarantor will, nor will it
permit any Subsidiary to, create, form or acquire any Subsidiaries, except for
Domestic Subsidiaries which are Credit Parties or which are joined as Additional
Credit Parties in accordance with the terms hereof. Neither Colgate, Victory,
the Borrower, nor any Subsidiary Guarantor will sell, transfer, pledge or
otherwise dispose of any Capital Stock or other equity interests in any of its
Subsidiaries, nor will it permit any of its Subsidiaries to issue, sell,
transfer, pledge or otherwise dispose of any of their Capital Stock or other
equity interests, except in a transaction permitted by Section 6.4.
|
Section
6
.
8
|
Fiscal Year;
Organizational Documents; Material Contracts; Subordinated Indebtedness
Documents.
|
Each of
the Credit Parties will not, nor will any Credit Party permit any Subsidiary to,
change its fiscal year or its accounting policies except as required by GAAP.
Except as permitted pursuant to Section 5.4, each of the Credit Parties will
not, nor will any Credit Party permit any Subsidiary to, amend, modify or change
its articles of incorporation (or corporate charter or other similar
organizational document) or bylaws (or other similar document) in a manner
adverse to the interests of the Lenders without the prior written consent of the
Required Lenders;
provided
that the
Company shall be permitted to amend such documents to provide for the issuance
of any classes or series of Capital Stock so long as such issuance does not
result in a Change of Control and the Capital Stock issued is not subject to
mandatory sinking fund payments, redemption or other acceleration or similar
rights or payments. Each of the Credit Parties will not, nor will any Credit
Party permit any Subsidiary to,
w
ithout
the prior written consent of the Administrative Agent, amend, modify, cancel or
terminate or fail to renew or extend or permit the amendment, modification,
cancellation or termination of any of the Material Contracts to the extent any
amendment, modification, cancellation, termination or failure to renew or extend
could reasonably be expected to have a Material Adverse Effect. Each of the
Credit Parties and their Subsidiaries will not, without the prior written
consent of the Required Lenders, amend, modify, waive or extend or permit the
amendment, modification, waiver or extension of any Subordinated Indebtedness or
of any documentation governing or evidencing such Subordinated Indebtedness in a
manner that is adverse to the interests of the Lenders or the issuer of such
Subordinated Indebtedness.
|
Section
6
.
9
|
Limitation on
Restricted Actions
.
|
No Credit
Party will, nor will it permit any Subsidiary to, directly or indirectly, create
or otherwise cause or suffer to exist or become effective any encumbrance or
restriction on the ability of any such Person to (a) pay dividends or make any
other distributions to any Credit Party on its Capital Stock or with respect to
any other interest or participation in, or measured by, its profits, (b) pay any
Indebtedness or other obligation owed to any Credit Party, (c) make loans or
advances to any Credit Party, (d) sell, lease or transfer any of its properties
or assets to any Credit Party, or (e) act as a guarantor and pledge its assets
pursuant to the Credit Documents or any renewals, refinancings, exchanges,
refundings or extensions thereof, except (in respect of any of the matters
referred to in clauses (a)-(d) above) for such encumbrances or restrictions
existing under or by reason of (i) this Agreement and the other Credit
Documents, (ii) applicable law, (iii) any document or instrument governing
Indebtedness incurred pursuant to Section 6.1(c) or Guaranty Obligations with
respect to any of the foregoing;
provided
that any
such restriction contained therein relates only to the asset or assets
constructed or acquired in connection therewith, or (iv) any Permitted Lien or
any document or instrument governing any Permitted Lien;
provided
that any
such restriction contained therein relates only to the asset or assets subject
to such Permitted Lien.
|
Section
6
.
10
|
Restricted
Payments
.
|
No Credit
Party will, nor will it permit any Subsidiary to, directly or indirectly,
declare, order, make or set apart any sum for or pay any Restricted Payment
except (
a
) to make
dividends or distributions payable solely in the same class of Capital Stock of
such Person (including, without limitation, stock splits provided that they are
in the same class of Capital Stock of such Person), (
b
) to make
dividends or other distributions (directly or indirectly through Subsidiaries)
payable to any Credit Party other than the Company, (
c
) to make
dividends or other distributions by a Foreign Subsidiary of the Company payable
(directly or indirectly through Subsidiaries) to any Credit Party or any other
Foreign Subsidiary, (
d
) to make
dividends payable solely to allow the Company, Colgate or Victory to pay federal
and state local taxes then due and owing, (
e
) so long
as no Event of Default has occurred and is continuing or would result therefrom,
to make (i) payments on intercompany Subordinated Indebtedness permitted under
Sections 6.1(b) and (d), or (ii) Permitted Investments in accordance with the
Tax Structure Documents;
provided
that
(
A
) no
payment shall be made pursuant to this Subsection from a Credit Party to the
Company or any Foreign Subsidiary thereof and (
B
) no
payment shall be made to Colgate or Victory except in accordance with the Tax
Structure Documents, (
f
) so long
as (
i
) no
Default or Event of Default exists or would exist on a Pro Forma Basis after
giving effect to such Restricted Payment and (
ii
) the
Leverage Ratio is less than 1.75 to 1.0 (
A
) before
giving effect to any such Restricted Payment and (
B
) on a
Pro Forma Basis after giving effect to any such Restricted Payment (and in the
case of any Restricted Payment or series of related Restricted Payments in an
amount in excess of $5,000,000, the Borrower shall have furnished to the
Administrative Agent a compliance certificate as to such compliance, together
with supporting calculations), to make Restricted Payments in an aggregate
amount that, taken together with the aggregate of all other Restricted Payments
made by the Credit Parties and their Subsidiaries (other than Restricted
Payments permitted under other subsections of this Section 6.10) from and after
the Closing Date, does not exceed the sum of 25% of Excess Cash Flow for the
period from the Closing Date to the end of the most recently ended fiscal year
for which the Company has delivered financial statements as required by Section
5.1(a) which then may be paid to the shareholders of the Company in the form of
a dividend or other distribution or may be used by the Company for other
corporate purposes, (
g
) so long
as no Default or Event of Default exists or would exist on a Pro Forma Basis
after giving effect to such Restricted Payment, to repurchase Capital Stock,
warrants, options or other rights to acquire Capital Stock of the Company from
current or former officers, employees or directors (or their heirs or estates)
of a Credit Party or any Subsidiary in connection with the death, disability or
termination of employment of any such Person in an aggregate amount not to
exceed $2,500,000 in any fiscal year and $5,000,000 during the term of this
Agreement, (
h
)
(
i
) to make
distributions to pay regularly scheduled interest payments on Subordinated
Indebtedness issued by a Credit Party permitted by Section 6.1(h) pursuant to
the subordination provisions applicable thereto
and
(
ii
) to the
extent that Net Cash Proceeds resulting from the issuance of Subordinated
Indebtedness pursuant to Section 6.1(h) shall have been applied to repay the
Term Loan as set forth in Section 2.7(b) (and not to finance Permitted
Acquisitions) and so long as no Default or Event of Default shall have occurred
and be continuing, or would result therefrom on an actual or Pro Forma Basis, if
any such Subordinated Indebtedness shall contain a provision permitting a holder
thereof to convert or exchange such Indebtedness for common equity of the
Company and/or cash, to make payments in respect thereof upon the occurrence of
the event giving rise to such holders right to conversion or exchange and
(
i
) so long
as no Default or Event of Default exists or would exist on a Pro Forma Basis
after giving effect to such Restricted Payment, (A) the Company may make earnout
payments and any other deferred payment paid as consideration pursuant to a
Permitted Acquisition by the Company and (B) the Borrower and its Subsidiaries
may make earnout payments and any other deferred payment paid as consideration
pursuant to a Permitted Acquisition by the Borrower or any of its
Subsidiaries.
|
Section
6
.
11
|
Sale
Leasebacks
.
|
No Credit
Party will, nor will it permit any Subsidiary to, directly or indirectly become
or remain liable as lessee or as guarantor or other surety with respect to any
lease, whether an operating lease or a Capital Lease, of any property (whether
real, personal or mixed), whether now owned or hereafter acquired, which any
Credit Party or any Subsidiary has sold or transferred or is to sell or transfer
to a Person which is not another Credit Party or Subsidiary
thereof.
|
Section
6
.
12
|
No Further Negative
Pledges
.
|
No Credit
Party will, nor will it permit any Subsidiary to, enter into, assume or become
subject to any agreement prohibiting or otherwise restricting the creation or
assumption of any Lien upon its properties or assets, whether now owned or
hereafter acquired, or requiring the grant of any security for such obligation
if security is given for some other obligation, except (a) pursuant to this
Agreement and the other Credit Documents, (b) pursuant to any document or
instrument governing Indebtedness incurred pursuant to Section 6.1(c),
provided
that any
such restriction contained therein relates only to the asset or assets
constructed or acquired in connection therewith and (c) in connection with any
Permitted Lien or any document or instrument governing any Permitted Lien;
provided
that any
such restriction contained therein relates only to the asset or assets subject
to such Permitted Lien.
|
Section
6
.
13
|
Accounts
.
|
Set forth
on
Schedule
6.13
is a
complete and accurate list of all checking, savings or other accounts (including
securities accounts) of the Credit Parties at any bank or other financial
institution, or any other account where money is or may be deposited or
maintained with any Person as of the Closing Date. At anytime on or after
November 22, 2006, each of the Credit Parties (other than the Company) will not,
nor will it permit any Subsidiary to, o
pen,
maintain or otherwise have any checking, savings or other accounts (including
securities accounts) at any bank or other financial institution, or any other
account where money is or may be deposited or maintained with any Person, other
than (
a
) the
accounts set forth on
Schedule
6.13
and
designated as unrestricted accounts;
provided
that the
balance on any such account does not exceed $500,000 and the aggregate balance
in all such accounts does not exceed $1,500,000, (
b
) deposit
accounts that are subject to a Deposit Account Control Agreement, (
c
)
securities accounts that are subject to a Securities Account Control Agreement,
(
d
) deposit
accounts established solely as payroll and other zero balance accounts and
(
e
) deposit
accounts, so long as at any time the balance in any such account does not exceed
$500,000 and the aggregate balance in all such accounts does not exceed
$1,500,000.
ARTICLE
VII
EVENTS OF DEFAULT
|
Section
7
.
1
|
Events of
Default
.
|
An Event
of Default shall exist upon the occurrence of any of the following specified
events (each an “
Event of
Default
”):
(
a
)
The
Borrower shall fail to pay any principal on any Loan when due in accordance with
the terms thereof or hereof; or the Borrower shall fail to reimburse the Issuing
Lender for any outstanding LOC Obligations when due in accordance with the terms
hereof; or the Borrower shall fail to pay any interest on any Loan or any fee or
other amount payable hereunder when due in accordance with the terms thereof or
hereof and such failure shall continue unremedied for three (3) Business Days
(or any Guarantor shall fail to pay on the Guaranty in respect of any of the
foregoing or in respect of any other Guaranty Obligations thereunder within the
aforesaid period of time); or
(
b
)
Any
representation or warranty made or deemed made herein or in any of the other
Credit Documents or which is contained in any certificate, document or financial
or other written statement furnished at any time under or in connection with
this Agreement shall prove to have been incorrect, false or misleading in any
material respect on or as of the date made or deemed made; or
(
c
)
(i) Any
of the Credit Parties or their Subsidiaries shall fail to perform, comply with
or observe any term, covenant or agreement applicable to it contained in Section
5.1(a), (b) and (c), Section 5.2, Section 5.4, Section 5.7(a) and (d), Section
5.9 or Article VI hereof; or (ii) any Credit Party shall fail to comply with any
other covenant, contained in this Credit Agreement or the other Credit Documents
or any other agreement, document or instrument among any Credit Party, the
Administrative Agent and the Lenders or executed by any Credit Party in favor of
the Administrative Agent or the Lenders (other than as described in Sections
7.1(a), 7.1(b) or 7.1(c)(i) above), and in the event such breach or failure to
comply is capable of cure, is not cured within thirty (30) days of its
occurrence; or
(
d
)
Any of
the Credit Parties or their Subsidiaries shall (i) default in any payment
of principal of or interest on any Indebtedness (other than the Notes) in a
principal amount outstanding of at least $5,000,000 in the aggregate for the
Credit Parties and their Subsidiaries beyond the period of grace (not to exceed
30 days), if any, provided in the instrument or agreement under which such
Indebtedness was created; (ii) default in the observance or performance of any
other agreement or condition relating to any Indebtedness in a principal amount
outstanding of at least $5,000,000 in the aggregate for the Credit Parties and
their Subsidiaries or contained in any instrument or agreement evidencing,
securing or relating thereto, or any other event shall occur or condition exist,
and, with respect to the foregoing, the effect of such default or other event or
condition is to cause, or to permit the holder or holders of such Indebtedness
or beneficiary or beneficiaries of such Indebtedness (or a trustee or agent on
behalf of such holder or holders or beneficiary or beneficiaries) to cause, with
the giving of notice if required, such Indebtedness to become due prior to its
stated maturity; or (
iii
) default
under any Secured Hedging Agreement; or
(
e
)
(i) Any
of the Credit Parties or their Subsidiaries shall commence any case, proceeding
or other action (A) under any existing or future law of any jurisdiction,
domestic or foreign, relating to bankruptcy, insolvency, reorganization or
relief of debtors, seeking to have an order for relief entered with respect to
it, or seeking to adjudicate it a bankrupt or insolvent, or seeking
reorganization, arrangement, adjustment, suspension of payment, winding-up,
liquidation, dissolution, composition or other relief with respect to it or its
debts, or (B) seeking appointment of a receiver, trustee, custodian,
conservator, administrator, administrative receiver, compulsory manager or other
similar official for it or for all or any substantial part of its assets, or the
Credit Parties or their Subsidiaries shall make a general assignment or
arrangement for the benefit of any of its creditors; or (ii) there shall be
commenced against any of the Credit Parties or their Subsidiaries any case,
proceeding or other action of a nature referred to in clause (i) above which (A)
results in the entry of an order for relief or any such adjudication or
appointment or (B) remains undismissed, undischarged or unbonded for, with
respect to such proceeding or other action in a jurisdiction outside the United
States, a period of thirty (30) days and, with respect to such proceeding or
other action in a United States jurisdiction, a period of sixty (60) days; or
(iii) there shall be commenced against any of the Credit Parties or their
Subsidiaries, any case, proceeding or other action seeking issuance of a warrant
of attachment, execution, distraint or similar process against all or any
substantial part of its assets which results in the entry of an order for any
such relief which shall not have been vacated, discharged, or stayed or bonded
pending appeal within, with respect to such case, proceeding or other action in
a jurisdiction outside the United States, thirty (30) days from the entry
thereof and, with respect such case, proceeding or other action in a United
States jurisdiction, sixty (60) days from the entry thereof; or (iv) any of the
Credit Parties or their Subsidiaries shall take any action in furtherance of, or
indicating its consent to, approval of, or acquiescence in, any of the acts set
forth in clauses (i), (ii), or (iii) above; or (v) any of the Credit Parties
(together with their Subsidiaries taken as a whole) shall fail to be Solvent;
or
(
f
)
One or
more judgments or decrees shall be entered against any of the Credit Parties and
shall not have been paid and satisfied, vacated, discharged, stayed or bonded
pending appeal within ten (10) days from the entry thereof to the extent such
judgments and decrees involve a liability (to the extent not paid when due or
covered by insurance in excess of $5,000,000 in the aggregate); or
(
g
)
(i) Any
Person shall engage in any “prohibited transaction” (as defined in Section 406
of ERISA or Section 4975 of the Code) involving any Single Employer Plan, (ii)
any “accumulated funding deficiency” (as defined in Section 302 of ERISA),
whether or not waived, shall exist with respect to any Single Employer Plan or
any Lien in favor of a Single Employer Plan or in favor of the PBGC with respect
to a Single Employer Plan (other than a Permitted Lien) shall arise on the
assets of any Credit Party or any Commonly Controlled Entity, (iii) a Reportable
Event shall occur with respect to, or proceedings shall commence to have a
trustee appointed, or a trustee shall be appointed, to administer or to
terminate, any Single Employer Plan, which Reportable Event or commencement of
proceedings or appointment of a Trustee is, in the reasonable opinion of the
Required Lenders, likely to result in the termination of such Plan for purposes
of Title IV of ERISA, (iv) any Single Employer Plan shall terminate for purposes
of Title IV of ERISA, or (v) any Credit Party or any Commonly Controlled
Entity shall incur any liability in connection with a withdrawal from, or the
Insolvency or Reorganization of, any Multiemployer Plan; and in each case in
clauses (i) through (v) above, such event or condition, together with all other
such events or conditions, if any, could reasonably be expected to have a
Material Adverse Effect; or
(
h
)
There
shall occur a Change of Control; or
(
i
)
The
Guaranty or any provision thereof shall cease to be in full force and effect or
any Guarantor or any Person authorized to act by or on behalf of any Guarantor
shall deny or disaffirm any Guarantor’s obligations under the Guaranty;
or
(
j
)
(i) Any
other Credit Document or any security interest or Lien granted thereunder shall
fail to be in full force and effect, shall be declared null and void or shall
fail to give the Administrative Agent and/or the Lenders the security interests,
liens, perfection, priority, rights, powers and privileges purported to be
created thereby (except as such documents may be terminated or no longer in
force and effect in accordance with the terms thereof, other than those
indemnities and provisions which by their terms shall survive); or (ii) any
Credit Party or any Person authorized to act by or on behalf of any Credit Party
shall deny or disaffirm any Credit Party Obligations or shall deny, disaffirm or
contest the validity, perfection or priority of any security interest or Lien
granted under the Security Documents; or
(
k
)
Any
default (which is not waived or cured within the applicable period of grace) or
event of default shall occur under any document governing or evidencing any
Subordinated Indebtedness or the subordination provisions contained therein
shall cease to be in full force and effect or to give the Administrative Agent
and the Lenders the rights, powers and privileges purported to be created
thereby; or
(
l
)
any
Credit Party shall be temporarily or permanently excluded from, or have payments
suspended under, (i) any Medicaid Provider Agreement, Medicaid Certification,
Medicare Provider Agreement or Medicare Certification or (ii) any Medical
Reimbursement Program, where such exclusion or suspension arises from fraud or
other claims or allegations which, individually or in the aggregate, could
reasonably be expected to have a Material Adverse Effect.
|
Section
7
.
2
|
Acceleration;
Remedies
.
|
Upon the
occurrence and during the continuation of an Event of Default, then, and in any
such event, (a) if such event is an Event of Default specified in Section 7.1(e)
above with respect to any Credit Party or any material Subsidiary of the
Company, automatically the Commitments shall immediately terminate and the Loans
(with accrued interest thereon), and all other amounts under the Credit
Documents (including without limitation the maximum amount of all contingent
liabilities under Letters of Credit) shall immediately become due and payable,
and (b) if such event is any other Event of Default, any or all of the following
actions may be taken: (i) with the written consent of the Required Lenders, the
Administrative Agent may, or upon the written request of the Required Lenders,
the Administrative Agent shall, by notice to the Borrower declare the
Commitments to be terminated forthwith, whereupon the Commitments shall
immediately terminate; (ii) the Administrative Agent may, or upon the written
request of the Required Lenders, the Administrative Agent shall, by notice of
default to the Borrower, declare the Loans (with accrued interest thereon) and
all other
amounts
owing under this Agreement and the Notes to be due and payable forthwith and
direct the Borrower to pay to the Administrative Agent cash collateral as
security for the outstanding LOC Obligations for subsequent drawings under then
outstanding Letters of Credit in an amount equal to the maximum amount of which
may be drawn under Letters of Credit then outstanding, whereupon the same shall
immediately become due and payable; (iii) exercise any rights or remedies of the
Administrative Agent or the Lenders under this Agreement or any other Credit
Document, including, without limitation, any rights or remedies with respect to
the Collateral; and (iv) exercise any rights or remedies available to the
Administrative Agent or Lenders under applicable law.
ARTICLE
VIII
THE AGENT
|
Section
8
.
1
|
Appointment
.
|
Each
Lender hereby irrevocably designates and appoints Wachovia Bank, National
Association as the Administrative Agent of such Lender under this Agreement, and
each such Lender irrevocably authorizes Wachovia Bank, National Association, as
the Administrative Agent for such Lender, to take such action on its behalf
under the provisions of this Agreement and to exercise such powers and perform
such duties as are expressly delegated to the Administrative Agent by the terms
of this Agreement, together with such other powers as are reasonably incidental
thereto. Notwithstanding any provision to the contrary elsewhere in this
Agreement, the Administrative Agent shall not have any duties or
responsibilities, except those expressly set forth herein, or any fiduciary
relationship with any Lender, and no implied covenants, functions,
responsibilities, duties, obligations or liabilities shall be read into this
Agreement or otherwise exist against the Administrative Agent.
|
Section
8
.
2
|
Delegation of
Duties
.
|
The
Administrative Agent may execute any of its duties under this Agreement by or
through agents or attorneys-in-fact and shall be entitled to advice of counsel
concerning all matters pertaining to such duties. The Administrative Agent shall
not be responsible for the negligence or misconduct of any agents or
attorneys-in-fact selected by it with reasonable care. Without limiting the
foregoing, but subject to the provisions of Section 8.3, the Administrative
Agent may appoint one of its affiliates as its agent to perform the functions of
the Administrative Agent hereunder relating to the advancing of funds to the
Borrower and distribution of funds to the Lenders and to perform such other
related functions of the Administrative Agent hereunder as are reasonably
incidental to such functions.
|
Section
8
.
3
|
Exculpatory
Provisions
.
|
Neither
the Administrative Agent nor any of its officers, directors, employees, agents,
attorneys-in-fact or affiliates shall be (i) liable for any action lawfully
taken or omitted to be taken by it or such Person under or in connection with
this Agreement (except for its or such Person’s own gross negligence or willful
misconduct) or (ii) responsible in any manner to any of the Lenders for any
recitals, statements, representations or warranties made by the Borrower or any
officer thereof contained in this Agreement or in any certificate, report,
statement or other document referred to or provided for in, or received by the
Administrative Agent under or in connection with, this Agreement or for the
value, validity, effectiveness, genuineness, enforceability or sufficiency of
any of the Credit Documents or for any failure of the Borrower to perform its
obligations hereunder or thereunder. The Administrative Agent shall not be under
any obligation to any Lender to ascertain or to inquire as to the observance or
performance by the Borrower of any of the agreements contained in, or conditions
of, this Agreement, or to inspect the properties, books or records of the
Borrower and its Subsidiaries.
|
Section
8
.
4
|
Reliance by
Administrative Agent
.
|
(
a
)
The
Administrative Agent shall be entitled to rely, and shall be fully protected in
relying, upon any Note, writing, resolution, notice, consent, certificate,
affidavit, letter, cablegram, telegram, telecopy, telex or teletype message,
statement, order or other document or conversation believed by it in good faith
to be genuine and correct and to have been signed, sent or made by the proper
Person or Persons and upon advice and statements of legal counsel (including,
without limitation, counsel to any Credit Party), independent accountants and
other experts selected by the Administrative Agent. The Administrative Agent may
deem and treat the payee of any Note as the owner thereof for all purposes
unless (a) a written notice of assignment, negotiation or transfer thereof shall
have been filed with the Administrative Agent and (b) the Administrative Agent
shall have received the written agreement of such assignee to be bound hereby as
fully and to the same extent as if such assignee were an original Lender party
hereto, in each case in form satisfactory to the Administrative Agent. The
Administrative Agent shall be fully justified in failing or refusing to take any
action under this Agreement unless it shall first receive such advice or
concurrence of the Required Lenders as it deems appropriate or it shall first be
indemnified to its satisfaction by the Lenders against any and all liability and
expense which may be incurred by it by reason of taking or continuing to take
any such action. The Administrative Agent shall in all cases be fully protected
in acting, or in refraining from acting, under any of the Credit Documents in
accordance with a request of the Required Lenders or all of the Lenders, as may
be required under this Agreement, and such request and any action taken or
failure to act pursuant thereto shall be binding upon all the Lenders and all
future holders of the Notes.
(
b
)
For
purposes of determining compliance with the conditions specified in
Section 4.1, each Lender that has signed this Agreement shall be deemed to
have consented to, approved or accepted or to be satisfied with, each document
or other matter required thereunder to be consented to or approved by or
acceptable or satisfactory to a Lender.
|
Section
8
.
5
|
Notice of
Default
.
|
The
Administrative Agent shall not be deemed to have knowledge or notice of the
occurrence of any Default or Event of Default hereunder unless the
Administrative Agent has received notice from a Lender or the Borrower referring
to this Agreement, describing such Default or Event of Default and stating that
such notice is a “notice of default”. In the event that the Administrative Agent
receives such a notice, the Administrative Agent shall give prompt notice
thereof to the Lenders. The Administrative Agent shall take such action with
respect to such Default or Event of Default as shall be reasonably directed by
the Required Lenders;
provided
,
however
, that
unless and until the Administrative Agent shall have received such directions,
the Administrative Agent may (but shall not be obligated to) take such action,
or refrain from taking such action, with respect to such Default or Event of
Default as it shall deem advisable in the best interests of the Lenders except
to the extent that this Credit Agreement expressly requires that such action be
taken, or not taken, only with the consent or upon the authorization of the
Required Lenders, or all of the Lenders, as the case may be.
|
Section
8
.
6
|
Non-Reliance on
Administrative Agent and Other Lenders
.
|
Each
Lender expressly acknowledges that neither the Administrative Agent nor any of
its officers, directors, employees, agents, attorneys-in-fact or affiliates has
made any representation or warranty to it and that no act by the Administrative
Agent hereinafter taken, including any review of the affairs of the Borrower,
shall be deemed to constitute any representation or warranty by the
Administrative Agent to any Lender. Each Lender represents to the Administrative
Agent that it has, independently and without reliance upon the Administrative
Agent or any other Lender, and based on such documents and information as it has
deemed appropriate, made its own appraisal of and investigation into the
business, operations, property, financial and other condition and
creditworthiness of the Borrower and made its own decision to make its Loans
hereunder and enter into this Agreement. Each Lender also represents that it
will, independently and without reliance upon the Administrative Agent or any
other Lender, and based on such documents and information as it shall deem
appropriate at the time, continue to make its own credit analysis, appraisals
and decisions in taking or not taking action under this Agreement, and to make
such investigation as it deems necessary to inform itself as to the business,
operations, property, financial and other condition and creditworthiness of the
Borrower. Except for notices, reports and other documents expressly required to
be furnished to the Lenders by the Administrative Agent hereunder, the
Administrative Agent shall not have any duty or responsibility to provide any
Lender with any credit or other information concerning the business, operations,
property, condition (financial or otherwise), prospects or creditworthiness of
the Borrower which may come into the possession of the Administrative Agent or
any of its officers, directors, employees, agents, attorneys-in-fact or
affiliates.
|
Section
8
.
7
|
Indemnification
.
|
The
Lenders agree to indemnify the Administrative Agent and the Revolving Lenders
agree to indemnify the Issuing Lender and the Swingline Lender, in each case in
its capacity hereunder and their Affiliates and their respective officers,
directors, agents and employees (to the extent not reimbursed by the Borrower
and without limiting any obligation of the Borrower to do so), ratably according
to their respective Commitment Percentages in effect on the date on which
indemnification is sought under this Section, from and against any and all
liabilities, obligations, losses, damages, penalties, actions, judgments, suits,
costs, expenses or disbursements of any kind whatsoever which may at any time
(including, without limitation, at any time following the payment of the Notes)
be imposed on, incurred by or asserted against any such indemnitee in any way
relating to or arising out of any Credit Document or any documents contemplated
by or referred to herein or therein or the transactions contemplated hereby or
thereby or any action taken or omitted by any such indemnitee under or in
connection with any of the foregoing;
provided
,
however
, that no
Lender shall be liable for the payment of any portion of such liabilities,
obligations, losses, damages, penalties, actions, judgments, suits, costs,
expenses or disbursements to the extent resulting from such indemnitee’s gross
negligence or willful misconduct, as determined by a court of competent
jurisdiction. The agreements in this Section 8.7 shall survive the termination
of this Agreement and payment of the Notes and all other amounts payable
hereunder.
|
Section
8
.
8
|
Administrative Agent
in Its Individual Capacity
.
|
The
Administrative Agent and its affiliates may make loans to, accept deposits from
and generally engage in any kind of business with the Borrower as though the
Administrative Agent were not the Administrative Agent hereunder. With respect
to its Loans made or renewed by it and any Note issued to it, the Administrative
Agent shall have the same rights and powers under this Agreement as any Lender
and may exercise the same as though it were not the Administrative Agent, and
the terms “Lender” and “Lenders” shall include the Administrative Agent in its
individual capacity.
|
Section
8
.
9
|
Successor
Administrative Agent
.
|
The
Administrative Agent may resign as Administrative Agent upon thirty (30)
days’ prior written notice to the Borrower and the Lenders. If the
Administrative Agent shall resign as Administrative Agent, then the Required
Lenders shall appoint from among the Lenders (with such Lender’s consent) a
successor agent for the Lenders, which successor agent shall in the absence of a
Default or an Event of Default be approved by the Borrower (which approval shall
not be unreasonably withheld or delayed), whereupon such successor agent shall
succeed to the rights, powers and duties of the Administrative Agent, and the
term “Administrative Agent” shall mean such successor agent effective upon such
appointment and approval, and the former Administrative Agent’s rights, powers
and duties as Administrative Agent shall be terminated, without any other or
further act or deed on the part of such former Administrative Agent or any of
the parties to this Agreement or any holders of the Notes. If no such successor
shall have been so appointed by the Required Lenders and shall have accepted
such appointment within thirty (30) days after the retiring Administrative
Agent gives notice of its resignation, then such resignation shall nonetheless
become effective in accordance with such notice and (
a
) the
retiring Administrative Agent shall be discharged from its duties and
obligations hereunder and under the other Credit Documents (except that in the
case of any Collateral held by the Administrative Agent on behalf of the Secured
Parties, the retiring Administrative Agent shall continue to hold such
Collateral until such time as a successor Administrative Agent is appointed) and
(b) all payments, communications and determinations provided to be made by,
to or through the Administrative Agent shall instead be made by or to (i) each
Lender and the Issuing Lender directly with respect to payments and
communications and (ii) the Required Lenders with respect to any determination,
until such time as the Required Lenders appoint a successor Administrative Agent
as provided for above in this paragraph. After any retiring Administrative
Agent’s resignation as Administrative Agent, the provisions of this Section 8.9
shall inure to its benefit as to any actions taken or omitted to be taken by it
while it was Administrative Agent under this Agreement.
|
Section
8
.
10
|
Other
Agents
.
|
None of
the Lenders or other Persons identified on the cover page or signature pages of
this Agreement as a “syndication agent,” “documentation agent,” “co-agent,”
“book manager,” “bookrunner,” “joint bookrunner,” “lead manager,” “arranger,”
“lead arranger,” “joint lead arrangers” or “co-arranger” shall have any right
(except as expressly set forth herein), power, obligation, liability,
responsibility or duty under this Agreement or under any other Credit Document
other than, in the case of such Lenders, those applicable to all Lenders as
such;
provided
,
however
, that
the agents and co-lead arrangers shall be entitled to the same rights,
protections, exculpations and indemnifications granted to the Administrative
Agent under this Article VIII in their capacity as an agent or co-lead
arranger. Without limiting the foregoing, none of the Lenders or other Persons
so identified shall have or be deemed to have any fiduciary relationship with
any Lender. Each Lender acknowledges that it has not relied, and will not rely,
on any of the Lenders or other Persons so identified in deciding to enter into
this Credit Agreement or in taking or not taking action hereunder.
|
Section
8
.
11
|
Releases
.
|
The
Administrative Agent will promptly release any Guarantor and any Lien on any
Collateral, which is sold, transferred or otherwise disposed of as permitted by
the Credit Agreement or as otherwise permitted by the Lenders or Required
Lenders, as applicable.
ARTICLE
IX
MISCELLANEOUS
|
Section
9
.
1
|
Amendments, Waivers
and Release of Collateral
.
|
Neither
this Agreement, nor any of the other Credit Documents, nor any terms hereof or
thereof may be amended, supplemented, waived or modified except in accordance
with the provisions of this Section. The Required Lenders may, or, with the
written consent of the Required Lenders, the Administrative Agent may, from time
to time, (a) enter into with the Credit Parties written amendments,
supplements or modifications hereto and/or to the other Credit Documents for the
purpose of adding, deleting or modifying any provisions to this Agreement or the
other Credit Documents or changing in any manner the rights or obligations of
the Lenders or of the Credit Parties hereunder or thereunder or (b) waive, on
such terms and conditions as the Required Lenders may specify in such
instrument, any of the requirements of this Agreement or the other Credit
Documents or any Default or Event of Default and its consequences;
provided
,
however
, that no
such waiver and no such amendment, waiver, supplement, modification or release
shall:
(
i
)
reduce
the amount or extend the scheduled date of maturity of any Loan, Note or LOC
Obligation or any installment thereon, or reduce the stated rate of any interest
or fee payable hereunder (except in connection with a waiver of interest at the
increased post-default rate set forth in Section 2.9 which shall be determined
by a vote of the Required Lenders) or extend the scheduled date of any payment
thereof or increase the amount or extend the expiration date of any Lender’s
Commitment, in each case without the written consent of each Lender directly
affected thereby;
provided
that, it
is understood and agreed that (A) no waiver, reduction or deferral of a
mandatory prepayment required pursuant to Section 2.7(b), nor any amendment of
Section 2.7(b) or the definitions of Asset Disposition, Debt Issuance, Equity
Issuance, Excess Cash Flow or Recovery Event,
shall
constitute a reduction of the amount of, or an extension of the scheduled date
of maturity of, or any installment of, any Loan, Note or LOC Obligation, (B) any
reduction in the stated rate of interest on Revolving Loans shall only require
the written consent of each Lender holding a Revolving Commitment and (C) any
reduction in the stated rate of interest on the Term Loan shall only require the
written consent of each Lender holding a portion of the outstanding Term Loan;
or
(
ii
)
amend,
modify or waive any provision of this Section or reduce the percentage specified
in the definition of Required Lenders, without the written consent of all the
Lenders; or
(
iii
)
amend,
modify or waive any provision of Article VIII without the written consent of the
then Administrative Agent; or
(
iv
)
release
the Borrower or all or substantially all of the Guarantors from obligations
under the Guaranty, without the written consent of all of the Lenders and the
Hedging Agreement Providers; or
(
v
)
release
all or substantially all of the Collateral without the written consent of all of
the Lenders and Hedging Agreement Providers; or
(
vi
)
subordinate
any Credit Party Obligations to any other Indebtedness or the Liens securing the
Credit Party Obligations to any other Indebtedness without the written consent
of all of the Lenders; or
(
vii
)
permit a
Letter of Credit to have an original expiry date more than twelve (12) months
from the date of issuance without the consent of each of the Revolving Lenders;
provided
, that
the expiry date of any Letter of Credit may be extended in accordance with the
terms of Section 2.3(a); or
(
viii
)
permit
any Credit Party to assign or transfer any of its rights or obligations under
this Agreement or other Credit Documents without the written consent of all of
the Lenders; or
(
ix
)
amend or
modify the definition of Credit Party Obligations to delete or exclude any
obligation or liability described therein without the written consent of each
Lender and each Hedging Agreement Provider directly affected thereby;
or
(
x
)
amend,
modify or waive any provision of the Credit Documents requiring consent,
approval or request of the Required Lenders or all Lenders without the written
consent of the Required Lenders or all the Lenders as appropriate;
or
(
xi
)
without
the consent of Revolving Lenders holding in the aggregate more than 50% of the
outstanding Revolving Commitments (or if the Revolving Commitments have been
terminated, the aggregate principal amount of outstanding Revolving Loans),
amend, modify or waive any provision in Section 4.2 or waive any Default or
Event of Default (or amend any Credit Document to effectively waive any Default
or Event of Default) if the effect of such amendment, modification or waiver is
that the Revolving Lenders shall be required to fund Revolving Loans when such
Lenders would otherwise not be required to do so; or
(
xii
)
amend,
modify or waive the order in which Credit Party Obligations are paid or in a
manner that would alter the pro rata sharing of payments by and among the
Lenders, including, without limitation, as provided in Section 2.12,
without the written consent of each Lender and each Hedging Agreement Provider
directly affected thereby; or
(
xiii
)
amend the
definitions of “Hedging Agreement,” “Secured Hedging Agreement,” or “Hedging
Agreement Provider” without the consent of any Hedging Agreement Provider that
would be adversely affected thereby.
provided
,
further
, that no
amendment, waiver or consent affecting the rights or duties of the
Administrative Agent, the Issuing Lender or the Swingline Lender under any
Credit Document shall in any event be effective, unless in writing and signed by
the Administrative Agent, the Issuing Lender and/or the Swingline Lender, as
applicable, in addition to the Lenders required hereinabove to take such action.
Any such
waiver, any such amendment, supplement or modification and any such release
shall apply equally to each of the Lenders and shall be binding upon the
Borrower, the other Credit Parties, the Lenders, the Administrative Agent and
all future holders of the Notes. In the case of any waiver, the Borrower, the
other Credit Parties, the Lenders and the Administrative Agent shall be restored
to their former position and rights hereunder and under the outstanding Loans
and Notes and other Credit Documents, and any Default or Event of Default
permanently waived shall be deemed to be cured and not continuing; but no such
waiver shall extend to any subsequent or other Default or Event of Default, or
impair any right consequent thereon.
Notwithstanding
any of the foregoing to the contrary, the consent of the Borrower shall not be
required for any amendment, modification or waiver of the provisions of Article
VIII (other than the provisions of Section 8.9);
provided
,
however
, that
the Administrative Agent will provide written notice to the Borrower of any such
amendment, modification or waiver.
Notwithstanding
the fact that the consent of all the Lenders is required in certain
circumstances as set forth above, (x) each Lender is entitled to vote as such
Lender sees fit on any bankruptcy reorganization plan that affects the Loans,
and each Lender acknowledges that the provisions of Section 1126(c) of the
Bankruptcy Code supersedes the unanimous consent provisions set forth herein and
(y) the Required Lenders may consent to allow a Credit Party to use cash
collateral in the context of a bankruptcy or insolvency proceeding.
Except as
otherwise provided in Article II, all notices, requests and demands to or upon
the respective parties hereto to be effective shall be in writing (including by
telecopy or other electronic communication with confirmed receipt from the
recipient), and, unless otherwise expressly provided herein, shall be deemed to
have been duly given or made (a) when delivered by hand, (b) when
transmitted via telecopy (or other electronic communication device with
confirmed receipt from the recipient) to the number set out herein, (c) the day
following the day on which the same has been delivered prepaid (or pursuant to
an invoice arrangement) to a reputable national overnight air courier service,
or (d) the third Business Day following the day on which the same is sent by
certified or registered mail, postage prepaid, in each case, addressed as
follows in the case of the Borrower, the other Credit Parties and the
Administrative Agent, and, in the case of each of the Lenders, as set forth in
such Lender’s Administrative Details Form, or to such other address as may be
hereafter notified by the respective parties hereto and any future holders of
the Notes:
|
The
Borrower
|
Orthofix
Holdings, Inc.
|
|
and
the other
|
The
Storrs Building, Suite 250
|
|
Credit
Parties:
|
10115
Kincey Avenue
|
Huntersville
Business Park
Huntersville,
North Carolina 28078
Attention:
Thomas
Hein
Telecopier:
704 948
2691
Telephone:
704 948
2635
|
The
Administrative
|
Wachovia
Bank, National Association, as Administrative
Agent
|
201 South
College Street
NC0680/CP8
Charlotte,
North Carolina 28288-0680
Attention:
Syndication
Agency Services
Telecopier:
(704)
715-1125
Telephone:
(704)
383-0288
with a
copy to:
Wachovia
Bank, National Association
One
Wachovia Center
301 South
College Street, TW 15
NC5562
Charlotte,
North Carolina 28288-0737
Attention:
Scott
Santa Cruz
Telecopier:
(704)
383-7611
Telephone:
(704)
383-1988
|
Section
9
.
3
|
No Waiver; Cumulative
Remedies
.
|
No
failure to exercise and no delay in exercising, on the part of the
Administrative Agent or any Lender, any right, remedy, power or privilege
hereunder shall operate as a waiver thereof; nor shall any single or partial
exercise of any right, remedy, power or privilege hereunder preclude any other
or further exercise thereof or the exercise of any other right, remedy, power or
privilege. The rights, remedies, powers and privileges herein provided are
cumulative and not exclusive of any rights, remedies, powers and privileges
provided by law.
|
Section
9
.
4
|
Survival of
Representations and Warranties
.
|
All
representations and warranties made hereunder and in any document, certificate
or statement delivered pursuant hereto or in connection herewith shall survive
the execution and delivery of this Agreement and the Notes and the making of the
Loans;
provided
that all
such representations and warranties shall terminate on the date upon which the
Commitments have been terminated, no Credit Document remains in effect and all
Credit Party Obligations have been paid in full.
|
Section
9
.
5
|
Payment of Expenses
and Taxes
.
|
The
Borrower agrees (a) to pay or reimburse the Administrative Agent and the
Arranger for all their reasonable out-of-pocket costs and expenses incurred in
connection with the development, preparation, negotiation, printing and
execution of, and any amendment, supplement or modification to, this Agreement
and the other Credit Documents and any other documents prepared in connection
herewith or therewith (including, without limitation, all CUSIP fees for
registration with S&P’s CUSIP Service Bureau, together with the reasonable
fees and disbursements of counsel to the Administrative Agent and the Arranger,
(b) to pay or reimburse the Administrative Agent and, if an Event of
Default shall have occurred and is continuing, each Lender for all its costs and
expenses incurred in connection with the enforcement or preservation of any
rights under this Agreement and the other Credit Documents, including, without
limitation, the reasonable fees and disbursements of counsel to the
Administrative Agent, and if applicable, and to the Lenders (including
reasonable allocated costs of in-house legal counsel), (c) on demand, to
pay, indemnify, and hold each Lender, the Administrative Agent and the Arranger
harmless from, any and all recording and filing fees and any and all liabilities
with respect to, or resulting from any delay in paying, stamp, excise and other
similar taxes, if any, which may be payable or determined to be payable in
connection with the execution and delivery of, or consummation or administration
of any of the transactions contemplated by, or any amendment, supplement or
modification of, or any waiver or consent under or in respect of, the Credit
Documents and any such other documents; except for any and all stamp, excise and
other similar taxes payable in connection with any transfer under Section 9.6 of
this Agreement, (d) to pay, indemnify, and hold each Lender, the
Administrative Agent, the Arranger and their Affiliates and their respective
officers, directors, employees, partners, members, counsel, agents,
representatives, advisors and affiliates (collectively called the
“
Indemnitees
”
)
harmless from and against, any and all other liabilities, obligations, losses,
damages, penalties, actions, judgments, suits, costs, expenses or disbursements
of any kind or nature whatsoever with respect to the execution, delivery,
enforcement, performance and administration of the Credit Documents and any such
other documents and the use, or proposed use, of proceeds of the Loans and
(e) to pay any civil penalty or fine assessed by the U.S. Department of the
Treasury’s Office of Foreign Assets Control against, and all reasonable costs
and expenses (including counsel fees and disbursements) incurred in connection
with defense thereof by the Administrative Agent or any Lender as a result of
the funding of Loans, the issuance of Letters of Credit, the acceptance of
payments or of Collateral due under the Credit Documents (all of the foregoing,
collectively, the “
Indemnified
Liabilities
”);
provided
,
however
, that
the Borrower shall not have any obligation hereunder to an Indemnitee with
respect to Indemnified Liabilities arising from the gross negligence or willful
misconduct of such Indemnitee, as determined by a court of competent
jurisdiction pursuant to a final non-appealable judgment. The agreements in this
Section shall survive repayment of the Loans, Notes and all other amounts
hereunder.
|
Section
9
.
