<PAGE>
Exhibit 10.58
AGREEMENT
This Agreement, dated as of December 3, 2003 is entered into by
and
among University of Massachusetts, a public
institution of higher education of
the Commonwealth of Massachusetts having an
address at 365 Plantation Street,
Suite 130, Worcester, MA 01605 ("UMass"),
Advanced BioScience Laboratories,
Inc., a Delaware corporation having its
principal place of business at 5510
Nicholson Lane, Kensington, MD 20895
("ABL") and CytRx Corporation, a Delaware
corporation having an address at 11726 San
Vicente Boulevard, Suite 650, Los
Angeles, California 90049 ("CytRx") with
reference to the following facts:
A. In
December 2002, UMass filed a provisional patent
application, U.S. Patent Application Serial
Number 60/430,732 (the "03-24 Patent
Filing") with the United States Patent and
Trademark Office covering a
foundational HIV vaccine technology
invention referred to by UMass as UMMC 03-24
(the "03-24 Technology").
B. In
May 2003, UMass granted an exclusive worldwide license to
the 03-24 Patent Filing and 03-24
Technology to CytRx pursuant to an Exclusive
License Agreement, dated as of April 15,
2003 by and between UMass and CytRx and
which UMass and CytRx have agreed to
clarify Section 4.8 of the Exclusive
License Agreement pursuant to an amendment
that will be substantially in the
form as provided to ABL (such Agreement, as
so amended, being referred to herein
as the "03-24 License Agreement").
C. In
June, 2000, ABL was awarded a $15 million NIH grant (NIAID
Prime Contract N01-05394) (the "NIH Grant")
in connection with the development
of a DNA-based HIV vaccine that
incorporates the 03-24 Technology (the "HIV
Vaccine") and on June 26, 2000, ABL entered
into a subcontract with UMass
(Subcontract No.
00454B-UMM-NAID-N01-A1-05395) (the "UMass Subcontract") in
connection with the development of the HIV
Vaccine.
D. ABL
anticipates filing in December 2003 or January 2004 an IND
with the United States Food and Drug
Administration ("FDA") for a Phase I
clinical trial of the HIV Vaccine (the
"IND") and to commence this Phase I trial
(the "Phase I Trial") within 30 to 60 days
following the IND being cleared by
the FDA.
E. In
September, 2003, ABL filed a provisional patent application
U. S. Patent Application Serial Number
60/503,907 (the "03-111 Patent Filing")
covering an HIV protein boost technology
invention referred to by UMass and ABL
as UMMC 03-111 (the "03-111
Technology").
F. ABL,
UMass and CytRx are willing to make the filing with the
United States Patent and Trademark Office
of a combined patent application (the
"Joint Patent Filing") for the 03-24
Technology and the 03-111 Technology that
will include all of the claims of the 03-24
Patent Filing and 03-111 Patent
Filing, with the Joint Patent Filing to be
conditioned on the terms set forth in
this Agreement. Both a U.S. non-provisional
patent application and a PCT
application designating all countries will
be filed simultaneously. Both the
non-provisional and the PCT applications
will claim priority to the 03-24 Patent
Filing.
<PAGE>
G. ABL,
CytRx and UMass have had discussions concerning the
development and commercialization of the
HIV Vaccine, as described in this
Agreement, and wish to provide for the
framework for negotiation of a definitive
agreement covering such development and
commercialization (the "Definitive
Collaborative Agreement"), as well for the
rights and obligations of each of the
parties in the event they are unable to
conclude the Definitive Collaborative
Agreement within the time period specified
in this Agreement.
NOW, THEREFORE, in consideration of the mutual representations
and
covenants contained herein, the parties
hereby agree as follows:
1.
Joint Patent Filing. The parties hereby agree that the Joint
Patent Filing will be made with the United
States Patent and Trademark Office by
no later than December 3, 2003. The Joint
Patent Filing shall be prepared by
Fish & Richardson, as counsel for
UMass, in consultation with patent counsel for
ABL and CytRx. The Joint Patent Filing
shall be submitted and prosecuted by Fish
& Richardson (or another patent firm
retained by UMass and reasonably acceptable
to ABL and CytRx). The Joint Patent Filing
shall also be filed in such foreign
jurisdictions as shall be requested by
either ABL or CytRx. The costs of
preparing, submitting and prosecuting the
Joint Patent Filing (limited to the
actual fees of the appropriate patent
offices and expenses of patent counsel for
UMass) shall be borne by CytRx, except that
ABL shall bear all of the legal fees
and other expenses of preparing, submitting
and prosecuting the Joint Patent
Filing in any foreign jurisdiction that it
requests be made. The Joint Patent
Filing will be submitted in a form so as to
avoid or minimize any prejudice to
the rights of the parties in the event the
Joint Patent Filing is divided into
divisional patent applications pursuant to
Section 6 hereof.
