SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 13D
(Amendment No. 2)
Under the Securities Exchange Act of 1934
ImClone Systems Incorporated
(Name of Issuer)
Common Stock, Par Value $0.001 Per Share
(Title of Class of Securities)
45245W109
(CUSIP Number)
Bristol-Myers Squibb Company
345 Park Avenue
New York, New York 10154
(212) 546-4000
Attn: General Counsel
(Name, Address and Telephone Number of Person Authorized to Receive Notices and
Communications)
March 5, 2002
(Date of Event which Requires Filing of this Statement)
If the filing person has previously filed a statement on Schedule 13G to
report the acquisition that is the subject of this Schedule 13D, and is filing
this schedule because of Sections 240.13d-1(e), 240.13d-1(f) or 240.13d-1(g),
check the following box [ ].
NOTE: Schedules filed in paper format shall include a signed original and five
copies of the schedule, including all exhibits. Sections 240.13d-7(b) for other
parties to whom copies are to be sent.
* The remainder of this cover page shall be filled out for a reporting
person's initial filing on this form with respect to the subject class of
securities, and for any subsequent amendment containing information which
would alter disclosures provided in a prior cover page.
The information required on the remainder of this cover page shall not be
deemed to be "filed" for the purpose of Section 18 of the Securities Exchange
Act of 1934 ("Act") or otherwise subject to the liabilities of that section of
the Act but shall be subject to all other provisions of the Act.
(Continued on following page(s))
CUSIP No. 45245W109
_______________________________________________________________________________
1 Names of Reporting Persons
Identification Nos. of Above Persons (entities only)
Bristol-Myers Squibb Company
22-0790350
_______________________________________________________________________________
Check the Appropriate Box if a Member of a Group
2 (a) [X]
(b) [ ]
_______________________________________________________________________________
3 SEC Use Only
_______________________________________________________________________________
4 Source of Funds
BK, OO
_______________________________________________________________________________
5 Check if Disclosure of Legal Proceedings is Required
Pursuant to Items 2(d) or 2(e) [ ]
_______________________________________________________________________________
6 Citizenship or Place of Organization
Delaware
_______________________________________________________________________________
7 Sole Voting Power
14,392,003
_______________________________________
Number of Shares 8 Shared Voting Power
Beneficially - 0 -
Owned by Each _______________________________________
Reporting 9 Sole Dispositive Power
Person with 14,392,003
_______________________________________
10 Shared Dispositive Power
- 0 -
_______________________________________________________________________________
Aggregate Amount Beneficially Owned by Each Reporting Person
11
14,392,003
_______________________________________________________________________________
Check Box if the Aggregate Amount in Row (11) Excludes
12 Certain Shares [ ]
_______________________________________________________________________________
Percent of Class Represented
13 by Amount in Row (11)
19.9%
_______________________________________________________________________________
Type of Reporting Person
14 CO
_______________________________________________________________________________
2
_______________________________________________________________________________
1 Names of Reporting Persons
Identification Nos. of Above Persons (entities only)
Bristol-Myers Squibb Biologics Company
22-3828046
_______________________________________________________________________________
Check the Appropriate Box if a Member of a Group
2 (a) [X]
(b) [ ]
_______________________________________________________________________________
3 SEC Use Only
_______________________________________________________________________________
4 Source of Funds
BK, OO
_______________________________________________________________________________
5 Check if Disclosure of Legal Proceedings is Required
Pursuant to Items 2(d) or 2(e) [ ]
_______________________________________________________________________________
6 Citizenship or Place of Organization
Delaware
_______________________________________________________________________________
7 Sole Voting Power
14,392,003
_______________________________________
Number of Shares 8 Shared Voting Power
Beneficially - 0 -
Owned by Each _______________________________________
Reporting 9 Sole Dispositive Power
Person with 14,392,003
_______________________________________
10 Shared Dispositive Power
- 0 -
_______________________________________________________________________________
Aggregate Amount Beneficially Owned by Each Reporting Person
11
14,392,003
_______________________________________________________________________________
Check Box if the Aggregate Amount in Row (11) Excludes
12 Certain Shares [ ]
_______________________________________________________________________________
Percent of Class Represented
13 by Amount in Row (11)
19.9%
_______________________________________________________________________________
Type of Reporting Person
14 CO
_______________________________________________________________________________
3
Item 1. Security and Issuer.
