In re Orthofix International N.V.
Orthofix International N.V. violated the FCPA’s books and records and internal controls provisions by permitting its Brazilian subsidiary to make $2.928 million in disguised bribes to government-employed doctors from 2011 to 2013, despite a prior 2012 FCPA settlement for similar misconduct in Mexico, and agreed to pay $6.119 million in penalties and remedial measures.
Orthofix International N.V. violated Sections 13(b)(2)(A) and 13(b)(2)(B) of the Exchange Act by allowing its Brazilian subsidiary to make approximately $2.928 million in improper payments to doctors at government hospitals between 2011 and 2013, disguised as legitimate expenses through third-party distributors. These payments occurred despite a prior 2012 SEC settlement for FCPA violations by its Mexican subsidiary, and Orthofix failed to implement adequate internal controls to prevent or detect the misconduct. To resolve the charges, Orthofix agreed to pay $2.928 million in disgorgement, $263,375 in prejudgment interest, and a $2.928 million civil penalty, while retaining an independent FCPA consultant to overhaul its compliance program.
Orthofix International N.V., a medical device company headquartered in Texas, violated the FCPA’s books and records and internal controls provisions by permitting its Brazilian subsidiary, Orthofix do Brasil LTDA, to make approximately $2.928 million in improper payments to doctors employed at government-owned hospitals between 2011 and 2013. These payments, disguised as legitimate expenses through inflated commissions, false invoices, and excessive discounts, were systematically recorded in Orthofix’s financial statements and generated illicit profits despite the company’s prior 2012 SEC settlement for similar FCPA violations by its Mexican subsidiary. Orthofix failed to implement adequate compliance controls, training, or oversight in Brazil, even as employees openly referred to the bribes as 'doctors’ commissions,' and only remediated after the misconduct was uncovered in 2013. To resolve the matter, Orthofix consented to a cease-and-desist order without admitting or denying guilt and agreed to pay $2.928 million in disgorgement, $263,375 in prejudgment interest, and a $2.928 million civil penalty. The company also committed to retain an independent FCPA consultant, selected jointly with the SEC, to conduct a comprehensive compliance review, submit a work plan within 30 days, and deliver a final report with recommendations within six months. Orthofix must adopt the consultant’s recommendations or propose alternatives subject to SEC approval, grant full access to personnel and records, report findings to its Board and the SEC, and undergo a post-implementation review with a written certification of compliance binding on any successor entity.
Extracted insights
- $4.90M $4.9 million $1M–$10M
- $2.93M $2,928,000 $1M–$10M
- $2.93M $2,928,000 $1M–$10M
- $2.22M $ 2,220,000 $1M–$10M
- $317K $317,000 $100K–$1M
- $263K $263,375 $100K–$1M
- person orthofix brazil
- person orthofix brazil senior personnel
- person orthofix do brasil ltda
- agency Securities and Exchange Commission
- Orthofix International N.V. violated Books and Records and Internal Controls Provisions of the Foreign Corrupt Practices Act of 1977
- Orthofix International N.V. organized under laws of Curacao
- Orthofix International N.V. headquartered in Lewisville, Texas
- Orthofix do Brasil LTDA is subsidiary of Orthofix International N.V.
- Orthofix Brazil Senior Personnel employed At Least Four Schemes to Make Improper Payments to Doctors at Government-Owned Hospitals from 2011 to 2013
- Orthofix Brazil made improper payments to Doctors Employed at Government-Owned Hospitals
- Improper Payments to Doctors generated illicit profits of $2,928,000
- Orthofix International N.V. charged by SEC in 2012 with violating Books and Records and Internal Controls Provisions of the FCPA in Connection with Bribes Paid to Mexican Officials
- Orthofix International N.V. violated Sections 13(b)(2)(A) and 13(b)(2)(B) of the Securities Exchange Act of 1934
- Orthofix International N.V. trades on Nasdaq Global Select Market under Symbol OFIX
- SEC instituted cease-and-desist proceedings against Orthofix International N.V.
- SEC issued order on January 18, 2017
UNITED STATES OF AMERICA
Before the
SECURITIES AND EXCHANGE COMMISSION
SECURITIES EXCHANGE ACT OF 1934
Release No. 79828 / January 18, 2017
ACCOUNTING AND AUDITING ENFORCEMENT
Release No. 3851 / January 18, 2017
ADMINISTRATIVE PROCEEDING
File No. 3-17800
In the Matter of
Orthofix International N.V.
Respondent.
ORDER INSTITUTING CEASE-AND-
DESIST PROCEEDINGS PURSUANT TO
SECTION 21C OF THE SECURITIES
EXCHANGE ACT OF 1934, MAKING
FINDINGS, AND IMPOSING REMEDIAL
SANCTIONS AND A CEASE-AND-DESIST
ORDER
I.
The Securities and Exchange Commission (“Commission”) deems it appropriate that
cease-and-desist proceedings be, and hereby are, instituted pursuant to Section 21C of the
Securities Exchange Act of 1934 (“Exchange Act”) against Orthofix International N.V.
(“Orthofix” or “Respondent”).
II.
In anticipation of the institution of these proceedings, Respondent has submitted an Offer
of Settlement (“Offer”) that the Commission has determined to accept. Respondent admits the
facts set forth in Paragraphs 1 through 20 below, acknowledges that its conduct violated the
federal securities laws, admits the Commission’s jurisdiction over it and the subject matter of
these proceedings, and consents to the entry of this Order Instituting Cease-and-Desist
Proceedings Pursuant to Section 21C of the Securities Exchange Act of 1934, Making Findings,
and Imposing Remedial Sanctions and a Cease-and-Desist Order (“Order”), as set forth below.
2
III.
On the basis of this Order and Respondent’s Offer, the Commission finds
1
that:
SUMMARY
This matter concerns violations of the books and records and internal controls provisions
of the Foreign Corrupt Practices Act of 1977 (“FCPA”) by Orthofix International N.V., a
medical device company organized under the laws of Curacao and headquartered in Lewisville,
Texas, and its Brazilian subsidiary, Orthofix do Brasil LTDA. From at least 2011 to 2013
(hereinafter “the relevant period”), senior personnel at Orthofix Brazil employed at least four
schemes, with third-party commercial representatives and distributors, to make improper
payments to doctors employed at government-owned hospitals to induce them to use Orthofix’s
products, thereby increasing sales. The improper payments to doctors employed at government
hospitals were improperly recorded as legitimate expenses and generated illicit profits to
Orthofix of approximately $2,928,000.
Orthofix also failed to devise and maintain a system of internal accounting controls
sufficient to provide reasonable assurances to detect and prevent such payments by Orthofix
Brazil, despite the fact that Orthofix had been charged by the Commission in 2012 with violating
the books and records and internal controls provisions of the FCPA in connection with bribes
paid to Mexican officials by its Mexican subsidiary.
