Company Name: Eli Lilly and Co.
Public Availability Date: December 19, 2007
Document Sections:
INQUIRY LETTER
INQUIRY LETTER
APPENDIX
STAFF REPLY LETTER
[INQUIRY LETTER]
VIA UPS OVERNIGHT DELIVERY
November 21, 2007
Securities and Exchange Commission
Division of Corporation Finance
Office of Chief Counsel
100F Street, NE
Washington, D.C. 20549
RE: Eli Lilly and Company - Shareholder Proposal Submitted by the Minnesota
State Board of Investment
Ladies and Gentlemen:
Enclosed on behalf of Eli Lilly and Company ("Lilly"), pursuant to Rule 14a-8(j)
under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), are
six copies of this letter as well as the shareholder proposal and supporting
statement by the Minnesota State Board of Investment (the "Proponent") attached
hereto as Exhibit A (the "Proposal") received by Lilly requesting a report "on
the long-term economic stability of the company and on the risks of liability to
[sic] legal claims that arise from the company's policy of limiting the
availability of the company's products to Canadian wholesalers or pharmacies
that allow purchase of its products by U.S. residents."
Except for the dates, this proposal is identical to the proposal we received in
both 2005 and 2006 from this proponent, and which we omitted from our proxy
statement based on your letters of January 11, 2006 and January 29, 2007, copies
of which are attached hereto as Exhibit B. In addition, the Division of
Corporation Finance reached the same conclusion with regard to this proposal in
response to requests from Merck & Co., Inc. (available January 11, 2006) and
Pfizer Inc. (available January 13, 2006 and January 29, 2007). On this basis, we
have requested that the Proponent withdraw the proposal to avoid burdening the
Division with another no-action request. However, as the Proponent has declined
to do so, we are requesting your consideration of this matter again this year.
We are not aware of any more recent decision or opinion of the Division of
Corporation Finance which runs counter to your letters of January 11, 2006 and
January 29, 2007. Therefore, we believe Lilly may properly omit the Proposal
from Lilly's 2008 proxy statement for the following reasons. To the extent these
arguments are based on matters of law, that letter represents a supporting legal
opinion of counsel.
I. Summary
We believe that the Proposal can properly be excluded under Rule 14a-8(i)(7),
allowing exclusion of a proposal relating to the company's ordinary business
operations, and under Rule 14a-8(i)(10), allowing exclusion of a proposal that
has already been substantially implemented. The staff has already reached the
same conclusion on the same proposal submitted to Lilly in 2005 and 2006. Eli
Lilly and Company (available January 11, 2006 and January 29, 2007).
II. Rule 14a-8(i)(7)
The Proposal deals with matters relating to the company's ordinary business
operations. Under Rule 14a-8(i)(7), a proposal dealing with a matter relating to
the company's ordinary business operations may be excluded from the company's
proxy materials. The Commission has clarified (in SEC Release No. 34-40018 (May
21, 1998)) that "the general underlying policy of this exclusion is consistent
with the policy of most state corporate laws: to confine the resolution of
ordinary business problems to management and the board of directors, since it is
impracticable for shareholders to decide how to solve such problems at an annual
shareholders meeting." The Commission went on to identify two central
considerations in examining the ordinary business exclusion.
The first relates to the subject matter of the proposal. Certain tasks are so
fundamental to management's ability to run a company on a day-to-day basis that
they could not, as a practical matter, be subject to direct shareholder
oversight.... However, proposals relating to such matters but focusing on
sufficiently significant social policy issues (e.g., significant discrimination
matters) generally would not be considered to be excludable, because the
proposals would transcend the day-to-day business matters and raise policy
issues so significant that it would be appropriate for a shareholder vote.
The second consideration relates to the degree to which the proposal seeks to
"micro-manage" the company by probing too deeply into matters of a complex
nature upon which shareholders, as a group, would not be in a position to make
an informed judgment. This consideration may come into play in a number of
circumstances, such as where the proposal involves intricate detail, or seeks to
impose specific time-frames or methods for implementing complex policies.
