Exhibit 10.28
[Letterhead]
September 2, 2003
Bioenvision, Inc.
000 Xxxxxxx Xxxxxx, Xxxxx 000
Xxx Xxxx, Xxx Xxxx 00000
Attn.: Xxxxx Xxxx
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")
--------------------------------------------------
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.
(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 supplemental patent certificate) of
any of the foregoing, and any confirmation patent or
registration patent or patent of addition based on any such
patent, and all foreign counterparts of any of the
foregoing, as well as all patent applications anywhere in
the world claiming, or entitled to claim, priority to any of
the foregoing and any patents issuing thereon, including
without limitation, reissues, reexaminations and extensions
thereof. Ilex Know-How means any information, method,
material, know-how, trade secret, data or copyright that is
necessary or useful for oral Clofarabine existing as of the
date of this Letter Agreement or is discovered or acquired
by Ilex during the term of this Letter Agreement but outside
the conduct of its activities with Bioenvision hereunder.
(b) Ownership. Ilex and Bioenvision shall jointly own any
invention, information, know-how, trade secret, data and
copyright, made or discovered by or for either party or both
parties, and any and all patentable inventions made, in the
conduct of their co-development activities for oral
Clofarabine formulation development hereunder ("Program
Technology") and such Program Technology shall be considered
to be jointly owned Improvements under Section 11.2 of the
Co-Development Agreement. The parties agree to joint
ownership of Program Technology irrespective of
inventorship. The parties further agree that any
subcontractor arrangement under this Letter Agreement shall
contain a provision under which the subcontractor assigns
all right and title in any invention, discovery,
information, know-how, trade secret, data, copyright and
patent ("Subcontractor Technology") made by the
subcontractor to both Ilex and Bioenvision as joint owners,
or if assigned solely to ILEX or Bioenvision, the party
receiving assignment shall promptly assign to the other
Party an undivided one-half ownership interest in such
Subcontractor Technology.
With respect to Program Technology, Ilex agrees to assign
and does hereby assign to Bioenvision an undivided one-half
ownership interest in any Program Technology made solely by
Ilex or jointly with Bioenvision; Bioenvision agrees to
assign and does hereby assign to Ilex an undivided one-half
ownership interest in any Program Technology made solely by
Bioenvision or jointly with Ilex. Ilex and Bioenvision agree
to cooperate with each other in the preparation, prosecution
and/or maintenance, as applicable, of all patents and patent
applications within Program Technology, including, without
limitation, execution of any and all papers as are necessary
or helpful in ensuring joint ownership.
The parties represent and warrant to each other that their
respective employees have executed agreements requiring
assignment to such party of all inventions made during the
course of and as a result of their association with such
party.
(c) Licenses to Program Technology. Bioenvision hereby grants to
Ilex an exclusive, royalty-free license, with the right to
sublicense, under Bioenvision's share of Program Technology
to make, have made, use, offer for sate, sell and import
oral Clofarabine in the Field, in the United States and
Canada. Ilex hereby grants to Bioenvision an exclusive,
royalty-free license, with the right to sublicense, under
Ilex's share of Program Technology to make, have made, use,
offer for sale, sell and import oral Clofarabine in the
Field, worldwide, except in the United States and Canada.
(d) Patent Filing on Program Technology. The Party originating
and/or subcontracting for any given Program Technology shall
have the right to prepare, prosecute and maintain patent
applications and patents within Program Technology using
patent counsel of its choice, to which the other Party has
no reasonable objection. The parties shall consult and
cooperate with each other in good faith and adopt a
prosecution strategy by mutual agreement. The
non-prosecuting Party shall be provided with copies of all
documents related to the preparation, filing, prosecution
and maintenance of such patents and patent applications in
sufficient time to review such documents and comment
thereon, if desired by the non-prosecuting Party, prior to
filing, provided, however, that if the non-prosecuting Party
has not commented on such documents prior to the deadline
for filing a response with the relevant government patent
office, the prosecuting Party shall be free to respond
without consideration of Ilex's comments. The Parties agree
to sign, where appropriate, any necessary documents for the
preparation, filing, prosecution and maintenance of such
patents and patent applications. The costs, including
without limitation, reasonable attorney's fees, of
preparing, filing, prosecuting (including interferences and
oppositions) shall be shared equally by the parties.
