exv10w3



 





Exhibit 10.3




Deferred Prosecution Agreement




          1. Zimmer, Inc. (the “Company”), by its undersigned attorneys, pursuant to authority
granted by the Board of Directors of its parent company, Zimmer Holdings, Inc. (referred to
herein as the “Board” or “Board of Directors”), and the United States Attorney’s Office for the
District of New Jersey (the “Office”), enter into this Deferred Prosecution Agreement (the
“DPA”). Except as specifically provided below, the DPA shall be in effect for a period of
eighteen (18) months from the date it is fully executed (the “Effective Date”).




          2. The Office has informed the Company that it will file, on or shortly after the
Effective Date of this DPA, a criminal complaint in the United States District Court for
the District of New Jersey charging the Company with conspiracy to commit violations of the
Federal Anti-Kickback Statute, contrary to Title 42, United States
Code, Sections 1320a - 7b,
in violation of Title 18, United States Code, Section 371, during the years 2002 through 2006
(the “Criminal Complaint”). This Office acknowledges that neither this DPA nor the Criminal
Complaint alleges the Company’s conduct adversely affected patient health or patient care.




          3. The Company and the Office agree that, upon filing of the Criminal Complaint in
accordance with the preceding paragraph, this DPA shall be publicly filed in the United States
District Court for the District of New Jersey, and the Company agrees to post the DPA
prominently on the Company website for the duration of the DPA.




          4. In light of the Company’s remedial actions to date and its willingness to (a) undertake
additional remediation as necessary; (b) acknowledge responsibility for its behavior; (c)
continue its cooperation with the Office and other government agencies; and (d) demonstrate its
good faith and commitment to full compliance with federal health care laws, the Office shall
recommend to the Court that prosecution of the Company on the Criminal Complaint be deferred for
a period of eighteen (18) months from the filing date of such Criminal Complaint. If the Court
declines to defer prosecution for any reason, this DPA shall be null and void, and the parties
will revert to their pre-DPA positions.




          5. Zimmer has provided substantial assistance to the Office’s investigation of the Company,
including, but not limited to fully complying with requests for information by the Office;
voluntarily providing significant and comprehensive information regarding the Company’s
practices and procedures in a timely and organized manner; and making numerous oral and written
presentations helpful to the Office’s investigation of the Company. Zimmer also took the
initiative to institute numerous and comprehensive compliance enhancements, including but not
limited to the following: (a) establishing an enhanced Corporate Compliance Program; (b)
appointing a Chief Compliance Officer who is a member of the Executive Committee of the Company,
who has direct reporting to the President and CEO, and the Board of Directors, and who is not
subordinate to the chief legal officer, the chief financial officer, or any sales or marketing
officers; (c) assigning a significant, dedicated and qualified compliance staff to the Chief Compliance Officer; (d)
creating executive-level oversight to evaluate and approve the




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Company’s business and
development Needs Assessments, and to evaluate and approve requests for Consulting Agreements
and other service relationships with Consultants; (e) conducting Needs Assessments to determine
Zimmer’s bona fide, commercially reasonable services needs, including detailed written protocols
implementing the Needs Assessment; (f) implementing and maintaining an electronic tracking
system for Consulting Services that ties to the Need Assessments; and (g) establishing internal
compliance audit processes and procedures. A number of compliance enhancements were developed
prior to the Company being notified of the Office’s investigation at significant cost and
expense to the Company, and the existence and effectiveness of these enhancements played a
significant role in the terms of this resolution.




General Commitment to Compliance and Remedial Actions 




          6. The Company commits itself to exemplary corporate citizenship, best practices of
effective corporate governance, the highest principles of honesty and professionalism, the
integrity of the operation of federal health care programs including Medicare and Medicaid, the
sanctity of the doctor-patient relationship, and a culture of openness, accountability, and
compliance throughout the Company. The Company also commits not to attempt to influence medical
practitioners and institutions to use the Company’s products through the use of unlawful
inducements. To advance and underscore this commitment, the Company agrees to take, or has
acknowledged that it has taken, the remedial and compliance measures
set forth herein.




          7. In matters relating to federal health care laws, the Company will cooperate fully with
all federal law enforcement and regulatory agencies, including but not limited to: the Criminal
and Civil Divisions of the Office; the United States Department of Justice, Criminal and Civil
Divisions; the United States Department of Health and Human Services, Office of Inspector
General (“HHS-OIG); the Federal Bureau of Investigation (“FBI”); and the United States Postal
Inspection Service (“USPIS”); provided, however, that such cooperation shall not require the
Company’s waiver of attorney-client and work product protections or any other applicable legal
privileges. Nothing in this DPA shall be construed as a waiver of any applicable attorney-client
or work product privileges (hereafter “privilege”).




          8. The Company shall communicate to its employees and distributors that Company personnel
and agents are required to report to the Company any suspected violations of any federal laws,
regulations, federal health care program requirements, or internal policies and procedures.




          9. The Company shall implement or continue its operation of an effective corporate
compliance program and function to ensure that internal controls are in place to prevent
recurrence of the activities that resulted in this DPA. The Company shall also develop and
implement policies, procedures, and practices designed to ensure compliance with federal health
care program requirements, including the Anti-Kickback Statute, with respect to all its
dealings with Consultants, as defined herein, and others who cause the purchase of Company
orthopedic products in the United States.




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          10. The Company shall adhere to the AdvaMed Code of Ethics on Interactions with Health Care
Professionals. The AdvaMed Code can be found at www.advamed.org. The principles set forth in the
AdvaMed Code are expressly incorporated as compliance requirements under this DPA.




          11. The Company agrees that its President and CEO, General Counsel, Compliance Officer,
and appropriate Company executives will meet quarterly with the Office and the Monitor, in
conjunction with the Monitor’s quarterly reports described in paragraph 19 herein.




Definitions




          12. “Consultant” is defined as any United States-based orthopedic surgeon, PhD, health care
professional, non-physician practitioner, medical fellow, resident or student, or any employee
or agent of any educational or health care organization the Company retains for any personal or
professional services or compensates or remunerates in any way, directly or indirectly, for or
in anticipation of personal or professional services relating to hip and knee reconstruction and
replacement. The term Consultant shall not include accountants, auditors, attorneys, fair market
value specialists, CME providers, reimbursement specialists, any non-physician engineering or
marketing consultants, or any other types of non-physician professionals or entities excluded
from this definition by the Monitor upon recommendation by the Company.




