Document:

exv10w1

Exhibit 10.1

AMENDED AND RESTATED EMPLOYMENT AGREEMENT

     THIS EMPLOYMENT AGREEMENT (the “Agreement”) is effective as of December 29, 2009 (the
“Effective Date”), by and between FIDELITY NATIONAL INFORMATION SERVICES, INC., a Georgia
corporation (the “Company”), and GARY A. NORCROSS (the “Employee”). In consideration of the mutual
covenants and agreements set forth herein, the parties agree as follows:

     1. Purpose and Release. The purpose of this Agreement is to: (i) amend, restate and
replace all prior agreements between Employee and Company, or one of its affiliates, relating to
the subject matter of this Agreement; (ii) recognize Employee’s significant contributions to the
overall financial performance and success of Company; (iii) protect Company’s business interests
through the addition of restrictive covenants; and (iv) provide a single, integrated document which
shall provide the basis for Employee’s continued employment by Company.

     2. Employment and Duties. Subject to the terms and conditions of this Agreement,
Company employs Employee to serve as Chief Operating Officer reporting to the Company’s Chief
Executive Officer (the “CEO”), or in such other capacity as may be mutually agreed by the parties.
Employee accepts such employment and agrees to undertake and discharge the duties, functions and
responsibilities commensurate with the aforesaid position and such other duties and
responsibilities as may be prescribed from time to time by the CEO or the Board of Directors of the
Company (the “Board”). Employee shall not be required to report to any individual other than the
CEO who occupies such position as of the Effective Date, and a breach of this provision shall be
considered a material breach. Except as expressly provided in this Agreement, Employee shall
devote substantially all business time, attention and effort to the performance of duties
hereunder, and shall not engage in any business, profession or occupation, for compensation or
otherwise without the express written consent of the CEO or Board, other than personal, personal
investment, charitable, or civic activities or other matters that do not conflict with Employee’s
duties.

     3. Term. The term of this Agreement shall commence on the Effective Date and shall
continue for a period of three (3) years ending on the third anniversary of the Effective Date or,
if later, ending on the last day of any extension made pursuant to the next sentence, subject to
prior termination as set forth in Section 8 (such term, including any extensions pursuant to the
next sentence, the “Employment Term”). The Employment Term shall be extended automatically for one
(1) additional year on the first anniversary of the Effective Date and for an additional year each
anniversary thereafter unless and until either party gives written notice to the other not to
extend the Employment Term before the anniversary date on which such extension would be
effectuated.

     4. Salary. During the Employment Term, Company shall pay Employee an annual base
salary, before deducting all applicable withholdings, of no less than $650,000.00 per year, payable
at the time and in the manner dictated by Company’s standard payroll policies. Such minimum annual
base salary may be periodically reviewed and increased (but not, at any point, decreased without
Employee’s express written consent) at the discretion of the CEO, Board or Compensation Committee
of the Board (the “Committee”) to reflect, among other
matters, cost of living increases and performance results (such annual base salary, including any increases,
the “Annual Base Salary”).

 

 

     5. Other Compensation and Fringe Benefits. In addition to any executive bonus,
pension, deferred compensation and long-term incentive plans which Company or an affiliate of
Company may from time to time make available to Employee, Employee shall be entitled to the
following during the Employment Term:

	 	(a)	 	equivalent or more beneficial medical and other insurance coverage (for
Employee and any covered dependents) provided by Company to executives with the same
corporate title (e.g., Corporate Executive Vice President);
	 
	 	(b)	 	supplemental disability insurance sufficient to provide a benefit to Employee
equal to two-thirds of Employee’s pre-disability Annual Base Salary, provided that such
coverage is available in the market using traditional standards of underwriting;
	 
	 	(c)	 	an annual incentive bonus opportunity under Company’s annual incentive plan
(“Annual Bonus Plan”) for each calendar year included in the Employment Term, with such
opportunity to be earned based upon attainment of performance objectives established by
the Board or Committee (“Annual Bonus”). Employee’s target Annual Bonus under the
Annual Bonus Plan shall be no less than 150% of Employee’s then current Annual Base
Salary, with a maximum of up to 300% of Employee’s then current Annual Base Salary
(collectively, the target and maximum Annual Bonus are referred to as the “Annual Bonus
Opportunity”). Employee’s Annual Bonus Opportunity may be periodically reviewed and
increased, but may not be decreased without Employee’s express written consent. If owed
pursuant to the terms of the Annual Bonus Plan, the Annual Bonus shall be paid no later
than the March 15th first following the calendar year to which the Annual
Bonus relates. Unless provided otherwise herein or the Board determines otherwise, no
Annual Bonus shall be paid to Employee unless Employee is employed by Company, or an
affiliate thereof, on the Annual Bonus payment date;
	 
	 	(d)	 	eligibility to participate in Company’s equity incentive plans; and
	 
	 	(e)	 	all other benefits and incentive opportunities customarily made available to
executives with the same corporate title.

     6. Vacation. For and during each calendar year within the Employment Term, Employee
shall be entitled to reasonable paid vacation periods and holidays consistent with Employee’s
position and in accordance with Company’s standard policies, or as the CEO, Board or Committee may
approve.

     7. Expense Reimbursement. In addition to the compensation and benefits provided
herein, Company shall, upon receipt of appropriate documentation, reimburse Employee each month for
reasonable travel, lodging, entertainment, promotion and other ordinary and necessary

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business expenses incurred during the Employment Term to the extent such reimbursement is
permitted under Company’s expense reimbursement policy.

     8. Termination of Employment. Company or Employee may terminate Employee’s employment
at any time and for any reason in accordance with Subsection (a) below. The Employment Term shall
be deemed to have ended on the last day of Employee’s employment. The Employment Term shall
terminate automatically upon Employee’s death.

	 	(a)	 	Notice of Termination. Any purported termination of Employee’s
employment (other than by reason of death) shall be communicated by written Notice of
Termination (as defined herein) from one party to the other in accordance with the
notice provisions contained in this Agreement. For purposes of this Agreement, a
“Notice of Termination” shall mean a notice that indicates the “Date of Termination”
and, with respect to a termination due to “Cause”, “Disability” or “Good Reason”, sets
forth in reasonable detail the facts and circumstances that are alleged to provide a
basis for such termination. A Notice of Termination from Company shall specify whether
the termination is with or without Cause or due to Employee’s Disability. A Notice of
Termination from Employee shall specify whether the termination is with or without Good
Reason.
	 
	 	(b)	 	Date of Termination. For purposes of this Agreement, “Date of
Termination” shall mean the date specified in the Notice of Termination (but in no
event shall such date be earlier than the thirtieth (30th) day following the
date the Notice of Termination is given) or the date of Employee’s death.
	 
