Document:

exv10w1

Exhibit 10.1

Addendum and Amendment to the Deferred Prosecution Agreement

1. Wright Medical Technology, Inc. (“Wright”), pursuant to authority granted by its Board of
Directors, and the United States Attorney’s Office for the District of New Jersey (the “Office”),
enter into this Addendum and Amendment to the Deferred Prosecution Agreement (the “Addendum”).

2. Wright and the Office agree to extend the term of the Deferred Prosecution Agreement currently
in effect between Wright and the Office (the “DPA”) by a period of 12 months, from September 29,
2011 to September 29, 2012. Unless expressly addressed herein, all other terms and conditions of
the DPA will remain in full force and effect until September 29, 2012.

3. Paragraphs 1 and 4 of the DPA are hereby amended to substitute “twenty-four (24) months” for
“twelve (12) months” and Paragraph 52 of the DPA is hereby stricken.

4. If the Office does not find, prior to September 29, 2012, that Wright has committed a knowing,
willful and uncured breach of a material provision of the DPA, then the Office agrees not to take
any additional action regarding any breach of the DPA referenced in the Office’s May 5, 2011
letter; provided, that the Office agrees that it will not make any such finding unless it first
gives Wright notice and an opportunity to be heard, as specified in DPA paragraph 50; and provided,
further, that the Office agrees that any such finding will be based on either (1) conduct that
occurs after the date of the execution of this Addendum (the “Addendum Execution Date”) or (2)
conduct that has occurred prior to the Addendum Execution Date of which the Monitor is not aware,
as of the Addendum Execution Date.

5. Wright and the Office agree to modify the date upon which the next report from the Monitor is
due from September 29, 2011 to November 29, 2011. Wright and the Office further agree that after
November 29, 2011, the Monitor reports will be due on April 29, 2012 and September 29, 2012.
Accordingly, DPA Paragraph 11 is amended to strike both instances of the word “quarterly,” and DPA
Paragraph 19(c) is amended to substitute “on December 29, 2010, March 29, 2011, June 29, 2011,
November 29, 2011, April 29, 2012, and September 29, 2012” for “on at least a quarterly basis,” and
the last sentence of DPA Paragraph 19(c) is amended to strike the word “quarterly.”

6. The Office agrees to move on September 15, 2011 for an Order, in the form attached as
Exhibit A, further continuing the proceedings in United States v. Wright Medical Technology, Inc.,
Mag. No. 10-8233 (MCA), through and including September 29, 2012.

	 	 	 	 	 

	AGREED TO:
	 	 	 	 
	 
	 	 	 	 
	/s/ David D. Stevens

	 	/s/ J. Gilmore Childers	 	 
	 

David D. Stevens

	 	 

J. Gilmore Childers
	 	 
	Chief Executive Officer

	 	Attorney for the United States, Acting Under	 	 
	Wright Medical Technology, Inc.

	 	Authority Conferred by 28 U.S.C. § 515	 	 
	 
	 	 	 	 
	9/15/11

	 	9/15/11	 	 
	 

Date

	 	 

Date
	 	 

 

 

DIRECTOR’S CERTIFICATE

     I have read this Addendum and Amendment to the Deferred Prosecution Agreement (“Addendum”) and
carefully reviewed every part of it with counsel for Wright Medical Technology, Inc. (the
“Company”). I understand its terms and voluntarily agree, on behalf of the Company, to each of
them. Before signing this Addendum, I consulted with the attorney for the Company. The attorney
fully advised me of the consequences of entering into this Addendum and no one has threatened or
forced me, or to my knowledge any person authorizing this Addendum on behalf of the Company, in any
way to enter into this Addendum. I am also satisfied with the attorney’s representation in this
matter. I certify that I am a director of the Company, and that I have been duly authorized by the
Board of Directors of the Company to execute this certificate on behalf of the Company.

	 	 	 	 	 

	/s/ David D. Stevens

	 	9/15/11	 	 
	 

Wright Medical Technology, Inc.

	 	 

Date
	 	 
	 
	 	 	 	 
	By: David D. Stevens
	 	 	 	 

 

 

CERTIFICATE OF COUNSEL

     I am counsel for Wright Medical Technology, Inc. (the “Company”). In connection with such
representation, I have reviewed and discussed this Addendum and Amendment to the Deferred
Prosecution Agreement (“Addendum”) with the authorized representative of the Company. Based on my
review and discussion, I am of the opinion that:

     1. David D. Stevens, Chief Executive Officer and a Director of the Company, is duly authorized
to enter into this Addendum on behalf of the Company; and

     2. This Addendum has been duly and validly authorized, executed and delivered on behalf of the
Company, and is a valid and binding obligation of the Company.

     Further, I have carefully reviewed this Addendum with directors of the Company. I have fully
advised these directors of the consequences of entering into this Addendum. To my knowledge, the
Company’s decision to enter into this Addendum is an informed and voluntary one.

