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Exhibit 10.10
LICENSE AGREEMENT
This License
Agreement ("AGREEMENT") is made as of this 13th day of
December, 2004 (the "EFFECTIVE DATE"), by
and between ABBOTT LABORATORIES, an
Illinois corporation, with its principal
office at 100 Abbott Park Road, Abbott
Park, Illinois 60064 ("ABBOTT"), and
ADVANCED LIFE SCIENCES HOLDINGS, INC., a
Delaware corporation, with its principal
office at 1440 Davey Road, Woodridge,
Illinois 60517 ("ALS").
WITNESSETH
WHEREAS, Abbott
is the holder of certain patent applications and patents
("PATENTS," as more fully defined below)
relating to the Compounds (as defined
below);
WHEREAS, Abbott
also possesses Know-How (as defined below) relating to the
Compounds; and
WHEREAS, ALS
wishes to obtain, and Abbott wishes to grant to ALS, an
exclusive license in the Territory (as
defined below) under Abbott's Technology
(as defined below) for the development,
manufacture and commercialization of
Products for Pharmaceutical Uses (as
defined below).
NOW THEREFORE,
in consideration of the mutual obligations and promises as
set forth herein, the parties do hereby
agree as follows:
1. DEFINITIONS. As used in this
Agreement, the following terms shall have
the following respective meanings:
1.1
"ABBOTT TECHNOLOGY" means the Patents and Know-How.
1.2
"AFFILIATE" means any corporation, company, partnership, joint
venture and/or other entity which controls,
is controlled by, or is under common
control of either party hereto. For
purposes of this definition, control shall
mean direct or indirect ownership of more
than fifty percent (50%) of the stock
or participating shares entitled to vote
for the election of directors (but only
as long as such ownership exists).
1.3
"COMPOUND A" means the compound known as ABT-773, its
enantiomers, racemates, isomers and any
pharmaceutically acceptable salt or
complex thereof, in its current and any
other formulation, and including any
Prodrugs and active metabolites, whether
made before or after the Effective
Date.
1.4
"COMPOUND B" means the compound known as ABT-210, its
enantiomers, racemates, isomers and any
pharmaceutically acceptable salt or
complex thereof, in its current and any
other formulation, and including any
Prodrugs and active metabolites, whether
made before or after the Effective
Date.
1.5
"COMPOUNDS" shall mean Compound A and Compound B,
collectively.
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1.6
"CONFIDENTIAL INFORMATION" means any and all information or
data relating to either Compound A or
Compound B and/or Product which, in the
course of carrying out a provision of this
Agreement, a party discloses to the
other party, its employees or
representatives, whether in writing, orally or by
observation, including, without limitation,
all scientific, clinical, technical,
commercial, financial and business
information and Know-How, and other
information or data considered confidential
in nature. Subject to SECTION 7.1
hereof, Abbott shall hold in confidence and
shall not directly or indirectly
disclose or provide to any third party
Confidential Information pertaining to
Compound A, Compound B or Abbott Technology
without ALS's prior written consent.
Confidential Information shall not include
information or any portion thereof
which:
(a) is known to
the receiving party at the time of
disclosure hereunder and documented by written records
made prior to the date of such disclosure;
(b) is
subsequently disclosed to the receiving party by an
unaffiliated third person who has the right to make such
disclosure;
(c) becomes
patented, published or otherwise part of the
public domain other than through the acts of the
receiving party; or
(d) is
independently developed by or for the receiving party
by person(s) having no knowledge of such information as
evidenced by its written records.
1.7
"EFFECTIVE DATE" shall have the meaning ascribed to such term
in the opening paragraph of this
Agreement.
1.8
"EXCLUSIVE LICENSE" means a license that operates to exclude
all others, including Abbott.
1.9
"FIRST COMMERCIAL SALE" means the first sale of Product in the
Territory, after Regulatory Approval, by
ALS or its Affiliates (or their
sublicensee(s)) to any unaffiliated third
party as evidenced by the selling
party's invoice or other relevant document
provided to such third party. A sale
to an unaffiliated third party shall not
include quantities delivered solely for
research purposes, for clinical trials or
quantities distributed as free samples
or promotions.