	 	(c)	 	No Waiver. The failure to set forth any fact or circumstance in a
Notice of Termination, which fact or circumstance was not known to the party giving the
Notice of Termination when the notice was given, shall not constitute a waiver of the
right to assert such fact or circumstance in an attempt to enforce any right under or
provision of this Agreement.
	 
	 	(d)	 	Cause. For purposes of this Agreement, a termination for “Cause” means
a termination by Company based upon Employee’s: (i) persistent failure to perform
duties consistent with a commercially reasonable standard of care (other than due to a
physical or mental impairment or due to an action or inaction directed by Company that
would otherwise constitute Good Reason); (ii) willful neglect of duties (other than due
to a physical or mental impairment or due to an action or inaction directed by Company
that would otherwise constitute Good Reason); (iii) conviction of, or pleading nolo
contendere to, criminal or other illegal activities involving dishonesty or moral
turpitude; (iv) material breach of this Agreement; (v) material breach of the Company’s
business policies, accounting practices or standards of ethics; or (vi) failure to
materially cooperate with or impeding an investigation authorized by the Board. The
Employee’s termination for Cause shall be effective when and if a resolution is duly
adopted by an affirmative vote of the Board stating that, in the good faith opinion of
the Board, the Employee is guilty of the conduct described in the Notice of Termination
and such conduct constitutes Cause under this Agreement; provided, however, that the
Employee

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	 	 	 	shall have been given reasonable opportunity (i) to cure any act or omission that
constitutes Cause if capable of cure and (ii), together with counsel, during the
thirty (30) day period following the receipt by the Employee of the Notice of
Termination and prior to the adoption of the Board’s resolution, to be heard by the
Board.

	 	(e)	 	Disability. For purposes of this Agreement, a termination based upon
“Disability” means a termination by Company based upon Employee’s entitlement to
long-term disability benefits under Company’s long-term disability plan or policy, as
the case may be, as in effect on the Date of Termination.
	 
	 	(f)	 	Good Reason. For purposes of this Agreement, a termination for “Good
Reason” means a termination by Employee based upon the occurrence (without Employee’s
express written consent) of any of the following:

	 	(i)	 	a material adverse change in Employee’s position or title, or a
material diminution in Employee’s managerial authority, duties or
responsibilities or the conditions under which such duties or responsibilities
are performed (e.g., a material reduction in the number or scope of
department(s), functional group(s) or personnel over which Employee has
managerial authority), in each case as in effect immediately following the
Effective Date;
	 
	 	(ii)	 	a material adverse change in the position to whom Employee
reports (e.g., CEO), or a material diminution in the managerial authority,
duties or responsibilities of the person in that position, in each case as in
effect immediately following the Effective Date;
	 
	 	(iii)	 	a material change in the geographic location of Employee’s
principal working location (currently, 601 Riverside Avenue, Jacksonville,
Florida), which Company has determined to be a relocation of more than
thirty-five (35) miles;
	 
	 	(iv)	 	a material diminution in Employee’s Annual Base Salary or
Annual Bonus Opportunity;
	 
	 	(v)	 	a material breach by Company of any of its obligations under
this Agreement;
	 
	 	(vi)	 	the Company giving Employee notice of its intent not to extend
the Employment Term any time during the one (1) year period immediately
following a Change in Control; or
	 
	 	(vii)	 	the failure of Company to obtain the assumption of this
Agreement as required by Section 20.

Notwithstanding the foregoing, Employee being placed on a paid leave for up to sixty (60) days
pending a determination of whether there is a basis to terminate Employee for Cause shall not

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constitute Good Reason. Employee’s continued employment shall not constitute consent to, or a
waiver of rights with respect to, any act or failure to act constituting Good Reason hereunder;
provided, however, that no such event described above shall constitute Good Reason unless: (1)
Employee gives Notice of Termination to Company specifying the condition or event relied upon for
such termination within ninety (90) days of the initial existence of such event and (2) Company
fails to cure the condition or event constituting Good Reason within thirty (30) days following
receipt of Employee’s Notice of Termination.

“Change in Control” shall mean a change in the ownership or effective control of the Company or a
change in control of a substantial portion of the assets of the Company, within the meaning of
Treasury Regulation Section 1.409A-3(i)(5). Company agrees to provide Employee with advance
written notice of the date of the one year period following a Change in Control.

     9. Obligations of Company Upon Termination.

	 	(a)	 	Termination by Company for a Reason Other than Cause, Death or Disability
and Termination by Employee for Good Reason. If Employee’s employment is
terminated during the Employment Term by: (1) Company for any reason other than Cause,
Death or Disability; or (2) Employee for Good Reason:

	 	(i)	 	Company shall pay Employee the following (collectively, the
“Accrued Obligations”): (A) within five (5) business days after the Date of
Termination, any earned but unpaid Annual Base Salary; (B) within a reasonable
time following submission of all applicable documentation, any expense
reimbursement payments owed to Employee for expenses incurred prior to the Date
of Termination; and (C) no later than March 15th of the year in which the Date
of Termination occurs, any earned but unpaid Annual Bonus payments relating to
the prior calendar year;
	 
	 	(ii)	 	Company shall pay Employee no later than March 15th
of the calendar year following the year in which the Date of Termination
occurs, a prorated Annual Bonus based upon the actual Annual Bonus that would
have been earned by Employee for the year in which the Date of Termination
occurs, ignoring any requirement under the Annual Bonus Plan that Employee must
be employed on the payment date (using Employee’s Annual Bonus Opportunity for
the prior year if no Annual Bonus Opportunity has been approved for the year in
which the Date of Termination occurs), multiplied by the percentage of the
calendar year completed before the Date of Termination;
	 
	 	(iii)	 	Company shall pay Employee as soon as practicable, but not
later than the sixty-fifth (65th) day after the Date of Termination, a lump-sum
payment equal to 300% of the sum of: (A) Employee’s Annual Base Salary in
effect immediately prior to the Date of Termination (disregarding any reduction
in Annual Base Salary to which Employee did not expressly consent in writing);
and (B) the highest Annual Bonus paid to Employee by Company within the three
(3) years preceding termination of employment or, if higher, the target Annual Bonus in the year in which the Date of
Termination occurs;

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	 	(iv)	 	All stock option, restricted stock and other equity-based
incentive awards granted by Company that were outstanding but not vested as of
the Date of Termination shall become immediately vested and/or payable, as the
case may be, unless the equity incentive awards are based upon satisfaction of
performance criteria; in which case, they will only vest pursuant to their
express terms;
	 
