defa14a
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
Proxy Statement Pursuant to Section 14(a) of the Securities
Exchange Act of 1934 (Amendment No. )
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Filed by the Registrant x |
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Filed by a Party other than the Registrant o |
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Check the appropriate box: |
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o Preliminary Proxy Statement |
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Confidential, for Use of the Commission Only (as permitted by
Rule 14a-6(e)(2)) |
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o Definitive Proxy Statement |
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x Definitive Additional Materials |
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Soliciting Material Pursuant to §240.14a-12 |
ELI LILLY AND COMPANY
(Name of Registrant as Specified In Its Charter)
(Name of Person(s) Filing Proxy
Statement, if other than the Registrant)
Payment of Filing Fee (Check the appropriate box):
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x No fee required. |
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o Fee computed on table below per Exchange Act Rules 14a-6(i)(4) and
0-11. |
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1) Title of each class of securities to which transaction applies: |
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2) Aggregate number of securities to which transaction applies: |
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3) Per unit price or other underlying value of transaction computed
pursuant to Exchange Act Rule 0-11 (set forth the amount on which the
filing fee is calculated and state how it was determined): |
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4) Proposed maximum aggregate value of transaction: |
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o Fee paid previously with preliminary materials. |
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o Check box if any part of the fee is offset as provided by Exchange Act
Rule 0-11(a)(2) and identify the filing for which the offsetting fee
was paid previously. Identify the previous filing by registration
statement number, or the Form or Schedule and the date of its filing. |
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1) Amount Previously Paid: |
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2) Form, Schedule or Registration Statement No.: |
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SEC 1913 (11-01) |
Persons who are to respond to the collection of information
contained in this form are not required to respond unless the form displays a currently valid
OMB control number. |
Since January 17, 2008, the company has been served with seven shareholder derivative
lawsuits: Lambrecht, et al. v. Taurel, et al., filed January 17, 2008, in the United States
District Court for the Southern District of Indiana; Staehr, et al. v. Eli Lilly and Company, et
al., filed March 27, 2008, in Marion County Superior Court in Indianapolis, Indiana; Waldman, et
al., v. Eli Lilly and Company, et al., filed February 11, 2008, in the United States District Court
for the Eastern District of New York; Solomon v. Eli Lilly and Company, et al., filed March 27,
2008, in Marion County Superior Court in Indianapolis, Indiana; Robbins v. Taurel, et al., filed
April 9, 2008, in the United States District Court for the Eastern District of New York; City of
Taylor General Employees Retirement System v. Taurel, et al., filed April 15, 2008, in the United
States District Court for the Eastern District of New York; and Zemprelli v. Taurel, et al., filed
June 24, 2008, in the United States District Court for the Southern District of Indiana. This
litigation is described on page 64 of our proxy statement, which was mailed to shareholders on
March 8, 2010. The purpose of this filing is to provide the following supplemental information
with regard to this litigation:
Subsequent to the filing of our Form 10-K on February 22, 2010, and the printing of our proxy
statement, the company has reached a proposed settlement agreement with the plaintiffs in the cases
referenced above. On March 5, 2010, we mailed a Notice of Settlement to shareholders as of the
proxy statement record date, providing information about the proposed settlement, shareholders
rights, and a settlement hearing scheduled to be held on April 29, 2010.
A copy of the Notice of Settlement is attached as Exhibit 1.
Exhibit
1
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
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N A. Lambrecht and Jeffrey P. Jannett, Derivatively and |
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on Behalf of Nominal Defendant Eli Lilly & Company, |
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Plaintiffs,
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) Civil Action No. |
v.
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) 08-cv-0068 WTL-TAB |
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Sidney Taurel, John C. Lechleiter, Sir Winfried Bischoff, |
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J. Michael Cook, Franklyn G. Pendergast, Kathi P. |
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Seifert, George M. Fisher, Alfred G. Gilman, Martin S. |
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Feldstein, J. Erik Fyrwald, Ellen R. Marram, Sir John |
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Rose, Charles E. Golden, Steven C. Beering, August M. |
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Watanabe, Linda Lay, Randall L. Tobias and J. Clayburn |
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LaForce, Jr., |
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Defendants.
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-and-
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ELI LILLY & COMPANY, |
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Nominal Defendant.
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NOTICE OF SETTLEMENT OF ELI LILLY & COMPANY
DERIVATIVE CLAIMS
TO: ALL PERSONS WHO OWNED ELI LILLY & COMPANY COMMON STOCK
AS OF FEBRUARY 12, 2010 (LILLY SHAREHOLDERS).
PLEASE READ THIS NOTICE CAREFULLY.
THE DISTRICT COURT FOR THE SOUTHERN DISTRICT OF INDIANA
(THE COURT) HAS AUTHORIZED THIS NOTICE TO BE SENT TO YOU.
THIS IS NOT A SOLICITATION.