1.10
"KNOW-HOW" means any proprietary technology, information,
methods of use, processes, techniques,
ideas or inventions (other than the
Patents) owned, possessed or used by Abbott
as of the Effective Date which is
directly related to or directly used in
connection with Compound A or Compound B
or the manufacture of Compound A, Compound
B and/or Product, including all trade
secrets and any other technical information
relating to development, use or sale
of Compound A, Compound B and/or Product,
provided that Abbott has the right to
license and/or sublicense to ALS. To the
extent that any such Know-How relates
to other compounds in addition to Compound
A and/or Compound B, Know-How shall
only include that portion of the Know-How
exclusively relating to Compound A
and/or Compound B.
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1.11 "NDA"
means an application (whether original, supplementary or
abbreviated) to the applicable Regulatory
Authority in a country of the
Territory, for Regulatory Approval. An NDA,
together with all supplemental
filings referencing the initial NDA filing,
shall be deemed one and the same NDA
for all purposes of this Agreement.
1.12 "NET
SALES" means gross sales of Product by ALS, by any
Affiliates of ALS, or by any sublicensees
of ALS, to unrelated third parties, in
arm's length transactions, including, but
not limited to, pharmaceutical
wholesalers, managed healthcare
organizations, pharmacies, hospitals or
dispensing physicians, less any of the
following charges or expenses that are
incurred in connection with gross sales of
the Product to such entities/persons
during the Term:
(a) discounts,
including cash discounts, customary trade
allowances or rebates actually taken, governmental
rebates, chargebacks, and group purchasing management
fees of up to three percent (3%) for formulary access;
(b) credits or
allowances given or made for rejection,
recall or return of previously sold Product actually
taken;
(c) any tax or
government charge, duty or assessment
(including any tax such as a value added or similar tax
or government charge) levied on the sale, transportation
or delivery of Product when included on the invoice or
other written document between the parties as payable by
the purchaser and collectable by ALS, its Affiliate or
sub-licensee; and
(d) freight,
postage, transportation, insurance and duties
on shipment of Product when included on the invoice or
other written document between the parties as payable by
the purchaser and collectable by ALS, its Affiliates or
sublicensees.
With respect to any gross sales of Product
by ALS, by any Affiliates of ALS, or
by any sublicensees of ALS, to unrelated
third parties in non-arm's length
transactions, "Net Sales" per unit of
Product shall be determined by using the
"Net Sales" per unit of Product in arm's
length transactions for the same
reporting period.
1.13
"PATENTS" means the patent applications and patents listed in
EXHIBIT A hereto and any patents issuing
upon such patent applications, any
amendments thereto, foreign equivalents in
the Territory, and any and all
substitutions, extensions, additions,
reissues, re-examinations, renewals,
divisions, continuations,
continuations-in-part or supplementary protection
certificates derived from or relating
thereto.
1.14
"PHARMACEUTICAL USES" means any therapeutic use of Compound A,
Compound B and/or Product in any
formulation or dosage form for the management
of a disease or condition of humans.
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1.15
"PRODRUG" means any compounds which, following administration,
are actively converted in the body to
Compound A or Compound B.
1.16
"PRODUCT" means any formulation containing either Compound A
or Compound B.
1.17
"REGULATORY APPROVAL" means all governmental approvals and
authorizations necessary for the
manufacture and commercial sale of a Product in
a country of the Territory, including, but
not limited to, marketing
authorization, pricing approval and pricing
reimbursement, as applicable.
1.18
"REGULATORY AUTHORITY" means the United States Food and Drug
Administration ("FDA") or any successor
entity and its equivalent in other
countries of the Territory, including, but
not limited to, EMEA.
1.19
"TERM" means the period commencing on the Effective Date and
ending as set forth in Section 9.1
below.