6
|
Successors and
Assigns; Participations; Purchasing Lenders
.
|
(
a
)
This
Agreement shall be binding upon and inure to the benefit of the Credit Parties,
the Lenders, the Administrative Agent, all future holders of the Notes and their
respective successors and assigns, except that the Credit Parties may not assign
or transfer any of their rights or obligations under this Agreement or the other
Credit Documents without the prior written consent of each Lender.
(
b
)
Any
Lender may, in the ordinary course of its business and in accordance with
applicable law, at any time sell to one or more banks or other entities
(“
Participants
”)
participating interests in any Loan owing to such Lender, any Note held by such
Lender, any Commitment of such Lender, or any other interest of such Lender
hereunder. In the event of any such sale by a Lender of participating interests
to a Participant, such Lender’s obligations under this Agreement to the other
parties to this Agreement shall remain unchanged, such Lender shall remain
solely responsible for the performance thereof, such Lender shall remain the
holder of any such Note for all purposes under this Agreement, and the Borrower
and the Administrative Agent shall continue to deal solely and directly with
such Lender in connection with such Lender’s rights and obligations under this
Agreement. No Lender shall transfer or grant any participation under which the
Participant shall have rights to approve any amendment to, or supplement,
modification or waiver of, this Agreement or any other Credit Document except to
the extent such amendment, supplement, modification or waiver would
(i) extend the scheduled maturity of any Loan or Note or any installment
thereon in which such Participant is participating, or reduce the stated rate or
extend the time of payment of interest or fees thereon (except in connection
with a waiver of interest at the increased post-default rate set forth in
Section 2.9 which shall be determined by a vote of the Required Lenders) or
reduce the principal amount thereof, or increase the amount of the Participant’s
participation over the amount thereof then in effect;
provided
that, it
is understood and agreed that (A) any waiver, reduction or deferral of a
mandatory prepayment required pursuant to Section 2.7(b) and any amendment of
Section 2.7(b) or the definitions of Asset Disposition, Debt Issuance, Equity
Issuance,
or
Recovery Event, (B) any waiver of any Default or Event of Default and (C) any
increase in any Commitment or Loan shall be permitted without consent of any
participant if the Participant’s participation is not increased as a result
thereof, (ii) release all or substantially all of the Guarantors from their
obligations under the Guaranty,
(iii)
release
all or substantially all of the Collateral, or
(iv)
consent
to the assignment or transfer by the Borrower of any of its rights and
obligations under this Agreement. In the case of any such participation, the
Participant shall not have any rights under this Agreement or any of the other
Credit Documents (the Participant’s rights against such Lender in respect of
such participation to be those set forth in the agreement executed by such
Lender in favor of the Participant relating thereto) and all amounts payable by
the Borrower hereunder shall be determined as if such Lender had not sold such
participation;
provided
that
each Participant shall be entitled to the benefits of Sections 2.14, 2.15, 2.16,
2.17 and 9.5 with respect to its participation in the Commitments and the Loans
outstanding from time to time;
provided
further
, that no
Participant shall be entitled to receive any greater amount pursuant to such
Sections than the transferor Lender would have been entitled to receive in
respect of the amount of the participation transferred by such transferor Lender
to such Participant had no such transfer occurred.
(
c
)
Any
Lender may, in accordance with applicable law, at any time, sell or assign to
any Lender or any Affiliate or Approved Fund thereof and to one or more
additional banks, insurance companies, financial institutions, investment funds
or other entities (“
Purchasing
Lenders
”), all
or any part of its rights and obligations under this Agreement and the Notes in
minimum amounts of (i) $1,000,000 (or such lesser amount approved by the
Administrative Agent and, so long as no Default or Event of Default shall have
occurred and be continuing, the Borrower) with respect to its Revolving
Commitment and its Revolving Loans (or, if less, the entire amount of such
Lender’s Revolving Commitment and Revolving Loans) and (ii) $1,000,000 (or
such lesser amount approved by the Administrative Agent and so long as no
Default or Event of Default shall have occurred and be continuing, the Borrower)
with respect to its Term Loans (or, if less, the entire amount of such Lender’s
Term Loans), pursuant to an Assignment Agreement, executed by such Purchasing
Lender and such transferor Lender, consented to (such consent not to be
unreasonably withheld or delayed) by the Administrative Agent, the Issuing
Lender and the Borrower (to the extent required), and delivered to the
Administrative Agent for its acceptance and recording in the Register;
provided
,
however
, that
(A) any sale or assignment to an existing Lender, or Affiliate or Approved
Fund thereof, shall not require the consent of the Borrower, the Issuing Lender
or the Administrative Agent (but shall be accepted and acknowledged by the
Administrative Agent for the sole purpose of recording same in the Register) nor
shall any such sale or assignment be subject to the minimum assignment amounts
specified herein, (B) so long as no Default or Event of Default shall have
occurred and be continuing, except as provided in the foregoing clause (A), any
sale or assignment of a portion of the Revolving Loans and a Revolving Loan
Commitment shall require the consent of the Borrower
(such
consent not to be unreasonably withheld), (C) except as provided in the
foregoing clause (ii), any sale or assignment of a portion of the Term Loan and
a Term Loan Commitment shall not require the consent of the Borrower and (D)
contemporaneous sales and/or assignments to a Purchasing Lender and its
Affiliates and Approved Funds shall be treated as one assignment for purposes of
determining compliance with the minimum assignment amounts specified herein.
Upon such execution, delivery, acceptance and recording, from and after the
Transfer Effective Date specified in such Assignment Agreement, (1) the
Purchasing Lender thereunder shall be a party hereto and, to the extent provided
in such Assignment Agreement, have the rights and obligations of a Lender
hereunder with a Commitment as set forth therein, and (2) the transferor
Lender thereunder shall, to the extent provided in such Assignment Agreement, be
released from its obligations under this Agreement (and, in the case of an
Assignment Agreement covering all or the remaining portion of a transferor
Lender’s rights and obligations under this Agreement, such transferor Lender
shall cease to be a party hereto;
provided
,
however
, that
such Lender shall continue to be entitled to any indemnification rights that
expressly survive hereunder). Such Assignment Agreement shall be deemed to amend
this Agreement to the extent, and only to the extent, necessary to reflect the
addition of such Purchasing Lender and the resulting adjustment of Commitment
Percentages arising from the purchase by such Purchasing Lender of all or a
portion of the rights and obligations of such transferor Lender under this
Agreement and the Notes. On or prior to the Transfer Effective Date specified in
such Assignment Agreement, the Borrower, at its own expense, shall execute and
deliver to the Administrative Agent in exchange for the Notes delivered to the
Administrative Agent pursuant to such Assignment Agreement new Notes to the
order of such Purchasing Lender in an amount equal to the Commitment assumed by
it pursuant to such Assignment Agreement and, unless the transferor Lender has
not retained a Commitment hereunder, new Notes to the order of the transferor
Lender in an amount equal to the Commitment retained by it hereunder. Such new
Notes shall be in the form of the Notes replaced thereby. Notwithstanding
anything to the contrary contained in this Section, a Lender may assign any or
all of its rights under this Agreement to an Affiliate or a Approved Fund of
such Lender without delivering an Assignment Agreement to the Administrative
Agent;
provided
,
however
, that
(x) the Credit Parties and the Administrative Agent may continue to deal solely
and directly with such assigning Lender until an Assignment Agreement has been
delivered to the Administrative Agent for recordation on the Register, (y) the
failure of such assigning Lender to deliver an Assignment Agreement to the
Administrative Agent shall not affect the legality, validity or binding effect
of such assignment and (z) an Assignment Agreement between the assigning Lender
and an Affiliate or Approved Fund of such Lender shall be effective as of the
date specified in such Assignment Agreement.
(
d
)
The
Administrative Agent shall maintain at its address referred to in
Section 9.2 a copy of each Assignment Agreement delivered to it and a
register (the “
Register
”) for
the recordation of the names and addresses of the Lenders and the Commitment of,
and principal amount of the Loans owing to, each Lender from time to time.
Subject to the requirements of Section 9.6(c), a Loan (and the related Note)
recorded on the Register may be assigned or sold in whole or in part upon
registration of such assignment or sale on the Register. The entries in the
Register shall be conclusive, in the absence of manifest error, and the
Borrower, the Administrative Agent and the Lenders may treat each Person whose
name is recorded in the Register as the owner of the Loan recorded therein for
all purposes of this Agreement. The Register shall be available for inspection
by the Borrower or any Lender at any reasonable time and from time to time upon
reasonable prior notice. In the case of an assignment pursuant to the last
sentence of Section 9.6(c) as to which an Assignment Agreement is not delivered
to the Administrative Agent, the assigning Lender shall, acting solely for this
purpose as a non-fiduciary agent of the Credit Parties, maintain a comparable
register on behalf of the Credit Parties. In the event that any Lender sells
participations in a Loan recorded on the Register, such Lender shall maintain a
register on which it enters the name of all participants in such Loans held by
it (the “
Participant
Register
”). A
Loan recorded on the Register (and the registered Note, if any, evidencing the
same) may be participated in whole or in part only by registration of such
participation on the Participant Register (and each registered Note shall
expressly so provide). Any participation of such Loan recorded on the Register
(and the registered Note, if any, evidencing the same) may be effected only by
the registration of such participation on the Participant Register.
(
e
)
Upon its
receipt of a duly executed Assignment Agreement, together with payment to the
Administrative Agent by the transferor Lender or the Purchasing Lender, as
agreed between them, of a registration and processing fee of $3,500 for each
Purchasing Lender (other than a Purchasing Lender that is an Affiliate or
Approved Fund of the transferor Lender) listed in such Assignment Agreement and
the Notes subject to such Assignment Agreement, the Administrative Agent shall
(i) accept such Assignment Agreement, (ii) record the information
contained therein in the Register and
(iii)
give
prompt notice of such acceptance and recordation to the Lenders and the
Borrower.
(
f
)
The
Borrower authorizes each Lender to disclose to any Participant or Purchasing
Lender (each, a “
Transferee
”) and
any prospective Transferee any and all financial information in such Lender’s
possession concerning the Borrower and its Subsidiaries which has been delivered
to such Lender by or on behalf of the Borrower pursuant to this Agreement or
which has been delivered to such Lender by or on behalf of the Borrower in
connection with such Lender’s credit evaluation of the Borrower and its
Affiliates prior to becoming a party to this Agreement, in each case subject to
Section 9.15.
(
g
)
At the
time of each assignment pursuant to this Section to a Person which is not
already a Lender hereunder and which is not a United States person (as such
term is defined in Section 7701(a)(30) of the Code) for Federal income tax
purposes, the respective assignee Lender shall provide to the Borrower and the
Administrative Agent the appropriate Internal Revenue Service Forms described in
Section 2.18.
(
h
)
Nothing
herein shall prohibit any Lender from pledging or assigning any of its rights
under this Agreement (including, without limitation, any right to payment of
principal and interest under any Note) to secure obligations of such Lender,
including without limitation, (i) any pledge or assignment to secure
obligations to a Federal Reserve Bank and (ii) in the case of any Lender
that is a fund or trust or entity that invests in commercial bank loans in the
ordinary course of business, any pledge or assignment to any holders of
obligations owed, or securities issued, by such Lender including to any trustee
for, or any other representative of, such holders; it being understood that the
requirements for assignments set forth in this Section shall not apply to any
such pledge or assignment of a security interest, except with respect to any
foreclosure or similar action taken by such pledgee or assignee with respect to
such pledge or assignment;
provided
that no
such pledge or assignment of a security interest shall release a Lender from any
of its obligations hereunder or substitute any such pledgee or assignee for such
Lender as a party hereto and no such pledgee or assignee shall have any voting
rights under this Agreement unless and until the requirements for assignments
set forth in this Section are complied with in connection with any foreclosure
or similar action taken by such pledgee or assignee.
|
Section
9
.
7
|
Adjustments;
Set-off
.
|
(
a
)
Each
Lender agrees that if any Lender (a “
benefited
Lender
”) shall
at any time receive any payment of all or part of its Loans, or interest
thereon, or receive any collateral in respect thereof (whether voluntarily or
involuntarily, by set-off, pursuant to events or proceedings of the nature
referred to in Section 7.1(e), or otherwise) in a greater proportion than any
such payment to or collateral received by any other Lender, if any, in respect
of such other Lender’s Loans, or interest thereon, such benefited Lender shall
purchase for cash from the other Lenders a participating interest in such
portion of each such other Lender’s Loan, or shall provide such other Lenders
with the benefits of any such collateral, or the proceeds thereof, as shall be
necessary to cause such benefited Lender to share the excess payment or benefits
of such collateral or proceeds ratably with each of the Lenders;
provided
,
however
, that if
all or any portion of such excess payment or benefits is thereafter recovered
from such benefited Lender, such purchase shall be rescinded, and the purchase
price and benefits returned, to the extent of such recovery, but without
interest. The Borrower agrees that each Lender so purchasing a portion of
another Lender’s Loans may exercise all rights of payment (including, without
limitation, rights of set-off) with respect to such portion as fully as if such
Lender were the direct holder of such portion.
(
b
)
In
addition to any rights and remedies of the Lenders provided by law (including,
without limitation, other rights of set-off), each Lender (and its Affiliates)
shall have the right, without prior notice to the Borrower, any such notice
being expressly waived by the Borrower to the extent permitted by applicable
law, in the event that all amounts under the Credit Agreement shall have become
immediately due and payable pursuant to Section 7.2, to setoff and appropriate
and apply any and all deposits (general or special, time or demand, provisional
or final), in any currency, and any other credits, indebtedness or claims, in
any currency, in each case whether direct or indirect, absolute or contingent,
matured or unmatured, at any time held by or owing to such Lender (and its
Affiliates) or any branch or agency thereof to or for the credit or the account
of the Borrower or any other Credit Party, or any part thereof in such amounts
as such Lender (and its Affiliates) may elect, against and on account of the
Loans and other Credit Party Obligations of the Borrower and the other Credit
Parties and claims of every nature and description of such Lender against the
Borrower and the other Credit Parties, in any currency, whether arising
hereunder, under any other Credit Document or any Secured Hedging Agreement
provided pursuant to the terms of this Agreement, as such Lender may elect,
whether or not such Lender or any other Lender has made any demand for payment
and although such obligations, liabilities and claims may be contingent or
unmatured. The aforesaid right of set-off may be exercised by such Lender (and
its Affiliates) against the Borrower, any other Credit Party or against any
trustee in bankruptcy, debtor in possession, assignee for the benefit of
creditors, receiver or execution, judgment or attachment creditor of the
Borrower or any other Credit Party, or against anyone else claiming through or
against the Borrower, any other Credit Party or any such trustee in bankruptcy,
debtor in possession, assignee for the benefit of creditors, receiver, or
execution, judgment or attachment creditor, notwithstanding the fact that such
right of set-off shall not have been exercised by such Lender (or its
Affiliates) prior to the occurrence of any Event of Default. Each Lender agrees
promptly to notify the Borrower and the Administrative Agent after any such
set-off and application made by such Lender (and its Affiliates);
provided
,
however
, that
the failure to give such notice shall not affect the validity of such set-off
and application.
|
Section
9
.
8
|
Table of Contents and
Section Headings
.
|
The table
of contents and the Section and subsection headings herein are intended for
convenience only and shall be ignored in construing this Agreement.
|
Section
9
.
9
|
Counterparts
.
|
This
Agreement may be executed by one or more of the parties to this Agreement on any
number of separate counterparts, and all of said counterparts taken together
shall be deemed to constitute one and the same agreement. Delivery of an
executed counterpart of a signature page of this Agreement by telecopy or email
shall be effective as delivery of a manually executed counterpart of this
Agreement and shall constitute a representation that an original executed
counterpart will follow.
|
Section
9
.
10
|
Effectiveness
.
|
This
Credit Agreement shall become effective on the date on which all of the parties
have signed a copy hereof (whether the same or different copies) and shall have
delivered the same to the Administrative Agent pursuant to Section 9.2 or, in
the case of the Lenders, shall have given to the Administrative Agent written,
telecopied or other electronic notice with confirmed receipt from the recipient
at such office that the same has been signed and mailed to it.
|
Section
9
.
11
|
Severability
.
|
Any
provision of this Agreement that is prohibited or unenforceable in any
jurisdiction shall, as to such jurisdiction, be ineffective to the extent of
such prohibition or unenforceability without invalidating the remaining
provisions hereof, and any such prohibition or unenforceability in any
jurisdiction shall not invalidate or render unenforceable such provision in any
other jurisdiction.
|
Section
9
.
12
|
Integration
.
|
This
Agreement and the other Credit Documents represent the agreement of the
Borrower, the Administrative Agent and the Lenders with respect to the subject
matter hereof, and there are no promises, undertakings, representations or
warranties by the Administrative Agent, the Borrower or any Lender relative to
the subject matter hereof not expressly set forth or referred to herein or in
the other Credit Documents or Fee Letters.
|
Section
9
.
13
|
Governing
Law
.
|
This
Agreement and the other Credit Documents (other than the UK Security Documents)
and the rights and obligations of the parties under this Agreement and the other
Credit Documents (other than the UK Security Documents) shall be governed by,
and construed and interpreted in accordance with, the law of the State of New
York.
|
Section
9
.
14
|
Consent to
Jurisdiction and Service of Process
.
|
All
judicial proceedings brought against any party hereto with respect to this
Agreement, any Note or any of the other Credit Documents may be brought in any
state or federal court of competent jurisdiction in the State of New York, and,
by execution and delivery of this Agreement, each of such parties accepts, for
itself and in connection with its properties, generally and unconditionally, the
non-exclusive jurisdiction of the aforesaid courts and irrevocably agrees to be
bound by any final judgment rendered thereby in connection with this Agreement,
any Note or any other Credit Document from which no appeal has been taken or is
available. The parties hereto irrevocably agree that all service of process in
any such proceedings in any such court may be effected by mailing a copy thereof
by registered or certified mail (or any substantially similar form of mail),
postage prepaid, to it at its address set forth in Section 9.2 or at such other
address of which the Administrative Agent or the Borrower shall have been
notified pursuant thereto, such service being hereby acknowledged by the parties
hereto to be effective and binding service in every respect. Each of the parties
hereto irrevocably waives any objection, including, without limitation, any
objection to the laying of venue based on the grounds of forum non conveniens
which it may now or hereafter have to the bringing of any such action or
proceeding in any such jurisdiction. Nothing herein shall affect the right to
serve process in any other manner permitted by law or shall limit the right of
any party to bring proceedings against any other party in the court of any other
jurisdiction.
|
Section
9
.
15
|
Confidentiality
.
|
Each of
the Administrative Agent, the Lenders and the Issuing Bank agrees to maintain
the confidentiality of the Information (as defined below), except that
Information may be disclosed (
a
) to its
Affiliates and to its and its Affiliates’ respective partners, directors,
officers, employees, agents, advisors and other representatives (it being
understood and agreed that the Persons to whom such disclosure is made will be
informed of the confidential nature of such Information and instructed to keep
such Information confidential), (
b
) to the
extent requested by any regulatory authority purporting to have jurisdiction
over it (including any self-regulatory authority, such as the National
Association of Insurance Commissioners), (
c
) to the
extent required by applicable laws or regulations or by any subpoena or similar
legal process, (
d
) to any
other party hereto, (
e
) in
connection with the exercise of any remedies hereunder or under any other Credit
Document or any action or proceeding relating to this Agreement or any other
Credit Document or the enforcement of rights hereunder or thereunder,
(
f
) subject
to an agreement containing provisions substantially the same as those of this
Section, to (
i
) any
assignee of or Participant in, or any prospective assignee of or Participant in,
any of its rights or obligations under this Agreement
,
(
ii
) any
actual or prospective counterparty (or its advisors) to any swap or derivative
transaction relating to the Borrower and its obligations, (
iii
) to an
investor or prospective investor in an Approved Fund
that
also agrees that Information shall be used solely for the purpose of evaluating
an investment in such Approved Fund, (
iv
) to a
trustee, collateral manager, servicer, backup servicer, noteholder or secured
party in an Approved Fund in connection with the administration, servicing and
reporting on the assets serving as collateral for an Approved Fund
, or
(
v
) to a
nationally recognized rating agency that requires access to information
regarding the Credit Parties, the Loans and Credit Documents in connection with
ratings issued with respect to an Approved Fund, (
g
) with
the consent of the Borrower or (
h
) to the
extent such Information (
i
) becomes
publicly available other than as a result of a breach of this Section or
(
ii
) becomes
available to the Administrative Agent, any Lender, the Issuing Bank or any of
their respective Affiliates on a nonconfidential basis from a source other than
a Credit Party.
For
purposes of this Section, “
Information
” means
all information received from any Credit Party or any of its Subsidiaries
relating to any Credit Party or any of its Subsidiaries or any of their
respective businesses, other than any such information that is available to the
Administrative Agent, any Lender or the Issuing Lender on a nonconfidential
basis prior to disclosure by any Credit Party or any of its Subsidiaries. Any
Person required to maintain the confidentiality of Information as provided in
this Section shall be considered to have complied with its obligation to do so
if such Person has exercised the same degree of care to maintain the
confidentiality of such Information as such Person would accord to its own
confidential information.
|
Section
9
.
16
|
Acknowledgments
.
|
The
Borrower and the other Credit Parties each hereby acknowledges
that:
(
a
)
it has
been advised by counsel in the negotiation, execution and delivery of each
Credit Document;
(
b
)
neither
the Administrative Agent nor any Lender has any fiduciary relationship with or
duty to the Borrower or any other Credit Party arising out of or in connection
with this Agreement and the relationship between Administrative Agent and
Lenders, on one hand, and the Borrower and the other Credit Parties, on the
other hand, in connection herewith is solely that of creditor and debtor;
and
(
c
)
no joint
venture exists among the Lenders or among the Borrower or the other Credit
Parties and the Lenders.
|
Section
9
.
17
|
Waivers of Jury
Trial
.
|
THE
BORROWER, THE OTHER CREDIT PARTIES, THE ADMINISTRATIVE AGENT AND THE LENDERS
HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVE, TO THE EXTENT PERMITTED BY
APPLICABLE LAW, TRIAL BY JURY IN ANY LEGAL ACTION OR PROCEEDING RELATING TO THIS
AGREEMENT OR ANY OTHER CREDIT DOCUMENT AND FOR ANY COUNTERCLAIM THEREIN.
Each of
the Borrower, the other Credit Parties, the Administrative Agent and the Lenders
agree not to assert any claim against any other party to this Agreement or any
their respective directors, officers, employees, attorneys, Affiliates or
agents, on any theory of liability, for special, indirect, consequential or
punitive damages arising out of or otherwise relating to any of the transactions
contemplated herein.
|
Section
9
.
18
|
Patriot Act
Notice
.
|
Each
Lender and the Administrative Agent (for itself and not on behalf of any other
party) hereby notifies the Borrower that, pursuant to the requirements of the
USA Patriot Act, Title III of Pub. L. 107-56, signed into law October 26, 2001
(the “
Patriot
Act
”), it is
required to obtain, verify and record information that identifies the Borrower
and the other Credit Parties, which information includes the name and address of
the Borrower and the other Credit Parties and other information that will allow
such Lender or the Administrative Agent, as applicable, to identify the Borrower
and the other Credit Parties in accordance with the Patriot Act.
|
Section
9
.
19
|
Resolution of Drafting
Ambiguities
.
|
Each
Credit Party acknowledges and agrees that it was represented by counsel in
connection with the execution and delivery of this Agreement and the other
Credit Documents to which it is a party, that it and its counsel reviewed and
participated in the preparation and negotiation hereof and thereof and that any
rule of construction to the effect that ambiguities are to be resolved against
the drafting party shall not be employed in the interpretation hereof or
thereof.
|
Section
9
.
20
|
Judgment Currency;
Payments in Dollars
.
|
If, for
the purposes of obtaining judgment in any court, it is necessary to convert a
sum due hereunder or under any other Credit Document in one currency into
another currency, the rate of exchange used shall be that at which in accordance
with normal banking procedures the Administrative Agent could purchase the first
currency with such other currency on the Business Day preceding that on which
final judgment is given. The obligation of each of the Credit Parties in respect
of any such sum due from it to the Administrative Agent or any Lender hereunder
or under the other Credit Documents shall, notwithstanding any judgment in a
currency (the “
Judgment
Currency
”) other
than Dollars, be discharged only to the extent that on the Business Day
following receipt by the Administrative Agent or such Lender of any sum adjudged
to be so due in the Judgment Currency, the Administrative Agent or such Lender
may in accordance with normal banking procedures purchase Dollars with the
Judgment Currency. If the amount of Dollars so purchased is less than the sum
originally due to the Administrative Agent or such Lender in Dollars, the
Borrower agrees, as a separate obligation and notwithstanding any such judgment,
to indemnify the Administrative Agent or such Lender or the Person to whom such
obligation was owing against such loss. If the amount of Dollars so purchased is
greater than the sum originally due to the Administrative Agent or such Lender
in such currency, the Administrative Agent and the Lenders agree to apply such
excess to any Credit Party Obligations then due and payable in accordance with
the terms of Section 2.12. Notwithstanding anything to the contrary in any
Credit Documents, all payments made by the Credit Parties under the Credit
Documents shall be made in Dollars.
|
Section
9
.
21
|
Arbitration
.
|
(
a
)
Notwithstanding
the provisions of Section 9.14 to the contrary, upon demand of any party
hereto, whether made before or within three (3) months after institution of
any judicial proceeding, any dispute, claim or controversy arising out of,
connected with or relating to this Agreement and other Credit Documents
(“
Disputes
”)
between or among parties to this Agreement shall be resolved by binding
arbitration as provided herein. Institution of a judicial proceeding by a party
does not waive the right of that party to demand arbitration hereunder. Disputes
may include, without limitation, tort claims, counterclaims, disputes as to
whether a matter is subject to arbitration, claims brought as class actions,
claims arising from Credit Documents executed in the future, or claims arising
out of or connected with the transaction reflected by this Agreement.
Arbitration
shall be conducted under and governed by the Commercial Arbitration Rules (the
“
Arbitration
Rules
”) of the
American Arbitration Association (the “
AAA
”) and
Title 9 of the U.S. Code. All arbitration hearings shall be conducted in
Charlotte, North Carolina. A hearing shall begin within ninety (90)
day
s of
demand for arbitration and all hearings shall be concluded within
120
day
s of
demand for arbitration. These time limitations may not be extended unless a
party shows cause for extension and then no more than a total extension of sixty
(60)
day
s. The
expedited procedures set forth in Rule 51
et
seq
. of the
Arbitration Rules shall be applicable to claims of less than $1,000,000. All
applicable statutes of limitation shall apply to any Dispute. A judgment upon
the award may be entered in any court having jurisdiction. Arbitrators shall be
licensed attorneys selected from the Commercial Financial Dispute Arbitration
Panel of the AAA. The parties hereto do not waive applicable Federal or state
substantive law except as provided herein.
(
b
)
Notwithstanding
the preceding binding arbitration provisions, the Administrative Agent, the
Lenders, the Borrowers and the other Credit Parties agree to preserve, without
diminution, certain remedies, as set forth below, that the Administrative Agent
on behalf of the Lenders may employ or exercise freely, independently or in
connection with an arbitration proceeding or after an arbitration action is
brought. The Administrative Agent on behalf of the Lenders shall have the right
to proceed in any court of proper jurisdiction or by self-help to exercise or
prosecute the following remedies, as and if applicable (i) all rights to
foreclose against any real or personal property or other security by exercising
a power of sale granted under Credit Documents or under applicable law or by
judicial foreclosure and sale, including a proceeding to confirm the sale;
(ii) all rights of self-help including peaceful occupation of real property
and collection of rents, set-off, and peaceful possession of personal property
and giving notices to and collecting obligations from account debtors;
(iii) obtaining provisional or ancillary remedies including injunctive
relief, sequestration, garnishment, attachment, appointment of receiver and
filing an involuntary bankruptcy proceeding; and (iv) when applicable, a
judgment by confession of judgment. Preservation of these remedies does not
limit the power of an arbitrator to grant similar remedies that may be requested
by a party in a Dispute.
(
c
)
The
parties hereto agree that they shall not have a remedy of punitive or exemplary
damages against the other in any Dispute and hereby waive any right or claim to
punitive or exemplary damages they have now or which may arise in the future in
connection with any Dispute whether the Dispute is resolved by arbitration or
judicially.
(
d
)
By
execution and delivery of this Agreement, each of the parties hereto accepts,
for itself and in connection with its properties, generally and unconditionally,
the non-exclusive jurisdiction relating to any arbitration proceedings conducted
under the Arbitration Rules in Charlotte, North Carolina and irrevocably agrees
to be bound by any final judgment rendered thereby in connection with this
Agreement from which no appeal has been taken or is available.
ARTICLE
X
GUARANTY
|
Section
10
.
1
|
The
Guaranty
.
|
In order
to induce the Lenders to enter into this Credit Agreement and any Hedging
Agreement Provider to enter into any Secured Hedging Agreement and to extend
credit hereunder and thereunder and in recognition of the direct benefits to be
received by the Guarantors from the Extensions of Credit hereunder and any
Secured Hedging Agreement, each of the Guarantors hereby agrees with the
Administrative Agent and the Lenders as follows: the Guarantor hereby
unconditionally and irrevocably jointly and severally guarantees as primary
obligor and not merely as surety the full and prompt payment when due, whether
upon maturity, by acceleration or otherwise, of any and all indebtedness of the
Borrower owed to the Administrative Agent, the Lenders and the Hedging Agreement
Providers. If any or all of the indebtedness becomes due and payable hereunder
or under any Secured Hedging Agreement, each Guarantor unconditionally promises
to pay such indebtedness to the Administrative Agent, the Lenders, the Hedging
Agreement Providers, or their respective order, or demand, together with any and
all reasonable expenses which may be incurred by the Administrative Agent, the
Lenders or the Hedging Agreement Providers in collecting any of the Credit Party
Obligations. The word “indebtedness” is used in this Article X in its most
comprehensive sense and includes any and all advances, debts, obligations and
liabilities of the Borrower and the Guarantors, including specifically all
Credit Party Obligations, arising in connection with this Credit Agreement, the
other Credit Documents or any Secured Hedging Agreement, in each case,
heretofore, now, or hereafter made, incurred or created, whether voluntarily or
involuntarily, absolute or contingent, liquidated or unliquidated, determined or
undetermined, whether or not such indebtedness is from time to time reduced, or
extinguished and thereafter increased or incurred, whether the Borrower and the
Guarantors may be liable individually or jointly with others, whether or not
recovery upon such indebtedness may be or hereafter become barred by any statute
of limitations, and whether or not such indebtedness may be or hereafter become
otherwise unenforceable. Notwithstanding anything herein or in any other Credit
Document to the contrary, the Guaranty provided hereunder is a guaranty of
payment and not of collection.
Notwithstanding
any provision to the contrary contained herein or in any other of the Credit
Documents, to the extent the obligations of a Guarantor shall be adjudicated to
be invalid or unenforceable for any reason (including, without limitation,
because of any applicable law relating to fraudulent conveyances or transfers)
then the obligations of each such Guarantor hereunder shall be limited to the
maximum amount that is permissible under applicable law (including, without
limitation, the Bankruptcy Code or its non-U.S. equivalent).
|
Section
10
.
2
|
Bankruptcy
.
|
Additionally,
each of the Guarantors unconditionally and irrevocably guarantees jointly and
severally the payment of any and all Credit Party Obligations of the Borrower to
the Lenders and any Hedging Agreement Provider whether or not due or payable by
the Borrower upon the occurrence of any of the events specified in
Section 7.1(e) as applicable to the Company, Colgate, Victory, the Borrower
or any material Subsidiaries of the Borrower, and unconditionally promises to
pay such Credit Party Obligations to the Administrative Agent for the account of
the Lenders and to any such Hedging Agreement Provider, or order, on demand, in
lawful money of the United States. Each of the Borrower and the Guarantors
further agrees that to the extent that the Borrower or a Guarantor shall make a
payment or a transfer of an interest in any property to the Administrative
Agent, any Lender or any Hedging Agreement Provider, which payment or transfer
or any part thereof is subsequently invalidated, declared to be fraudulent or
preferential, or otherwise is avoided, and/or required to be repaid to the
Borrower or a Guarantor, the
estate of
the Borrower or a Guarantor, a trustee, receiver or any other party under any
bankruptcy law, state or federal law, common law or other applicable law or
equitable cause, then to the extent of such avoidance or repayment, the
obligation or part thereof intended to be satisfied shall be revived and
continued in full force and effect as if said payment had not been
made.
|
Section
10
.
3
|
Nature of
Liability
.
|
The
liability of each Guarantor hereunder is exclusive and independent of any
security for or other guaranty of the Credit Party Obligations of the Borrower
whether executed by any such Guarantor, any other guarantor or by any other
party, and no Guarantor’s liability hereunder shall be affected or impaired by
(a) any direction as to application of payment by the Borrower or by any other
party, or (b) any other continuing or other guaranty, undertaking or maximum
liability of a guarantor or of any other party as to the Credit Party
Obligations of the Borrower, or (c) any payment on or in reduction of any such
other guaranty or undertaking, or (d) any dissolution, termination or increase,
decrease or change in personnel by the Borrower, or (e) any payment made to the
Administrative Agent, the Lenders or any Hedging Agreement Provider on the
Credit Party Obligations that the Administrative Agent, such Lenders or such
Hedging Agreement Provider repay the Borrower pursuant to court order in any
bankruptcy, reorganization, arrangement, moratorium or other debtor relief
proceeding, and each of the Guarantors waives any right to the deferral or
modification of its obligations hereunder by reason of any such
proceeding.
|
Section
10
.
4
|
Independent
Obligation
.
|
The
obligations of each Guarantor hereunder are independent of the obligations of
any other guarantor or the Borrower, and a separate action or actions may be
brought and prosecuted against each Guarantor whether or not action is brought
against any other guarantor or the Borrower and whether or not any other
Guarantor or the Borrower is joined in any such action or actions.
|
Section
10
.
5
|
Authorization
.
|
Each of
the Guarantors authorizes the Administrative Agent, each Lender and each Hedging
Agreement Provider without notice or demand (except as shall be required by
applicable law and cannot be waived), and without affecting or impairing its
liability hereunder, from time to time to (a) renew, compromise, extend,
increase, accelerate or otherwise change the time for payment of, or otherwise
change the terms of the Credit Party Obligations or any part thereof in
accordance with this Agreement and any Secured Hedging Agreement, as applicable,
including any increase or decrease of the rate of interest thereon, (b) take and
hold security from any Guarantor or any other party for the payment of this
Guaranty or the Credit Party Obligations and exchange, enforce, waive and
release any such security, (c) apply such security and direct the order or
manner of sale thereof as the Administrative Agent and the Lenders in their
discretion may determine in accordance with the terms of this Agreement and the
other Credit Documents and (d) release or substitute any one or more endorsers,
Guarantors, the Borrower or other obligors.
|
Section
10
.
6
|
Reliance
.
|
It is not
necessary for the Administrative Agent, the Lenders or any Hedging Agreement
Providers to inquire into the capacity or powers of the Borrower or the
officers, directors, members, partners or agents acting or purporting to act on
its behalf, and any indebtedness made or created in reliance upon the professed
exercise of such powers shall be guaranteed hereunder.
(
a
)
Each of
the Guarantors waives any right (except as shall be required by applicable law
and cannot be waived) to require the Administrative Agent, any Lender or any
Hedging Agreement Provider to (i) proceed against the Borrower, any other
guarantor or any other party, (ii) proceed against or exhaust any security held
from the Borrower, any other guarantor or any other party, or (iii) pursue any
other remedy in the Administrative Agent’s, any Lender’s or any Hedging
Agreement Provider’s power whatsoever. Each of the Guarantors waives any defense
based on or arising out of any defense of the Borrower, any other guarantor or
any other party other than payment in full of the Credit Party Obligations,
including without limitation any defense based on or arising out of
(
A
) the
disability of the Borrower, any other guarantor or any other party,
(
B
) the
unenforceability or invalidity of the Credit Party Obligations or any part
thereof from any cause, (
C
) the
failure to properly perfect any Lien on the Collateral, (
D
) the
amendment, modification or waiver of any Credit Document without the consent of
such Guarantor, (
E
) any law
or regulation of any jurisdiction or any other event affecting any term of the
Guaranty or the other Credit Party Obligations, or (
F
) the
cessation from any cause of the liability of the Borrower other than payment in
full of the Credit Party Obligations. The Administrative Agent or any of the
Lenders may, at their election, foreclose on any security held by the
Administrative Agent or a Lender by one or more judicial or nonjudicial sales,
whether or not every aspect of any such sale is commercially reasonable (to the
extent such sale is permitted by applicable law), or exercise any other right or
remedy the Administrative Agent and any Lender may have against the Borrower or
any other party, or any security, without affecting or impairing in any way the
liability of any Guarantor hereunder except to the extent the Credit Party
Obligations have been paid in full. Each of the Guarantors, to the extent
permitted by law, waives any defense arising out of any such election by the
Administrative Agent and each of the Lenders, even though such election operates
to impair or extinguish any right of reimbursement or subrogation or other right
or remedy of the Guarantors against the Borrower or any other party or any
security.
(
b
)
Each of
the Guarantors waives all presentments, demands for performance, protests and
notices, including without limitation notices of nonperformance, notices of
protest, notices of dishonor, notices of acceptance of this Guaranty, and
notices of the existence, creation or incurring of new or additional Credit
Party Obligations. Each Guarantor assumes all responsibility for being and
keeping itself informed of the Borrower’s financial condition and assets, and of
all other circumstances bearing upon the risk of nonpayment of the Credit Party
Obligations and the nature, scope and extent of the risks which such Guarantor
assumes and incurs hereunder, and agrees that neither the Administrative Agent
nor any Lender shall have any duty to advise such Guarantor of information known
to it regarding such circumstances or risks.
(
c
)
Each of
the Guarantors hereby agrees it will not exercise any rights of subrogation
which it may at any time otherwise have as a result of this Guaranty (whether
contractual, under Section 509 of the U.S. Bankruptcy Code, or otherwise) to the
claims of the Lenders or the Hedging Agreement Provider against the Borrower or
any other guarantor of the Credit Party Obligations of the Borrower owing to the
Lenders or such Hedging Agreement Provider (collectively, the “
Other
Parties
”) or any
contractual, statutory or common law rights of reimbursement, contribution or
indemnity from any Other Party which it may at any time otherwise have as a
result of this Guaranty until such time as the Credit Party Obligations shall
have been paid in full, no Credit Document or Secured Hedging Agreement remains
in effect and the Commitments have been terminated. Each of the Guarantors
hereby further agrees not to exercise any right to enforce any other remedy
which the Administrative Agent, the Lenders or any Hedging Agreement Provider
now has or may hereafter have against any Other Party, any endorser or any other
guarantor of all or any part of the Credit Party Obligations of the Borrower and
any benefit of, and any right to participate in, any security or collateral
given to or for the benefit of the Lenders and/or the Hedging Agreement
Providers to secure payment of the Credit Party Obligations of the Borrower
until such time as the Credit Party Obligations shall have been paid in full, no
Credit Document or Secured Hedging Agreement remains in effect and the
Commitments have been terminated.
|
Section
10
.
8
|
Limitation on
Enforcement
.
|
The
Lenders and the Hedging Agreement Providers agree that this Guaranty may be
enforced only by the action of the Administrative Agent acting upon the
instructions of the Required Lenders or any such Hedging Agreement Provider
(only with respect to obligations under the applicable Secured Hedging
Agreement) and that no Lender or Hedging Agreement Provider shall have any right
individually to seek to enforce or to enforce this Guaranty, it being understood
and agreed that such rights and remedies may be exercised by the Administrative
Agent for the benefit of the Lenders under the terms of this Credit Agreement
and for the benefit of any Hedging Agreement Provider under any Secured Hedging
Agreement. The Lenders and the Hedging Agreement Providers further agree that
this Guaranty may not be enforced against any director, officer, employee or
stockholder of the Guarantors.
|
Section
10
.
9
|
Confirmation of
Payment
.
|
The
Administrative Agent and the Lenders will, upon request after payment of the
Credit Party Obligations under the Credit Documents which are the subject of
this Guaranty and termination of the Commitments relating thereto, confirm to
the Borrower, the Guarantors or any other Person that the Credit Party
Obligations under the Credit Documents have been paid in full and the
Commitments relating thereto terminated, and this Guaranty released, subject to
the provisions of Section 10.2.
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly
executed and delivered by its proper and duly authorized officers as of the day
and year first above written.
BORROWER
:
|
ORTHOFIX
HOLDINGS, INC.,
|
|
|
a
Delaware corporation
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Vice
President and Secretary
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
GUARANTORS
:
|
ORTHOFIX
INTERNATIONAL N.V.,
|
|
|
a
Netherlands Antilles corporation
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Cheif
Financial Officer
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
COLGATE
MEDICAL LIMITED,
|
|
|
a
company formed under the laws of England and Wales
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Director
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
VICTORY
MEDICAL LIMITED,
|
|
|
a
company formed under the laws of England and Wales
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Director
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
ORTHOFIX
INC.,
|
|
|
a
Minnesota corporation
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Chief
Financial Officer, Vice President and Treasurer
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
BREG
INC.,
|
|
|
a
California corporation
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Assistant
Secretary
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
ORTHOFIX
US LLC,
|
|
|
a
Delaware limited liability company
|
|
|
|
|
|
|
By:
|
ORTHOFIX
UK LTD,
|
|
|
|
Sole
Member
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Secretary
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
AMEI
TECHNOLOGIES INC.,
|
|
|
a
Delaware corporation
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Treasurer
and Assistant Secretary
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
NEOMEDICS,
INC., a New Jersey corporation
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Treasurer
and Assistant Secretary
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
OSTEOGENICS
INC., a Delaware corporation
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Treasurer
and Assistant Secretary
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
BLACKSTONE
MEDICAL, INC.,
|
|
|
a
Massachusetts corporation
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Treasurer
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
SWIFTSURE
MEDICAL LIMITED,
|
|
|
a
company formed under the laws of England and Wales
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
|
ORTHOFIX
UK LTD,
|
|
|
a
company formed under the laws of England and Wales
|
|
|
|
|
|
|
By:
|
/s/
Thomas Hein
|
|
|
Name:
|
Thomas
Hein
|
|
|
Title:
|
Director
|
|
|
|
|
|
|
|
|
|
|
[Signature
Pages Continue]
|
|
ORTHOFIX
HOLDING, INC.