By engaging in the foregoing conduct, Orthofix violated the books and records and
internal controls provisions of the federal securities laws set forth in Sections 13(b)(2)(A) and
13(b)(2)(B) of the Exchange Act.
RESPONDENT
Orthofix International N.V. (“Orthofix,” “Respondent,” or “Company”) is a limited
liability company formed under the laws of Curacao and headquartered in Lewisville, Texas. It
is a diversified medical device company that develops and sells surgical and non-surgical
medical products to medical professionals in various market sectors, including orthopedics. It
distributes its products both domestically in the United States and internationally in multiple
countries. Orthofix’s common stock is registered with the Commission pursuant to Section 12(b)
of the Exchange Act and currently trades on the Nasdaq Global Select Market under the symbol
“OFIX.”
1
The findings herein are made pursuant to Respondent’s Offer and are not binding on any other person or
entity in this or any other proceeding.
3
RELEVANT ENTITY
Orthofix do Brasil LTDA (“Orthofix Brazil”) is a wholly-owned subsidiary of
Orthofix headquartered in Sao Paulo, Brazil. Orthofix Brazil markets and sells extremity
fixation products through direct and indirect sales to public and private sector customers. From
2011 to 2013, approximately 12.5 % of Orthofix Brazil’s sales were made to public sector
customers, such as government-owned hospitals and associated doctors, and the remaining
87.5% to private customers, including non-government-owned hospitals and associated doctors.
Orthofix consolidated Orthofix Brazil’s financial statements into its financials.
FACTS
A. Prior Commission Enforcement Action Against Orthofix
1. In 2012, the Commission filed a settled civil injunctive action in United States
District Court for the Eastern District of Texas alleging that Orthofix had violated the books and
records and internal controls provisions of the FCPA through its Mexican subsidiary, Promeca
S.A. de C.V. (“Promeca”). From at least 2003 to 2010, Promeca made improper payments
totaling approximately $317,000 to employees of a government agency in Mexico. These
improper payments, recorded as training and promotional expenses, generated illicit net profits to
Orthofix of approximately $4.9 million.
2. Orthofix settled the matter by consenting to the entry of a final judgment that (i)
enjoined the company from violating Sections 13(b)(2)(A) and 13(b)(2)(B) of the Exchange Act,
(ii) ordered Orthofix to pay disgorgement and prejudgment interest of approximately $5.2
million, and (iii) ordered Orthofix to undertake certain remedial measures concerning its FCPA
compliance program, including self-reporting to the staff for a two-year term regarding its
remediation efforts. In a parallel criminal investigation, Orthofix entered into a deferred-
prosecution agreement in which it admitted, accepted, and acknowledged responsibility for
specific conduct related to Promeca’s operations in Mexico, and paid a $ 2,220,000 criminal fine.
B. Background
3. During the relevant period, Orthofix Brazil accounted for approximately 5-7% of
Orthofix’s consolidated net sales. During the relevant period, Orthofix Brazil sold its products
through either (i) direct sales to a customer through third-party commercial representative
entities who provide assistance and receive a commission, or (ii) indirect sales through a third-
party distributor that purchased the products from Orthofix Brazil, held the inventory, and resold
them to an end customer.
4. During the relevant period, Orthofix Brazil engaged in direct sales with the
assistance of third-party commercial representatives who helped to market and sell its products
in Brazil. These commercial representatives also employed sales agents to make sales.
Commercial representative sales comprised approximately two-thirds of the sales of the
4
subsidiary. In addition, Orthofix Brazil engaged sixteen distributors to conduct indirect sales.
Orthofix Brazil sold its products to the distributors who in turn resold the products to health care
providers, including private and government-owned hospitals, in various regions in Brazil.
Indirect sales through distributors comprised about one-third of the sales of the subsidiary.
5. Orthofix provided budgets, financial targets, and guidance to Orthofix Brazil and
approved certain actions and expenditures. Orthofix also received regular updates from Orthofix
Brazil on many details regarding sales opportunities, numbers, and business developments.
Orthofix set internal sales targets and management imposed pressure on subsidiaries to meet
those targets. Orthofix’s reporting structure and relationship with its subsidiaries was
decentralized during the relevant time period, complicating parent oversight, compliance
monitoring, and communication with U.S. executives. Orthofix lacked adequate training,
policies, processes, and corporate culture that would have allowed employees at its subsidiaries
to raise compliance concerns to the parent level.
C. Orthofix Brazil Made Improper Payments to Doctors Through Commercial
Representatives
6. During the relevant period, Orthofix Brazil entered into agreements with third-
party commercial representatives to directly sell its products to hospitals and doctors in Brazil,
and it paid commissions to those commercial representatives as part of such agreements.
Orthofix Brazil’s commercial representatives in turn made improper payments to certain doctors
at government owned hospitals in exchange for sales contracts.
7. The scheme involving commercial representatives worked in one of two ways. In
the first scenario, commercial representatives made arrangements to pay doctors a specific
amount, usually constituting 20-25% of the sales price, in exchange for using Orthofix products.
After doctors performed a procedure using Orthofix’s products, Orthofix Brazil typically billed
the hospital for the products used. Orthofix Brazil then paid a commission of approximately 33-
43% of the sales price to the commercial representative responsible for the sale, who then used a
portion of that commission to make certain agreed upon payments to doctors.
8. In the second scenario, a company related to the commercial representative sent
Orthofix Brazil false invoices for services such as marketing that were never provided. The
former general manager of Orthofix Brazil approved these payments and the former finance
director of Orthofix Brazil instructed Orthofix Brazil employees to classify the payments as
“administrative expenses.” The services were never rendered and the payments were not
administrative expenses but rather provided funds that were intended to be used to make
improper payments to certain doctors. The payments were intentionally improperly recorded as
legitimate expenses to hide the true nature of the payments.
9. Certain Orthofix Brazil employees knew that commercial representatives were
paying doctors and were involved in the schemes. The former general manager was responsible
for negotiating the arrangements with the commercial representatives, and he instructed the
former finance director and other lower level Orthofix Brazil employees to make the commission
5
payments to commercial representatives. Payments to commercial representatives were referred
to by these employees as “doctors’ commissions.” Orthofix Brazil employees and commercial
representatives openly discussed payment percentages, total amounts, and payment instructions
for making direct deposits or in-person payments to doctors.
D. Orthofix Brazil Made Improper Payments to Doctors Through Distributors
10. Similar to the schemes involving commercial representatives, Orthofix Brazil
used third-party distributors in two ways to make improper payments to doctors. In the first
scenario, Orthofix Brazil provided a high discount ranging in certain instances of up to 70% to
the distributors, who then used part of the profit generated by that discount to make improper
payments to certain doctors. The high discounts were purportedly meant to allow distributors to
make a sufficient profit while also covering their overhead costs. In reality, part of the discount
was often used to make the improper payments to certain doctors at public hospitals. Employees
of the distributors openly discussed the improper payment scheme in emails to certain Orthofix
Brazil employees. For example, in 2011, one distributor emailed an Orthofix Brazil employee
that “[t]he agreement with the physicians is to make the payment after using the material,”
indicating a promise to pay doctors after they used Orthofix products. The four distributors that
made improper payments to doctors on behalf of Orthofix Brazil openly discussed the improper
payments in person with certain Orthofix Brazil employees and demanded higher discounts from
the company to facilitate the payments.