Item 1 is hereby amended, in pertinent part, by the following:
This Amendment No. 2 to Schedule 13D relating to the Common Stock,
par value $.001 per share, of ImClone Systems Incorporated ("ImClone") is
being filed on behalf of the undersigned to further amend their disclosure
with respect to Section 13(d) of the Act and the rules and regulations
thereunder. Such disclosure constituted part of the undersigned's Schedule TO
previously filed on September 28, 2001, as amended by filings made on October
12, 2001, October 26, 2001, October 29, 2001 and November 1, 2001. Such
disclosure was also amended by Amendment No. 1 to Schedule 13D filed by the
undersigned on February 6, 2002 ("Amendment No. 1").
Item 4. Purpose of the Transaction.
Item 4 is hereby amended, in pertinent part, by the following:
As set forth in Amendment No. 1, on February 5, 2002, Bristol-Myers
Squibb Company (the "Company") proposed to restructure certain terms of its
commercial arrangement with ImClone in connection with the Company's
evaluation of its relationship with ImClone. On March 5, 2002, the Company and
ImClone announced that they had agreed to restructure certain provisions of
the Development, Promotion, Distribution and Supply Agreement, dated as of
September 19, 2001, by and among ImClone, the Company and E.R. Squibb & Sons,
LLC (the "Distribution Agreement"). The amendment to the Distribution
Agreement in respect of such restructuring is attached hereto as Exhibit A and
is incorporated herein by reference. In addition, the joint press release of
the Company and ImClone in respect of such restructuring is attached hereto as
Exhibit B and is incorporated herein by reference.
Item 7. Material to be Filed as Exhibits.
Exhibit A Amendment No. 1, dated March 5, 2002, to the Development, Promotion,
Distribution and Supply Agreement, dated as of September 19, 2001,
by and among ImClone Systems Incorporated, Bristol-Myers Squibb
Company and E.R. Squibb & Sons, LLC.*
Exhibit B Joint press release of Bristol-Myers Squibb Company and
ImClone Systems Incorporated, dated March 5, 2002.
* Certain portions of this agreement have been omitted pursuant to an
application for confidential treatment filed with the Securities and Exchange
Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934,
as amended.
4
Signature
After reasonable inquiry and to the best of my knowledge and belief,
I certify that the information set forth in this statement is true, complete
and correct.
Date: March 6, 2002
BRISTOL-MYERS SQUIBB COMPANY
by: /s/ Frederick S. Schiff
----------------------------------
Name: Frederick S. Schiff
Title: Senior Vice President and Chief
Financial Officer
BRISTOL-MYERS SQUIBB BIOLOGICS COMPANY
by: /s/ Sandra Leung
----------------------------------
Name: Sandra Leung
Title: Vice President and Secretary
5
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR SUCH PORTIONS BY BRISTOL-MYERS
SQUIBB COMPANY, BRISTOL-MYERS SQUIBB BIOLOGICS COMPANY AND IMCLONE SYSTEMS
INCORPORATED. THESE PORTIONS HAVE BEEN MARKED WITH TWO ASTERISKS ENCLOSED IN
THE BRACKETS (I.E., [**]). THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
EXHIBIT A
AMENDMENT NO. 1 TO DEVELOPMENT, PROMOTION,
DISTRIBUTION AND SUPPLY AGREEMENT
AMENDMENT NO. 1 dated as of March 5, 2002 (this "Amendment"), by and
among E. R. SQUIBB & SONS, LLC, a limited liability company organized and
existing under the laws of the State of Delaware, having offices located at
Route 206 and Province Line Road, Princeton, New Jersey ("ERS"), BRISTOL-MYERS
SQUIBB COMPANY, a corporation organized and existing under the laws of the
State of Delaware, having offices located at Route 206 and Province Line Road,
Princeton, New Jersey ("BMS") and IMCLONE SYSTEMS INCORPORATED, a corporation
organized under the laws of the State of Delaware, having offices located at
180 Varick Street, New York, New York 10014 (the "Company").
PRELIMINARY STATEMENTS
A. ERS, BMS and the Company are parties to the Development,
Promotion, Distribution and Supply Agreement dated as of September 19, 2001
(the "Commercial Agreement") pursuant to which the Parties have agreed to
collaborate on the development and commercialization of Products in the
Territory.