CREDIT
AGREEMENT
ADMINISTRATIVE
AGENT
:
|
WACHOVIA
BANK, NATIONAL ASSOCIATION,
|
|
|
as
Administrative Agent for the Lenders and as a Lender
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/
Scott Santa Cruz
|
|
|
Name:
|
Scott
Santa Cruz
|
|
|
Title:
|
Director
|
|
Schedule
1.1-1
ACCOUNT DESIGNATION
LETTER
[Date]
Wachovia
Bank, National Association
Charlotte
Plaza
201 South
College Street, CP-8
Charlotte,
North Carolina 28288-0680
Attn:
Syndication Agency Services
Ladies
and Gentlemen:
This
Account Designation Letter is delivered to you by Orthofix Holdings, Inc., a
Delaware corporation (the "
Borrower
"), pursuant
to Section 4.1 of the Credit Agreement dated as of September 22, 2006 (as
amended, restated or otherwise modified from time to time, the "
Credit Agreement
") by
and among the Borrower, the Guarantors from time to time party thereto, the
Lenders from time to time party thereto and Wachovia Bank, National Association,
as Administrative Agent (the "
Administrative
Agent
").
The
Administrative Agent is hereby authorized to disburse all Loan proceeds into the
following account, unless the Borrower shall designate, in writing to the
Administrative Agent, one or more other accounts:
[INSERT
Name of Bank/
ABA
Routing Number/
and
Account Number]
Notwithstanding
the foregoing, on the Closing Date, funds borrowed under the Credit Agreement
shall be sent to the institutions and/or persons designated on payment
instructions to be delivered separately.
Capitalized
terms defined in the Credit Agreement shall have the same meanings when used
herein.
This
Account Designation Notice may, upon execution, be delivered by facsimile or
electronic mail, which shall be deemed for all purposes to be an original
signature.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
|
ORTHOFIX
HOLDINGS, INC.,
|
|
|
a
Delaware corporation
|
|
Schedule
1.1-3
PERMITTED
LIENS
1.
|
Liens of Blackstone
Medical, Inc.
|
State
|
Secured Party
|
Filing Information
|
Collateral
|
MA
|
Dell
Financial Services
|
Original
200317586280
01/13/2003
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200317907850
1/27/2003
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200317908550
01/27/2003
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200318824200
03/06/2003
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200319159860
3/20/2003
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200319252390
3/24/2003
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200426944870
1/23/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200427265280
2/4/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200427406700
2/10/2004
|
Leased
Equipment
|
State
|
Secured Party
|
Filing Information
|
Collateral
|
MA
|
CIT
Communications Finance
|
Original
200428486990
3/24/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200433832410
10/21/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200434069400
11/01/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200434697540
11/26/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200435072120
12/13/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200435401290
12/27/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200535933420
01/18/2005
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200536198990
01/28/2005
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200536673460
02/17/2005
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200536927680
03/01/2005
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200429426850
04/29/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200430192300
05/27/2004
|
Leased
Equipment
|
State
|
Secured Party
|
Filing Information
|
Collateral
|
MA
|
Dell
Financial Services
|
Original
200430838000
06/22/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200431230380
07/07/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200431846040
08/02/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200432783380
09/09/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200433262550
09/29/2004
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200538080130
04/11/2005
|
Leased
Equipment
|
MA
|
Dell
Financial Services
|
Original
200538080310
04/11/2005
|
Leased
Equipment
|
MA
|
CIT
Communications Finance Corporation
|
Original
200542215030
09/22/2005
|
Leased
Equipment
|
MA
|
IOS
Capital
|
Original
200544074860
12/09/2005
|
Leased
Equipment
|
MA
|
IOS
Capital
|
Original
200649531790
07/11/2006
|
Leased
Equipment
|
MA
|
CIT
Bank
|
Original
200645236130
01/27/2006
|
Specific
Equipment
|
MA
|
Winthrop
Resources
|
Original
200645830680
02/22/2006
|
Leased
Equipment
|
Schedule
2.1(b)(i)
[FORM
OF]
NOTICE OF
BORROWING
[Date]
Wachovia
Bank, National Association
Charlotte
Plaza
201 South
College Street, CP-8
Charlotte,
North Carolina 28288-0680
Attn:
Syndication Agency Services
Ladies
and Gentlemen:
Pursuant
to subsection [2.1(b)][2.4(b)] of the Credit Agreement dated as of September 22,
2006 (as amended, restated or otherwise modified prior to the date hereof, the
"
Credit
Agreement
") by and among Orthofix Holdings, Inc., a Delaware corporation
(the "
Borrower
"), the
Guarantors from time to time party thereto, the Lenders from time to time party
thereto and Wachovia Bank, National Association, as Administrative Agent (the
"
Administrative
Agent
"), the Borrower hereby requests that the following Loans be made on
[date] as follows (the "
Proposed
Borrowing
"):
I.
|
Revolving
Loans requested:
|
|
(1)
|
Total
Amount of Revolving Loans Requested
|
$
______
|
|
(2)
|
Amount
of (1) to be allocated to LIBOR Rate Loans
|
$
______
|
|
(3)
|
Amount
of (1) to be allocated to Alternate Base Rate Loans
|
$
______
|
|
(4)
|
Interest
Periods and amounts to be allocated thereto in respect of the LIBOR Rate
Loans referenced in (2) (amounts must total
(2)):
|
|
(iii)
|
three
months
|
$
______
|
|
Total
LIBOR Rate Loans
|
$
______
|
NOTE:
REVOLVING LOAN BORROWINGS MUST BE IN MINIMUM AMOUNTS OF $1,000,000 AND IN
INTEGRAL MULTIPLES OF $500,000 IN EXCESS THEREOF.
II.
|
Swingline
Loans requested:
|
|
(1)
|
Total
Amount of Swingline Loans Requested $
______
|
NOTE:
|
SWINGLINE
LOAN BORROWINGS MUST BE IN MINIMUM AMOUNTS OF $100,000 AND IN INTEGRAL
AMOUNTS OF $100,000 IN EXCESS
THEREOF.
|
Capitalized
terms defined in the Credit Agreement shall have the same meanings when used
herein.
The
undersigned hereby certifies that the following statements will be true on the
date of the Proposed Borrowing:
(A) The
representations and warranties made by the Credit Parties in the Credit
Agreement, the Security Documents and which are contained in any certificate
furnished at any time under or in connection therewith will be true and correct
as though such representations and warranties had been made on and as of the
date of such Proposed Borrowing (it being understood that any representation or
warranty which by its terms is made of a specified date shall be required to be
true and correct only as of such specified date);
(B) no
Default or Event of Default has occurred and is continuing, or would result from
such Proposed Borrowing (other than a Default or Event of Default that has been
waived in accordance with the Credit Agreement); and
(C) immediately
after giving effect to the making of the Proposed Borrowing (and the application
of the proceeds thereof), (i) the sum of outstanding Revolving Loans plus
outstanding LOC Obligations plus outstanding Swingline Loans shall not exceed
the Revolving Committed Amount, (ii) the outstanding LOC Obligations shall not
exceed the LOC Committed Amount and (iii) the outstanding Swingline Loans shall
not exceed the Swingline Committed Amount.
Delivery
of an executed counterpart of this Notice of Borrowing by telecopier or
electronic mail with receipt confirmed shall be effective as delivery of an
original executed counterpart of this Notice of Borrowing.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
|
ORTHOFIX
HOLDINGS, INC.,
|
|
|
a
Delaware corporation
|
|
Schedule
2.1(e)
[FORM
OF]
REVOLVING
NOTE
[Date]
FOR VALUE
RECEIVED, the undersigned, Orthofix Holdings, Inc., a Delaware corporation (the
"
Borrower
"),
hereby unconditionally promises to pay, on the Revolver Maturity Date (as
defined in the Credit Agreement referred to below), to the order of (the "
Lender
") at the
office of Wachovia Bank, National Association located at Charlotte Plaza, 201
South College Street, CP-8, Charlotte, North Carolina 28288-0680, in lawful
money of the United States of America and in same day funds, the aggregate
unpaid principal amount of all Revolving Loans made by the Lender to the
Borrower pursuant to Section 2.1 of the Credit Agreement referred to below. The
Borrower further agrees to pay interest in like money at such office on the
unpaid principal amount hereof and, to the extent permitted by law, accrued
interest in respect hereof from time to time from the date hereof until payment
in full of the principal amount hereof and accrued interest hereon, at the rates
and on the dates set forth in the Credit Agreement.
The
holder of this Note is authorized to endorse the date and amount of each
Revolving Loan made pursuant to Section 2.1 of the Credit Agreement and each
payment of principal and interest with respect thereto and its character as a
LIBOR Rate Loan or an Alternate Base Rate Loan on
Schedule 1
annexed
hereto and made a part hereof, or on a continuation thereof which shall be
attached hereto and made a part hereof, which endorsement shall constitute
prima facie
evidence
of the accuracy of the information endorsed (absent error);
provided
,
however
, that the
failure to make any such endorsement shall not affect the obligations of the
undersigned under this Note.
This Note
is one of the Revolving Notes referred to in the Credit Agreement dated as of
September 22, 2006 (as amended, restated or otherwise modified from time to
time, the "
Credit
Agreement
") by and among the Borrower, the Guarantors from time to time
party thereto, the Lenders from time to time party thereto and Wachovia Bank,
National Association, as Administrative Agent (the "
Administrative
Agent
"), and is entitled to the benefits thereof. Capitalized terms used
but not otherwise defined herein shall have the meanings provided in the Credit
Agreement.
Upon the
occurrence of any one or more of the Events of Default specified in the Credit
Agreement, all amounts then remaining unpaid on this Note shall become, or may
be declared to be, immediately due and payable, all as provided therein. In the
event this Note is not paid when due at any stated or accelerated maturity, the
Borrower agrees to pay, in addition to principal and interest, all costs of
collection, including reasonable documented attorneys' fees.
All
parties now and hereafter liable with respect to this Note, whether maker,
principal, surety, endorser or otherwise, hereby waive presentment, demand,
protest and all other notices of any kind.
This Note
shall be governed by, and construed and interpreted in accordance with, the laws
of the State of New York.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
|
ORTHOFIX
HOLDINGS, INC.,
|
|
|
a
Delaware corporation
|
|
SCHEDULE
1
to
Revolving
Note
LOANS AND PAYMENTS OF
PRINCIPAL
Date
|
|
Amount
of
Loan
|
|
Type
of
Loan
1
|
|
Interest
|
|
Interest
Rate
|
|
Interest
Period
|
|
Maturity
Date
|
|
Principal
Paid
or
Converted
|
|
Principal
Balance
|
|
Notation
Made
By
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
|
_____
|
__________________________
1
|
The
type of Loan may be represented either by "L" for LIBOR Rate Loans or
"ABR" for Alternate Base Rate
Loans.
|
Schedule
2.2(d)
[FORM
OF]
TERM
NOTE
[Date]
FOR VALUE
RECEIVED, the undersigned, Orthofix Holdings, Inc., a Delaware corporation (the
"
Borrower
"),
hereby unconditionally promises to pay, on the Term Loan Maturity Date (as
defined in the Credit Agreement referred to below), to the order of (the "
Lender
") at the
office of Wachovia Bank, National Association at Charlotte Plaza, 201 South
College Street, CP-8, Charlotte, North Carolina 28288-0680, in lawful money of
the United States of America and in same day funds, the aggregate unpaid
principal amount of the Term Loan made by the Lender to the Borrower pursuant to
Section 2.2 of the Credit Agreement referred to below. The Borrower further
agrees to pay interest in like money at such office on the unpaid principal
amount hereof and, to the extent permitted by law, accrued interest in respect
hereof from time to time from the date hereof until payment in full of the
principal amount hereof and accrued interest hereon, at the rates and on the
dates set forth in the Credit Agreement.
The
holder of this Note is authorized to endorse the date and amount of each payment
of principal and interest with respect to the Term Loan evidenced by this Note
and the portion thereof that constitutes a LIBOR Rate Loan or an Alternate Base
Rate Loan on
Schedule
1
annexed hereto and made a part hereof, or on a continuation thereof
which shall be attached hereto and made a part hereof, which endorsement shall
constitute
prima
facie
evidence of the accuracy of the information endorsed (absent
error);
provided
,
however
, that the
failure to make any such endorsement shall not affect the obligations of the
undersigned under this Note.
This Note
is one of the Term Notes referred to in the Credit Agreement, dated as of
September 22, 2006 (as amended, restated or otherwise modified from time to
time, the "
Credit
Agreement
"), by and among the Borrower, the Guarantors from time to time
party thereto, the lenders from time to time party thereto (the "
Lenders
") and
Wachovia Bank, National Association, as Administrative Agent for the Lenders
(the "
Administrative
Agent
"), and is entitled to the benefits thereof. Capitalized terms used
but not otherwise defined herein shall have the meanings provided in the Credit
Agreement.
Upon the
occurrence of any one or more of the Events of Default specified in the Credit
Agreement, all amounts then remaining unpaid on this Note shall become, or may
be declared to be, immediately due and payable, all as provided therein. In the
event this Note is not paid when due at any stated or accelerated maturity, the
Borrower agrees to pay, in addition to principal and interest, all costs of
collection, including reasonable attorneys' fees.
All
parties now and hereafter liable with respect to this Note, whether maker,
principal, surety, endorser or otherwise, hereby waive presentment, demand,
protest and all other notices of any kind.
This Note
shall be governed by, and construed and interpreted in accordance with, the laws
of the State of New York.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
|
ORTHOFIX
HOLDINGS, INC.,
|
|
|
a
Delaware corporation
|
|
SCHEDULE
1
to
Term
Note
LOANS AND PAYMENTS OF
PRINCIPAL
Date
|
|
Amount
of
Loan
|
|
Type
of
Loan
1
|
|
Interest
|
|
Interest
Rate
|
|
Interest
Period
|
|
Maturity
Date
|
|
Principal
Paid
or
Converted
|
|
Principal
Balance
|
|
Notation
Made
By
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
|
____
|
____
|
|
____
|
|
____
|
|
____
|
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____________________
1
|
The
type of Loan may be represented either by "L" for LIBOR Rate Loans or
"ABR" for Alternate Base Rate
Loans.
|
Schedule
2.4(d)
[FORM
OF]
SWINGLINE
NOTE
[Date]
FOR VALUE
RECEIVED, the undersigned, Orthofix Holdings, Inc., a Delaware corporation (the
"
Borrower
"),
hereby unconditionally promises to pay, on each date specified in the Credit
Agreement referred to below for the payment of principal hereof and on the
Revolver Maturity Date (as defined in the Credit Agreement referred to below),
to the order of Wachovia Bank, National Association (the "
Swingline Lender
") at
the office of Wachovia Bank, National Association located at Charlotte Plaza,
201 South College Street, CP-8, Charlotte, North Carolina 28288-0680, in lawful
money of the United States of America and in same day funds, the principal
amount of the aggregate unpaid principal amount of all Swingline Loans made by
the Swingline Lender to the Borrower pursuant to Section 2.4 of the Credit
Agreement referred to below. The Borrower further agrees to pay interest in like
money at such office on the unpaid principal amount hereof and, to the extent
permitted by law, accrued interest in respect hereof from time to time from the
date hereof until payment in full of the principal amount hereof and accrued
interest hereon, at the rates and on the dates set forth in the Credit
Agreement.
The
holder of this Note is authorized to endorse the date and amount of each
Swingline Loan made pursuant to Section 2.4 of the Credit Agreement and each
payment of principal and interest with respect thereto on
Schedule 1
annexed
hereto and made a part hereof, or on a continuation thereof which shall be
attached hereto and made a part hereof, which endorsement shall constitute
prima facie
evidence
of the accuracy of the information endorsed (absent error);
provided
,
however
, that the
failure to make any such endorsement shall not affect the obligations of the
undersigned under this Note.
This Note
is the Swingline Note referred to in the Credit Agreement dated as of September
22, 2006 (as amended, restated or otherwise modified from time to time, the
"
Credit
Agreement
") by and among the Borrower, the Guarantors from time to time
party thereto, the Lenders from time to time party thereto and Wachovia Bank,
National Association, as Administrative Agent (the "
Administrative
Agent
"), and is entitled to the benefits thereof. Capitalized terms used
but not otherwise defined herein shall have the meanings provided in the Credit
Agreement.
Upon the
occurrence of any one or more of the Events of Default specified in the Credit
Agreement, all amounts then remaining unpaid on this Note shall become, or may
be declared to be, immediately due and payable, all as provided therein. In the
event this Note is not paid when due at any stated or accelerated maturity, the
Borrower agrees to pay, in addition to principal and interest, all costs of
collection, including reasonable documented attorneys' fees.
All
parties now and hereafter liable with respect to this Note, whether maker,
principal, surety, endorser or otherwise, hereby waive presentment, demand,
protest and all other notices of any kind.
This Note
shall be governed by, and construed and interpreted in accordance with, the laws
of the State of New York.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
|
ORTHOFIX
HOLDINGS, INC.,
|
|
|
a
Delaware corporation
|
|
SCHEDULE
1
to
Swingline
Note
LOANS AND PAYMENTS OF
PRINCIPAL
Date
|
|
Amount
of
Loan
|
|
Principal
Paid
|
|
Interest
|
|
Principal
Balance
|
|
Notation
Made By
|
|
|
|
|
|
|
|
|
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|
|
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|
|
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|
|
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|
|
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|
|
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|
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|
|
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|
|
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|
|
_______
|
|
_______
|
|
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|
_______
|
|
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|
|
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|
|
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|
|
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|
|
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|
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|
|
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|
|
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|
|
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|
|
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|
|
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|
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|
|
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|
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|
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|
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|
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|
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|
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|
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|
_______
|
|
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|
|
_______
|
|
_______
|
|
_______
|
|
_______
|
Schedule
2.10
[FORM
OF]
NOTICE OF
CONVERSION/EXTENSION
[Date]
Wachovia
Bank, National Association
Charlotte
Plaza
201 South
College Street, CP-8
Charlotte,
North Carolina 28288-0680
Attn:
Syndication Agency Services
Ladies
and Gentlemen:
Pursuant
to Section 2.10 of the Credit Agreement dated as of September 22, 2006 (as
amended, restated or otherwise modified prior to the date hereof, the "
Credit Agreement
") by
and among Orthofix Holdings, Inc., a Delaware corporation (the "
Borrower
"), the
Guarantors from time to time party thereto, the Lenders from time to time party
thereto and Wachovia Bank, National Association, as Administrative Agent (the
"
Administrative
Agent
"), the Borrower hereby requests conversion or extension of the
following Loans be made on [date] as follows (the "
Proposed
Conversion/Extension
"):
|
(1)
|
Total
Amount of Revolving Loans to be converted/extended
|
$
______
|
|
(2)
|
Amount
of (1) to be allocated to LIBOR Rate Loans
|
$
______
|
|
(3)
|
Amount
of (1) to be allocated to Alternate Base Rate Loans
|
$
______
|
|
(4)
|
Interest
Periods and amounts to be allocated thereto in respect of the LIBOR Rate
Loans referenced in (2) (amounts must total
(2)):
|
|
(ii)
|
three
months
|
$
______
|
|
Total
LIBOR Rate Loans
|
$
______
|
NOTE:
|
CONVERSIONS
MUST BE (A) IN THE CASE OF REVOLVING LOANS, $1,000,000 OR A WHOLE MULTIPLE
OF $500,000 IN EXCESS THEREOF AND (B) IN THE CASE OF THE TERM LOAN,
$2,000,000 OR A WHOLE MULTPLE OF $1,000,000 IN EXCESS
THEREOF.
|
Capitalized
terms defined in the Credit Agreement shall have the same meanings when used
herein.
The
undersigned hereby certifies that as of the date of the Proposed
Conversion/Extension, no Default or Event of Default has occurred and is
continuing, or would result from such Proposed Conversion/Extension or from the
application of the proceeds thereof.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
|
ORTHOFIX
HOLDINGS, INC.,
|
|
|
a
Delaware corporation
|
|
Schedule
2.
[FORM
OF]
TAX
EXEMPT CERTIFICATE
[Date]
Reference
is hereby made to the Credit Agreement dated as of September 22, 2006 (as
amended, restated or otherwise modified prior to the date hereof, the "
Credit Agreement
") by
and among Orthofix Holdings, Inc., a Delaware corporation (the "
Borrower
"), the
Guarantors from time to time party thereto, the Lenders from time to time party
thereto and Wachovia Bank, National Association, as Administrative Agent (the
"
Administrative
Agent
"). Pursuant to the provisions of Section 2.18 of the Credit
Agreement, the undersigned hereby certifies that it is not a "bank" as such term
is used in Section 881(c)(3)(A) of the Internal Revenue Code of 1986, as
amended.
This Tax
Exempt Certificate may, upon execution, be delivered by facsimile or electronic
mail, which shall be deemed for all purposes to be an original
signature.
|
[NAME
OF LENDER]
|
|
|
|
|
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
Schedule
3.3
QUI TAM
MATTERS
1.
|
Orthofix Inc. and
Orthofix International N.V.
|
|
a)
|
U.S.
ex rel. Karen Neel v. Orthofix, Inc. and Orthofix International
N.V.
,
Civil Action No. 3-00CV1333-D (N.D.
Texas).
|
The
plaintiff filed a whistleblower complaint under the federal False Claims Act
relating to the appropriateness of claims Orthofix, Inc. submitted to federal
health programs for the off-label use of certain FDA-approved pulsed electronic
magnetic field devices and related billing and coding practices. The matter was
resolved via settlement Orthofix, Inc. paid $1.6 million to the United States
Department of Justice, admitted no wrongdoing and was not found to have violated
applicable law.
Schedule
3.8
LITIGATION
|
a)
|
Daniel
Webb v. Orthofix. Inc.
,
United States
District Court for the Eastern District of Washington; Civil Action No.
CV-06-5053 EFS.
|
Plaintiff
alleges that he was negligently provided with the incorrect model of an Orthofix
bone stimulator when he sustained a fracture of the left hip. The case was filed
in April 2006 in state court and was removed to the United States District Court
for the Eastern District of Washington. No trial date has been assigned. The
parties have only recently commenced discovery. Orthofix is vigorously
contesting all of plaintiffs liability and damage claims, and plans to file a
motion seeking dismissal of plaintiffs action.
|
b)
|
Fugate
v. Orthofix. Inc.
,
296th Judicial
District Collin County Court; Civil Action No.
296-2940-05.
|
Plaintiff
alleges that he was discharged from employment because of a disability. Orthofix
has filed a motion for summary judgment which was denied. Mediation is scheduled
for October 26, 2006.
|
c)
|
Bone
Growth Stimulator Reclassification
Proceeding
|
Orthofix
Inc. is currently involved in a proceeding before the FDA addressing whether the
regulatory classification of Orthofix Inc.'s Physio-Stim and Spinal-Stim bone
growth stimulation products should be reclassified from FDA Class III to FDA
Class II. Orthofix Inc. is actively participating in this proceeding and
maintains that the current FDA Class III classification is correct. A meeting
was held on June 2, 2006 before the FDA's Orthopedic and Rehabilitation Devices
panel for the purpose of gathering information to allow the panel to recommend
to the FDA whether reclassification is appropriate. At the conclusion of the
meeting, the Panel determined that the present FDA Class III classification for
the products at issue is proper. Orthofix Inc. does not know when or whether the
FDA will reach a final determination on this classification issue or whether any
such determination will adversely impact Orthofix Inc.'s ability to market or
sell these products.
|
a)
|
Deborah
Casillas and Adam Casillas v. Omnimotion, Orthofix, Breg, Healthsouth, NSC
Channel Islands and Channel Islands Sursicenter
,
State of California
Superior Court, County of San Bernardino; Case Number VCVVS
040349.
|
This
matter involves alleged cold injuries sustained while plaintiff was using a Breg
Polar Care 300 unit on her elbow following surgery. At this time, we are in the
process of obtaining plaintiffs medical records and thereafter will schedule her
deposition. Very little discovery has taken place.
|
b)
|
John
Dade Theriot v. Brgs, Inc. and related distributor action for
indemnification
.
State of California Superior Court, County of San Francisco; Case
Number CGC 04-431658; and related Distributor action for
indemnification.
|
This
matter involved alleged cold injuries sustained while plaintiff was using two
Polar Care 500 units, one on each knee. The jury returned a verdict in favor of
the plaintiff against Breg on theories of product liability and negligence in
the amount of $4.1 million. Except for the distributors of the Breg product who
wish to retain their rights to proceed against Breg for indemnification, the
other parties are currently in the process of settling the case, following a
stipulation to vacate the judgment and grant a new trial. The amount of the
verdict is insured.
|
c)
|
Russell
P. Dunnum, MD v. Breg Inc.
,
State of California
Superior Court, County of San Diego; Case Number
GIC860901.
|
This
matter involves an alleged injury sustained when a catheter of the Pain Care
2000 broke off in plaintiffs knee upon removal. Discovery is just
beginning.
|
d)
|
Denise
Chlopek v. Breg, Inc.
,
United States Court
of Appeals for the Seventh Circuit; Docket No.
06-2927.
|
Plaintiff
alleged that her right great toe was amputated as a result of using the Breg
Polar Care 300 cold therapy unit. The jury returned a verdict in favor of Breg
and found that there was no defective condition related to the product.
Plaintiff filed a Motion for a New Trial which was denied and is currently being
appealed.
|
e)
|
Ann
L. Perkins v. The Orthopedic Store and The Orthopedic Store v. Breg,
Inc.
,
District Court Bexar County, Texas; Case No.
2006-CI-06600.
|
Plaintiff
used a Polar Care 500 following ankle surgery. She claims to have sustained
tissue necrosis. Plaintiff did not sue Breg. Instead, Breg has been named as a
third party defendant by The Orthopedic Store, a Durable Medical Equipment
dealer who was a customer of Breg. The Orthopedic Store purchased the Polar Care
500 from Breg and leased it to the plaintiff. The plaintiff is still in the
process of adding medical professionals to the lawsuit and accordingly there has
not been any discovery.
|
f)
|
Dismissal
Related Allegations for Employee Sam Rehan (being handled by British
attorneys). We do not believe this matter is currently in
litigation.
|
3.
|
Blackstone Medical,
Inc.
|
|
a)
|
NovaBone Products,
LLC
|
On
January 11, 2006, the Company received a letter from NovaBone Products, LLC,
claiming an interest in certain intellectual property being developed by the
Company relating to the processing of natural bone product with bioglass, a
developmental product underway at the Company.
|
b)
|
Berrios
v. Blackstone Medical, Inc.,
Circuit Court of
the 18th District in and for Brevard, Florida; Case No.
05-2005-CA-017339.
|
The
Plaintiff is claiming damages because of allegedly defective bone screws and
fixation hardware sold by the Company. This matter was referred to the Company's
products liability insurance carrier and is being defended by counsel selected
by that carrier.
In 2005,
the Company received correspondence dated December 13, 2005 from one of its
suppliers, TissueNet Custom Applications, LLC ("TissueNet") claiming that the
Company had breached a five year contract under which TissueNet supplied
precision tooled allograft implants to the Company for resale. We are unable to
determine whether a further claim will be made by TissueNet. The Company is also
disputing certain invoices (Nos. 2045 and 2046) that have been presented by
TissueNet. The value of the disputed invoices is approximately
$138,700.
|
d)
|
Frederic
H. Leeds v. Blackstone Medical, Inc.
,
Second Judicial
District Court of the State of Nevada, in and for the County of Washoe;
Case No. CV-06-01218.
|
The
Plaintiff is claiming damages because of allegedly defective bone screws and
fixation hardware sold by the Company. This matter was referred to the Company's
products liability insurance carrier and is being defended by counsel selected
by that carrier.
Schedule
3.12
SUBSIDIARIES
Subsidiary
|
Jurisdiction
of Incorporation/ Organization
|
Owner(s)
|
No.
Shares of Capital Stock/ Equity Interests Outstanding
|
No.
Shares of Capital Stock/ Equity Interests Held By [Each]
Owner
|
Percentage
Ownership of [Each] Owner
|
Orthosonics
Ltd
|
UK
|
Orthofix
International N.V.
|
120
|
120
|
100%
|
Orthofix
B.V.
|
Amsterdam
|
Orthofix
International N.V.
|
3,118,860
|
3,118,860
|
100%
|
Novamedix
Services Ltd (Cyprus)
|
UK
|
Orthofix
International N.V.
|
50,000
|
50,000
|
100%
|
Inter
Medical Supplies Ltd
|
Cyprus
|
Orthofix
International N.V.
|
10,000
|
10,000
|
100%
|
Novamedix
Distribution Ltd
|
Cyprus
|
Orthofix
International N.V.
|
4,000
|
4,000
|
100%
|
Inter
Medical Supplies Ltd (Seychelles)
|
Seychelles
|
Orthofix
International N.V.
|
5,000
|
5,000
|
100%
|
Novamedix
Ltd
|
UK
|
Orthofix
International N.V.
|
28,617
common,
5,050
preferred
|
28,617
common, 5,050 preferred
|
100%
|
Orthofix
Mexico S.A. de C.V.
|
Mexico
|
Orthofix
International N.V.
|
100,000
|
61,250
|
61.25%
|
Orthofix
de Brasil
|
Brazil
|
Orthofix
International N.V.
|
5,000
|
4,475
shares owned by Orthofix International NV; 325 shares owned by Jorge
Fuchs; 200 shares owned by Jose Augusto Proenca
|
89.5%
owned by Orthofix International NV;
|
Orthofix
SRL/DMO
|
Italy
|
Orthofix
B.V.
|
3,000,000
|
3,000,000
|
100%
|
Orthofix
GmbH
|
Germany
|
Orthofix
B.V.
|
2,065,000
|
2,065,000
|
100%
|
Orthofix
LTD
|
UK
|
Orthofix
B.V.
|
1,426,256
|
1,426,256
|
100%
|
Orthofix
SA
|
France
|
Orthofix
B.V.
|
120,000
|
120,000
|
100%
|
Subsidiary
|
Jurisdiction
of Incorporation/ Organization
|
Owner(s)
|
No.
Shares of Capital Stock/ Equity Interests Outstanding
|
No.
Shares of Capital Stock/ Equity Interests Held By [Each]
Owner
|
Percentage
Ownership of [Each] Owner
|
Orthofix
AG
|
Switzerland
|
Orthofix
B.V.
|
100
|
100
|
100%
|
Orthofix
International II B.V.
|
Amsterdam
|
Orthofix
B.V.
|
22,449
|
22,449
|
100%
|
Intavent
Orthofix LTD
|
UK
|
Orthofix
International II B.V.
|
10,000
|
10,000
|
100%
|
Colgate
Medical Ltd
|
UK
|
Intavent
Orthofix LTD
|
587,879
|
587,879
|
100%
|
Victory
Medical Limited
|
UK
|
Colgate
Medical Ltd
|
4,000,000
|
4,000,000
|
100%
|
Orthofix
Holdings, Inc.
|
Delaware
|
Victory
Medical Limited
|
100
|
100
|
100%
|
Breg
Inc.
|
California
|
Orthofix
Holdings, Inc.
|
1
|
1
|
100%
|
Orthofix
Inc.
|
Minnesota
|
Orthofix
Holdings, Inc.
|
100
|
100
|
100%
|
Swiftsure
Medical Limited
|
UK
|
Orthofix
Holdings, Inc.
|
12,251,885
|
12,251,885
|
100%
|
Breg
Mexico
|
Mexico
|
Breg
Inc.; Orthofix International N.V.
|
N/A
|
N/A
|
99.9%
owned by
Breg
Inc.; 0.1% owned by
Orthofix
International N.V.
|
Breg
Deutschland GmbH
|
Germany
|
Orthofix
GmbH
|
N/A
|
N/A
|
52%
owned by Orthofix GmbH; 48% owned by
Stephan
Michels, Ronald Hansjorg, Nikolaus Murges and Albert
Engal
|
Implantes
Y Sistemas Medicos
|
Puerto
Rico
|
Orthofix
Inc.
|
100
|
100
|
100%
|
Osteogenics
Inc.
|
Delaware
|
Orthofix
Inc.
|
1,000
|
1,000
|
100%
|
AMEI
Technologies Inc.
|
Delaware
|
Orthofix
Inc.
|
1,000
|
1,000
|
100%
|
Neomedics,
Inc.
|
New
Jersey
|
AMEI
Technologies Inc.
|
1,428,000
|
1,428,000
|
100%
|
Subsidiary
|
Jurisdiction
of
Incorporation/
Organization
|
Owner(s)
|
No.
Shares of
Capital
Stock/
Equity
Interests Outstanding
|
No.
Shares of
Capital
Stock/
Equity
Interests Held By [Each] Owner
|
Percentage
Ownership
of
[Each] Owner
|
Orthofix
UK
Ltd
|
UK
|
Swiftsure
Medical
Limited
|
2
|
2
|
100%
|
Orthofix
US
LLC
|
Delaware
|
Orthofix
UK
Ltd
|
0
|
0
|
100%
|
Blackstone
Medical,
Inc.
|
Massachusett
s
|
Orthofix
Holdings,
Inc.
|
8,000,000
Class
A Voting Common
Stock;
19,000,000
Class
B Nonvoting Common Stock
|
8,000,000
Class
A
Voting Common Stock;
19,000,000
Class B
Nonvoting
Common Stock
|
100%
of Class A
and
B
|
Blackstone
GmbH
|
Germany
|
Blackstone
Medical,
Inc.
|
0
|
0
|
100%
|
Goldstone
GmbH
|
Switzerland
|
Blackstone
Medical,
Inc.; Blackstone GmbH
|
0
|
0
|
50%
owned by
Blackstone
Medical, Inc.; 50% owned by
Blackstone
GmbH
|
Schedule
3.16
INTELLECTUAL
PROPERTY
|
i.
|
Joint
Development and Technology Rights Agreement by and between Medicine Lodge,
Inc. and Breg, Inc., dated February 11, 2002; including Assignment of U.S.
Patent Application 10/218,106 to Breg, Inc. and Assignment of U.S. Patent
Application 10/270,091 to Breg,
Inc.
|
|
ii.
|
Agreement
between Professional Football Athletic Trainers Society (PFATS) and Breg,
Inc, dated. April 26, 1999; First Renewal Agreement between PFATS and
Breg, Inc., dated August 1, 2001; Second Renewal Agreement Between PFATS
and Breg, Inc., dated September 1,
2003.
|
|
iii.
|
Supplier
Agreement between Alpine Canada Alpin and Breg, Inc., dated August 1,
2001; Supplier Agreement between Alpine Canada Alpin and Breg, Inc. dated
April 14, 2003.
|
|
iv.
|
Exclusive
License Agreement between Breg, Inc. and Kevin Speer, M.D., dated January
1, 1997.
|
|
v.
|
Exclusive
License Agreement between Breg, Inc. and James C. Esch, M.D., dated
October 1, 1990.
|
|
vi.
|
Exclusive
License and Assignment Agreement between Breg, Inc. and Ken Yamaguchi,
dated October 21, 2003.
|
|
vii.
|
License
of Patent Agreement between Breg, Inc. and Cincinnati SubZero Products,
Inc., dated October 13, 1992.
|
|
viii.
|
Biodex
Settlement Agreement.
|
|
ix.
|
DonJoy
Settlement Agreement.
|
|
x.
|
Term
Royalty Agreement between Breg, Inc. and Bill Brennan and John Gregory,
dated May 1, 2002.
|
|
xi.
|
Exclusive
Distributor Agreement between Accu-Fit, Inc. and Breg, Inc., dated
November 1, 2002.
|
|
xii.
|
Supply
Agreement between Life-Tech, Inc. and Breg, Inc., dated October 18,
2002.
|
|
xiii.
|
Distributor
Agreement between Ultra Athlete, LLC f/k/a Athlete Protection Gear, LLC
and Breg, Inc., dated March 26, 2003 (replaced Distributor Agreement
between Athlete Protection Gear, LLC and Breg, Inc., dated June 19,
2003).
|
|
xiv.
|
Agreement
between Breg, Inc. and Orthofix Inc. for Distribution of Pulsed
ElectroMagnetic Fields Device Systems and related products, dated October
22, 2001.
|
|
xv.
|
Master
Services Agreement, dated August 26, 2002, between Breg, Inc. and Kenexa
Technology Inc.
|
|
i.
|
License
Agreement between Orthofix, Inc. and Innovative Orthotics relating to
EZ-Brace technology.
|
|
ii.
|
License
Agreement between Orthofix, Inc., Jack Farr, M.D. and Scott Gillogly, M.D.
relating to Oasis technology.
|
|
iii.
|
License
Agreement between Orthofix, Inc. and Morphographics, L.C. relating to
Guided Growth Plate ("8-Plate")
technology.
|
|
iv.
|
Product
Development and Distribution Agreement between Orthofix, Inc., Orthodyne,
Inc. and J. Dean Cole, M.D. relating to Intramedullary Skeletal Kinetic
Distractor ("ISKD") Systems.
|
|
v.
|
License
Agreement between Orthofix, Inc. and Silvatec Medical Company Inc.
relating to Lapidus Plate
technology.
|
|
vi.
|
License
Agreement between Orthofix, Inc. and Brian Adams, M.D., Michael Harsman,
M.D. and John Pepper, M.D. relating to Bone Staple and Trigger Finger
Release technology.
|
|
vii.
|
License
Agreement between Orthofix, Inc. and David Nelson, M.D. relating to
Contours Radial Distal Plate
technology.
|
|
viii.
|
License
Agreement between Orthofix, Inc. and L. Andrew Koman, M.D. relating to M2
minirail technology.
|
|
c)
|
Blackstone Medical,
Inc.
|
|
i.
|
End
User License Agreement dated December 1, 2005 by and between the
Blackstone and Epicor Software
Corporation.
|
|
ii.
|
License
Agreement dated as of December 2, 2003 by and between Blackstone and Cross
Medical Products, Inc.
|
|
iii.
|
Professional
Service Agreement dated May 30, 2006 by and between Blackstone and IQS,
Inc.
|
|
iv.
|
Services
Agreement dated October 25, 2004 by and between Blackstone and Atrium
Medical Corporation.
|
|
v.
|
Amended
and Restated Agreement between Blackstone and Robert S. Bray, Jr., M.D.,
dated December 16, 1998.
|
|
a)
|
Blackstone Medical,
Inc.
|
|
i.
|
Letter
dated January 31, 2003 from Mark Finkelstein of Latham & Watkins LLP
to Matthew Lyons, President of Blackstone regarding potential infringement
of patents owned by Cross Medical Products,
Inc.
|
|
ii.
|
Blackstone
is aware that certain patents that it licenses from Cross Medical
Products, Inc. are the subject of a pending lawsuit between Medtronic
Sofamor Danek and Cross Medical Products,
Inc.
|
|
iii.
|
Blackstone
is aware that Cross Medical Products, Inc. does not agree with Blackstone
as to the scope of the license granted to Blackstone under the License
Agreement between the parties.
|
|
iv.
|
On
July 10, 2006, Blackstone wrote to EBI requesting consent to the transfer
of the license in the context of the Blackstone/Orthofix transaction. On
July 28, 2006, EBI wrote to Blackstone declining to grant consent to the
transfer of the license. On September 11, 2006, representatives of
Orthofix, Blackstone and EBI met to address EBI's refusal to grant
consent. At that meeting, the parties agreed to refrain from initiating
any litigation, pending commercial negotiations to resolve the dispute
relating to the transfer of the
license.
|
PATENTS
Patent/
Application
No.
|
Credit
Party
|
Title
|
Jurisdiction
|
Date
of
Issuance/
Application
|
Status
|
5181902
|
AMEI
Technologies Inc
|
Double-Transducer
System for PEMF Therapy
|
US
|
1/26/93
|
Active
|
11/408617
|
AMEI
Technologies Inc
|
Drive
Systems and Device Incorporating Drive Systems
|
US
|
4/21/06
|
Pending
|
11/115009
|
AMEI
Technologies Inc
|
Screw
Extration and Insertion Device
|
US
|
4/26/05
|
Pending
|
5269747
|
AMEI
Technologies Inc
|
Double-transducer
system for PEMF therapy
|
US
|
12/14/93
|
Active
|
5195941
|
AMEI
Technologies Inc
|
Contoured
Triangular Transducer System for PEMF Therapy
|
US
|
3/23/93
|
Active
|
5351389
|
AMEI
Technologies Inc
|
Method
for fabricating a contoured triangular transducer system
|
US
|
10/4/94
|
Active
|
5401233
|
AMEI
Technologies Inc
|
Contoured
triagular transducer system for PEMF therapy
|
US
|
3/28/95
|
Active
|
5314401
|
AMEI
Technologies Inc
|
Conformable
PEMF Transducer
|
US
|
5/24/94
|
Active
|
5304210
|
AMEI
Technologies Inc
|
Apparatus
for Distributed Bone Growth Stimulation
|
US
|
4/19/94
|
Active
|
5452407
|
AMEI
Technologies Inc
|
Method
for representing a patient's treatment site as data for use with a CAD or
CAM device
|
US
|
9/19/95
|
Active
|
5441527
|
AMEI
Technologies Inc
|
Implantable
Bone Growth Stimulator and Method of Operation
|
US
|
8/15/95
|
Active
|
D353889
|
AMEI
Technologies Inc
|
Implantable
Tissue Growth Stimulator
|
US
|
12/27/94
|
Active
|
0,561,068
|
AMEI
Technologies Inc
|
Implantable
Tissue Growth Stimulator
|
European
|
3/3/99
|
Active
|
5565005
|
AMEI
Technologies Inc
|
Implantable
Tissue Growth Stimulator and Method of Operation
|
US
|
10/15/96
|
Active
|
5766231
|
AMEI
Technologies Inc
|
Implantable
Tissue Growth Stimulator and Method of Operation
|
US
|
6/16/98
|
Active
|
0,611,583
|
AMEI
Technologies Inc
|
Implantable
Tissue Growth Stimulator and Method of Operation
|
European
|
4/7/99
|
Active
|
5524624
|
AMEI
Technologies Inc
|
Apparatus
and Method for Stimulating Tissue Growth with Ultrasound
|
US
|
6/11/96
|
Active
|
D361555
|
AMEI
Technologies Inc
|
Combined
Programmer and Monitor for an Implantable Tissue Growth
Stimulator
|
US
|
8/22/95
|
Active
|
5304179
|
AMEI
Technologies Inc
|
System
and Method for Installing a Spinal Fixation System at Variable
Angles
|
US
|
4/19/94
|
Active
|
5437669
|
AMEI
Technologies Inc
|
Spinal
Fixation Systems with Bifurcated Connectors
|
US
|
8/1/95
|
Active
|
5704904
|
AMEI
Technologies Inc
|
Inflatable
Lumbar Traction Device
|
US
|
1/6/98
|
Active
|
5950628
|
AMEI
Technologies Inc
|
Inflatable
Wearable Traction Device
|
US
|
9/14/99
|
Active
|
5724993
|
AMEI
Technologies Inc
|
Inflatable
Spinal Traction Device
|
US
|
3/10/98
|
Active
|
0,837,666
|
AMEI
Technologies Inc
|
Ambulatory
Spinal Traction Device
|
US/European
|
2/11/04
|
Active
|
310906
|
AMEI
Technologies Inc
|
Ambulatory
Spinal Traction Device
|
Norway
|
9/17/01
|
Active
|
122495
|
AMEI
Technologies Inc
|
Ambulatory
Spinal Traction Device
|
Israel
|
7/22/02
|
Active
|
699290
|
AMEI
Technologies Inc
|
Inflatable
Spinal Traction Device
|
Australia
|
3/11/99
|
Active
|
Patent/
Application No.
