8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 14, 2012

Orthofix International N.V.

(Exact name of Registrant as specified in its charter)

Curaçao	0-19961	N/A
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

7 Abraham de Veerstraat Curaçao	N/A
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: 011-59-99-465-8525

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01. Entry into a Material Definitive Agreement.

Amended Plea Agreement Regarding Regenerative Bone Growth Stimulation Business Matter

On December 14, 2012, Orthofix Inc., a wholly owned subsidiary of Orthofix International N.V. (the “Company”), entered into an amended plea agreement (the “Amended Plea Agreement”) with the United States Attorney’s Office for the District of Massachusetts (the “Boston USAO”) and the United States Department of Justice (the “DOJ”). The Amended Plea Agreement supersedes the prior plea agreement (the “Prior Plea Agreement”) that Orthofix Inc. entered into with the Boston USAO and the DOJ on June 7, 2012, which was described further in the Company’s Current Report on Form 8-K, as amended, filed on June 7, 2012 (the “Prior Form 8-K”).

Under the Amended Plea Agreement, which was accepted by the United States District Court for the District of Massachusetts on the same date, Orthofix Inc. has plead guilty to one felony count of obstruction of a federal audit (18 U.S.C. §1516). The Amended Plea Agreement recommends that Orthofix Inc. be sentenced to (i) a criminal fine of $7,765,737, and (ii) a mandatory special assessment of $400. These recommended economic terms, and the agreed-upon criminal charge, were the same as those previously agreed to in the Prior Plea Agreement. However, the Amended Plea Agreement provided that Orthofix Inc.’s plea would be entered under Federal Rule of Criminal Procedure 11(c)(1)(B), as opposed to Rule 11(c)(1)(C), thereby granting the court additional sentencing discretion.

Under the terms of the final sentencing order instituted by the court after it accepted the plea, Orthofix Inc. has been ordered to pay a fine in the same amount as recommended in the Amended Plea Agreement. In addition, the court has imposed a five year term of probation, with special conditions which mandate certain non-disparagement obligations and order Orthofix Inc. to continue complying with the terms of the Company’s previously-disclosed 5-year corporate integrity agreement through the expiration of its term.

The foregoing description of the Amended Plea Agreement does not purport to be complete and is qualified in its entirety by the text of the Amended Plea Agreement, which is filed herewith as Exhibit 10.1 and which is incorporated herein by reference. The settlement agreement and corporate integrity agreement described in and filed with the Prior Form 8-K were not amended, and remain in full force and effect on their original terms.

Item 7.01. Regulation FD Disclosure.

On December 16, 2012, the Company issued a press release regarding the matters described above. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

The information included in this Current Report on Form 8-K under this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

10.1	Amended Plea Agreement, entered into on December 14, 2012, among the United States Attorney for the District of Massachusetts, the Department of Justice and Orthofix Inc.
99.1	Press Release, dated December 16, 2012.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Orthofix International N.V.
By:	/s/ Jeffrey M. Schumm
	Jeffrey M. Schumm Senior Vice President, General Counsel and Corporate Secretary

Date: December 19, 2012

EXHIBIT INDEX

Exhibit No.	Description
10.1	Amended Plea Agreement, entered into on December 14, 2012, among the United States Attorney for the District of Massachusetts, the Department of Justice and Orthofix Inc.
99.1	Press Release, dated December 16, 2012.

