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Exhibit 10.60
COLLABORATION AGREEMENT
This Collaboration Agreement, dated as of December 22, 2003
(the
"Agreement") 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
(the "03-24 License Agreement" and as
amended and restated pursuant to this
Agreement, the "Amended and Restated 03-24
License Agreement").
C. In
June 2000, ABL was awarded a $15 million contract from the
National Institutes of Health (NIAID Prime
Contract N01-05394) (the "NIH Prime
Contract") in connection with the
development of a DNA-based 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 an HIV vaccine using the
03-24 Technology and the 03-111
Technology and currently being developed by
UMass and ABL under the NIH Prime
Contract and the UMass Subcontract (the
"HIV Vaccine"). The HIV Vaccine will
include for purposes of this Agreement the
foregoing vaccine product
notwithstanding the expiration or early
termination of either the NIH Prime
Contract or the UMass Subcontract.
D.
ABL
anticipates filing in January 2004 an investigational new
drug application (as defined in the United
States Federal Food, Drug and
Cosmetic Act of 1938, as amended from time
to time (the "Act")) with the United
States Food and Drug Administration ("FDA")
for a Phase I clinical trial of the
HIV Vaccine (the "IND") and expects 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. On
December 3, 2003, ABL and UMass made a joint filing with
the United States Patent and Trademark
Office of a combined patent application
(the "Joint Patent
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Filing") for the 03-24 Technology and the
03-111 Technology that included all of
the claims of the 03-24 Patent Filing and
03-111 Patent Filing and other claims
relating to the 03-24 Technology and 03-111
Technology. Both a U.S.
non-provisional patent application and a
PCT application designating all
countries were filed simultaneously. Both
the non-provisional and the PCT
applications claim priority to the 03-24
Patent Filing.
G. In
conjunction with the Joint Patent Filing, ABL, CytRx and
UMass entered into an Agreement dated as of
December 3, 2003 (the "Patent Filing
Agreement"), regarding the development and
commercialization of the HIV Vaccine
and providing for the framework for
negotiation of this Agreement as a
definitive agreement covering such
development and commercialization.
H. ABL,
CytRx and UMass now wish to enter into this Agreement
regarding the development and
commercialization of the HIV Vaccine in accordance
with the Patent Filing Agreement.
NOW, THEREFORE, in consideration of the mutual representations
and
covenants contained herein, the parties
hereby agree as follows:
1.
Definitions.
1.1 "ABL
Licensed Product" means any product that cannot
be developed, manufactured, used, or sold
without (i) infringing one or more
claims under the ABL Related Technology, or
(ii) using some portion of the ABL
Related Technology.
1.2 "ABL
Related Technology" means any additional
technologies outside of the 03-24
Technology and the 03-111 Technology that
satisfy all of the following: (i) are now
or subsequently owned or licensed to
ABL, including any technologies that may be
acquired by ABL pursuant to its
option for an exclusive license under
Section 9 of the UMass Subcontract, (ii)
result from work done by UMass under the
UMass Subcontract for a DNA-based HIV
vaccine with protein boost, and (iii) are
deemed necessary or advantageous by
CytRx for the development or
commercialization of the HIV Vaccine.
1.3 "ABL
Sublicense Agreement" means the sublicense
agreement between CytRx and ABL described
in Section 14.4.
1.4 "ABL
Royalty Period" means the partial calendar
quarter commencing on the date on which the
first ABL Licensed Product is sold
or used and every complete or partial
calendar quarter thereafter during which
(i) this Agreement remains in effect and
each country where ABL's patent rights
to the ABL Related Technology have not
expired or been abandoned or revoked and
(ii) CytRx, its Affiliates and/or
sublicensees are selling ABL Licensed Product.
1.5
"Affiliate" means any legal entity (such as a
corporation, partnership, or limited
liability company) that is controlled by or
controls the entity in question. For the
purposes of this definition, the term
"control" means (i) beneficial ownership of
at least 50% of the voting
securities of a corporation or other
business organization with voting
securities
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or (ii) a 50% or greater interest in the
net assets or profits of a partnership
or other business organization without
voting securities.
1.6
"Collaborative Press Release" means the joint ABL and
CytRx press release announcing the signing
of this Agreement.