11. In the second scenario involving distributors, Orthofix Brazil made payments for
services that were never rendered. These payments were inaccurately described in the
company’s books and records as “consulting for sales” payments made to a company related to
one of the distributors, when, in fact, the payments to the distributor were made to facilitate
improper payments to doctors.
12. The general manager, finance director, and certain other Orthofix Brazil
employees no longer associated with Orthofix Brazil knew that distributors were using excessive
discounts and making payments on false invoices to pay doctors. Nevertheless, Orthofix Brazil
improperly recorded the payments as legitimate business expenses to hide the true nature of the
payments.
E. Orthofix Failed to Maintain Accurate Books and Records
13. Orthofix Brazil improperly recorded certain payments to commercial
representatives and discounts to third-party distributors, portions of which were used to make
improper payments to doctors, as commissions, discounts, consulting fees, administrative
expenses, and other legitimate business expenses in its books and records that were subsequently
consolidated into Orthofix’s books and records, rendering them inaccurate.
F. Orthofix Lacked Adequate Internal Accounting Controls
6
14. Orthofix failed in a timely manner to devise and maintain an adequate system of
internal accounting controls in Brazil, even after the company had been charged previously for
internal controls failings in the Commission’s earlier case against it for improper payments in
Mexico. The controls in place during the relevant period were minimal and clearly deficient.
15. The internal accounting controls were deficient with respect to the setting,
approval, and payment of commissions and discounts. Orthofix had no policies or processes in
place to standardize or centrally approve and monitor the commissions and discounts that
Orthofix Brazil was providing to third parties, which allowed Orthofix Brazil to push through
high commissions and discounts that ultimately were used to facilitate improper payments. The
decentralized nature of Orthofix’s business in Brazil allowed Orthofix Brazil to easily evade the
policies and controls that Orthofix did have in place when the conduct occurred. An indirect
reporting structure created gaps in supervision that provided the opportunity to orchestrate and
execute the bribery schemes without detection.
16. Furthermore, a lack of centralized global accounting and payment controls
allowed Orthofix Brazil to record the improper payments as legitimate business expenses. Given
the prior corruption and internal controls issues at its Mexican subsidiary, Orthofix was aware of
deficiencies in its controls and the FCPA risks at its subsidiaries’ operations. Despite these red
flags, Orthofix failed to establish better controls and supervision over its subsidiaries in high risk
countries.
COOPERATION AND REMEDIAL ACTION
17. Orthofix disclosed the Brazil allegations as part of its ongoing self-reporting
obligations undertaken as part of its earlier settlement with the Commission for its conduct
related to Mexico discussed above. Orthofix cooperated with the investigation by, among other
things: (i) conducting a thorough and timely internal investigation; (ii) voluntarily producing
documents and other information in a timely manner, identifying significant documents and
translating documents from Portuguese; (iii) compiling financial data and analysis; (iv) providing
detailed witness interview downloads, Power-Point presentations summarizing its findings, and
timelines; and (v) assisting us in our efforts to coordinate witness interviews with current and
former Orthofix and Orthofix Brazil employees.
18. Although the Company took remedial steps following the resolution of the
Promeca allegations in 2012, Orthofix did not start fully implementing sufficient remedial steps
until after the discovery of the Brazil conduct in late 2013. Though delayed, these efforts have
been significant. Orthofix and Orthofix Brazil now have terminated problematic representatives
and distributors; developed and implemented new global accounting policies to provide further
structure and guidance to foreign subsidiaries; established an internal audit function and
expanded Orthofix’s compliance department; conducted extensive audits of third-party vendors
used by subsidiaries; and revised existing trainings and implemented additional compliance
training for employees.
7
LEGAL STANDARDS AND VIOLATIONS
19. As a result of the conduct described above, Orthofix violated Section 13(b)(2)(A)
of the Exchange Act, which requires issuers to make and keep books, records, and accounts
which, in reasonable detail, accurately and fairly reflect their transactions and dispositions of the
assets of the issuer.
20. In addition, as a result of the conduct described above, Orthofix violated Section
13(b)(2)(B) of the Exchange Act, which requires issuers to devise and maintain a system of
internal accounting controls sufficient to provide reasonable assurances that (i) transactions are
executed in accordance with management’s general or specific authorization; (ii) transactions are
recorded as necessary (I) to permit preparation of financial statements in conformity with
generally accepted accounting principles or any other criteria applicable to such statements, and
(II) to maintain accountability for assets; (iii) access to assets is permitted only in accordance
with management’s general or specific authorization; and (iv) the recorded accountability for
assets is compared with the existing assets at reasonable intervals and appropriate action is taken
with respect to any differences.
IV.
In view of the foregoing, the Commission deems it appropriate to impose the sanctions
agreed to in Respondent’s Offer.
Accordingly, it is hereby ORDERED that:
A. Pursuant to Section 21C of the Exchange Act, Respondent cease and desist from
committing or causing any violations and any future violations of Sections 13(b)(2)(A) and
13(b)(2)(B) of the Exchange Act [15 U.S.C. §§ 78m(b)(2)(A) and 78m(b)(2)(B)].
B. Respondent shall, within thirty days of the entry of this Order, pay disgorgement
of $2,928,000, prejudgment interest of $263,375, and a civil money penalty in the amount of
$2,928,000 to the Securities and Exchange Commission. If timely payment is not made,
additional interest shall accrue pursuant to 31 U.S.C. § 3717. Payment must be made in one of
the following three ways:
1. Respondent may transmit payment electronically to the Commission, which
will provide detailed ACH transfer/Fedwire instructions upon request;
2. Respondent may make direct payment from a bank account via Pay.gov
through the SEC website at http://www.sec.gov/about/offices/ofin.htm; or
3. Respondent may pay by certified check, bank cashier’s check, or United
States postal money order, made payable to the Securities and Exchange
Commission and hand-delivered or mailed to:
8
Enterprise Services Center
Accounts Receivable Branch
HQ Bldg., Room 181, AMZ-341
6500 South MacArthur Boulevard
Oklahoma City, OK 73169
Payments by check or money order must be accompanied by a cover letter identifying
Orthofix as a Respondent in these proceedings, and the file number of these proceedings; a copy
of the cover letter and check or money order must be sent to Kara N. Brockmeyer, Division of
Enforcement, Securities and Exchange Commission, 100 F Street, NE, Washington, DC 20549-
5720.