B. On October 30, 2001, pursuant to the Commercial Agreement, the
Company submitted a biologics license application for a Product under Section
351 of the Public Health Service Act. On December 28, 2001, the FDA notified
the Company that it would refuse to file such biologics license application
(the "Refusal to File").
C. In light of the Refusal to File and subsequent discussions with
the FDA, the Parties have agreed to amend the Commercial Agreement as set
forth in this Amendment.
NOW, THEREFORE, in consideration of the foregoing preliminary
statements and the mutual agreements and covenants set forth herein, the
Parties hereby agree as follows:
1. DEFINITIONS.
1.1 Definitions in the Commercial Agreement. Capitalized terms used
but not defined in this Amendment (including the Preliminary Statements set
forth above) shall have the meanings set forth in the Commercial Agreement.
References in the Commercial Agreement to "this Agreement" shall be deemed to
refer to the Commercial Agreement as amended by this Amendment.
Notwithstanding the foregoing, the date of the Commercial Agreement, as
amended hereby, shall in all instances remain September 19, 2001, and
references to "the date hereof", "the date of this Agreement" and "the
Effective Date" in the Commercial Agreement shall continue to refer to
September 19, 2001.
2. MANAGEMENT.
2.1 Clinical and Regulatory Oversight. The Parties agree that Andrew
Bodnar ("Bodnar") shall, for so long as he is willing to serve, be entitled to
oversee the implementation of the Clinical Development Plan and the process
for seeking Registration of Products pursuant to the Commercial Agreement.
Bodnar shall be entitled to attend meetings of any Committee, and any
Committee may from time to time consult with Bodnar with respect to any matter
relating to the Clinical Development Plan or Registration of the Product;
provided that Bodnar shall not have any powers, rights or responsibilities of
a member of a Committee (except to the extent he otherwise has such powers,
rights or responsibilities in his capacity as a member of such Committee), and
Bodnar's authority shall be subject to the authority of the Committees and the
other provisions of the Commercial Agreement. Bodnar shall also be entitled to
attend any meetings between the Company and the FDA with respect to a Product.
6
Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
3. CLINICAL DEVELOPMENT PLAN/CLINICAL BUDGET
3.1 Product Development Committee Meeting.
(a) As soon as reasonably practicable after the date hereof, the PDC
shall meet to amend and modify the Clinical Development Plan pursuant to the
Commercial Agreement to reflect the current strategy of the Parties with
respect to Registration of the Product. Such amended and modified Clinical
Development Plan (the "Modified Clinical Plan") shall include the matters
referred to in Section 4.3(b) of the Commercial Agreement, and shall be a
"Clinical Development Plan" within the meaning of Section 1.20 of the
Commercial Agreement.
(b) At the meeting referred to in Section 3.1(a), the PDC shall also
modify the Clinical Budget relating to the Registrational Studies pursuant to
the Commercial Agreement to reflect the Modified Clinical Plan; provided that
such modified Clinical Budget (the "Modified Clinical Budget") shall (i) be
equal in the aggregate to the Clinical Budget in effect as of the date hereof
(the "Existing Clinical Budget") and (ii) in respect of any year prior to
2005, not be less than 80% of the budget for such year under the Existing
Clinical Budget. Unless and until the Modified Clinical Budget is approved in
accordance with the Commercial Agreement, the Existing Clinical Budget shall
remain in effect.
3.2 Joint Manufacturing Committee Meeting. As soon as reasonably
practicable after the meeting referred to in Section 3.1(a), the JMC shall
meet to amend Exhibit 8.12 (B)(i) to the Commercial Agreement to reflect the
Modified Clinical Budget.