This notice (the Notice) advises you of the proposed settlement (the Settlement) of derivative
claims brought against certain current and former directors and officers (Individual Defendants)
of Eli Lilly &
Company (Lilly or the Company). The parties to the Derivative Claims (as defined below) have
entered into a Stipulation of Settlement (the Stipulation), which is subject to Court approval
before becoming final. As detailed below, the parties believe that the proposed Settlement
provides substantial benefits to the Company, and is in the best interests of the Company and its
shareholders. If the Settlement is approved by the Court, all Released Claims against all of the
Released Parties (as those terms are defined in the Stipulation and described in this Notice) will
be dismissed with prejudice. You are provided this Notice because records indicate you are a
shareholder of Lilly as of February 12, 2010.
A hearing (the Settlement Hearing) is scheduled to be held on April 29, 2010 at 10:00 a.m. before
the Honorable William T. Lawrence in Room 307 of the United States Courthouse, 46 E. Ohio Street,
Indianapolis, IN 46204, for the purposes of determining, among other issues, whether to: (i)
finally approve the Settlement; (ii) dismiss the Derivative Complaints (as defined below) with
prejudice; (iii) award attorneys fees and reimbursement of expenses to Plaintiffs Counsel (as
defined in the Stipulation); and (iv) award incentive payments to named plaintiffs. This Notice
summarizes the nature of the Derivative Claims, the terms of the proposed Settlement, and your
rights in connection with the Settlement and the Settlement Hearing. Nothing in this Notice
constitutes a finding of the Court regarding the merits of the claims or defenses asserted by any
party, the merits of the Settlement, or any other matter, nor does it reflect the views of the
Court.
The Individual Defendants have denied and continue to deny each and every one of the claims and
contentions alleged in the Derivative Claims and contend that the claims asserted against them in
the Derivative Claims are without merit.
YOU SHOULD READ THE NOTICE CAREFULLY BECAUSE YOUR LEGAL RIGHTS MAY BE AFFECTED.
What are the Derivative Claims About?
The Derivative Claims1 that are the subject of this Notice seek recovery on behalf of
Lilly based on claims of breach of fiduciary duty asserted against the Individual Defendants. In
2007, three Lilly shareholders wrote to Lillys board of directors (Board) demanding that the
Board take remedial action for alleged breaches of fiduciary duty (the Demand Letters). A
variety of issues were raised in the Demand Letters regarding Lillys purportedly illegal marketing
and promotion of Prozac, Evista, and Zyprexa, including concealment of metabolic side effects of
Zyprexa and off-label marketing, and best price reporting in connection with Axid, Evista, Humalog,
Humulin, Prozac and Zyprexa. The alleged wrongful conduct has been the subject of governmental
investigations and private civil actions, resolved by Lilly with the government in January 2009 and
with the bulk of the private personal injury civil litigants by 2007. The alleged wrongful conduct
also is the subject of third party payor litigation, which are actions against the Company claiming
overcharges on these drugs.
Between January and June 2008, a total of seven shareholder derivative complaints (the Derivative
Complaints) were filed on behalf of Lilly alleging, in part, that the Individual Defendants
breached their fiduciary duties of care and oversight in connection with the alleged misconduct
described above, exposing Lilly to substantial risk of damage, including regulatory and private
investigations and litigation. These complaints were filed in three separate courts: two in the
United States District Court for the Southern District of Indiana; three in the United States
District Court for the Eastern District of New York; and two in the Marion Superior Court in the
State of Indiana. Together, the Demand Letters and Derivative Complaints are referred to in this
Notice as the Derivative Claims, and the attorneys for plaintiffs in these actions are referred
to as Plaintiffs Counsel.
What Are the Terms of the Proposed Settlement?
The Company has implemented and/or will implement enhancements to and changes in Lillys corporate
governance, compliance and risk management systems. Certain of the provisions of the Settlement
are enhancements to prior governance practices; others provide for adoption of certain governance
reforms; and others are commitments to maintain in place current governance practices. For a
comprehensive description of the terms of the proposed Settlement, please refer to the Corporate
Governance Terms, found as Exhibit A to the Stipulation (Exhibit A), available from Plaintiffs
Counsel, the Court or the Notice Administrator, The Garden City Group (see below for details). You
may also request copies of Plaintiffs Brief in Support of Preliminary Approval and the reports of
plaintiffs experts2, which further describe the provisions of the proposed Settlement
and the benefits they provide to Lilly and its shareholders. As set forth in more detail in the
Stipulation, the parties acknowledge and agree that the Derivative Claims filed by the plaintiffs,
and the negotiations leading to this Settlement, were a substantial factor in the decisions by the
Company to adopt, implement, enhance and/or maintain the corporate governance provisions set forth
in Exhibit A, and that the corporate governance provisions provide a substantial benefit to the
Company, including in the prevention and detection of potential violations of law, regulation and
Company policy. A summary of the terms of the proposed Settlement appears below.