EX-10.1

Exhibit 10.1

U.S. Department of Justice   Carmen M. Ortiz United States Attorney District of Massachusetts

Main Reception: (617) 748-3100	John Joseph Moakley United States Courthouse
	1 Courthouse Way
	Suite 9200
	Boston, Massachusetts 02210

June 5, 2012

Brien T. O’Connor

Ropes & Gray, LLP

800 Boylston Street

Boston, MA 02199

Re: United States v. Orthofix, Inc.,

Dear Mr. O’Connor:

This letter sets forth the Agreement between the United States Attorney for the District of Massachusetts (“the U.S. Attorney”) and the Department of Justice (collectively, the United States Department of Justice and the U.S. Attorney will be referred to as the “United States”) and your client, Orthofix, Inc. (“Defendant” or “Orthofix”), in the above-referenced case. The Agreement is as follows:

1. Change of Plea

At the earliest practicable date, Defendant shall waive indictment and plead guilty to the Information attached to this Agreement as Exhibit A charging it with: Obstruction of Federal Audit in violation of 18 U.S.C. §1516. Defendant expressly and unequivocally admits that it committed the crime charged in the Information, did so knowingly and intentionally, with an intent to deceive or defraud the United States, and is in fact guilty of that offense. Defendant also agrees to waive venue and any legal or procedural defects in the Information.

2. Penalties

With respect to the count of conviction, Defendant faces the following maximum penalties:

a. A fine of $500,000, or twice the gross gain/loss, whichever is greater. 18 U.S.C. §§3571(c) and (d). The gross gain resulting from the offense is $6,471,448. Thus the maximum fine is $12,942,896.

b. A term of probation of not more than five (5) years. 18 U.S.C. §3561(c)(1);

c. Restitution to any victims of the offense. See 18 U.S.C. §3563(b)(2); and

d. With respect to the count of conviction, Defendant shall pay a mandatory special assessment of $400. 18 U.S.C. §3013.

3. Fed. R. Crim. P. 11(c)(1)(B) Plea

This plea agreement is made pursuant to Fed. R. Crim. P. 11(c)(1)(B), and Defendant’s plea will be tendered pursuant to that provision.

4. Sentencing Guidelines

The parties agree jointly to take the following positions at sentencing under the United States Sentencing Guidelines:

a. The parties agree that the Guideline Manual in effect as of November 1, 2010 should be used in determining Defendant’s sentence. See U.S.S.G. §§1B1.11(a).

b. The parties agree that the base fine is $6,471,448, in that such amount was the pecuniary gain to Defendant from the offense. See U.S.S.G. §§8C2.4(a)(2).

c. Pursuant to U.S.S.G. §8C2.5, the culpability score is 6 as determined as follows:

(1) Base culpability score is five (5) pursuant to U.S.S.G. §8C2.5(a);

(2) Add three (3) points pursuant to U.S.S.G. §8C2.5(b)(3)(A), in that the organization had 200 or more employees and an individual within high-level personnel of the organization participated in, condoned, or was willfully ignorant of the offense;

(3) Deduct two (2) points pursuant to U.S.S.G. §8C2.5(g)(2).

d. Pursuant to U.S.S.G. §8C2.6, the appropriate multiplier range associated with a culpability score of 6 is 1.2 to 2.4.

e. Thus, the Guideline Fine Range is $7,765,737 to $12,942,896. See 18 U.S.C. §§3571(c) and (d) (maximum fine is twice the gross gain or gross loss).

f. The parties agree that: (1) disgorgement pursuant to U.S.S.G. §8C2.9 is not necessary; (2) there is no basis for a downward departure or deviation under the U.S.S.G.; and (3) a fine within the guideline range will result in a reasonable sentence taking into consideration all of the factors set forth in 18 U.S.C. §§3553(a), 3572.

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The U.S. Attorney may, at her sole option, be released from her commitments under this Agreement, including, but not limited to, her agreement that Paragraph 5 constitutes the appropriate disposition of this case, if at any time between Defendant’s execution of this Agreement and sentencing, Defendant:

(a) Fails to admit a complete factual basis for the plea;

(b) Fails to truthfully admit its conduct in the offenses of conviction;

(c) Falsely denies, or frivolously contests, relevant conduct for which Defendant is accountable under U.S.S.G. §1B1.3;

(d) Fails to provide truthful information about its financial status;

(e) Gives false or misleading testimony in any proceeding relating to the criminal conduct charged in this case and any relevant conduct for which Defendant is accountable under U.S.S.G. §1B1.3;

(f) Engages in acts which form a basis for finding that Defendant has obstructed or impeded the administration of justice under U.S.S.G. §3C1.1;

(g) Commits a crime; or

(h) Attempts to withdraw its guilty plea.