1.7 "Good
Manufacturing Practices" means the then-current
good manufacturing practices required by
the FDA, as set forth in the Act and
the regulations promulgated thereunder, for
the manufacture and testing of
pharmaceutical materials, and comparable
laws or regulations applicable to the
manufacture and testing of pharmaceutical
materials in jurisdictions outside the
United States.
1.8 "Phase I
Completion" means the completion of the
Phase I Trial.
1.9
"Manufacturing
Agreement" means the commercial
manufacturing agreement that may be entered
into by and between ABL or its
Affiliate and CytRx or its Affiliate
pursuant to the terms of Section 7.2.
1.10
"Net Sales" means the gross amount received based on
billed or invoiced sales by the applicable
party or its Affiliates or
sublicensees of ABL Licensed Products or
New Vaccine products (as applicable,
the "Product"), less the following: (i)
customary trade, quantity, or cash
discounts and commissions to non-affiliated
brokers or agents to the extent
actually allowed and taken; (ii) amounts
repaid or credited by reason of
rejection or return; (iii) to the extent
separately stated on purchase orders,
invoices, or other documents of sale, any
taxes or other governmental charges
levied on the production, sale,
transportation, delivery, or use of a Product
which is paid by or on behalf of the
applicable party or its Affiliates or
sublicensees; (iv) outbound transportation
costs prepaid or allowed and costs of
insurance in transit; and (v) sales at or
below the fully burdened cost of
manufacturing Product, solely for research
or clinical testing of such Product
or for indigent or similar public support
or compassionate use programs. In any
transfers of Products between the
applicable party or its Affiliates or
sublicensees and its Affiliate or
sublicensee, Net Sales shall be calculated
based on the final sale of the Product to
an independent third party. In the
event that the applicable party or its
Affiliates or sublicensees receives
non-monetary consideration for any
Products, Net Sales shall be calculated based
on the fair market value of such
consideration. In the event that CytRx or ABL
or their Affiliates or sublicensees use or
dispose of a Product in the provision
of a commercial service, the Product shall
be considered sold and the Net Sales
shall be calculated based on the sales
price of the Product to an independent
third party during the same period or, in
the absence of such sales, on the fair
market value of the Product as determined
by CytRx and ABL in good faith.
1.11
"New Vaccine" means any HIV vaccine other than the
HIV Vaccine.
1.12
"New Vaccine Party" means a party to this Agreement
seeking to commercialize a New Vaccine.
1.13
"UMass Related Technology" means any additional
technologies outside of the 03-24
Technology and 03-111 Technology that (i) are
owned or licensed to UMass, and have not
been acquired by or licensed to ABL
pursuant to ABL's option for an
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exclusive license under Section 9 of the
UMass Subcontract, (ii) result from
work done by UMass under the UMass
Subcontract, and (iii) are deemed necessary
or advantageous to CytRx for the
development or commercialization of the HIV
Vaccine.
1.14
"Vaccine Assignment" means the irrevocable assignment
by ABL to CytRx of all of ABL's rights,
title and interest in and to the HIV
Vaccine, including without limitation ABL's
right to develop, make, have made,
use, offer for sale, market and sell the
HIV Vaccine worldwide. Notwithstanding
the foregoing, the Vaccine Assignment will
be subject to and subordinate to any
rights that the Government of the United
States may have to the HIV Vaccine by
virtue of the NIH Prime Contract
funding.
1.15
"91-03 License" means the exclusive, worldwide
license for the 91-03 Technology.
1.16
"91-03 Technology" means the technology referred to
by UMass as UMMC 91-03.
2.
Joint Patent Filing. The Joint Patent Filing shall be
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. In the event any patent office
divides or takes other similar action
with respect to the Joint Patent Filing,
each of the parties to this Agreement
shall have the same rights and obligations
and access to the 03-24 Technology
and 03-111 Technology under this Agreement
that it would have had in the absence
of any such division or other similar
action.
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.
3. IND
Filing. 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, to commence the
Phase I Trial within 30 days following
FDA clearance of the IND and to complete
the Phase I Trial within 18 months from
the commencement of the trial. ABL shall
notify UMass and CytRx in writing
within two business days 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.
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4.
Phase I Trial.