C. Amounts ordered to be paid as civil money penalties pursuant to this Order shall
be treated as penalties paid to the government for all purposes, including all tax purposes. To
preserve the deterrent effect of the civil penalty, Respondent agrees that in any Related Investor
Action, it shall not argue that it is entitled to, nor shall it benefit by, offset or reduction of any
award of compensatory damages by the amount of any part of Respondent’s payment of a civil
penalty in this action (“Penalty Offset”). If the court in any Related Investor Action grants such a
Penalty Offset, Respondent agrees that it shall, within 30 days after entry of a final order
granting the Penalty Offset, notify the Commission’s counsel in this action and pay the amount
of the Penalty Offset to the Securities and Exchange Commission. Such a payment shall not be
deemed an additional civil penalty and shall not be deemed to change the amount of the civil
penalty imposed in this proceeding. For purposes of this paragraph, a “Related Investor Action”
means a private damages action brought against Respondent by or on behalf of one or more
investors based on substantially the same facts as alleged in the Order instituted by the
Commission in this proceeding.
D. Respondent shall comply with the following undertakings:
1. Retain an independent consultant (the “Independent Consultant”) not
unacceptable to the Staff within sixty (60) calendar days after the issuance of
this Order. Within thirty (30) calendar days after the issuance of this Order,
Respondent shall recommend to the Staff three qualified candidates to serve
as the Independent Consultant. The Staff shall provide feedback to
Respondent within fifteen (15) calendar days of receiving Respondent’s
recommendations.
2. The Independent Consultant candidates shall have, at a minimum, the
following qualifications: demonstrated expertise with respect to the FCPA,
including experience counseling on FCPA issues; experience designing and/or
reviewing corporate compliance policies, procedures, and internal controls,
including FCPA-specific policies, procedures, and internal controls; ability to
access and deploy resources as necessary to discharge the Independent
Consultant’s duties as described herein; and independence from Respondent
9
to ensure effective and impartial performance of the Independent Consultant’s
duties.
3. The Independent Consultant should not have provided legal, auditing, or other
services to, or have had any affiliations with, the Respondent during the two
years prior to the issuance of this Order.
4. Respondent shall retain the Independent Consultant for a period of one (1)
year from the date of the engagement. Respondent shall exclusively bear all
costs, including compensation and expenses, associated with the retention of
the Independent Consultant.
5. To ensure the independence of the Independent Consultant, Respondent shall
not have the authority to terminate the Independent Consultant without the
prior written approval of the Staff.
6. The Independent Consultant’s responsibility is to review and evaluate
Respondent’s internal controls, record-keeping and financial reporting policies
and procedures as they relate to its compliance with the books and records,
internal accounting controls, and anti-bribery provisions of the FCPA (“the
Policies and Procedures”) and to make recommendations designed to
reasonably improve the Policies and Procedures. This review and evaluation
shall include an assessment of the Policies and Procedures as actually
implemented and how FCPA compliance fits within Respondent’s ethics and
compliance function. The Independent Consultant shall consider whether the
ethics and compliance function has sufficient resources, authority, and
independence, and provides sufficient training and guidance.
7. Respondent and the Independent Consultant shall agree that the Independent
Consultant is an independent third-party and not an employee or agent of the
Respondent. In addition, Respondent and the Independent Consultant agree
that no attorney-client relationship shall be formed between them.
8. Respondent shall require the Independent Consultant to enter in an agreement
with Respondent providing that, for the period of engagement and for a period
of two years from completion of the engagement, the Independent Consultant
shall not enter into any employment, consultant, attorney-client, auditing or
other professional relationship with Respondent, or any of its present or
former affiliates, directors, officers, employees, or agents acting in their
capacity as such. Any firm with which the Independent Consultant is
affiliated or of which he/she is a member, and any person engaged to assist the
Independent Consultant in performance of his/her duties under this Order shall
not, without prior written consent of the Staff enter into any employment,
consultant, attorney-client, auditing or other professional relationship with
Respondent, or any of its present or former affiliates, directors, officers,
10
employees, or agents acting in their capacity as such for the period of the
engagement and for a period of two (2) years after the engagement.
9. Respondent shall require the Independent Consultant to prepare a written
work plan and submit it to Respondent and the Staff for comment within thirty
(30) calendar days of commencing the engagement. The Respondent’s
comments shall be provided to the Independent Consultant no more than
fifteen (15) calendar days after receipt of the written work plan. In order to
conduct an effective initial review and to understand fully any deficiencies in
the Policies and Procedures, including how FCPA compliance fits within
Respondent’s ethics and compliance function, the Independent Consultant’s
initial work plan shall include such steps as are reasonably necessary to
develop an understanding of the facts and circumstances surrounding any
violations that may have occurred as reflected in this matter and to assess the
effectiveness of Respondent’s existing Policies and Procedures, and of
Respondent’s ethics and compliance program. Any dispute between
Respondent and the Independent Consultant with respect to the work plan
shall be decided by the Staff.
10. Respondent shall cooperate fully with the Independent Consultant, and the
Independent Consultant shall have the authority to take such reasonable steps
as, in his or her view, may be necessary to be fully informed about
Respondent’s Policies and Procedures in accordance with the principles set
forth herein and applicable law, including data protection, blocking statutes,
and labor laws and regulations applicable to Respondent. To that end
Respondent shall provide the Independent Consultant with access to all
information, documents, records, facilities and/or employees, as requested by
the Independent Consultant, that fall within the scope of the Independent
Consultant’s responsibility, except as provided in this paragraph; and provide
guidance on applicable laws (such as relevant data protection, blocking
statutes, and labor laws).
11. In the event the Respondent seeks to withhold from the Independent
Consultant access to information, documents, records, facilities and/or
employees of Respondent that may be subject to a claim of attorney-client
privilege or to the attorney work product doctrine, or where Respondent
reasonably believes production would otherwise be inconsistent with
applicable law or beyond the scope of these undertakings, Respondent shall
work cooperatively with the Independent Consultant. If the matter cannot be
resolved, at the request of the Independent Consultant, Respondent shall
promptly provide written notice to the Independent Consultant and the Staff.
Such notice shall include a general description of the nature of the
information, documents, records, facilities and/or employees that are being
withheld, as well as the basis for the claim. To the extent Respondent has
provided information to the Staff in the course of the investigation leading to
11
this action pursuant to a non-waiver of privilege agreement, Respondent and
the Independent Consultant may agree to production of such information to
the Independent Consultant pursuant to a similar non-waiver agreement.
12. Respondent shall require the Independent Consultant to issue a written report
(“Report”), within six (6) months after being retained to review Respondent’s
Policies and Procedures: (a) summarizing its review and evaluation, and (b) if
necessary, making recommendations based on its review and evaluation that
are reasonably designed to improve Respondent’s Policies and Procedures.
Respondent shall require that the Independent Consultant provide the Report
to the Board of Directors of Respondent and simultaneously transmit a copy to
the Staff at the following address: Ansu N. Banerjee, Assistant Regional
Director, Division of Enforcement, Securities and Exchange Commission, 444
South Flower Street, Suite 900, Los Angeles, California 90071.