	 	(v)	 	Any life insurance coverage provided by the Company shall
terminate at the same time as life insurance coverage would normally terminate
for any other employee that terminates employment with the Company, and
Employee shall have the right to convert that life insurance coverage to an
individual policy under the regular rules of the Company’s group policy. In
addition, as soon as practicable, but not later than the sixty-fifth (65th) day
after the Date of Termination, Company shall pay Employee a lump sum cash
payment equal to thirty-six monthly life insurance premiums based on the
monthly premiums that would be due assuming that Employee had converted
Company’s life insurance coverage that was in effect on the Notice of
Termination into an individual policy; and
	 
	 	(vi)	 	As long as Employee pays the full monthly premiums for COBRA
coverage, Company shall provide Employee and, as applicable, Employee’s
eligible dependents with continued medical and dental coverage, on the same
basis as provided to Company’s active executives and their dependents until the
earlier of: (i) three (3) years after the Date of Termination; or (ii) the date
Employee is first eligible for medical and dental coverage (without
pre-existing condition limitations) with a subsequent employer. In addition,
as soon as practicable, but not later than the sixty-fifth (65th) day after the
Date of Termination, Company shall pay Employee a lump sum cash payment equal
to thirty-six monthly medical and dental COBRA premiums based on the level of
coverage in effect for the Employee (e.g., employee only or family coverage) on
the Date of Termination.

	 	(b)	 	Termination by Company for Cause and by Employee without Good Reason.
If Employee’s employment is terminated during the Employment Term by Company for Cause
or by Employee without Good Reason, Company’s only obligation under this Agreement
shall be payment of any Accrued Obligations.
	 
	 	(c)	 	Termination due to Death or Disability. If Employee’s employment is
terminated during the Employment Term due to death or Disability, Company shall pay
Employee (or to Employee’s estate or personal representative in the case of death), as
soon as practicable, but not later than the sixty-fifth (65th) day after the Date of
Termination: (i) any Accrued Obligations; plus (ii) a prorated Annual Bonus based upon
the target Annual Bonus Opportunity in the year in which the

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	 	 	 	Date of Termination occurred (or the prior year if no target Annual Bonus
Opportunity has yet been determined) multiplied by the percentage of the calendar
year completed before the Date of Termination; plus (iii) the unpaid portion of the
Annual Base Salary that would have been paid through the remainder of the Employment
Term.

     10. Non-Delegation of Employee’s Rights. The obligations, rights and benefits of
Employee hereunder are personal and may not be delegated, assigned or transferred in any manner
whatsoever, nor are such obligations, rights or benefits subject to involuntary alienation,
assignment or transfer.

     11. Confidential Information. Employee will occupy a position of trust and confidence
and will have access to and learn substantial information about Company and its affiliates and
their operations that is confidential or not generally known in the industry including, without
limitation, information that relates to purchasing, sales, customers, marketing, and the financial
positions and financing arrangements of Company and its affiliates. Employee agrees that all such
information is proprietary or confidential, or constitutes trade secrets and is the sole property
of Company and/or its affiliates, as the case may be. Employee will keep confidential, and will not
reproduce, copy or disclose to any other person or firm, any such information or any documents or
information relating to Company’s or its affiliates’ methods, processes, customers, accounts,
analyses, systems, charts, programs, procedures, correspondence or records, or any other documents
used or owned by Company or any of its affiliates, nor will Employee advise, discuss with or in any
way assist any other person, firm or entity in obtaining or learning about any of the items
described in this section. Accordingly, during the Employment Term and at all times thereafter
Employee will not disclose, or permit or encourage anyone else to disclose, any such information,
nor will Employee utilize any such information, either alone or with others, outside the scope of
Employee’s duties and responsibilities with Company and its affiliates.

     12. Non-Competition.

	 	(a)	 	During Employment Term. During the Employment Term Employee will devote
such business time, attention and energies reasonably necessary to the diligent and
faithful performance of the services to Company and its affiliates, and will not engage
in any way whatsoever, directly or indirectly, in any business that is a direct
competitor with Company’s or its affiliates’ principal business, nor solicit customers,
suppliers or employees of Company or affiliates on behalf of, or in any other manner
work for or assist any business which is a direct competitor with Company’s or its
affiliates’ principal business. In addition, during the Employment Term, Employee will
undertake no planning for or organization of any business activity competitive with the
work performed as an employee of Company, and Employee will not combine or conspire
with any other employee of Company or any other person for the purpose of organizing
any such competitive business activity.
	 
	 	(b)	 	After Employment Term. The parties acknowledge that Employee will
acquire substantial knowledge and information concerning the business of Company and

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	 	 	 	its affiliates as a result of employment. The parties further acknowledge that the
scope of business in which Company and its affiliates are engaged as of the
Effective Date is national and very competitive and one in which few companies can
successfully compete. Competition by Employee in that business after the Employment
Term would severely injure Company and its affiliates. Accordingly, for a period of
one (1) year after Employee’s employment terminates for any reason whatsoever,
except as otherwise stated herein below, Employee agrees: (1) not to become an
employee, consultant, advisor, principal, partner or substantial shareholder of any
firm or business that directly competes with Company or its affiliates in their
principal products and markets; and (2), on behalf of any such competitive firm or
business, not to solicit any person or business that was at the time of such
termination and remains a customer or prospective customer, a supplier or
prospective supplier, or an employee of Company or an affiliate. Notwithstanding
any of the foregoing provisions to the contrary, Employee shall not be subject to
the restrictions set forth in this Subsection (b) if Employee’s employment is
terminated by Company without Cause or by Employee for Good Reason under paragraph
8(f)(i-v), but shall apply if Employee’s employment is terminated by Employee for
Good Reason under paragraph 8(f)(vi ) or (vii). However, if Employee’s employment
is terminated by Employee for Good Reason under any of the events specified in
paragraph 8(f)(i-iv) and such event(s) occur within one year of a Change in Control,
then Employee shall be subject to the restrictions set forth in this Subsection (b).

	 	(c)	 	Exclusion. Working, directly or indirectly, for any of the following
entities shall not be considered competitive to Company or its affiliates for the
purpose of this section: (i) Fidelity National Financial, Inc., its affiliates or their
successors; (ii) Lender Processing Services Inc., its affiliates or their successors;
or (iii) Fidelity National Information Services, Inc., its affiliates or their
successors, if this Agreement is assumed by a third party as contemplated herein.

     13. Return of Company Documents. Upon termination of the Employment Term, Employee
shall return immediately to Company all records and documents of or pertaining to Company or its
affiliates and shall not make or retain any copy or extract of any such record or document, or any
other property of Company or its affiliates.

