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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): April 27, 2004
BRISTOL-MYERS SQUIBB COMPANY
(Exact Name of Registrant as Specified in its Charter)
Delaware 1-1136 22-079-0350
(State or Other Jurisdiction (Commission File (IRS Employer
of Incorporation) Number) Identification Number)
345 Park Avenue
New York, NY 10154
(Address of Principal Executive Office)
Registrant's telephone number, including area code: (212) 546-4000
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Item 5. OTHER EVENTS
On April 27, 2004, the Company entered into a collaboration agreement with
Merck & Co., Inc. for worldwide co-development and co-promotion for
muraglitazar, the Company's dual PPAR (peroxisome proliferator activated
receptor) agonist, currently in Phase III clinical development for use in
treating Type 2 diabetes. Under the terms of the agreement, the Company
received a $100 million upfront payment in May 2004, and is entitled to
receive $275 million in additional payments upon the achievement of certain
regulatory milestones. The Company and Merck will jointly develop the clinical
and marketing strategy for muraglitazar, share equally in future development
and commercialization costs and co-promote the product to physicians on a
global basis, with Merck to receive payments based on net sales levels. As
announced previously, an NDA for muraglitazar is expected to be submitted to
the FDA within the next nine to twelve months for U.S. regulatory approval. In
addition, the collaboration includes a back-up compound to muraglitazar, with
the same mechanism of action (PPAR), which is anticipated to enter Phase II
clinical trials for the treatment of Type 2 diabetes this year.
The agreement will expire on a product-by-product and country-by-country basis
upon the latest of (i) the expiration of the last to expire Bristol-Myers
Squibb patent or patent that is jointly funded in each case with respect to
the applicable product in the applicable country, (ii) the expiration of any
additional statutory or administrative protections that grant exclusivity with
respect to the applicable product in the applicable country, and (iii) the
cessation of the sale of the applicable product in the applicable country
following first commercial sale of that product in that country. The basic
composition of matter patent for muraglitazar in the United States expires in
2020. Patent applications in various countries in the European Union are
pending. The Company also may be entitled to additional statutory or
administrative protections in the United States and the European Union that
would grant exclusivity with respect to muraglitazar beyond 2020. It is not
possible to predict the length of market exclusivity for any of the Company's
products, including muraglitazar, with certainty because of the complex
interaction between patent and regulatory forms of exclusivity, and inherent
uncertainties about the enforceability of certain intellectual property
rights. Accordingly, the agreement could terminate with respect to
muraglitazar prior to the current patent expiration date. In addition, due to
the inclusion in the collaboration of the back-up compound and the possibility
that the back-up compound will be developed to the point of being a
commercially marketed product, the term of the agreement could possibly extend
beyond the patent expiration date and exclusivity period relating to
muraglitazar.
In addition to customary termination provisions for cause, Merck also has the
right to terminate the agreement for any reason upon not less than six months
prior written notice to the Company. However, this right of termination can be
exercised by Merck with respect to any product only during the period between
the completion of Phase III clinical trials relating to such product and the
time the NDA for such product is filed with the FDA. This right also can be
exercised by Merck after the second anniversary of the date of filing of the
NDA for such product with the FDA if the product has not been commercially
launched in the United States at such time, or, if commercially launched in
the United States, after the second anniversary of the commercial launch of
such product in the United States. With respect to the European Union, Merck
can exercise this right of termination after the second anniversary of the
commercial launch of such product in the European Union or, if not
commercially launched in the European Union, the third anniversary of the
commercial launch of the product in the
United States. Upon any early termination, the Company will retain control of
all rights to muraglitazar.
The agreement also provides that, except as described below, for so long as
the collaboration between the Company and Merck remains in effect with respect
to at least one country in the world, each party and its affiliates will not,
and will cause its affiliates not to, advise, assist or encourage others to,
directly or indirectly, without the consent of the other party: (i) acquire,
announce an intention to acquire, offer or propose to acquire or agree to
acquire, directly or indirectly, alone or in concert with others, by purchase,
gift or otherwise, any direct or indirect beneficial ownership (within the
meaning of Rule 13d-3 under the Securities Exchange Act of 1934, as amended
(the "Exchange Act")) or interest in any securities of the other party or any
of its affiliates that are entitled to vote for the election of directors of
such party or affiliate ("Voting Securities") or direct or indirect rights,
warrants or options to acquire, or securities convertible into or exchangeable
for, any Voting Securities of the other party or any of its affiliates; (ii)
effect or seek, initiate, offer or propose or participate in or assist any
other person to effect or seek, initiate, offer or propose any (A) tender or
exchange offer, merger, consolidation or other business combination involving
the other party or any of its affiliates; or (B) any recapitalization,
restructuring, liquidation, dissolution, sale of all or substantially all of
its assets or other extraordinary transaction with respect to the other party
or any of its affiliates; (iii) make, or in any way participate in, directly
or indirectly, alone or in concert with others, any "solicitation" of
"proxies" to vote (as such terms are used in the proxy rules of the United
States Securities and Exchange Commission promulgated pursuant to Section 14
of the Exchange Act) with respect to the other party or any of its affiliates