5. Agreed Disposition

Pursuant to Fed. R. Crim. P. 11(c)(1)(B), the U.S. Attorney and Defendant agree that the following is a reasonable and appropriate disposition of this case:

(a) a criminal fine in the amount of $7,765,737, to be paid within two business days of the date of sentencing;

(b) a mandatory special assessment in the amount of $400;

(c) in light of the pending civil actions, including United States ex rel. Bierman v. Orthofix International, N.V., et al, C.A. No. 05-10557-EFH (District of Massachusetts), and the Civil Settlement Agreement between Orthofix and others and the United States relating to the civil action, which is being signed contemporaneously with this plea agreement, and attached hereto as Exhibit B, which requires payment of $34,234,263 plus interest, the parties agree that the complication and prolongation of the sentencing process that would result

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from an attempt to fashion a restitution order outweighs the need to provide restitution to the non-federal victims, if any, in this case. See, 18 U.S.C. §3663(a)(1)(B)(ii). Therefore the United States agrees that it will not seek a separate restitution order as to Orthofix as part of the resolution of the Information and the Parties agree that the appropriate resolution of this case does not include a restitution order.

(d) The United States agrees that it will not seek a term of probation in light of the Corporate Integrity Agreement entered into between Orthofix and the Office of Inspector General of the Department of Health and Human Services, attached as Exhibit C.

6. No Further Prosecution of Orthofix

Pursuant to Fed. R. Crim. P. 11(c)(1)(A), the United States agrees that, other than the charge in the attached Information, it shall not further prosecute Orthofix for any additional federal criminal charges with respect to the conduct: (a) covered by the Information; or (b) was the subject of the investigation of Orthofix by the federal grand jury in Massachusetts; or (c) currently known to the United States regarding illegal sales, promotion and marketing practices in connection with Orthofix bone growth stimulators (Spinal-Stim, Physio-Stim and Cervical-Stim) during the period 1999 through 2010.

This declination is expressly contingent on:

(1) the guilty plea of Orthofix being accepted by the Court and not withdrawn;

(2) Orthofix’s performance of all of its obligations, including without limitation its cooperation obligations, as set forth in this Agreement. If Orthofix’s guilty plea is not accepted by the Court or is withdrawn for any reason, or if Orthofix should fail to perform an obligation under this Agreement, this declination of prosecution shall be null and void.

The United States reserves the right to prosecute any individual, including but not limited to present and former officers, directors, employees, and agents of Orthofix, in connection with the conduct encompassed by this plea agreement, within the scope of the grand jury investigation, or known to the U.S. Attorney.

7. Payment of Mandatory Special Assessment

Defendant agrees to pay the mandatory special assessment to the Clerk of the Court on or before the date of sentencing.

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8. Cooperation

Orthofix acknowledges that its prior, ongoing, and future cooperation is important and a material factor underlying the decision by the United States to enter into this Agreement, and therefore, Orthofix agrees to continue to cooperate fully and actively with the United States, and any other agency of the government designated by the United States regarding any matter about which Orthofix has knowledge or information in any ongoing investigation, trial, or other proceeding arising out of any ongoing federal investigation of its current and former officers, agents, and employees on the subject matters identified in paragraphs 6(a)-(c) above. Orthofix’s above cooperation shall include, but not be limited to the following:

(a) Completely and truthfully disclosing all non-privileged information in its possession about which the United States may inquire, including but not limited to all information about activities of Orthofix and present and former officers, directors, employees and agents of Orthofix;