	 	 	 	 	 

	/s/ Karen F. Green

	 	9/15/11	 	 
	 

Karen F. Green, Esq

	 	 

Date
	 	 
	Wilmer Cutler Pickering Hale and Dorr LLP
	 	 	 	 

 

 

CERTIFIED COPY OF RESOLUTION

     Upon motion duly made, seconded, and unanimously carried by the affirmative vote of all the
Directors present, the following resolutions were adopted:

     WHEREAS, Wright Medical Technology, Inc. (the “Company”) has been
engaged in discussions with the United States Attorney’s Office for the District of New Jersey
(the “Office”) regarding an alleged breach of its Deferred Prosecution Agreement with that Office;

     WHEREAS, the Board of the Company consents to resolution of these discussions by entering into
the Addendum and Amendment to the Deferred Prosecution Agreement (“Addendum”) that the Company’s
Board of Directors has reviewed with outside counsel representing the Company;

     NOW THEREFORE, BE IT RESOLVED that David D. Stevens, the Company’s Chief Executive Officer and
a Director, be, and hereby is, authorized to execute the Addendum on behalf of the Company
substantially in the same form as reviewed by the Company’s Board of Directors at this meeting and
as attached hereto as Exhibit A, and is authorized to execute the Director’s Certificate attached
thereto.

 

 

SECRETARY’S CERTIFICATION

     I, Thomas McAllister, the duly elected Secretary of Wright Medical Technology, Inc. (the
“Company”), a corporation duly organized under the laws of the State of Delaware, hereby certify
that the following is a true and exact copy of a resolution approved by the Board of Directors of
the Company at its telephonic meeting held on the 13th day of September, 2011;

     WHEREAS, Wright Medical Technology, Inc. has been engaged in discussions with the United
States Attorney’s Office for the District of New Jersey (the “Office”) regarding resolution of an
alleged breach of its Deferred Prosecution Agreement with the Office;

     WHEREAS, the Board of Directors of the Company consents to resolution of these discussions on
behalf of the Company by entering into an Addendum and Amendment to the Deferred Prosecution
Agreement (“Addendum”) that the Board of Directors has reviewed with outside counsel representing
the Company;

     NOW THEREFORE, BE IT RESOLVED that David D. Stevens, the Company’s Chief Executive Officer and
a Director, be, and hereby is, authorized to execute the Addendum on behalf of the Company
substantially in the same form as reviewed by the Board of Directors at this meeting and as
attached hereto as Exhibit A, and is authorized to execute the Director’s Certificate attached
thereto.

     IN WITNESS WHEREOF, I have hereunto signed my name as Secretary and affixed the Seal of said
Corporation this 15th day of September, 2011.

	 	 	 	 	 

	 

	 	/s/ Thomas McAllister	 	 
	 

	 	 

Thomas McAllister, Secretaryexv10w2

EXHIBIT 10.2

AMENDMENT TO CORPORATE INTEGRITY AGREEMENT

between the 

Office of Inspector General

of the 

Department of Health and Human Services

and 

Wright Medical Technology, Inc.

	I.	 	Preamble

Effective September 29, 2010, Wright Medical Technology, Inc. (Wright) entered into a
Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United
States Department of Health and Human Services. Contemporaneously with the CIA, Wright entered
into a Settlement Agreement and Deferred Prosecution Agreement (DPA) with the United States.

Wright hereby enters into this Amendment to the CIA (Amendment). This Amendment applies only to
U.S. operations of Wright that are subject to U.S. Federal health care program requirements. Wright
will be entering into an agreement with the United States to extend the period of the DP A for an
additional twelve months. Wright’s execution of the DPA is a condition precedent to this Amendment.

	II.	 	Revised Terms
	 
	 	 	A. Continuation of CIA and Term of Amendment.
	 
	 	 	All of the obligations set forth in the CIA shall continue for the period set forth in the
CIA, and Wright shall comply with the CIA obligations for the remainder of the term of the
CIA, as revised by this Amendment.

Wright Medical Technology, Inc. — Amendment to Corporate Integrity Agreement

1

 

	B.	 	Suspension of Certain Terms in the CIA.

The requirements set forth in Section III.A through Section III.C. and Section III.E of the
CIA will be suspended during the first 24 months of the CIA unless (a) the DPA is no longer
in effect; or (b) OIG lifts the suspension. The requirements set forth in Section III.D of
the CIA will be suspended during the first 12 months of the CIA unless (a) the DPA is no
longer in effect; or (b) OIG lifts the suspension. All other terms of Section II.B of the
CIA remain unchanged.

	C.	 	Correspondence with the United States Attorney’s Office for the District of
New Jersey.

	 	1.	 	Wright shall submit to OIG any official notice or report
produced by
the United States Attorney’s Office for the District of New Jersey
pursuant to the DPA within 5 days of Wright receiving any official
notice or report from the United States Attorney’s Office for the
District of New Jersey.
	 