          13. “Consulting Agreement” includes all contracts with Consultants for services to be
performed on behalf of the Company. This includes, but is not limited to, agreements for
compensation, payments, remuneration, honoraria, fellowships, professional meetings, speaking
engagements, teaching, publications, clinical studies, fee-for-service consulting, product
development and license agreements, research, and professional services agreements. The term
“Consulting Agreement” also includes agreements to provide grants, donations, sponsorships and
other forms of payment to medical educational organizations, medical societies and training
institutions.




          14. “Consulting Services” or “Services” include any and all professional services
provided by a Consultant to or on behalf of the Company.




          15. “Payment” shall include any and all compensation or remuneration paid to or for the
benefit of Consultants, including but not limited to payments and reimbursements for personal
or professional services, any type of securities, registered or unregistered, meals,
entertainment, travel, gifts, grants, honoraria, charitable contributions, donations,
sponsorships, research grants, clinical studies, professional meetings, product training,
medical education, research funding, product development services, in-kind services (e.g., use
of aircraft), advertising, promotion, and marketing expenses or support, and royalties or
other payments for transfer of documented intellectual property. Unless otherwise approved by
the Monitor, the Company shall only compensate or remunerate Consultants through direct
Payments made pursuant to a Consulting Agreement. The Company shall not knowingly make any
Payments to



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Consultants indirectly, such as through distributors.




Retention and Obligations of a Monitor 




          16. The Company agrees that until the expiration of this DPA, it will retain an
outside, independent individual (the “Monitor”) selected by the Office, after consultation
with the Company, to evaluate and monitor the Company’s compliance with the DPA. Among the
conditions of the Monitor’s retention are that the Monitor is independent of the Company,
the Monitor works exclusively for and at the direction of the Office, and no attorney-client
relationship shall be formed between the Monitor and the Company.




          17. The Monitor shall have access to all non-privileged Company documents and information
the Monitor determines are reasonably necessary to assist in the execution of his or her duties.
The Monitor shall have the authority to meet with any officer, employee, or agent of the
Company. The Company shall use its best efforts to have its independent distributors for hip and
knee reconstruction and replacement products and their employees and agents fully cooperate and
meet with the Monitor as requested. For all distributor agreements for hip and knee
reconstruction and replacement products and renewals executed after the Effective Date, the
Company shall require provisions allowing the Monitor access to non-privileged relevant
documents and information relating to Consulting Agreements and Services, and compliance with
all applicable provisions of the DPA.




          18. The Monitor shall conduct a review and evaluation of all Company policies,
practices, and procedures relating to compliance with the DPA and the following subjects, and
report and make written recommendations as necessary (“Recommendations”) to the Company and
the Office concerning same:





	 	a.	 	The corporate structure and governance of the Company relative to
selecting, engaging, and paying Consultants;
	 
	 	b.	 	The effectiveness of the procedures and practices at the Company to select,
engage, and pay Consultants in exchange for the provision of Services to the
Company, as well as the related legal, compliance, research and development,
marketing, sales, internal controls, and finance functions;
	 
	 	c.	 	The effectiveness of the training and education programs in the following
areas: federal health care laws concerning relationships between the Company and
Consultants; Medicare, Medicaid and other health care benefit programs; ethics;
and compliance and corporate governance issues relating to federal health care
laws;
	 
	 	d.	 	The structure and content of agreements memorializing arrangements to engage
and pay Consultants in exchange for the provision of Services to




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	 	 	 	the Company, and the Company’s payments to Consultants made
thereunder. The Monitor shall have access to and may review all
previously entered agreements to the extent he or she reasonably deems
necessary; and
	 
	 	e.	 	The influence, actual or potential, over Consultants’ selection of Company
products as a result of the financial relationships between the
Company and those Consultants.





19. The Monitor shall, inter alia:





	 	a.	 	Monitor and review the Company’s compliance with this DPA and all applicable
federal health care laws, statutes, regulations, and programs, including the
Anti-Kickback Statute, relating to the sale and marketing of hip and knee
reconstruction and replacement products;
	 
	 	b.	 	As requested by the Office, cooperate with the Criminal and Civil
Divisions of the Office, the United States Department of Justice,
Criminal and Civil Divisions, HHS-OIG, the FBI and the USPIS, and, as
requested by the Office, provide information about the Company’s
compliance with the terms of this DPA;
	 
	 	c.	 	Provide written reports to the Office, on at least a quarterly basis,
concerning the Company’s compliance with this DPA. In these reports or at other
times the Monitor deems appropriate, the Monitor shall make Recommendations to
the Company to take any steps he or she reasonably believes are necessary for
the Company to comply with the terms of this DPA and enhance future compliance
with federal health care laws as related to the sale and marketing of hip and
knee reconstruction and replacement products; and, as agreed by the Company or
mandated by the Office pursuant to paragraph 47, require the Company to take
such steps when it is agreed that such steps are reasonable and necessary for
compliance with the DPA. The first report to the Office shall be due three
months after the Effective Date, and subsequent reports shall be made quarterly
thereafter;
	 
	 	d.	 	After consultation with the Company and the Office, and allowing reasonable
time for the Company or the Office to object, the Monitor may retain, at the
Company’s expense, consultants, accountants or other professionals the Monitor
reasonably deems necessary to assist the Monitor in the execution of the
Monitor’s duties. Before retention, these consultants, accountants or other
professionals shall provide to the Monitor and the Company a proposed budget. If
the Company believes the costs to be unreasonable, the Company may bring the
matter to the Office’s attention for dispute resolution by the Office;