13. Respondent shall adopt all recommendations in the Report within sixty (60)
days of the issuance of the Report; provided, however, that, as to any
recommendations that Respondent considers to be unduly burdensome,
impractical, or costly, Respondent need not adopt the recommendations at that
time, but may submit in writing to the Staff, within thirty (30) days of
receiving the Report, an alternative policy or procedure designed to achieve
the same objective or purpose. Respondent and the Independent Consultant
shall attempt in good faith to reach an agreement relating to each
recommendation Respondent considers unduly burdensome, impractical, or
costly. In the event that Respondent and the Independent Consultant are
unable to agree on an alternative proposal within thirty (30) days, Respondent
will abide by the determinations of the Staff.
14. Upon completion of the implementation, the Independent Consultant shall
have thirty (30) calendar days to complete a follow-up review to confirm that
Respondent has implemented the recommendations or agreed-upon
alternatives and continued the application of the Policies and Procedures, and
to deliver a supplemental report to the Board of Directors of Respondent and
the Staff setting forth its conclusions and whether any further improvements
should be implemented.
15. Respondent agrees that the Staff may extend any of the dates set forth above
at its direction.
16. Respondent shall certify, in writing, compliance with the undertaking(s) set
forth above. The certification shall identify the undertaking(s), provide
written evidence of compliance in the form of a narrative, and be supported by
exhibits sufficient to demonstrate compliance. The Staff may make
reasonable requests for further evidence of compliance, and Respondent
agrees to provide such evidence. Respondent shall submit the certification
12
and supporting material to Ansu N. Banerjee, Assistant Regional Director,
Division of Enforcement, with a copy to the Office of Chief Counsel of the
Enforcement Division, no later than sixty (60) days from the date of the
completion of the undertakings.
17. Respondent agrees that these undertakings shall be binding upon any
successor in interest to Respondent or any acquirer of substantially all of
Respondent’s assets and liabilities or business.
By the Commission.
Brent J. Fields
Secretary
UNITED STATES OF AMERICA
Before the
SECURITIES AND EXCHANGE COMMISSION
SECURITIES EXCHANGE ACT OF 1934
Release No. 79828 / January 18, 2017
ACCOUNTING AND AUDITING ENFORCEMENT
Release No. 3851 / January 18, 2017
ADMINISTRATIVE PROCEEDING
File No. 3-17800
In the Matter of
Orthofix International N.V.
Respondent.
ORDER INSTITUTING CEASE-AND-
DESIST PROCEEDINGS PURSUANT TO
SECTION 21C OF THE SECURITIES
EXCHANGE ACT OF 1934, MAKING
FINDINGS, AND IMPOSING REMEDIAL
SANCTIONS AND A CEASE-AND-DESIST
ORDER
I.
The Securities and Exchange Commission (“Commission”) deems it appropriate that
cease-and-desist proceedings be, and hereby are, instituted pursuant to Section 21C of the
Securities Exchange Act of 1934 (“Exchange Act”) against Orthofix International N.V.
(“Orthofix” or “Respondent”).
II.
In anticipation of the institution of these proceedings, Respondent has submitted an Offer
of Settlement (“Offer”) that the Commission has determined to accept. Respondent admits the
facts set forth in Paragraphs 1 through 20 below, acknowledges that its conduct violated the
federal securities laws, admits the Commission’s jurisdiction over it and the subject matter of
these proceedings, and consents to the entry of this Order Instituting Cease-and-Desist
Proceedings Pursuant to Section 21C of the Securities Exchange Act of 1934, Making Findings,
and Imposing Remedial Sanctions and a Cease-and-Desist Order (“Order”), as set forth below.
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III.
On the basis of this Order and Respondent’s Offer, the Commission finds
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that:
SUMMARY
This matter concerns violations of the books and records and internal controls provisions
of the Foreign Corrupt Practices Act of 1977 (“FCPA”) by Orthofix International N.V., a
medical device company organized under the laws of Curacao and headquartered in Lewisville,
Texas, and its Brazilian subsidiary, Orthofix do Brasil LTDA. From at least 2011 to 2013
(hereinafter “the relevant period”), senior personnel at Orthofix Brazil employed at least four
schemes, with third-party commercial representatives and distributors, to make improper
payments to doctors employed at government-owned hospitals to induce them to use Orthofix’s
products, thereby increasing sales. The improper payments to doctors employed at government
hospitals were improperly recorded as legitimate expenses and generated illicit profits to
Orthofix of approximately $2,928,000.
Orthofix also failed to devise and maintain a system of internal accounting controls
sufficient to provide reasonable assurances to detect and prevent such payments by Orthofix
Brazil, despite the fact that Orthofix had been charged by the Commission in 2012 with violating
the books and records and internal controls provisions of the FCPA in connection with bribes
paid to Mexican officials by its Mexican subsidiary.
By engaging in the foregoing conduct, Orthofix violated the books and records and
internal controls provisions of the federal securities laws set forth in Sections 13(b)(2)(A) and
13(b)(2)(B) of the Exchange Act.
RESPONDENT
Orthofix International N.V. (“Orthofix,” “Respondent,” or “Company”) is a limited
liability company formed under the laws of Curacao and headquartered in Lewisville, Texas. It
is a diversified medical device company that develops and sells surgical and non-surgical
medical products to medical professionals in various market sectors, including orthopedics. It
distributes its products both domestically in the United States and internationally in multiple
countries. Orthofix’s common stock is registered with the Commission pursuant to Section 12(b)
of the Exchange Act and currently trades on the Nasdaq Global Select Market under the symbol
“OFIX.”
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The findings herein are made pursuant to Respondent’s Offer and are not binding on any other person or
entity in this or any other proceeding.
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RELEVANT ENTITY
Orthofix do Brasil LTDA (“Orthofix Brazil”) is a wholly-owned subsidiary of
Orthofix headquartered in Sao Paulo, Brazil. Orthofix Brazil markets and sells extremity
fixation products through direct and indirect sales to public and private sector customers. From
2011 to 2013, approximately 12.5 % of Orthofix Brazil’s sales were made to public sector
customers, such as government-owned hospitals and associated doctors, and the remaining
87.5% to private customers, including non-government-owned hospitals and associated doctors.
Orthofix consolidated Orthofix Brazil’s financial statements into its financials.
FACTS
A. Prior Commission Enforcement Action Against Orthofix
1. In 2012, the Commission filed a settled civil injunctive action in United States
District Court for the Eastern District of Texas alleging that Orthofix had violated the books and
records and internal controls provisions of the FCPA through its Mexican subsidiary, Promeca
S.A. de C.V. (“Promeca”). From at least 2003 to 2010, Promeca made improper payments
totaling approximately $317,000 to employees of a government agency in Mexico. These
improper payments, recorded as training and promotional expenses, generated illicit net profits to
Orthofix of approximately $4.9 million.