UMass shall decide all patent prosecution matters in consultation
with
ABL and CytRx. ABL and CytRx shall receive
copies of all material correspondence
from any patent office within a reasonable
amount of time and shall be provided
with copies of all proposed material
filings or other submissions to any patent
office so as to afford ABL and CytRx with a
reasonable opportunity to comment
upon such proposed filing or
submission.
2.
Filing of IND; Commencement of Phase I Trial. ABL shall use
its commercially reasonable best efforts to
file the IND by no later than
January 31, 2004, to obtain clearance of
the IND by the FDA and to commence the
Phase I Trial by no later than February
2004. ABL shall notify UMass and CytRx
in writing within one business day
following the IND filing and the commencement
of the Phase I Trial and shall promptly
provide UMass and CytRx with all
material correspondence received from or
delivered to the FDA or the institution
at which the Phase I Trial will be
conducted relating to the IND or Phase I
Trial.
3.
Disclosure. Upon the signing of the Definitive Collaborative
Agreement, the parties shall jointly issue
a press release announcing such
signing, with the text of such press
release to contain a summary description of
the material terms of the Definitive
Collaborative Agreement (but not the
specific royalty rates or other similar
financial terms) and to be reasonably
acceptable to all of the parties (the
"Collaborative Press Release"). In the
event ABL determines to file and does file
the IND prior to the signing of the
Definitive Collaborative Agreement or the
issuance of the Collaborative Press
Release, CytRx shall be entitled
immediately following such filing to issue a
press release in substantially the form
attached
2
<PAGE>
hereto as Exhibit A (the "IND Press
Release"). If the IND is filed after the
issuance of the Collaborative Press
Release, the parties shall jointly issue a
press release announcing such filing, with
the text of such press release to be
reasonably acceptable to all of the
parties.
4.
Definitive Collaborative Agreement. The parties shall
negotiate in good faith to enter into the
Definitive Collaborative Agreement by
no later than January 31, 2004. The parties
agree that, apart from the
obligation to negotiate in good faith upon
the terms stated herein, this Section
4 represents only the intent of the parties
and shall not be binding upon the
parties. The Definitive Collaborative
Agreement shall contain the following
provisions, together with such other terms
and conditions as would customarily
be included in an agreement of that
type:
4.1 Phase I
Trial. UMass, in consultation with CytRx,
will be responsible as provided in the
UMass Subcontract for carrying out the
Phase I Trial. CytRx will have no financial
responsibility for carrying out the
Phase I Trial.
4.2
Assignment
of HIV Vaccine. Following completion of
the Phase I Trial, ABL will assign to CytRx
ownership of the HIV Vaccine
(subject to its economic interest in the
vaccine as described below), with CytRx
to thereafter be the sponsor for FDA
purposes of the HIV Vaccine. ABL and UMass
will cooperate with CytRx in making all
necessary FDA and foreign healthcare
regulatory agency filings to reflect this
assignment and will provide CytRx with
copies of all filings and correspondence
with the FDA and any foreign healthcare
regulatory agencies in connection with the
HIV Vaccine.
4.3 Subsequent
Clinical Development of HIV Vaccine. CytRx
will be responsible at its own expense for
carrying out and completing all
clinical trials after the Phase I Trial
that are required to obtain FDA
marketing approval for the HIV Vaccine and
marketing approval for any other
countries that shall be agreed to by ABL
and CytRx. The parties acknowledge that
CytRx may seek to obtain additional NIH or
other government or private grants to
support the foregoing clinical development
of the HIV Vaccine, and UMass agrees
to reasonably assist CytRx in filing for
and obtaining such grants. CytRx shall
consult with ABL and UMass in connection
with all material matters relating to
the development of the HIV Vaccine.
4.4
Manufacture of HIV Vaccine. Provided that ABL or its
affiliate has the required regulatory
approvals and manufacturing capacity at
the time, ABL or its affiliate shall have
an option (which must be exercised
within 30 days of being notified by CytRx
that CytRx has received an "approvable
NDA" letter from the FDA for the HIV
Vaccine or equivalent notification from any
foreign healthcare regulatory agency) to
acquire the commercial manufacturing
rights for the HIV Vaccine for the United
States or any other applicable
territory. The terms of the commercial
manufacturing agreement shall be
negotiated in good faith by ABL and CytRx
and shall include such economic and
other terms as are customarily contained in
an agreement of that type.
4.5 Marketing
of HIV Vaccine. CytRx will be responsible
at its own expense for the marketing of
th