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	 	e.	 	Monitor the preparation of and approve the Needs Assessment and any
Modifications thereto described in paragraphs 27-29 herein;
	 
	 	f.	 	Review and approve all new or renewed Consulting Agreements executed between
the Effective Date and the date the Needs Assessment is approved;
	 
	 	g.	 	Review in his or her discretion any requests for Consulting Services made
between the Effective Date and the date the Needs Assessment is approved;
	 
	 	h.	 	Review in his or her discretion any Payments made to Consultants between the
Effective Date and the date the Needs Assessment is approved;
	 
	 	i.	 	Review and approve in his or her discretion all Consulting Agreements with
new Consultants executed after the Needs Assessment is approved;
	 
	 	j.	 	Review in his or her discretion any Consulting Agreement renewals executed
after the Needs Assessment is approved;
	 
	 	k.	 	Review in his or her discretion any requests for Consulting Services made
after the Needs Assessment is approved;
	 
	 	l.	 	Review in his or her discretion any Payments made to Consultants after the
Needs Assessment is approved;
	 
	 	m.	 	Review in his or her discretion any payments made to CME providers,
reimbursement specialists, any non-physician engineering or marketing
consultants, or other excluded consultants as described in paragraph 12;
	 
	 	n.	 	Review in his or her discretion any payments made to Consultants as
honoraria, fellowships, gifts, donations, charitable contributions and other
non-Service payments as described in paragraph 27;
	 
	 	o.	 	Review and approve any new or substitute Consultants as described in
paragraphs 33 and 34 herein;
	 
	 	p.	 	Approve any changes to the Hourly Rate or any Payments made at a rate other
than the Hourly Rate, as described in paragraphs 35-37 herein;
	 
	 	q.	 	Monitor the Consultant disclosure obligations as described in paragraphs
40-41 herein; and





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	 	r.	 	Monitor the information received by the confidential hotline and e-mail
address as described in paragraph 43 herein.





          In the event the Monitor opposes any Consulting Agreement, request for Consulting
Services, or request for Payment, the Monitor will promptly meet with the Company to discuss
his or her concerns. The Consulting Agreement shall not be executed, the Consulting Services
shall not be rendered, or the Payment shall not be made unless and until the Monitor’s
objections are remedied. All actions of the Monitor in this regard shall be subject to review
by the Office and shall not require the Company to breach any existing contractual requirements
so long as they comply with all applicable laws. The Office will act promptly to resolve any
issues on a good faith and reasonable basis.




          20. The Company shall promptly notify the Monitor and the Office in writing of any
credible evidence of criminal corporate conduct as well as of any known criminal investigations
of any type of the corporation or any of its officers or directors that becomes known to the
Company after the Effective Date. In addition, the Company shall promptly notify the Monitor
and the Office in writing of any credible evidence of criminal conduct or serious wrongdoing
relating to federal health care laws by the Company, its officers, employees and agents. The
Company shall provide the Monitor and the Office with all relevant non-privileged documents and
information concerning such allegations, including but not limited to internal audit reports,
letters threatening litigation, “whistleblower” complaints, civil complaints, and documents
produced in civil litigation. In addition, the Company shall report to the Monitor and the
Office concerning its planned investigative measures and any resulting remedial measures,
internal and external. The Monitor in his or her discretion may conduct an investigation into
any such matters; and nothing in this paragraph shall be construed as limiting the ability of
the Monitor to investigate and report to the Company and the Office
concerning such matters.




Remedial Measures 




          Responsibilities of Compliance  Office 




          21. The Compliance Office (“Compliance Office”) and Chief Compliance Officer (“Compliance
Officer”) shall be responsible for monitoring the day-to-day compliance activities of the
Company. The Compliance Officer shall be a member of the Operating Committee of the Company who
reports directly to the President and CEO and shall not be a subordinate to the chief legal
officer, the chief financial officer, or any sales or marketing officers. The Compliance Officer
shall make periodic (at least quarterly) reports regarding compliance matters to the Company
Board of Directors and is authorized to report on such matters directly to the Company Board of
Directors at any time.




          22. The Compliance Officer shall have the authority to meet with, and require reports and
certifications on any subject from, any officer or employee of the Company.



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          23. The Compliance Office shall be responsible for oversight, evaluation, and approval of
the Company’s Needs Assessments (described more fully at paragraphs 27-29), and shall evaluate
and approve requests for Consulting Agreements, Services, and Payments, subject to review and approval by the Monitor as set forth in paragraph 19.




          24. The Compliance Office shall be responsible for approving the Consulting Services
budget. All requests for Consulting Services and Payments must be made to and approved by the
Compliance Office. Any Payments to or for the benefit of a Consultant must be approved by the
Compliance Office, subject to review of the Monitor as set forth in paragraph 19.




          25. Consulting Agreements shall be managed by Company employees who have no sales
responsibilities and who report to the Compliance Office on Consulting issues. These
employees shall interface directly with the Consultants on the terms of their Consulting
Agreements and on issues relating to Payments.




          26. From the Effective Date until the Needs Assessment is approved, all requests for
Consulting Services and Payments shall be pre-approved by the Compliance Office. In
considering these requests, the Compliance Office and any other Company personnel with
knowledge of the request shall evaluate the bona fides of the activity for which the Services
or Payments are requested, subject to review of the Monitor. No Consulting Services may be
approved unless the Compliance Office verifies that the Company has a bona fide commercial
need for such services. No Payments may be made without appropriate documentation and
verification of services rendered on a standard form to be developed by the Compliance Office
and approved by the Monitor.




Needs Assessment 




          27. The Company shall complete a Needs Assessment no later than December 31, 2007, and
annually thereafter. The Needs Assessment may be modified if bona fide, commercially reasonable,
unexpected business needs arise (“Modification”). The Needs Assessment must reflect the
Company’s expected, commercially reasonable needs for all Consulting Services to fulfill its
medical, clinical, training, educational, and research and development needs. The Needs
Assessment shall also contain a budget for the total amount of honoraria, fellowships, gifts,
donations, charitable contributions, and any other payments contemplated to be made to
Consultants for which no Consulting Services are provided. The Needs Assessment and any
Modifications as defined herein shall be prepared in consultation with those areas of the
Company that have bona fide needs for the services to be performed. The Needs Assessment and any
Modifications must be approved by the Compliance Officer and the Monitor before they are
finalized. As of January 1, 2008, the Needs Assessment and any Modifications shall be used as a
basis for Consultant selection and all Consulting Agreements, Services and Payments. The
Compliance Officer shall attest to the best of his or her knowledge, after conducting reasonable
due diligence, that the Needs Assessment and any Modifications reflect the bona fide,
commercially reasonable consulting needs of the Company.