Staff Bulletin No. 14C (June 28, 2005), further clarified the application of
Rule 14a-8(i)(7) to proposals referencing environmental or public health issues,
stating:
To the extent that a proposal and supporting statement focus on the company
engaging in an internal assessment of the risks or liabilities that the company
faces as a result of its operations that may adversely affect the environment or
the public's health, we concur with the company's view that there is a basis for
it to exclude the proposal under rule 14a-8(i)(7) as relating to an evaluation
of risk. To the extent that a proposal and supporting statement focus on the
company minimizing or eliminating operations that may adversely affect the
environment or the public's health, we do not concur with the company's view
that there is a basis for it to exclude the proposal under rule 14a 8(i)(7).
The Proposal presented by the proponent fits into the former category of
proposals described in the Staff Bulletin. It references a public health issue -
here the issue of affordable access to medicines - but in actuality is related
to the ordinary business of the company because it focuses on an internal
assessment of the risks or liabilities that the company faces as a result of its
current policy of linking supply of its products to Canadian wholesalers to
Canadian patient demand. Although the proposal discusses U.S. pharmaceutical
pricing, the Proposal neither requests that the company change its operating
principles or policies, nor claims that production of the report itself would
address an important social policy. Instead, the proposal asks the board to
complete an internal analysis of the risks that the company faces as a result of
its current practices. The proponent cannot avoid Rule 14a-8(i)(7) by simply
citing a significant policy issue in connection with the ordinary business
matters raised. See Xcel Energy Inc. (available Apr. 1, 2003) and Cinergy Corp.
(available Feb. 5, 2004) (both permitting the exclusion of a proposal requesting
a report on the economic risks of current emissions and the benefits of reducing
them); The Mead Corporation (available Jan. 31, 2001) (permitting the exclusion
of a proposal requesting a report on risks faced by the company); see also,
Wal-Mart Stores, Inc. (available Mar. 15, 1999) (permitting the exclusion of a
proposal requiring the company to report on actions it has taken to ensure that
its suppliers do not use slave or child labor where a single element to be
included in the report related to ordinary business matters); Chrysler Corp.
(available Feb. 18, 1998) (permitting exclusion of a proposal requiring the
company to review and report on its international codes and standards in six
areas including human rights, child labor and environmental standards, where one
item related to ordinary business and another was ambiguous). As a result, the
Proposal may be properly omitted, consistent with the Commission's rationale
above.
This result fits with the Commission's consistent position that analysis of
risks and benefits of company policies in financial terms is a fundamental and
ongoing part of a company's ordinary business operations, and best left to
management and the board of directors, See Xcel Energy (available April 1,
2003), Cinergy Corp. (available Feb. 5, 2004), and The Mead Corporation
(available Jan. 31, 2001) (all excluding proposals related to a request for a
report on the company's environmental risks). A current, indepth understanding
of the risks facing the company is an essential element of both day-to-day
activities and the company's long-term strategy.
In addition, this result is consistent with the Commission's approach to
proposals which seek to "micro-manage" a company. The Proposal requests analysis
of the company's supply-chain policies and practices with regard to 1) the
long-term stability of the company and 2) to the risk of legal liability. Both
questions require complicated and detailed financial analysis to complete,
including looking at the company's global product lines and pricing structures,
contractual obligations, the competitive landscape, international laws,
political trends, customer and public perception, as well as other variables.