     14. Improvements and Inventions. Any and all improvements or inventions that Employee
may make or participate in during the Employment Term, unless wholly unrelated to the business of
Company and its affiliates and not produced within the scope of Employee’s employment hereunder,
shall be the sole and exclusive property of Company. Employee shall, whenever requested by Company,
execute and deliver any and all documents that Company deems appropriate in order to apply for and
obtain patents or copyrights in improvements or inventions or in order to assign and/or convey to
Company the sole and exclusive right, title and interest in and to such improvements, inventions,
patents, copyrights or applications.

     15. Actions and Survival. The parties agree and acknowledge that the rights conveyed
by this Agreement are of a unique and special nature and that Company will not have an adequate
remedy at law in the event of a failure by Employee to abide by its terms and

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conditions, nor will money damages adequately compensate for such injury. Therefore, in the
event of a breach of this Agreement by Employee, Company shall have the right, among other rights,
to damages sustained thereby and to obtain an injunction or decree of specific performance from a
court of competent jurisdiction to restrain or compel Employee to perform as agreed herein.
Notwithstanding any termination of this Agreement or Employee’s employment, Section 9 shall remain
in effect until all obligations and benefits resulting from a termination of Employee’s employment
during the Term are satisfied. In addition, Sections 10 through 26 shall survive the termination of
this Agreement or Employee’s employment and shall remain in effect for the periods specified
therein or, if no period is specified, until all obligations thereunder have been satisfied.
Nothing in this Agreement shall in any way limit or exclude any other right granted by law or
equity to Company.

     16. Release. Notwithstanding any provision herein to the contrary, Company may
require that, prior to payment, distribution or other benefit under this Agreement (other than due
to Employee’s death), Employee shall have executed a complete release of Company and its affiliates
and related parties in such form as is reasonably required by Company, and any waiting periods
contained in such release shall have expired. With respect to any release required to receive
payments, distributions or other benefits owed pursuant to this Agreement, Company must provide
Employee with the form of release no later than seven (7) days after the Date of Termination and
the release must be signed by Employee and returned to Company, unchanged, effective and
irrevocable, no later than sixty (60) days after the Date of Termination.

     17. No Mitigation. Company agrees that, if Employee’s employment hereunder is
terminated during the Employment Term, Employee is not required to seek other employment or to
attempt in any way to reduce any amounts payable to Employee by Company hereunder. Further, the
amount of any payment or benefit provided for hereunder shall not be reduced by any compensation
earned by Employee as the result of employment by another employer, by retirement benefits or
otherwise.

     18. Entire Agreement and Amendment. This Agreement embodies the entire agreement and
understanding of the parties hereto in respect of the subject matter of this Agreement, and
supersedes and replaces all prior agreements, understandings and commitments with respect to such
subject matter. This Agreement may be amended only by a written document signed by both parties to
this Agreement.

     19. Governing Law. This Agreement shall be governed by, and construed in accordance
with, the laws of the State of Florida, excluding any conflicts or choice of law rule or principle
that might otherwise refer construction or interpretation of this Agreement to the substantive law
of another jurisdiction. Any litigation pertaining to this Agreement shall be exclusively
adjudicated in courts located in Duval County, Florida.

     20. Successors. This Agreement may not be assigned by Employee. In addition to any
obligations imposed by law upon any successor to Company, Company will require any successor
(whether direct or indirect, by purchase, merger, consolidation or otherwise) to all or
substantially all of the stock, business and/or assets of Company, to expressly assume and agree to
perform this Agreement in the same manner and to the same extent that Company would be required to
perform it if no such succession had taken place. Failure of Company to obtain such

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assumption by a successor shall be a material breach of this Agreement. Employee agrees and
consents to any such assumption by a successor of Company, as well as any assignment of this
Agreement by Company for that purpose. As used in this Agreement, “Company” shall mean Company as
herein before defined as well as any such successor that expressly assumes this Agreement or
otherwise becomes bound by all of its terms and provisions by operation of law. This Agreement
shall be binding upon and inure to the benefit of the parties and their permitted successors or
assigns.

     21. Counterparts. This Agreement may be executed in counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and the same instrument.

     22. Attorneys’ Fees. If any party finds it necessary to employ legal counsel or to
bring an action at law or other proceedings against the other party to interpret or enforce any of
the terms hereof, the party prevailing in any such action or other proceeding shall be promptly
paid by the other party its reasonable legal fees, court costs and litigation expenses, all as
determined by the court and not a jury, and such payment shall be made by the non-prevailing party
within sixty (60) days of the date the right to the payment amount is so determined; provided,
however, that following Employees termination of employment with the Company, if any party finds it
necessary to employ legal counsel or to bring an action at law or other proceedings against the
other party to interpret or enforce any of the terms hereof, Company shall pay (on an ongoing
basis) to Employee to the fullest extent permitted by law, all legal fees, court costs and
litigation expenses reasonably incurred by Employee or others on Employee’s behalf (such amounts
collectively referred to as the “Reimbursed Amounts”); provided, further, that Employee shall
reimburse Company for the Reimbursed Amounts if it is determined that a majority of Employee’s
claims or defenses were frivolous or without merit. Requests for payment of Reimbursed Amounts,
together with all documents required by the Company to substantiate them, must be submitted to
Company no later than ninety (90) days after the expense was incurred. The Reimbursed Amounts shall
be paid by Company within ninety (90) days after receiving the request and all substantiating
documents requested from Employee. The rights under this section shall survive the termination of
employment and this Agreement until the expiration of the applicable statute of limitations.

     23. Severability. If any section, subsection or provision hereof is found for any
reason whatsoever to be invalid or inoperative, that section, subsection or provision shall be
deemed severable and shall not affect the force and validity of any other provision of this
Agreement. If any covenant herein is determined by a court to be overly broad thereby making the
covenant unenforceable, the parties agree and it is their desire that such court shall substitute a
reasonable judicially enforceable limitation in place of the offensive part of the covenant and
that as so modified the covenant shall be as fully enforceable as if set forth herein by the
parties themselves in the modified form. The covenants of Employee in this Agreement shall each be
construed as an agreement independent of any other provision in this Agreement, and the existence
of any claim or cause of action of Employee against Company, whether predicated on this Agreement
or otherwise, shall not constitute a defense to the enforcement by Company of the covenants in this
Agreement.

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     24. Notices. Any notice, request, or instruction to be given hereunder shall be in
writing and shall be deemed given when personally delivered or three (3) days after being sent by
United States Certified Mail, postage prepaid, with Return Receipt Requested, to the parties at
their respective addresses set forth below:

To Company:

Fidelity National Information Services, Inc.

601 Riverside Avenue

Jacksonville, FL 32204

Attention: General Counsel

To Employee:

At the most recent address on file at Company

     25. Waiver of Breach. The waiver by any party of any provisions of this Agreement
shall not operate or be construed as a waiver of any prior or subsequent breach by the other party.

