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Exhibit 10.12
UIC Intellectual Property Office
EXCLUSIVE LICENSE AGREEMENT
for UIC's technology
Betulinic Acid as Anti-Melanoma (CN43)
Semi-Synthesis of Betulinic Acid and Derivatives (CQ15)
Use of Betulinic Acid for Cancer Treatment (CQ16)
Treatment and Prevention of Human Melanoma with Betulinic
Acid
Derivatives (CQ17)
TABLE OF CONTENTS
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PREAMBLE
ARTICLES:
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I DEFINITIONS
II GRANT
III DUE DILIGENCE
IV PAYMENTS
V REPORTS AND RECORDS
VI PATENT PROSECUTION
VII INFRINGEMENT
VIII PRODUCT LIABILITY
IX EXPORT CONTROLS
X NON-USE OF NAMES
XI ASSIGNMENTS
XII TERMINATION
XIII PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
XIV MISCELLANEOUS PROVISIONS
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UIC Intellectual Property Office
This Agreement is entered into this second day of December, 1999
("Effective
Date") by and between THE BOARD OF TRUSTEES OF THE UNIVERSITY OF
ILLINOIS, a
body corporate and politic of the State of Illinois through its
Office of The
Vice Chancellor for Research, Intellectual Property Office, 1737
West Polk
Street, Chicago, Illinois 60612 and on behalf of the Chicago
campus and units
reporting to it (hereinafter "UNIVERSITY") and Advanced Life
Sciences, a
corporation of the State of Illinois with principal offices at
12305 S.
New Avenue, Suite E, Lemont, IL, 60439, (hereinafter
"LICENSEE").
WITNESSETH
WHEREAS, in the course of research conducted under UNIVERSITY
auspices, John M.
Pezzuto, Tapas K. DasGupta, Darrick S.H.L. Kim, Mary Lou
Schmidt, Konrad Marc
Kuzmanoff, and Lydia Ling-Indeck, of UNIVERSITY, (the
"INVENTOR(S)"), have
produced inventions entitled "Betulinic Acid as Anti-Melanoma"
(CN43), and/or,
"Semi-Synthesis of Betulinic Acid and Derivatives" (CQ15),
and/or, "Use of
Betulinic Acid for Cancer Treatment" (CQ16), and/or, "Treatment
and Prevention
of Human Melanoma with Betulinic Acid Derivatives" (CQ17)
(collectively called
the "INVENTION");
WHEREAS, pursuant to assignments by the INVENTORS to UNIVERSITY
of all
their right, title and interest in and to the INVENTION and any
patents
resulting therefrom, UNIVERSITY is the owner of the INVENTION
and the
corresponding Patent Rights, and has the right to grant licenses
under said
Patent Rights;
WHEREAS, UNIVERSITY desires to have the Patent Rights utilized
in the
public interest and is willing to grant a license to its
interest thereunder;
WHEREAS, LICENSEE seeks to commercially develop the Patent
Rights through a
thorough, vigorous and diligent program of exploiting the Patent
Rights whereby
public utilization shall result therefrom; and
NOW, THEREFORE, in consideration of the premises and the mutual
covenants
contained herein, the parties hereto agree as follows:
ARTICLE I - DEFINITIONS
For the purpose of this Agreement, the following words and
phrases shall
have the following meanings:
1.1 "LICENSEE" shall mean Advanced Life Sciences.
1.2. "Affiliate" shall mean any person, firm, corporation or
other
entity controlling, controlled by, or under common control with
a party hereto.
The term "control" wherever used throughout this Agreement shall
mean ownership,
directly or indirectly, of more than 50% of the
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equity capital. Other than LICENSEE, any corporation, company,
partnership,
joint venture, firm, individual or other entity which does not
come within this
definition shall be a "Non-Affiliate".
1.3 "Patent Rights" shall mean all of the following
UNIVERSITY
intellectual property:
(a) the United States patent applications entitled " Method
and
Composition for Selectively Inhibiting Melanoma Using
Betulinic
Acid", filed in the United States Patent Office on March 3,
1995, and assigned Serial Number 08/407,756; "Methods of
Manufacturing Betulinic Acid", filed in the United States
Patent Office on March 27, 1997, and assigned Serial Number
08/826,217; "Method and Composition for Selectively
Inhibiting
Melanoma Using Betulinic Acid", filed in the United States
Patent Office on May 16, 1997, and assigned Serial Number
08/858,011; "Method and Composition for Treating Cancers",
filed in the United States Patent Office on May 16, 1997,
and
assigned Serial Number 08/857,413, and all foreign patent
applications based on this U.S. application;
(b) United States and foreign patents issued from this
application,
and divisionals and continuations of this application;
(c) claims of U.S. and foreign continuation-in-part
applications,
and of the resulting patents, which are directed to subject
matter specifically described in the U.S. patent
applications
Serial Numbers as listed herein;
(d) any reissues or re-examinations of patents described in
(a),
(b), or (c), above.