4. PAYMENTS.
4.1 Payments to the Company.
(a) As partial consideration to the Company for the rights granted
to ERS under the Commercial Agreement and for entering into this Amendment,
ERS shall pay to the Company a non-refundable and non-creditable payment of
$140,000,000 on March 7, 2002 in immediately available funds by wire transfer
to an account specified by the Company.
(b) Section 6.2 of the Commercial Agreement is amended by deleting
paragraph (a) thereof in its entirety and replacing it with the following:
"(a) As further consideration to the Company for the rights granted
to ERS under this Agreement, ERS shall pay to the Company the
following non-refundable and non-creditable payments on the date or
upon the occurrence of the events, as the case may be, set forth
below:
Date/Event Payment
---------- -------
March 5, 2003 $60,000,000
Upon receipt of written Registration in the
US from the FDA with respect to any
indication for a Product (the "First $250,000,000
Indication").
7
Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
Date/Event Payment
---------- -------
Upon receipt of written Registration in the
US from the FDA with respect to any
indication relating to a different tumor type $250,000,000
from the First Indication (the "Second
Indication").
The Party who receives notice of Registration from the FDA shall be
responsible for promptly informing the other Parties when such event
occurs. The payments required with respect to receipt of
Registration pursuant to this Section 6.2(a) shall be paid within 30
days (by wire transfer in immediately available funds to an account
specified by the Company) after the earlier to occur of: (i) ERS
receiving notice of the Registration from the FDA or (ii) the
Company notifying ERS of such Registration. The Parties understand
that the First Indication and the Second Indication may be included
in the same Registration; provided that any indication or series of
indications relating to the same tumor type (e.g., colorectal
cancer) shall, for all purposes under this Section 6.2, constitute
one indication and no subsequent indication in respect of the tumor
type for which the First Indication was received shall be considered
a Second Indication."
4.2 Distribution Fees.
(a) Section 6 of the Commercial Agreement is amended by
deleting Sections 6.3 and 6.4 in their entirety and replacing them with the
following:
"Section 6.3 Distribution Fees for North America. As further
consideration to the Company for the rights granted to ERS in North
America under this Agreement, ERS shall pay to the Company a
Distribution Fee for North America equal to 39% of Net Sales in
North America during each calendar year (or portion thereof)."
(b) Section 6 of the Commercial Agreement is further amended by
renumbering Section 6.5 as "Section 6.4" and Section 6.6 as "Section 6.5".
(c) Section 16.2 of the Commercial Agreement is amended by
deleting ", subject to Section 6.4" from the first sentence thereof.
5. PROJECTIONS.
5.1 Base Case Projections. Exhibit 1.13 to the Commercial Agreement
is deleted in its entirety and replaced by Exhibit 1.13 to this Amendment.
5.2 Low Case Projections. Exhibit 1.68 to the Commercial Agreement
is deleted in its entirety and replaced by Exhibit 1.68 to this Amendment.
5.3 Marketing Budget. Exhibits 5.2(A) and 5.2(B) to the Commercial
Agreement are deleted in their entirety and replaced by Exhibits 5.2(A) and
5.2(B) to this Amendment.
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Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
5.4 Commercial API Supply. Exhibit 8.12(B)(ii) to the Commercial
Agreement is deleted in its entirety and replaced by Exhibit 8.12(B)(ii) to
this Amendment.
5.5 Non-Registrational Clinical Budget. The portion of Exhibit
4.3(A) to the Commercial Agreement related to Non-Registrational Studies is
deleted in its entirety and replaced by Exhibit 4.3(A) to this Amendment.
6. REPRESENTATIONS AND WARRANTIES.
Each Party represents and warrants to each of the other Parties, as
of the date of this Amendment, that:
(a) such Party is duly organized, validly existing and in good
standing under the laws of the jurisdiction of its incorporation and has full
corporate power and authority to enter into this Amendment and to carry out
the provisions hereof;
(b) such Party has taken all corporate action necessary to
authorize the execution and delivery of this Amendment and the performance of
its obligations under this Amendment and has full power and authority to enter
into this Amendment and perform its obligations under this Amendment; and
(c) this Amendment has been duly executed by such Party and
constitutes a valid and legally binding obligation of such Party, enforceable
in accordance with its terms, subject to and limited by: (i) applicable
bankruptcy, insolvency, reorganization, moratorium, and other laws generally
applicable to creditors' rights; and (ii) judicial discretion in the
availability of equitable relief.