2. Orthofix settled the matter by consenting to the entry of a final judgment that (i)
enjoined the company from violating Sections 13(b)(2)(A) and 13(b)(2)(B) of the Exchange Act,
(ii) ordered Orthofix to pay disgorgement and prejudgment interest of approximately $5.2
million, and (iii) ordered Orthofix to undertake certain remedial measures concerning its FCPA
compliance program, including self-reporting to the staff for a two-year term regarding its
remediation efforts. In a parallel criminal investigation, Orthofix entered into a deferred-
prosecution agreement in which it admitted, accepted, and acknowledged responsibility for
specific conduct related to Promeca’s operations in Mexico, and paid a $ 2,220,000 criminal fine.
B. Background
3. During the relevant period, Orthofix Brazil accounted for approximately 5-7% of
Orthofix’s consolidated net sales. During the relevant period, Orthofix Brazil sold its products
through either (i) direct sales to a customer through third-party commercial representative
entities who provide assistance and receive a commission, or (ii) indirect sales through a third-
party distributor that purchased the products from Orthofix Brazil, held the inventory, and resold
them to an end customer.
4. During the relevant period, Orthofix Brazil engaged in direct sales with the
assistance of third-party commercial representatives who helped to market and sell its products
in Brazil. These commercial representatives also employed sales agents to make sales.
Commercial representative sales comprised approximately two-thirds of the sales of the
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subsidiary. In addition, Orthofix Brazil engaged sixteen distributors to conduct indirect sales.
Orthofix Brazil sold its products to the distributors who in turn resold the products to health care
providers, including private and government-owned hospitals, in various regions in Brazil.
Indirect sales through distributors comprised about one-third of the sales of the subsidiary.
5. Orthofix provided budgets, financial targets, and guidance to Orthofix Brazil and
approved certain actions and expenditures. Orthofix also received regular updates from Orthofix
Brazil on many details regarding sales opportunities, numbers, and business developments.
Orthofix set internal sales targets and management imposed pressure on subsidiaries to meet
those targets. Orthofix’s reporting structure and relationship with its subsidiaries was
decentralized during the relevant time period, complicating parent oversight, compliance
monitoring, and communication with U.S. executives. Orthofix lacked adequate training,
policies, processes, and corporate culture that would have allowed employees at its subsidiaries
to raise compliance concerns to the parent level.
C. Orthofix Brazil Made Improper Payments to Doctors Through Commercial
Representatives
6. During the relevant period, Orthofix Brazil entered into agreements with third-
party commercial representatives to directly sell its products to hospitals and doctors in Brazil,
and it paid commissions to those commercial representatives as part of such agreements.
Orthofix Brazil’s commercial representatives in turn made improper payments to certain doctors
at government owned hospitals in exchange for sales contracts.
7. The scheme involving commercial representatives worked in one of two ways. In
the first scenario, commercial representatives made arrangements to pay doctors a specific
amount, usually constituting 20-25% of the sales price, in exchange for using Orthofix products.
After doctors performed a procedure using Orthofix’s products, Orthofix Brazil typically billed
the hospital for the products used. Orthofix Brazil then paid a commission of approximately 33-
43% of the sales price to the commercial representative responsible for the sale, who then used a
portion of that commission to make certain agreed upon payments to doctors.
8. In the second scenario, a company related to the commercial representative sent
Orthofix Brazil false invoices for services such as marketing that were never provided. The
former general manager of Orthofix Brazil approved these payments and the former finance
director of Orthofix Brazil instructed Orthofix Brazil employees to classify the payments as
“administrative expenses.” The services were never rendered and the payments were not
administrative expenses but rather provided funds that were intended to be used to make
improper payments to certain doctors. The payments were intentionally improperly recorded as
legitimate expenses to hide the true nature of the payments.
9. Certain Orthofix Brazil employees knew that commercial representatives were
paying doctors and were involved in the schemes. The former general manager was responsible
for negotiating the arrangements with the commercial representatives, and he instructed the
former finance director and other lower level Orthofix Brazil employees to make the commission
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payments to commercial representatives. Payments to commercial representatives were referred
to by these employees as “doctors’ commissions.” Orthofix Brazil employees and commercial
representatives openly discussed payment percentages, total amounts, and payment instructions
for making direct deposits or in-person payments to doctors.
D. Orthofix Brazil Made Improper Payments to Doctors Through Distributors
10. Similar to the schemes involving commercial representatives, Orthofix Brazil
used third-party distributors in two ways to make improper payments to doctors. In the first
scenario, Orthofix Brazil provided a high discount ranging in certain instances of up to 70% to
the distributors, who then used part of the profit generated by that discount to make improper
payments to certain doctors. The high discounts were purportedly meant to allow distributors to
make a sufficient profit while also covering their overhead costs. In reality, part of the discount
was often used to make the improper payments to certain doctors at public hospitals. Employees
of the distributors openly discussed the improper payment scheme in emails to certain Orthofix
Brazil employees. For example, in 2011, one distributor emailed an Orthofix Brazil employee
that “[t]he agreement with the physicians is to make the payment after using the material,”
indicating a promise to pay doctors after they used Orthofix products. The four distributors that
made improper payments to doctors on behalf of Orthofix Brazil openly discussed the improper
payments in person with certain Orthofix Brazil employees and demanded higher discounts from
the company to facilitate the payments.
11. In the second scenario involving distributors, Orthofix Brazil made payments for
services that were never rendered. These payments were inaccurately described in the
company’s books and records as “consulting for sales” payments made to a company related to
one of the distributors, when, in fact, the payments to the distributor were made to facilitate
improper payments to doctors.
12. The general manager, finance director, and certain other Orthofix Brazil
employees no longer associated with Orthofix Brazil knew that distributors were using excessive
discounts and making payments on false invoices to pay doctors. Nevertheless, Orthofix Brazil
improperly recorded the payments as legitimate business expenses to hide the true nature of the
payments.
E. Orthofix Failed to Maintain Accurate Books and Records
13. Orthofix Brazil improperly recorded certain payments to commercial
representatives and discounts to third-party distributors, portions of which were used to make
improper payments to doctors, as commissions, discounts, consulting fees, administrative
expenses, and other legitimate business expenses in its books and records that were subsequently
consolidated into Orthofix’s books and records, rendering them inaccurate.
F. Orthofix Lacked Adequate Internal Accounting Controls
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14. Orthofix failed in a timely manner to devise and maintain an adequate system of
internal accounting controls in Brazil, even after the company had been charged previously for
internal controls failings in the Commission’s earlier case against it for improper payments in
Mexico. The controls in place during the relevant period were minimal and clearly deficient.