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A derivative claim is a claim brought by a
shareholder on behalf of a company, rather than on behalf of the shareholders
of the company. The recovery sought in a derivative action is for the benefit
of the company rather than directly for individual shareholders. |
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Plaintiffs Counsel retained as experts in
this action individuals with experience and expertise in areas which were the
focus of the parties negotiations: Dr. Mitchell Glass, in the areas of drug
development and pharmaceutical operations; Professor Donald C. Langevoort, in
the areas of corporate governance and compliance; and Mr. James Lam, in the
area of enterprise risk management. Dr. Glass, Professor Langevoort and Mr.
Lam have each filed an expert report in connection with the proposed
Settlement. |
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A. The Product Safety and Medical Risk Management Core Objective
Lilly will adopt a Product Safety and Medical Risk Management Core Objective, and shall adopt
policies and procedures to support scientific excellence in the development and communication of
product safety and effectiveness information and of the medical and scientific risks and benefits
throughout the life cycle of both products and product candidates. These policies and procedures
shall be intended to ensure that objective scientific inquiry, analysis and communication in
matters affecting patient safety and benefit shall be of paramount importance. The Settlement sets
forth responsibilities in connection with the achievement of the Product Safety and Medical Risk
Management Core Objective at both the management and Board level.
B. The Compliance Core Objective
Lilly will adopt a resolution stating that the Companys compliance core objectives shall include
operating Lillys business to deliver quality, innovative medicines that improve individual patient
outcomes; operating Lillys business in compliance with applicable law and regulations; conducting
Lillys activities and having policies and procedures in place to avoid adverse regulatory
enforcement action; and promptly detecting, correcting and preventing the recurrence of off-label
promotion activities violative of applicable law, regulation, and/or Company policy by any Lilly
employee or any person acting on Lillys behalf. The Settlement reflects Board oversight of
compliance and risk management matters, and provides for enhanced resources, responsibilities and
procedures at the management level within Lilly directed to compliance.
C. Board Level Provisions
1. The Science & Technology Committee (STC)
The STC shall assist the Board in exercising oversight of product safety and medical risk
management matters. Amendments to the STC charter provide for STC reporting to the Board regarding
the safety and effectiveness of Lillys marketed products and drugs/compounds in late-stage
clinical development, STC responsibility to assist the Board in exercising reasonable oversight of
product safety and medical risk management at Lilly, and the ability of the STC to retain outside
scientific, medical and risk management consultants and to speak freely with members of management.
The Settlement provides for timely information flow to the STC from multiple sources within Lilly,
including: (i) periodic reporting from management to provide reasonable assurances of the effective
design and implementation of policies and procedures supporting the Product Safety and Medical Risk
Management Core Objective, including annual reports from the Chief Medical Officer (CMO)
regarding the implementation and ongoing monitoring of such policies and procedures, the
identification of important medical and scientific risks, and the resolution of those risks; (ii)
not less than annual reporting from the CMO addressing steps taken to assess and resolve patient
safety risks affecting products and product candidates; (iii) CMO reporting addressing the
propriety of the planned scope of initial marketing for products nearing first major launch; (iv)
prompt CMO reporting under certain circumstances regarding patient safety issues relating to
product labeling or promotion, or other product safety matters; (v) at least annual reports from
the Vice President-Quality regarding significant findings of monitoring and audits of the policies,
procedures and systems put in place to achieve the Product Safety and Medical Risk Management Core
Objective; and (vi) at least annual reporting from the Vice President-Global Patient Safety
(VP-GPS) regarding unresolved patient safety issues that have been elevated to the Corporate
Patient Safety Committee and the remediation of such issues.
The STC charter will be revised to require the STC annually to assess the adequacy of the reporting
and information flows it receives, and to make such changes as are required to maintain and enhance
the committees effectiveness, including recommending to the full Board any desirable changes to
its charter or membership.
2. The Public Policy and Compliance Committee
The PPCC exercises oversight responsibility for non-financial compliance and non-financial
enterprise risk management (ERM) at Lilly. The Settlement provides for enhanced oversight
responsibilities by the PPCC in
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connection with these functions, as well as for certain oversight
responsibilities in connection with operational audit at the Company.3 The PPCC and the
Chief Ethics and Compliance Officer (CECO) will develop an agenda that specifies the topics for
the CECOs quarterly substantive reporting to the PPCC on compliance matters, including
implementation of existing compliance programs, processes for receiving and investigating
compliance or ethics-related complaints, exceptions reporting, the allocation of resources to the
compliance organization and compliance-related initiatives and, as appropriate, plans of action to
respond to emerging trends from a preventive compliance standpoint. In addition, the CECO will
promptly report compliance matters directly to the chair of the PPCC as warranted.
The PPCC will annually review and approve the aspects of Lillys annual integrated audit plan
related to certain aspects of legal and regulatory compliance. The PPCC will receive periodic
reports from both the General Auditor and the Vice President-Quality regarding the status of the
implementation of the aspects of the audit plan over which each has responsibility, and will
receive prompt reports regarding material findings, with management providing follow up reports
until such time as the findings have been remediated to the PPCCs satisfaction. At least
annually, the General Auditor will report on the Internal Audit Departments assessment of the
effectiveness of the Companys compliance and related risk management controls at Lilly. All three
of these officers, as well as the General Counsel, will have direct access to the PPCC, and will be
regularly invited to attend committee meetings. The CECO, General Auditor and Vice
President-Quality will have private sessions at least semiannually with the PPCC to discuss, among
other things, management support for their organizations, including resources and leadership tone.