If either party elects not to file or continue to prosecute
or maintain any patent application or patent within Program
Technology, such party shall give written notice to the
other party within a reasonable time (i.e., with sufficient
time for the continuing party to take whatever action may be
necessary or desired) and such continuing party shall
thereafter have the right, at its sole discretion, to
prepare, file, prosecute and maintain such patent
application or patent in its own name and at its own
expense. In such case, the non-continuing party agrees to
assign and does hereby assign to the continuing party all
right, title and interest in and to any such patent
application or patent.
(e) Notices. Each party shall provide prompt written notice to
the other party of any Program Technology. In no event shall
such notice be later than thirty (30) days after any
invention within Program Technology is made.
(f) Enforcement. If either party becomes aware of any
infringement of patents within Program Technology, such
party shall notify the other party of the infringement in
writing and provide a summary of the relevant facts and
circumstances known to such party relating to such
infringement. Neither party shall notify a third party of
the infringement without first obtaining written consent of
the other party, which consent shall not be unreasonably
withheld or delayed. The parties shall cooperate in good
faith as to how to proceed against the alleged infringer. If
the parties agree to institute legal proceedings against
such infringer, unless otherwise agreed, the party
commercializing in the country where the infringement is
occurring shall have the right to prosecute, at its own
expense, and to recover, for its own account, any damages,
awards or settlements resulting therefrom. The
non-prosecuting party agrees that the other party may join
such non-prosecuting party as a party plaintiff in any such
suit, without expense to the non-prosecuting party. Neither
party shall settle nor compromise any such suit or enter
into any consent order for settlement or compromise that
adversely affects the relevant patent rights without the
prior written consent of the other party, which consent
shall not be unreasonably withheld or delayed.
The non-prosecuting party agrees to cooperate with the other
party, at such other party's request and expense, in
connection with the enforcement or defense of Ilex Patent or
patents within Program Technology. The granting of
sublicenses to any alleged infringer shall be in accordance
with the licenses granted herein.
4. Termination.
(a) At Will. Either party may terminate its activities with
respect to co-development of oral Clofarabine upon sixty
(60) days written notice to the non-terminating party. The
licenses granted in Paragraphs 3a and 3c hereunder shall
survive such termination, and except for such licenses, the
provisions of the Agreement with respect to oral Clofarabine
shall remain in full force and effect.
(b) For Breach. If either party at any time defaults or
materially breaches any of the terms or provisions of this
Letter Agreement, and fails to remedy any such default or
material breach within sixty (60) days after receipt of
written notice thereof by the non-breaching party, this
Letter Agreement shall terminate effective as of the date of
such notice. Upon termination under this Paragraph 4b, the
breaching party hereby grants to the non-breaching party an
exclusive, worldwide, royalty-free license, with the right
to sublicense, to practice the Program Technology in the
Field.
5. Conflict With Agreement. If any of the terms or provisions herein with
respect solely to oral Clofarabine conflict with any terms or provisions of the
Agreement, the terms and provisions of this Letter Agreement shall govern only
with respect to oral Clofarabine.
If the foregoing terms and conditions are acceptable to
Bioenvision, please indicate agreement by signing and dating the enclosed
duplicate original of this Letter Agreement and First Amendment to Agreement and
return one executed original to the undersigned, keeping one original for your
records.
Very truly yours,
Ilex Products, Inc.
/s/ Xx X. Xxxxxxxx
------------------
Xx X. Xxxxxxxx,
Vice President, Licensing & Intellectual
Property
Accepted and agreed on behalf of Bioenvision, Inc.
By: /s/ Xxxxx X. Xxxx
--------------------------------------
Title: Director of Finance, General Counsel
------------------------------------