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          28. The Needs Assessment shall establish or incorporate by reference detailed protocols or
procedures that must be followed before a Consulting Agreement will be authorized. The Needs
Assessment must identify and quantify the services needed within each discrete service category
(e.g., operating room training, speaking engagements, clinical studies, product development
groups), and provide written support for the needs.
The Needs Assessment must set forth the nature of the services needed, the range of hours
or other quantitative measure needed to complete the services, the number of Consultants needed,
and the maximum fair market value compensation to be paid for each consulting service. The Needs
Assessment shall also identify the qualifications and expertise required to perform the
services. The Needs Assessment shall ensure that Services are distributed appropriately to all
regions of the country.




          29. The Needs Assessment and any approved Modifications shall be used to define and limit
all Consulting Services performed for the Company for the ensuing year. All Consulting
Agreements entered into by the Company shall be for services specified and enumerated by the
Needs Assessment and any approved Modifications. No Consulting Agreement shall be entered into
with any Consultant for services outside those specified in the Needs Assessment and any
approved Modifications, or for services exceeding the number of services specified in the Needs
Assessment and any approved Modifications. For example, if the Needs Assessment specifies that
the Company will require Consultants to conduct 50 speaking engagements on a particular topic,
once the total number of contracted-for speaking engagements reaches 50, the Company may not
engage any additional Consultants for such speaking engagements unless it obtains an approved
Modification.




          30. The Company shall maintain a record of all Consulting Services provided under the
Needs Assessment and any Modification. Monthly reports will be issued by the Compliance Office
to the Monitor and to senior executives in the areas in which services are provided summarizing
the Consulting Services provided or submitted for Payment, by Consultant, by region, and by
total, with a list of services left to be provided during the calendar year in fulfillment of
the Needs Assessment.




          Consulting Agreements 




          31. All Consulting Agreements shall be in writing and executed by the Compliance Officer,
the President, the General Counsel, the Director of Research & Development for product
development and research agreements, and the Director of Clinical for clinical services
agreements (including clinical trials, clinical studies, follow-up visits). On an annual basis,
the Compliance Officer, the Director of Research & Development for product development and
research agreements, and the Director of Clinical for clinical services agreements shall attest
and certify in writing that, based on their reasonable inquiry and knowledge, all Consulting
Agreements and all Consulting Services performed thereunder were bona fide, commercially
reasonable, and compliant with all federal health care programs. The Company shall not enter
into Consulting Agreements with Consultants through any third parties, including distributors.



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          32. All Consulting Agreements for Consulting Services to be rendered in 2008 and thereafter
shall be for a term of the calendar year, with the exception of product development agreements
that could result in the payment of royalties, clinical agreements, and external research
agreements, which may be for a length appropriate to the type of Service being rendered, upon
approval of the Monitor. All Consulting Agreements shall identify the specific Services to be
provided as defined by the Needs Assessment and any Modification thereto, and specify the rate
to be paid for each Service. The Company may
not enter into Consulting Agreements for Services exceeding the total number of Services
set forth in the Needs Assessment and any Modification thereto. Consultants shall be paid only
for the actual time expended in providing Consulting Services, in hourly billing increments or
other reasonable quantitative measure as identified in the Needs Assessment, without regard to
the total amount of consulting services permissible under their Consulting Agreements.




          New and Substitute Consultants 




          33. The Compliance Office, in consultation with the Monitor and appropriate Company
employees, shall conduct an evaluation of each new Consultant to be considered for a Consulting
Agreement. This evaluation shall ensure the proposed Consultant’s qualifications and experience
are commensurate with those required by the Needs Assessment and any Modification thereto, and
that any new relationship meets an unfilled bona fide commercial need of the Company.




          34. In the event a Consultant is unable to provide service to the Company under a
Consulting Agreement in any given year, the Company may substitute another Consultant or retain
a new Consultant to perform the specified yet unfulfilled Consulting Services of the Consulting
Agreement. The substitute Consultant must be authorized by the Compliance Officer and approved
by the Monitor after conducting a substantive review of the Consultant’s qualifications and
expertise.




          Payments to Consultants 




          35. A Company employee or representative must be present for every Consulting Service,
except that the Monitor, upon application by the Compliance Office, may exempt certain Services
from this requirement (such as collection of clinical study data, travel or preparation time).
Upon completion of the Consulting Service, both the Company employee (or representative) in
attendance and the Consultant must independently verify in writing that the Service took place,
identify the participants present and length of service, and summarize the Service provided.
These verifications must be certified, made under penalty of perjury, and submitted to the
Compliance Office within ninety (90) calendar days of the date of the Service and as a condition
precedent to any Payments being issued under a Consulting Agreement.




          36. For all Consulting Agreements entered into after the Effective Date of this DPA, the
Company agrees to make Payments to Consultants at a fair market value hourly rate (“Hourly




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Rate”) of no more than $500 per hour for time actually expended by a Consultant performing
Consulting Services. In the event the Company wishes to make Payments to a Consultant at a
higher Hourly Rate or at a different rate because of the Consultant’s special expertise or the
nature of the service (such as a per patient rate for clinical studies), the Company must
obtain or have obtained a fair market value analysis conducted by an independent organization
with expertise in valuation as approved or accepted by the Monitor. Any changes to the Hourly
Rate or Payments other than at the Hourly Rate must be approved by the Monitor.