	 	2.	 	Wright shall submit to OIG any official notice, report, or
response
Wright provides to the United States Attorney’s Office for the
District of New Jersey at the same time Wright provides the official
notice, report, or response to the United States Attorney’s Office for
the District of New Jersey.
	 
	 	3.	 	Any written documentation Wright provides to or receives from
the
United States Attorney’s Office for the District of New Jersey
pursuant to the DPA shall be made available to the OIG upon
request.

	D.	 	Implementation Report and First Annual Report Requirements.

The Implementation Report and the first Annual Report shall be received by OIG no later
than 90 days after the end of the second Reporting Period. In addition to the requirements
of Section V.C of the CIA, the first Annual Report shall contain the following:

	 	1.	 	a description of the Focus Arrangements Tracking System
required by Section III.D. 1.a of the CIA;

Wright Medical Technology, Inc. — Amendment to Corporate Integrity Agreement

2

 

	 	2.	 	a description of the internal review and approval process required
by Section III.D.l.e of the CIA: and
	 
	 	3.	 	a description of the tracking and monitoring procedures and
other
Focus Arrangements Procedures required by Section III.D.l of the
CIA.

	 	 	Wright shall not have to report in the First Annual Report on Sections III.A through III.C
of the CIA or Section III.E of the CIA. Wright shall not have to include Sections V.A.7, .8,
and .9 of the CIA in the Implementation Report, unless Wright makes changes to the
information reported in response to these requirements in the First Annual Report.
	 
	 	 	Subsequent Annual Reports shall be received by the OIG no later than 60 days after the
anniversary date of the Effective Date.

	III.	 	Effective and Binding Agreement

	 	A.	 	Section XI of the CIA remains in effect through the term of the CIA. As of
the Effective Date of this Amendment, Section XI of the CIA is amended to
include the following provisions, which shall apply through the term of this
Amendment:
	 
	 	B.	 	Wright and OIG agree as follows:

	 	1.	 	This Amendment shall be binding on the successors, assigns, and
transferees of Wright.
	 
	 	2.	 	This Amendment shall become final and binding on the date the
final signature is obtained on the Amendment.
	 
	 	3.	 	The CIA, as revised by this Amendment, constitutes the complete
agreement between the parties and may not be amended except by
written consent of the parties.
	 
	 	4.	 	The undersigned Wright signatories represent and warrant that
they
are authorized to execute this Amendment. The undersigned OIG
signatories represent that they are signing this Amendment in their

Wright Medical Technology, Inc. — Amendment to Corporate Integrity Agreement

3

 

	 	 	 	official capacity and that they are authorized to execute this
Amendment.
	 
	 	5.	 	 This Amendment may be executed in counterparts, each of
which constitutes an original and all of which constitute one and the same
Amendment. Facsimiles of signatures shall constitute acceptable, binding
signatures for purposes of this Amendment.

Wright Medical Technology, Inc. — Amendment to Corporate Integrity Agreement

4

 

On Behalf of Wright Medical Technology, Inc.

	 	 	 	 	 

	/s/ : David
D. Stevens

	 	9/13/11	 	 
	 
 DAVID
D. STEVENS

	 	 

DATE
	 	 
	Interim Chief Executive Officer
	 	 	 	 
	Wright Medical Technology, Inc.
	 	 	 	 
	 
	 	 	 	 
	/s/ : Thomas
N. Bulleit, Jr.

	 	9/12/11	 	 
	 
 THOMAS
N. BULLEIT, JR., ESQ.

	 	 

DATE
	 	 
	Hogan Lovells US LLP
	 	 	 	 
	Counsel for Wright Medical Technology, Inc.
	 	 	 	 
	 
	 	 	 	 
	/s/ : Karen
F. Green

	 	9/13/11	 	 
	 
 KAREN
F. GREEN

	 	 

DATE
	 	 
	Wilmer Cutler Pickering Hale and Dorr LLP
	 	 	 	 
	Counsel for Wright Medical Technology, Inc.
	 	 	 	 

Wright Medical Technology, Inc. — Amendment to Corporate Integrity Agreement

5

 

On Behalf of the Office of Inspector General

of the Department of Health and Human Services

	 	 	 	 	 

	/s/ : Gregory
E. Demske

	 	9/14/11	 	 
	 
 GREGORY
E. DEMSKE

	 	 

DATE
	 	 
	Assistant Inspector General for Legal Affairs
	 	 	 	 
	Office of Inspector General
	 	 	 	 
	U. S. Department of Health and Human Services
	 	 	 	 
	 
	 	 	 	 
	/s/ : Laura
E. Ellis

	 	9/14/11	 	 
	 
 LAURA
E. ELLIS

	 	 

DATE
	 	 
	Senior Counsel
	 	 	 	 
	Office of Inspector General
	 	 	 	 
	U. S. Department of Health and Human Services
	 	 	 	 

Wright Medical Technology, Inc. — Amendment to Corporate Integrity Agreement

6

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00194-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00194-of-00352.parquet"}]]