(b) Assembling, organizing and providing all non-privileged documents, records, and other evidence in Orthofix’s possession, custody, or control as may be requested by the United States;

(c) Using its reasonable best efforts to make available its present and former officers, directors and employees to provide information and/or testimony as requested by the United States, including testimony before a grand jury, a trial court, other court proceeding, as well as interviews with law enforcement authorities. Cooperation under this paragraph shall include identification of witnesses who, to Orthofix’s knowledge, obtained in the ordinary course of business, auditing or monitoring, have material information concerning any criminal prosecution and/or trial, civil trial, or other legal proceedings brought by the United States against any present or former officer, director, or employee of Orthofix;

(d) Providing testimony or information necessary to identify or establish the original location, authenticity, or other basis for admission into evidence of documents or physical evidence in any criminal or other proceeding as requested by the United States; and

(e) Providing active assistance, including assistance by current counsel (including undersigned counsel) and/or successor counsel, internal or external, in connection with any investigation, criminal prosecution, and/or trial, civil trial, or other legal proceeding brought by the United States against any present or former officer, director, or employee of Orthofix.

However, notwithstanding any provision of this agreement, Orthofix is not required to: (1) request of its current or former officers, agents, or employees that they forego seeking the advice of an attorney nor that they act contrary to that advice; (2) take any action against its officers, agents, or employees for following their attorney’s advice; and (3) waive any claim of privilege or work product protection.

9. Probation Department Not Bound By Agreement

The sentencing disposition agreed upon by the parties and their respective calculations under the Sentencing Guidelines are not binding upon the United States Probation Office.

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10. Civil and Administrative Liability

By entering into this Agreement, the U.S. Attorney does not compromise any civil or administrative liability, including but not limited to any False Claims Act or tax liability, which Orthofix may have incurred or may incur as a result of Orthofix’s conduct and its plea of guilty to the charges specified in Paragraph 1 of this Agreement.

Orthofix’s civil liability to the United States in connection with certain of the matters under investigation by the United States is resolved in the Civil Settlement Agreement, attached as Exhibit B, according to the terms set forth in that Agreement.

11. Waiver of Defenses

If Orthofix’s guilty plea is not accepted by the Court for whatever reason, or is later withdrawn for whatever reason, or if Orthofix breaches this Agreement, Orthofix hereby waives, and agrees it will not interpose, if charges are filed within six months of the date on which such guilty plea is rejected or withdrawn or a breach is declared by the USAO, any defense to any charges brought against it which it might otherwise have under the Constitution for pre-indictment delay, any statute of limitations, or the Speedy Trial Act, except any such defense that Orthofix may already have for conduct occurring before November 13, 2004.

12. Breach of Agreement

If the U.S. Attorney determines that Orthofix has failed to comply with any material provision of this Agreement, the United States may, at its sole option, be released from its commitments under this Agreement in its entirety by notifying Orthofix, through counsel or otherwise, in writing. The United States may also pursue all remedies available under the law, even if it elects not to be released from its commitments under this Agreement. Orthofix recognizes that no such breach by Orthofix of an obligation under this Agreement shall be grounds for withdrawal of its guilty plea. Orthofix understands that should it breach any material provision of this Agreement, the U.S. Attorney will have the right to use against Orthofix before any grand jury, at any trial or hearing, or for sentencing purposes, any statements which may be made by Orthofix, and any information, materials, documents or objects which may be provided by it to the government subsequent to this Agreement, without any limitation.

Orthofix understands and agrees that this Rule 11(c)(1)(B) plea agreement and its agreed upon criminal disposition:

a. are wholly dependent upon Orthofix’s timely compliance with the provisions of the attached Civil Settlement Agreement, including the requirement in the agreement that Orthofix pay to the United States the amount of $34,234,263, plus interest continuing until and including the day before complete payment is made in accord with the terms of the Civil Settlement Agreement; and that

b. failure by Orthofix to comply fully with the terms of this Agreement or the attached Civil Settlement Agreement will constitute a breach of this Agreement; provided, however, that a breach of the Corporate Integrity Agreement (CIA) attached hereto as Exhibit C does not constitute a breach of this Plea Agreement, and any disputes arising under the CIA shall be resolved exclusively through the dispute resolution provisions of the CIA.