          37. With respect to product development agreements and renewals entered into after the
Effective Date and for all Services to be rendered after
January 1, 2008, the Company shall pay a
Consultant on a product development team for the actual time spent providing Services to the
Company, at no more than the Hourly Rate. In addition to the Hourly Rate payments, the Company
may pay each member of a product development team royalties on any product the team may develop.
The number of Consultants serving on a product development team must not exceed the number
reasonably necessary to achieve the identified design and development
needs of the project. The
aggregate royalties paid per project to all Consultants shall not exceed fair market value
expressed as a certain percentage of all domestic and international product sales of the product
or products that are the subject of the product development agreement as proposed by the Company
and approved by the Monitor. These royalty payments and Hourly Rate payments shall be the only
compensation a Consultant may receive for participation on a product design team; that is, the
Company shall not make any flat rate payments or minimum guaranteed payments in lieu of or in
addition to Hourly Rate payments and royalty payments. The Company may offset royalty payments
to a Consultant with Hourly Rate payments for Services the Consultant appropriately performed.
The Company may pay royalties to a Consultant only for Intellectual Property received by the
Company for products that have actually been sold.
(Products may be considered to have been sold when the products are transferred to an
unrelated third-party or to a Company affiliate located outside the United States.) If the
Intellectual Property has been patented in the United States, royalty payments may not extend
beyond the life of the U.S. patent. If the Intellectual Property has not been patented,
royalties may not extend beyond a reasonable period (in light of factors such as the life cycle
and commercial advantages of the products and Intellectual Property and the burden of
administering the royalty arrangement). As used herein, “Intellectual Property” includes
patents, trade secrets and know-how received by the Company from the Consultant or product
development team under a product development agreement. The Company shall establish processes
for reviewing individual Consultant contributions to determine whether Intellectual Property has
been provided to the Company, such processes shall be approved by the Monitor. The persons
responsible for deciding whether Intellectual Property has been provided shall not be involved
in sales functions, and their decision is subject to Monitor approval. The identity of
royalty-bearing products must be reasonable (in light of factors such as the scope of
Intellectual Property transferred, the relationship of the Intellectual Property to the products
and the burden of administering the royalty arrangement) and is subject to Monitor approval.
Royalties must not be paid in advance or in anticipation of product development that might
result in a royalty. No royalty may be paid to a Consultant that is earned by virtue of the use
of the product in question by the Consultant or



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by any member of a practice group of which the Consultant is a member. In lieu of royalties,
a fixed amount may be paid for Intellectual Property provided to the Company, provided the
amount is commercially reasonable and subject to Monitor approval. For patents and patent
applications that are not assigned or licensed to the Company under a product development
agreement, royalties, patent fees, patent costs, and/or a fixed amount may be paid for the
acquisition or licensing of such patents and
patent applications, subject to Monitor approval.




          38. All Consultants on product design teams shall submit invoices, at least quarterly, and
supporting documentation for services rendered to the Company’s design team project manager for
approval, prior to any Payments being made. A Company employee shall be present at all meetings
of product development teams. That employee shall report the date, the participants, and a
summary of the meeting to the project manager. The project manager must certify in writing that
the invoices reflect bona fide services provided by the Consultant. These invoices, supporting
documentation, and certification must be submitted to the Compliance Office for Payment.




          39. In addition, the following practices have been or shall be implemented no later
than sixty (60) calendar days after the Effective Date:





	 	a.	 	The Company may not make Payments to Consultants for collection of clinical
data unless there is a written agreement defining the required procedures and
protocol and the amount of clinical data to be collected by the Consultant,
pre-approved by the Director of Clinical.
	 
	 	b.	 	The Company may not make Payments to Consultants for research unless there is
a written agreement defining the required procedures and protocol, pre-approved
by the Director of Research and Development. The Company may not provide
unrestricted grants to Consultants.
	 
	 	c.	 	The Company may not fund any fellowships for fellows who work with any
Consultant, with the exception of fellowship funding to legitimate medical
education foundations or institutions so long as that funding is approved in
advance by the Compliance Office and the Monitor;
	 
	 	d.	 	The Company may not make charitable contributions to 501(c)(3) organizations
that are, to the best of the Company’s knowledge after reasonable due diligence
is conducted, controlled by a Consultant or an immediate family member of a
Consultant, or at which an immediate family member of a Consultant is employed.
All charitable contributions must be approved in advance by the Compliance
Office in consultation with the Monitor. The Monitor has the discretion to make
exceptions to the above standard;





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	 	e.	 	Other than Consulting Agreements, the sale of products and associated
equipment and instruments and the purchase of Intellectual Property, the
Company may have no commercial dealings with any Consultant or any entity or
organization that the Company has reason to believe, after reasonable due
diligence is conducted, is controlled by the Consultant or an immediate family
member of the Consultant. The Monitor has the discretion to make exceptions to
the above standard;
	 
	 	f.	 	The Company shall not hire or engage as an agent or distributor anyone in
order to induce a Consultant to use or purchase Company
products; and
	 
	 	g.	 	The Compliance Office shall notify the Monitor of any employees or
independent distributors who are known to bear an immediate family
relationship to any Consultant. In such cases, the Monitor may recommend
changes in assignment or case coverage to avoid actual or perceived conflict
of interest.





Disclosure 




          40. All new Consulting Agreements and renewals shall require Consultants to disclose
their financial engagement with the Company to their patients, as well as affiliated
hospitals.




          41. Within thirty (30) calendar days of the Effective Date of this DPA, the Company shall
prominently feature on its web site the name, city, and state of residence for each of the
Company’s Consultants who were retained at any time in 2007, who provided Consulting Services
to the Company at any time in 2007, or who received any Payments from the Company in 2007. The
Company shall also there disclose the Payments made to each Consultant to date in 2007 within
$25,000 increments, and, within sixty (60) calendar days of the Effective Date, all other
Payments made in other than dollar form. Within ten (10) calendar days after a new Consulting
Agreement or renewal is executed, the Company shall post the name of the Consultant on its web
site. If the Company has or does enter into a Consulting Agreement with an entity rather than
an individual, the Company shall post both the name of the entity and the individual providing
Services to the Company under the Consulting Agreement. Payment information shall be updated
quarterly during the term of this DPA to reflect the total Payments made to each Consultant
within $25,000 increments, and all other Payments made in other than dollar form. The Company
must also disclose this information to the Consultant’s affiliated hospitals.