1.4 A "Licensed Product" shall mean any product or part
thereof
developed by or on behalf of LICENSEE which:
(a) is covered in whole or in part by an issued, unexpired claim
or
a pending claim contained in the Patent Rights in the
country
in which any product is made, used or sold; or
(b) is manufactured by using a process which is covered in whole
or
in part by an issued, unexpired claim or a pending claim
contained in the Patent Rights in the country in which any
such
process is used or in which any such product is used or
sold.
1.5 A "Licensed Process" shall mean any process which is covered
in
whole or in part by an issued, unexpired claim or a pending
claim contained in
the Patent Rights in any country in which such process is
practiced.
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1.6 "Net Sales" shall mean LICENSEE's or Affiliate's billings
for sales
of Licensed Products or Licensed Processes produced hereunder
less the sum of
the following:
(a) discounts allowed in amounts customary in the trade;
(b) sales, tariff duties and/or use taxes directly imposed and
with
reference to particular sales;
(c) outbound transportation prepaid or allowed;
(d) amounts allowed or credited on returns; and
(e) bad debts and uncollectible receivables.
No deductions shall be made for commissions paid to individuals
whether
they be with independent sales agencies or regularly employed by
LICENSEE of
Affiliates and on its payroll, or for cost of collections.
Licensed Products
shall be considered "sold" when billed or invoiced.
1.7 "Sublicense" shall mean the right to make, use or sell
Licensed
Products or Licensed Processes, other than by outright sale to
any non-Affiliate
(including any non-Affiliated distributor).
1.8 "FIELD OF USE" shall mean the use of the INVENTION in the
field of
human therapeutics.
1.9 "TERRITORY" shall mean the use of the INVENTION in the area
of the
World.
ARTICLE II - GRANT
2.1 UNIVERSITY hereby grants to LICENSEE an exclusive worldwide
right
and license in the FIELD OF USE and in the TERRITORY, including
the right to
sublicense, to make, have made, use, lease and sell products,
processes and
other applications which is or are covered by, embodied in, or
derived from the
INVENTION, and/or the Patent Rights until the end of the last to
expire patent
of the Patent Rights or until this Agreement shall be
terminated, as hereinafter
provided, whichever occurs first, and subject to the rights
reserved or observed
in Section 2.2 below.
2.2 Notwithstanding any other provisions of this Agreement, it
is agreed
that UNIVERSITY shall retain the right to practice the licensed
Patent Rights
for its own non-commercial teaching and research activities.
2.3 LICENSEE hereby agrees that every sublicensing agreement to
which it
shall be party and which shall relate to the rights, privileges
and license
granted hereunder shall contain a statement describing the date
upon which
LICENSEE'S exclusive rights, privileges and license hereunder
shall terminate.
2.4 LICENSEE agrees that any sublicenses granted by it shall
provide
that the obligations to UNIVERSITY of Article III, Sections 3.1
and 3.2(c), V,
VII, VIII, IX, X, XII, and
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XIV of this Agreement shall be binding upon the sublicensee as
if it were a
party to this Agreement. LICENSEE further agrees to attach
copies of these
Articles to sublicense agreements.
2.5 LICENSEE agrees to forward to UNIVERSITY a copy of any and
all fully
executed sublicense agreements, and further agrees to forward to
UNIVERSITY
annually a copy of such reports received by LICENSEE from its
sublicensees
during the preceding twelve (12) month period under the
sublicenses as shall be
pertinent to a royalty accounting under said sublicense
agreements.
2.6 If LICENSEE receives from sublicensees anything of value in
lieu of
cash payments based upon payment obligations of any sublicense
under this
Agreement, LICENSEE shall pay UNIVERSITY royalty income based on
the fair market
value of such payment, unless UNIVERSITY waives in writing such
payment
obligation.
