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.
Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
Squibb Biologics Company and ImClone Systems Incorporated.
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.
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
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Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
Squibb Biologics Company and ImClone Systems Incorporated.
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
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March 5, 2003 $60,000,000
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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").
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Upon receipt of written Registration in
the US from the FDA with respect to any
indication relating to a different tumor
type from the First Indication (the $250,000,000
"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.
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Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
Squibb Biologics Company and ImClone Systems Incorporated.
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.
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.
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Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
Squibb Biologics Company and ImClone Systems Incorporated.
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 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.
***
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
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Title: President and Chief Executive Officer
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E. R. SQUIBB & SONS, LLC
By: /s/ John L. McGoldrick
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Name: John L. McGoldrick
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Title: Vice President
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BRISTOL-MYERS SQUIBB COMPANY
By: /s/ Sandra Leung
-----------------------------------------
Name: Sandra Leung
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Title: Secretary
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Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers
Squibb Biologics Company and ImClone Systems Incorporated.
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Exhibit 1.13 -- Base Case Projections
United States and Japan C225 Sales
($MM)
2002 2003 2004 2005 2006 2007
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Base Case
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U.S. Sales - [**] [**] [**] [**] [**]
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Japan Sales - - - - - [**]
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Total C225 Sales - [**] [**] [**] [**] [**]
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Development, Promotion, Distribution and Supply Agreement - E. R. Squibb & Sons LLC, Bristol-Myers Squibb Co., and ImClone Systems Inc.
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