Compliance, Training, Hotline 




          42. The Company agrees to enhance, support, and maintain its existing training and
education programs, including any programs recommended by the Monitor pursuant to paragraph 18,
above. The programs, which shall be reviewed and approved by the Company President and



13









 






CEO, Board of Directors, General Counsel, Compliance Officer, and the Monitor, shall be
designed to advance and underscore the Company’s commitment to exemplary corporate citizenship,
to best practices of effective corporate governance and the highest principles of integrity and
professionalism, and to fostering a culture of openness, accountability and compliance with
federal health care laws throughout the Company. Completion of such training shall be mandatory
for all Company officers, executives, and employees who are involved in Sales, Marketing, Legal,
Compliance, and other senior executives at the Company as proposed by the Company and approved
by the Monitor (collectively the “Mandatory Participants”). Such training and education shall
cover, at a minimum, all relevant federal health care laws and regulations, internal controls in
place concerning
Consultants and their Consulting Agreements with the Company, and the obligations assumed
by, and responses expected of, the Mandatory Participants upon learning of improper, illegal, or
potentially illegal acts relating to the Company’s sales and marketing of hip and knee
reconstruction and replacement products. The Company President and CEO, Board of Directors,
General Counsel and Compliance Officer shall communicate to the Mandatory Participants, in
writing or by video, their review and endorsement of the training and education programs. The
Company shall commence providing this training within ninety (90) calendar days after the
Effective Date of this DPA.




          43. The Company agrees to establish and/or maintain a confidential hotline and e-mail
address, of which Company employees, agents, and customers are informed and can use to notify
the Company of any concerns about unlawful conduct, other wrongdoing, or evidence that Company
practices do not conform to the requirements of this Agreement. This hotline and e-mail
address shall be reviewed by the Monitor. The Company shall post information about this hotline
on its website and shall inform all those who avail themselves of the hotline of the Company’s
commitment to non-retaliation and to maintain confidentiality and anonymity with respect to
such reports.




          44. [this paragraph left blank intentionally]




Disclosure of Monitor Reports 




          45. The Company agrees that the Monitor may disclose his or her written reports, as
directed by the Office, to any other federal law enforcement or regulatory agency in furtherance
of an investigation of any other matters discovered by, or brought to the attention of, the
Office in connection with the Office’s investigation of the Company or the implementation of
this DPA. The Company may identify any trade secret or proprietary information contained in any
report, and request that the Monitor redact such information prior to disclosure.




Replacement
of Monitor 




14









 





          46. The Company agrees that if the Monitor resigns or is unable to serve the balance of
his or her term, a successor shall be selected by the Office, in consultation with the Company,
within forty-five (45) calendar days. The Company agrees that all provisions in this DPA that
apply to the Monitor shall apply to any successor Monitor. The Company shall be given the
opportunity to meet the successor Monitor before he or she is retained and to submit any
objections to the Office.




Adopting
Recommendations of Monitor 




          47. The Company shall adopt all Recommendations contained in each report submitted by the
Monitor to the Office, unless the Company objects to the Recommendation and the Office agrees
that adoption of the Recommendation should not be required. The Monitor’s reports to the Office
shall not be received or reviewed by the Company prior to submission to the Office; such
reports will be preliminary until the Company is given the opportunity, within ten (10)
calendar days after the submission of the report to the Office, to comment to the Monitor and
the Office in writing upon such reports, and the Monitor has reviewed and provided to the Office responses to such
comments, upon which such reports shall be considered final. In the event the Company disagrees
with any Recommendation of the Monitor, the Company and the Monitor may present the issue to
the United States Attorney for his consideration and final decision, which is non-appealable.




Meeting
with the U.S. Attorney 




          48. Within thirty (30) calendar days of the Effective Date of this DPA, the Company agrees
to call a meeting, on a date mutually agreed upon by the Company and the Office, of Company
senior compliance, sales, and marketing executives, and any other Company employees who the
Company desires to attend, such meeting to be attended by the United States Attorney and other
representatives of the Office for the purpose of communicating the goals and expected effect of
this DPA.




Cooperation 




          49. The Company agrees that its continuing cooperation during the term of this DPA shall
include, but shall not be limited to, the following:





	 	a.	 	Not engaging in or attempting to engage in any criminal conduct;
	 
	 	b.	 	Completely, truthfully and promptly disclosing all non-privileged information
concerning all matters about which the Office and other government agencies
designated by the Office may inquire with respect to the Company’s compliance
with health care laws, and continuing to provide the Office, upon request, all
non-privileged documents and other materials relating to such inquiries;





15









 





	 	c.	 	Consenting to any order sought by the Office permitting disclosure to the
Civil Division of the United States Department of Justice of any materials
relating to compliance with federal health care laws that constitute “matters
occurring before the grand jury” within the meaning of Rule 6(e) of the Federal
Rules of Criminal Procedure. If the Company asserts that any such any material
contains trade secrets or other proprietary information, the Company shall
propose redactions to the Office prior to disclosure to any other governmental
entity, or the material shall be accompanied by a prominent warning notifying the
agency of the protected status of the material;
	 
	 	d.	 	Making available current Company officers and employees and using its best
efforts to make available former Company officers and employees to provide
information and/or testimony at all reasonable times as requested by the Office,
including sworn testimony before a federal grand jury or in federal trials, as
well as interviews with federal law enforcement authorities as may relate to
matters involving compliance with health care laws. The Company is not required
to request of its current or former officers and employees that they forego
seeking the advice of an
attorney nor that they act contrary to that advice. Cooperation under this
paragraph shall include, upon request, identification of witnesses who, to the
Company’s knowledge, may have material non-privileged information regarding the
matters under investigation;
	 
	 	e.	 	Providing testimony, certifications, and other non-privileged information
deemed necessary by the Office or a court to identify or establish the original
location, authenticity, or other evidentiary foundation necessary to admit into
evidence documents in any criminal or other proceeding relating to compliance
with health care laws as requested by the Office;
	 
	 	f.	 	The Company acknowledges and understands that its future cooperation is an
important factor in the decision of the Office to enter into this DPA, and the
Company agrees to continue to cooperate fully with the Office, and with any other
government agency designated by the Office, regarding any issue about which the
Company has knowledge or information with respect to compliance with health care
laws;
	 
	 	g.	 	This agreement to cooperate does not apply to any information provided by the
Company to legal counsel in connection with the provision of legal advice and the
legal advice itself, or to information or documents prepared in anticipation of
litigation, and nothing in this DPA shall be construed to require the Company to
provide any such information or advice to the Office or any other government
agency; and





16









 





	 	h.	 	The cooperation provisions in this paragraph shall not apply in the event that
the Office pursues a criminal prosecution against the Company.