15. The internal accounting controls were deficient with respect to the setting,
approval, and payment of commissions and discounts. Orthofix had no policies or processes in
place to standardize or centrally approve and monitor the commissions and discounts that
Orthofix Brazil was providing to third parties, which allowed Orthofix Brazil to push through
high commissions and discounts that ultimately were used to facilitate improper payments. The
decentralized nature of Orthofix’s business in Brazil allowed Orthofix Brazil to easily evade the
policies and controls that Orthofix did have in place when the conduct occurred. An indirect
reporting structure created gaps in supervision that provided the opportunity to orchestrate and
execute the bribery schemes without detection.
16. Furthermore, a lack of centralized global accounting and payment controls
allowed Orthofix Brazil to record the improper payments as legitimate business expenses. Given
the prior corruption and internal controls issues at its Mexican subsidiary, Orthofix was aware of
deficiencies in its controls and the FCPA risks at its subsidiaries’ operations. Despite these red
flags, Orthofix failed to establish better controls and supervision over its subsidiaries in high risk
countries.
COOPERATION AND REMEDIAL ACTION
17. Orthofix disclosed the Brazil allegations as part of its ongoing self-reporting
obligations undertaken as part of its earlier settlement with the Commission for its conduct
related to Mexico discussed above. Orthofix cooperated with the investigation by, among other
things: (i) conducting a thorough and timely internal investigation; (ii) voluntarily producing
documents and other information in a timely manner, identifying significant documents and
translating documents from Portuguese; (iii) compiling financial data and analysis; (iv) providing
detailed witness interview downloads, Power-Point presentations summarizing its findings, and
timelines; and (v) assisting us in our efforts to coordinate witness interviews with current and
former Orthofix and Orthofix Brazil employees.
18. Although the Company took remedial steps following the resolution of the
Promeca allegations in 2012, Orthofix did not start fully implementing sufficient remedial steps
until after the discovery of the Brazil conduct in late 2013. Though delayed, these efforts have
been significant. Orthofix and Orthofix Brazil now have terminated problematic representatives
and distributors; developed and implemented new global accounting policies to provide further
structure and guidance to foreign subsidiaries; established an internal audit function and
expanded Orthofix’s compliance department; conducted extensive audits of third-party vendors
used by subsidiaries; and revised existing trainings and implemented additional compliance
training for employees.
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LEGAL STANDARDS AND VIOLATIONS
19. As a result of the conduct described above, Orthofix violated Section 13(b)(2)(A)
of the Exchange Act, which requires issuers to make and keep books, records, and accounts
which, in reasonable detail, accurately and fairly reflect their transactions and dispositions of the
assets of the issuer.
20. In addition, as a result of the conduct described above, Orthofix violated Section
13(b)(2)(B) of the Exchange Act, which requires issuers to devise and maintain a system of
internal accounting controls sufficient to provide reasonable assurances that (i) transactions are
executed in accordance with management’s general or specific authorization; (ii) transactions are
recorded as necessary (I) to permit preparation of financial statements in conformity with
generally accepted accounting principles or any other criteria applicable to such statements, and
(II) to maintain accountability for assets; (iii) access to assets is permitted only in accordance
with management’s general or specific authorization; and (iv) the recorded accountability for
assets is compared with the existing assets at reasonable intervals and appropriate action is taken
with respect to any differences.
IV.
In view of the foregoing, the Commission deems it appropriate to impose the sanctions
agreed to in Respondent’s Offer.
Accordingly, it is hereby ORDERED that:
A. Pursuant to Section 21C of the Exchange Act, Respondent cease and desist from
committing or causing any violations and any future violations of Sections 13(b)(2)(A) and
13(b)(2)(B) of the Exchange Act [15 U.S.C. §§ 78m(b)(2)(A) and 78m(b)(2)(B)].
B. Respondent shall, within thirty days of the entry of this Order, pay disgorgement
of $2,928,000, prejudgment interest of $263,375, and a civil money penalty in the amount of
$2,928,000 to the Securities and Exchange Commission. If timely payment is not made,
additional interest shall accrue pursuant to 31 U.S.C. § 3717. Payment must be made in one of
the following three ways:
1. Respondent may transmit payment electronically to the Commission, which
will provide detailed ACH transfer/Fedwire instructions upon request;
2. Respondent may make direct payment from a bank account via Pay.gov
through the SEC website at http://www.sec.gov/about/offices/ofin.htm; or
3. Respondent may pay by certified check, bank cashier’s check, or United
States postal money order, made payable to the Securities and Exchange
Commission and hand-delivered or mailed to:
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Enterprise Services Center
Accounts Receivable Branch
HQ Bldg., Room 181, AMZ-341
6500 South MacArthur Boulevard
Oklahoma City, OK 73169
Payments by check or money order must be accompanied by a cover letter identifying
Orthofix as a Respondent in these proceedings, and the file number of these proceedings; a copy
of the cover letter and check or money order must be sent to Kara N. Brockmeyer, Division of
Enforcement, Securities and Exchange Commission, 100 F Street, NE, Washington, DC 20549-
5720.
C. Amounts ordered to be paid as civil money penalties pursuant to this Order shall
be treated as penalties paid to the government for all purposes, including all tax purposes. To
preserve the deterrent effect of the civil penalty, Respondent agrees that in any Related Investor
Action, it shall not argue that it is entitled to, nor shall it benefit by, offset or reduction of any
award of compensatory damages by the amount of any part of Respondent’s payment of a civil
penalty in this action (“Penalty Offset”). If the court in any Related Investor Action grants such a
Penalty Offset, Respondent agrees that it shall, within 30 days after entry of a final order
granting the Penalty Offset, notify the Commission’s counsel in this action and pay the amount
of the Penalty Offset to the Securities and Exchange Commission. Such a payment shall not be
deemed an additional civil penalty and shall not be deemed to change the amount of the civil
penalty imposed in this proceeding. For purposes of this paragraph, a “Related Investor Action”
means a private damages action brought against Respondent by or on behalf of one or more
investors based on substantially the same facts as alleged in the Order instituted by the
Commission in this proceeding.
D. Respondent shall comply with the following undertakings:
1. Retain an independent consultant (the “Independent Consultant”) not
unacceptable to the Staff within sixty (60) calendar days after the issuance of
this Order. Within thirty (30) calendar days after the issuance of this Order,
Respondent shall recommend to the Staff three qualified candidates to serve
as the Independent Consultant. The Staff shall provide feedback to
Respondent within fifteen (15) calendar days of receiving Respondent’s
recommendations.
2. The Independent Consultant candidates shall have, at a minimum, the
following qualifications: demonstrated expertise with respect to the FCPA,
including experience counseling on FCPA issues; experience designing and/or
reviewing corporate compliance policies, procedures, and internal controls,
including FCPA-specific policies, procedures, and internal controls; ability to
access and deploy resources as necessary to discharge the Independent
Consultant’s duties as described herein; and independence from Respondent
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to ensure effective and impartial performance of the Independent Consultant’s
duties.
3. The Independent Consultant should not have provided legal, auditing, or other
services to, or have had any affiliations with, the Respondent during the two
years prior to the issuance of this Order.