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In the event Orthofix at any time hereafter breaches any material provision of this Agreement, Orthofix understands that: (1) the United States will as of the date of that breach be relieved of any obligations it may have in this Agreement and the attached Civil Settlement Agreement, including but not limited to the promise not to further prosecute Orthofix as set forth in this Agreement; and (2) Orthofix will not be relieved of its obligation to make the payments set forth in this Agreement and the attached Civil Settlement Agreement, nor will it be entitled to return of any monies already paid. Moreover, in the event of a breach, Orthofix hereby waives, and agrees it will not interpose, any defense to any charges brought against it which it might otherwise have under the Constitution for pre-indictment delay, any statute of limitations, or the Speedy Trial Act, except any such defense that Orthofix may already have for conduct occurring before November 13, 2004.

13. Corporate Authorization

Orthofix’s acknowledgment of this Agreement and execution of this Agreement on behalf of the corporation is attached as Exhibit D. Orthofix shall provide to the U.S. Attorney and the Court a certified copy of a resolution of Orthofix, Inc.’s governing authority, affirming that it has authority to enter into the Plea Agreement and has (1) reviewed the Information in this case and the proposed Plea Agreement; (2) consulted with legal counsel in connection with the matter; (3) voted to enter into the proposed Plea Agreement; (4) voted to authorize Orthofix to plead guilty to the charge specified in the Information; and (5) voted to authorize the corporate officer identified below to execute the Plea Agreement and all other documents necessary to carry out the provisions of the Plea Agreement. A copy of the resolution is attached as Exhibit E. Orthofix agrees that either a duly authorized corporate officer or a duly authorized attorney for Orthofix, at the discretion of the Court, shall appear on behalf of Orthofix and enter the guilty plea and will also appear for the imposition of sentence.

14. Who Is Bound By Agreement

This Agreement is binding upon Orthofix and the Office of the United States Attorney for the District of Massachusetts, the United States Attorney’s Offices for each of the other 93 judicial districts of the United States, the Consumer Protection Branch of the Department of Justice, and the Criminal Division of the United States Department of Justice on the matters set forth above in Paragraph 6. A copy of the letter to United States Attorney Carmen M. Ortiz from Lanny A. Breuer, Assistant Attorney General, Criminal Division, Department of Justice, authorizing this Agreement is attached as Exhibit F. Orthofix understands that this Agreement does not bind any state or local prosecutive authorities, the Tax Division of the U.S. Department of Justice, or the Internal Revenue Service of the U.S. Department of the Treasury.

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15. Complete Agreement

This letter contains the complete and only agreement between the parties relating to the disposition of this case. No promises, representations or agreements have been made other than those set forth in this Agreement and its attachments. This Agreement supersedes prior understandings, if any, of the parties, whether written or oral. This Agreement can be modified or supplemented only in a written memorandum signed by the parties or on the record in court.

If this letter accurately reflects the agreement between the United States and Orthofix, please have the authorized representative of Orthofix, Inc. sign the Acknowledgment of Agreement below. Please also sign as Witness and return the original of this letter to Assistant U.S. Attorney David Schumacher of the United States Attorney’s Office for the District of Massachusetts.