The Proposal also acknowledges that the subject matter of the Proposal is the
subject of legal dispute. Further, the implied alternative to the company's
current approach, facilitating importation of prescription drugs into the U.S.,
is currently prohibited by U.S. law. Thus, the proponent intends that this
analysis include financial valuations of variables such as changes in U.S. and
Canadian law and regulation, the outcome and/or likelihood of litigation, and
shifts in public opinion - all of which are difficult to quantify and none of
which are within the company's control. The requested analysis requires a deep
understanding of the industry, applicable law, and the political landscape as
well as analysis of strategic information that is proprietary to the company and
highly confidential. It also requires significant business judgment, more
properly exercised by company management and the board of directors than by
shareholders who, as a group, would not be in a position to make an informed
judgment. Although company management is responsible for the implementation of
risk management at all levels of the company, risk management strategy and
policy design is overseen by the board of directors. See Indiana Code 23-17-12-1
Sec. 1(b)(2), "...the business and affairs of the corporation [shall be] managed
under the direction of the corporation's board of directors." Thus, under
Indiana law, issuance of this type of report is within the scope of
responsibilities assigned to the board. The Proposal also requests an analysis
of the long-term stability of the company over an indefinite period of time with
a deadline of September 30, 2008 - both elements of the Proposal indicate an
improper attempt to "micro-manage".
III. Rule 14a-8(i)(10)
In addition to the rationale discussed above, the company should be able to
exclude the Proposal on the grounds that it has already been substantially
implemented, based on Rule 14a-8(i)(10). See SEC Release No. 34-20091 (Aug. 16,
1983). The Commission has concurred that a proposal has been "substantially
implemented" where a company can demonstrate that it has already adopted
policies or acted to address each element of a shareholder proposal. See
Albertson's Inc., (Mar. 23, 2005); Exxon Mobil Corp. (available Jan. 24, 2001);
Nordstrom Inc. (available Feb. 8, 1995); The Gap, Inc. (available Mar. 8, 1996).
The Proposal consists of two elements: a report on (1) the effects on the
long-term economic stability of the company and (2) the risks of liability for
legal claims, in both instances in light of the company's policy of limiting the
availability of the company's products to Canadian wholesalers or pharmacies
that allow purchase of its products by U.S. residents. The company regularly
communicates material information about both of these subjects in various ways,
as required or permitted by law, including SEC filings, press releases, and
quarterly earnings and other investor conference calls. In particular,
Regulation S-K requires the company to disclose material risks facing the
company in the company's annual report on 10-K, and to update this disclosure on
a quarterly basis in the company's 10-Q filings. Excerpts of these disclosures
are provided below. Although these disclosures are not in the format of a single
report, the company's implementation need not mirror the format requested by the
proponent. See Albertson's Inc., (available Mar. 23, 2005); The Talbots, Inc.
(available Apr. 5, 2002); Cisco Systems, Inc. (available Aug. 11, 2003); Exxon
Mobil Corp. (available Jan. 24, 2001); The Gap, Inc. (available Mar. 16, 2001);
E.I. du Pont de Nemours and Co. (available Feb. 14, 1995); The Boeing Co.
(available Feb. 7, 1994). The discussion of these risks occurs in the context of
a broader discussion of the risks facing the company, and is addressed in three
broad categories: risks to the company due to pricing pressures, risks to the
company due to laws or regulations, and risks of litigation. To require a
special and separate report on risks related only to the company's policy with
respect to supply to Canada is unnecessary, duplicative, and would exclude this
broader context. The company also reports on importation, pricing and access to
medicines (the proponent's underlying social concerns) in its Corporate
Citizenship Report, published on the company's website at www.Lilly.com and
updated annually.
The following information related to the risk (both legal and with regard to the
long-term economic stability of the company) of Canadian product supply policies
has already been provided to shareholders or is available on the company's
website:
A. 2006 Annual Report of form 10-K, filed February 28, 2007, p.19
In the United States, implementation of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA), which provides a prescription
drug benefit under the Medicare program, took effect January 1, 2006. In 2006,
we experienced a one-time sales benefit as a result of MMA: however, in the long
term there is additional risk of increased pricing pressures. While the MMA
prohibits the Secretary of Health and Human Services (HHS) from directly
negotiating prescription drug prices with manufacturers, legislation was passed
in early 2007 by the U.S. House of Representatives that would require HHS to
negotiate directly with pharmaceutical manufacturers. This legislation will be
considered by the U.S. Senate, MMA retains the authority of the Secretary of HHS
to prohibit the importation of prescription drugs. Legislation to allow for
broad-scale importation has been presented to both the House of Representatives
and the Senate. The proposed legislation could remove that authority and allow
for the importation of products into the U.S. If adopted, such legislation would
likely have a negative effect on our U.S. sales. Current importation language
allows for medication to be carried in person from Canada to the U.S. and does
not authorize mail or Internet importation. Further, the language disallows
certain medications including injectibles. We believe the expanded prescription
drug coverage for seniors under the MMA has further alleviated the perceived
need for a federal importation scheme. However, notwithstanding the federal law
that continues to prohibit all but the very narrow drug importation detailed
above, several states have implemented importation schemes for their citizens,
usually involving a website that links patients to selected Canadian pharmacies.