1.20
"TERRITORY" means the entire world, except Japan.
1.21
"VALID CLAIM" means a claim of an unexpired issued Patent that
has not been withdrawn, canceled or
disclaimed nor held invalid or unenforceable
by a court or government agency of
competent jurisdiction in an unappealed or
unappealable decision.
2. LICENSE GRANT. Subject to
the terms and conditions of this Agreement,
Abbott hereby grants to ALS an Exclusive
License in the Territory, under Abbott
Technology, for all Pharmaceutical Uses,
with the right to grant sublicenses
pursuant to SECTION 5.5 hereof, to (i)
research, develop, make or have made,
Compound A, Compound B and Product(s); (ii)
apply for and obtain Regulatory
Approvals, all as may be required to
manufacture and commercialize Product(s);
and (iii) register, use, import/export,
market, offer to sell and sell,
Product(s) and Compound A and Compound
B.
3. INFORMATION;
EXCLUSIVITY.
3.1
DELIVERY OF INFORMATION/CONSULTATION WITH ABBOTT PERSONNEL.
(a) On or before
December 31, 2004, Abbott shall, to the
extent it has not already done so, deliver to ALS the
information under Abbott's and its Affiliates' control
involving
the Compounds constituting Patents and
Know-How excluding any attorney-client privileged
information. Abbott shall also, promptly after the
Effective Date, transfer to ALS Abbott's interests in
Investigational New Drug application no. 57,836, such
transfer being subject, in all respects, to applicable
Regulatory Approvals.
(b) From the
Effective Date until the six (6) month
anniversary of the Effective Date (the "CONSULTATION
PERIOD"), Abbott shall make its
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technical personnel familiar with the development of
Compound A and/or Compound B available to ALS upon its
request for reasonable consultation at reasonable times
and places. ; provided, however, that Abbott shall not
be obligated to make any such personnel available at any
particular time if in doing so it would interfere with
Abbott's business operations (the "CONSULTATION
SERVICES"). During the Consultation Period, Abbott shall
provide a maximum of one hundred twenty (120) man hours
of Consultation Services (to the extent not utilized
under that certain Option Agreement between Abbott and
ALS dated as of October 29, 2004, as amended). The first
one hundred and twenty (120) man hours of such
Consultation Services shall be GRATIS to ALS and
thereafter, ALS shall pay Abbott $275.00 per hour (the
"CONSULTATION RATE") for such Consultation Services.
Abbott shall provide such Consultation Services on an
"as is" basis, without any representation or warranty as
to accuracy, completeness or quality. ALS shall have
sole responsibility for its decision to take or not take
any action based upon such Consultation Services, and
for the effect and consequences of such actions or
inactions. If, after the Consultation Period, ALS
requires any additional Consulting Services, ALS shall
make a request for such services in writing. Abbott
shall not be obligated to provide such additional
Consultation Services but it shall not unreasonably
withhold such Consultation Services from ALS. Any such
additional Consultation Services shall be billed at the
Consultation Rate. ALS agrees to reimburse Abbott for
all reasonable out-of-pocket expenses, if any, incurred
by Abbott in providing the Consultation Services. Abbott
shall invoice ALS for such expenses and ALS shall pay
such
invoices with thirty (30) days of its receipt
thereof.
4. PURCHASE OF ABBOTT INVENTORY
OF CLINICAL SUPPLIES, BULK COMPOUND AND
CHEMICAL INTERMEDIATES.
4.1
PURCHASE OF INVENTORY. ALS shall purchase approximately 1,125
kg. of bulk Compound A (the
"Inventory").
4.2
PURCHASE PRICE.
