AMENDMENT TO CORPORATE INTEGRITY AGREEMENT between the Office of Inspector General of the Department of Health and Human Services and Wright Medical Technology, Inc.
EXHIBIT 10.2
AMENDMENT TO CORPORATE INTEGRITY AGREEMENT
between the
Office of Inspector General
of the
Department of Health and Human Services
and
Xxxxxx Medical Technology, Inc.
between the
Office of Inspector General
of the
Department of Health and Human Services
and
Xxxxxx Medical Technology, Inc.
I. | Preamble |
Effective September 29, 2010, Xxxxxx Medical Technology, Inc. (Xxxxxx) 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, Xxxxxx entered
into a Settlement Agreement and Deferred Prosecution Agreement (DPA) with the United States.
Xxxxxx hereby enters into this Amendment to the CIA (Amendment). This Amendment applies only to
U.S. operations of Xxxxxx that are subject to U.S. Federal health care program requirements. Xxxxxx
will be entering into an agreement with the United States to extend the period of the DP A for an
additional twelve months. Xxxxxx’x 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 Xxxxxx shall comply with the CIA obligations for the remainder of the term of the CIA, as revised by this Amendment. |
Xxxxxx Medical Technology, Inc. — Amendment to Corporate Integrity Agreement
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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CIA will be suspended during the first 24 months of the CIA unless (a) the DPA is no longer
in effect; or (b) OIG lifts the suspension.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the CIA will be suspended during the first 12 months of the CIA unless (a) the DPA is no
longer in effect; or (b) OIG lifts the suspension.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. | Xxxxxx 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 Xxxxxx receiving any official notice or report from the United States Attorney’s Office for the District of New Jersey. | ||
2. | Xxxxxx shall submit to OIG any official notice, report, or response Xxxxxx provides to the United States Attorney’s Office for the District of New Jersey at the same time Xxxxxx provides the official notice, report, or response to the United States Attorney’s Office for the District of New Jersey. | ||
3. | Any written documentation Xxxxxx 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; |
Xxxxxx Medical Technology, Inc. — Amendment to Corporate Integrity Agreement
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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. |
Xxxxxx 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. Xxxxxx shall not have to include Sections V.A.7, .8, and .9 of the CIA in the Implementation Report, unless Xxxxxx 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: | ||
X. | Xxxxxx and OIG agree as follows: |
1. | This Amendment shall be binding on the successors, assigns, and transferees of Xxxxxx. | ||
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 Xxxxxx 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 |
Xxxxxx Medical Technology, Inc. — Amendment to Corporate Integrity Agreement
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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. |
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On Behalf of Xxxxxx Medical Technology, Inc.
/s/ : Xxxxx
X. Xxxxxxx
|
9/13/11 | |||
Interim Chief Executive Officer |
||||
Xxxxxx Medical Technology, Inc. |
||||
/s/ : Xxxxxx
X. Xxxxxxx, Xx.
|
0/00/00 | |||
Xxxxx Lovells US LLP |
||||
Counsel for Xxxxxx Medical Technology, Inc. |
||||
/s/ : Xxxxx
X. Xxxxx
|
9/13/11 | |||
Xxxxxx Xxxxxx Xxxxxxxxx Xxxx and Xxxx LLP |
||||
Counsel for Xxxxxx Medical Technology, Inc. |
Xxxxxx Medical Technology, Inc. — Amendment to Corporate Integrity Agreement
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On Behalf of the Office of Inspector General
of the Department of Health and Human Services
of the Department of Health and Human Services
/s/ : Xxxxxxx
X. Xxxxxx
|
9/14/11 | |||
Assistant Inspector General for Legal Affairs |
||||
Office of Inspector General |
||||
U. S. Department of Health and Human Services |
||||
/s/ : Xxxxx
X. Xxxxx
|
9/14/11 | |||
Senior Counsel |
||||
Office of Inspector General |
||||
U. S. Department of Health and Human Services |
Xxxxxx Medical Technology, Inc. — Amendment to Corporate Integrity Agreement
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