     26. Tax.

	 	(a)	 	Withholding. Company or an affiliate may deduct from all compensation
and benefits payable under this Agreement any taxes or withholdings Company is required
to deduct pursuant to state, federal or local laws.
	 
	 	(b)	 	Section 409A. This Agreement and any payment, distribution or other
benefit hereunder shall comply with the requirements of Section 409A of the Code, as
well as any related regulations or other guidance promulgated by the U.S. Department of
the Treasury or the Internal Revenue Service (“Section 409A”), to the extent
applicable. Notwithstanding anything to the contrary, to the extent Employee is a
“specified employee” under Section 409A, no payment, distribution or other benefit
described in this Agreement constituting a distribution of deferred compensation
(within the meaning of Treasury Regulation Section 1.409A-1(b)) to be paid during the
six-month period following a separation from service (within the meaning of Treasury
Regulation Section 1.409A-1(h)) will be made during such six-month period. Instead, any
such deferred compensation shall be paid on the first business day following the
six-month anniversary of the separation from service. In no event may Employee,
directly or indirectly, designate the calendar year of a payment. Any provision that
would cause this Agreement or any payment, distribution or other benefit to fail to
satisfy the requirements of Section 409A shall have no force or effect and, to the
extent an amendment would be effective for purposes of Section 409A, the parties agree
to such amendment as needed to comply with Section 409A and that such amendment shall
be retroactive to the extent permitted by Section 409A. Notwithstanding anything to the
contrary, for purposes of this Agreement, Employee shall not be deemed to have
terminated employment unless and until a

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	 	 	 	separation from service (within the meaning of Treasury Regulation Section
1.409A-1(h)) has occurred. Notwithstanding anything to the contrary, all
reimbursements and in-kind benefits provided under this Agreement shall be made or
provided in accordance with the requirements of Section 409A, including, where
applicable, the requirement that (i) any reimbursement shall be for expenses
incurred during the time period specified in this Agreement, (ii) the amount of
expenses eligible for reimbursement, or in-kind benefits provided, during a calendar
year may not affect the expenses eligible for reimbursement, or in-kind benefits to
be provided, in any other calendar year, (iii) the reimbursement of an eligible
expense will be made not later than the last day of the Employee’s taxable year
following the taxable year in which such expense was incurred, and (iv) the right to
reimbursement or in-kind benefits is not subject to liquidation or exchange for
another benefit.

	 	(c)	 	Excise Taxes. If any payments or benefits paid or provided or to be
paid or provided to Employee or for Employee’s benefit pursuant to the terms of this
Agreement or otherwise in connection with, or arising out of, employment with Company
or its subsidiaries or the termination thereof (a “Payment” and, collectively, the
“Payments”) would be subject to the excise tax imposed by Section 4999 of the Code (the
“Excise Tax”), then Employee may elect for such Payments to be reduced to one dollar
less than the amount that would constitute a “parachute payment” under Section 280G of
the Code (the “Scaled Back Amount”). Any such election must be in writing and delivered
to Company within thirty (30) days after the Date of Termination. If Employee does not
elect to have Payments reduced to the Scaled Back Amount, Employee shall be responsible
for payment of any Excise Tax resulting from the Payments and Employee shall not be
entitled to a gross-up payment under this Agreement or any other for such Excise Tax.
If the Payments are to be reduced, they shall be reduced in the following order of
priority: (i) first from cash compensation, (ii) next from equity compensation, then
(iii) pro-rated among all remaining payments and benefits. To the extent there is a
question as to which Payments within any of the foregoing categories are to be reduced
first, the Payments that will produce the greatest present value reduction in the
Payments with the least reduction in economic value provided to Employee shall be
reduced first.

12

 

     IN WITNESS WHEREOF the parties have executed this Agreement to be effective as of the date
first set forth above.

	 	 	 	 	 
	 	FIDELITY NATIONAL INFORMATION SERVICES, INC.

 	 
	 	By:  	/s/ Frank R. Martire
 	 
	 	 	Its:  President and Chief Executive Officer

 	 
	 	 	 	 
	 
	 	GARY A. NORCROSS

 	 
	 	                             /s/ Gary A. Norcross
 	 
	 	 	 
	 	 	 
	 

13Exhibit 10.1

Exhibit 10.1

Michael Theis, Esq.

Peter Spivack, Esq.

Hogan and Hartson LLP

One Tabor Center, Suite 1500

1200 Seventeenth Street

Denver, Colorado 80202

December 17, 2009

Re: Spectranetics Non-Prosecution Agreement

Dear Messrs. Theis & Spivack:

1. On the understandings specified below, the United States Attorney’s Office for the District
of Colorado and the United States Department of Justice’s Office of Consumer Litigation
(collectively the “Offices”) will not criminally prosecute The Spectranetics Corporation
(“Spectranetics”), or any of its direct or indirect subsidiaries, for any crimes (except for
criminal tax violations as to which these Offices cannot and do not make any agreement), of which
the Offices are aware, related to the conduct by or attributable to Spectranetics that is described
in Exhibit A to this agreement, attached hereto, in the District of Colorado concerning a
conspiracy to commit mail and wire fraud, smuggling and or other import violations, and to violate
provisions of the Food, Drug and Cosmetic Act relating to Spectranetics medical devices from 2003
to 2008.

2. This Non-Prosecution Agreement (“NPA”) does not provide any protection against prosecution
for any crimes or other wrongdoing during the relevant time period except as set forth above, and
applies only to Spectranetics and its direct and indirect subsidiaries, and not to any other
entities nor any individuals.

3. Spectranetics expressly understands that the protections provided to it by this Agreement
shall not apply to any successor entities, whether the successor’s interest arises through a merger
or plan of reorganization, unless and until such successor formally adopts and executes this
Agreement, with the written consent of the Offices herein. The protections arising from this
Agreement will not apply to any purchasers of all or substantially all of the assets of
Spectranetics, unless such purchaser enters into a written agreement, on terms acceptable to these
Offices, agreeing in substance to undertake all obligations set forth in this Agreement. Without
limiting the effect of any other provision of this agreement, these Offices understand and
Spectranetics agrees that should Spectranetics acquire, directly or indirectly, another entity, via
merger, purchase of all or substantially all of their assets or otherwise, Spectranetics will make
reasonable efforts to, and will be afforded a prudent period of time to ensure, that the
newly-acquired entity adopts and implements a compliance program substantially similar in substance
to that adopted by Spectranetics as part of this Agreement and the Corporate Integrity Agreement as
described in Paragraph 7 herein.