4.1 Conduct of
Phase I Trial. As set forth in the UMass
Subcontract, UMass will be responsible for
carrying out the Phase I Trial,
including the preparation of all elements
required for conducting a human Phase
I clinical trial, the recruiting of
patients, the conduct and management of the
Phase I Trial and assistance with the
collation of data and preparation of
required reports summarizing the data
generated by the Phase I Trial for
submission to the FDA upon the Phase I
Completion. Subject to applicable
confidentiality obligations, UMass shall
consult with ABL and CytRx with respect
to the status and conduct of the Phase I
Trial and the submission of any
required reports to the FDA in connection
with the Phase I Trial. ABL and UMass
shall provide each of the parties to this
Agreement with copies of all
correspondence delivered to or received
from the FDA during and after the Phase
I Trial relating to such trial, subject to
applicable federal laws and
regulations covering confidentiality as
applied either under the NIH Prime
Contract or FDA regulations. In the event
all of the required patients to
complete the Phase I Trial have not been
enrolled within 30 days following the
IND being cleared by the FDA, CytRx will be
permitted to direct the patient
recruitment efforts in consultation with
UMass, to the extent CytRx's activities
are consistent with applicable FDA and
other federal regulations. ABL, UMass and
CytRx shall agree on a schedule for each
stage of the Phase I Trial and the
submission of the data generated by the
Phase I Trial that is consistent with
the final submission of such data to the
FDA within 18 months of FDA clearance
of the IND. Should performance of the Phase
I Trial fall more than 30 days
behind this schedule, CytRx shall be
entitled, subject to the terms of the NIH
Prime Contract and the UMass Subcontract,
in consultation with UMass to direct
the work necessary to complete that stage
of the Phase I Trial. CytRx shall be
entitled to be reimbursed out of the NIH
Prime Contract or the UMass Subcontract
to the maximum extent permitted under the
terms of those contracts for its
out-of-pocket expenses incurred in
performing the recruitment or other work
described in this Section 4.1.
4.2
Expenses
of Phase I Trial. Except as specifically set
forth in Section 4.1 and this Section 4.2,
CytRx shall bear no responsibility
for carrying out any aspect of the Phase I
Trial or incur any costs or
liabilities in connection therewith. In the
event completion of the Phase I
Trial requires expenditures not covered
under the UMass Subcontract, such
expenditures shall be funded, to the
maximum extent possible, under the
remaining funds from the NIH Prime
Contract. In the event the remaining funds
from the NIH Prime Contract are
insufficient to cover all of the costs to
complete the Phase I Trial, CytRx may elect
to pay for all of those expenses
(after all of the available funds from the
NIH Prime Contract have first been
applied). CytRx shall be entitled to offset
all of the foregoing excess expenses
that it pays against any milestone payments
(other than the first milestone
payments to ABL due upon the IND filing)
that it becomes obligated to pay under
the Amended and Restated 03-24 License
Agreement.
4.3
Maintenance of NIH Prime Contract. ABL and UMass
shall use their commercially reasonable
efforts to maintain in effect the NIH
Prime Contract and UMass Subcontract, which
are currently anticipated to
continue through completion of the Phase I
Trial. In the event of the early
cancellation of the NIH Prime Contract for
any reason, UMass agrees to continue
to conduct the Phase I Trial as
contemplated by the UMass Subcontract, provided
that it receives compensation for its
services comparable to that which was
provided
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for by the UMass Subcontract. Subject to
complying with this Section 4.3, ABL
shall have no liability to UMass and CytRx
due to such cancellation.
4.4
Insurance;
Indemnification. ABL shall maintain
clinical trial insurance for the Phase I
Trial in an amount and form in
accordance with the NIH Prime Contract and
UMass Subcontract and shall provide
CytRx with evidence of such insurance
coverage. ABL or, to the extent allowable
by law, UMass, as the case may be, shall
indemnify and hold harmless CytRx and
its officers, directors, employees, agents
and affiliates from and against all
liabilities and expenses (including
reasonable attorneys fees) resulting
directly from ABL's or UMass's negligence
or intentional misconduct in the
conduct of the Phase I Trial.
5.
Assignment of HIV Vaccine.
5.1
Assignment. The Vaccine Assignment shall occur
immediately following the Phase I
Completion. ABL hereby represents that to the
best of its knowledge no other party has
any rights to, liens upon or interest
in the HIV Vaccine, except to the extent of
the Joint Patent Filing, any
government retained rights which may arise
by operation of federal laws
governing products and intellectual
property developed under government
contracts