pp. 13 and 15
While it is not possible to predict or determine the outcome of the ... legal
actions brought against us, we believe that ... the resolution of ... such
matters will not have a material adverse effect on our consolidated financial
position or liquidity but could possibly be material to the consolidated results
of operations in any one accounting period.
During 2004 we, along with several other pharmaceutical companies, were named in
one consolidated case in Minnesota federal court brought on behalf of consumers
alleging that the conduct of pharmaceutical companies in preventing commercial
importation of prescription drugs from outside the United States violated
antitrust laws and one case in California state court brought by several
pharmacies in which plaintiffs' claims are less specifically stated, but are
substantially similar to the claims asserted in Minnesota. Both cases seek
restitution for alleged overpayments for pharmaceuticals and an injunction
against the allegedly violative conduct. The federal district court in the
Minnesota case has dismissed the federal claims, ruling that the state claims
must be brought in separate state court actions. The Eighth Circuit Court of
Appeals has affirmed the district court's decision. In the California case,
summary judgment has been granted to Lilly and the other defendants. The
plaintiffs have appealed that decision.
Page 34
FINANCIAL EXPECTATIONS FOR 2007 ... Actual results could differ materially and
will depend on, among other things ... the impact of governmental actions
regarding pricing, importation, and reimbursement for pharmaceuticals.
B. 10-Q filed November 3, 2007, p. 17
In the United States, implementation of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA), which provides a prescription
drug benefit under the Medicare program, took effect January 1, 2006. Various
measures have been discussed and/or passed in both the U.S. House of
Representatives and U.S. Senate that would legalize the importation of
prescription drugs and either allow or require the Secretary of Health and Human
Services to negotiate drug prices directly with pharmaceutical manufacturers. We
expect pricing pressures at the federal and state levels to continue.
p. 25
Actual results could differ materially and will depend on, among other things,
the ... impact of governmental actions regarding pricing, importation, and
reimbursement for pharmaceuticals....
C. Lilly Website - Access to Medicines
(http://www.lilly.com/products/access/state_fed_efforts.html) Importation
Lilly strongly opposes the importation/re-importation of prescription drugs.
Allowing the importation of drugs is really about importing foreign price
controls into the United States. The result would be devastating to the
research-based pharmaceutical industry as revenues available for R&D would be
diminished significantly.
There is no guarantee that drugs that have been shipped to foreign countries,
which have their own storage requirements, and returned to the U.S. for resale
are unadulterated. These drugs may have been improperly stored, handled and/or
shipped. Prohibitions against importation are designed to ensure that
adulterated, counterfeit and unapproved drugs do not enter the U.S. The FDA
repeatedly has stated that no matter what safeguards are added, it cannot ensure
the safety of imported drugs. Problems that arise from use of imported drugs
undermine public confidence in the U.S. drug supply.
D. 2005 Proxy Statement
The company made the following statements in 2005 in opposition to a shareholder
proposal requesting the company to implement a policy of not constraining
importation of drugs from foreign markets and to report on that policy to
shareholders.
Statement in Opposition to the Proposal Regarding Importation of Drugs The
public policy and compliance committee of the board has reviewed the shareholder
proposal and finds that it is not in the best of interest of shareholders as it
asks us to develop and promulgate a policy that is in direct conflict with
existing laws of the United States and our objective of ensuring safe supply of
our drugs around the world. In addition, such a policy would harm our ability to
discover and develop innovative drugs.