 

 

 

4. It is understood that Spectranetics:

	 	a.	 	shall truthfully and completely disclose all information with respect to
the activities of Spectranetics, its present and former officers and
employees, and others concerning all matters about which these Offices
inquire of it, and that such information can be used for any purpose except
as otherwise limited by this Agreement;

	 	b.	 	shall cooperate fully with these Offices, the United States
Food and Drug Administration (“FDA”), Immigration and Customs Enforcement, and
any other law enforcement or regulatory agencies designated by these Offices.
This continued cooperation shall include consenting to any order sought by
these Offices permitting disclosure to these Offices of any materials relating
to compliance with federal laws that constitute “matters occurring before the
grand jury” within the meaning of Rule 6(e) of the Federal Rules of Criminal
Procedure;

	 	c.	 	shall, at these Offices’ request, use its best efforts promptly
to secure the attendance and truthful statements or testimony of any officer,
agent, or employee at any meeting or interview or before the grand jury or at
any trial or any court proceedings;

	 	d.	 	shall promptly provide these Offices, upon request, any
document, record, or other tangible evidence within its possession, custody, or
control relating to matters or conduct about which these Offices or any
designated law enforcement agency inquires;

	 	e.	 	shall promptly bring to these Offices’ attention all criminal
conduct by or criminal investigations of Spectranetics or its respective senior
managerial employees that come to the attention of Spectranetics’ Board of
Directors or senior management, as well as any administrative proceeding or
civil action brought by any governmental authority that alleges criminal
violations by Spectranetics; and,

	 	f.	 	acknowledges and understands that its future cooperation is an
important factor in the decision of these Offices to enter into this NPA, and
Spectranetics agrees to continue to cooperate fully with these Offices, and
with any other government agency designated by these Offices, regarding any
issue about which Spectranetics has knowledge or information with respect to
compliance with federal laws.

5. This agreement to cooperate does not apply to any information protected by the
attorney-client or attorney work-product privileges (“privileged information”) and nothing in this
NPA, including paragraphs 4(a) through (f) above, shall be construed to require Spectranetics to
provide any privileged information to these Offices or any other government agency. This agreement
to cooperate shall not apply in the event that these Offices pursue a criminal
prosecution against Spectranetics. In the event that any materials or information requested
pursuant to paragraph 4 of this NPA contains trade secrets, confidential commercial information, or
other proprietary information (“proprietary information”), such material or information shall be
accompanied by a prominent warning notifying the Offices of the proprietary status of the materials
and information, and these Offices will make every good faith effort to protect the proprietary
information from public disclosure.

 

Page 2 of 11

 

6. Spectranetics accepts and acknowledges responsibility for, and agrees that it will not
contest, the facts as set forth in Exhibit A, incorporated herein by reference. Spectranetics
further agrees that neither it nor its subsidiaries, through its present or future board of
directors, attorneys, officers, agents, or management employees, will make any public statements
contradicting any of the facts as set forth in Exhibit A. Any such contradictory public statement
by Spectranetics, its subsidiaries, its present or future board of directors, attorneys, officers,
agents or management employees, shall constitute a breach of this Agreement, and Spectranetics
would be subject to prosecution by these Offices pursuant to the terms of this Agreement. The
decision of whether any public statement by any such person contradicting a fact contained in
Exhibit A will be imputed to Spectranetics for the purposes of determining whether Spectranetics
has breached this agreement shall be at the sole discretion of these Offices. Upon these Offices’
reaching a determination that such a contradictory statement has been made by Spectranetics, these
Offices shall notify Spectranetics and Spectranetics may avoid a breach of this Agreement by
publicly repudiating such statement after notification by these Offices. This paragraph is not
intended to apply to any statement made by any individual in the course of any criminal,
regulatory, or civil case initiated by the United States against such individuals unless the
individual is speaking on behalf of Spectranetics.

7. It is further understood that Spectranetics shall, in conjunction with this agreement: (a)
adhere to and maintain the enhanced corporate compliance procedures Spectranetics has implemented,
including but not limited to the measures described in Exhibit A; (b) execute a Civil Settlement
Agreement with the United States Attorney for the District of Colorado and the Frauds Section of
the Commercial Litigation Branch of the Department of Justice, and; (c) execute a Corporate
Integrity Agreement (“CIA”) with the Office of the Inspector General for the United States
Department of Health and Human Services that will specify additional protections and procedures to
prevent future violations of law.

8. This Agreement, and Spectranetics’ obligations hereunder, shall remain in effect for a term
of (a) twenty-four (24) months from the day this Agreement is executed or (b) the date upon which
all prosecutions arising out of the conduct described in the opening paragraph of this Agreement
(involving Spectranetics, its employees, or any others) are final, whichever is later.

9. It is understood that, should these Offices determine that Spectranetics has committed any
crimes during the term of this agreement, or that Spectranetics or any of its representatives have
given false, incomplete, or misleading testimony or information, or should Spectranetics otherwise
violate any provision of this Agreement, Spectranetics shall thereafter be subject to prosecution
for any federal violation of which these Offices have knowledge,
including perjury and obstruction of justice; and, any such prosecution that is not
time-barred by the applicable statute of limitations on the date of the signing of this Agreement
may be commenced against Spectranetics, notwithstanding the expiration of the statute of
limitations between the signing of this Agreement and the commencement of such prosecution.

 

Page 3 of 11

 

10. Should these Offices determine, in good faith and in their sole discretion, that
during the term of this NPA that Spectranetics has committed any criminal conduct subsequent to the
Effective Date of this NPA, Spectranetics shall, in the discretion of these Offices, thereafter be
subject to prosecution by these Offices for any criminal conduct subsequent to the Effective Date.

11. It is understood that if these Offices determine that Spectranetics has committed any
crime after signing this Agreement or that Spectranetics or any of its representatives have given
false, incomplete, or misleading testimony or information, or has otherwise violated any provision
of this Agreement, (a) all statements made by Spectranetics’ representatives to these Offices, FDA,
Immigration and Customs Enforcement, or other designated law enforcement agents, and any testimony
given by Spectranetics’ representatives before a grand jury or other tribunal, whether prior to or
subsequent to the signing of this Agreement, and any leads from such statement or testimony shall
be admissible in evidence in any criminal proceeding brought against Spectranetics; and (b)
Spectranetics shall assert no claim under the United States Constitution, any statute, Rule 410 of
the Federal Rules of Evidence, or any other federal rule that such statements or any leads
therefrom should be suppressed. It is the intent of this Agreement to waive all rights in the
foregoing respects.