|
Credit
Party
|
Title
|
Jurisdiction
|
Date
of Issuance/ Application
|
Status
|
5743844
|
AMEI
Technologies Inc
|
High
Efficiency Pulsed Electromagnetic Field (PEMF) Stimulation Therapy Method
and System
|
US
|
4/28/98
|
Active
|
6,261,221B1
|
AMEI
Technologies Inc
|
Flexible
Coil Pulsed Electromagnetic Field (PEMF) Stimulation Therapy
System
|
US
|
7/17/01
|
Active
|
6132362
|
AMEI
Technologies Inc
|
Pulsed
Electromagnetic Field (PEMF) Stimulation Therapy System with Bi-Phasic
Coil
|
US
|
10/17/00
|
Active
|
6117575
|
AMEI
Technologies Inc
|
Battery
Compartment
|
US
|
9/12/00
|
Active
|
6024691
|
AMEI
Technologies Inc
|
Cervical
Collar with Integrated Electrical Circuitry for Electromagnetic field
Therapy
|
US
|
2/15/00
|
Active
|
6418345B1
|
AMEI
Technologies Inc
|
PEMF
Stimulator for Treating Osteoporosis and Stimulating Tissue
Growth
|
US
|
7/9/02
|
Active
|
5507211
|
AMEI
Technologies Inc
|
Releasable
Socket
|
US
|
4/16/96
|
Active
|
6839595
|
AMEI
Technologies Inc
|
PEMF
Stimulator for Treating Osteoporosis and Stimulating Tissue
Growth
|
US
|
1/4/05
|
Active
|
1100582
|
AMEI
Technologies Inc
|
PEMF
Treatment for Osteoporosis and Tissue Growth Stimulation
|
European
|
6/15/05
|
|
6678562
|
AMEI
Technologies Inc
|
Combined
Tissue/Bone Growth Stimulator and External Fixation Device
|
US
|
1/13/04
|
|
1248659
|
AMEI
Technologies Inc
|
Combined
Tissue/Bone Growth Stimulator and External Fixation Device
|
European
|
|
Active
|
D348198
|
AMEI
Technologies Inc
|
Interlaminar
Clamp
|
US
|
6/28/94
|
Active
|
4735196
|
AMEI
Technologies Inc
|
Cervical-Thoracic
Orthosis and Method
|
US
|
4/5/88
|
Active
|
6635025
|
AMEI
Technologies Inc
|
Traction
Device Adjustment Mechanism and Method
|
US
|
10/21/03
|
Active
|
6974432
|
AMEI
Technologies Inc
|
Traction
Device Adjustment Mechanism and Method
|
US
|
12/13/05
|
Active
|
6533740
|
AMEI
Technologies Inc
|
Lifting
Mechanism for a Traction Device
|
US
|
3/18/03
|
Active
|
6776767
|
AMEI
Technologies Inc
|
Traction
Device and Associated Lifting Mechanism
|
US
|
8/17/04
|
Active
|
6702771
|
AMEI
Technologies Inc
|
Canting
Mechanism for Ambulatory Support Device
|
US
|
3/9/04
|
Active
|
6746413
|
AMEI
Technologies Inc
|
Canting
Mechanism for Ambulatory Support Device
|
US
|
6/8/04
|
Active
|
6689082
|
AMEI
Technologies Inc
|
Traction
Device
|
US
|
2/10/04
|
Active
|
6364824
|
Orthofix
Inc.
|
Stimulating
Cell Receptor Activity Using Electromagnetic Fields
|
US
|
4/2/04
|
Active
|
7089060
|
AMEI
Technologies Inc
|
Stimulating
Cell Growth Using Pulsed Electro-Magnetic Fields (PEMF)
|
US
|
8/8/06
|
Active
|
Patent/
Application No.
|
Credit
Party
|
Title
|
Jurisdiction
|
Date
of Issuance/ Application
|
Status
|
7074201
|
AMEI
Technologies Inc
|
Measurement
Device for Fitting a Bracing Device
|
US/Patent
Cooperation Treaty
|
|
Active
|
6997892
|
AMEI
Technologies Inc
|
Ambulatory
Cyclic Traction Device
|
US
|
2/4/06
|
Active
|
03773260.9
2004/034872
|
AMEI
Technologies Inc
|
Ambulatory
Cyclic Traction Device
|
European/Patent
Cooperation Treaty
|
|
Active
|
7070572
|
AMEI
Technologies Inc
|
Dynamically
Adjustable Stabilization Brace
|
US/Patent
Cooperation Treaty
|
|
Active
|
10/712574
|
AMEI
Technologies Inc
|
Apparatus
and Method for Maintaining Bones in Healing Position
|
US/Patent
Cooperation Treaty
|
11/13/03
|
Pending
|
10/393,541
|
AMEI
Technologies Inc
|
Field
Adjustable Traction Device
|
US
|
|
Pending
|
11/244879
|
AMEI
Technologies Inc
|
Bone
Alignment Implant and Method of Use
|
US
|
|
Pending
|
6322571
|
AMEI
Technologies Inc
|
Apparatus
and Method for Placing Sutures in the Lacerated End of a Tendon and
Similar Body Tissues
|
US/Patent
Cooperation Treaty
|
11/27/01
|
Active
|
6342060
|
AMEI
Technologies Inc
|
Tendon
Passing Device and Method
|
US/Patent
Cooperation Treaty
|
1/29/02
|
Active
|
7001351
|
AMEI
Technologies Inc
|
Brace
with Integrated Lumbar Support System
|
US
|
2/21/06
|
Active
|
10/629,192
|
AMEI
Technologies Inc
|
Fixation
Device and Method for Treating Contractures and Other Orthopedic
Indications
|
US
|
7/29/03
|
Pending
|
6936019
|
Breg
Inc.
|
Strap
Connector Assembly for an Orthopedic Brace
|
US
|
8/30/05
|
Active
|
6893414
B2
|
Breg
Inc.
|
Integrated
Infusion and Aspiration System and Method
|
US
|
5/17/05
|
Active
|
6802823
B2
|
Breg
Inc.
|
Medication
Delivery System Having Selective Automated or Manual
Discharge
|
US
|
10/12/04
|
Active
|
Patent/
Application No.
|
Credit
Party
|
Title
|
Jurisdiction
|
Date
of Issuance/ Application
|
Status
|
6719728
B2
|
Breg
Inc.
|
Patient
Controlled Medication Delivery System with Overmedication Prevention
(2000L)
|
US
|
4/13/2004
|
Active
|
6719713
B2
|
Breg
Inc.
|
Strap
Attachment Assembly for an Orthopedic Brace
|
US
|
4/13/2004
|
Active
|
D486870
S
|
Breg
Inc.
|
Continuous
Passive Motion Device for a Shoulder or Elbow (Shoulder
CPM)
|
US
|
2/17/2004
|
Active
|
6551264
B1
|
Breg
Inc.
|
Orthosis
for Dynamically Stabilizing the Patello-Femoral Joint
|
US
|
4/22/2003
|
Active
|
6270481
B1
|
Breg
Inc.
|
Patient-Controlled
Medication Delivery System (2000 & 2000L)
|
US
|
8/7/2001
|
Active
|
6260890
B1
|
Breg
Inc.
|
Tubing
Connector
|
US
|
7/17/2001
|
Active
|
6176869
B1
|
Breg
Inc.
|
Fluid
Drive Mechanism for a Therapeutic Treatment System
|
US
|
1/23/2001
|
Active
|
DES.430,288
|
Breg
Inc.
|
Medical
Infusion Pump (2000 & 2000L)
|
US
|
8/29/2000
|
Active
|
DES.430,289
|
Breg
Inc.
|
Infusion
Pump for Administering a Fluid Medication (2000 &
2000L)
|
US
|
8/29/2000
|
Active
|
REEXAM
(U.S. 5,330,519)
|
Breg
Inc.
|
Therapeutic
Nonambient Temperature Fluid Circulation System
|
US
|
7/6/1999
|
Active
|
REEXAM(U.S.
5,330,519)
|
Breg
Inc.
|
Therapeutic
Nonambient Temperature Fluid Circulation System
|
US
|
11/10/1998
|
Active
|
5827208
|
Breg
Inc.
|
Hinge
For an Orthopedic Brace Having a Selectively Positionable Stop to Limit
Rotation
|
US
|
10/27/1998
|
Active
|
5807294
|
Breg
Inc.
|
Adjustable
Hinge Assembly for an Osteoarthritic Knee Brace
|
US
|
9/15/1998
|
Active
|
5782780
|
Breg
Inc.
|
Method
of Forming a Contoured Orthotic Member
|
US
|
7/21/1998
|
Active
|
5772618
|
Breg
Inc.
|
Hinge
Plate For an Orthopedic Brace
|
US
|
6/30/1998
|
Active
|
5672152
|
Breg
Inc.
|
Hinge
For an Orthopedic Brace Having an Adjustable Range of
Rotation
|
US
|
9/30/1997
|
Active
|
DES.383,848
|
Breg
Inc.
|
Cold
Therapy Pad
|
US
|
9/16/1997
|
Active
|
DES.383,547
|
Breg
Inc.
|
Cold
Therapy Pad With Mounting Straps
|
US
|
9/9/1997
|
Active
|
5662695
|
Breg
Inc.
|
Occlusion-Resistant
Fluid Pad Conformable to a Body for Therapeutic Treatment
Thereof
|
US
|
9/2/1997
|
Active
|
5507792
|
Breg
Inc.
|
Therapeutic
Treatment Device Having a Heat Transfer Element and a Pump for Circulating
a Treatment Fluid Therethrough
|
US
|
4/16/1996
|
Active
|
5417720
|
Breg
Inc.
|
Nonambient
Temperature Pad Conformable to a Body For Therapeutic Treatment
Thereof
|
US
|
5/23/1995
|
Active
|
DES.352,781
|
Breg
Inc.
|
Therapeutic
Fluid Flow Line
|
US
|
11/22/1994
|
Active
|
DES.
351,472
|
Breg
Inc.
|
Therapeutic
Fluid Circulation Pad for the Eyes
|
US
|
10/11/1994
|
Active
|
5352174
|
Breg
Inc.
|
Shoulder
Exercise System
|
US
|
10/4/1994
|
Active
|
5330519
|
Breg
Inc.
|
Therapeutic
Nonambient Temperature Fluid Circulation System
|
US
|
7/19/1994
|
Active
|
DES.
348,518
|
Breg
Inc.
|
Therapeutic
Fluid Circulation Pad for Breasts
|
US
|
7/5/1994
|
Active
|
Patent/
Application No.
|
Credit
Party
|
Title
|
Jurisdiction
|
Date
of Issuance/ Application
|
Status
|
DES.
348,106
|
Breg
Inc.
|
Therapeutic
Fluid Circulation Pad for Body Joints
|
US
|
6/21/1994
|
Active
|
DES.345,802
|
Breg
Inc.
|
Therapeutic
Fluid Pump
|
US
|
4/5/1994
|
Active
|
DES.345,803
|
Breg
Inc.
|
Therapeutic
Fluid Flow Controller
|
US
|
4/5/1994
|
Active
|
DES.
345,609
|
Breg
Inc.
|
Nonambient
Temperature Pad Conformable to a Body for Therapeutic Treatment Thereof
(Therapeutic Fluid Circulation Pad)
|
US
|
3/29/1994
|
Active
|
5241951
|
Breg
Inc.
|
Therapeutic
Nonambient Temperature Fluid Circulation System
|
US
|
9/7/1993
|
Active
|
5232020
|
Breg
Inc.
|
Shutoff
Valve Having a Unitary Valve Body (Housing)
|
US
|
8/3/1993
|
Active
|
5112045
|
Breg
Inc.
|
Kinesthetic
Diagnostic and Rehabilitation Device
|
US
|
5/12/1992
|
Active
|
5080089
|
Breg
Inc.
|
Therapeutic
Apparatus Applying Compression and a Nonambient Temperature
Fluid
|
US
|
1/14/1992
|
Active
|
11/285,827
|
Breg
Inc.
|
Non-Ambient
Temperature Therapy System with Automatic Treatment Temperature
Maintenance (new cold therapy)
|
US
|
11/22/2005
|
Pending
|
11/040,814
|
Breg
Inc.
|
Frame
for an Orthopedic Brace Including Offset Hinges
|
US
|
1/2/2005
|
Pending
|
11/067,305
|
Breg
Inc.
|
Method
for Fitting an Orthopedic Brace to the Body
|
US
|
1/12/2005
|
Pending
|
11/039,448
|
Breg
Inc.
|
Releasably
Locking Hinge for an Orthopedic Brace Having Adjustable Rotation
Limits
|
|
1/12/2005
|
Pending
|
11/039,056
|
Breg
Inc.
|
Support
Assembly for an Orthopedic Brace having a Length-Adjusting
Mechanism
|
US
|
1/12/2002
|
Pending
|
10/933,619
|
Breg
Inc.
|
Medication
Delivery System Having Selective Automated or Manual Discharge (Division
of pat no. 6,802,823)
|
|
9/2/2004
|
Pending
|
10/860,963
|
Breg
Inc.
|
Shoulder
Stabilizing Restraint
|
US
|
6/4/2004
|
Pending
|
10/745,900
|
Breg
Inc.
|
Orthopedic
Walker Having a Soft Boot with a Deformable Insert
|
US
|
12/24/2003
|
Pending
|
10/728,736
|
Breg
Inc.
|
Knee
Brace Providing Dynamic Tracking of the Patello-Femoral
Joint
|
US
|
12/5/2003
|
Pending
|
10/420,344
|
Breg
Inc.
|
Orthosis
Providing Dynamic Tracking of the Patello-Femoral Joint Continuation in
Part.
|
US
|
4/22/2003
|
Pending
|
10/285,861
|
Breg
Inc.
|
Continuous
Passive Motion Device for Rehabilitation of the Elbow or
Shoulder
|
US
|
1/11/2002
|
Pending
|
10/270,091
|
Breg
Inc.
|
Catheter
Assemblies for Controlled Movement of Fluid
|
US
|
10/14/2002
|
Pending
|
PCT/
|
Breg
Inc.
|
Frame
for an Orthopedic Brace Including Offset Hinges
|
All
countries
|
12/29/2005
|
Pending
|
PCT/US03/25069
|
Breg
Inc.
|
Integrated
Infusion and Aspiration System and Method
|
All
countries
|
8/11/2003
|
Pending
|
10/896,515
|
Breg
Inc.
|
Integrated
Infusion and Aspiration System and Method
|
US
|
8/12/2002
|
Pending
|
Patent/
Application No.
|
Credit
Party
|
Title
|
Jurisdiction
|
Data
of
Issuance/
Application
|
Status
|
2002951449
|
Blackstone
Medical Inc.
|
An
Arthroscopy Irrigation Device
|
All
countries except Taiwan
|
|
Pending
|
2001285096
|
Blackstone
Medical Inc.
|
A
Surgical Cross-Connecting Apparatus
|
Australia
|
|
Active
|
2420147
|
Blackstone
Medical Inc.
|
A
Surgical Cross-Connecting Apparatus
|
Canada
|
|
Active
|
01816670.9
|
Blackstone
Medical Inc.
|
A
Surgical Cross-Connecting Apparatus
|
China
|
|
Active
|
01964217.2
|
Blackstone
Medical Inc.
|
A
Surgical Cross-Connecting Apparatus
|
EPO
|
|
Active
|
PA/a/2003/001514
|
Blackstone
Medical Inc.
|
A
Surgical Cross-Connecting Apparatus
|
Mexico
|
|
Active
|
NI201003
90120338
|
Blackstone
Medical Inc.
|
A
Surgical Cross-Connecting Apparatus
|
Taiwan
|
|
Active
|
6,524,310
|
Blackstone
Medical Inc.
|
A
Surgical Cross-Connecting Apparatus
|
US
|
2/25/2003
|
Active
|
04105071.7
|
Blackstone
Medical Inc.
|
A
Surgical Cross-Connecting Apparatus
|
Hong
Kong
|
|
Active
|
N1243052
91102582
|
Blackstone
Medical Inc.
|
Orthopedic
Implant and Method for Orthopedic Treatment
|
Taiwan
|
|
Active
|
10/676,062
|
Blackstone
Medical Inc.
|
Bone
Plate Assembly Provided with Screw Locking Mechanisms
|
US
|
|
Active
|
2003275367
|
Blackstone
Medical Inc.
|
Bone
Plate Assembly Provided with Screw Locking Mechanisms
|
Australia
|
|
Active
|
2504215
|
Blackstone
Medical Inc.
|
Bone
Plate Assembly Provided with Screw Locking Mechanisms
|
Canada
|
|
Active
|
03759643.4
|
Blackstone
Medical Inc.
|
Bone
Plate Assembly Provided with Screw Locking Mechanisms
|
EPO
|
|
Active
|
PA/a/2005/004596
|
Blackstone
Medical Inc.
|
Bone
Plate Assembly Provided with Screw Locking Mechanisms
|
Mexico
|
|
Active
|
06101761.9
|
Blackstone
Medical Inc.
|
Bone
Plate Assembly Provided with Screw Locking Mechanisms
|
Hong
Kong
|
|
Active
|
6,960,232
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc
|
US
|
11/1/2005
|
Active
|
2003228697
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc
|
Australia
|
|
Active
|
03726462.9
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc
|
EPO
|
|
Active
|
2003-587291
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc
|
Japan
|
|
Active
|
10/891,635
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc
|
US
|
|
Active
|
US04/22778
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc
|
PCT
|
|
Active
|
6,413,259
|
Blackstone
Medical Inc.
|
Bone
Plate Assembly Including a Screw Retaining Member
|
US
|
7/2/2002
|
Active
|
6,648,893
|
Blackstone
Medical Inc.
|
Facet
Fixation Devices
|
US
|
11/18/2003
|
Active
|
6,238,396
|
Blackstone
Medical Inc.
|
Surgical
Cross-Connecting Apparatus and Related Methods
|
US
|
5/29/2001
|
Active
|
2424814
|
Blackstone
Medical Inc.
|
Surgical
Cross-Connecting Apparatus and Related Methods
|
Canada
|
|
Active
|
6,540,748
|
Blackstone
Medical Inc.
|
A
Surgical Screw System and Method of Use
|
US
|
4/1/2003
|
Active
|
2423973
|
Blackstone
Medical Inc.
|
A
Surgical Screw System and Related Methods
|
Canada
|
|
Active
|
10/968,586
|
Blackstone
Medical Inc.
|
Vertebral
Body Replacement Apparatus and Method
|
US
|
|
Active
|
2004284933
|
Blackstone
Medical Inc.
|
Vertebral
Body Replacement Apparatus and Method
|
Australia
|
|
Active
|
2542833
|
Blackstone
Medical Inc.
|
Vertebral
Body Replacement Apparatus and Method
|
Canada
|
|
Active
|
Patent/
Application No.
|
Credit
Party
|
Title
|
Jurisdiction
|
Date
of
Issuance/
Application
|
Status
|
04795903.6
|
Blackstone
Medical Inc.
|
Vertebral
Body Replacement Apparatus and Method
|
EPO
|
|
|
|
Blackstone
Medical Inc.
|
Vertebral
Body Replacement Apparatus and Method
|
Japan
|
|
|
PA/a/2006/004374
|
Blackstone
Medical Inc.
|
Vertebral
Body Replacement Apparatus and Method
|
Mexico
|
|
|
11/031,362
|
Blackstone
Medical Inc.
|
Vertebral
Body Replacement Apparatus and Method
|
US
|
|
|
US2005/000376
|
Blackstone
Medical Inc.
|
Vertebral
Body Replacement Apparatus and Method
|
PCT
|
|
|
10/968,585
|
Blackstone
Medical Inc.
|
Bone
Plate and Method for Using Bone Plate
|
US
|
|
|
11/092,273
|
Blackstone
Medical Inc.
|
Bone
Plate and Method for Using Bone Plate
|
US
|
|
|
US2005/010540
|
Blackstone
Medical Inc.
|
Bone
Plate and Method for Using Bone Plate
|
PCT
|
|
|
10/928,955
|
Blackstone
Medical Inc.
|
Multi-Axial
Connection System
|
US
|
|
|
US2005/029836
|
Blackstone
Medical Inc.
|
Multi-Axial
Connection System
|
PCT
|
|
|
11/388,666
|
Blackstone
Medical Inc.
|
Multi-Axial
Connection System
|
US
|
|
|
US2006/010738
|
Blackstone
Medical Inc.
|
Multi-Axial
Connection System
|
PCT
|
|
|
11/228,117
|
Blackstone
Medical Inc.
|
Anterior
Cervical Plating System
|
US
|
|
|
60/703,546
|
Blackstone
Medical Inc.
|
Nerve
Protection System
|
US
|
|
|
60/719,424
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc-Crimped Ring Design
|
US
|
|
|
60/748,333
|
Blackstone
Medical Inc.
|
Device
and Method for Holding and Inserting One or More Components of a Pedicle
Screw
|
US
|
|
|
60/759,944
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc (aka Crimped Ring-Dacron)
I
|
US
|
|
|
60/772,812
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc (aka Concentric Columns)
I
|
US
|
|
|
60/780,903
|
Blackstone
Medical Inc.
|
System
and Method for Dynamic Stabilization of the Spine
|
US
|
|
|
60/744,871
|
Blackstone
Medical Inc.
|
Percutaneous
Facet Fusion Device and Method
|
US
|
|
|
60/745,303
|
Blackstone
Medical Inc.
|
Artificial
Intervertebral Disc (aka Radially Crimped Dacron)
|
US
|
|
|
TRADEMARKS
Registration/
Application
No.
|
Credit
Party
|
Trademark
|
Jurisdiction
|
Registration/
Application
Date
|
Status
|
2646432
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
Argentina
|
|
Pending
|
827344643
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
Brazil
|
|
Pending
|
827942516
|
AMEI
Technologies, Inc.
|
GOTFRIED
PC.C.P & Design
|
Brazil
|
|
Pending
|
827318537
|
AMEI
Technologies, Inc.
|
MIOT
|
Brazil
|
|
Pending
|
824347269
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
Brazil
|
|
Pending
|
824631633
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
Brazil
|
|
Pending
|
828089400
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
Brazil
|
|
|
1254566
|
AMEI
Technologies, Inc.
|
BLADERUNNER
|
Canada
|
|
Pending
|
1254565
|
AMEI
Technologies, Inc.
|
CONTOURS
VPS
|
Canada
|
|
Pending
|
1254260
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
Canada
|
|
Pending
|
1254188
|
AMEI
Technologies, Inc.
|
MIOT
|
Canada
|
|
Pending
|
4614955
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
China
|
|
Pending
|
4556233
|
AMEI
Technologies, Inc.
|
MIOT
|
China
|
|
Pending
|
T2005-037367
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
Colombia
|
|
Pending
|
4733911
|
AMEI
Technologies, Inc.
|
GOTFRIED
PC.C.P & Design
|
CTM
|
|
Pending
|
40-2005-18478
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM &
Design
|
Republic
of
Korea
(South)
|
|
Pending
|
40-2005-15399
|
AMEI
Technologies, Inc.
|
MIOT
|
Republic
of
Korea
(South)
|
|
Pending
|
97116
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
Saudi
Arabia
|
|
Pending
|
95541
|
AMEI
Technologies, Inc.
|
MIOT
|
Saudi
Arabia
|
|
Pending
|
2005/07005
|
AMEI
Technologies, Inc.
|
BLADERUNNER
|
South
Africa
|
|
Pending
|
2005/07005
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
South
Africa
|
|
Pending
|
2005/04886
|
AMEI
Technologies, Inc.
|
MIOT
|
South
Africa
|
|
Pending
|
78526886
|
AMEI
Technologies, Inc.
|
BLADERUNNER
|
US
|
|
Pending
|
Registration/
Application
No.
|
Credit
Party
|
Trademark
|
Jurisdiction
|
Registration/
Application
Date
|
Status
|
78663808
|
AMEI
Technologies, Inc.
|
BONEMAX
& Design
|
US
|
|
Pending
|
78834578
|
AMEI
Technologies, Inc.
|
MAKING
LIFE BETTER THROUGH INNOVATIONS IN HEALING
|
US
|
|
Pending
|
78504027
|
AMEI
Technologies, Inc.
|
MIOT
|
US
|
|
Pending
|
78607031
|
AMEI
Technologies, Inc.
|
OSTEOMAX
|
US
|
|
Pending
|
1050584
|
AMEI
Technologies, Inc.
|
BLADERUNNER
|
|
4/13/2005
|
Registered
|
1051609
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
|
11/28/2005
|
Registered
|
1046353
|
AMEI
Technologies, Inc.
|
MIOT
|
|
3/15/2005
|
Registered
|
893347
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
|
10/26/2001
|
Registered
|
893350
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
|
10/26/2001
|
Registered
|
906762
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
|
3/19/2002
|
Registered
|
619612
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
|
12/31/1993
|
Registered
|
619614
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
|
12/31/1993
|
Registered
|
544186
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
Benelux
|
10/3/1994
|
Registered
|
770936
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
Benelux
|
2/22/2005
|
Registered
|
0544185
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
Benelux
|
10/3/1994
|
Registered
|
770937
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
Benelux
|
2/22/2005
|
Registered
|
TMA449580
|
AMEI
Technologies, Inc.
|
AME
& Design
|
Canada
|
11/3/1995
|
Registered
|
TMA535437
|
AMEI
Technologies, Inc.
|
CERVICAL-STIM
|
Canada
|
10/23/2000
|
Registered
|
TMA626724
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
Canada
|
11/25/2004
|
Registered
|
TMA638133
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
Canada
|
4/22/2005
|
Registered
|
TMA539243
|
AMEI
Technologies, Inc.
|
OSTEO-TITE
|
Canada
|
1/8/2001
|
Registered
|
TMA542417
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
Canada
|
3/15/2001
|
Registered
|
TMA446011
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
Canada
|
8/11/1995
|
Registered
|
636707
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
Chile
|
7/18/2002
|
Registered
|
642654
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
Chile
|
9/23/2002
|
Registered
|
3013024
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
China
|
1/28/2003
|
Registered
|
3119623
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
China
|
1/28/2003
|
Registered
|
305007
|
AMEI
Technologies, Inc.
|
MIOT
|
Colombia
|
10/24/2005
|
Registered
|
4386967
|
AMEI
Technologies, Inc.
|
BLADERUNNER
|
CTM
|
4/13/2005
|
Registered
|
000884122
|
AMEI
Technologies, Inc.
|
CERVICAL-STIM
|
CTM
|
11/17/1999
|
Registered
|
4386901
|
AMEI
Technologies, Inc.
|
CONTOURS
VPS
|
CTM
|
4/13/2005
|
Registered
|
4409389
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
CTM
|
4/20/2005
|
Registered
|
001260728
|
AMEI
Technologies, Inc.
|
EZBRACE
|
CTM
|
11/8/2000
|
Registered
|
4338331
|
AMEI
Technologies, Inc.
|
MIOT
|
CTM
|
3/14/2005
|
Registered
|
002431559
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
CTM
|
3/31/2003
|
Registered
|
002624088
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
CTM
|
1/12/2004
|
Registered
|
00851634
|
AMEI
Technologies, Inc.
|
OSTEO-TITE
|
CTM
|
10/4/1999
|
Registered
|
94502900
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
France
|
7/8/1994
|
Registered
|
9450291
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
France
|
7/8/1994
|
Registered
|
153124
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
Germany
|
6/2/2003
|
Registered
|
Registration/
Application
No.
|
Credit
Party
|
Trademark
|
Jurisdiction
|
Registration/
Application
Date
|
Status
|
155984
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
Germany
|
5/5/2003
|
Registered
|
153124
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
Israel
|
6/2/2003
|
Registered
|
155984
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
Israel
|
5/5/2003
|
Registered
|
4896847
|
AMEI
Technologies, Inc.
|
BLADERUNNER
|
Japan
|
9/22/2005
|
Registered
|
4399290
|
AMEI
Technologies, Inc.
|
CERVICAL-STIM
|
Japan
|
7/14/2000
|
Registered
|
4896849
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
Japan
|
9/22/2005
|
Registered
|
4882077
|
AMEI
Technologies, Inc.
|
MIOT
|
Japan
|
7/22/2005
|
Registered
|
4399289
|
AMEI
Technologies, Inc.
|
OSTEO-TITE
|
Japan
|
7/14/2000
|
Registered
|
4411424
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
Japan
|
8/25/2000
|
Registered
|
4325121
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
Japan
|
10/15/1999
|
Registered
|
4513042
|
AMEI
Technologies, Inc.
|
THE
HEALING ADVANTAGE
|
Japan
|
10/12/2001
|
Registered
|
101697
|
AMEI
Technologies, Inc.
|
MIOT
|
Lebanon
|
4/6/2005
|
Registered
|
913396
|
AMEI
Technologies, Inc.
|
BLADERUNNER
|
Mexico
|
12/13/2005
|
Registered
|
913397
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
Mexico
|
12/12/2005
|
Registered
|
920317
|
AMEI
Technologies, Inc.
|
GOTFRIED
PC.C.P & Design
|
Mexico
|
2/22/2006
|
Registered
|
909464
|
AMEI
Technologies, Inc.
|
MIOT
|
Mexico
|
11/23/2005
|
Registered
|
753560
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
Mexico
|
6/28/2002
|
Registered
|
784276
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
Mexico
|
3/24/2003
|
Registered
|
755668
|
AMEI
Technologies, Inc.
|
STORM
|
Mexico
|
7/25/2002
|
Registered
|
726603
|
AMEI
Technologies, Inc.
|
MIOT
|
New
Zealand
|
10/21/2004
|
Registered
|
647685
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
New
Zealand
|
5/2/2002
|
Registered
|
654028
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
New
Zealand
|
9/5/2002
|
Registered
|
215452
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
Norway
|
8/15/2002
|
Registered
|
217336
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
Norway
|
1/23/2003
|
Registered
|
141850
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
Panama
|
4/19/2005
|
Registered
|
141636
|
AMEI
Technologies, Inc.
|
MIOT
|
Panama
|
4/8/2015
|
Registered
|
246514
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
Paraguay
|
5/8/2002
|
Registered
|
255993
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
Paraguay
|
4/9/2003
|
Registered
|
659808
|
AMEI
Technologies, Inc.
|
BLADERUNNER
|
Republic
of
Korea
(South)
|
4/24/2006
|
Registered
|
5432131
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
Republic
of
Korea
(South)
|
3/14/2003
|
Registered
|
554995
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Device
|
Republic
of
Korea
(South)
|
7/30/2003
|
Registered
|
Registration/
Application
No.
|
Credit
Party
|
Trademark
|
Jurisdiction
|
Registration/
Application
Date
|
Status
|
56175
|
AMEI
Technologies, Inc.
|
MIOT
|
Republic
of
Korea
(South)
|
11/30/2005
|
Registered
|
1557943
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
United
Kingdom
|
11/3/1995
|
Registered
|
1557944
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
United
Kingdom
|
12/1/1995
|
Registered
|
1981113
|
AMEI
Technologies, Inc.
|
1-800-BONEFIX
|
US
|
6/18/1996
|
Registered
|
2265742
|
AMEI
Technologies, Inc.
|
CERVICAL-STIM
|
US
|
7/27/1999
|
Registered
|
3103333
|
AMEI
Technologies, Inc.
|
CONTOURS
VPS
|
US
|
6/13/2006
|
Registered
|
3094296
|
AMEI
Technologies, Inc.
|
EIGHT-PLATE
GUIDED GROWTH SYSTEM & Design
|
US
|
5/16/2006
|
Registered
|
2592020
|
AMEI
Technologies, Inc.
|
EZBRACE
|
US
|
7/9/2002
|
Registered
|
3090036
|
AMEI
Technologies, Inc.
|
GOTFRIED
PC.C.P & Design
|
US
|
5/9/2006
|
Registered
|
2991110
|
AMEI
Technologies, Inc.
|
I
ISKD & Design
|
US
|
9/6/2005
|
Registered
|
3029777
|
AMEI
Technologies, Inc.
|
M2
MULTIPLANAR MINIRAIL & Design
|
US
|
12/13/2005
|
Registered
|
2574017
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
|
US
|
5/28/2002
|
Registered
|
2708888
|
AMEI
Technologies, Inc.
|
ORTHOTRAC
& Design
|
US
|
4/22/2003
|
Registered
|
2269876
|
AMEI
Technologies, Inc.
|
OSTEO-TITE
|
US
|
8/10/1999
|
Registered
|
1701625
|
AMEI
Technologies, Inc.
|
PHYSIO-STIM
|
US
|
7/21/1992
|
Registered
|
1384143
|
AMEI
Technologies, Inc.
|
SPINAL-STIM
|
US
|
2/25/1986
|
Registered
|
2789136
|
AMEI
Technologies, Inc.
|
THE
HEALING ADVANTAGE
|
US
|
12/2/2003
|
Registered
|
2427678
|
AMEI
Technologies, Inc.
|
BMD-STIM
|
US
|
2/6/2001
|
Registered
|
Registration/
Application
No.
|
Credit
Party
|
Trademark
|
Jurisdiction
|
Registration/
Application
Date
|
Status
|
2,750,593
|
Breg
Inc.
|
PTO
|
US
|
8/12/2003
|
Registered
|
2,734,767
|
Breg
Inc.
|
Breg
|
US
|
7/8/2003
|
Registered
|
2,692,824
|
Breg
Inc.
|
B
stylized letters
|
US
|
3/4/2003
|
Registered
|
2,692,823
|
Breg
Inc.
|
B
Breg
|
US
|
3/4/2003
|
Registered
|
2,393,538
|
Breg
Inc.
|
THE
TRADITION
|
US
|
10/10/2000
|
Registered
|
2,664,714
|
Breg
Inc.
|
PAIN
CARE
|
US
|
12/17/2002
|
Registered
|
2,445,909
|
Breg
Inc.
|
POLAR
CARE
|
US
|
4/24/2001
|
Registered
|
1,898,777
|
Breg
Inc.
|
FLEX-MATE
|
US
|
6/13/1995
|
Registered
|
1,710,735
|
Breg
Inc.
|
B
Breg and design
|
US
|
8/25/1992
|
Registered
|
1,726,657
|
Breg
Inc.
|
Design
only
|
US
|
10/20/1992
|
Registered
|
1,712,650
|
Breg
Inc.
|
BREG
|
US
|
9/1/1992
|
Registered
|
2,041,086
|
Breg
Inc.
|
BREG
|
DE
|
7/23/1993
|
|
751,644
|
Breg
Inc.
|
BREG
|
Mexico
|
11/18/2005
|
|
2,791,770
|
Breg
Inc.
|
BREG
|
EC
|
|
|
1,720,605
|
Breg
Inc.
|
BREG
|
Spain
|
|
Registered
|
649,826
|
Breg
Inc.
|
BREG
|
Italy
|
|
Registered
|
2,041,086
|
Breg
Inc.
|
BREG
|
Germany
|
|
Registered
|
94/432
165
|
Breg
Inc.
|
BREG
|
France
|
|
Registered
|
3,052,822
|
Breg
Inc.
|
BREG
|
Japan
|
|
Registered
|
VR006441994
|
Breg
Inc.
|
BREG
|
Denmark
|
|
Registered
|
160,042
|
Breg
Inc.
|
BREG
|
Norway
|
|
Registered
|
827,731,922
|
Breg
Inc.
|
BREG
|
Brazil
|
8/3/2005
|
Registered
|
827,731,949
|
Breg
Inc.
|
POLAR
CARE
|
Brazil
|
8/3/2005
|
Registered
|
Registration/
Application
No.
|
Credit
Party
|
Trademark
|
Jurisdiction
|
Registration/
Application
Date
|
Status
|
751,647
|
Breg
Inc.
|
POLAR
CARE
|
Mexico
|
11/18/2005
|
Registered
|
3,066,723
|
Breg
Inc.
|
ORTHO
SELECT
|
US
|
3/7/2006
|
Registered
|
3,050,423
|
Breg
Inc.
|
FUSION
|
US
|
1/24/2006
|
Registered
|
3,050,899
|
Breg
Inc.
|
FUSION
and twin F design
|
US
|
1/24/2006
|
Registered
|
3,050,900
|
Breg
Inc.
|
twin
F design
|
US
|
1/24/2006
|
Registered
|
3,020,950
|
Breg
Inc.
|
PAIN
CARE
|
US
|
11/29/2005
|
Registered
|
3,012,237
|
Breg
Inc.
|
T
SCOPE
|
US
|
11/1/2005
|
Registered
|
2,900,945
|
Breg
Inc.
|
NEUTRAL
WEDGE
|
US
|
11/2/2004
|
Registered
|
2,855,229
|
Breg
Inc.
|
ARTHOTAP
|
US
|
6/15/2004
|
Registered
|
2,796,013
|
Breg
Inc.
|
AIRMESH
|
US
|
12/16/2003
|
Registered
|
2,775,794
|
Breg
Inc.
|
X2K
|
US
|
10/21/2003
|
Registered
|
78/963,043
|
Breg
Inc.
|
KOOL
SLING
|
US
|
8/29/2006
|
Pending
|
78/959,137
|
Breg
Inc.
|
KODIAK
|
US
|
8/23/2006
|
Pending
|
78/881,001
|
Breg
Inc.
|
PAINDRAIN
|
US
|
5/10/2006
|
Pending
|
78/722,922
|
Blackstone
Medical Inc.
|
Advent
|
US
|
9/29/2005
|
Pending
|
3091181
|
Blackstone
Medical Inc.
|
Alloquent
|
US
|
5/9/2006
|
Active
|
3101182
|
Blackstone
Medical Inc.
|
Ascent
|
US
|
6/6/2006
|
Active
|
2347454
|
Blackstone
Medical Inc.
|
Blackstone
|
US
|
5/2/2000
|
Active
|
3078373
|
Blackstone
Medical Inc.
|
Breakthrough
Thinking
|
US
|
4/11/2006
|
Active
|
78/415,732
|
Blackstone
Medical Inc.
|
Construx
|
US
|
5/10/2006
|
Pending
|
76/626,832
|
Blackstone
Medical Inc.
|
Hallmark
|
US
|
1/4/2005
|
Pending
|
76/634,301
|
Blackstone
Medical Inc.
|
Icon
|
US
|
3/25/2005
|
Pending
|
76/627,654
|
Blackstone
Medical Inc.
|
Newbridge
|
US
|
1/12/2005
|
Pending
|
78/415,714
|
Blackstone
Medical Inc.
|
Ngage
|
US
|
5/10/2004
|
Pending
|
78/932,408
|
Blackstone
Medical Inc.
|
Origen
DBM
|
US
|
7/18/2006
|
Pending
|
78/880,509
|
Blackstone
Medical Inc.
|
Pillar
|
US
|
5/10/2006
|
Pending
|
78/880,515
|
Blackstone
Medical Inc.
|
Proview
|
US
|
5/10/2006
|
Pending
|
78/415,658
|
Blackstone
Medical Inc.
|
Reveal
|
US
|
|
|
78/935,508
|
Blackstone
Medical Inc.
|
Reliant
|
US
|
7/18/2006
|
|
78/751,479
|
Blackstone
Medical Inc.
|
Trinity
and Design
|
US
|
11/10/2005
|
Pending
|
78/752,413
|
Blackstone
Medical Inc.
|
Trinity
|
US
|
11/11/2005
|
Pending
|
76/625,481
|
Blackstone
Medical Inc.
|
Unity
|
US
|
12/23/2004
|
Pending
|
76/635,940
|
Blackstone
Medical Inc.
|
Unity
51
|
US
|
|
|
Schedule
3.19(a)
LOCATION OF REAL
PROPERTY
|
a)
|
Street
Address:
|
1720
Bray Central Drive, McKinney, TX 75069
|
|
|
State:
|
Texas
|
|
|
County:
|
Collin
County
|
|
|
|
|
|
b)
|
Street
Address:
|
2611
Commerce Way, Vista, CA 92081
|
|
|
State:
|
California
|
|
|
County:
|
San
Diego County
|
|
|
|
|
|
c)
|
Street
Address:
|
10115
Kincey Avenue, Suite 250,
|
|
|
|
Huntersville
Park, Huntersville, NC 28078
|
|
|
State:
|
North
Carolina
|
|
|
County:
|
Mecklenburg
County
|
|
|
|
|
|
d)
|
Street
Address:
|
90
Brookdale Drive, Springfield, MA 01104
|
|
|
State:
|
Massachusetts
|
|
|
County:
|
Hampden
County
|
|
|
|
|
|
e)
|
Street
Address:
|
1211
Hamburg Turnpike, Suite 214,
|
|
|
|
Wayne,
NJ 07470
|
|
|
State:
|
New
Jersey
|
|
|
County:
|
Passaic
County
|
None.
