Exhibit 10.28
[Letterhead]
September 2, 2003
Bioenvision, Inc.
509 Madison Avenue, Suite 404
New York, New York 10022
Attn.: David Luci
Re: Letter
Agreement For Co-Development Of An
Oral Clofarabine Formulation and First Amendment
to Co-Development Agreement dated March 12, 2001
between Bioenvision, Inc. and ILEX Products, Inc.
("Agreement")
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Dear Mr. Luci:
Bioenvision, Inc.
("Bioenvision") and ILEX Products, Inc. ("Ilex") are
desirous of co-developing an oral formulation of Clofarabine.
The purpose of
this Letter Agreement (the "Letter
Agreement") is to set
forth the agreed upon
terms and conditions for co-developing
the oral Clofarabine.
As such terms and
conditions may differ from those in the
Agreement,
this letter
shall also be
deemed to amend the relevant terms of the
Agreement to the extent applicable to
co-development of an oral Clofarabine formulation. Bioenvision and Ilex
understand and agree that except as
expressly amended in this letter, the terms
and provisions of the Agreement shall remain in full force and effect as
originally executed.
Ilex and Bioenvision hereby agree that the following terms and
provisions shall apply to their
co-development of an oral Clofarabine
formulation. Capitalized terms used, but
not defined herein, shall have the
meanings ascribed thereto in the
Agreement.
1. Co-Development of Oral Clofarabine
(a)
Joint Development Plan. Notwithstanding Section 2 of the
Agreement, Ilex and Bioenvision shall jointly co-develop for
commercialization an oral Clofarabine formulation. Promptly
after execution of this Letter Agreement, the parties shall
discuss and agree upon a joint development plan for
co-development of an oral Clofarabine formulation, which
ILEX, on a day to day basis, shall manage, administer, and
coordinate, including, without limitation, assignment of
activities to be performed by the parties or subcontractors.
Contemplated activities include, without limitation,
analytical work to develop the oral formulation, and
performance of an oral bridging study. As of the date of
this Letter Agreement, ILEX has filed documents with the FDA
that are necessary to initiate human clinical trials of a
certain Clofarabine formulation, and based on such filing
expect to commence such clinical trials by September 30,
2003. The parties agree that if commencement of such
clinical trials is delayed by two (2) months, the parties
shall jointly manage, administer and coordinate all
subsequent activities for their co-development of oral
Clofarabine. The parties agree to work exclusively with each
other to co-develop oral Clofarabine and accordingly,
neither party shall engage in any activity for the
development of an oral Clofarabine formulation outside of
this Letter Agreement.
(b)
Reporting Requirements. Each party shall provide to the
other party quarterly written progress reports describing
progress on its activities during the preceding quarter.
Such reports shall include all relevant data as well, as
identify and describe any Program Technology, as defined in
paragraph 3b, below.
<PAGE>
(c)
Funding. Bioenvision and Ilex shall share equally all of the
costs and expenses incurred for the development of the oral
Clofarabine formulation. An initial agreed upon budget is
attached as Exhibit A hereto and made a part hereof. Such
initial budget, for Four Hundred Fifty-Five Thousand Three
Hundred Sixty United States Dollars ($455,360.00),
constitutes a good faith estimate of anticipated costs and
expenses, but is not a final budget. The parties acknowledge
and agree that it is reasonable to assume that there will be
additional costs not included in the initial budget, such as
for the conduct of stability studies and further
manufacturing campaigns. Any adjustments to the initial
budget shall be approved in advance in writing by both
parties.
It is expressly understood that except as to co-funding the
development of oral Clofarabine, all of the payment
provisions of the Agreement are unaffected by this Letter
Agreement.
(d)
Payments and Invoicing. All costs and expenses for
performing the oral Clofarabine development activities shall
be incurred initially by Ilex. On a monthly basis, Ilex
shall invoice Bioenvision for fifty percent (50%) of the
preceding month's costs. Each such invoice shall contain
reasonable detail describing the nature and amount of the
incurred expenses. Bioenvision shall pay Ilex the amount of
each invoice within thirty (30) days after Bioenvision's
receipt of each such invoice. Payments shall be made in
United States dollars by wire transfer to an account
designated in writing to Bioenvision. Any disputes shall be
resolved in accordance with Section 22 (Dispute Resolution)
of the Agreement.
2. Commercialization. Unless
otherwise agreed in writing by the parties from
time to time, commercialization of oral
Clofarabine in the Field shall be in
accordance with the Agreement.
3. Intellectual Property
Matters
(a)
Licenses to Bioenvision. Ilex hereby grants to Bioenvision
an
exclusive with the right to sublicense, worldwide,
license, except for the United States and Canada, under the
Ilex Technology (royalty-free, subject only to the terms and
conditions set forth in the Agreement for Improvements) to
make, have made, use, offer for sale, sell, and import oral
Clofarabine in the Field. During the Term of the license,
ILEX also hereby grants to Bioenvision the option to obtain
from ILEX a non-exclusive license under ILEX technology to
make, have made, use, offer for sale, and import Clofarabine
for any human health related use outside of the Field, which
license shall be royalty-free outside of the United States
and Canada, and royalty-bearing inside the United States and
Canada at a reasonable royalty to be agreed upon.
For
purposes hereof, Ilex Technology means and includes Ilex
Patents and Ilex Know-How. Ilex Patents means the patents
and patent applications listed on Exhibit B hereto and made
a part hereof, and any continuation, continuation-in-part,
division, provisional or any substitute application, any
patent anywhere in the world issued with respect to any such
patent applications, any reissue, reexamination, renewal or
extension (including any