4. Respondent shall retain the Independent Consultant for a period of one (1)
year from the date of the engagement. Respondent shall exclusively bear all
costs, including compensation and expenses, associated with the retention of
the Independent Consultant.
5. To ensure the independence of the Independent Consultant, Respondent shall
not have the authority to terminate the Independent Consultant without the
prior written approval of the Staff.
6. The Independent Consultant’s responsibility is to review and evaluate
Respondent’s internal controls, record-keeping and financial reporting policies
and procedures as they relate to its compliance with the books and records,
internal accounting controls, and anti-bribery provisions of the FCPA (“the
Policies and Procedures”) and to make recommendations designed to
reasonably improve the Policies and Procedures. This review and evaluation
shall include an assessment of the Policies and Procedures as actually
implemented and how FCPA compliance fits within Respondent’s ethics and
compliance function. The Independent Consultant shall consider whether the
ethics and compliance function has sufficient resources, authority, and
independence, and provides sufficient training and guidance.
7. Respondent and the Independent Consultant shall agree that the Independent
Consultant is an independent third-party and not an employee or agent of the
Respondent. In addition, Respondent and the Independent Consultant agree
that no attorney-client relationship shall be formed between them.
8. Respondent shall require the Independent Consultant to enter in an agreement
with Respondent providing that, for the period of engagement and for a period
of two years from completion of the engagement, the Independent Consultant
shall not enter into any employment, consultant, attorney-client, auditing or
other professional relationship with Respondent, or any of its present or
former affiliates, directors, officers, employees, or agents acting in their
capacity as such. Any firm with which the Independent Consultant is
affiliated or of which he/she is a member, and any person engaged to assist the
Independent Consultant in performance of his/her duties under this Order shall
not, without prior written consent of the Staff enter into any employment,
consultant, attorney-client, auditing or other professional relationship with
Respondent, or any of its present or former affiliates, directors, officers,
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employees, or agents acting in their capacity as such for the period of the
engagement and for a period of two (2) years after the engagement.
9. Respondent shall require the Independent Consultant to prepare a written
work plan and submit it to Respondent and the Staff for comment within thirty
(30) calendar days of commencing the engagement. The Respondent’s
comments shall be provided to the Independent Consultant no more than
fifteen (15) calendar days after receipt of the written work plan. In order to
conduct an effective initial review and to understand fully any deficiencies in
the Policies and Procedures, including how FCPA compliance fits within
Respondent’s ethics and compliance function, the Independent Consultant’s
initial work plan shall include such steps as are reasonably necessary to
develop an understanding of the facts and circumstances surrounding any
violations that may have occurred as reflected in this matter and to assess the
effectiveness of Respondent’s existing Policies and Procedures, and of
Respondent’s ethics and compliance program. Any dispute between
Respondent and the Independent Consultant with respect to the work plan
shall be decided by the Staff.
10. Respondent shall cooperate fully with the Independent Consultant, and the
Independent Consultant shall have the authority to take such reasonable steps
as, in his or her view, may be necessary to be fully informed about
Respondent’s Policies and Procedures in accordance with the principles set
forth herein and applicable law, including data protection, blocking statutes,
and labor laws and regulations applicable to Respondent. To that end
Respondent shall provide the Independent Consultant with access to all
information, documents, records, facilities and/or employees, as requested by
the Independent Consultant, that fall within the scope of the Independent
Consultant’s responsibility, except as provided in this paragraph; and provide
guidance on applicable laws (such as relevant data protection, blocking
statutes, and labor laws).
11. In the event the Respondent seeks to withhold from the Independent
Consultant access to information, documents, records, facilities and/or
employees of Respondent that may be subject to a claim of attorney-client
privilege or to the attorney work product doctrine, or where Respondent
reasonably believes production would otherwise be inconsistent with
applicable law or beyond the scope of these undertakings, Respondent shall
work cooperatively with the Independent Consultant. If the matter cannot be
resolved, at the request of the Independent Consultant, Respondent shall
promptly provide written notice to the Independent Consultant and the Staff.
Such notice shall include a general description of the nature of the
information, documents, records, facilities and/or employees that are being
withheld, as well as the basis for the claim. To the extent Respondent has
provided information to the Staff in the course of the investigation leading to
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this action pursuant to a non-waiver of privilege agreement, Respondent and
the Independent Consultant may agree to production of such information to
the Independent Consultant pursuant to a similar non-waiver agreement.
12. Respondent shall require the Independent Consultant to issue a written report
(“Report”), within six (6) months after being retained to review Respondent’s
Policies and Procedures: (a) summarizing its review and evaluation, and (b) if
necessary, making recommendations based on its review and evaluation that
are reasonably designed to improve Respondent’s Policies and Procedures.
Respondent shall require that the Independent Consultant provide the Report
to the Board of Directors of Respondent and simultaneously transmit a copy to
the Staff at the following address: Ansu N. Banerjee, Assistant Regional
Director, Division of Enforcement, Securities and Exchange Commission, 444
South Flower Street, Suite 900, Los Angeles, California 90071.
13. Respondent shall adopt all recommendations in the Report within sixty (60)
days of the issuance of the Report; provided, however, that, as to any
recommendations that Respondent considers to be unduly burdensome,
impractical, or costly, Respondent need not adopt the recommendations at that
time, but may submit in writing to the Staff, within thirty (30) days of
receiving the Report, an alternative policy or procedure designed to achieve
the same objective or purpose. Respondent and the Independent Consultant
shall attempt in good faith to reach an agreement relating to each
recommendation Respondent considers unduly burdensome, impractical, or
costly. In the event that Respondent and the Independent Consultant are
unable to agree on an alternative proposal within thirty (30) days, Respondent
will abide by the determinations of the Staff.
14. Upon completion of the implementation, the Independent Consultant shall
have thirty (30) calendar days to complete a follow-up review to confirm that
Respondent has implemented the recommendations or agreed-upon
alternatives and continued the application of the Policies and Procedures, and
to deliver a supplemental report to the Board of Directors of Respondent and
the Staff setting forth its conclusions and whether any further improvements
should be implemented.
15. Respondent agrees that the Staff may extend any of the dates set forth above
at its direction.
16. Respondent shall certify, in writing, compliance with the undertaking(s) set
forth above. The certification shall identify the undertaking(s), provide
written evidence of compliance in the form of a narrative, and be supported by
exhibits sufficient to demonstrate compliance. The Staff may make
reasonable requests for further evidence of compliance, and Respondent
agrees to provide such evidence. Respondent shall submit the certification
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and supporting material to Ansu N. Banerjee, Assistant Regional Director,
Division of Enforcement, with a copy to the Office of Chief Counsel of the
Enforcement Division, no later than sixty (60) days from the date of the
completion of the undertakings.
17. Respondent agrees that these undertakings shall be binding upon any
successor in interest to Respondent or any acquirer of substantially all of
Respondent’s assets and liabilities or business.
By the Commission.
Brent J. Fields
Secretary