Schedule
3.19(b)
LOCATION OF
COLLATERAL
Address
(including county)
|
Value
of Collateral
|
10115
Kincey Avenue, Suite 250
Huntersville,
NC 28078
Mecklenburg
County
|
$121,917
|
1720
Bray Central Drive
McKinney,
TX 75069
Collin
County
|
$17,966,908
|
2611
Commerce Way
Vista,
CA 92081
San
Diego County
|
$13,485,000
|
90
Brookdale Drive
Springfield,
MA 01104
Hampden
County
|
$11,738,600
|
1211
Hamburg Turnpike, Suite 214
Wayne,
NJ 07470
Passaic
County
|
$279,087
|
Schedule
3.19(c)
CHIEF EXECUTIVE
OFFICES
Credit
Party
|
Jurisdiction
of
Incorporation/
Organization
|
Chief
Executive
Office
|
Principal
Place
of
Business
|
Tax
Identification
Number/Tax
Reference
Number
|
Organization
Identification
Number
|
Orthofix
International
N.V.
|
Netherlands
Antilles
|
10115
Kincey
Avenue,
Suite
250,
Huntersville,
NC
28078
Mecklenburg
County
|
7
Abraham de
Veerstraat
Curacao,
Netherlands
Antilles
|
117.595.068
|
None
|
Colgate
Medical Ltd
|
UK
|
5
Burney
Court,
Cordwallis
Park,
Maidenhead,
Berks
SL6
7BZ
|
5
Burney
Court,
Cordwallis
Park,
Maidenhead,
Berks
SL6
7BZ
|
610
67740
10890
|
01311455
|
Orthofix
Holdings, Inc.
|
Delaware
|
10115
Kincey
Avenue,
Suite
250,
Huntersville,
NC
28078
Mecklenburg
County
|
10115
Kincey
Avenue,
Suite
250,
Huntersville,
NC
28078
Mecklenburg
County
|
52-2436054
|
3741422
|
Victory
Medical
Limited
|
UK
|
5
Burney
Court,
Cordwallis
Park,
Maidenhead,
Berks
SL6
7BZ
|
5
Burney
Court,
Cordwallis
Park,
Maidenhead,
Berks
SL6
7BZ
|
610
75400
20346
|
05594778
|
Swiftsure
Medical
Limited
|
UK
|
5
Burney
Court,
Cordwallis
Park,
Maidenhead,
Berks
SL6
|
5
Burney
Court,
Cordwallis
Park,
Maidenhead,
Berks
SL6
|
610
54745
13575
|
05594781
|
Credit
Party
|
Jurisdiction
of
Incorporation/
Organization
|
Chief
Executive
Office
|
Principal
Place
of
Business
|
Tax
Identification
Number/Tax
Reference
Number
|
Organization
Identification
Number
|
|
|
7BZ
|
7BZ
|
|
|
Orthofix
UK Ltd
|
UK
|
5
Burney
Court,
Cordwallis
Park,
Maidenhead,
Berks
SL6
7BZ
|
5
Burney
Court,
Cordwallis
Park,
Maidenhead,
Berks
SL6
7BZ
|
610
17836
02273
|
05000721
|
Orthofix
Inc.
|
Minnesota
|
1720
Bray
Central
Drive,
McKinney,
TX
75069
Collin
County
|
1720
Bray
Central
Drive,
McKinney,
TX
75069
Collin
County
|
75-2608036
|
8R-468
|
Breg
Inc.
|
California
|
2611
Commerce
Way,
Vista,
CA
92081
San
Diego
County
|
2611
Commerce
Way,
Vista,
CA
92081
San
Diego
County
|
33-0361048
|
C1635882
|
Orthofix
US LLC
|
Delaware
|
10115
Kincey
Avenue,
Suite
250,
Huntersville,
NC
28078
Mecklenburg
County
|
10115
Kincey
Avenue,
Suite
250,
Huntersville,
NC
28078
Mecklenburg
County
|
52-2436057
|
3742359
|
AMEI
Technologies
Inc.
|
Delaware
|
1720
Bray
Central
Drive,
McKinney,
TX
75069
Collin
County
|
1720
Bray
Central
Drive,
McKinney,
TX
75069
Collin
County
|
51-0349533
|
3978372
|
Osteogenics
Inc.
|
Delaware
|
1720
Bray
Central
Drive,
McKinney,
TX
75069
|
1720
Bray
Central
Drive,
McKinney,
TX
75069
|
75-2571587
|
2440883
|
Credit
Party
|
Jurisdiction
of
Incorporation/
Organization
|
Chief
Executive
Office
|
Principal
Place
of
Business
|
Tax
Identification
Number/Tax
Reference
Number
|
Organization
Identification
Number
|
|
|
Collin
County
|
Collin
County
|
|
|
Neomedics,
Inc.
|
New
Jersey
|
1720
Bray
Central
Drive,
McKinney,
TX
75069
Collin
County
|
1720
Bray
Central
Drive,
McKinney,
TX
75069
Collin
County
|
22-3370043
|
0100624244
|
Blackstone
Medical,
Inc.
|
Massachusetts
|
90
Brookdale
Drive,
Springfield,
MA
01104
Hampden
County
1211
Hamburg
Turnpike,
Suite
214,
Wayne,
New
Jersey
07470
Passaic
County
|
90
Brookdale
Drive,
Springfield,
MA
01104
|
04-3290472
|
None
|
Schedule
3.19(d)
MORTGAGED
PROPERTIES
|
a)
|
Street
Address:
|
1720
Bray Central Drive, McKinney, TX
75069
|
|
b)
|
Street
Address:
|
2611
Commerce Way, Vista, CA 92081
|
|
c)
|
Street
Address:
|
90
Brookdale Drive, Springfield, MA
01104
|
None
Schedule
3.21
LABOR
MATTERS
1.
|
The
employees of Orthofix International N.V.'s Orthofix Srl subsidiary are
represented for the purposes of collective bargaining by a labor
organization as mandated by Italian
law.
|
Schedule
3.29
MATERIAL
CONTRACTS
1.
|
Orthofix International
N.V.
|
|
a)
|
Employment
Agreement, dated November 20, 2003, between Orthofix International N.V.
and Bradley R. Mason, filed with the SEC in an 8-K dated November 26,
2003.
|
|
b)
|
Employment
Agreement, dated April 15, 2005, between Orthofix International N.V. and
Charles W. Federico, filed with the SEC in an 8-K dated April 18,
2005.
|
|
c)
|
Employment
Agreement, as amended, dated December 29, 2005, between Orthofix
International N.V. and Charles W. Federico, filed with the SEC in an 8-K
dated December 30, 2005.
|
|
d)
|
Employment
Agreement, dated July 13, 2006, between the Company and Thomas Hein, filed
with the SEC in an 8-K dated July 18,
2006.
|
|
e)
|
Employment
Agreement, dated July 13, 2006, between Orthofix Inc. and Alan W.
Milinazzo, filed with the SEC in an 8-K dated July 18,
2006.
|
|
f)
|
Employment
Agreement, dated July 13, 2006, between Orthofix Inc. and Michael M.
Finegan, filed with the SEC in an 8-K dated July 18,
2006.
|
|
g)
|
Employment
Agreement, dated July 13, 2006, between Orthofix Inc. and Raymond C.
Kolls, filed with the SEC in an 8-K dated July 18,
2006.
|
2.
|
Blackstone Medical,
Inc.
|
|
a)
|
Distribution
and Supply Agreement by and between Blackstone and Osiris Therapeutics,
Inc. dated November __, 2005. Section 11.2 provides that Blackstone may
transfer the agreement in connection with a merger with the prior written
consent of Osiris, such consent not to be unreasonably withheld.
1
|
|
b)
|
Agreement
between Blackstone and Invibio, Inc. dated as of October 23, 2003. Section
4.3 provides that neither party may assign a right or obligation under the
agreement without first obtaining the other party's written
consent.
|
______________________
1
Note:
Document executed, but not dated.
|
c)
|
License
Agreement dated December 2, 2003 by and between Blackstone and Cross
Medical Products, Inc. Section 6.1 provides that the parties may assign
any or all of their rights or delegate any or all of their duties under
the agreement only upon the prior written consent of the other party, but
such consent shall not be unreasonably withheld in the event a party
wishes to assign the agreement to a purchaser of all or substantially all
of its assets relating to the '237 Patent, the '555 Patent or the Licensed
Product.
|
|
a)
|
Extension
of Lease between Breg, Inc. and North County Industrial Park, LP
(Vista).
|
|
b)
|
Lease
Agreement between Breg Mexico S. de R.L de C.V. and Industrias Asociadas
Maquiladoras, S.A. de C.V.
(Mexicali).
|
|
c)
|
GPO
Agreements; Amerinet; Consorta; Novation; Healthtrust; OPGA; DOD and VA
Government Contracts; and Hanger.
|
4.
|
Tax
Structure Documents (as defined in the Credit
Agreement).
|
Schedule
3.30
INSURANCE
|
1.
|
Orthofix Holdings,
Inc. and its Domestic
Subsidiaries
|
Type
of Insurance
|
Carrier
|
Policy
Number
|
Amount
|
Expiration
Date
|
Product
Liability
|
Medmarc
Casualty Insurance Company
|
06NC380002
|
$10,000,000
Per Occurrence $10,000,000 Aggregate $1,000,000 Separate Defense Cost
Limit $250,000 per Occurrence SIR $1,000,000 Aggregate SIR
|
04/01/07
|
Excess
Product Liability
|
Lexington
Insurance Company
|
715-75-77
|
$5,000,000
Per Occurrence $5,000,000 Aggregate
|
04/01/07
|
General
Liability
|
Travelers
Property Casualty Company of America
|
Y-630-
6108A144-TIL-06
|
$2,000,000
General Aggregate $1,000,000 Each Occurrence Limit $1,000,000
Personal/Advertising Injury $300,000 Fire Damage Legal Liability $10,000
Medical Payments Per Person Product Liability Excluded
|
04/01/07
|
Property
including Equipment Breakdown
|
Travelers
Property Casualty Company of America
|
Y-630-
6108A144-TIL-06
|
$6,000,000
Real Property $25,854,000 Business Personal Property $100,145,000 Business
Interruption $10,500,000 Inland Marine $25,000 PD Deductible $50,000 PD
Deductible Flood/EQ 5%/$250,000 min. CA EQ Deductible 72 Hr BI
Deductible
|
04/01/07
|
Inland
Marine
|
Travelers
Property Casualty Company of America
|
Y-630-
6108A144-TIL-06
|
$10,500,000
Inland Marine Limit $25,000 Deductible $50,000 Deductible
Flood/EQ
|
04/01/07
|
Automobile
Liability & Physical Damage
|
Travelers
Property Casualty Company of America
|
Y-810-
6108A132-TIL-06
|
$1,000,000
BI & PD Combined Single Limit
|
04/01/07
|
Workers
Compensation
|
The
Travelers Indemnity Company of Connecticut
|
YEUB-6117A90-3-06
|
Statutory
WC Limits $1,000,000 Employers Liability Limits
|
04/01/07
|
Foreign
Liability
|
St.
Paul Fire & Marine Insurance Company
|
GB06800892
|
$1,000,000
Each Occurrence $2,000,000 Aggregate Product Liability
Excluded
|
04/01/07
|
Umbrella
|
National
Union Fire Insurance Company of Pittsburgh, PA
|
BE6565109
|
$25,000,000
Per Occurrence $25,000,000 Aggregate $10,000 SIR Product Liability
Excluded
|
04/01/07
|
California
Earthquake
|
Glencoe
Insurance Company
|
305506XF-1
|
$3,000,000
excess of Travelers $2,000,000 5% deductible per location (min.
$500,0000)
|
04/01/07
|
Marine
Ocean Cargo
|
Continental
Insurance Company
|
OC0243831
|
$1,000,000
Any One Conveyance $1,000 Deductible
|
04/01/07
|
|
2.
|
Orthofix International
N.V. and its Subsidiaries
|
Type
of Insurance
|
Carrier
|
Policy
Number
|
Amount
|
Expiration
Date
|
Crime
|
St.
Paul Fire & Marine Insurance Company
|
429CF0600
|
$3,000,000
limit $25,000 Deductible
|
09/07/07
|
Employment
Practices Liability
|
St.
Paul Mercury Insurance Company
|
EC09000870
|
$5,000,000
limit $100,000 Deductible
|
09/07/07
|
Kidnap
& Ransom
|
St.
Paul Fire & Marine Insurance Company
|
429CF0601
|
$3,000,000
per Insured Event
|
09/07/07
|
Fiduciary
Liability
|
Federal
Insurance Company
|
8139-0905
|
$3,000,000
Each Claim $3,000,000 Each policy period $10,000 Retention
|
09/07/07
|
Directors
& Officers
|
St.
Paul Mercury Insurance Company
|
EC09000869
|
$15,000,000
Limit $250,000 Retention $500,000 Retention SEC Claims
|
09/07/07
|
Excess
Directors & Officers
|
Federal
Insurance Company
|
6803-3515
|
$10,000,000
limit excess of $15,000,000
|
09/07/07
|
|
3.
|
Blackstone
Medical, Inc.
|
Type
of Insurance
|
Carrier
|
Policy
Number
|
Amount
|
Expiration
Date
|
Product
Liability
|
Noetic
Specialty Insurance Co.
|
NO6MA380001
|
Aggregate:
$10,000,000 Each Occurrence: $10,000,000
|
01/06/07
|
Schedule
4.1-1
[FORM
OF]
SECRETARY'S
CERTIFICATE
Pursuant
to Section 4.1(b) of the Credit Agreement dated as of September 22, 2006 (the
"
Credit
Agreement
") by and among Orthofix Holdings, Inc., a Delaware corporation
(the "
Borrower
"), the
Guarantors from time to time party thereto, the Lenders from time to time party
thereto and Wachovia Bank, National Association, as Administrative Agent (the
"
Administrative
Agent
"), the undersigned _______of
[CREDIT PARTY]
(the "
Company
") hereby
certifies as follows:
1. Attached
hereto as
Exhibit
A
is a true and complete copy of the [articles of incorporation]
[certificate of formation] [certificate of limited partnership] of the Company
and all amendments thereto as in effect on the date hereof certified as a recent
date by the appropriate Governmental Authority of the state of [incorporation]
[organization] of the Company.
2. Attached
hereto as
Exhibit
B
is a true and complete copy of the [bylaws] [operating agreement]
[partnership agreement] of the Company and all amendments thereto as in effect
on the date hereof.
3. Attached
hereto as
Exhibit
C
is a true and complete copy of resolutions duly adopted by the [board
of directors] [members] [managers] [partners] of the Company on ________
_____. Such resolutions have not in any way been rescinded or
modified and have been in full force and effect since their adoption to and
including the date hereof, and such resolutions are the only corporate
proceedings of the Company now in force relating to or affecting the matters
referred to therein.
4. Attached
hereto as
Exhibit
D
is a true and complete copy of the certificates of good standing,
existence or its equivalent of the Company, each certified as a recent date by
the appropriate Governmental Authority of the state of [incorporation]
[organization] of the Company or any other state in which the failure to so
qualify and be in good standing could reasonably be expected to have a Material
Adverse Effect.
5. The
following persons are now the duly elected and qualified [officers] [directors]
of the Company, [holding the offices indicated next to the names below on the
date hereof,] and the signatures appearing opposite the names of the [officers]
[directors] below are their true and genuine signatures, and each of such
[officers] [directors] is duly authorized to execute and deliver on behalf of
the Company, the Credit Agreement, the Notes and the other Credit Documents to
be issued pursuant thereto:
Name
|
[Office]
[Director]
|
Signature
|
|
|
|
|
|
|
|
|
|
This
Certificate may, upon execution, be delivered by facsimile or electronic mail,
which shall be deemed for all purposes to be an original signature.
Capitalized
terms defined in the Credit Agreement shall have the same meanings when used
herein.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
IN
WITNESS WHEREOF, the undersigned hereunder subscribes his/her
name
effective as of the __ day of _______, ___.
I,
___________________________, the ____________________________ of the Company,
hereby certify that ___________________________________
is the duly elected and qualified
_____________________________ of the Company and that his/her true and genuine
signature is set forth above.
Schedule
4.1-2
[FORM
OF]
SOLVENCY
CERTIFICATE
The
undersigned, Thomas Hein, Chief Financial Officer of ORTHOFIX INTERNATIONAL,
N.V., a Netherlands Antilles corporation (the "
Company
"), is
familiar with the properties, businesses, assets and liabilities of the Credit
Parties and is duly authorized to execute this certificate (this "
Solvency
Certificate
") on behalf of the Credit Parties.
This
Solvency Certificate is delivered pursuant to Section 4.1(j) of that certain
Credit Agreement dated as of September 22, 2006 (the "
Credit Agreement
") by
and among Orthofix Holdings, Inc., a Delaware corporation (the "
Borrower
"), the
Guarantors from time to time party thereto, the Lenders from time to time party
thereto and Wachovia Bank, National Association, as Administrative Agent (the
"
Administrative
Agent
"). All capitalized terms used and not defined herein have the
meanings stated in the Credit Agreement.
1. The
undersigned certifies that he has made such investigation and inquiries as to
the financial condition of the Credit Parties as the undersigned deems necessary
and prudent for the purpose of providing this Solvency Certificate. The
undersigned acknowledges that the Administrative Agent and the Lenders are
relying on the truth and accuracy of this Solvency Certificate in connection
with the making of Loans and other Extensions of Credit under the Credit
Agreement.
2. The
undersigned certifies that the financial information, projections and
assumptions which underlie and form the basis for the representations made in
this Solvency Certificate were reasonable when made and were made in good faith
and continue to be reasonable as of the date hereof.
BASED ON
THE FOREGOING, the undersigned certifies that after giving effect to the
Acquisition, the Loans and other Extensions of Credit made on the Closing
Date:
A. On
the date hereof, each of the Credit Parties is able to pay its
debts and
other liabilities, contingent obligations and other commitments as
they
become due.
B. Each
of the Credit Parties does not intend to, and does not
believe
that it will, incur debts or liabilities beyond its ability to pay as such
debts and
liabilities become due.
C.
On the date hereof, each of the Credit Parties is not engaged in
any
business or transaction, and is not about to engage in any business or
transaction,
for which the assets of such Credit Party would constitute
unreasonably
small capital after giving due consideration to the prevailing
practice
in the industry in which the Credit Parties and their Subsidiaries
are
engaged or are to engage.
D.
On the date hereof, the present fair saleable value of the
consolidated
assets of the Credit Parties and their Subsidiaries, measured
on
a
going concern basis, exceeds all probable liabilities of the Credit Parties and
their
Subsidiaries, on a consolidated basis, including contingent liabilities
incurred
pursuant to the Credit Agreement.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
|
ORTHOFIX
INTERNATIONAL, N.V.,
|
|
|
a
Netherlands Antilles corporation
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
|
Title:
|
|
|
[FORM
OF]
LENDER
CONSENT
TO:
|
Wachovia
Bank, National Association, as Administrative
Agent
|
RE:
|
Credit
Agreement dated as of September 22, 2006 (the "
Credit
Agreement
") by and among Orthofix Holdings, Inc., a Delaware
corporation (the "
Borrower
"), the
Guarantors from time to time party thereto, the Lenders from time to time
party thereto (the "
Lenders
") and
Wachovia Bank, National Association, as Administrative Agent (the "
Administrative
Agent
").
|
This
Consent is given pursuant to the Credit Agreement referenced above. The
undersigned hereby (i) approves the Credit Agreement, (ii) authorizes and
appoints the Administrative Agent as its agent in accordance with the terms of
Article VIII of the Credit Agreement and (iii) authorizes the Administrative
Agent to execute and deliver the Credit Agreement on its behalf and, by its
execution below, the undersigned agrees to be bound as a Lender by the terms and
conditions of the Credit Agreement as if the undersigned had directly executed
and delivered a signature page to the Credit Agreement. By becoming a Lender
under the Credit Agreement pursuant to this Consent, the undersigned agrees to
make Extensions of Credit to the Borrower up to the amount of its Commitments in
accordance with the terms of the Credit Agreement. Capitalized terms used herein
and not otherwise defined shall have the meanings set forth in the Credit
Agreement.
Delivery
of this Consent by telecopy shall be effective as an original.
A duly
authorized officer of the undersigned has executed this
Consent
as of the
_____ day of ______, ___.
|
|
|
,
|
|
|
as
a Lender
|
|
|
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
|
Name:
|
|
|
|
|
Title:
|
|
|
|
[FORM
OF]
JOINDER
AGREEMENT
THIS JOINDER AGREEMENT
(the "
Agreement
"), dated as of
__________,
_____, is by and between _______________, a _____________ (the "
New Domestic
Subsidiary
"), and
WACHOVIA BANK, NATIONAL ASSOCIATION,
in its capacity as Administrative Agent under that certain Credit
Agreement dated as of September 22, 2006 (as amended, restated or otherwise
modified prior to the date hereof, the "
Credit Agreement
") by
and among Orthofix Holdings, Inc., a Delaware corporation (the "
Borrower
"), the
Guarantors from time to time party thereto, the Lenders from time to time party
thereto and Wachovia Bank, National Association, as Administrative Agent (the
"
Administrative
Agent
"). All of the defined terms in the Credit Agreement are
incorporated herein by reference.
The New
Domestic Subsidiary is an Additional Credit Party, and, consequently, the Credit
Parties are required by Section 5.10 of the Credit Agreement to cause the New
Domestic Subsidiary to become a "Guarantor" thereunder.
Accordingly,
the New Domestic Subsidiary and the Borrower hereby agree as follows with the
Administrative Agent, for the benefit of the Lenders:
1.
The New
Domestic Subsidiary hereby acknowledges, agrees and confirms that, by its
execution of this Agreement, the New Domestic Subsidiary will be deemed to be a
party to and a "Guarantor" under the Credit Agreement and shall have all of the
obligations of a Guarantor thereunder as if it had executed the Credit
Agreement. The New Domestic Subsidiary hereby ratifies, as of the date hereof,
and agrees to be bound by, all of the terms, provisions and conditions contained
in the applicable Credit Documents, including without limitation (a) all of the
representations and warranties set forth in Article III of the Credit Agreement
and (b) all of the affirmative and negative covenants set forth in Articles V
and VI of the Credit Agreement. Without limiting the generality of the foregoing
terms of this Paragraph 1, the New Domestic Subsidiary hereby guarantees,
jointly and severally together with the other Guarantors, the prompt payment of
the Credit Party Obligations in accordance with Article X of the Credit
Agreement.
2.
The New
Domestic Subsidiary hereby acknowledges, agrees and confirms that, by its
execution of this Agreement, the New Domestic Subsidiary will be deemed to be a
party to the Security Agreement, and shall have all the rights and obligations
of an "Obligor" (as such term is defined in the Security Agreement) thereunder
as if it had executed the Security Agreement. The New Domestic
Subsidiary hereby agrees to be bound by, all of the terms, provisions and
conditions contained in the Security Agreement. Without
limiting the generality of the foregoing terms of this Paragraph 2, the New
Domestic Subsidiary hereby grants to the Administrative Agent, for the benefit
of the Lenders, a continuing security interest in, and a right of set off, to
the extent applicable, against any and all right, title and interest of the New
Domestic Subsidiary in and to the Collateral (as such term is defined in Section
2 of the Security Agreement) of the New Domestic Subsidiary.
3. The
New Domestic Subsidiary hereby acknowledges, agrees and confirms that, by its
execution of this Agreement, the New Domestic Subsidiary will be deemed to be a
party to the Pledge Agreement, and shall have all the rights and obligations of
a "Pledgor" thereunder as if it had executed the Pledge Agreement. The New
Domestic Subsidiary hereby agrees to be bound by, all the terms, provisions and
conditions contained in the Pledge Agreement. Without limiting the generality of
the foregoing terms of this Paragraph 3, the New Domestic Subsidiary hereby
pledges and assigns to the Administrative Agent, for the benefit of the Lenders,
and grants to the Administrative Agent, for the benefit of the Lenders, a
continuing security interest in any and all right, title and interest of the New
Domestic Subsidiary in and to Pledged Capital Stock (as such term is defined in
Section 2 of the Pledge Agreement) and the other Pledged Collateral (as such
term is defined in Section 2 of the Pledge Agreement).
4. The
New Domestic Subsidiary acknowledges and confirms that it has received a copy of
the Credit Agreement and the schedules and exhibits thereto and each Security
Document and the schedules and exhibits thereto. The schedules to the Credit
Agreement and the Security Documents are hereby supplemented (to the extent
permitted under the Credit Agreement or Security Documents) to include the
information shown on the attached
Schedule A
.
5. The
Borrower confirms that the Credit Agreement is and, upon the New Domestic
Subsidiary becoming a Guarantor, shall continue to be, in full force and effect.
The parties hereto confirm and agree that immediately upon the New Domestic
Subsidiary becoming a Guarantor under the Credit Agreement, the term "Credit
Party Obligations," as used in the Credit Agreement, shall include all
obligations of the New Domestic Subsidiary under the Credit Agreement and under
each other Credit Document.
6. Each
of the Borrower and the New Domestic Subsidiary agrees that at any time and from
time to time, upon the written request of the Administrative Agent, it will
execute and deliver such further documents and do such further acts as the
Administrative Agent may reasonably request in accordance with the terms and
conditions of the Credit Agreement in order to effect the purposes of this
Agreement.
7. This
Agreement (a) may be executed in two or more counterparts, each of which shall
constitute an original but all of which when taken together shall constitute one
contract and (b) may, upon execution, be delivered by facsimile or electronic
mail, which shall be deemed for all purposes to be an original
signature.
8. This
Agreement shall be governed by and construed and enforced in accordance with the
laws of the State of New York. The terms of Sections 9.14 and 9.17 of the Credit
Agreement are incorporated herein by reference,
mutatis mutandis,
and the
parties hereto agree to such terms.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
IN
WITNESS WHEREOF, each of the Borrower and the New Domestic Subsidiary has caused
this Agreement to be duly executed by its authorized officer, and the
Administrative Agent, for the benefit of the Lenders, has caused the same to be
accepted by its authorized officer, as of the day and year first above
written.
BORROWER:
|
ORTHOFIX
HOLDINGS, INC.,
|
|
|
a
Delaware corporation
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
|
Title:
|
|
|
|
|
|
|
|
|
|
|
NEW
DOMESTIC SUBSIDIARY:
|
[NEW
DOMESTIC SUBSIDIARY]
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Name:
|
|
|
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Title:
|
|
|
Acknowledged
and accepted:
WACHOVIA
BANK, NATIONAL ASSOCIATION,
as
Administrative Agent
SCHEDULE
A
to
Joinder
Agreement
Schedules to Credit
Agreement
Schedules to Security
Agreement
Schedules to Pledge
Agreement
Schedule 6.
(b)
INDEBTEDNESS
1.
|
Orthofix International
N.V.
|
|
a)
|
Letter
of Credit issued by Bank of America in favor of to Orthofix de Centro
America S.A in the amount of $243,185.35, cash collateralized by an
Orthofix International N.V. certificate of deposit with Bank of America.
The letter of credit expires on July 31,
2007.
|
|
b)
|
Guarantee
by Orthofix International N.V. of the payment obligation of Orthofix Inc.
to Michael M. Finegan pursuant to that certain Employment Agreement, dated
July 13, 2006, between Orthofix Inc. and Michael M.
Finegan.
|
|
c)
|
Guarantee
by Orthofix International N.V. of the payment obligation of Orthofix Inc.
to Raymond C. Kolls pursuant to that certain Employment Agreement, dated
July 13, 2006, between Orthofix Inc. and Raymond C.
Kolls.
|
|
d)
|
Guarantee
by Orthofix International N.V. of the payment obligation of Orthofix Inc.
to Thomas Hein pursuant to that certain Employment Agreement, dated July
13, 2006, between Orthofix Inc. and Thomas
Hein.
|
|
e)
|
Guarantee
by Orthofix International N.V. of the payment obligation of Orthofix Inc.
to Alan W. Milinazzo pursuant to that certain Employment Agreement, dated
July 13, 2006, between Orthofix Inc. and Alan W.
Milinazzo.
|
2.
|
Orthofix Holdings.
Inc.
|
|
a)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $35,561,349, dated as of December 29,
2003.
|
|
b)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix US LLC in the
principal amount of USD $129,000,000, dated as of December 30,
2003.
|
|
c)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $15,000,000, dated as of September 24,
2004.
|
|
d)
|
Note
issued by Ortho-fix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $7,000,000, dated as of December 16,
2004.
|
|
e)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $6,400,000, dated as of December 22,
2004.
|
|
f)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $3,000,000, dated as of September 19,
2005.
|
|
g)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $3,300,000, dated as of June 16,
2005.
|
|
h)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $5,500,000, dated as of September 22,
2005.
|
|
i)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $6,500,000, dated as of December 15,
2005.
|
|
j)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $3,500,000, dated as of March 17,
2006.
|
|
k)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $9,000,000, dated as of March 22,
2006.
|
|
l)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the amount
of USD $4,050,000, dated as of June 22,
2006.
|
|
m)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $900,000, dated as of September 14,
2006.
|
|
n)
|
Note
issued by Orthofix Holdings Inc. in favor of Blackstone Medical, Inc. in
the amount of USD $333,000,000, dated as of September 22,
2006.
|
|
a)
|
Note
issued by Orthofix Inc. in favor of AMEI Technologies Inc. in the
principal amount of USD $5,000,000, dated as of April 30,
1996.
|
|
b)
|
Note
issued by Orthofix Inc. in favor of AMEI Technologies Inc. in the
principal amount of USD $5,000,000, dated as of September 30,
1997.
|
|
c)
|
Note
issued by Orthofix Inc. in favor of AMEI Technologies Inc. in the
principal amount of USD $150,000,000, dated as of October 31,
1997.
|
|
d)
|
Note
issued by Orthofix Inc. in favor of Osteogenics Inc. in the principal
amount of USD $1,000,000, dated as of January 21,
2000.
|
|
a)
|
Note
issued by Breg Inc. in favor of Orthofix Holdings, Inc. in the principal
amount of USD $125,170,148.14, dated as of December 30,
2003.
|
|
b)
|
Breg
Inc. is a guarantor of Breg Mexico's lease agreement for the facility in
Mexicali, Mexico.
|
5.
|
AMEI Technologies
Inc.
|
|
a)
|
Note
issued by AMEI Technologies Inc. in favor of Osteogenics Inc. in the
principal amount of USD $20,000,000, dated May 6,
1998.
|
|
a)
|
Available
line of credit established and issued collectively by Unicredit BABK,
Banco Popolare di Verona and Banco of Brescia, in favor of Orthofix
SRL/DMO, in a maximum principal amount at any time outstanding of
€6,800,000. This line of credit is renewed each
April.
|
|
a)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $11,779,217.08, dated as of December 27,
2004.
|
|
b)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $5,000,000, dated as of September 26,
2005.
|
|
c)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $4,700,000, dated as of December 22,
2005.
|
|
d)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $10,600,000, dated as of March 29,
2006.
|
|
e)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $10,000,000, dated as of September 27,
2004.
|
|
f)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix International N.V. in
the principal amount of USD $4,725,000 dated as of June 16,
2005.
|
8.
|
Blackstone Medical,
Inc.
|
|
a)
|
Demand
Convertible Promissory Note dated January 24, 2003 in principal amount of
USD $215,000 made by Blackstone Medical, Inc. in favor of Michael W.
Lyons.
1
|
|
b)
|
Demand
Convertible Promissory Note dated January 24, 2003 in principal amount of
USD $215,000 made by Blackstone Medical, Inc. in favor of Matthew V.
Lyons.
1
|
|
c)
|
Demand
Convertible Promissory Note dated January 24, 2003 in principal amount of
USD $215,000 made by Blackstone Medical, Inc. in favor of William G. Lyons
III.
1
|
|
d)
|
Master
Lease Finance Agreement dated as of September 28, 2004 by and between
Banknorth Leasing Corp. and Blackstone Medical, Inc. and schedules
thereto.
2
|
|
e)
|
Lease
dated January 23, 2003 by and between Banknorth Leasing Corp. and
Blackstone Medical, Inc.
2
|
|
f)
|
Lease
dated April 4, 2003 by and between Banknorth Leasing Corp. and Blackstone
Medical, Inc.
2
|
________________________
1
Expected
to be converted into common stock immediately prior to the Effective Time of the
Orthofix-Blackstone merger.
2
This
capital lease is expected to be paid off immediately prior to the Effective Time
of the Orthofix-Blackstone merger.
Schedule
6.4(a)
PERMITTED ASSET
SALES
1.
|
1,500,000
shares of Innovative Spinal Technologies, owned by Orthofix
Inc.
|
2.
|
1,500,000
shares of OPED AG, owned by Orthofix International
N.V.
|
3.
|
3,470,000
shares of OrthoRx, owned by Orthofix International
N.V.
|
Schedule
6.5
INVESTMENTS
1.
|
Orthofix International
N.V.
|
|
a)
|
Investment
in Innovative Spinal Technologies in the amount of USD
$1,500,000.
|
|
b)
|
Investment
in OPED AG in the amount of USD
$2,500,000.
|
|
c)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $35,561,349, dated as of December 29,
2003.
|
|
d)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $6,400,000, dated as of December 22,
2004.
|
|
e)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $3,300,000, dated as of June 16,
2005.
|
|
f)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $5,500,000, dated as of September 22,
2005.
|
|
g)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix International N.V.
in the principal amount of USD $3,500,000, dated as of March 17,
2006.
|
|
i)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix International N.V. in
the principal amount of USD $4,725,000 dated June 16,
2005.
|
2.
|
Orthofix Holdings,
Inc.
|
|
a)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $5,000,000, dated as of September 26,
2005.
|
|
b)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $4,700,000, dated as of December 22,
2005.
|
|
c)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $10,600,000, dated as of March 29,
2006.
|
|
d)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $11,779,217.08, dated as of December 27,
2004.
|
|
e)
|
Note
issued by Colgate Medical Ltd in favor of Orthofix Holdings, Inc. in the
principal amount of USD $10,000,000, dated as of September 27,
2004.
|
|
f)
|
Note
issued by Breg Inc. in favor of Orthofix Holdings, Inc. in the principal
amount of USD $125,170,148.14, dated as of December 30,
2003.
|
|
a)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix US LLC in the
principal amount of USD $129,000,000, dated as of December 30,
2003.
|
|
a)
|
Investment
in Bio Wave in the amount of USD
$500,000.
|
|
b)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $15,000,000, dated as of September 24,
2004.
|
|
c)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $7,000,000, dated as of December 16,
2004.
|
|
d)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $3,000,000, dated as of September 19,
2005.
|
|
e)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $6,500,000, dated as of December 15,
2005.
|
|
f)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $9,000,000, dated March 22,
2006.
|
|
g)
|
Note
issued by Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
principal amount of USD $900,000, dated as of September 14,
2006.
|
|
h)
|
Note issued by
Orthofix Holdings, Inc. in favor of Orthofix Inc. in the
amount
of USD $4,050,000, dated as of June 22,
2006.
|
|
a)
|
Investment
in Orthospot in the amount of USD
$531,831.
|
6.
|
AMEI Technologies
Inc.
|
|
a)
|
Note
issued by Orthofix Inc. in favor of AMEI Technologies Inc. in the
principal amount of USD $5,000,000, dated as of April 30,
1996.
|
|
b)
|
Note
issued by Orthofix Inc. in favor of AMEI Technologies Inc. in the
principal amount of USD $5,000,000, dated as of September 30,
1997.
|
|
c)
|
Note
issued by Orthofix Inc. in favor of AMEI Technologies Inc. in the
principal amount of USD $150,000,000, dated as of October 31,
1997.
|
|
a)
|
Note
issued by AMEI Technologies Inc. in favor of Osteogenics Inc. in the
principal amount of USD $20,000,000, dated May 6,
1998.
|
|
b)
|
Note
issued by Orthofix Inc. in favor of Osteogenics Inc. in the principal
amount of USD $1,000,000, dated as of January 21,
2000.
|
8.
|
Blackstone Medical,
Inc.
|
|
a)
|
Note
issued by Orthofix Holdings, Inc. in favor of Blackstone Medical, Inc. in
the amount of USD $333,000,000, dated as of September 22,
2006.
|
Schedule
6.13
ACCOUNTS
1.
|
Orthofix International
N.V.
|
|
Type
of Account:
|
Operating
|
|
Type
of Account:
|
Investment
|
|
Type
of Account:
|
Checking
|
|
Type
of Account:
|
CD
- Costa Rica
|
2.
|
Orthofix Holdings,
Inc.
|
|
Type
of Account:
|
Operating
|
3.
|
Victory Medical
Limited
|
|
Type
of Account:
|
Operating
|
|
Type
of Account:
|
Operating
|
|
Type
of Account:
|
Operating
|
|
Type
of Account:
|
Checking
|
|
Type
of Account:
|
Operating
|
|
Type
of Account:
|
Operating
|
7.
|
AMEI Technologies
Inc.
|
|
a)
|
Bank:
|
Wilmington
Trust
|
|
Type
of Account:
|
Checking
|
|
b)
|
Bank:
|
Wilmington
Trust
|
|
Type
of Account:
|
Investment
|
|
Type
of Account:
|
Operating
|
9.
|
Swiftsure Medical
Limited
|
|
Type
of Account:
|
Operating
|
|
Type
of Account:
|
Operating
|
|
Type
of Account:
|
Investment
|
11.
|
Blackstone Medical,
Inc.
|
|
a)
|
Bank
of America account to be opened promptly following
closing.
|
Schedule
9.6(c)
ASSIGNMENT
AGREEMENT
This
Assignment Agreement (the "
Assignment
Agreement
") is dated as of the Effective Date set forth below and is
entered into by and between [the] [each] Assignor identified in item 1 below
([the] [each, an] "
Assignor
") and [the]
[each] Assignee identified in item 2 below ([the][each, an] "
Assignee
"). [It is
understood and agreed that the rights and obligations of [the Assignors] [the
Assignees] hereunder are several and not joint.]1 Capitalized terms used but not
defined herein shall have the meanings given to them in the Credit Agreement
identified below (as amended, the "
Credit Agreement
"),
receipt of a copy of which is hereby acknowledged by [the] [each] Assignee. The
Standard Terms and Conditions set forth in Annex 1 attached hereto are hereby
agreed to and incorporated herein by reference and made a part of this
Assignment Agreement as if set forth herein in full.
For an
agreed consideration, [the] [each] Assignor hereby irrevocably sells and assigns
to [the Assignee][the respective Assignees], and [the][each] Assignee hereby
irrevocably purchases and assumes from [the Assignor] [the respective
Assignors], subject to and in accordance with the Standard Terms and Conditions
and the Credit Agreement, as of the Effective Date inserted by the
Administrative Agent as contemplated below (i) all of [the Assignor's][the
respective Assignors'] rights and obligations in [its capacity as a Lender]
[their respective capacities as Lenders] under the Credit Agreement and any
other documents or instruments delivered pursuant thereto to the extent related
to the amount and percentage interest identified below of all of such
outstanding rights and obligations of [the Assignor] [the respective Assignors]
under the respective facilities identified below (including without limitation
any letters of credit, guarantees, and swingline loans included in such
facilities) and (ii) to the extent permitted to be assigned under applicable
law, all claims, suits, causes of action and any other right of [the Assignor
(in its capacity as a Lender)] [the respective Assignors (in their respective
capacities as Lenders)] against any Person, whether known or unknown, arising
under or in connection with the Credit Agreement, any other documents or
instruments delivered pursuant thereto or the loan transactions governed thereby
or in any way based on or related to any of the foregoing, including, but not
limited to, contract claims, tort claims, malpractice claims, statutory claims
and all other claims at law or in equity related to the rights and obligations
sold and assigned pursuant to clause (i) above (the rights and obligations sold
and assigned by [the] [any] Assignor to [the] [any] Assignee pursuant to clauses
(i) and (ii) above being referred to herein collectively as [the][an] "
Assigned Interest
").
Each such sale and assignment is without recourse to [the] [any] Assignor and,
except as expressly provided in this Assignment Agreement, without
representation or warranty by [the] [any] Assignor.
1. Assignor
[s]: _________________________________________
_________________________________________
_____________________
1
Include bracketed language if there are either multiple Assignors or multiple
Assignees.
2.
Assignee[s]:
_________________________________________
_________________________________________
[for each
Assignee, indicate [Affiliate] [Approved Fund] of
[identify
Lender]
3.
|
Borrower:
|
Orthofix
Holdings, Inc., a Delaware
corporation
|
4.
|
Administrative
Agent:
|
Wachovia
Bank, National Association, as the administrative agent under the Credit
Agreement.
|
5.
|
Credit
Agreement:
|
The
Credit Agreement dated as of September 22, 2006 among the Borrower, the
guarantors from time to time party thereto, the lenders and other
financial institutions from time to time party thereto, and Wachovia Bank,
National Association, as Administrative
Agent.
|
Assignor[s]
|
Assignee[s]
|
Facility
Assigned
|
Aggregate
Amount of Commitment/ Loans for all Lenders
|
Amount
of Commitment/
Loans
Assigned
|
Percentage
Assigned of Commitment/ Loans
|
CUSIP
Number
|
|
|
|
$
|
$
|
%
|
|
|
|
|
$
|
$
|
%
|
|
|
|
|
$
|
$
|
%
|
|
[7.
|
Trade
Date: _____________________________
|
]
2
|
Effective
Date: _________________ __ , 20__.
[REMAINDER
OF PAGE INTENTIONALLY LEFT BLANK]
_____________________________
2
To be
completed if the Assignor(s) and the Assignee(s) intend that the minimum
assignment amount is to be determined as of the Trade Date.
The terms
set forth in this Assignment Agreement are hereby agreed to
|
ASSIGNOR[S]
|
|
|
[NAME
OF ASSIGNOR]
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Title:
|
|
|
|
ASSIGNEE[S]
|
|
|
[NAME
OF ASSIGNEE]
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Title:
|
|
|
|
[Consented
to and] Accepted:
|
|
|
|
|
|
WACHOVIA
BANK, NATIONAL ASSOCIATION, as
|
|
|
Administrative
Agent
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Title:
|
|
|
|
[Consented
to:]
|
|
|
|
|
|
[NAME
OF RELEVANT PARTY]
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
|
Title:
|
|
|
ANNEX
1
STANDARD
TERMS AND CONDITIONS FOR
ASSIGNMENT
AGREEMENT
1.
Representations and
Warranties
.
1.1
Assignor[s]
. [The]
[Each] Assignor (a) represents and warrants that (i) it is the legal and
beneficial owner of [the] [the relevant] Assigned Interest, (ii) [the] [such]
Assigned Interest is free and clear of any lien, encumbrance or other adverse
claim and (iii) it has full power and authority, and has taken all action
necessary, to execute and deliver this Assignment Agreement and to consummate
the transactions contemplated hereby; and (b) assumes no responsibility with
respect to (i) any statements, warranties or representations made in or in
connection with the Credit Agreement or any other Credit Document, (ii) the
execution, legality, validity, enforceability, genuineness, sufficiency or value
of the Credit Documents or any collateral thereunder, (iii) the financial
condition of the Company, any of its Subsidiaries or Affiliates or any other
Person obligated in respect of any Credit Document or (iv) the performance or
observance by the Company, any of its Subsidiaries or Affiliates or any other
Person of any of their respective obligations under any Credit
Document.
1.2.
Assignee[s]
.
[The] [Each] Assignee (a) represents and warrants that (i) it has full power and
authority, and has taken all action necessary, to execute and deliver this
Assignment Agreement and to consummate the transactions contemplated hereby and
to become a Lender under the Credit Agreement, (ii) it meets all the
requirements to be an assignee under Section 9.6 of the Credit Agreement
(subject to such consents, if any, as may be required under Section 9.6 of the
Credit Agreement), (iii) from and after the Effective Date, it shall be bound by
the provisions of the Credit Agreement as a Lender thereunder and, to the extent
of [the] [the relevant] Assigned Interest, shall have the obligations of a
Lender thereunder, (iv) it is sophisticated with respect to decisions to acquire
assets of the type represented by the Assigned Interest and either it, or the
person exercising discretion in making its decision to acquire the Assigned
Interest, is experienced in acquiring assets of such type, (v) it has received a
copy of the Credit Agreement, and has received or has been accorded the
opportunity to receive copies of the most recent financial statements delivered
pursuant to Section 5.1 thereof, as applicable, and such other documents and
information as it deems appropriate to make its own credit analysis and decision
to enter into this Assignment Agreement and to purchase [the] [such] Assigned
Interest, and (vi) it has, independently and without reliance upon the
Administrative Agent or any other Lender and based on such documents and
information as it has deemed appropriate, made its own credit analysis and
decision to enter into this Assignment Agreement and to purchase [the] [such]
Assigned Interest; and (b) agrees that (i) it will, independently and without
reliance on the Administrative Agent, [the] [any] Assignor or any other Lender,
and based on such documents and information as it shall deem appropriate at the
time, continue to make its own credit decisions in taking or not taking action
under the Credit Documents, and (ii) it will perform in accordance with their
terms all of the obligations which by the terms of the Credit Documents are
required to be performed by it as a Lender.