12. Nothing in this Agreement shall be construed as a waiver of any attorney-client or
work-product privileges. Without limiting the generality of the foregoing, Spectranetics
specifically notes that the Offices executed a search warrant at the premises of Spectranetics
business on September 4, 2008, and that Spectranetics did not and has not voluntarily waived any
privileges with respect to those documents. The Offices acknowledge that Spectranetics promptly
informed them that the Offices had likely taken certain privileged information in executing the
search warrants and that the Offices agreed not to review such material as part of its
investigation, thereby assuring that no privileges were waived. Spectranetics agrees that any
disclosure of material or information to these Offices since January 1, 2009, that might otherwise
be protected under an attorney-client or any other privilege was done so by Spectranetics
voluntarily and of its own free will, and further agrees that such disclosure was not predicate to
the decision by these Offices to enter into this agreement with Spectranetics.

13. It is further understood that Spectranetics and these Offices shall disclose this
Agreement to the public.

14. Nothing in this NPA affects in any way any civil, administrative, regulatory claims,
causes of action, or rights of any federal or state agency.

15. Nothing in this NPA restricts in any way the ability of these Offices to investigate
and prosecute any current or former Spectranetics officer, employee, agent, or attorney.

 

Page 4 of 11

 

16. It is understood that this NPA is limited to Spectranetics and these Offices, and it
cannot bind other federal, state, or local authorities. These Offices will bring this NPA and the
cooperation of Spectranetics, including its compliance with its obligations under this NPA, to the
attention of other prosecuting offices, if accurate and requested to do so.

17. It is understood that by signing this Agreement, the parties representing
Spectranetics are certifying that they possess the authority to do so on behalf of Spectranetics,
and have obtained all necessary authority from the Board of Directors of Spectranetics as required
by the corporate by-laws that govern such grants or authority.

18. With respect to this matter, from the date of the execution of this Agreement forward, the
Agreement supersedes all prior, if any, understandings, promises and/or conditions between these
Offices and Spectranetics. No additional promises, agreements, and conditions have been entered
into other than those set forth in this letter and none will be entered into unless in writing and
signed by all parties.

	 	 	 	 	 
	 	Sincerely,

DAVID GAOUETTE

Acting United States Attorney

 	 
	 	By:  	/s/ Jaime
Pena	 
	 	 	JAIME PENA 	 
	 	 	Assistant U.S. Attorney

1225 17th Street

Suite 700

Denver, CO 80202 (303) 454-0100

Jaime.Pena2@usdoj.gov 	 
	 
	 	  	/s/
 John W. M. Claud	 12/28/09
	 	 	JOHN W. M. CLAUD 	 
	 	 	Trial Attorney

Office of Consumer Litigation

Department of Justice

P.O. Box 386

Washington, D.C. 20044 (202) 514-5747

John.Claud@usdoj.gov

Counsel for the United States 	 

 

Page 5 of 11

 

	 	 	 	 	 

OF COUNSEL:

DAVID S. CADE

Acting General Counsel

MICHAEL M. LANDA

Acting Associate General Counsel

Food and Drug Division

ERIC M. BLUMBERG

Deputy Chief Counsel, Litigation

MICHAEL VARRONE

Associate Chief Counsel

U.S. Department of Health and

Human Services

Office of the General Counsel

5600 Fishers Lane, GCF-1

Rockville, Maryland 20857

 

Page 6 of 11

 

AGREED AND CONSENTED TO

	 	 	 	 	 	 	 
	/s/ Emile Geisenheimer	 	 	 	12/17/2009	 	 
	 

Emile Geisenheimer

	 	 	 	 

Date
	 	 
	Chairman of the Board and Chief Executive Officer
	 	 	 	 	 	 
	The Spectranetics Corporation
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	APPROVED:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	/s/ Peter Spivack	 	 	 	12/22/2009	 	 
	 

Peter Spivack, Esq.

	 	 	 	 

Date
	 	 
	Attorney for The Spectranetics Corporation
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	/s/ Michael Theis	 	 	 	12/18/2009	 	 
	 

Michael Theis, Esq.

	 	 	 	 

Date
	 	 
	Attorney for The Spectranetics Corporation
	 	 	 	 	 	 

 

Page 7 of 11

 

EXHIBIT A

In any criminal prosecution or regulatory action brought by the United States, the following
statement shall be admissible against the Spectranetics Corporation (hereafter, “Spectranetics”)
and/or any of its subsidiaries, as agreed to in Paragraph 11 of the Non-Prosecution Agreement.

Spectranetics is based in Colorado Springs, Colorado. Spectranetics manufactures medical
lasers and peripheral devices associated with them. Those peripheral devices include catheters
that serve as intravenous sleeves that contain optical fibers that deliver laser energy to the
treatment location within the vasculature. Physicians use the lasers and peripheral devices to
perform a number of different procedures, including atherectomies, which are types of procedures
that remove plaque buildup from arteries or vein grafts in order to ease blood flow.

The U.S. Food and Drug Administration’s (“FDA”) Center for Devices and Radiological Health
(“CDRH”) has determined that Spectranetics’ lasers are Class III medical devices. Spectranetics’
laser catheters are Class II and III devices.

CORAL and CORAL REEF Studies

Spectranetics is the holder of an FDA-approved pre-market application (“PMA”) for the CVX-300
Excimer Laser system, PMA P910001, for use in patients with coronary artery disease. As part of
that PMA, FDA has approved the Spectranetics ELCA (“Excimer Laser Coronary Angioplasty”) Laser
Catheters for the treatment of saphenous vein bypass grafts that have become occluded; that is, to
remove arterial plaque constricting blood flow through the transplanted vessels that form the
bypass.1 Spectranetics’ FDA-approved PMA does not include a conditional requirement
that physicians also use distal protection when using the device. Distal protection is a device
such as a mesh basket or other vascular safety device that collects plaque and other debris that
may become dislodged during such procedures.

Spectranetics devised, implemented, and maintained a study named “CORAL” (COronary
graft Results after Atherectomy with Lasers), which occurred between May
2003 and December 2004. CORAL’s clinical objectives were to: (1) test the ability of
Spectranetics’ lasers to dissolve or disintegrate plaque, obviating the need for the use of distal
protection; and, (2) study angiographic results and 30-day major adverse cardiac events (“MACE”)
after
procedures in which doctors used Spectranetics’ excimer laser. The procedures included in
CORAL did not use distal protection.

 

	 	 	 
	1	 	Occluded vessels can be treated by either angioplasty,
the widening of the vessel through the use of stents and balloons, or through
atherectomy, the removal of plaque from the vessel.

 

Page 8 of 11

 

The objective of CORAL was to compare the MACE rates from CORAL patients to those of a
previous study in 2002, the “SAFER” study,2 that measured MACE rates in procedures using
only stents and balloon catheters. The SAFER study concluded that distal protection was warranted
in angioplasty procedures using stents and balloon catheters in order to markedly decrease the risk
of adverse events.