Breach of Agreement 




          50. Should the Office determine, in good faith and in its sole discretion, during the
term of this DPA that the Company has committed any criminal conduct relating to compliance
with health care laws subsequent to the Effective Date of this DPA, the Company shall, in the
discretion of the Office, thereafter be subject to prosecution for any federal crimes of which
the Office has knowledge.




          51. Should the Office determine in good faith and in its sole discretion that the Company
has knowingly and willfully breached any material provision of this DPA, the Office shall
provide written notice to the Company of the alleged breach and provide the Company with a
two-week period from receipt of such notice in which to make a presentation to the Office to
demonstrate that no breach occurred, or, to the extent applicable, that the breach was not
material or knowingly and willfully committed or has been cured. The parties understand and
agree that should the Company fail to make a presentation to the Office within the two-week
period after receiving written notice of an alleged breach, it shall be conclusively presumed
that the Company is in breach of this DPA. In the event the Office determines, in good faith and
in its sole discretion, that a second material breach has occurred, or that the first material
breach has not been
adequately cured, the Office shall provide written notice to the Company of the breach, and
the breach may result, in the sole discretion of the Office, in the prosecution of the Company
relating to the allegations set forth in the criminal complaint described in paragraph 2 above.
In the event of any breach of this DPA that results in a prosecution of the Company, such
prosecution may be premised upon any information provided by or on behalf of the Company to the
Office at any time, unless otherwise agreed when the information was provided. The parties
further understand and agree that the determination whether the Company has breached this DPA
rests solely in the discretion of the Office, and the exercise of discretion by the Office under
this paragraph is not subject to review in any court or tribunal outside the Department of
Justice.




          52. In the event of breach of this DPA as defined in paragraph 50 or 51 above, the
Company may be subject to exclusion by OIG-HHS from participation in all federal health care
programs. Such exclusion shall have national effect and shall also apply to all other federal
procurement and non-procurement programs. Federal health care programs shall not pay anyone for
services or items manufactured, furnished, or distributed by the Company in any capacity while
the Company is excluded. This payment prohibition applies to the Company and all other
individuals and entities (including, for example, anyone who employs or contracts with the
Company, and any hospital or other provider where the Company provides services). The exclusion
applies regardless of who submits the claim or other request for payment. The Company shall not
submit or cause to be submitted to any federal health care program any claim or request for
payment for services or items manufactured, furnished, or distributed by the Company during the
exclusion. Violation of the conditions of the exclusion may result in criminal prosecution, the
imposition of civil monetary penalties and assessments, and an



17









 






additional period of exclusion. The Company further agrees to hold the federal health care
programs, and all federal beneficiaries and/or sponsors, harmless from any financial
responsibility for services or items manufactured, furnished or distributed to such providers,
beneficiaries or sponsors after the effective date of the exclusion. The Company waives any
further notice of the exclusion under 42 U.S.C. § 1320a-7(b)(7), and agrees not to contest such
exclusion either administratively or in any state or federal court. Reinstatement to program
participation is not automatic. If at the end of the period of exclusion the Company wishes to
apply for reinstatement, the Company must submit a written request for reinstatement to the OIG
in accordance with the provisions of 42 C.F.R. §§ 1001.3001-.3005. The Company will not be
reinstated unless and until the OIG approves such request for reinstatement.




Waivers and Limitations 




          53. The Company shall expressly waive all rights to a speedy trial pursuant to the Sixth
Amendment of the United States Constitution, Title 18, United States Code, Section 3161,
Federal Rule of Criminal Procedure 48(b), and any applicable Local Rules of the United States
District Court for the District of New Jersey, for the period that this DPA is in effect for
any prosecution of the Company relating to the allegations set forth in the criminal complaint
described in paragraph 2 above.




          54. In case of a knowing and willful material breach of this DPA, any prosecution
of the Company relating to the allegations set forth in the criminal complaint described in
paragraph 2 above that is not time-barred by the applicable statute of limitations as of the
Effective Date of this DPA may be commenced against the Company notwithstanding the expiration
of any applicable statute of limitations during the term of the DPA. The Company agrees to waive
any claims of improper venue with respect to any prosecution of the Company relating to the
allegations set forth in the criminal complaint described in paragraph 2 above. This waiver is
knowing and voluntary and in express reliance on the advice of counsel. Any such waiver shall
terminate upon final expiration of this DPA.




          55. The Company agrees that, if after the Effective Date, it sells all or substantially all
of the Company’s business operations as they exist as of the Effective Date to a single
purchaser or group of affiliated purchasers during the term of this DPA, or merges with a third
party in a transaction in which the Company is not the surviving entity, the Company shall
include in any contract for such sale or merger a provision binding the purchaser, successor, or
surviving entity to the obligations contained in this DPA.




          56. The Company is simultaneously entering into an agreement with the Office’s Civil
Division (the “Civil Settlement Agreement’) regarding the payment of money to settle certain
civil claims. The Company is also simultaneously entering into a Corporate Integrity Agreement
(“CIA”) with HHS-OIG to implement certain specified compliance measures. Failure by the Company
to comply fully with those material terms of the Civil Settlement Agreement called to occur
during the Effective Period of this DPA may constitute a breach of this DPA; provided, however,
that a breach of the CIA referenced in the Civil Settlement Agreement does not




18









 







constitute a breach of this DPA. Any disputes arising under the CIA shall be resolved
exclusively through the dispute resolution provisions of the CIA.




          57. Nothing in this DPA restricts in any way the ability of the Office to investigate
and prosecute any current or former Company officer, employee, agent or attorney.




          58. It is understood that this DPA is limited to the Company and the Office, and it cannot
bind other federal, state or local authorities. However, the Office will bring this DPA, the
Department of Justice Petite Policy, and the cooperation of the Company and its compliance with
its other obligations under this DPA to the attention of other prosecuting offices, if requested
to do so.




Dismissal
of Complaint 




          59. The Office agrees that if the Company is in full compliance with all of its obligations
under this DPA, the Office, within ten (10) calendar days of the expiration of the term of this
DPA, will seek dismissal with prejudice of the criminal complaint described in paragraph 2
above. Except as otherwise provided herein, during and upon the conclusion of the term of this
DPA, the Office agrees that it will not prosecute the Company further for the matters that have
been the subject of the Office’s investigation relating to this DPA, including but not limited
to Payments that the Company made to Consultants between 2002 and 2006.