2.
Payments
. From and
after the Effective Date, the Administrative Agent shall make all payments in
respect of [the] [each] Assigned Interest (including payments of principal,
interest, fees and other amounts) to [the] [the relevant] Assignor for amounts
which have accrued to but excluding the Effective Date and to [the] [the
relevant] Assignee for amounts which have accrued from and after the Effective
Date.
3.
General Provisions
.
This Assignment Agreement shall be binding upon, and inure to the benefit of,
the parties hereto and their respective successors and assigns. This Assignment
Agreement may be executed in any number of counterparts, which together shall
constitute one instrument. Delivery of an executed counterpart of a signature
page of this Assignment Agreement by telecopy shall be effective as delivery of
a manually executed counterpart of this Assignment Agreement. This Assignment
Agreement shall be governed by, and construed in accordance with, the law of the
State of New York.
Exhibit
10.51
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.
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
by
and between
MUSCULOSKELETAL
TRANSPLANT FOUNDATION, INC.
(“MTF”)
and
ORTHOFIX
HOLDINGS, INC.
(“ORTHOFIX”)
[*] 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.
MATRIX COMMERCIALIZATION
COLLABORATION AGREEMENT
THIS MATRIX COMMERCIALIZATION
COLLABORATION AGREEMENT
(this “
Agreement
”) is dated
as of July 24, 2008 and effective as of the Effective Date (as defined herein),
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 10115 Kincey Avenue, Suite 250, Huntersville,
North Carolina 28078 (“
Orthofix
”) (each
individually a “
Party
” and
collectively the “
Parties
”).
W
I
T
N
E
S
S
E
T
H
:
WHEREAS
,
the Parties desire to
collaborate with respect to the development and commercialization of an
allogeneic cancellous bone matrix containing viable mesenchymal stem cells
and/or osteoprogenitor cells and conforming to the Specifications (as defined
herein) (the “
Matrix
”);
WHEREAS,
neither Party currently
makes the Matrix commercially available, and the Parties believe that they can
develop and commercialize the Matrix more effectively and efficiently
together than on their own;
WHEREAS
,
in furtherance of the
foregoing, simultaneously on the date hereof, Orthofix and MTF have entered into
that certain Matrix Development Collaboration Agreement dated as of the date
hereof (the “
Development
Agreement
”), pursuant to which the Parties will collaborate on research
and development of the Matrix and further modification of the Specifications (as
defined therein and, for purposes hereof, as the same are revised or
supplemented from time to time during the Term in accordance with
Section 10.4
, the
“
Specifications
”);
WHEREAS
, pursuant to the
Development Agreement, (a) each of MTF and Orthofix will retain ownership
of all right, title and interest in and to all of the Existing MTF Technology
(as defined herein) and the Existing Orthofix Technology (as defined herein),
respectively, and (b) each of MTF and Orthofix will assign to the other
Party an undivided joint ownership interest in and to all right, title and
interest in all Developed Technology (as defined herein);
WHEREAS
, the Parties wish,
subject to the terms and conditions hereof, to collaborate on the
commercialization of the Matrix and, to effectuate that collaboration, wish to
give exclusive responsibility to (a) MTF to Process (as defined herein)
quantities of the Matrix using human tissue procured by MTF and fulfill orders
for the Matrix submitted to MTF and (b) Orthofix to market the
Matrix;
WHEREAS
, in furtherance of the
foregoing, the Parties wish, subject to the terms and conditions hereof, to
specify which of them will be responsible financially and otherwise for each
type of activity related to the commercialization of the Matrix during the Term
(as defined herein) and the manner in which the Parties will allocate the
Service Fees (as defined herein) resulting from transfers of the Matrix during
the Term;
[*] 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.
WHEREAS
, subject to the terms
and conditions hereof (a) MTF wishes to grant to Orthofix certain rights
with respect to the Existing MTF Technology and with respect to MTF’s joint
ownership interest in the Developed Technology, and (b) Orthofix wishes to
grant to MTF certain rights with respect to the Existing Orthofix Technology and
with respect to Orthofix’s joint ownership interest in the Developed Technology;
and
WHEREAS
, this Agreement will
become effective on the Effective Date.
NOW,
THEREFORE
,
in consideration of the
foregoing premises and mutual covenants and promises set forth herein, the
Parties agree as follows:
ARTICLE
I
DEFINITIONS
Capitalized
terms used herein which are not otherwise defined in the text of this Agreement
will have the respective meanings assigned thereto in
Addendum I
attached
hereto and incorporated herein by reference, for all purposes of this Agreement
(such definitions to be equally applicable to both the singular and the plural
forms of the terms defined). Whenever the context may require, any
pronoun will include the corresponding masculine, feminine and neuter
forms.
ARTICLE
II
SUPPLY
OF MATRIX; APPOINTMENT; FORECASTS; ORDERS; ETC.
(a)
Supply and Distribution of
Matrix
. Subject to the provisions of this Agreement and during
the Term hereof, Orthofix agrees to use Reasonable Commercial Efforts to market
the Matrix and achieve maximum orders therefor, and will have the right to
solicit and place with MTF orders for the Matrix (such orders conforming to the
provisions of this Agreement, together with any orders placed directly with MTF
by Customers and accepted by MTF, collectively referred to herein as the “
Authorized Orders
”);
and, subject to the provisions of this Agreement and during the Term hereof, MTF
agrees to use Reasonable Commercial Efforts to Process, supply and distribute
the Matrix. In exchange for MTF’s supply and distribution of the
Matrix pursuant to and in accordance with Authorized Orders, MTF will be
entitled to the Service Fee established in accordance with
Section 4.1
for each
delivery of the Matrix and to retain the Service Fee it collects for each
transaction less the Marketing Fee payable to Orthofix.
[*] 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.
(b)
Obligation to
Supply
.
Each calendar
quarter, MTF will use Reasonable Commercial Efforts to Process, supply and
distribute to the recipients identified in the Authorized Orders (the “
Customers
”) such
quantities of the Matrix for which Orthofix solicits orders pursuant to the
provisions of this Agreement up to the quantity forecasted for such calendar
quarter in the most recent Forecast. MTF will use good faith efforts
to Process, supply and distribute to the Customers any quantities of the Matrix
for which Orthofix solicits orders pursuant to the provisions of this Agreement,
to the extent that such quantities cause total quantities of orders solicited by
Orthofix during a calendar quarter to exceed the quantity forecasted for such
calendar quarter in the most recent Forecast. Notwithstanding any
provision to the contrary contained in this Agreement, the Parties acknowledge
that Orthofix will not be construed as a Customer hereunder and will not
purchase Matrix for its own account or for redelivery. If MTF
determines that it is reasonably likely to default in any material respect in
its obligation above to deliver such quantities of Matrix in accordance with the
terms of this Agreement as called for in any Authorized Order for any calendar
quarter, (i) MTF will give Orthofix prompt written notice describing such
circumstances, together with a proposed course of action to remedy such failure,
including if applicable, any actions described in the Contingency Plan, and (ii)
the Steering Committee will determine the priority in which MTF will fulfill
Authorized Orders, subject to MTF’s obligations under its agreements with Third
Parties.
(c)
Exclusive
Arrangement
. During the Term (i) MTF may not Process, supply
or distribute the Matrix to or on behalf of any Third Party, other than a
Customer, (ii) Orthofix may not market or solicit orders for the Matrix
except in accordance with
ARTICLE V
, and (iii)
Orthofix may not Process, supply or distribute the Matrix, or procure the
Processing, supply or distribution of the Matrix, except pursuant to the
provisions of this Agreement with respect to the Collaboration.
(d)
Supply
.
Beginning on the
Effective Date and at the beginning of each calendar quarter thereafter through
the end of the Term, MTF will use Reasonable Commercial Efforts: (x) to maintain
in inventory a commercially-saleable quantity of the Matrix that is sufficient
to satisfy [*] percent ([*]%) of [*] ([*]) days of Orthofix’s requirements for
the Matrix for such calendar quarter as identified in the Forecast submitted by
Orthofix for such calendar quarter; and (y) throughout each calendar quarter
during the Term, to Process, on a daily basis, sufficient commercially-saleable
quantities of the Matrix to enable timely fulfillment of Orthofix’s requirements
for the Matrix for the remaining periods covered by such Forecast.
(e)
Failure to
Supply
.
If at any time
MTF is unable, as a result of the circumstances contemplated by the Contingency
Plan, in any material respect to fulfill Authorized Orders for the Matrix
solicited by Orthofix in accordance with the provisions of this Agreement which
do not cause the total quantities of the Matrix for which Orthofix solicits
orders pursuant to the provisions of this Agreement during a calendar quarter to
exceed the Forecast for such calendar quarter, MTF will be obligated to
implement the Contingency Plan to remedy such failure. If MTF is
unable to fulfill Authorized Orders for the Matrix solicited by Orthofix in
accordance with the provisions of this Agreement sufficient to meet the Forecast
for a period of two (2) consecutive calendar quarters, then Orthofix may elect,
by written notice to MTF, to have all Authorized Orders for the Matrix solicited
by Orthofix fulfilled by an alternative source of supply pursuant to those
standards contained in this Agreement relevant to the Processing and supply of
the Matrix, applied
mutatis
mutandis
; provided,
however, that upon MTF’s demonstration to Orthofix that it is in compliance with
Section 2.1(d)
and is able to fulfill Authorized Orders in the amount of Orthofix’s Forecast
for the then-current calendar quarter, Orthofix will use Reasonable Commercial
Efforts to transition fulfillment of Authorized Orders to MTF as promptly as
practicable after such demonstration.
[*] 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.
2.2
Forecasts.
The
Parties acknowledge and agree that the collection of Donor Tissue involves
significant procurement lead times and the Parties will cooperate in a mutual
effort to predict demand for the Matrix in order to maintain high levels of
fulfillment to Customers. Orthofix will submit to MTF no later than
the fifteenth (15
th
) day
of the month preceding the start of every calendar quarter (i.e., December 15,
March 15, June 15, and September 15) during the Term, a rolling forecast (a
“
Forecast
”)
setting forth orders that Orthofix reasonably believes will be solicited by
Orthofix during the four (4) calendar quarters commencing with the beginning of
the subsequent calendar quarter. Each Forecast will amend the prior
forecasts for periods covered by the new Forecast. Orthofix will make
all Forecasts in good faith given market and other information available to
Orthofix;
provided
,
however
, under no
circumstances whatsoever will any Forecasts made hereunder be deemed to be an
order for the production of the Matrix or otherwise binding on Orthofix or its
Affiliates. The Forecast (and each modification thereof) will be
subject to approval by the Steering Committee.
2.3
Orders;
Fulfillment.
Each order solicited by Orthofix shall be subject
to acceptance in accordance with the MTF’s customary order acceptance procedures
with respect to the Matrix, which as currently in effect are set forth in
Exhibit A
attached
hereto and incorporated herein by reference and are subject to change from time
to time by MTF; it being acknowledged and agreed that MTF may reject any order
in the event of reasonable concerns regarding the creditworthiness of the
proposed Customer and the ability of the proposed Customer to pay the Service
Fee related to such order. Any and all orders subject to MTF’s
standard terms and conditions, including, without limitation, its standard
warranty, with respect to the Matrix. MTF will use Reasonable
Commercial Efforts to supply and deliver the Matrix in accordance with
Section 2.1(b)
on the
delivery dates specified in such Authorized Order, subject to a minimum
lead-time of 45 days to fill such Authorized Order assuming donor availability,
unless otherwise mutually agreed in writing by MTF and such
Customer. MTF will use good faith efforts to meet any request of
Customers for delivery of Matrix in inventory in less than 7 days, and further,
MTF will attempt to accommodate any changes requested by any Customer in
delivery schedules for the Matrix following MTF’s receipt of Authorized Orders
from such Customer. MTF will provide to Orthofix copies of any
Authorized Orders sent directly to MTF by Customers, promptly after the receipt
thereof by MTF. MTF will not be entitled to accept any orders for the
Matrix other than Authorized Orders.
[*] 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.
2.4
Packaging, Delivery and Shipping
Terms.
MTF will use Reasonable Commercial Efforts to package
and label all Matrix for shipment as determined by Orthofix subject to the
immediately succeeding sentence. Orthofix will determine all trademarks,
branding, marketing, packaging and labeling to be used in connection with the
Matrix;
provided
,
however
, that MTF
will have the right to consent to all packaging and labeling, which consent will
not be unreasonably withheld, conditioned or delayed so long as such packaging
and labeling is in compliance with applicable Laws and the Specifications and
includes a prominent reference in form approved by MTF and reasonably acceptable
to Orthofix that the Matrix is supplied by MTF. Each Party will
provide the other Party with at least thirty (30) days prior written notice of
any packaging or labeling changes (including brand names) for approval as
aforesaid, and MTF will be entitled to recover, and Orthofix will be responsible
to pay to MTF, all reasonable out-of-pocket costs that MTF incurs associated
with any packaging and labeling change requested by Orthofix;
provided
,
further
, that, after
receipt of any change notice from Orthofix, MTF will use Reasonable Commercial
Efforts to minimize such costs. Each shipment of the Matrix will have
a unique identification number that identifies the Lot.
2.5
Materials and
Components.
MTF will use Reasonable Commercial Efforts to
provide, at its cost and expense, all materials, including Donor Tissue,
equipment, machinery, facilities, components, and other resources required in
connection with Processing of the Matrix hereunder. MTF agrees that
it will conduct audits of its suppliers of materials, including Donor Tissue,
and components of the Matrix hereunder on such basis as MTF may reasonably
determine to monitor whether such suppliers are producing the materials and
components in accordance with all applicable Laws and to determine whether such
suppliers will continue to be able to supply a sufficient quantity and quality
of such materials and components.
2.6
Billing and
Collection.
MTF will submit invoices in its customary form for
each shipment of the Matrix to the Customer simultaneously with
shipment. Customers will be required to remit the total amount of
Service Fees identified in such invoice within thirty (30) days of the invoice
date. In the event any such Customer fails to pay the Service Fee in
accordance with this
Section 2.6
, MTF may,
in addition to any other remedies available to it, assess interest on all unpaid
amounts. MTF will use Reasonable Commercial Efforts to timely collect
all Service Fees.
2.7
Customer
Support.
MTF will be primarily responsible for providing
prompt pre- and post-distribution service for the Matrix. MTF will
use Reasonable Commercial Efforts timely to respond to general questions from
Customers, recipients of the Matrix pursuant to Authorized Orders and any
physician user or similar clinical personnel user of the Matrix concerning the
Matrix, and assist such Persons in the diagnosis and correction of problems
encountered in connection with the Matrix. Each of the Parties will:
(a) conduct the Collaboration in a manner that reflects favorably at all times
on the Matrix and the good name, good will and reputation of each of MTF and
Orthofix; (b) avoid deceptive, misleading or unethical practices that are
or might be detrimental to Orthofix, MTF, the Matrix or the public;
(c) make no false or misleading representations with regard to Orthofix,
MTF or the Matrix; (d) make no representations, warranties or guarantees to
Customers or recipients of the Matrix pursuant to Authorized Orders with respect
to the Specifications, features or capabilities of the Matrix that are
inconsistent with the mutually agreed-upon literature and other marketing
materials distributed by Orthofix or that are otherwise prohibited by this
Agreement; and (e) not enter into any contract or engage in any practice
detrimental to the interests of Orthofix, MTF or the Matrix.
[*] 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.
2.8
Marketing
Support.
MTF will provide such support of Orthofix’s marketing
activities during the Term as Orthofix may reasonably request from time to
time. MTF will use Reasonable Commercial Efforts to answer promptly
queries concerning the Matrix or use of the Matrix which Orthofix may submit to
MTF in connection with Orthofix’s marketing activities under this
Agreement.
2.9
Subcontracting
.
Each Party has
the right, exercisable in its sole discretion, to subcontract or delegate any of
its responsibilities under this Agreement without the prior written consent of
the other Party. Each Party’s subcontractors will be subject to
confidentiality obligations at least as stringent as provided in this
Agreement. All Improvements discovered, made or conceived by each
subcontractor in the course of performance of such activities will be assigned
to the Subcontracting Party and will be deemed to be Developed Technology for
purposes of this Agreement. Notwithstanding any subcontract
hereunder, each Party will be responsible, and will remain liable, for the
performance of all of its obligations under this Agreement and for any breach
thereof by any of its subcontractors and by any further subcontractor of any of
its subcontractors.
ARTICLE
III
STEERING
COMMITTEE
3.1
Membership.
Contemporaneously
with the execution and delivery of this Agreement, the Parties will establish,
and will maintain throughout the Term, a Steering Committee consisting of an
even number of members agreed upon by the Parties, an equal number of whom will
be designated by each Party and act as its representatives, to supervise and
manage the activities of the Parties under this Agreement and the Collaboration,
subject to the provisions of this Agreement. Steering Committee
representatives of each Party will, individually or collectively, have expertise
and/or responsibility to such Party in business and/or tissue
development. Subject to the obligation to use good-faith efforts to
preserve the continuity of Steering Committee membership, each Party may replace
any or all of its representatives on the Steering Committee at any time upon
written notice to the other Party, and any member of the Steering Committee may
designate a substitute to attend and perform the functions of that member at any
meeting of the Steering Committee. The initial members of the
Steering Committee are identified in
Exhibit B
attached
hereto. With the prior written consent of the Steering Committee in
each case, a representative of a Party on the Steering Committee may invite one
or more non-members (subject to the confidentiality provisions set forth in
ARTICLE XVI
) as
deemed necessary to help explore and consider matters before the Steering
Committee.
[*] 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.
3.2
Meetings.
The Steering
Committee will meet on a monthly basis, in person, or via telephone or video
conference, and more frequently as the Steering Committee deems appropriate, on
such dates, and at such places and times, as the Steering Committee
determines. Meetings of the Steering Committee that are held in
person will alternate between the offices of the Parties, or such other place as
the Steering Committee may determine. The members of the Steering Committee also
may convene or be polled or consulted from time to time by means of
telecommunications, videoconferences, electronic mail or other correspondence,
as deemed necessary or appropriate and as the Steering Committee may
determine.
3.3
Authority.
The Steering
Committee is authorized to take the following actions:
(a)
facilitate
the Parties’ exchange of information to be provided under this Agreement
concerning the overall strategy and progress of the Collaboration;
(b)
ensure
open communication between the Parties as related to the Collaboration and as
provided under this Agreement;
(c)
approve
the Forecasts and any changes thereto;
(d)
determine
any priorities in fulfilling Authorized Orders in the circumstances described
under the last sentence of
Section 2.1(b)
hereof; and
(e)
subject
to the terms and provisions of this Agreement, resolve any other issues and
questions that may arise under this Agreement that are expressly assigned to the
Steering Committee by the terms hereof or by the mutual agreement of the
Parties.
For
avoidance of doubt, the Steering Committee will not have the power to amend or
waive compliance with this Agreement.
3.4
Actions.
The
Steering Committee will operate by consensus, and the representatives of each
Party will have a single collective vote. If the Steering Committee
cannot reach consensus on any matter by the end of the meeting immediately
following the meeting during which the Steering Committee first attempted to
reach consensus on such matter, the matter will be escalated promptly to the
Chief Executive Officer of MTF and the Chief Executive Officer of Orthofix for
resolution pursuant to the dispute resolution procedure set forth in
ARTICLE
XIX
.
3.5
Expenses.
Each Party will be responsible for all travel and related costs and expenses for
its members and approved invitees to attend meetings of, and otherwise
participate on, the Steering Committee.
[*] 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.
ARTICLE
IV
SERVICE
FEE; AUDIT
4.1
Service
Fee.
(a)
Service
Fee
. Orthofix will, in compliance with all applicable Laws,
propose the service fees for Processing, marketing and sale of the Matrix
pursuant to an Authorized Order (a “
Service Fee
”) at
least annually at the beginning of each calendar year or as market conditions
warrant, which shall in each instance be subject to concurrence by MTF in its
reasonable discretion. Notwithstanding anything in this Agreement to
the contrary, MTF will be entitled to retain, after payment of applicable
Marketing Fees to Orthofix pursuant to
Section 5.2
, the
remainder of the Service Fee which in no event will (unless otherwise agreed
upon by the Parties) equate to less than $[*] per cc of the Matrix (the “
Minimum Service
Fee
”);
provided
,
however
, that such
Minimum Service Fee will, unless otherwise agreed upon by the Parties, be
increased annually by a percentage equal to the percentage increase in the CPI
over the measurement period, and
provided
,
further
, that in the
event of an increase in actual costs of Processing, supplying and distributing
the Matrix demonstrated by MTF or a change in market conditions demonstrated by
Orthofix such that continued Processing and Commercialization of the Matrix at
the Service Fee and the Marketing Fee, as the same are calculated in accordance
with this
ARTICLE
IV
, is no longer commercially reasonable, the Parties will meet promptly
to negotiate in good faith for purposes of adjusting the Service Fee and the
Marketing Fee in order to maintain the commercial viability of the
Matrix. Any adjustment of the Service Fee will become effective as of
the first day of calendar year, if applicable, or as otherwise agreed upon by
the Parties.
(b)
Statements
. Within
fifteen (15) days after the end of each calendar month, MTF will provide to
Orthofix a written statement (the “
Monthly Statement
”)
which sets forth (i) all Service Fees invoiced for such month pursuant to
Authorized Orders, (ii) all Service Fees received by MTF during such month for
the supply and distribution of the Matrix pursuant to Authorized Orders, (iii)
the Marketing Fee payable to Orthofix for such month calculated in accordance
with
Section
5.2
, (iv) all Service Fees that have been invoiced and not timely paid as
of the end of such month and (v) a list of all Authorized Orders received during
such month, including the name of the Customer identified in each such
Authorized Order and the quantity of the Matrix ordered pursuant to each such
Authorized Order.
4.2
Service
Fee Audit.
(a)
Performance of Service Fee
Audits
. MTF will maintain complete and accurate books and
records of all Service Fees as a result of Authorized Orders in accordance with
generally accepted accounting principles consistently applied during the Term
and for at least two (2) years thereafter. Orthofix will have the
right, not more frequently than one (1) time in any calendar year, during normal
business hours upon not less than five (5) days’ prior written notice to MTF, to
examine and copy such books and records for the purpose of verifying MTF’s
compliance with the terms and conditions of
Section
5.2
. The expenses of such Audits will be borne by Orthofix;
provided
,
however
, that MTF
will be charged for the reasonable expense of any such Audit that establishes an
underpayment by five percent (5%) or more of the amounts owed to Orthofix during
the audited period. Within thirty (30) days of completing the
results of any Audit hereunder, Orthofix will submit to MTF a written report
outlining its findings and/or observations from any such
Audit. Orthofix will provide MTF a written notice identifying any
claimed underpayment of Marketing Fees (the “
Underpayment Notice
”)
to Orthofix as a result of such Audit.
[*] 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.
(b)
Audit Feedback
Dispute
. If MTF objects in good faith to any allegation of
underpayment of the Marketing Fees identified in an Underpayment Notice, MTF
will provide Orthofix with written notice of such dispute (the “
Dispute Notice
”)
within thirty (30) days after MTF’s receipt of the Underpayment
Notice. The Dispute Notice will set forth in reasonable detail the
basis for such disagreement described therein. Thereafter, Orthofix
and MTF will attempt in good faith to resolve any such dispute as promptly as
practicable in accordance with the provisions of
ARTICLE
XIX
. Upon expiration of the thirty (30) day period after
delivery of the Underpayment Notice, if no Dispute Notice will have been
delivered, or within ten (10) days after the resolution of any disputed items in
any Dispute Notice, as the case may be, any payment required by MTF pursuant to
this
Section
4.2
will be made by wire transfer of immediately available funds to an
account designated by Orthofix. Orthofix may assess interest at a
rate of one percent (1%) per month on all unpaid amounts required under this
Section
4.2
.
(c)
Acknowledgement
. Orthofix’s
and/or Orthofix’s representatives’ exercise of the Audit and inspection rights
hereunder will in no way waive, modify or diminish MTF’s obligations under this
Agreement or limit any other remedy Orthofix has under this
Agreement.
ARTICLE
V
MARKETING
OBLIGATIONS; MARKETING FEE
5.1
Marketing
Obligations.
Subject to the terms and conditions of this
Agreement, during the Term Orthofix will serve as an exclusive marketing
representative with authority to market and solicit orders for the Matrix in the
Territory. Subject to the terms and conditions of this Agreement, all
marketing activities for the Matrix during the Term will be the sole
responsibility of Orthofix. Orthofix will prepare and submit to MTF
an annual marketing plan for the Matrix (the “
Marketing Plan
”),
consistent with the provisions hereof, for review and approval by MTF (which
approval MTF will not unreasonably withhold, condition or
delay). Orthofix will also submit to MTF for review and approval
(which approval MTF will not unreasonably withhold, condition or delay) all
marketing and promotional materials, consistent with the provisions hereof, that
Orthofix intends to utilize for its marketing activities related to the
Matrix. Orthofix will not deviate from or provide information
inconsistent with any of the marketing and promotional materials to any
Customers or potential Customers or otherwise make representations to such
Persons not previously approved by MTF. Orthofix will use
Commercially Reasonable Efforts to market the Matrix in accordance with the
Marketing Plan;
provided
,
however
, that
Orthofix will be entitled to amend the terms of the Marketing Plan from time to
time, consistent with the provisions hereof, subject to MTF’s approval which
approval MTF will not unreasonably withhold, condition or delay. All
Authorized Orders for the Matrix solicited by Orthofix or its permitted
designees will be placed in accordance with MTF’s customary procedures with
respect to the Matrix.
[*] 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.
5.2
Marketing Fee.
As
compensation for services performed hereunder, Orthofix will be entitled to
receive a monthly fee (a “
Marketing Fee
”) equal
to [*] percent ([*]%) of the total amount of Service Fees received by MTF during
the previous calendar month pursuant to Authorized Orders, subject in each case
to MTF’s right to receive the Minimum Service Fee. The Marketing Fee
for each month will be payable together with the delivery of the Monthly
Statement for that month. In the event that MTF fails to pay the
Marketing Fee shown on any Monthly Statement in accordance with this
Section 5.2
,
Orthofix 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. All payments due hereunder to Orthofix will be made in
arrears in United States Dollars by wire transfer of immediately available funds
to an account designated by Orthofix in writing to MTF.
ARTICLE
VI
FUTURE
INITIATIVES
6.1
Future Development.
From time
to time during the Term, the Parties will, without limiting any other term or
provision of this Agreement, endeavor to identify new development initiatives,
including but not limited to line extensions, enhancements and improvements to
the Matrix (other than changes to the Specifications that may be agreed upon by
the Steering Committee for development under this Agreement), and if mutually
agreed upon by the Parties, will negotiate in good faith for purposes of
entering into development agreements with respect to any such
initiatives.
6.2
Rights
of First Offer and First Refusal.
(a)
First
Offer
. If a concept for a [*] (a “
Product Concept
”), is
developed by either Party, at any time during the Term, the Party developing
such concept (the “
Offering Party
”) will
communicate such concept to the other Party (the “
Offeree Party
”) in
reasonable detail (the “
First Offer Notice
”)
and will offer to the Offeree Party for a period of thirty (30) days from the
date of the First Offer Notice a right-of-first offer to collaborate in the
development and commercialization of such Product Concept in accordance with
such terms as may be mutually agreed upon by the Parties. The Offeree
Party will, within such thirty (30) days from receipt of the First Offer Notice,
advise the Offering Party that it is not interested in the Product Concept or
submit to the Offering Party its proposal for the development and
commercialization of the Product Concept (the “
Product Concept
Proposal
”). In the event that the Product Concept Proposal
submitted is unacceptable, in whole or in part, to the Offering Party, the
Parties will negotiate in good faith to resolve the outstanding
issues. In the event that the Parties fail to reach a mutual
agreement upon a definitive agreement regarding development and
commercialization of the Product Concept within one hundred twenty (120) days
from receipt of the First Offer Notice, the offer will be deemed to have been
rejected, and the Offering Party will be entitled, free from the restrictions of
this
Section
6.2(a)
and
Section 16.2
hereof,
to develop and commercialize the Product Concept independently or, subject to
the provisions of
Section 6.2(b)
, with
one or more Third Parties.
[*] 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.
(b)
First
Refusal
. Prior to entering into one or more agreements with
one or more Third Parties, at any time during the Term, for development and/or
commercialization of a Product Concept of the type required to be submitted by
it to the other Party pursuant to
Section 6.2(a)
,
either Party (the “
Proposing Party
”)
will communicate to the other Party (the “
Receiving Party
”) in
writing the identity of the Third Party or Third Parties with which the
Proposing Party proposes to enter into the agreement(s), any other relevant
materials provided by the Third Party or Third Parties, and the terms of the
proposed agreement(s) (a “
First Refusal
Notice
”) and will grant to the Receiving Party for a period of thirty
(30) days from the date of the First Refusal Notice a right-of-first refusal to
develop and/or commercialize such Product Concept on terms which are
substantially the same as those terms in the proposed
agreement(s). The Receiving Party will, within such thirty (30) days
from receipt of the First Refusal Notice from the Proposing Party, advise the
Proposing Party that it is not interested in the Product Concept or submit to
the Proposing Party notice of its exercise of the right-of-first refusal and
confirm the terms thereof consistent with the foregoing. In the event
that the Receiving Party does not accept the offer in writing within the
prescribed thirty (30) day period, the Proposing Party will be entitled, for a
period expiring one hundred twenty (120) days after the termination of such
thirty-day period, free from the restrictions of this
ARTICLE VI
and
Section 16.2
hereof,
to enter into the proposed agreement(s) with the proposed Third Party or Third
Parties. In the event of any material change(s) to the terms of the
proposed agreement(s) or any change in the identity of the Third Party or Third
Parties with which the Proposing Party proposes to enter into the proposed
agreement(s), or in the event that the Proposing Party and the identified Third
Party or Third Parties have not entered into the proposed agreement(s) prior to
the expiration of the one hundred twenty (120) day period as aforesaid, the
Receiving Party will, if during the Term, again have a right-of-first refusal
with respect to such Product Concept in accordance with the terms of this
Section
6.2(b)
.
(c)
No
Waiver
. Either Party’s failure to exercise the right-of-first
offer under
Section
6.2(a)
will not result in a waiver of such Party’s right-of-first refusal
under
Section 6.2(b)
and either Party’s failure to exercise the rights-of-first offer and
-first refusal contained in this
Section 6.2
for any
Product Concept will not result in a waiver of either right with respect to any
other Product Concept.
[*] 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.
ARTICLE
VII
INTELLECTUAL
PROPERTY
7.1
Existing
Technology.
(a)
Existing MTF
Technology
. MTF will retain sole and exclusive ownership of
all right, title and interest in and to: (x) all of the Existing MTF Technology
(subject only to its express license to Orthofix set forth hereunder); and (y)
if and to the extent not otherwise provided under this Agreement or the
Development Agreement, any and all improvements, enhancements, modifications,
purifications, optimizations or further development of or to the Existing MTF
Technology. MTF hereby grants to Orthofix (i) a non-exclusive, worldwide,
royalty-free license, together with the right to sublicense, during the Term,
under such Existing MTF Technology, to exercise any of Orthofix’s privileges and
to perform any of Orthofix’s obligations under this Agreement in connection with
the Collaboration, and to perform any of MTF’s obligations under this Agreement
in the event that MTF fails to fulfill its obligations under this Agreement, and
(ii) a non-exclusive, perpetual, irrevocable, worldwide, royalty-free license,
together with the right to sublicense, under such Existing MTF Technology,
solely insofar as is necessary to apply the 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 this Agreement or any termination
of this Agreement (x) pursuant to
Section 13.4
or (y)
by Orthofix pursuant to
Section 13.2
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 this
Agreement.
(b)
Existing Orthofix
Technology
. Orthofix will retain sole and exclusive ownership
of all right, title and interest in and to: (x) all of the Existing Orthofix
Technology (subject only to its express license to MTF set forth hereunder); and
(y) if and to the extent not otherwise provided under this Agreement or the
Development Agreement, to any and all improvements, enhancements, modifications,
optimizations or further developments of or to the Existing Orthofix
Technology. Orthofix hereby grants to MTF (i) a non-exclusive,
worldwide, royalty-free license, together with the right to sublicense, during
the Term, under such Existing Orthofix Technology, to exercise any of MTF’s
privileges and perform any of MTF’s obligations under this Agreement in
connection with the Collaboration, and (ii) a non-exclusive, perpetual,
irrevocable, worldwide, royalty-free license, together with the right to
sublicense, under such Existing Orthofix Technology, solely insofar as in
necessary to apply the 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 MTF only on and
after any expiration of this Agreement or any termination of this Agreement (x)
pursuant to
Section
13.4
or (y) by MTF pursuant to
Section 13.2
and a
determination in a final non-appealable decision by a court of competent
jurisdiction that Orthofix has committed, and failed to cure within the
permitted cure period, a material breach or material default under 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.
7.2
Developed
Technology.
(a)
Developed
Technology
. Orthofix and MTF will jointly own any and all
Developed Technology. In furtherance of the foregoing, each Party
hereby assigns and agrees to assign to the other Party an undivided joint
ownership interest in and to all right, title and interest in all Developed
Technology, including all intellectual property rights therein, whether
developed solely by such Party or its employees, agents or subcontractors, or
whether developed jointly by the Parties, their employees, agents or
subcontractors under this Agreement. Each Party will, upon request by
the other Party, execute specific assignments and take any action necessary to
enable the other Party to secure its joint ownership interest in the Developed
Technology or any component thereof. By virtue of their joint
ownership, MTF and Orthofix will each enjoy, without limitation, the right to
apply the Developed Technology to offer to sell the Matrix and perform services
related to the Matrix in accordance with this Agreement, and the right to
license such right, during the Term. By virtue of its joint ownership
interest, MTF will enjoy, without limitation, the right to apply the Developed
Technology to make, use, sell and import the Matrix and perform services related
to the Matrix in accordance with this Agreement, and the right to license such
right, during the Term. Except for purposes of exercising its
privileges and performing its obligations under this Agreement in connection
with the Collaboration, Orthofix will not exercise or license its right to apply
the Developed Technology for purposes of making, using, selling or importing the
Matrix during the Term. For the avoidance of doubt, the Parties
acknowledge and agree that all right, title and interest in and to any
improvements, enhancements, modifications, purifications, optimizations or
further developments of or to the Developed Technology not constituting
Improvements hereunder will be owned solely and exclusively by the Party
responsible for the discovery, creation or conception thereof.
(b)
Conditional Exclusive
License Grants
.
(i)
MTF
hereby grants to Orthofix, which grant will be exercised by Orthofix only in the
event of any termination of this Agreement by Orthofix pursuant to
Section 13.2
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 this Agreement, an
exclusive, perpetual, irrevocable, worldwide, royalty-free license, with the
right to sublicense, under MTF’s undivided joint ownership interest in the
Developed Technology to make, use, sell, offer to sell and import the
Matrix.
(ii)
Orthofix
hereby grants to MTF, which grant will be exercised by MTF only in the event of
any termination of this Agreement by MTF pursuant to
Section 13.2
and
a determination in a final, non-appealable decision by a court of competent
jurisdiction that Orthofix has committed, and failed to cure within the
permitted cure period, a material breach or material default under this
Agreement, an exclusive, perpetual, irrevocable, worldwide, royalty-free
license, with the right to sublicense, under Orthofix’s undivided joint
ownership interest in the Developed Technology to make, use, sell, offer to sell
and import the Matrix.
[*] 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.
(c)
Disclosures of Developed
Technology
. Each Party will make a complete and prompt written
disclosure to the other Party hereto specifically detailing the features and
concepts of any and all ideas, designs, discoveries, inventions, improvements,
and, in general, all things encompassed within the Developed Technology that are
conceived of, reduced to practice, or otherwise developed, solely or jointly by
such Party and/or Persons working under such Party’s direction
and/or Persons employed or engaged by such Party during the Term and
in performance of the activities under this Agreement. Each Party will
require each Person employed or engaged by such Party in connection with the
performance of the activities under this Agreement to enter into a written
agreement pursuant to which such Person (i) agrees to disclose to such
Party promptly in writing all such ideas, designs, discoveries, inventions,
improvements, and, in general, all things encompassed within the Developed
Technology, and (ii) assigns to such Party all such ideas, designs,
discoveries, inventions, improvements and all intellectual property rights
therein, and, in general, all things encompassed within the Developed
Technology.
7.3
Trademark
Licenses.
(a)
MTF
Marks
. MTF hereby grants to Orthofix, during the Term, a
non-exclusive, worldwide license, to use and apply the trademark “MTF” and any
and all other related trademarks, logos, service marks, slogans and taglines
designated by MTF in writing from time to time (the “
MTF Marks
”) in
connection with Orthofix’s promotion and marketing of the Matrix in the
Territory, in accordance with the terms of this Agreement. Any such
use in or on labels, packages, advertisements, pamphlets or other graphic or
aural materials or otherwise hereunder will require prior written approval from
MTF, and will in each instance indicate that the MTF Mark belongs to
MTF. Orthofix will regularly provide to MTF samples of all intended
uses of the MTF Marks. Orthofix will comply with all notice and
marking requirements, and all additional standards of quality control, as
required by MTF for the protection and enforcement of the MTF Marks and the
registrations thereof and will not use the MTF Marks in any manner which might
dilute or tarnish the MTF Marks or reflect adversely on MTF or any of its
Affiliates. All goodwill associated with the use of the MTF Marks by
Orthofix will inure to the benefit of MTF. MTF shall have no
obligation to maintain any MTF Mark and, upon notice by MTF to Orthofix to such
effect, Orthofix shall cease further use thereof. Orthofix shall not
have the right to sublicense its rights under this
Section 7.3(a)
except
as otherwise provided under
Section
2.9
.
[*] 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.
(b)
Orthofix
Marks
. Orthofix hereby grants to MTF, during the Term, a
non-exclusive, worldwide license, to use and apply the trademark “Orthofix” and
any and all other related trademarks, logos, service marks, slogans and taglines
designated by Orthofix in writing from time to time (the “
Orthofix Marks
”) in
connection with packaging, supply and distribution of the Matrix in the
Territory, in accordance with the terms of this Agreement. Any such
use in or on labels, packages, advertisements, pamphlets or other graphic or
aural materials or otherwise hereunder will require prior written approval from
Orthofix, and will in each instance indicate that the Orthofix Mark belongs to
Orthofix. MTF will regularly provide to Orthofix samples of all
intended uses of the Orthofix Marks. MTF will comply with all notice
and marking requirements, and all additional standards of quality control, as
required by Orthofix for the protection and enforcement of the Orthofix Marks
and the registrations thereof and will not use the Orthofix Marks in any manner
which might dilute or tarnish the Orthofix Marks or reflect adversely on
Orthofix or any of its Affiliates. All goodwill associated with the
use of the Orthofix Marks by MTF will inure to the benefit of
Orthofix. Orthofix shall have no obligation to maintain any Orthofix
Mark and, upon notice by Orthofix to MTF to such effect, MTF shall cease further
use thereof. MTF shall not have the rights to sublicense its rights
under this
Section
7.3(b)
except as provided under
Section
2.9
.
7.4
Prosecution
of Intellectual Property.
(a)
Existing Orthofix
Technology
. Subject to
Section 7.4(d)
,
Orthofix will have the sole right to file, prosecute and maintain patent
applications and other registrations with respect to the Existing Orthofix
Technology. All costs and expenses associated with the filing,
prosecution and maintenance of patent applications and other registrations with
respect to the Existing Orthofix Technology will be the responsibility of
Orthofix;
provided
,
however
, that if MTF
exercises its right to file, prosecute and maintain a patent application or
other registration with respect to the Existing Orthofix Technology as it
relates to the Matrix pursuant to
Section 6.4(d)
,
the costs of filing, prosecuting and maintaining such patent application or
other registration will be the responsibility of MTF.
(b)
Existing MTF
Technology
. Subject to
Section 7.4(d)
, MTF
will have the sole right to file, prosecute and maintain patent applications and
other registrations with respect to the Existing MTF Technology. All
costs and expenses associated with the filing, prosecution and maintenance of
patent applications and other registrations with respect to the Existing MTF
Technology will be the responsibility of MTF;
provided
,
however
, that if
Orthofix exercises its right to file, prosecute and maintain a patent
application or other registration with respect to the Existing MTF Technology as
it relates to the Matrix pursuant
Section 7.4(d)
, the
costs of filing, prosecuting and maintaining such patent application or other
registration will be the responsibility of Orthofix.
[*] 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.
(c)
Developed
Technology
. Subject to
Section 7.4(d)
,
Orthofix will have the sole right to file, prosecute and maintain patent
applications and other registrations with respect to the Developed
Technology. All costs and expenses associated with the filing,
prosecution and maintenance of patent applications and other registrations with
respect to the Developed Technology will be the responsibility of Orthofix;
provided
,
however
, that if MTF
exercises its right to file, prosecute or maintain patent applications or other
registrations with respect to the Developed Technology pursuant to
Section 7.4(d)
, the
costs of filing, prosecuting and maintaining such patent application or other
registration will be the responsibility of MTF.
(d)
Election Not to File,
Prosecute or Maintain
. In the event that a Party elects not to
file, prosecute or maintain a patent application or other registration with
respect to the Existing Orthofix Technology as it relates to the Matrix or the
Existing MTF Technology as it relates to the Matrix or with respect
to the Developed Technology (as applicable), the other Party will be entitled to
provide written notice to such Party of the other Party’s intent to file,
prosecute or maintain such patent application or other registration, and if such
Party fails to notify the other Party within thirty (30) days after such written
notice that it has commenced filing, prosecuting or maintaining such patent
application or other registration, as the case may be, the other Party will be
entitled to file, prosecute and maintain such patent application or other
registration in the owning Party’s name.
(e)
Cooperation
. Without
limiting any obligation under
Section 11.1
, each
Party will cooperate with, and provide all reasonable aid and technical
assistance to, the other Party in obtaining any patent or other intellectual
property protection or right as it relates to the Matrix as permitted under this
Section 7.4
, and
will keep all books and records, including notebooks, data, opinions, searches,
reports, notes, summaries and the like, irrespective of the form, and execute
(and require its employees, agents, consultants and contractors to execute) all
documents reasonably necessary for purposes of procuring, maintaining, enforcing
and defending such intellectual property rights. In furtherance of
the foregoing, each Party shall, during the Term, inform the other Party at
reasonable regular intervals, or at such other Party’s reasonable request, about
the status of any patent application, patent or other registration as it relates
to the Matrix.
7.5
Enforcement
of Intellectual Property.
(a)
Notification of Third-Party
Infringement
. Each Party will notify the other Party promptly
in writing in the event that any information is brought to its attention
regarding any potential infringement by a Third Party of (i) the Existing MTF
Technology or the Existing Orthofix Technology, in each case, insofar as
relating to the uses licensed hereunder, (ii) the MTF Marks or the Orthofix
Marks, in each case, insofar as relating to the uses licensed hereunder, and/or
(iii) the Developed Technology.