Importation of pharmaceuticals into the United States is illegal, and the safety
of illegally imported products cannot be ensured. Efforts to open the Canadian
system to supply the much larger United States market would open United States
consurners to threats of counterfeit products, product tampering, and product
integrity problems with their medicines. The Canadian government has stated that
it will not establish regulatory processes to address the safety and integrity
of pharmaceuticals passing through Canada destined for other countries. The U.S.
Food and Drug Administration has repeatedly stated that it cannot guarantee the
safety of medicine coming into the United States from outside the current
regulatory framework. In fact, at the end of last year, the U.S. Department of
Health and Human Services Task Force on Drug Importation (HHS task force)
reported on its year-long examination of the risks and benefits of importation.
The HHS task force, composed of leaders from across federal government, gathered
information from around the world, heard testimony from stakeholders of all
kinds, and concluded that allowing importation from other countries would open a
channel for potentially dangerous counterfeit drugs.
Maintaining product integrity is essential to patient safety. The company's
decision to supply Canadian wholesalers only sufficient product to meet local
Canadian demand is consistent with historical company contract requirements and
with our evaluation of the safety of the Canadian system. If the company does
not take steps to protect the United States and Canadian supply chains from
counterfeiting and tampering, patients could be placed at risk and we could face
legal and financial threats and harm to our reputation.
Also, in its 2005 Proxy Statement, the company responded to an identical
proposal to the current Proposal (submitted by the same shareholder). In that
response, the company expressly addressed its assessment of risks it faces (both
business and legal) as a result of its Canadian supply policy:
Statement in Opposition to the Proposal Regarding Limiting Product Supply to
Canada
... We disclose material financial and legal risks to the company in Forms 10-Q,
10-K, and 8-K filings with the Securities and Exchange Commission (SEC), and
public policy issues such as access to medicines in our annual Corporate
Responsibility Report (available on our website at responsible.lilly.com). We
believe the business risks from our supply chain management practices are
immaterial, do not warrant further discussion in our SEC filings, and do not
rise to the level of a special report. We have acted independently to develop
supply chain management systems, policies, and associated customer contracts. We
do not believe we will assume regulatory risk by employing our current global
strategy linking supply of our products to Canadian wholesalers to Canadian
patient demand. Moreover, while we have disclosed in our SEC filings that we
(along with several other pharmaceutical companies) have been named in lawsuits
alleging that our conduct in preventing commercial importation of prescription
drugs violates antitrust laws, we believe the suits are without merit and will
not have a material impact on our operations.
The Federal Food, Drug, and Cosmetic Act makes it illegal to import unapproved,
misbranded, and adulterated drugs into the United States, which includes foreign
versions of U.S.-approved medications. We adhere to these laws. Importation of
pharmaceutical products puts patients at greater risk of buying and receiving
product that is outdated or otherwise compromised, or counterfeit copies of our
products that contain inert or overly potent ingredients.
Finally, although not part of the Proposal's resolution section, the social
policy of concern to the proponent is pharmaceutical pricing. The company has
reported extensively on this issue in its Corporate Citizenship Report, which is
available on its website at www.Lilly.com. The report also contains a
description of the company's access programs which provide free or discounted
medicines to eligible patients, and its philanthropic partnership to fight
multi-drug resistant TB. All of these programs provide medicines to those who
might otherwise not be able to afford them.
The company has already published information that is responsive to the Proposal
and addresses its "essential objectives" Therefore, we believe the Proposal can
be omitted from our proxy materials as it has already been substantially
implemented.
IV. Conclusion
The company believes, for the reasons stated above, that the Proposal may be
properly omitted from the company's proxy materials.
In accordance with Rule 14a-8(j), we are by separate letter advising the
Proponent of Lilly's intention to omit the Proposal from its proxy statement and
providing it with a copy of this letter and the attached exhibits.