	Very truly yours,
	/s/ Carmen M. Ortiz
	CARMEN M. ORTIZ
	UNITED STATES ATTORNEY
	DISTRICT OF MASSACHUSETTS
By:	/s/ David S. Schumacher 12/14/12
	DAVID S. SCHUMACHER
	Assistant U.S. Attorney
By:	/s/ Jeremy M. Sternberg
	JEREMY M. STERNBERG
	Assistant U.S. Attorney

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ACKNOWLEDGMENT OF PLEA AGREEMENT

The Board of Directors of Orthofix Inc. (the “Board”) has authorized me to execute this Plea Agreement on behalf of Orthofix Inc. The Board has read this Plea Agreement and the attached criminal Information, in their entirety and has discussed them fully in consultation with Orthofix Inc.’s attorneys. The Board acknowledges that these documents fully set forth Orthofix Inc.’s agreement with the United States. The Board further states that no additional promises or representations have been made to Orthofix Inc. by any officials of the United States in connection with the disposition of this matter, other than those set forth in the Plea Agreement.

Dated: December 14, 2012	/s/ Jeffrey M. Schumm
	Jeffrey M. Schumm
	Senior Vice President, General Counsel, and
	Corporate Secretary
	Orthofix, Inc.
Dated: December 14, 2012	/s/ Brien T. O’Connor
	Brien T. O’Connor
	Ropes & Gray, LLP
	Counsel for Orthofix, Inc.

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EX-99.1

Exhibit 99.1

Orthofix Concludes Bone Growth Stimulator Investigation

LEWISVILLE, Texas – December 16, 2012 (BUSINESS WIRE) – Orthofix International N.V., (NASDAQ:OFIX) (the Company) announced today that it has resolved all matters related to the investigation of its bone growth stimulation business. Consistent with the agreement in principle that the Company previously announced in May 2011, the Company will pay approximately $43 million to resolve all civil and criminal matters, which included a plea to obstruction of a June 2008 federal audit. These charges were previously recorded in the first quarter of 2011. As part of the resolution, the Court imposed a five-year term of probation, during which the Company must continue to comply with the terms of its previously-executed Corporate Integrity Agreement. This final settlement also includes the resolution of a related qui tam complaint filed against the Company, which remains pending against several of its competitors.

President and Chief Executive Officer Robert Vaters commented, “I am very pleased with the final resolution of these matters. Over the last few years, we have made significant investments in compliance and have made many organizational changes to enhance the ethical culture of the Company. Through this transformation we have established an ethical tone at the Company where integrity and commitment to compliance are paramount. Looking forward, I am eager to maintain our leadership position with our Regenerative Stimulation product offering based on providing superior patient outcomes and driving value in the healthcare system.”

The resolution of these matters represents the Company’s third major government investigation settlement this year, following the final resolution of the investigation concerning the Company’s Blackstone Medical Inc. subsidiary and the resolution of the self-reported Foreign Corrupt Practices Act matter announced earlier this year. “I would like to thank our Senior Vice President, General Counsel, Corporate Secretary, Jeffrey Schumm, for his tireless efforts in navigating the Company to the conclusion of each of these difficult investigations,” said Mr. Vaters. “We emerge from these resolutions as a Company deeply committed to the highest levels of integrity and ethics which, along with our unique value proposition for bone repair and regeneration, we believe will position us for continued long term growth.”

Forward-Looking Statements:

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries and are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

The forward-looking statements in this release do not constitute guarantees or promises of future performance. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release (which contains information current as of the date hereof, whether as a result of new information, future events or circumstances, or otherwise.

About Orthofix:

Orthofix International N.V. is a diversified, global medical device company focused on developing and delivering innovative repair and regenerative solutions to the spine and orthopedic markets. Orthofix’s products are widely distributed around the world to orthopedic surgeons and patients via Orthofix’s sales representatives and its subsidiaries, and via collaborations with other leading orthopedic product companies. In addition, Orthofix is collaborating on R&D activities with leading research and clinical organizations such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation, and Texas Scottish Rite Hospital for Children. For more information about Orthofix, please visit www.orthofix.com.

Contact:

Mark Quick

Director of Investor Relations and Business Development

markquick@orthofix.com

214-937-2924

Source:

Orthofix International N.V.