(b)
Existing Orthofix
Technology; Orthofix Marks
. Subject to
Section 7.5(e)
,
Orthofix will have the sole power and discretion to enforce and exploit Existing
Orthofix Technology and Orthofix Marks against Third Parties by civil lawsuit or
licensing, and will control any enforcement action brought by it with respect to
any alleged infringement of the Existing Orthofix Technology and Orthofix
Marks. Orthofix will bear the costs and retain any amounts received
in connection with such enforcement and exploitation actions.
[*] 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.
(c)
Existing MTF Technology; MTF
Marks
. Subject to
Sections 7.5(d)
and
(e)
, MTF will
have the sole power and discretion to enforce and exploit Existing MTF
Technology and MTF Marks against Third Parties by civil lawsuit or (subject to
the rights licensed hereunder) licensing, and will control any enforcement
action brought by it with respect to any alleged infringement of the Existing
MTF Technology and MTF Marks. MTF will bear the costs and retain any
amounts received in connection with such enforcement and exploitation
actions.
(d)
Developed
Technology
.
(i)
Subject
to the additional provisions of this
Section 7.5(d)
and
Section 7.5(e)
,
during the Term Orthofix will have the sole power and discretion to enforce and
exploit, against Third Parties that offer a product or service that competes
with the Matrix, by civil lawsuit or licensing, and will control any enforcement
action brought by it against such Third Party with respect to any alleged
infringement of, the Developed Technology or the Developed Technology in
combination with the Existing MTF Technology licensed
hereunder. Orthofix will pay all costs and fees associated with
instituting any such action and will have control over selection of counsel and
all strategic decisions relating to the action; provided, however, that any
settlement proposed by Orthofix to be entered into will be subject to MTF’s
prior written approval (which approval MTF will not unreasonably withhold,
condition or delay). Any amounts received in connection with such
enforcement and exploitation actions will be applied as follows:
(A) first,
to Orthofix in the amount of its costs and fees associated with instituting and
maintaining such action and,
(B) next,
to Orthofix in the amount of all costs incurred by Orthofix for filing,
prosecution and maintenance of patent applications and other registrations with
respect to the Developed Technology, and
(C) next,
to MTF in the amount of all costs incurred by MTF for filing, prosecution and
maintenance of patent applications and other registrations with respect to the
Developed Technology, and
(D) then,
[*] percent ([*]%) of any remaining amount to Orthofix and [*] ([*]%) of any
remaining amount to 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.
(ii)
Subject
to the additional provisions of this
Section 7.4(d)
and
Section 7.4(e)
,
during the Term, MTF will have the sole power and discretion to enforce and
exploit, against Third Parties that offer a product or service that does not
compete with the Matrix, by civil lawsuit or licensing, and will control any
enforcement action brought by it against any such Third Party with respect to
any alleged infringement of, the Developed Technology or the Developed
Technology in combination with any Existing Orthofix Technology licensed
hereunder. MTF will pay all costs and fees associated with
instituting any such action and will have control over selection of counsel and
all strategic decisions relating to the action; provided, however, that any
settlement proposed by MTF to be entered into will be subject to Orthofix’s
prior written approval (which approval Orthofix will not unreasonably withhold,
condition or delay). Any amounts received in connection with such
enforcement and exploitation actions will be applied as follows:
(A) first,
to MTF in the amount of its costs and fees associated with instituting and
maintaining such action, and
(B) next,
to MTF in the amount of all costs incurred by MTF for filing, prosecution and
maintenance of patent applications and other registrations with respect to the
Developed Technology, and
(C) next,
to Orthofix in the amount of all costs incurred by Orthofix for filing,
prosecution and maintenance of patent applications and other registrations with
respect to the Developed Technology, and
(D) then,
any remaining amount to be allocated between the Parties in accordance with
their respective damages suffered as a result of the circumstances at issue in
such action.
(iii)
If
either Party declines to approve a settlement of an action brought by the other
Party to enforce rights in the Developed Technology, the Party that declines to
approve the proposed settlement will be fully responsible for, all reasonable
costs and fees incurred for maintaining the enforcement action and subsequent
settlement efforts relating to the period after the date on which approval of
the proposed settlement was declined.
(e)
Election Not to
Enforce
. Each Party may, from time to time, request that the
other Party take action to enforce and exploit the Existing MTF Technology or
the Existing Orthofix Technology as it relates to the Matrix or the rights
licensed hereunder or the Developed Technology (as applicable). If
the Party with the right to enforce and exploit the Existing MTF Technology or
the Existing Orthofix Technology as it relates to the Matrix or the rights
licensed hereunder or the Developed Technology (as applicable) elects not to
enforce or exploit the applicable Existing Orthofix Technology, Existing MTF
Technology, or Developed Technology, the other Party will be entitled to provide
written notice to such Party of its intent to enforce and exploit such Existing
Orthofix Technology, Existing MTF Technology, or Developed Technology, as
applicable and, if such Party fails to notify the other Party within thirty (30)
days after such written notice that it has commenced to enforce and exploit the
same, the other Party will be entitled to enforce and exploit such Existing
Orthofix Technology, Existing MTF Technology, or Developed Technology, as
applicable, at its own expense and to retain amounts received in connection with
such enforcement and exploitation actions.
[*] 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.
(f)
Cooperation
. The
Parties will at all times cooperate with each other, share material notices and
filings in a timely manner and be kept informed of the status of any proceeding
under
Sections
7.4(b)
,
(c)
,
(d)
or
(e)
with respect to
the Matrix or any rights licensed hereunder by the Party undertaking such
enforcement. Without limiting the generality of the foregoing, each
Party will provide such reasonable cooperation and assistance as the other Party
may reasonably request in any legal action to enforce any rights subject to
Sections
7.5(b)
,
(c)
,
(d)
or
(e)
with respect to
the Matrix or any rights licensed hereunder, including joining such action as a
necessary party, at the enforcing Party’s expense.
ARTICLE
VIII
REPRESENTATIONS
AND WARRANTIES OF MTF
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 as follows:
8.1
Organization, Good Standing and
Authority.
MTF is duly formed, validly existing and in good
standing under the laws of the District of Columbia, and is duly qualified as a
foreign corporation to transact business and is in good standing in each
jurisdiction in which such qualification is required except to the extent that
such failure to qualify or maintain good standing would not materially adversely
affect its ability to perform its obligations under this Agreement. MTF
has full corporate power and authority to own the assets owned by it and to
lease the properties and assets held by it under lease, in each case insofar as
to be applied hereunder, and to carry on and participate in the
Collaboration.
8.2
Organizational and Governing
Documents; Approval.
This Agreement has been approved by all
necessary corporate action of MTF and no other corporate proceedings on the part
of MTF are necessary to authorize the execution and delivery of this Agreement,
or the consummation of the transactions contemplated hereby, under the District
of Columbia Nonprofit Corporation Act, MTF’s organizational documents or
otherwise.
8.3
Due Execution and
Delivery.
MTF has all necessary power and authority to
execute, deliver and perform this Agreement. MTF has duly executed and
delivered this Agreement and assuming the due authorization, execution and
delivery of this Agreement by Orthofix, this Agreement constitutes the legal,
valid and binding obligations of MTF enforceable against it in accordance with
its terms, except that such enforcement (a) may be limited by bankruptcy,
insolvency, moratorium or similar laws affecting creditors’ rights generally,
and (b) is subject to the availability of equitable remedies, as determined
in the discretion of the court before which such a proceeding may be
brought.
[*] 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.
8.4
Consents; No Conflict.
Except
for the approval of MTF’s Board of Directors which has been obtained prior to
the date of this Agreement, no material consent, authorization, permit, waiver
or approval of or from, or notice to, any Person or any governmental authority
is required as a condition to the execution and delivery of this Agreement by
MTF or the performance of MTF’s obligations hereunder. The execution
and delivery of this Agreement and the performance of MTF’s obligations
hereunder will not give rise to a right of termination of, contravene or
constitute a default under, or be an event which with the giving of notice or
passage of time or both will become a default under, or give to others any
rights of termination or cancellation of, or give rise to a right of
acceleration of the performance required by or maturity of, or result in the
creation of any lien, charge or encumbrance, claim, cost, tax, losses or loss of
any rights with respect to the Collaboration or the Matrix pursuant to any of
the terms, conditions or provisions of or under any applicable Law, MTF’s
organizational documents or any material written or oral contract or agreement
to which MTF is a party or by which its assets are bound.
8.5
Litigation and
Claims.
There is no claim, suit, proceeding or other
investigation pending, or to MTF’s Knowledge, threatened against MTF that would
preclude MTF from entering into this Agreement or performing its obligations
hereunder. MTF is not in default with respect to any order, writ,
injunction or decree of any governmental entity known to or served upon MTF in
any manner that would preclude MTF from entering into this Agreement or
performing its obligations hereunder. There is no action or suit by MTF
and relating to the Collaboration or the Matrix that is pending, threatened or
contemplated against any other Person.
8.6
Compliance With
Laws.
To MTF’s Knowledge, (a) MTF is not in material violation
of or in material default under any Law applicable to MTF with respect to the
Collaboration or the Matrix, including the PHSA and relevant sections of the
FDCA, the NOTA and
21 C.F.R. Part 1271
,
Human Cells, Tissues, and Cellular or Tissue-Based Products, in each case as
currently applied by the FDA or other Regulatory Authority, (b) all material
permits have been issued or granted to MTF (i) pursuant to which MTF
currently operates or holds any interest in the property relating to the
Collaboration or the Matrix, or (ii) which are required for its
participation in the Collaboration as contemplated by this Agreement or the
holding of any such interest, and (c) all such permits are in full force and
effect and constitute all material permits required to permit MTF to participate
in the Collaboration.
8.7
Authorizations;
Regulatory Compliance.
[*] 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.
(a)
HCT/P Status.
T
he Matrix, as marketed in accordance with,
and within, labeling approved by MTF, will satisfy the FDA’s definition of an
HCT/P subject to regulation solely under Section 361 of the PHSA and the
provisions of 21 C.F.R. Part 1271 as currently applied by the FDA,
i.e
., the Matrix as so
marketed, and in such context, will be a 361 HCT/P. The Matrix, as so
marketed, and in such context, will be minimally manipulated, intended for
homologous use, will not involve combination with another article (with certain
limited exceptions), will not have a systemic effect and is not dependent upon
the metabolic activity of living cells for its primary function in order to
satisfy the FDA’s requirements (as set forth in 21 C.F.R. 1271.10 and other
provisions in 21 C.F.R. Part 1271 as currently applied by the FDA).
(b)
Lot Compliance
Specifications
and all applicable Laws, including the FDA’s
requirements in 21 C.F.R. Part 1271 regarding Donor Eligibility (Subpart C),
cGTP (Subpart D) and Labeling (21 C.F.R
§
1271.370), in each case as currently applied by the FDA
or other Regulatory Authority.
(c)
Investigation and
Reporting
. MTF will investigate and report to the applicable
Regulatory Authority adverse reaction reports and HCT/P deviations with respect
to the Matrix in accordance with the requirements of 21 C.F.R. Part 1271 Subpart
E.
(d)
No Violation or
Default
. To MTF’s Knowledge, MTF is not under investigation
with respect to, has not been threatened to be charged with, nor has been given
notice of, any material violation of or material default under any Law that
could interfere with or delay the Processing and Commercialization of the Matrix
pursuant to this Agreement.
(e)
No Enforcement
Actions
. In the past twelve (12) months, MTF has not received
from the FDA or any other governmental entity, any notice of adverse findings,
Form 483s, FDA warning letters, regulatory letters, notices of violations,
detentions or seizures of product, suits for injunctive relief or other
enforcement actions against MTF that could interfere with or delay in any
material respect the Processing of the Matrix pursuant to this
Agreement.
8.8
Matrix
Warranties.
MTF warrants that all quantities of the Matrix
supplied pursuant to any Authorized Orders (a) will conform with the
Specifications, will be free from defects in materials or workmanship and will
not be adulterated, misbranded, contaminated, tampered with or otherwise altered
or mishandled while in the custody or control of MTF; (b) will have been
Processed, supplied and distributed in accordance with the Specifications and in
compliance in any material respect with all applicable Laws; and (c) will not be
Processed, supplied, or distributed in violation of any agreement, judgment,
order, or decree to which MTF is a party.
8.9
Intellectual
Property.
The Existing MTF Technology licensed under this
Agreement is Controlled by MTF, and is free and clear of any liens, charges and
encumbrances created by MTF. MTF is not aware of any infringement of
a valid claim of an existing Patent, or any other intellectual property right in
connection with the Existing MTF Technology licensed under this Agreement, and
has disclosed to Orthofix all reasonably relevant information regarding the
Existing MTF Technology licensed under this Agreement, including all patent
opinions obtained by MTF related thereto. To MTF’s Knowledge, no
Patent included in the Existing MTF Technology licensed under this Agreement is
invalid or unenforceable, in whole or in part.
[*] 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.
8.10
Disclaimer of
Warranties.
EXCEPT AS EXPRESSLY SET FORTH IN THIS
ARTICLE VIII
, MTF
MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, IN FACT
OR BY OPERATION OF LAW, AND MTF DISCLAIMS, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE
IX
REPRESENTATIONS
AND WARRANTIES OF ORTHOFIX
Orthofix
hereby represents and warrants to MTF as of the Effective Date as
follows:
9.1
Organization, Good Standing and
Authority.
Orthofix is duly formed, validly existing and in
good standing under the laws of the State of Delaware, and is duly qualified as
a foreign corporation to transact business and is in good standing in each
jurisdiction in which such qualification is required except to the extent that
such failure to qualify or maintain good standing would not materially adversely
affect its ability to perform its obligations under this Agreement.
Orthofix has full corporate power and authority to own the assets owned by it
and to lease the properties and assets held by it under lease, in each case
insofar as to be applied hereunder, and to carry on and participate in the
Collaboration.
9.2
Organizational and Governing
Documents; Approval.
This Agreement has been approved by all necessary
corporate action of Orthofix and no other corporate proceedings on the part of
Orthofix are necessary to authorize the execution and delivery of this Agreement
or the consummation of the transactions contemplated hereby under the Delaware
General Corporation Law, Orthofix’s organizational documents or
otherwise.
9.3
Due Execution and
Delivery.
Orthofix has all necessary power and authority to
execute, deliver and perform this Agreement. Orthofix has duly executed
and delivered this Agreement and assuming the due authorization, execution and
delivery of this Agreement by MTF, this Agreement constitutes the legal, valid
and binding obligations of Orthofix enforceable against it in accordance with
its terms, except that such enforcement (a) may be limited by bankruptcy,
insolvency, moratorium or similar laws affecting creditors’ rights generally,
and (b) is subject to the availability of equitable remedies, as determined
in the discretion of the court before which such a proceeding may be
brought.
9.4
Consents; No
Conflict.
Except for the approval of Orthofix’s Board of
Directors which has been obtained prior to the date of this Agreement, no
material consent, authorization, permit, waiver or approval of or from, or
notice to, any Person or any governmental authority is required as a condition
to the execution and delivery of this Agreement by Orthofix or the performance
of Orthofix’s obligations hereunder. The execution and delivery of this
Agreement and the performance of Orthofix’s obligations hereunder will not give
rise to a right of termination of, contravene or constitute a default under, or
be an event which with the giving of notice or passage of time or both will
become a default under, or give to others any rights of termination or
cancellation of, or give rise to a right of acceleration of the performance
required by or maturity of, or result in the creation of any lien, charge or
encumbrance, claim, cost, tax, losses or loss of any rights with respect to the
Matrix pursuant to any of the terms, conditions or provisions of or under any
applicable Law, Orthofix’s organizational documents or any material written or
oral contract or agreement to which Orthofix is a party or by which its assets
are bound.
[*] 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.
9.5
Litigation and
Claims.
There is no claim, suit, proceeding or other
investigation pending, or, to Orthofix’s Knowledge, threatened against Orthofix
that would preclude Orthofix from entering into this Agreement or performing its
obligations hereunder. Orthofix is not in default with respect to any
order, writ, injunction or decree of any governmental entity known to or served
upon Orthofix in any manner that would preclude Orthofix from entering into this
Agreement or performing its obligations hereunder. There is no action
or suit by Orthofix and relating to the Collaboration or the Matrix that is
pending, threatened or contemplated against any other Person.
9.6
Compliance With
Laws.
To Orthofix’s Knowledge, (a) Orthofix is not in material
violation of or in material default under any Law applicable to Orthofix with
respect to the Collaboration or the Matrix, including the PHSA and relevant
sections of the FDCA, the NOTA and 21 C.F.R. Part 1271, Human Cells,
Tissues, and Cellular or Tissue-Based Products, in each case as currently
applied by the FDA or other Regulatory Authority, (b) all material permits have
been issued or granted to Orthofix (i) pursuant to which Orthofix currently
operates or holds any interest in the property relating to the Collaboration or
the Matrix, or (ii) which are required for its participation in the
Collaboration as contemplated by this Agreement or the holding of any such
interest, and (c) all such permits are in full force and effect and constitute
all material permits required to permit MTF to participate in the
Collaboration.
9.7
Intellectual
Property.
The Existing Orthofix Technology licensed under this
Agreement is Controlled by Orthofix, and, except as set forth on
Schedule 9.7
attached
hereto, is free and clear of any liens, charges and encumbrances created by
Orthofix. Orthofix is not aware of any infringement of a valid claim
of an existing patent or any other intellectual property right in connection
with the Existing Orthofix Technology licensed under this Agreement, and has
disclosed to MTF all reasonably relevant information regarding the Existing
Orthofix Technology licensed under this Agreement, including all patent opinions
obtained by Orthofix related thereto. To Orthofix’s Knowledge, no
Patent included in the Existing Orthofix Technology licensed under this
Agreement is invalid or unenforceable, in whole or in part.
[*] 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.
9.8
Disclaimer of
Warranties.
EXCEPT AS EXPRESSLY SET FORTH IN THIS
ARTICLE IX
, ORTHOFIX
MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, IN FACT
OR BY OPERATION OF LAW, AND ORTHOFIX DISCLAIMS, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE
X
SPECIFICATIONS
10.1
General.
The Parties agree
that the Matrix will at all times conform to, comply with, and will be
Processed, supplied and distributed in accordance with, the Specifications and
applicable Law. Set forth in
Exhibits C
and
D
attached hereto and
incorporated herein by reference are, respectively, the Specifications and the
procedures established pursuant to the Development Agreement for verification
that each Lot complies with the Specifications (the “
Release Criteria
”)
which may be subsequently amended in accordance with the terms of the
Development Agreement and the terms hereof.
10.2
Certificate of
Analysis.
Within fifteen (15) days after the end of each
calendar month, MTF will deliver to Orthofix a COA with respect to each Lot from
which any Authorized Order was fulfilled during the immediately preceding
calendar month. Set forth in
Exhibit E
attached
hereto and incorporated herein by reference is the form of COA.
10.3
Notice of Failure to Meet
Specifications.
MTF will notify Orthofix promptly, but in any
event within seventy-two (72) hours, after its discovery that any Lot, which has
previously been approved in accordance with procedures set forth herein, fails
to comply in any material respect with the Specifications. MTF will
notify Orthofix of such fact along with details concerning the nature of any
such failure to meet the Specifications. MTF will make, at its
expense, such further internal investigation of any failure to meet the
Specifications that it deems appropriate under the circumstances, as required by
Law, and otherwise consistent with its obligations hereunder. MTF
will be solely responsible for all costs associated with failure by any Lot to
meet the Specifications.
10.4
Changes to Specifications and Release
Criteria.
Either Party may request a change to the
Specifications (including line extensions) or 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 obligations to Process, supply and
distribute the Matrix in accordance with this Agreement; 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 under this Agreement. 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 under 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 obligations to Process, supply and distribute the Matrix in
accordance with this Agreement. No change to the Specifications or
the Release Criteria will become effective unless and until approved by the
Steering Committee.
[*] 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.
10.5
Compliance with Specifications and
Release Criteria.
MTF will conduct quality control testing of
each Lot prior to shipment to verify that such Lot satisfies the Specifications
and the Release Criteria and will retain records pertaining to such testing as
required by applicable Laws. MTF will not ship any Lot hereunder
which, as indicated by quality control testing as set forth above, does not
satisfy any of the foregoing requirements.
ARTICLE
XI
BOOKS
AND RECORDS; COMPLIANCE AUDITS
AND
RELATED REGULATORY MATTERS
11.1
Books
and Records; Compliance Audits.
(a)
Books and
Records
.
Each Party will
maintain complete and accurate books, records and documentation related to its
activities hereunder, including, without limitation, its Processing, supply,
distribution and Commercialization (as applicable) of the Matrix hereunder for
the longer of (i) five (5) years after shipment of any quantity of the
Matrix, or (ii) the period of time required by applicable Laws; provided,
however, that each Party will maintain during the Term and for six (6) years
after issuance of the last of any Patent(s) issued to such Party for the
Developed Technology, complete and accurate books, records, and documentation
related to any such Patent(s) and related intellectual property, in sufficient
detail and in good scientific manner appropriate for establishing and defending
any such Patent(s) and related intellectual property, which will fully and
properly reflect in all material respects all work done and results achieved by
such Party in connection therewith. No records required by this
Agreement will be discarded by either Party without specific prior written
notification of such Party’s intent to discard to the other Party. Those
records (or copies of those records) that such Party is unwilling to retain
will, at the request of the other Party, be transferred to the other Party for
storage. Without limitation of the foregoing,
MTF will maintain, in accordance with all applicable
Laws, required records, including records relating to complaints, Donor
Eligibility Requirements, cGTP, and reporting to the FDA under 21 C.F.R. Part
1271.
(b)
Performance of
Audit
. Subject to the provisions of
Section 4.2
(which
shall apply, exclusively, to the subject matter thereof), each Party will be
entitled, at its own expense and in connection with the Collaboration, to Audit
any facility, quality systems, books, records and regulatory documentation of
the other Party related to the other Party’s activities hereunder, during the
Term and, in the case of such books, records and documentation, thereafter for
the respective time periods described in
Section
11.1(a)
. This right of Audit will also accrue to such Party’s
representatives designated to inspect on its behalf or in cooperation with such
Party, provided that such representatives agree in writing to be bound by the
same confidentiality requirements that apply to the auditing Party under this
Agreement. Such Audits will be for the purpose of quality assurance
and control and confirming the audited Party’s compliance with applicable Laws
and its obligations under this Agreement and exercising any privileges under
this Agreement. Upon reasonable prior notice, each Party will provide
the other Party and its designated representatives with reasonable access to
such Party’s facilities and documentation during normal business hours for the
purpose of conducting such Audit.
[*] 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.
(c)
Audit
Feedback
. Within thirty (30) days after completing the results
of any Audit hereunder, an auditing Party will submit to the audited Party a
written report outlining its findings and/or observations from any such
Audit. If deficiencies are discovered during an Audit that could, in
the auditing Party’s reasonable opinion, prevent the audited Party from
satisfying its obligations under this Agreement, then, provided that the audited
Party agrees with the auditing Party’s opinion, the audited Party will promptly
correct such deficiencies at its own expense and prior to filling new or
outstanding Authorized Orders, and will notify the auditing Party in writing
when such deficiencies are corrected. If the audited Party does not
agree with the auditing Party’s opinion, the Parties will direct the dispute to
the Steering Committee.
(d)
Acknowledgement
. A
Party’s or its representative’s exercise of its Audit rights hereunder will in
no way waive, modify or diminish the other Party’s obligations under this
Agreement.
11.2
Regulatory
Matters.
(a)
Compliance
. Each
Party will, during the Term, comply in all material respects with all Laws
applicable to the Matrix and to the activities, including Processing and
Commercialization (as applicable), undertaken by such Party pursuant to this
Agreement. MTF will Process, supply and distribute the Matrix in
compliance in all material respects with the quality control procedures approved
under the Development Agreement.
(b)
AATB
Standards
. MTF will maintain membership in the AATB during the
Term, unless MTF notifies Orthofix to the contrary in writing, and whether or
not MTF maintains such membership, MTF will comply in all material respects with
the most current voluntary standards adopted by the AATB applicable to its
activities undertaken pursuant to this Agreement.
(c)
Regulatory Filings; Related
Data
. MTF will prepare and submit all regulatory filings,
submissions and payments necessary to permit the Processing and
Commercialization of the Matrix as contemplated under the Marketing Plan, and
will gather and maintain data and records in connection therewith (including for
potential submissions or reporting to the FDA and other Regulatory
Authorities). Notwithstanding MTF’s responsibility for regulatory and
legal compliance, all material regulatory submissions will be subject to review
and approval by the Steering Committee which approval will not be unreasonably
withheld, conditioned or delayed.
[*] 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.
11.3
Complaints.
(a)
Records;
Notification
. Each of Orthofix and MTF will keep written
records of all customer complaints that it receives and promptly advise the
other Party in writing or by electronic mail of all such complaints, and will
notify the other Party by telephone of all potential adverse reactions involving
communicable disease within twenty-four (24) hours of knowledge thereof and in
writing or by electronic mail within two (2) business days of receipt of the
preliminary details thereof.
(b)
Complaint
Handling
. MTF will be responsible for complaint handling,
investigations and reports to the FDA and other governmental authorities as
required by Law, including the provisions of 21 C.F.R. Part
1271. Each Party will cooperate fully with the other Party in dealing
with customer complaints concerning the Matrix and will take such action to
promptly resolve such complaints as may be reasonably requested by the other
Party. Orthofix will reasonably cooperate with MTF to enable MTF to
fulfill all applicable governmental investigation and reporting requirements
arising from complaints or adverse events or reactions.
11.4
Regulatory
Correspondence.
During the Term, MTF will notify Orthofix
promptly (but in any event within seventy-two (72 hours)) of (a) any
establishment inspection observations (including any FDA Form 483), letter,
citation, indictment, claim, lawsuit, or enforcement proceeding threatened,
issued or instituted by any governmental authority to or against MTF relating to
the Processing of the Matrix hereunder, (b) any notice, order, correspondence,
or other form of communication threatening or proposing to revoke or suspend or
of any communication that revokes any license, registration, authorization,
approval, exemption, allowance, or permit held or maintained by MTF relating to
the Processing of the Matrix hereunder, or (c) any charge brought against MTF
or, to MTF’s Knowledge, any director, officer, employee or consultant of MTF
under any Law for any act or omission relating to the development of the Matrix
or otherwise relating to regulation of the Matrix under any applicable Law.
During the Term, Orthofix will notify MTF promptly (but in any event within
seventy-two (72) hours) of any charge brought against Orthofix or, to Orthofix’s
Knowledge, against any director, officer, employee or consultant of Orthofix
under any Law for any act or omission relating to the development of the Matrix
or otherwise relating to regulation of the Matrix under any applicable
Law.
[*] 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.
11.5
Regulatory
Inspections.
If MTF or a subcontractor is inspected by any
agent of any Regulatory Authority (a “
Regulatory
Inspection
”) in connection with its processing of the Matrix hereunder,
MTF will promptly notify Orthofix of the results (and, in any event, will do so
within seventy-two (72) hours of completion of the inspection), including any
establishment inspection observations (including any FDA Form 483), letter,
citation, significant oral comments or observations, written comments or notices
received from the AATB or any applicable Regulatory Authority, which relate to
the development or Processing of the Matrix hereunder, if
applicable. With respect to the forgoing, each Party will, during the
Term, provide to the other Party, promptly upon such other Party’s request,
copies of any notice or correspondence from or to any Regulatory Authority that
directly relates to the Matrix. Such notices and correspondence are
considered Confidential Information in accordance with this Agreement. The
Parties will cooperate in the development and review of responses that are
required to be submitted to any Regulatory Authority relating to the development
or Processing of the Matrix hereunder prior to submission to the Regulatory
Authority. MTF hereby further agrees to advise Orthofix promptly
(and, in any event, within seventy-two (72) hours) of learning of any announced
or scheduled Regulatory Inspection of any Facility, or any facility of a
subcontractor of MTF, where such Regulatory Inspection is anticipated to be
specifically related to the Matrix or its Processing hereunder. In
such cases, MTF agrees to permit, to the extent reasonably practical, one or
more representative(s) of Orthofix to be present if requested by
Orthofix.
ARTICLE
XII
RECALLS
Either
Party who becomes aware of any defect, problem or adverse condition in the
Matrix will promptly notify the other Party of such defect, problem or adverse
condition. MTF will have responsibility for determining whether to
initiate, and for initiating and conducting, any recall, market withdrawal,
field action, removal, correction or field notice (a “
Recall
”) related to
the Matrix. Orthofix will cooperate with MTF in the conduct of any
Recall. MTF will bear the costs and expenses of any Recall related to
the Matrix, including reasonable costs incurred by Orthofix. Orthofix
will have the right to initiate at its own expense any patient testing with
respect to the Matrix other than that which is required by Law, and Orthofix’s
election to initiate such testing will not affect MTF’s indemnification
obligations hereunder. Nothing contained herein will be construed as
restricting the right of either Party to make a timely report of such matters to
any Regulatory Authority or take other action that it deems to be appropriate or
required by applicable Laws.
ARTICLE
XIII
TERM;
TERMINATION
13.1
Term
.
Unless sooner terminated
pursuant to the terms herein, this Agreement will commence on the Effective Date
and will continue until the tenth (10
th
)
anniversary of the Effective Date (the “
Initial
Term
”). Six months prior to the date of expiration of the
Initial Term, and six (6) months prior to the expiration of any renewal term, as
applicable, the Parties will begin negotiating in good faith for purposes of
renewing this Agreement for an additional two (2) year term to begin immediately
upon the expiration of the then-current term. In the event that the
Parties are unable to reach agreement on renewal by the date of expiration of
the then-current term, each Party will reduce to writing its final proposal with
respect to renewal, this Agreement shall expire by its terms on such date, and
for a period of two (2) years after such date neither Party will enter into an
agreement for Commercialization of the Matrix with any Third Party on terms less
favorable to it than those which were offered by the other Party and set forth
in such 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.
13.2
Termination for Default
.
Either Party may
terminate this Agreement in the event of the material breach or material default
by the other Party of the material terms and conditions hereof which is not
cured as set forth in this
Section
13.2
. In the event of such a material breach or material
default, the terminating Party will first give to the defaulting Party written
notice of the proposed termination of this Agreement, specifying the grounds
therefor. Upon receipt of such notice, the defaulting Party will have
sixty (60) days to cure such material breach or material default. If
the defaulting Party does not cure such breach or default within such period,
then this Agreement will terminate automatically on the sixtieth (60
th
) day
after receipt by the defaulting Party of the termination
notice. Termination of this Agreement pursuant to this
Section 13.2
will not
affect any other rights or remedies which may be available to the non-defaulting
Party.
13.3
Termination for Bankruptcy,
Insolvency
.
A Party may
terminate this Agreement upon the occurrence of either of the
following:
(a)
the
entry of a decree or order for relief by a court having jurisdiction in the
premises in respect of the other Party in an involuntary case under the United
States Bankruptcy Code, as now constituted or hereafter amended (the “
Bankruptcy Code
”), or
any other applicable federal or state insolvency or other similar Law and the
continuance of any such decree or order unstayed and in effect for a period of
sixty (60) consecutive days; or
(b)
the
filing by the other Party of a petition for relief under the Bankruptcy Code or
any other applicable federal or state insolvency or other similar
Law.
All
licenses granted by each Party to the other Party in this Agreement are, and
will otherwise be deemed to be, for the purpose of Section 365(n) of the
Bankruptcy Code, the licenses of rights to “intellectual property” as defined
under Section 101 of the Bankruptcy Code. Each Party, as a licensee
of intellectual property rights under this Agreement, will retain and may fully
exercise all of its rights and elections under the Bankruptcy Code. The
Parties hereto further agree that, in the event that any proceeding will be
instituted by or against either Party seeking to adjudicate it as bankrupt or
insolvent, or seeking liquidation, winding up, reorganization, arrangement,
adjustment, protection, relief or composition of it or its debts under any Law
relating to bankruptcy, insolvency, or reorganization or relief of debtors, or
seeking an entry of an order for relief or the appointment of a receiver,
trustee or other similar official for it or any substantial part of its property
or it will take any action to authorize any of the foregoing actions, the other
Party will have the right to retain and enforce its rights in and to such
Party’s intellectual property under this Agreement in accordance with Section
365(n) of the Bankruptcy Code.
[*] 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.
13.4
Other Termination
Rights.
Either Party may terminate this Agreement upon written
notice to the other Party (a) if a court or Regulatory Authority that regulates
the Matrix takes any action the result of which would prohibit or significantly
restrict the sale, marketing, use, or manufacture of the Matrix, (b) if,
prior to the Effective Date of this Agreement, the Development Agreement is
terminated for any reason, or (c) pursuant to
Section
17.3
. Orthofix may further terminate this Agreement upon
written notice to MTF: (x) in the event of an Infringement Claim or a reasonable
determination by Orthofix that an Infringement Claim is likely to be initiated,
if after written notice by Orthofix to MTF to cease Processing, supplying and
distributing the Matrix, MTF continues to Process, supply or distribute the
Matrix during the Cessation Period or (y) if Orthofix enters into any settlement
with the consent of MTF of an Infringement Claim pursuant to which Orthofix
agrees not to Process or Commercialize the Matrix.
13.5
Expiration;
Termination; Consequences.
(a)
Survival
. The
following provisions, in accordance with their respective terms, will survive
termination or expiration of this Agreement for any reason:
Section 4.2
(Service
Fee Audit),
ARTICLE VII
(Intellectual Property),
Section 8.10
(Disclaimer of Warranties),
Section 9.8
(Disclaimer of Warranties),
Section 11.1
(Books
and Records; Compliance Audits),
Section 13.3
(Termination for Bankruptcy, Insolvency),
Section 13.5
(Expiration; Termination; Consequences),
ARTICLE XIV
(Indemnification; Insurance),
ARTICLE XV
(Disclaimer of Indirect Damages),
ARTICLE XVI
(Confidentiality; Restrictive Covenants; Publications),
ARTICLE XVIII
(Press Releases; Use of Names),
ARTICLE IX
(Dispute Resolution) and
ARTICLE XX
(Miscellaneous).
(b)
Return of Confidential
Information
. Upon termination or expiration of this Agreement,
each Party will immediately deliver to the other (and cause its employees,
agents, representatives and subcontractors to so deliver), at such Party’s
expense, all Confidential Information of the other Party, including any and all
copies, duplications, summaries and/or notes thereof or derived therefrom,
regardless of the format;
provided
,
however
, that each
Party will, upon reasonable notice to such Party and during such Party’s normal
business hours, provide the other Party with access to Confidential Information
as is reasonably necessary for purposes of the requesting Party’s compliance
with applicable Laws or in connection with such Party’s defense of any
Third-Party claims related thereto.
(c)
Accrued
Obligations
. Expiration or termination of this Agreement will
not relieve the Parties of any obligation accruing prior to the effective date
of such expiration or termination, including, with respect to MTF, (i) the
fulfillment of any outstanding Authorized Orders received prior to the effective
date of expiration or termination of this Agreement and (ii) payment to Orthofix
of any Marketing Fees due and payable as a result of Authorized Orders received
prior to the effective date of expiration or termination 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.
ARTICLE
XIV
INDEMNIFICATION;
INSURANCE
14.1
Indemnification by
Orthofix
.
Orthofix hereby agrees
to indemnify, defend, and hold harmless MTF, its Affiliates and their respective
directors, officers, employees, agents, successors and permitted assigns (the
“
MTF
Indemnitees
”) from and against any and all damages, losses, liabilities,
claims, actions, proceedings, and expenses (including reasonable attorneys’ fees
and expenses) (collectively, “
Damages
”) resulting
from or arising out of (a) any unauthorized claim made by Orthofix with respect
to the Matrix that is inconsistent with the Specifications, with the labeling or
materials approved by MTF, (b) Orthofix’s breach of any of its representations,
warranties or covenants hereunder, (c) Orthofix’s gross negligence or willful
misconduct or the grossly negligent actions or willful misconduct of any of
Orthofix’s Affiliates, employees, directors or agents in connection with this
Agreement, including, without limitation, any product liability and other claims
for personal injury or death caused by the Matrix if resulting form such
actions, and (d) any Third-Party claim that the Processing, distribution or
supply under this Agreement and for purposes of the Collaboration of the Matrix
in accordance with the Specifications and for which Orthofix is paid a Marketing
Fee (or which is delivered in furtherance of Orthofix’s marketing efforts or as
a result of Orthofix’s introduction regardless of whether a Marketing Fee is
paid) violates the intellectual property rights of a Third Party and/or
infringes the valid claim of an existing Patent of a Third Party (an “
Infringement Claim
”),
it being understood that a Third-Party Claim regarding the development or
Processing of the Matrix independent of the Collaboration shall not be within
the definition of “Infringement Claim;”
provided
,
however
,
that
(i)
in
the event of an Infringement Claim or a reasonable determination by Orthofix
that an Infringement Claim is likely to be initiated, Orthofix will have the
right to direct MTF, by written notice, to cease Processing, supplying and
distributing the Matrix during the period beginning upon MTF’s receipt of
such notice and continuing until MTF’s receipt of written notice from Orthofix
that the Infringement Claim has been satisfactorily resolved in Orthofix’s
reasonable determination or is no longer expected to be initiated (the
“
Cessation
Period
”), and Orthofix will have no obligation to indemnify or
hold harmless MTF or the MTF Indemnitees from or against any Damages
attributable to any Processing, supply or distribution of the Matrix during
the Cessation Period; and
(ii)
Orthofix
will not be required to indemnify, defend and hold harmless the MTF Indemnitees
from or against any counter-claim or other claim against an enforcement action
filed by MTF (in exercising its step-in rights pursuant to
Section 6.5(e)
) with
respect to any alleged infringement of the Existing Orthofix Technology or the
Developed Technology.
[*] 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.
In the
event that Orthofix directs MTF, by written notice, to cease development and
Processing of the Matrix based on a reasonable determination that an
Infringement Claim is likely to be initiated and MTF complies therewith,
Orthofix shall reimburse MTF for fifty percent (50%) of MTF’s actual, documented
cost for processing the quantity of the Matrix in MTF’s inventory on the date of
such notice and fifty percent (50%) of MTF’s actual documented cost for all
Matrix work in process on such date.
14.2
Indemnification by
MTF.
MTF hereby agrees to indemnify, defend, and hold harmless
Orthofix, its Affiliates and their respective directors, officers, employees,
agents, successors and permitted assigns from and against any and all Damages,
resulting from or arising out of (a) MTF’s breach of any of its
representations, warranties, or covenants hereunder, (b) MTF’s gross
negligence or willful misconduct or the grossly negligent actions or willful
misconduct of any of MTF’s Affiliates, employees, officers, directors or agents
in connection with this Agreement and (c) product liability and other
claims for personal injury or death caused by the Matrix insofar as Processed
and supplied by MTF.
14.3
Third-Party
Claims Procedure.
(a)
Notice of
Claims
. Each Party indemnified under the provisions of this
Agreement, upon receipt of written notice of any claim, or the service of a
summons or other initial legal process upon it in any action instituted against
it by a Third Party, in respect of any claim for which such Party is entitled to
indemnification in accordance with this Agreement, will promptly give written
notice of such claim, or the commencement of such action, or threat thereof to
the Party from whom indemnity will be sought hereunder;
provided
,
however
, the failure
to provide such notice will not relieve the indemnifying Party of any of its
obligations hereunder except to the extent the indemnifying Party is materially
prejudiced by such failure. The indemnifying Party will be entitled
at its own expense to participate in the defense of such claim or action, or, if
it will elect, to assume control of such defense, in which event such defense
will be conducted by counsel chosen by such indemnifying Party, which counsel
may be any counsel reasonably satisfactory to the indemnified Party against whom
such claim is asserted, and the indemnified Party will bear all fees and
expenses of any additional counsel retained by it. Notwithstanding
the immediately preceding sentence, if the named parties in such action
(including impleaded parties) include the indemnified and the indemnifying
Parties, and the indemnified Party will have been advised by counsel that there
may be a conflict between the positions of the indemnifying Party and the
indemnified Party in conducting the defense of such action or that there are
legal defenses available to such indemnified Party different from or in addition
to those available to the indemnifying Party, then counsel for the indemnified
Party will be entitled, if the indemnified Party so elects, to conduct the
defense to the extent reasonably determined by such counsel to be necessary to
protect the interests of the indemnified Party, at the expense of the
indemnifying Party, if it is determined by agreement of the indemnifying Party
and the indemnified Party or by a court of competent jurisdiction that the
indemnified Party is entitled to indemnification hereunder for the Damages
giving rise to such action. If the indemnifying Party elects not to
assume the defense of such claim or action, then such indemnifying Party will
reimburse such indemnified Party for the reasonable fees and expenses of any
counsel retained by it, and will be bound by the results obtained by the
indemnified Party in respect of such claim or action if it is determined by
agreement of the indemnifying Party and the indemnified Party or by a court of
competent jurisdiction that the indemnified Party is entitled to indemnification
hereunder for the Damages giving rise to such action;
provided
,
however
, that no such
claim or action will be settled without the written consent of the indemnifying
Party, which consent will not be unreasonably withheld, conditioned or delayed
and
provided
,
further
, that
an indemnified Party that declines to consent to a proposed settlement will not
be entitled to be indemnified against, and will be fully responsible for, (i)
the amount, if any, by which any subsequent settlement amount or damages award
exceeds the amount of the proposed settlement that was declined, and (ii) all
reasonable costs of defense and settlement relating to the period after the date
on which consent to the proposed the proposed settlement was
declined.
[*] 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.
(b)
Payment
Terms
. All amounts payable under this
ARTICLE XIV
will be
paid promptly after receipt by the indemnifying Party of written notice from the
indemnified Party stating that such Damages have been incurred, the amount
thereof and of the related indemnity payment and substantiation of such amount
and such indemnity payment;
provided
,
however
, any disputed
amounts will be due and payable promptly after such amounts are finally
determined by a court of competent jurisdiction or by mutual agreement of the
Parties to be owing by the indemnifying Party to the indemnified
Party.
14.4
Insurance.
Each
Party will procure and maintain comprehensive general liability and product
liability insurance (or, in the case of MTF, professional liability insurance),
in amounts of not less than $2,000,000 per incident and $10,000,000 in the
aggregate annually. Each Party will maintain such insurance during
the Term and for a period of ten (10) years following the end of the
Term. Each Party will cause the other Party to be named as an
additional insured under such insurance and will provide the other Party proof
of such insurance upon request. Each Party will give the other Party
at least thirty (30) days notice of any cancellation, termination or change in
such insurance.
[*] 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.
ARTICLE
XV
DISCLAIMER
OF INDIRECT DAMAGES;
LIMITATIONS
ON LIABILITY
Notwithstanding
any other provision contained in this Agreement:
15.1
Indirect
Damages.
In no event will either Party be liable to the other
Party for incidental, special, consequential or other indirect damages,
including any claims for damages based upon lost profits (it being acknowledged
and agreed that amounts paid or incurred by a Party to any Third Parties,
whether or not constituting indirect damages to such Third Parties, shall not be
construed as indirect damages to such Party).