We respectfully request your confirmation that the Division of Corporation
Finance will not recommend to the Commission any action If Lilly omits the
Proposal from its proxy materials for its 2008 Annual Meeting of Shareholders.
We would appreciate your response not later than February 1, 2008 so that Lilly
may be able to meet its timetable for distributing its proxy materials.
Should you disagree with our conclusions, we would appreciate an opportunity to
confer with you prior to the issuance of the staff's Rule 14a-8(j) response. If
you have any questions with respect to the foregoing, please do not hesitate to
call me at 317-276-5835.
Please acknowledge receipt of this letter and the attached material by stamping
and returning the enclosed copy of this letter in the self-addressed stamped
envelope.
Very truly yours,
/s/
James B. Lootens
Enclosures
cc: Howard J. Bicker
Executive Director
Minnesota State Board of Investment
60 Empire Drive, Suite 355
St. Paul, MN 55103
[INQUIRY LETTER]
October 19, 2007
Mr. James B. Lootens
Secretary
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285
Dear Mr. Lootens:
The Minnesota State Board of Investment (MSBI) has asked me to notify you of our
intention to sponsor the enclosed proposal for consideration and approval of
stockholders at the next annual meeting. I submit it to you in accordance with
the general rules and regulations under Rule 14a-8 of the Securities Exchange
Act of 1934 and ask that our name be included in your proxy statements.
The enclosed letter from State Street Bank and Trust Company of Boston asserts
the Board's ownership, for more than a year, of your outstanding shares.
Under current policies affecting MSBI portfolio, the MSBI will continue to hold
shares in your company through the date of the 2008 Annual Meeting.
Sincerely,
/s/
Howard J. Bicker
Executive Director
HJB:dfg
[APPENDIX]
Importation
WHEREAS, current business practices of the company have resulted in a pricing
structure that charges United States customers significantly higher prices for
the same prescription medicines made available at significantly lower prices in
Canada, other developed countries and world markets; and
WHEREAS, governmental agencies and individuals in the United States are
demanding affordable drug prices and are taking actions to access lower priced
products from Canada and other world markets; and
WHEREAS, according to published reports, the company has cut supplies of its
medicines to Canadian wholesalers and companies that it claims allowed its
product to be sold to Americans seeking lower prices available in the Canadian
market; and
WHEREAS, according to published reports, the company's actions have resulted in
lawsuits and threatened lawsuits; and
WHEREAS, the company's actions to limit supply of medicines in Canada may
violate local, national and international laws and could result in large
settlements, large awards of damages and potential punitive damages which would
negatively impact the economic stability of the company and the value ot its
shares.
RESOLVED:
Shareholders request the Board of Directors to prepare a report on the effects
on the long-term economic stability of the company and on the risks of liability
to legal claims that arise from the company's policy of limiting the
availability of the company's products to Canadian wholesalers or pharmacies
that allow purchase of its products by U.S. residents. The report should be
prepared at reasonable cost and omitting proprietary information, by September
30, 2008.
SUPPORTING STATEMENT
We urge shareholders to vote FOR this proposal.
[STAFF REPLY LETTER]
December 19, 2007
Response of the Office of Chief Counsel
Division of Corporation Finance
Re: Eli Lilly and Company Incoming letter dated November 21, 2007
The proposal requests the board to prepare a report on "the effects on the
long-term economic stability of the company and on the risks of liability to
legal claims" resulting from the company's policy of limiting the availability
of the company's products to Canadian wholesalers or pharmacies that allow
purchase of its products by U.S. residents.
There appears to be some basis for your view that Lilly may exclude the proposal
under rule 14a-8(i)(7), as relating to Lilly's ordinary business operations
(i.e., evaluation of risk). Accordingly, we will not recommend enforcement
action to the Commission if Lilly omits the proposal from its proxy materials in
reliance on rule 14a-8(i)(7). In reaching this position, we have not found it
necessary to address the alternative basis for omission upon which Lilly relies.
Sincerely,
/s/
John R. Fieldsend
Attorney-Adviser
|