The PPCC Chairman, in consultation with the PPCC, shall approve the appointment and
retention of the CECO. The Audit Committee Chairman, in consultation with the Audit Committee,
will approve the appointment and retention of the Companys General Auditor. The PPCC will annually
assess the adequacy of the reporting and information flows it receives, and will make such changes
as are required to maintain and enhance the committees effectiveness, including recommending to
the full Board any desirable changes to its charter or membership.
The PPCC shall oversee the process by which ERM programs are reviewed by Lillys Board and its
various committees, with specific responsibility for the non-financial compliance risk aspects of
the ERM program. The PPCC will receive a report each year from the CECO regarding the design,
implementation and operation of Lillys ERM program, as well as reports concerning risk management
aspects of Company strategic initiatives and developments affecting the Companys business,
operations and affairs. At least one PPCC meeting per year shall be a joint session with the Audit
Committee to review major non-financial compliance matters, and the PCCC will coordinate with the
Audit Committee to assist in assuring that appropriate risk disclosures are included in the
Companys public financial reports as required by law.
3. The Compensation Committee
The Compensation Committee of the Board, as part of a review of the performance and associated
compensation decisions for executive officers at Lilly, annually will discuss with the CEO the
compliance performance of executive officers. The Vice President of Human Resources, Global
Compensation and Benefits will report annually to the Compensation Committee regarding the results
of periodic monitoring of compliance objectives, which (as discussed below) must be set by
executive officers.
4. Other Board Level Provisions
Lillys CEO and the Chairman of the Board of Directors, in consultation with the CECO, will design
periodic communications regarding a culture of compliance and performance with integrity. The CEO
will meet at least annually with senior management to emphasize the importance of compliance and to
emphasize their roles and accountability for both compliance and ethics at Lilly. In addition, the
Settlement includes provisions related to enhancement of Lillys Board level corporate governance
practices, including factors to be considered in nominating and renominating directors; limitations
on the number of public company boards on which a director may sit; the Companys independence
standards; risk, governance and compliance training for directors; the annual election of the
Presiding Director from among Lillys independent directors; and the
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Operational audit provides a means to assess
whether compliance and risk management systems are operating as designed and
intended. |
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requirement to include a question in the self-assessment
questionnaires directed to Board and committee performance
regarding compliance and oversight.
D. Management Level Provisions
1. The Chief Medical Officer
The Chief Medical Officer (CMO) shall monitor the implementation of Lillys policies, procedures,
systems and internal controls designed to achieve the Product Safety and Medical Risk Management
Core Objective; shall report on the status and findings of such monitoring annually to the STC; and
shall take steps necessary to pursue the continuous improvement of those policies, procedures,
systems and internal controls. The CMO: (i) shall be in charge of Lillys combined Global Medical,
Regulatory and Safety Departments; (ii) shall have senior executive authority and oversight
responsibility for all product safety functions at Lilly, including pharmacovigilance, and the
activities of the Vice President-Global Patient Safety and all subordinate Product Safety
Physicians (discussed below); (iii) shall be the senior medical officer of the Company, and shall
have executive authority over all medical physicians employed in drug development and medical
research by the Company on issues of drug utility and safety and regulatory compliance; (iv) shall
act as chairman of the Companys Medical Review Committee; and (v) shall assess annually the
staffing and funding requirements necessary to fulfill his responsibilities and may, in
consultation with the Executive Vice President of Science and Technology, reorganize, reduce or
augment his staff.
2. The Vice President-Global Patient Safety
The Vice President-Global Patient Safety (VP-GPS), who reports to the CMO, is responsible for all
scientific analysis and interpretation of data and studies and surveillance relating to product
utility and safety, derived from investigation within Lilly through all phases of pre-clinical and
clinical development, as well as all pharmacovigilance and pharmacoepidemiology activities relating
to Lilly products and product candidates.
The VP-GPS has responsibility for developing and implementing policies and procedures, among other
things, for ascertaining and addressing issues arising around the safety of Lillys products; for
data acquisition, analysis, interpretation and reporting; for making corresponding recommendations
to the CMO; and for maintaining practices at Lilly to facilitate the collection and timely
disclosure of information concerning the safe use of Lilly products. The VP-GPS is responsible for
providing recommendations to the CMO regarding the initiation of the next stage of a product or
product candidates development or expansion of commercialization, based on a determination as to
whether the database and weight of evidence support appropriate benefit versus risk across all
target populations. The VP-GPS will make recommendations to the CMO regarding whether proposed
additional studies would add usefully to the weight of evidence for a products safety profile,
including with respect to resolving open issues around off-label patient populations and safety.
The VP-GPS also has responsibility for recommending to the CMO and Global Product Labeling
Committee all safety-related labeling changes for Lilly products.