2.7 The license granted hereunder shall not be construed to
confer any
rights upon LICENSEE by implication, estoppel or otherwise as to
any technology
not included in the Patent Rights.
ARTICLE III - DUE DILIGENCE
3.1 LICENSEE and its sublicensees shall use their best efforts
to bring
Licensed Products or Licensed Processes to market through a
thorough, vigorous
and diligent program for exploitation of the Patent Rights.
3.2 In addition, LICENSEE shall adhere to the following
milestones:
(a) LICENSEE shall deliver to UNIVERSITY, within six months of
the
date of execution of this Agreement, its detailed business,
research and development plan including relevant schedules
of
capital investments needed to implement the plan, financial,
equipment and facility plans, number and kind of personnel
and
time planned for each phase of development of the Patents
Rights for a three year period. Similar reports shall be
provided to UNIVERSITY annually to relay update and status
information on LICENSEE's business, research and development
progress, including projections of activity anticipated for
the
next reporting year.
(b) LICENSEE shall be responsible for diligently and
promptly
taking all reasonable steps to secure all required and/or
necessary governmental approvals to sell, exploit, or market
any and all Licensed Products. LICENSEE shall advise
UNIVERSITY, through annual reports to be provided after
December 31 of each year pursuant to Section 5.2 below, of
its
program of development for and status of obtaining said
approvals. In the event UNIVERSITY, after full examination
of
each such report,
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determines that the LICENSEE is not taking reasonable steps
to
secure all required and/or necessary governmental approvals
as
specified above, UNIVERSITY shall notify LICENSEE. If
LICENSEE
fails to so satisfy UNIVERSITY, then UNIVERSITY shall give
notice of same and may terminate this Agreement pursuant to
Section 12.3 below.
(c) LICENSEE shall initiate at its expense, Phase I clinical
trials
within three months of the approval of an Investigational
New
Drug application (IND) by the U.S. Food and Drug
Administration
(FDA).
3.3 LICENSEE's failure to perform in accordance with Sections
3.1 and
3.2 above shall be grounds for UNIVERSITY to terminate this
Agreement pursuant
to Section 12.3 below.
ARTICLE IV - PAYMENTS
4.1 For the rights, privileges and licenses granted hereunder,
LICENSEE
shall pay to the UNIVERSITY, in the manner hereinafter provided,
until the end
of the last to expire patent of the Patent Rights or until this
Agreement shall
be terminated, as hereinafter provided, whichever occurs
first:
(a) a nonrefundable license issue fee of Fifteen Thousand
Dollars
($15,000), payable immediately upon signing this Agreement;
(b) a royalty in an amount equal to six percent (6%) of the
Net
Sales by LICENSEE or any Affiliate of the Licensed Products
or
Licensed Processes;
(c) a royalty of six percent (6%) of Net Sales made by
Sublicensee
and twenty percent (20%) of all income, other than Net Sales
based income, paid by Sublicensee to LICENSEE;
(d) milestone payments as follows: (i) Ten Thousand Dollars
($
10,000) upon the filing of an IND; (ii) Twenty Five Thousand
($25,000) upon the filing of a New Drug Application (NDA)
from
the FDA for each Licensed Product for which LICENSEE receives
a
NDA; (iii) One Hundred Thousand Dollars ($100,000) upon
receipt
of a NDA from the Food and Drug Administration for each
Licensed Product for which LICENSEE receives a NDA; and
(e) during the term of this agreement, LICENSEE agrees to
pay
UNIVERSITY annual Minimum Royalty Payments, starting after
the
first sale of LICENSED PRODUCTS in the amount of Five
Thousand
Dollars ($5,000) per Royalty Year.
(f) LICENSEE shall reimburse UNIVERSITY for patent costs
pursuant
to ARTICLE VI, section 6.3, herein.
4.2 No multiple royalties shall be payable because any Licensed
Product,
its manufacture, use, lease or sale are or shall be covered by
more than one of
the Patent Rights
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UIC Intellectual Property Office
patent applications or Patent Rights patents licensed under this
Agreement, or
to be covered in more than one subsection of Section 4.1
hereof.
4.3 Royalty payments shall be paid in United States dollars in
Chicago,
Illinois, or at such other place as UNIVERSITY may reasonably
designate
consistent with applicable laws and regulations. If any currency
conversion
shall be required in connection with the payment of royalties
hereunder, such
conversion shall be made by using
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