7. MISCELLANEOUS.
7.1 Prior Events. Each Party hereby acknowledges and agrees that a
requirement by the FDA that the Company (i) reformat and reanalyze the
clinical data from the two clinical studies (Nos.9923 and 0141) conducted by
the Company in connection with the Registration Application submitted to the
FDA on October 30, 2001 and (ii) submit data from clinical study No. 007
currently being conducted by Merck KGaA in Europe for the use of the Product
to treat refractory colorectal cancer to support a resubmission of the
Registration Application, does not constitute, in and of itself without
further FDA requirements, a "material delay" under Section 4.8 of the
Commercial Agreement or give rise, as of the date hereof, to "a significant
concern regarding a regulatory or patient safety issue that would seriously
impact the long term viability of all Products" under Section 13.3 of the
Commercial Agreement; provided that this Section 7.1 does not, and shall in no
circumstances be construed as, an admission of the occurrence of, or as an
indication of what may constitute or be considered in the determination of the
existence of, a "material delay" under Section 4.8 of the Commercial Agreement
or such a "significant concern" under Section 13.3 of the Commercial
Agreement.
7.2 Manufacturing Facility. As soon as reasonably practicable after
the date hereof, the Company shall resume construction of the BB-50 plant (the
"Plant"), and use its commercially reasonable efforts to pursue diligently the
construction of the Plant, substantially in accordance with the plans and
specifications previously provided to BMS. The Company shall use its
commercially reasonable efforts to complete such construction by [**].
7.3 Press Release. Immediately following execution of this
Amendment, the Parties shall issue a joint press release in the form
previously agreed by the Parties.
7.4 Rights. Except as specifically set forth herein, the Commercial
Agreement shall remain unchanged and in full force and effect. The Parties
acknowledge and agree that there are no
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Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
amendments, modifications or waivers in respect of the Commercial Agreement
other than those specifically set forth in this Amendment.
7.5 Governing Law. This Amendment shall be governed by and
interpreted in accordance with the laws of the State of New York without
regard to conflicts of law principles.
7.6 Descriptive Headings. The descriptive headings of this Amendment
are for convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Amendment.
7.7 Counterparts. This Amendment may be executed simultaneously in
any number of counterparts, any one of which need not contain the signature of
more than one Party but all such counterparts taken together shall constitute
one and the same agreement.
***
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Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
IN WITNESS WHEREOF, each of the Parties has caused this Amendment to
be executed by its duly authorized representative as of the day and year first
above written.
IMCLONE SYSTEMS INCORPORATED
By: /s/ Samuel D. Waksal
-------------------------------------
Name: Samuel D. Waksal
-------------------------------------
Title: President and Chief Executive Officer
-------------------------------------
E. R. SQUIBB & SONS, LLC
By: /s/ John L. McGoldrick
-------------------------------------
Name: John L. McGoldrick
-------------------------------------
Title: Vice President
-------------------------------------
BRISTOL-MYERS SQUIBB COMPANY
By: /s/ Sandra Leung
-------------------------------------
Name: Sandra Leung
-------------------------------------
Title: Secretary
-------------------------------------
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Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
---------------------------------------------------------------------------------------------------------------------------
Exhibit 1.13 -- Base Case Projections
United States and Japan C225 Sales
($MM)
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
---------------------------------------------------------------------------------------------------------------------------
Base Case
---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
U.S. Sales - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
Japan Sales - - - - - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
Total C225 Sales - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
===========================================================================================================================
Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
-------------------------------------------------------------------------------------------------------------------------------
Exhibit 1.68 -- Low Case Projections
United States and Japan C225 Sales
($MM)
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
-------------------------------------------------------------------------------------------------------------------------------
Low Case
-------------------------------------------------------------------------------------------------------------------------------
U.S. Sales - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
-------------------------------------------------------------------------------------------------------------------------------
Japan Sales - - - - - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
-------------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------------------------------
Total C225 Sales - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
===============================================================================================================================
Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
-------------------------------------------------------------------------
Exhibit 5.2A -- Marketing Budget
2001-2004
($MM)
2001 2002 2003 2004