The VP-GPS will exercise oversight over all Product Safety Physicians (PSPs, discussed below),
including assigning PSPs to products and product candidates, ensuring that the PSPs have completed
full and accurate safety assessments prior to each Medical Review Committee meeting concerning
relevant products and product candidates, and making recommendations regarding the hiring,
retention, performance evaluation, compensation and promotion of PSPs, which recommendations shall
afford primary weight to assessment of each PSPs effectiveness in promoting the Product Safety and
Medical Risk Management Core Objective with respect to the product or products for which each such
officer is responsible.
3. Product Safety Physicians
Every Lilly product currently on the market and every product candidate at the Company entering
large scale development will have a Product Safety Physician (PSP) with responsibility for safety
issues throughout that products life cycle. The PSP assigned to each product or product candidate
is responsible for assuring that safety issues affecting the product/product candidate to which the
PSP is assigned are given primary weight in all labeling decisions, including (as noted above)
elevating any disagreements concerning safety issues in labeling decisions to, among others, the
VP-GPS and CMO as appropriate and necessary, to assure that the
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matter is resolved in a manner
consistent with the Companys policy to maintain the primacy of patient benefit and safety. The
PSP must, at least annually (and more often as necessary) report to the VP-GPS on patient safety
aspects of the Clinical Plan Document (CPD, see below), including making recommendations for
reprioritizing clinical resources when the PSP believes such additional resources are necessary to
fully develop robust patient safety information for the product. The allocation of required
funding will be ensured through Lillys budget management and approval processes.
The PSP is accountable to ensure that all available product data is comprehensively reviewed for
patient safety issues, that significant patient safety issues are promptly analyzed and
interpreted, and that such patient safety issues are fully explored, where appropriate, through the
development of additional hypotheses and testing thereof, and the collection of additional data.
PSPs are responsible for ensuring that the scientific evidence supporting a benefit/risk assessment
of a product is not overstated or presented in a misleading way. PSPs shall coordinate with the
VP-GPS and the regulatory function at Lilly to assure that all product safety data, analysis,
interpretation and investigations are appropriately disclosed to the FDA and corresponding foreign
regulators. Comprehensive documentation of all communications relating to the investigation,
analysis, interpretation and communication of safety issues relating to the product are maintained
within approved GPS documentation archives and as per GPS Standard Operating Procedures (SOPs).
4. The Clinical Plan Document Template
Lilly has adopted and shall maintain during the Agreed Upon Term (as defined below) a Clinical Plan
Document Template (CPD), which will: (1) define and document the medical research activities and
regulatory strategy associated with the clinical development of a product from First Human Dose
(FHD) through the end of the product life cycle; (2) be linked to the Development Core Safety
Information, the Core Data Sheet (CDS), Development Safety Update Reports, Periodic Safety Update
Reports, and Safety Risk Management Plans; (3) track all important identified medical, regulatory
and safety issues to resolution throughout the life cycle of each product; and (4) document
supporting resource and budget information. The Medical Review
Committee will review the CPD at least annually or more
frequently as new events or data dictate or as needed based on ongoing safety surveillance efforts.
5. Enhanced Global Ethics, Compliance and Operational Risk Management
The Chief Ethics and Compliance Officer (CECO), along with the Chief Executive Officer, are
responsible for taking all actions necessary and appropriate to achieve the Compliance Core
Objective. The CECO shall be a member of the senior management of the Company and shall be a
member of the Executive Committee of the Company Lillys most senior management committee. In
addition, the Company shall
create the following new Vice President and Senior Director level positions to further support the
centralized global compliance and ERM function: (i) Vice President, Global Compliance Strategy and
Enterprise Risk Management, who shall report to the CECO and assist the CECO in the development of
global compliance strategy, partnering with senior leaders across Lilly to promote highly ethical
and compliant behaviors, and addressing emerging regulatory and enforcement trends and
enterprise-level risks; (ii) Vice President, Global Ethics and Compliance Officer, Business
Liaison, who shall report to the CECO and shall oversee the compliance function within the Company
and its various U.S.-based and International affiliates and shall be responsible for developing and
implementing policies, procedures and practices designed to promote compliance in that affiliate
with applicable law or requirements regarding applicable health care programs4; (iii)
Senior Director, Enterprise Risk Management, who shall report to the Vice President, Global
Compliance Strategy and Enterprise Risk Management, and shall assist the CECO in administration of
enterprise risk management at the Company; and (iv) CIA Project Manager, who shall assist the CECO
in implementing and monitoring policies, procedures and practices designed to promote compliance
with the Companys obligations under the Corporate Integrity Agreement with the Office of Inspector
General of the Department of Health and Human Services, dated January 14, 2009 (the CIA).
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Compliance officers of the Companys
U.S.-based affiliate and International OUS affiliates (responsible for
promoting compliance in each affiliate) will report directly up through the
Vice President, Global Ethics and Compliance Officer, Business Liaison,
providing for compliance reporting independent of the business lines. |
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All compliance-related investigations (with limited exceptions) shall be conducted under the
authority of the CECO, and all requested exceptions from Lilly compliance policies and procedures
must be reviewed in advance by the CECO and the legal department. Any determination to grant an
exception that is contrary to the CECOs recommendation must be immediately reported to the CECO.