15.2
Maximum Aggregate
Liability.
The maximum aggregate liability of MTF hereunder
for any and all causes whatsoever, and Orthofix’s remedies, and whether or not
MTF is notified of the possibility of Damages to Orthofix, will be limited to
the amount of the Service Fees retained by MTF hereunder. The maximum
aggregate liability of Orthofix hereunder for any and all causes whatsoever, and
MTF’s remedies, and whether or not Orthofix is notified of the possibility of
Damages to MTF, will be limited to the amount of Marketing Fees paid to Orthofix
hereunder.
15.3
Exceptions.
The
disclaimer and limitations set forth in this
ARTICLE XV
will not
apply to any liability of either Party arising under
Section 6.2
(Rights
of First Offer and First Refusal),
ARTICLE XIV
(Indemnification and Insurance), other than under
Section 14.1(a)
,
Section
14.1(b)
,
Section 14.2(a)
thereof, and
ARTICLE
XVI
(Confidentiality; Restrictive Covenants; Publication).
ARTICLE
XVI
CONFIDENTIALITY;
RESTRICTIVE COVENANTS; PUBLICATION
16.1
Treatment
of Confidential Information.
(a)
Obligation;
Exceptions
. All Confidential Information disclosed by one
Party to the other Party hereunder will be maintained in confidence by the
receiving Party and will not be disclosed to any Third Party or used for any
purpose except as set forth herein without the prior written consent of the
disclosing Party, for a period of ten (10) years from disclosure of such
Confidential Information, except to the extent that such Confidential
Information:
(i)
is known by receiving Party at the time of its receipt, and not through a
prior disclosure by the disclosing Party, as documented by the receiving Party’s
business records;
(ii)
is
or becomes part of the public domain through no fault of the receiving
Party;
(iii)
is
subsequently disclosed to the receiving Party by a Third Party who may lawfully
do so and is not under an obligation of confidentiality to the disclosing
Party;
[*] 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.
(iv)
is
developed by the receiving Party independently of Confidential Information
received from the disclosing Party, as documented by the receiving Party’s
business records;
(v)
is
disclosed to a governmental agency (A) in order to obtain Patents with
respect to the Matrix, but such disclosure may be made only to the extent
reasonably necessary to obtain such Patents, or (B) as part of or in connection
with any mandatory filing with a governmental agency; and/or
(vi)
is
deemed necessary by either Party to be disclosed to its Affiliates, agents,
consultants, and/or other Third Parties for the Processing and/or
Commercialization of the Matrix and/or in connection with a permitted licensing
transaction and/or a permitted assignment under this Agreement, and/or loan,
financing or investment and/or acquisition, merger, consolidation or similar
transaction (or for such entities to determine their interest in performing such
activities) in each case on the condition that any Third Parties to whom such
disclosures are made agree to be bound by the confidentiality and non-use
obligations contained in this Agreement;
provided
,
however
, that the
term of confidentiality for such Third Parties will be no less than ten (10)
years.
(b)
Aggregated
Information
. Any combination of features or disclosures will
not be deemed to fall within the foregoing exclusions merely because individual
features are published or available to the general public or in the rightful
possession of the receiving Party unless the combination itself falls within the
applicable exclusion.
(c)
Required
Disclosures
. If a Party is required by judicial or
administrative process to disclose Confidential Information that is subject to
the non-disclosure provisions of this
ARTICLE XVI
such
Party will promptly inform the other Party of the disclosure that is being
sought in order to provide the other Party an opportunity to challenge or limit
the disclosure obligations. Confidential Information that is
disclosed by judicial or administrative process will remain otherwise subject to
the confidentiality and non-use provisions of this
ARTICLE XVI
, and the
Party disclosing Confidential Information pursuant to law or court order will
take all steps reasonably necessary, including without limitation obtaining an
order of confidentiality, to ensure the continued confidential treatment of such
Confidential Information.
16.2
Non-Compete.
Subject
to the provisions of
Section 6.2(a)
and
Section 6.2(b)
,
during the Term and for one (1) year thereafter, neither Party will, and will
not permit any of its Affiliates to, except as provided in this Agreement,
directly or indirectly, as a principal, agent, owner, joint venturer, investor,
manager, operator or consultant, engage in the Processing, development,
manufacture, sale, marketing, use, import, export, supply, distribution or other
Commercialization in the Territory of bone-growth allograft products containing
viable allogeneic stem cells derived from cadavers; provided, however, that the
Parties acknowledge and agree that (a) Orthofix is a party to the Osiris
Agreement under which Orthofix distributes a bone allograft product, under the
trademark “Trinity”™, that contains viable allogeneic stem cells derived from
cadavers, (b) as of the date hereof, Orthofix has an existing inventory of the
Trinity product, (c) Orthofix shall be entitled to exhaust such inventory of the
Trinity product, but in no event subsequent to the later of (i) six (6) months
after the Effective Date or (ii) October 1, 2009, before placing orders with MTF
for the Matrix, (d) Orthofix may fill orders for all or any portion of the
quantities set forth in any Forecast from such inventory of the Trinity product
before placing orders with MTF for the Matrix, but in no event later than the
period described under clause (c) immediately preceding, and (e) proceeding as
set forth herein will not be deemed to be a violation by Orthofix of
Section 6
, this
Section 16.2
or any
other provision of this Agreement. Each Party acknowledges and agrees
that the covenants and agreements set forth in this
Section 16.2
have been specifically negotiated and are essential and material terms and
conditions of this Agreement and a material part of the transactions
contemplated by this Agreement and the Development 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.
16.3
Non-Solicitation.
During
the Term and, for a period of one (1) year thereafter, neither Party will
directly or indirectly solicit, engage or hire any employee or contractor of the
other Party or its Affiliates;
provided
,
however
, that nothing
herein will prohibit either Party, directly or indirectly (for such Party’s own
account or for the account of any other Person), from soliciting for employment,
hiring or employing (a) any Person who responds to a general solicitation
or advertisement in a newspaper, on the internet, or in some similar medium that
is not directed at any individual employee or group of employees of the other
Party; (b) any Person whose employment has been terminated without cause by
the other Party; or (c) any Person referred by a recruiter, as long as such
recruiter is directed to not target or solicit employees of the other
Party.
16.4
Publications.
Each
of Orthofix and MTF will have the right to publish, during the Term or after its
expiration or termination, the results of research related to the Matrix that is
conducted during the Term, subject in each instance to the prior written
approval of the other Party, which approval will not be unreasonably withheld,
conditioned or delayed. The Party seeking to publish any such results
will submit the proposed publication to the other Party for review a minimum of
sixty (60) days prior to the contemplated publication and the non-publishing
Party will have a reasonable opportunity to recommend any changes that it
reasonably believes are necessary. If the non-publishing Party does
not object to such publication or recommend any changes in writing within such
sixty (60) day period such approval will be deemed granted.
ARTICLE
XVII
FORCE
MAJEURE
17.1
Effects of Force Majeure
.
Neither Party
will be held liable or responsible for failure or delay in fulfilling or
performing any of its obligations under this Agreement to the extent that such
failure or delay is caused or occasioned by acts of God, acts of the public
enemy, fire, explosion, flood, drought, hurricane, weather conditions, war,
riot, sabotage, embargo, strikes or other labor disputes (a “
Force Majeure
Event
”);
provided
,
however
, that in the
event of a Force Majeure Event affecting the Processing of the Matrix, MTF will
use Reasonable Commercial Efforts to implement the Contingency Plan before it
will be entitled to be excused from its obligations under this Agreement
pursuant to this
Section
17.1
. Such excuse will continue as long as the Force Majeure
Event continues. Upon cessation of such Force Majeure Event, such
Party will promptly resume performance hereunder.
[*] 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.
17.2
Notice of Force
Majeure.
Each Party agrees to give the other Party prompt
written notice of the occurrence of any Force Majeure Event, the nature thereof,
and the extent to which the affected Party will be unable fully to perform its
obligations hereunder. Each Party further agrees to use Reasonable
Commercial Efforts to correct the Force Majeure Event as quickly as possible and
to give the other Party prompt written notice when it is again fully able to
perform such obligations.
17.3
Termination
.
If a Force
Majeure Event lasts for more than sixty (60) calendar days and during such
period MTF cannot Process the Matrix (or arrange for the Processing of the
Matrix pursuant to the Contingency Plan) as a result of the Force Majeure Event,
Orthofix may use an alternative supplier of the Matrix to fulfill Authorized
Orders for the shorter of (i) the duration of the Force Majeure Event or (ii)
the period (not exceeding one-hundred eighty (180) days beyond the cessation of
the Force Majeure Event) necessary to allow Orthofix to honor, on behalf of MTF,
the Authorized Orders, if any, to any Customer in effect at the time of
cessation. If, as a result of a Force Majeure Event, a Party is
unable fully to perform its obligations hereunder for any consecutive period of
one hundred eighty (180) days, the other Party will have the right to terminate
this Agreement in its entirety, upon providing written notice to the
non-performing Party, such termination to be effective thirty (30) days from the
date of such notice.
ARTICLE
XVIII
PRESS
RELEASES; USE OF NAMES
18.1
Press
Releases.
Except as otherwise required by Law or any rule of
the NASDAQ Stock Market, any announcement, press release, publicity, or other
public statement related to this Agreement or either Party’s performance
hereunder prepared by one Party will be submitted to the other Party prior to
release for approval, which approval will not be unreasonably withheld,
conditioned or delayed by such other Party.
18.2
Use of
Names.
Except as otherwise required by Law or by the terms of
this Agreement or as mutually agreed upon by the Parties, neither Party will
make any use of the name of the other Party in any advertising or promotional
material, or otherwise, without the prior written consent of the other Party,
which consent will not be unreasonably withheld, conditioned or delayed by such
other Party.
[*] 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.
ARTICLE
XIX
DISPUTE
RESOLUTION
19.1
Internal
Escalation.
The Parties recognize that a bona fide dispute as
to certain matters may from time to time arise during the Term which relates to
either Party’s rights and/or obligations hereunder, including without
limitation, the inability of the Steering Committee under
Section 3.3
to reach
a determination on any issue that the Steering Committee is authorized to
consider. Except with respect to any right to injunctive relief for
any claims arising from any section of
ARTICLE XVI
or
Section 20.3
, in the
event of the occurrence of such a dispute, either Party will be required, by
written notice to the other Party, to have such dispute referred to the
respective chief executive officers of the Parties, for attempted resolution by
good faith negotiations within thirty (30) days after such notice is
received.
19.2
Mediation.
Except
with respect to any right to injunctive relief for any claims arising from any
section of
ARTICLE
XVI
or
Section
20.3
, in the event the Parties’ respective chief executive officers are
not able to resolve such dispute within the thirty (30) day period set forth in
Section 19.1
,
or such other period of time to which the Parties may mutually agree in
writing, the Parties will endeavor in good faith to resolve the
dispute through mediation under the CPR Mediation Procedure in effect on the
date of this Agreement. Unless otherwise mutually agreed to in
writing, the parties will select a mediator from the CPR Panels of Distinguished
Neutrals.
19.3
Legal Process.
In
the event that the Parties are not able to resolve such dispute within forty
five (45) days after initiation of the mediation procedure set forth in
Section 18.2
, or such
other period of time to which the Parties may mutually agree in writing, each
Party will have the right to pursue any and all remedies available at law or in
equity.
19.4
Venue.
For any
court proceeding initiated with respect to this Agreement (i) Orthofix hereby
irrevocably and unconditionally consents to the submission to the non-exclusive
jurisdiction of the United States District Court for the District of New Jersey,
and the courts of the State of New Jersey located within that district, if such
court proceeding is initiated by MTF and (ii) MTF hereby irrevocably and
unconditionally consents to the submission to the non-exclusive jurisdiction of
the United States District Court for the Western District of North Carolina, and
the courts of the State of North Carolina located within that district, if such
court proceeding is initiated by Orthofix. Each Party further
irrevocably and unconditionally (i) agrees that service of any process, summons,
notice or document by registered mail or as otherwise provided in this Agreement
shall be effective service of process for any action, suit or proceeding brought
against it in any court whose jurisdiction is accepted as aforesaid, (ii) waives
any objection to the laying of venue of any action, suit or proceeding arising
out of this Agreement in such courts, and (iii) agrees not to plead or claim in
any such court that any such action, suit or proceeding brought in any such
court has been brought in an inconvenient forum.
[*] 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.
ARTICLE
XX
MISCELLANEOUS
20.1
Independent
Contractors.
Although the Parties are engaged in a
Collaboration to Process and Commercialize the Matrix and have made and will
make contributions, financial and otherwise, to such Collaboration, the
relationship between Orthofix and MTF is that of independent contractors and
nothing herein will be deemed to constitute the relationship of partners, or
principal and agent between Orthofix and MTF. Neither Party will have
any express or implied right or authority to assume or create any obligations on
behalf of or in the name of the other Party or to bind the other Party to any
contract, agreement, or undertaking with any Third Party.
20.2
Assignment.
Neither
Party may assign this Agreement, in whole or in part, without the prior written
consent of the other Party;
provided
,
however
, that either
Party may assign this Agreement without the prior written consent of the other
Party to an Affiliate of such Party or in connection with a merger or sale of
all or substantially all of the stock or assets of such Party to a Third
Party. Any permitted assignee will assume in writing all obligations
of its assignor under this Agreement. No assignment will relieve
either Party of its responsibility for the performance of its obligations
hereunder. This Agreement will be binding upon and will inure to the benefit of
the Parties and their respective permitted successors and assigns and nothing in
this Agreement is intended to or shall confer any benefits, rights or remedies
unto any Person other than the Parties and their respective permitted successors
and assigns. Without limiting the generality of the foregoing, and
notwithstanding any representation or warranty of MTF provided herein with
respect to the Matrix or any other matter, Orthofix acknowledges and agrees that
all such representations and warranties are for the exclusive benefit of
Orthofix under this Agreement and will not be applicable or transferable to any
Customer or any other Person.
20.3
Injunctive Relief; Specific
Performance
.
Notwithstanding
anything to the contrary in
ARTICLE XIX
, the
Parties understand and agree that, in view of the uniqueness of the Matrix and
the long term Process, supply and distribution of the Matrix contemplated
hereunder, each Party will be entitled to specific performance and other forms
of injunctive relief in the event that the other Party breaches its obligations
hereunder (including, without limitation, under
ARTICLE XVI
), in
addition to any other remedy to which it may entitled, at law or in
equity.
20.4
Waiver.
No failure
or delay on the part of either Party hereto to exercise any right, power, or
privilege hereunder or under any instrument executed pursuant hereto will
operate as a waiver, nor will any single or partial exercise of any right,
power, or privilege preclude any other or further exercise thereof or the
exercise of any other right, power, or privilege.
[*] 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.
20.5
Severability.
Both Parties
expressly agree and contract that it is not the intention of either Party to
violate any public policy, applicable Laws, treaties, or decisions of any
government or agency thereof. If any provision or part thereof
contained in this Agreement is declared invalid by any court of competent
jurisdiction or a government agency having jurisdiction, such declaration will
not affect the remainder of the provision or the other provisions and each will
remain in full force and effect.
20.6
Headings.
All
headings in this Agreement are for convenience of reference only and will not
affect the interpretation of this Agreement.
20.7
Interpretation.
The
words “include”, “includes” and “including” and words of similar import will be
deemed to be followed by the phrase “without limitation” or “but not limited
to,” as the context may warrant. Unless the context requires
otherwise (a) any definition of or reference to any agreement, instrument or
other document herein will be construed as referring to such agreement,
instrument or other document as from time to time amended, supplemented or
otherwise modified (subject to any restrictions on such amendments, supplements
or modifications set forth herein); (b) any reference herein to any entity will
be construed to include the entity’s successors and assigns; (c) the words
“herein”, “hereof” and “hereunder”, and words of similar import, will be
construed to refer to this Agreement in its entirety and not to any particular
provision hereof; and (d) all references herein to Articles, Sections, Addenda,
Exhibits or Schedules will be construed to refer to Articles, Sections, Addenda,
Exhibits and Schedules of this Agreement.
20.8
Notices.
All
notices and other communications required or permitted to be given under this
Agreement will be in writing and will be delivered personally or sent by (a)
registered or certified mail, return receipt requested; (b) a
nationally-recognized courier service guaranteeing next-day delivery, charges
prepaid; or (c) facsimile (with the original promptly sent by any of the
foregoing manners). Any such notices will be addressed to the
receiving Party at such Party’s address set forth below, or at such other
address as may from time to time be furnished by similar notice by either
Party:
If to
MTF:
Musculoskeletal
Transplant Foundation, Inc.
125 May
Street
Suite
300
Edison,
New Jersey 08837
Attention: Bruce
W. Stroever
Facsimile
No.: (732) 661-2297
[*] 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.
With a
copy (which will not constitute notice) to:
McCarter
& English, LLP
Four
Gateway Center
100
Mulberry Street
Newark,
New Jersey 07102
Attention:
Howard Kailes, Esq.
Facsimile
No.: (973) 624-7070
If to
Orthofix:
Orthofix
Holdings, Inc. (c/o Orthofix International N.V.)
The
Storrs Building
Suite
250
10115
Kincey Avenue
Huntersville
Business Park
Huntersville,
NC 28078
Attention:
Chief
Executive Officer and General Counsel
Facsimile
No.: (704) 948-2690
With a
copy (which will not constitute notice) to:
Hogan
& Hartson LLP
8300
Greensboro Drive
Suite
1100
McLean,
VA 22102
Attention: Philip
D. Porter
Facsimile
No.: (703) 610-6200
Any such
notice or communication will be effective upon such personal delivery or
delivery to such courier, upon transmission by facsimile (with acknowledgement
of a complete transmission), or three (3) days after it is sent by such
registered or certified mail, as the case may be. Copies will be sent
in the same manner as originals.
20.9
Counterparts.
This Agreement
and any amendment or supplement hereto may be executed in counterparts, each of
which will be deemed to be an original, and all of which taken together will
constitute one and the same instrument.
20.10
Governing Law.
All
questions of inventorship, and all other Patent rights of the Parties, will be
governed by the laws of jurisdiction from which the Patent in question issued or
in which the Patent application was filed. In all other respects, the
validity, interpretation, and performance of this Agreement will be governed and
construed in accordance with the laws of the State of Delaware, without regard
to the conflicts of laws provisions 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.
20.11
Waiver of Rule of
Construction.
Each Party has had the opportunity to consult
with counsel in connection with the review, drafting and negotiation of this
Agreement. Accordingly, the rule of construction that any ambiguity
in this Agreement will be construed against the drafter will not
apply.
20.12
Further Assurance.
Each Party
will duly execute and deliver, or cause to be duly executed and delivered, such
further instruments, and do and cause to be done such further acts and things,
including the filing of such assignments, agreements, documents and instruments,
as may be necessary or as the other Party may reasonably request in connection
with this Agreement or to carry out more effectively the provisions and
purposes, or to better assure and confirm unto such other Party its rights and
remedies under this Agreement.
20.13
Entire
Agreement.
This Agreement, including all addenda, exhibits and
schedules referred to herein, constitute the full understanding of the Parties
with respect to the subject matter hereof and a complete and exclusive statement
of the terms of their agreement. This Agreement or any provision
hereof cannot be amended, changed, supplemented, or waived except in a writing
signed by each of the Parties hereto. No modification to this
Agreement will be effected by the acknowledgment or acceptance of any purchase
order or shipping instruction form or similar documents containing terms or
conditions at variance with or in addition to those set forth
herein. Any term or condition of any purchase order, sales
acknowledgment, or document which is in addition to, different from, or contrary
to the terms and conditions of this Agreement will be void.
[The
rest of this page is intentionally left blank.]
[*] 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.
IN WITNESS WHEREOF,
the
Parties have caused this Matrix Commercialization Collaboration Agreement to be
duly executed and delivered as of the date first written above.
|
MUSCULOSKELETAL
TRANSPLANT FOUNDATION, INC.
|
|
|
|
|
|
|
|
By:
|
/s/ Bruce W.
Stroever
|
|
Name:
|
Bruce W.
Stroever
|
|
Title:
|
President and
CEO
|
|
|
|
|
|
|
|
ORTHOFIX
HOLDINGS, INC.
|
|
|
|
|
|
|
|
By:
|
/s/ Alan
Milinazzo
|
|
Name:
|
Alan Milinazzo
|
|
Title:
|
Group President and
CEO
|
[*] 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.
LIST OF ADDENDA AND
EXHIBITS
Addendum
1 – Definitions
Exhibit
A – MTF Order Acceptance Procedures
Exhibit
B – Initial Steering Committee
Exhibit
C – Specifications
Exhibit
D – Release Criteria
Exhibit
E – COA
Exhibit
F – Contingency Plan
Exhibit
G – MTF’s Knowledge
Exhibit
H – Orthofix’s Knowledge
[*] 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.
Schedule
9.7 – Intellectual Property
The
Existing Orthofix Technology is subject to certain liens pursuant to the Credit
Agreement, dated as of September 22, 2006, among Orthofix Holdings, Inc.,
Orthofix International N.V., Colgate Medical Limited, Victory Medical Limited,
Swiftsure Medical Limited, Orthofix UK LTD, certain subsidiaries of Orthofix
International N.V. identified therein, the Lenders identified therein, and
Wachovia Bank, National Association, as Administrative Agent, as amended (the
“Credit Agreement”), and including the Security Documents, as defined in the
Credit 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.
Addendum
1 – Definitions
The
following terms, whether used in the singular or plural, will have the meanings
assigned to them below for purposes of this Agreement:
“
AATB
” means the
American Association of Tissue Banks.
“
Affiliate
” means any
corporation or non-corporate entity which controls, is controlled by, or is
under common control with a Party. A corporation or non-corporate
entity will be regarded as in control of another corporation if it owns or
directly or indirectly controls at least fifty percent (50%) of the voting stock
of the other corporation or (a) in the absence of the ownership of at least
fifty percent (50%) of the voting stock of a corporation or (b) in the case of a
non-corporate entity, the power to direct or cause the direction of the
management and policies of such corporation or non-corporate entity, as
applicable.
“
Agreement
” means this
Matrix Commercialization Collaboration Agreement.
“
Audit
” means a
reasonable review and/or inspection by either Party or its representatives of
Service Fee records in accordance with
Section 4.2
and/or
facilities, processes, procedures, and documents (or of any subcontractor
permitted pursuant to
Section 2.9
) as
described in
Section
10.1
of this Agreement.
“
Authorized Orders
”
has the meaning set forth in
Section 2.1(a)
.
“
Bankruptcy Code
” has
the meaning set forth in
Section
13.3(a)
.
“
Certificate of
Analysis
” or “
COA
” means the
certificate for each Lot delivered hereunder confirming compliance with the
Specifications.
“
Cessation Period
” has
the meaning set forth in
Section
14.1
.
“
cGTP
” means current
Good Tissue Practice requirements set forth in 21 C.F.R. Part 1271, Subpart D,
as in effect and as may be amended or replaced by the FDA from time to
time.
“
Collaboration
” means
the Processing and Commercialization of the Matrix by the Parties pursuant to
the terms and conditions of this Agreement.
“
Commercialization
”
or
“
Commercialize
” means
activities directed to obtaining pricing and reimbursement approvals, marketing,
promoting, distributing, importing, supplying or transferring the
Matrix.
[*] 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.
“
Confidential
Information
” means information which is disclosed by a Party (the “
Disclosing Party
”) to
the other Party (the “
Receiving Party
”) in
whatever media, and is marked, identified or otherwise acknowledged to be
confidential at the time of disclosure.
“
Contingency Plan
”
means the contingency plan for the Processing and fulfillment of Authorized
Orders in the event of any interruption in MTF’s Processing capability as a
result of cessation of all or substantially all Processing operations with
respect to the Matrix at MTF’s facility located in Edison, New Jersey, set forth
in
Exhibit F
and as it may be subsequently amended from time to time in accordance with the
procedures set forth herein and in the Development Agreement.
“
Control
,”
“
Controls
” or “
Controlled by
” means,
with respect to any item of or right under Patents, Know-How, Technology or
Inventions, the possession of (whether by ownership or license, other than
pursuant to this Agreement) or the ability of a Party to grant access to, or a
license or sublicense of, such items or right as provided for herein without
violating the terms of any agreement or other arrangement with any Third Party
existing at the time such Party would be required hereunder to grant the other
Party such access or license or sublicense.
“
CPI
” means the “Price
for Index for all Urban Consumers, U.S. city average, all items, for the then
immediately preceding 12-month period” as published by the U.S.
Government.
“
Customers
” has the
meaning set forth in
Section 2.1(b)
.
“
Damages
” has the
meaning set forth in
Section
14.1
.
“
Developed Technology
”
means the Developed Technology (as defined in the Development Agreement) in
existence as of the Effective Date, and all Improvements during the Term with
respect thereto, including, without limitation, all Patents relating to the
foregoing.
“
Development
Agreement
” has the meaning set forth in the Recitals.
“
Dispute Notice
” has
the meaning set forth in
Section
4.2(b)
.
“
Donor
” means a human
tissue donor.
“
Donor Eligibility
Requirements
” means the requirements set forth in 21 C.F.R. Part 1271,
subpart C, as in effect and as may be amended or replaced by the FDA from time
to time.
“
Donor Tissue
” means
human musculoskeletal tissue, including bone and connective tissue.
“
Effective Date
” means
the date of completion of the last Development Milestone pursuant to the
Development Plan (as those terms are defined in the Development
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.
“
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 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 (b) solely for purposes of
Section
7.1
(a)(ii)
, such
Technology, Inventions and Know-How Controlled by MTF 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.
“
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 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 (b) solely for purposes of
Section
7.1
(b)(ii)
, such
Technology, Inventions and Know-How Controlled by Orthofix 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.
“
Facility
” means MTF’s
facility located at 125 May Street, Suite 300, Edison, New Jersey or any other
facility of MTF where it performs any of its obligations under this
Agreement.
“
FDA
” means the United
States Food and Drug Administration, or any successor entity.
“
FDCA
” means the
United States Federal Food, Drug, and Cosmetic Act, as amended.
“
First Offer Notice
”
has the meaning set forth in
Section
6.2(a)
.
“
First Refusal Notice
”
has the meaning set forth in
Section
6.2(b)
.
“
Force Majeure Event
”
has the meaning set forth in
Section
17.1
.
“
Forecast
” has the
meaning set forth in
Section
2.2
.
“
HCT/P
” means a human
cells, tissues, or cellular or tissue-based product that the FDA regulates
solely under Section 361 of the PHSA and the provisions of 21 C.F.R. Part
1271.
“
Improvement
”
means any enhancement,
modification, purification, optimization, or further development made under and
pursuant to this Agreement during the Term, whether or not patentable, that
results from either (a) a change to the Specifications that is agreed upon by
the Steering Committee for development under this Agreement, or (b) a new
development initiative with respect to the Matrix that is the subject of a new
development agreement mutually agreed upon by the Parties in accordance with
Section
6.1
.
[*] 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.
“
Infringement Claim
”
has the meaning set forth in
Section
14.1
.
“
Initial Term
” has the
meaning set forth in
Section
13.1
.
“
Invention
” means any
process, method, composition of matter, article of manufacture, discovery or
finding.
“
Know-How
” means (a)
any scientific or technical information, results and data of any type
whatsoever, in any tangible or intangible form whatsoever, including databases,
practices, methods, techniques, specifications, formulations, formulae,
knowledge, know-how, skill, experience, test data including pharmacological,
medicinal chemistry, biological, chemical, biochemical, toxicological and
clinical test data, analytical and quality control data, stability data, studies
and procedures, and manufacturing process and development information, results
and data and (b) any biological, chemical or physical materials.
“
Laws
” means all
national, federal, state, provincial and local laws, statute, rules,
regulations, ordinances, administrative order, court order, requirements and
guidance of any governmental authority or instrumentality, domestic or
otherwise, including the PHSA, the NOTA, 21 C.F.R. Parts 1270 and 1271, Human
Cells, Tissues, and Cellular or Tissue-Based Products, cGTP, state tissue
banking statutes and regulations, Donor Eligibility Requirements, and other
rules, regulations, guidance or standards promulgated or issued by any
Regulatory Authority or the AATB, as each may be amended from time to
time.
“
Lot
” means a quantity
of the Matrix, Processed in accordance with the Specifications, resulting from a
single production run traceable to a single Donor.
“
Marketing Fee
” has
the meaning set forth in
Section 5.2
.
“
Marketing Plan
” has
the meaning set forth in
Section 5.1
.
“
Matrix
” has the
meaning set forth in the Recitals.
“
Minimum Service Fee
”
has the meaning set forth in
Section 4.1(a)
.
“
Monthly Statement
”
has the meaning set forth in
Section
4.1(b)
.
“
MTF
” has the meaning
set forth in the Preamble.
“
MTF Indemnitees
” has
the meaning set forth in
Section
14.1
.
“
MTF Marks
” has the
meaning set forth in
Section 7.3(a)
.
“
MTF’s Knowledge
” and
phrases of similar import mean, the actual knowledge of a particular fact of the
individuals identified on
Exhibit
G
[*] 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.
“
NOTA
” means the
United States National Organ Transplant Act, 42 U.S.C. Section
274e.
“
Offeree Party
” has
the meaning set forth in
Section
6.2(a)
.
“
Offering Party
” has
the meaning set forth in
Section
6.2(a)
.
“
Orthofix
” has the
meaning set forth in the Preamble.
“
Orthofix Marks
” has
the meaning set forth in
Section 7.3(b)
.
“
Orthofix’s Knowledge
”
and phrases of similar import mean, the actual knowledge of a particular fact of
the individuals identified on
Exhibit
H
.
“
Osiris Agreement
”
means the Distribution and Supply Agreement, dated November 10, 2005, between
Osiris Therapeutics, Inc. and Orthofix.
“
Party
” has the
meaning set forth in the Preamble.
“
Patent(s)
” means (a)
all patents and patent applications in any country or supranational jurisdiction
and (b) any provisionals, substitutions, divisions, continuations, continuations
in part, reissues, renewals, registrations, confirmations, reexaminations,
extensions, supplementary protection certificates and the like, of any such
patents or patent applications.
“
Person
” means an
individual, corporation, partnership, limited liability company, trust, business
trust, association, joint stock company, joint venture, pool, syndicate, sole
proprietorship, unincorporated organization, governmental authority or any other
form of entity not specifically listed herein.
“
PHSA
” means the
United States Public Health Service Act, 42 U.S.C. §201
et seq.
“
Process
” or “
Processing
” means any
or all of the acts of manufacturing (including procuring materials, and
determining suitability of Donor Tissue and Donors for manufacturing), handling,
storing, releasing, analyzing, testing, packaging, labeling and preparing for
shipment.
“
Product Concept
” has
the meaning set forth in
Section
6.2(a)
.
“
Product Concept
Proposal
” has the meaning set forth in
Section
6.2(a)
.
“
Proposing Party
” has
the meaning set forth in
Section
6.2(b)
.
“
Reasonable Commercial
Efforts
” means with respect to the efforts to be expended by a Party with
respect to any objective, reasonable, good faith efforts to accomplish such
objective as such Party would normally use to accomplish a similar objective
under similar circumstances, it being understood and agreed that with respect to
the Processing or Commercialization of the Matrix, such efforts will be similar
to those efforts and resources commonly used by a Party for a similar human
tissue product owned by it or to which it has rights, which product is at a
similar stage in its development or product life and is of similar market
potential taking into account efficacy, safety, labeling, the competitiveness of
alternative products in the marketplace, the patent and other proprietary
position of the product, the likelihood of regulatory approval given the
regulatory structure involved, the commercial viability of the product,
availability of alternative products and other relevant
factors. Reasonable Commercial Efforts may change over time,
reflecting changes in the status of the Matrix and the market
needs.
[*] 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.
“
Recall
” has the
meaning set forth in
ARTICLE
XII
.
“
Receiving Party
” has
the meaning set forth in
Section
6.2(b)
.
“
Regulatory Authority
”
means any government regulatory authority, domestic or otherwise with
jurisdiction over the activities of the Parties pursuant to this Agreement and
over the development, Processing, marketing, reimbursement and/or pricing of the
Matrix in the Territory, including, in the United States, the FDA.
“
Regulatory
Inspection
” has the meaning set forth in
Section
11.5
.
“
Release Criteria
” has
the meaning set forth in
Section
10.1
.
“
Service Fee
” has the
meaning set forth in
Section
4.1(a)
.
“
Specifications
” has
the meaning set forth in the Recitals.
“
Steering Committee
”
means the Committee described in greater detail in
ARTICLE III
that has
the authority set forth therein, the initial composition of which is set forth
in
Exhibit
B
.
“
Subcontracting Party
”
means, with respect to any subcontractor, the Party that has engaged that
subcontractor.
“
Technology
” means all
intellectual property rights, including but not limited to such rights with
respect to designs, prototypes, processes, drawings, descriptions, data, and
inventions, whether patentable or not.
“
Term
” means the
Initial Term as defined in
Section 13.1
hereof, and any renewal or extension of this Agreement pursuant to
Section 13.1
.
“
Territory
” means all
of the countries in the world, and their territories and
possessions.
“
Third Party
” means
any party other than Orthofix, MTF, and their respective
Affiliates.
[*] 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.
“
Underpayment Notice
”
has the meaning set forth in
Section
4.2
(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.
EXHIBIT
A
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
MTF Order Acceptance
Procedures*
Orders; Service Fees
1.
All orders
for Matrix shall be subject to MTF’s standard terms and conditions,
including, without limitation, its standard warranty, and, subject to the
foregoing, the terms set forth in this Exhibit A in effect on the date of
this Agreement as from time to time revised by MTF.
2.
All new
customers must provide MTF with their complete bill to and ship to
address, contact name and telephone number on company
letterhead.
3.
Unless
otherwise agreed upon in writing, the Matrix will be billed at the service
fees in effect at the time of shipment. Service fees are
subject to change without notice unless a definite term of effectiveness
is otherwise stipulated by MTF. Unless otherwise specifically indicated,
all service fees and order acknowledgements are understood to be F.O.B.
MTF’s premises in Edison, New Jersey.
4.
Service fees and
conditions given in MTF’s order acknowledgements are effective only for
deliveries to be used in the country of the named customer.
5.
Service fees on the
specified tissue and products are exclusive of all taxes, including,
without limitation, taxes on processing, sales, receipts, gross income,
occupation, use and similar taxes. Whenever applicable, any tax
or taxes will be added to the invoice as a separate charge to be paid by
the customer.
6.
Transportation
and insurance of shipments shall be arranged by MTF on behalf of the
customer at the customer’s expense and risk.
7.
Products
or services not stipulated in any order will be charged
separately.
Terms of Payment
1.
Where, at
MTF’s option, credit is extended, payment is due within thirty days after
the date of the invoice.
2.
All orders
paid by credit card must have credit card pre-approval prior to
shipment.
3.
Unless
otherwise specifically stipulated, all payments are to be made in United
States currency. Payment is considered made if and to the extent that the
aforementioned funds are placed at the unrestricted disposal of
MTF.
4.
The
customer shall comply with all required dates of payment notwithstanding
any delay in transportation, delivery or acceptance of shipments for
reasons beyond MTF’s control.
Delivery
1.
The delivery times
indicated in MTF’s order acknowledgements are based on MTF’s ability to
secure the necessary tissue and other materials and on processing
conditions prevailing at that time. In the event of changes
occurring in any of such circumstances, MTF reserves the right
at any time to advise the customer of a revised time for
delivery.
2.
MTF will
not recognize any claim for damages in respect of delay in
delivery.
3.
Shipment
to transportation carrier’s pick-up point will be done
when
necessary for facilitation of delivery.
4.
MTF will
only ship tissue and/or tissue classified as a medical device
to hospitals,
medical offices, dental offices, and other tissue banks for frozen tissue
storage purposes.
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absolute
property of MTF provided that the customer may be given credit therefore,
if applicable.
Return Policy
1.
In order
to maintain strict quality control protocols, there is a no-return policy
for all frozen bone and frozen soft tissue.
2.
Freeze
dried tissue may be returned for credit under the following circumstances
without a restocking fee: (i) the tissue does not conform to MTF’s
warranty (if such claims are reported to MTF within thirty days of the
date of invoice); (ii) the tissue/packaging is damaged in shipment (if
claims for damaged tissue packages are reported to MTF within five days of
receipt of the shipment of tissue; or (iii) order discrepancies (if
reported to MTF within five days of receipt of the shipment of
tissue).
3.
All other
return requests must be made within thirty days of the original invoice
date and will be subject to a restocking charge of twenty percent of the
cost of the tissue. Freight charges will not be
credited.
4.
All
returns must be accompanied by a Return Authorization Number
(RA#). An RA# may be obtained by contacting MTF’s Customer
Service Advocate at 1-800-946-9008 extension 2307 (Customer Service hours
are Monday through Friday 8:15 a.m. to 6:30 p.m. eastern
time).
Warranties
1.
MTF’s
standard warranty to the customer, extending to conformity of the Matrix
to MTF’s published specifications therefor, will constitute MTF’s sole
warranty to the customer.
MTF will make no other warranty
or guarantee, express or implied or statutory, in fact or by operation of
law, and MTF disclaims, without limitation, the implied warranties of
merchantability and fitness for a particular purpose.
2.
In the
event that any tissue does not meet MTF’s warranty, MTF’s liability and
the customer’s sole remedy, whether in contract, under any warranty, in
tort (including negligence), in strict liability or otherwise, shall be
limited, in all respects, to reimbursement or replacement of
the non-conforming shipment and shall not exceed the return of the amount
of the service fee paid by the customer.
3. MTF
shall not in any event be liable for damages or indemnity for direct or
incidental, consequential or other indirect damages, including any claims
for damages based upon lost profits, or other liabilities in any way
arising from or sustained as a result of an order and/or the processing,
sale, distribution or delivery of the tissue.
Cancellation
1.
If the
customer ceases to conduct its operations in the normal course or if any
proceeding under the bankruptcy or insolvency laws is brought by or
against the customer or a receiver for the customer is appointed or
applied for or an assignment is made by the customer for the benefit of
creditors, MTF may terminate the order without liability and without
prejudicing MTF’s rights with respect to deliveries previously
made.
2.
In the
event of non-compliance by the customer with the any of MTF’s standard
terms and conditions, MTF shall be at liberty to cancel any order or part
thereof immediately and to demand immediate payment for shipment already
delivered.
3.
MTF may
further at any time cancel an order for any other reason, including,
without limitation, breach by the customer, with respect to tissue and
materials not theretofore
delivered.
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[*] 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.
The use of
and risk of loss to the tissue shall pass to the customer upon delivery of
the tissue to the carrier for shipment.
6.
MTF will
have the right, in addition to all other rights it may possess at any
time, for credit reasons or because of the customer’s default or defaults,
to withhold shipments, in whole or in part, and to recall shipments in
transit, retake shipments and repossess all tissue which is stored with
MTF for the customer’s account without the necessity of taking any other
proceedings and the customer consents that all shipments so recalled,
retaken or repossessed shall become the
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Other
1.
MTF will
not be required to accept any order which, unless waived by MTF, purports
not to incorporate MTF’s standard terms and conditions or which provides
for any term or condition which is inconsistent with MTF’s standard terms
and conditions.
2.
MTF will not be
responsible for delays caused by acts of God, official enactments,
epidemics, mobilization, war, riots, breakdown of processing facility,
strikes, lockouts, boycotts, or any labor issues directly or indirectly
affecting MTF’s processing or those of its suppliers or any other event
beyond MTF’s control.
3.
The rights
and duties of the parties shall be determined by the laws of the State of
New Jersey and the customer consents and submits to the jurisdiction of
the courts of the State of New Jersey for all purposes in connection with
controversy, claim, action or proceeding arising out of or relating to any
order and final judgment in any such controversy, claim, action or
proceeding shall be conclusive and may be enforced in any other
jurisdiction within or outside the State of New
Jersey.
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*In the
event of any inconsistency between any provision of this Exhibit A and any
provision in the body of the Agreement, the provision in the body of the
Agreement shall control.
[*] 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.
EXHIBIT
B
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
Initial Steering
Committee
MTF
designees
Joseph
Yaccarino, Executive Vice President, Processing Operations
Michael
Schuler, Vice President, New Business Development
Kim
Fitzgerald, Vice President, Marketing
Orthofix
designees
Michael
Finegan, Vice President, Corporate Development
Nicole
Esposito, Global Products Manager Biologics
Raymond
Linovitz, Medical Director, Blackstone Medical
[*] 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.
EXHIBIT
C
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
Specifications for the
Matrix
Allogeneic
cancellous bone matrix containing viable mesenchymal stem cells and/or
osteoprogenitor cells and conforming to the
following: [*]
[*] 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.
EXHIBIT
D
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
Release Criteria for the
Matrix
1.
|
For
each donor lot: [*]
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[*] 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.
EXHIBIT
E
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
Certificate of
Analysis
CERTIFICATE
OF ANALYSIS
Donor Lot
_____
Date__________
The
above-referenced Donor Lot complies with the release criteria set forth below as
indicated:
Criteria
|
Meets
Standard
|
Deviates from Standard
|
[
*
]
|
|
|
[
*
]
|
|
|
[
*
]
|
|
|
[
*
]
|
|
|
[
*
]
|
|
|
|
MUSCULOSKELETAL
TRANSPLANT
|
|
FOUNDATION,
INC.
|
|
|
|
|
|
|
|
By
|
|
|
Name:
|
|
|
Title:
|
|
[*] 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.
EXHIBIT
F
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
Contingency Plan for the
Matrix
The
primary facility for processing the Matrix will be MTF’s facility located in
Edison, New Jersey where processing will take place in the rooms where all fresh
tissue processing currently is performed, which include the appropriate clean
rooms, equipment, and trained personnel.
In the
event of a cessation of all or substantially all Processing operations with
respect to the Matrix at MTF’s Edison facility, MTF will use Reasonable
Commercial Efforts to implement the following actions in order to continue to
supply Matrix:
|
·
|
processing
will be transferred to MTF’s facility located in Jessup, Pennsylvania
(expected completion, 1/2009);
|
|
·
|
any
specialized equipment for Matrix processing will be duplicated in the
Jessup facility;
|
|
·
|
MTF’s
trained personnel from the Edison facility will work in the Jessup
facility and train Jessup personnel until the Jessup facility’s processing
capabilities is operational and Jessup personnel are
trained;
|
|
·
|
usable
work in process and finished goods inventory will be relocated to Jessup;
and
|
|
·
|
order
fulfillment will be relocated to the Jessup
facility.
|
[*] 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.
EXHIBIT
G
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
MTF’s
Knowledge
|
Arthur
A. Gertzman, Executive Vice President, Research and Development and Chief
Science Officer
|
|
Michael
Schuler, Vice President, New Business
Development
|
[*] 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.
EXHIBIT
H
MATRIX
COMMERCIALIZATION COLLABORATION AGREEMENT
Orthofix’s
Knowledge
Michael
M. Finegan, Vice President of Corporate Development
Raymond
Linovitz, Medical Director, Blackstone Medical
Raymond
C. Kolls, Senior Vice President, General Counsel and Corporate
Secretary
[*] 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.