Spectranetics compensated each participating doctor per patient whom he or she enrolled in the
study, apart from the doctor’s Medicare or insurance billing for the procedure. Spectranetics
maintained oversight over the study, and was fully aware of the results. The original enrollment
goal of the study was for 250 patients. Following initial difficulty with enrollments,
Spectranetics reduced the goal to 150 patients in late 2003 or early 2004. The final enrollment of
142 total patients consisted of 97 patients whose angiographic results Spectranetics actually
assessed.

Also in 2003, Spectranetics initiated the CORAL REEF (COronary graft Results
after Atherectomy with Laser: REtrieval of Emboli with a
Filter) study, which enrolled ten patients. In CORAL REEF, the participating physicians
used distal protection to collect embolic plaque and/or debris that lasers dislodged but did not
disintegrate. The objective of CORAL REEF was to study outcomes after laser coronary atherectomy
and stenting in saphenous vein bypass grafts, which included an analysis of embolic debris
collected by use of distal protection. Spectranetics arranged for the examination of the volume
and size of retrieved particles in order to demonstrate the feasibility of retrieval and
measurement of debris produced by vascular intervention in vein grafts.

Spectranetics ended both CORAL and CORAL REEF in late 2004. MACE rates in the CORAL study
were higher than expected. CORAL REEF ended upon its completed enrollment of ten patients.

A Spectranetics 10-Q filing with the Securities and Exchange Commission on May 11, 2005,
summarized the results from CORAL and CORAL REEF.

Spectranetics first reported to the FDA a summary and bibliography of the results from the
CORAL and CORAL REEF registries in its 2008 annual report for the CVX-300, which was filed in
September 2009.

 

	 	 	 
	2	 	The Saphenous vein graft Angioplasty
Free of Emboli Randomized (“SAFER”) trial was an
801-patient study in which patients undergoing saphenous vein graft
intervention underwent either stenting with a conventional guidewire or
stenting with a distal protection device.

 

Page 9 of 11

 

FMD Guidewires

From approximately May 2005 until November 2007, Spectranetics was negotiating with Japanese
manufacturer Future Medical Design Co., Ltd. (“FMD”) to become a distributor for catheter
guidewires that FMD would produce in Japan. During the relevant time period, no catheter
guidewires manufactured by FMD were the subject of: (1) an FDA-approved pre-market approval
application, under 21 U.S.C. § 360e(a)(2) and 21 C.F.R. Part 814; (2) a “510(k) clearance” based on
substantial equivalency to a device already placed into one of the three statutory classification
categories, under 21 U.S.C. §§ 360c(a)(1) and 360(k) and 21 C.F.R. Part 807 — Subpart E; (3) an
investigational device exemption under 21 U.S.C. § 360j(g), for the use of a device on humans on an
experimental basis; or (4) an exemption for certain devices as set forth in 21 U.S.C. § 360(l).

Spectranetics, through the actions of officers, managers, agents, and other employees acting
on behalf of Spectranetics, caused the FMD guidewires, which lacked FDA approval and clearance, and
lacked any exemption from such approval or clearance, to be imported into the United States, and,
knowing the devices did not have FDA approval or clearance, or an exemption from such approval or
clearance, distributed them in interstate commerce to physicians for use in humans. Spectranetics
concluded that no more than ten wires were distributed for such purposes. Certain Spectranetics
officers, managers, agents, and other employees involved in this distribution were aware that the
physicians were using guidewires that lacked approval, clearance, or any exemption from approval or
clearance. Upon their entry into the United States, the guidewires were not accurately declared or
classified to Customs as medical devices or medical equipment by the individuals who brought them
in, or caused them to be imported.

BMT Balloons

From approximately October 2007 until September 2008, Spectranetics was also negotiating with
German manufacturer Bavaria Medizin Technologie (“BMT”) to become a distributor for Percutaneous
Transluminal Angioplasty (“PTA”) balloons, which BMT manufactures in Germany. Additionally during
this time, certain Spectranetics officers, managers, agents, and other employees accepted receipt
from BMT of guidewires manufactured by BMT. During the relevant time period, neither PTA balloon
catheters nor guidewires manufactured by BMT were the subject of an FDA-approved pre-market
approval application, under 21 U.S.C. § 360e(a)(2) and 21 C.F.R. Part 814; (2) a “510(k) clearance”
based on substantial equivalency to a device already placed into one of the three statutory
classification categories, under 21 U.S.C. §§ 360c(a)(1) and 360(k) and 21 C.F.R. Part 807 —
Subpart E; (3) an investigational device exemption under 21 U.S.C. § 360j(g), for the use of a
device on humans on an experimental basis; or (4) an exemption for certain devices as set forth in
21 U.S.C. § 360(l).

 

Page 10 of 11

 

Spectranetics, through the actions of officers, managers, agents, and other employees acting
on behalf of Spectranetics, caused the BMT balloons, which lacked FDA approval and
clearance, and lacked any exemption from such approval or clearance to be imported into the
United States and, knowing the devices did not have FDA approval or clearance, or an exemption from
such approval or clearance, distributed them in interstate commerce to physicians for use in
humans. Spectranetics concluded that no more than five balloons were distributed for such
purposes. Certain Spectranetics officers, managers, agents, and other employees involved in this
distribution were aware that the physicians were using balloons that lacked approval, clearance, or
any exemption from approval or clearance. Upon their entry into the United States, the balloons
were not accurately declared or classified to Customs as medical devices or medical equipment by
the individuals who brought them in, or caused them to be imported.

The Offices’ Investigation and Responsive Corporate Actions

As discussed above, on September 4, 2008, agents from FDA’s Office of Criminal
Investigations and from Immigrations and Customs Enforcement executed a federal search warrant at
Spectranetics corporate headquarters in Colorado Springs, Colorado. After the execution of the
search warrant, Spectranetics revised its FDA compliance procedures, and its internal investigation
determined that wrongdoing was limited to a certain number of officers, managers, agents, and other
employees.

Spectranetics has cooperated with these Offices in their investigation into any wrongdoing
committed by officers or employees, and continues to do so. Spectranetics has also taken remedial
measures, including but not limited to: (1) responsive personnel actions; (2) disclosing its own
research and scientific information relating to the above described incidents that was helpful to
the investigation by these Offices; (3) providing additional specific company wide formal training
on FDA compliance procedures; (4) issuing further FDA compliance guidelines to all of its officers
or employees; (5) continuing to retain and consult with counsel familiar with FDA laws and
regulations; (6) improving its FDA compliance hotline complaint process, and providing additional
training to compliance personnel on procedures for investigating complaints; (7) creating a
corporate compliance charter and compliance auditing system; and (8) appointing a Chief Compliance
Officer.

 

Page 11 of 11

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