On an annual basis, the CECO will assess the staffing and funding necessary to carry out his or her
responsibilities, and may, in consultation with Lillys Chief Executive Officer, reorganize, reduce
or augment the staff. In addition, if, during the Agreed Upon Term, the CECO wishes to seek
additional funding for compliance-related expenditures, he or she shall be permitted at his or her
option to petition directly the Board or an appropriate committee of the Board that such funding be
included in or covered by business plans and budgets that are approved by the Board or such
committee.
6. Enterprise Risk Management
The CECO is also responsible for Lillys ERM function. The Compliance and Risk Management
Committee shall assist the CECO and the Senior Director of Enterprise Risk Management in
identifying, prioritizing, assessing, evaluating and mitigating risks across the enterprise. As
discussed above, the Settlement provides for the creation of two new senior positions related to
ERM: the Vice President, Global Compliance Strategy and Enterprise Risk Management and the Senior
Director, Enterprise Risk Management.
7. Compensation Provisions
The Company shall continue to make the promotion of, and adherence to, the Companys Code of
Conduct, The Red Book, an element in evaluating the performance of all employees. In addition, all
senior management personnel shall include a compliance objective and measurement of that objective
in their annual performance management plans. Those objectives may, and will, differ based on job
content and level. To insure these compliance objectives are included in these executives
performance management plans, Lilly will undertake periodic monitoring and sample auditing.
Achievement of performance objectives will factor in compensation decisions for these senior
executives. The CECO shall provide compliance performance feedback for senior management to both
the CEO (as part of the semi-annual executive review and during the end-of-year performance review)
and Human Resources (as input to the Companys on-going succession management review process).
8. Compliance Training
The Settlement provides for Lilly to retain an expert recommended by Plaintiffs Counsel for
compliance-related leadership training presentations for its U.S.-based affiliates.
9. Discipline
If the Company determines that an employee has violated any law, regulation, or Company policy or
procedure, including Federal health care program requirements, FDA requirements, or Company policy
regarding the same, the Company must respond with disciplinary action that the Company deems
appropriate. In addition, the CECO will provide the CEO on a quarterly basis an organizational
level summary regarding compliance-related performance issues and disciplinary actions, and the CEO
will be advised specifically of all compliance-related performance issues and disciplinary actions
involving senior management, and be involved in determining the associated compensation
consequences that will result from these issues and actions.
10. Monitoring
Monitoring-related responsibilities include: (i) at least annually, the results of the annual
surveys of interactions with health care professionals set forth in the CIA, will be reported to
the PPCC; (ii) field force monitoring, in the form of ride-alongs with sales representatives,
shall be based on a relative assessment of the potential risk for improper off-label promotion;
(iii) all communications to external parties regarding products and product candidates, including
by the Lilly Answers Center over which the CMO shall have executive authority, shall include only
medical and scientific conclusions approved by Lilly Medical, with additional review and
consultation may be provided by Lilly Regulatory and Lilly Legal; and (iv) specific provisions
related to the monitoring of FDA-regulated speaker programs and educational grants and continuing
medical education.
E. The Three Year Commitment Period and Funding Commitment
The Company has agreed to maintain its commitment to the effective implementation of the provisions
set forth in Exhibit A for a three year period from the date the Settlement receives Court approval
(the Agreed Upon Term). In addition, the Settlement provides that during the Agreed Upon Term,
Lilly will commit from its treasury funds as are necessary to implement the provisions set forth in
Exhibit A.
1. What Are the Reasons for the Settlement?
The parties believe that the Settlement, as set forth in the Stipulation and Exhibit A attached
thereto, confers substantial benefits upon Lilly and its
shareholders. In their reports, plaintiffs experts have opined that the relief achieved under the Settlement provides substantial
benefits to Lilly; that the Settlement places Lilly at the forefront of the industry; and that the
Settlement provides a sound foundation for the management of drugs and drug candidates throughout
their life cycle at Lilly.
The Settlement has been achieved after significant review and analysis of over 85,000 pages of
contemporaneous documents and deposition testimony relating to the underlying claims. The detailed
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provisions of the Settlement reflect the results of intensive negotiations between the parties,
undertaken with the benefit of extensive discussions involving senior Lilly personnel, Plaintiffs
Counsel and experts retained on behalf of plaintiffs. In addition, the parties sought the
assistance and expertise of retired Chief Magistrate Judge Edward A. Infante, an experienced
mediator in the resolution of complex litigation such as the Derivative Claims.
As reflected in the Stipulation, the parties agree that the Settlement provides substantial
benefits to Lilly and its shareholders, and supports the prevention and detection of potential
violations of law, regulation and Company policy. In recommending that the parties settle at this
time under the terms and conditions set forth in the Settlement, Plaintiffs Counsel have weighed
the risks of further litigation against the substantial benefits that counsel were able to obtain
for Lilly and its shareholders pursuant to the Settlement.