(whether or not such solicitation is subject to regulation under Regulation
14A promulgated under the Exchange Act) or otherwise solicit any consent or
communicate with or seek to advise or influence any person with respect to the
voting of such other party's (or its affiliates') Voting Securities; (iv)
deposit any Voting Securities of the other party or any of its affiliates into
a voting trust or subject any such Voting Securities to any arrangement or
agreement with respect to the voting thereof; (v) initiate, propose or
otherwise solicit stockholders of the other party or any of its affiliates for
the approval of one or more stockholder proposals as described in Rule 14a-8
under the Exchange Act with respect to the other party or any of its
affiliates or their bylaws or other constituent documents, or induce or
attempt to induce any other person to initiate any such stockholder proposal
with respect to the other party or any of its affiliates or their bylaws or
other constituent documents; (vi) seek election to or seek to place a
representative on the Board of Directors of the other party or any of its
affiliates or seek the removal of any member of the Board of Directors of the
other party of any of its affiliates; (vii) call or seek to have called any
meeting of the stockholders of the other party or any of its affiliates;
(viii) request, or take any action to obtain, any list of holders of Voting
Securities of the other party or any of its affiliates; (ix) form, join or in
any way participate in a "group" (within the meaning of Section 13(d)(3) of
the Exchange Act) with respect to any Voting Securities of the other party or
any of its affiliates or direct or indirect rights, warrants or options to
acquire, or securities convertible into or exchangeable for, any Voting
Securities of the other party or any of its affiliates; (x) otherwise act,
alone or in concert with others, to seek to control the Board of Directors or
influence the management of the other party or any of its affiliates, provided
that nothing in this clause (x) shall prevent such party or any affiliate of
such party, either acting alone or in concert with others, from taking such
action or refraining from taking such action as it believes is required of it
under applicable law; or
(xi) enter into any agreements, discussions or arrangements with any person
other than the Company, Merck or an affiliate of either of them with respect
to any of the foregoing; or (xii) seek to waive, amend or modify any of the
provisions contained herein (these provisions, collectively, the "Standstill
Agreement").
The Standstill Agreement does not prohibit a party or any of its affiliates
from acquiring Voting Securities of the other party or any of its affiliates
by or through (i) a diversified mutual or pension fund managed by an
independent investment adviser or pension plan established for the benefit of
the employees of such party or its affiliates, (ii) any employee benefit plan
of such party or any of its affiliates or (iii) any stock portfolios not
controlled by such party or any of its affiliates that invest in the other
party or any of its affiliates among other companies; provided that such party
or any of its affiliates does not, directly or indirectly, request the trustee
or administrator or investment adviser of such fund, plan or portfolio to
acquire such Voting Securities and provided that no such fund, plan or
portfolio acquires more than five percent (5%) of any class of Voting
Securities of such other party or any of its affiliates. Further, the
Standstill Agreement does not prevent any party or any of its affiliates from
acquiring securities of another pharmaceutical or biotechnology company or
other person that beneficially owns any securities of the other party or any
of its affiliates.
The provisions in the Standstill Agreement will be suspended solely to permit
a party and its affiliates (collectively the "Acquiring Party") to: (i) take
any of the actions described above to the extent the other party or any of its
affiliates specifically invites the Acquiring Party to take such actions or
(ii) to compete in an Acquisition Transaction (as defined below) with respect
to the other party or any of its affiliates if such Acquisition Transaction
shall have been publicly proposed by the other party or any of its affiliates
or by a person unaffiliated with the Acquiring Party and accepted or approved
by the other party or its affiliate, or if rejected or not approved by the
other party and its affiliates, pursued on a unilateral basis pursuant to a
tender or exchange offer and/or a proxy solicitation, or if the other party or
its affiliate shall have entered into an agreement in principle or definitive
agreement providing for such Acquisition Transaction. "Acquisition
Transaction" means (A) any direct or indirect divestiture or sale by a party
or any of its affiliates of assets representing thirty-five percent (35%) or
more of the market capitalization of a party or of thirty-five percent (35%)
or more of the Voting Securities of or equity interest in such party or any of
its subsidiaries, or (B) any tender offer or exchange offer that if
consummated would result in any person or group beneficially owning
thirty-five percent (35%) or more of any class of Voting Securities of such
party or affiliate, or (C) any merger, consolidation, business combination,
recapitalization or similar transaction involving such party or any of its
affiliates representing thirty-five percent (35%) or more of the market
capitalization of such party or of thirty-five percent (35%) or more of the
Voting Securities of or equity interest in such party or any of its
subsidiaries."
Incorporated by reference in its entirety is a press release issued by the
Registrant on April 28, 2004, attached as Exhibit 99, announcing the
co-development and co-promotion agreement with Merck & Co., Inc.
Item 7(c). EXHIBITS
Exhibit 99 - Press release dated April 28, 2004 announcing the co-development
and co-promotion agreement with Merck & Co., Inc.
SIGNATURE
Under the requirements of the Securities Exchange Act of 1934, the Registrant
has caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
BRISTOL-MYERS SQUIBB COMPANY
By: /s/ Sandra Leung
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Sandra Leung
Secretary
Dated: May 10, 2004
EXHIBIT INDEX
Exhibit Number Description
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99 Press release dated April 28, 2004 regarding Registrant's
Co-Development and Co-Promotion Agreement with Merck & Co., Inc.