The Full Agreement




          60. This DPA constitutes the full and complete agreement between the Company and the Office
and supersedes any previous agreement between them. No additional promises, agreements, or
conditions have been entered into other than those set forth in this DPA, and none will be
entered into unless in writing and signed by the Office, Company counsel, and a duly authorized
representative of the Company. It is understood that the Office may permit exceptions to or
excuse particular requirements set forth in this DPA at the written request of the Company or
the Monitor, but any such permission shall be in writing.




AGREED TO:




	 	 	 	 	 
	/s/ David C. Dvorak

	 	/s/ Christopher J. Christie
	 	 
	 

	 	 	 	 
	David C. Dvorak

	 	Christopher J. Christie	 	 
	Chief Executive Officer and President

	 	United States Attorney	 	 
	Zimmer Holdings, Inc.

	 	District of New Jersey	 	 
	 
	 	 	 	 
	9/27/07
	 	9/27/07	 	 
	 

	 	 	 	 
	Date

	 	Date	 	 






19









 






DIRECTOR’S CERTIFICATE




          I have read this agreement and carefully reviewed every part of it with counsel for the
Company. I understand the terms of this Deferred Prosecution Agreement and voluntarily agree, on
behalf of Zimmer Holdings, Inc. and Zimmer Inc., to each of the terms. Before signing this
Deferred Prosecution Agreement, I consulted with the attorney for the Company. The attorney
fully advised me of the Company’s rights, of possible defenses, of the Sentencing Guidelines’
provisions, and of the consequences of entering into this Deferred Prosecution Agreement. No
promises or inducements have been made other than those contained in this Deferred Prosecution
Agreement. Furthermore, no one has threatened or forced me, or to my knowledge any person
authorizing this Deferred Prosecution Agreement on behalf of the Company, in any way to enter
into this Deferred Prosecution Agreement. I am also satisfied with the attorney’s representation
in this matter. I certify that I am a director of Zimmer Holdings,
Inc., and that I have been
duly authorized by the Board of Directors of Zimmer Holdings, Inc. to execute this certificate
on behalf of the Company.




	 	 	 	 	 
	 
	/s/ David C. Dvorak 
	 	    9/27/07 

	 	 
	Zimmer Holdings, Inc.

	 	Date	 	 






20









 






CERTIFICATE
OF COUNSEL 




          I am counsel for the Company. In connection with such representation, I have examined
relevant Company documents, and have discussed this Deferred Prosecution Agreement with the
authorized representative of the Company. Based on my review of the foregoing materials and
discussions, I am of the opinion that:




          1. The undersigned counsel is duly authorized to enter into this Deferred
Prosecution Agreement on behalf of the Company; and




          2. This Deferred Prosecution Agreement 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 every part of this Deferred Prosecution Agreement with
directors of the Company. I have fully advised these directors of the Company’s rights, of
possible defenses, of the Sentencing Guidelines’ provisions, and of the consequences of entering
into this Agreement. To my knowledge, the Company’s decision to enter into this Agreement is an
informed and voluntary one.




	 	 	 	 	 
	/s/ Frederick Robinson 
	 	    9/27/07 

	 	 
	Fulbright & Jaworski, L.L.P.

	 	Date	 	 
	Attorneys for the Company
	 	 	 	 






21









 






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, Zimmer, Inc. has been engaged in discussions with the United States
Attorney’s Office for the District of New Jersey (the “Office”) in connection with an
investigation being conducted by the Office;




          WHEREAS, the Board of Directors of Zimmer Holdings, Inc. consents to resolution of these
discussions by entering into a deferred prosecution agreement that the Zimmer Holdings, Inc.
Board of Directors has reviewed with outside counsel representing Zimmer, relating to a
criminal complaint to be filed in the U.S. District Court for the District of New Jersey
charging Zimmer, Inc. with conspiracy to commit violations of the federal anti-kickback
statute;




          NOW THEREFORE, BE IT RESOLVED that outside counsel representing Zimmer Holdings, Inc. and
Zimmer, Inc. from Fulbright & Jaworski L.L.P. be, and they hereby are authorized to execute
the Deferred Prosecution Agreement on behalf of Zimmer substantially in the same form as
reviewed by the Company Board of Directors at this meeting and as attached hereto as Exhibit
A, and that a Director of Zimmer Holdings Inc. is authorized to execute the Director’s
Certificate attached thereto.




22









 





SECRETARY’S CERTIFICATION




          I, Chad F. Phipps, the duly elected Secretary of Zimmer Holdings, Inc. (the parent
company of Zimmer, Inc., which is referred to in the accompanying Deferred Prosecution
Agreement as 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 a meeting held at the
[location] on the [date];




          WHEREAS, Zimmer, Inc. has been engaged in discussions with the United States
Attorney’s Office for the District of New Jersey (the “Office”) in connection with an
investigation being conducted by the Office into activities of Zimmer, Inc. relating to
certain payments to Consultants who have selected orthopaedic hip and knee replacement
products manufactured by the Company in surgeries performed by them;




          WHEREAS, the Board of Directors of the Company consents to resolution of these discussions
on behalf of Zimmer, Inc. by entering into a deferred prosecution agreement that the Board of
Directors has reviewed with outside counsel representing Zimmer, relating to a criminal
complaint to be filed in the U.S. District Court for the District of New Jersey charging Zimmer,
Inc. with conspiracy to commit violations of the federal anti-kickback statute;




          NOW THEREFORE, BE IT RESOLVED that outside counsel representing Zimmer from Fulbright &
Jaworski, L.L.P. be, and they hereby are authorized to execute the Deferred Prosecution
Agreement on behalf of Zimmer substantially in the same form as reviewed by the Board of
Directors at this meeting and as attached hereto as Exhibit A, and that a Director of the
Company 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 27th day of September, 2007.




	 	 	 	 	 
	 

	 	/s/ Chad F. Phipps
	 	 
	 

	 	 	 	 
	 

	 	Chad F. Phipps, Secretary	 	 
	 

	 	Zimmer Holdings, Inc.	 	 






SEAL





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