2. What Attorneys Fees And Expenses Will Be Paid?
An additional term of the Settlement is the parties agreement that Plaintiffs Counsel will
seek an award of attorneys fees of $8,750,000, inclusive of expenses incurred in the prosecution
and settlement of the Derivative Actions. Plaintiffs expenses are approximately $450,000.00,
including expert fees and expenses. Any award of fees and expenses will be paid in part by Lilly
and in part by the Companys directors and officers insurance carriers. Plaintiffs Counsel have
been retained by their clients on a contingent fee basis and, thus, to date Plaintiffs Counsel
have not been paid for either their legal services or as reimbursement for expenses they have
incurred in connection with the litigation of the Derivative Actions.
The attorneys fees and award of expenses for which Plaintiffs Counsel will seek Court
approval were the subject of arms-length negotiations among the parties conducted under the
auspices of the Mediator only after the terms of the proposed Settlement were agreed upon. The
attorneys fees were a matter of scrutiny and analysis by separate counsel for the directors and
officers insurance carriers. The Mediator had a detailed understanding of the litigation and the
intensive negotiation process, the nature and extent of Plaintiffs Counsels work throughout the
litigation, and was able to call upon this knowledge in mediating an agreed upon amount which all
of the parties could support as fully reflective of the services Plaintiffs Counsel rendered to
Lilly. The Company does not oppose the request of Plaintiffs Counsel.
3. Incentive Awards to Plaintiffs
Plaintiffs Counsel will also apply to the Court for incentive awards to be paid to the named
plaintiffs in the Derivative Actions in an aggregate amount not to exceed $35,000.00, in
recognition of their efforts in initiating and pursuing this litigation. Any incentive awards to
plaintiffs authorized by the Court shall be paid from the Court-approved award of attorneys fees.
4. What Will Happen at the Settlement Hearing?
The Court has scheduled a Settlement Hearing for April 29, 2010, at 10:00 a.m. At this hearing,
the Court will hear any objections any Lilly Shareholder may raise as to any aspect of the
Settlement. At or following the hearing, the Court will determine whether the Settlement is fair,
reasonable, and adequate, and determine whether to enter a final order approving the Settlement.
The Court will also consider the matter of attorneys fees and incentive awards to plaintiffs, and
in what amount to award attorneys fees and reimbursement of expenses to Plaintiffs Counsel and/or
incentive awards to plaintiffs. Pending final determination of whether the Settlement should be
approved, the Settling Parties and all Lilly Shareholders (as of February 12, 2010) are each barred
and enjoined from instituting or prosecuting any action that asserts any of the Released Claims
against any Released Parties (as those terms are described below and defined in the Stipulation).
YOU ARE NOT REQUIRED TO PARTICIPATE IN OR ATTEND THE SETTLEMENT HEARING, BUT MAY DO SO IF YOU WISH.
If you are a current Lilly Shareholder and you wish to express an objection to any portion of the
Settlement, you must send a signed letter or other signed written submission with proof of your
current ownership of Lilly common stock, stating that you object to the Settlement in Lambrecht, et
al. v. Taurel, et al., C.A. No. 1:08-cv-0068-DFH-TAB (S.D. IN.) and Zemprelli vs. Taurel et al.,
C.A. No. 1:08-cv-0874-SEB-TAB (S.D. IN.). You must include your name, address, telephone number,
how many Lilly shares you currently own, the most recently available brokerage statement
evidencing such ownership, a detailed description of your specific objections to any matter
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before
the Court, all the grounds for your objections, and any documents you wish the Court to consider.
Mail the objection and any supporting papers to the Court and each of the attorneys listed at the
addresses provided below to arrive no later than April 15, 2010. YOUR OBJECTION MUST BE IN WRITING
AND RECEIVED BY THIS DATE TO BE CONSIDERED. If your objection is not received in a timely manner,
the Court may deem it waived and may not consider it.
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Court |
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Plaintiffs Counsel |
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Defense Counsel |
Clerk of the Court
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Karen L. Morris
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Robert L. Hickok |
United States Courthouse
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Morris and Morris LLC
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Pepper Hamilton LLP |
46 E. Ohio Street,
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Counselors At Law
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3000 Two Logan Square |
Room 105
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4001 Kennett Pike, Suite 300
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Eighteenth and Arch Streets |
Indianapolis, IN 46204
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Wilmington, DE 19807
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Philadelphia, PA 19103-2799 |
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Richard D. Greenfield
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Teri Cotton Santos |
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Greenfield & Goodman, LLC
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Assistant General Counsel |
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250 Hudson Street-8th Floor
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Litigation |
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New York, NY 10013
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Eli Lilly and Company |
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Lilly Corporate Center |
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Indianapolis, IN 46285 |
The Court will consider your written objection whether or not you choose to attend the Settlement
Hearing. You may also choose to retain your own lawyer at your own expense to represent you with
respect to any objections you may have. If you or your lawyer would like to speak at the
Settlement Hearing, you must send a letter stating that you intend to appear and speak at the
Settlement Hearing. The letter must include the names of any witnesses you may call to testify and
must identify any documents you intend to introduce into evidence at the Settlement Hearing. The
letter must also include your name, address, telephone number, how many shares of Lilly common
stock you currently own, and the most recently available brokerage statement evidencing such
ownership. Your letter must be
received no later than April 15, 2010 by the Clerk of the Court, Plaintiffs Counsel, and defense
counsel, at the addresses provided above. The date of the Settlement Hearing is subject to change
without further published notice to Lilly Shareholders. If you or your lawyer intend to attend the
Settlement Hearing, you should confirm the date and time with Plaintiffs Counsel.