-------------------------------------------------------------------------
Total A&P Expense [**] [**] [**] [**]
-------------------------------------------------------------------------
U.S. [**] [**] [**] [**]
-------------------------------------------------------------------------
Japan - - - -
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Distribution & Other Fees - - [**] [**]
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Total Sales Force - - [**] [**]
-------------------------------------------------------------------------
U.S. - - [**] [**]
-------------------------------------------------------------------------
Japan - - - -
-------------------------------------------------------------------------
# Reps [**] [**]
=========================================================================
Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
----------------------------------------------------------------------------------------------------------------------
Exhibit 5.2B -- Indicative Marketing Budget
2005-2017
($MM)
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
----------------------------------------------------------------------------------------------------------------------
Total A&P Expense [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
----------------------------------------------------------------------------------------------------------------------
U.S. [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
----------------------------------------------------------------------------------------------------------------------
Japan - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
Distribution & Other Fees [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
----------------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------------
Total Sales Force [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
----------------------------------------------------------------------------------------------------------------------
U.S. [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
----------------------------------------------------------------------------------------------------------------------
Japan - - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
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Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
--------------------------------------------------------------------------------------------------------------------------------
Exhibit 8.12B (ii)
United States and Japan C225 Commercial Volume
Kilograms
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
--------------------------------------------------------------------------------------------------------------------------------
Base Case
--------------------------------------------------------------------------------------------------------------------------------
United States - Lonza [**] [**] - - - - - - - - - - - - - -
--------------------------------------------------------------------------------------------------------------------------------
United States - IMCL - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
--------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------
Japan - Lonza - - - - - - - - - - - - - - - -
--------------------------------------------------------------------------------------------------------------------------------
Japan - IMCL - - - - - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
--------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------
Total - Lonza [**] [**] - - - - - - - - - - - - - -
--------------------------------------------------------------------------------------------------------------------------------
Total - IMCL - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
================================================================================================================================
Confidential treatment requested by Bristol-Myers Squibb Company,
Bristol-Myers Squibb Biologics Company and ImClone Systems Incorporated.
----------------------------------------------------------------------------------------------------------------------------------
Exhibit 4.3A -- C225 Clinical Spending
Non-Registrational Studies
($MM)
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Total
----------------------------------------------------------------------------------------------------------------------------------
Non-Regis-
trational
Studies [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
---------------------------------------------------------------------------------------------------------------------------------
U.S. [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] - [**]
---------------------------------------------------------------------------------------------------------------------------------
Japan - - - - - - [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
---------------------------------------------------------------------------------------------------------------------------------
EXHIBIT B
ImClone Systems Contacts:
-------------------------
Andrea F. Rabney or Andrew Merrill or
Jason E. Farber David Pitts
ImClone Systems Incorporated Abernathy MacGregor
(646) 638-5058 (212) 371-5999
Bristol-Myers Squibb Contacts:
------------------------------
Nancy Goldfarb Timothy Cost
Media Relations Investor Relations
212/546-5107 212/546-4103
IMCLONE SYSTEMS AND BRISTOL-MYERS SQUIBB ANNOUNCE REVISED
TERMS OF COMMERCIALIZATION AGREEMENT FOR ERBITUX(TM)
NEW YORK, NY - March 5, 2002 - Bristol-Myers Squibb Company (NYSE:BMY) and
ImClone Systems Incorporated (Nasdaq: IMCL) announced today the revision of
certain terms in the companies' commercialization agreement for the
co-development and co- promotion of ERBITUX(TM) in the United States, Canada
and Japan. The companies have agreed to changes in certain economics of the
agreement and have agreed to the expansion of the clinical and strategic role
of Bristol-Myers Squibb in the ERBITUX development program.