5. What Is the Effect of the Courts Approval of the Settlement?
The full terms of the dismissal of Released Claims are set forth in the Stipulation. The following
is only a summary. Upon the Effective Date (as defined in the Stipulation), the Releasing Parties
(who include plaintiffs (individually, and derivatively on behalf of Lilly), Lilly, and the Lilly
Shareholders), will fully, finally, and forever release all Released Claims against the Released
Parties (who include all Settling Defendants, their family members and others acting on their
behalf), and the Released Parties will fully, finally, and forever release plaintiffs and
Plaintiffs Counsel from all claims or demands relating to or arising out of, or connected with the
institution, prosecution, assertion, settlement, or resolution of the Derivative Complaints and/or
the Released Claims.
The Released Claims means any and all claims, demands, rights, remedies, causes of action or
liabilities, whether based on federal, state, local, statutory, common or foreign law or any other
law, rule, regulation, or principle of equity, whether known or unknown, including without
limitation Unknown Claims (as defined in the Stipulation), whether suspected or unsuspected,
whether contingent or non-contingent, whether accrued or unaccrued, whether or not concealed or
hidden, whether factual or legal, and for any remedy whether at equity or law, that were or that
could have been asserted through the Record Date against the Released Parties in the Derivative
Complaints or the Demand Letters, or by any Lilly Shareholder claiming in the right of, or on
behalf of Lilly, arising out of, relating to or based upon, directly or indirectly, in any way, any
of the facts, allegations, transactions, events, occurrences, acts, disclosures, statements,
omissions, failures to act, or matters set forth, referred to, or alleged in the Derivative
Complaints and/or the Demand Letters. By operation of the Judgment, the Releasing Parties shall
have waived any and all provisions, rights, and benefits conferred by California Civil Code § 1542
and by any law of any state or territory of the United States, or principle of common law, which is
similar, comparable, or equivalent to California Civil Code § 1542, which provides that: A
general release does not extend to claims which the creditor does not know or suspect to exist in
his favor at
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the time of executing the release, which if known by him must have materially affected
his settlement with the debtor. Upon the Effective Date, all Releasing Parties will be enjoined
and barred from bringing any Released Claims against any of the Released Parties.
6. Special Notice to Securities Brokers and Other Nominees
If you held Lilly common stock as of February 12, 2010 for the beneficial interest of a person or
organization other than yourself, the Court has directed that, WITHIN TEN DAYS OF YOUR RECEIPT OF
THIS NOTICE, you provide to the Notice Administrator the name and last known address of each person
or organization for whom or which you held such stock as of February 12, 2010, preferably
electronically in MS Word files, or in an MS Excel data table setting forth: (1) beneficial holder
name, (2) street address, and (3) city/state/zip. All communications concerning the foregoing
should be addressed to the Notice Administrator: The Garden City Group, at the following address:
Eli Lilly and Company Shareholder Derivative Litigations, c/o The Garden City Group, Inc., Notice
Administrator, P.O. Box 9542, Dublin, OH 43017-4842. Nominees may apply to be reimbursed for
actual, and reasonable out-of-pocket expenses incurred in identifying and notifying beneficial
owners.
How Do You Get More Information about the Derivative Claims and the Settlement?
This Notice summarizes the Settlement. The Stipulation of Settlement sets forth the complete terms
of the Settlement. In addition, Plaintiffs Counsel will file with the Court papers in support of
final approval of the Settlement, an award of attorneys fees and payment of an incentive award to
named plaintiffs no later than April 1, 2010. You can
view these documents, as well as other relevant documents filed in connection with the settlement
of the Derivative Claims, by inspecting the papers filed in the Derivative Claims at the office of
the Clerk of Court, United States Courthouse, 46 E. Ohio Street, Room 105, Indianapolis, IN 46204,
during normal business hours, or by requesting a copy of the relevant documents from either
Plaintiffs Counsel (at the addresses provided above), or the Notice Administrator, The Garden City
Group, at the following address and toll-free number: Eli Lilly and Company Shareholder Derivative
Litigations, c/o The Garden City Group, Inc., Notice Administrator, P.O. Box 9542, Dublin, OH
43017-4842, 1(888) 377-9637. If you have questions about the Settlement, you may contact
Plaintiffs Counsel listed above.
PLEASE DO NOT CALL THE COURT OR LILLY REGARDING THIS NOTICE
DATE: March 3, 2010
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