Under the revised terms:
o In lieu of the $300 million milestone payment agreed upon in the
original agreement, Bristol-Myers Squibb will pay ImClone Systems
$140 million in cash upon signing of the revised agreement and $60
million in cash on the one-year anniversary of the signing.
o Bristol-Myers Squibb will pay ImClone Systems the originally agreed
upon $500 million milestone payment, based on the approval by the
U.S. Food and Drug Administration (FDA) of ERBITUX, in two parts:
$250 million will be paid upon approval of the initial indication,
and the remaining $250 million will be paid upon approval of a
second indication.
o ImClone Systems will receive a distribution fee based on a flat rate
of 39 percent of product revenues in North America.
o The term of the agreement will continue to run through 2018.
The companies said that Andrew G. Bodnar, M.D., J.D., senior vice
president of Medical and External Affairs, Bristol-Myers Squibb, and a member
of ImClone Systems' Board of Directors, will oversee a joint ImClone Systems
and Bristol-Myers Squibb team implementing a single clinical and regulatory
plan for ERBITUX. Governance of all
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committees provided for in the original agreement will remain unchanged.
"ImClone Systems' objective is to move ERBITUX through the
regulatory process and to patients with cancer expeditiously," said Robert F.
Goldhammer, chairman of ImClone Systems. "The leadership and focus of ImClone
Systems' senior management and the firm commitment and support of its partner,
Bristol-Myers Squibb, strengthens our ability to achieve this goal."
"We are confident that we will now be able to move forward in our
partnership with ImClone Systems for the development of ERBITUX," said Peter
R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb. "As the
world leader in oncology, we are looking forward to playing an expanded
clinical and strategic role related to the ERBITUX development program,
working in close collaboration with the ImClone Systems team. The revised
agreement also reflects the adjusted timeline to market launch based on the
current development path for ERBITUX, which has been modified following the
February 26th meeting with the FDA."
"ImClone Systems continues to believe that ERBITUX has great
potential to treat patients with cancer, and our efforts are focused on
gaining FDA approval for the drug," stated Samuel D. Waksal, Ph.D., president
and chief executive officer of ImClone Systems. "This agreement reflects the
companies' mutual commitment to see ERBITUX jointly developed and successfully
moved through the regulatory process."
"I am delighted to have the opportunity to lead a joint
Bristol-Myers Squibb and ImClone Systems team that will work diligently to
bring ERBITUX through the clinical and regulatory process as quickly and
efficiently as possible. Our combined resources - together with our strong
commitment to this product - will be fully engaged in this process," said Dr.
Bodnar.
ERBITUX is an investigational drug designed to target and block the
Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of
certain cancer cells.
Bristol-Myers Squibb is a $19 billion pharmaceutical and related
health care products company whose mission is to extend and enhance human
life.
ImClone Systems Incorporated is committed to advancing oncology care
by developing a portfolio of targeted biologic treatments, designed to address
the medical needs of patients with a variety of cancers. The Company's three
programs include growth factor blockers, cancer vaccines and angiogenesis
inhibitors. ImClone Systems' strategy is to become a fully integrated
biopharmaceutical company, taking its development programs from the research
stage to the market. ImClone Systems is headquartered in New York with
manufacturing facilities in Somerville, New Jersey.
EXCEPT FOR THE HISTORICAL INFORMATION CONTAINED HEREIN, THE MATTERS
DISCUSSED IN THIS NEWS RELEASE MAY INCLUDE FORWARD-LOOKING STATEMENTS. ACTUAL
RESULTS MAY DIFFER MATERIALLY FROM THOSE PREDICTED IN SUCH FORWARD-LOOKING
STATEMENTS DUE TO THE RISKS AND UNCERTAINTIES INHERENT IN THE COMPANIES'
BUSINESS, INCLUDING, WITHOUT LIMITATION, RISKS AND UNCERTAINTIES IN OBTAINING
AND MAINTAINING REGULATORY APPROVAL, MARKET ACCEPTANCE OF AND CONTINUING
DEMAND FOR THE COMPANIES' PRODUCTS AND THE IMPACT OF COMPETITIVE PRODUCTS AND
PRICING. THE COMPANIES UNDERTAKE NO OBLIGATION TO REVISE OR UPDATE THIS PRESS
RELEASE TO REFLECT EVENTS OR CIRCUMSTANCES AFTER THE DATE HEREOF.
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