(a) ALS shall
pay to Abbott, as the purchase price for the
Inventory to be purchased under this ARTICLE 4, the
aggregate amount of Ten Million Dollars ($10,000,000),
payable as follows: (a) Two Million Dollars ($2,000,000)
upon the execution of this Agreement, (b) Seven Million
Dollars ($7,000,000) on or before May 1, 2005 and (c)
One Million Dollars ($1,000,000) on or before June 30,
2005. Abbott shall ship approximately a pro rata portion
of the Inventory to ALS upon receipt of each of the
foregoing payments (i.e. approximately twenty percent
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(20%) of the Inventory shall be shipped by Abbott upon
receipt of the initial payment of Two Million Dollars
($2,000,000)) unless otherwise agreed by the parties in
writing.
4.3
TESTING OF INVENTORY. At any time after the Effective Date,
ALS shall have the right to have its
personnel present to witness the removal
and testing of samples of the Inventory.
Abbott shall make reasonable efforts to
provide ALS with advance notice of such
testing and sampling. ALS shall have the
right to review and take copies of the test
records relating to such sampling
and testing. Abbott shall use reasonable
commercial efforts to complete the
tests described in the Schedule of Release
Specification Tests set forth in
EXHIBIT B no later than the December 6,
2004. If, using the tests described in
the Schedule of Release Specification
Tests, it is determined that GREATER THAN
OR EQUAL TO ninety percent (90%) of the
Inventory meets the release
specifications set forth in the Schedule of
Release Specification Tests set
forth in Exhibit B, ALS shall be deemed to
have accepted the Inventory. If, in
the alternative, it is determined that LESS
THAN ninety percent (90%) of the
Inventory meets the release specifications
set forth in the Schedule of Release
Specification Tests set forth in Exhibit B,
ALS shall be deemed to have accepted
the Inventory; provided, however, that ALS
and Abbott shall thereafter negotiate
in good faith a reduction in the purchase
price for the Inventory that is
commensurate with such shortfall in
Inventory. ALS shall have the right to
submit the results of the Release
Specification Tests set forth in Exhibit B to
a Regulatory Authority.
5.
DEVELOPMENT/MANUFACTURING/MARKETING/DISTRIBUTION BY
ABBOTT/OTHER.
5.1
CLINICAL DEVELOPMENT. ALS shall use commercially reasonable
and diligent efforts to develop the
Compounds for one or more treatment
indications. For purposes of this SECTION
5.1(a), development of an indication
shall be deemed to have commenced upon
enrollment of the first subject in the
first clinical study for an indication
using the formulation selected for
clinical development. ALS shall have sole
responsibility for designing,
conducting and paying for the cost of the
clinical development of Product and
shall use commercially reasonable efforts
to diligently conduct such clinical
development.
5.2
COMMERCIALIZATION. ALS shall, assuming Regulatory Approval,
use commercially reasonable efforts to
commercialize Product in the United
States and the European Union by itself or
through its Affiliates and
sublicensees, using at least that level of
effort as a pharmaceutical company of
comparable size and resources would use
with similar compounds.
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5.3
MARKETING. ALS shall have sole responsibility for marketing
Product, including entering into any
co-marketing and/or co-promotion
arrangements. ALS shall distribute all
Product samples in the United States in
accordance with the Prescription Drug
Marketing Act.
5.4
MANUFACTURING. ALS and its Affiliates shall have sole
responsibility for manufacturing
Product.
5.5
SUBLICENSING. ALS may sublicense its rights under this
Agreement at any time without obtaining
Abbott's consent.
5.6
DISTRIBUTION BY ABBOTT. If ALS determines that Product should
be marketed or distributed by ALS and a
co-marketer or a co-distributor in any
country or countries of the Territory, it
shall grant Abbott a "Right of First
Negotiation" (as hereinafter defined) to
become the co-marketer or
co-distributor with ALS, in such countries.
If ALS determines that Product
should be marketed by a sole distributor in
any country or countries of the
Territory, it shall grant Abbott the "Right
of First Negotiation" to become the
exclusive distributor in such countries.
"RIGHT OF FIRST NEGOTIATION" shall mean
the exclusive right, for a period of ninety
(90) days, to negotiate with ALS to
agree upon and execute a definitive
agreement to become the co-marketer,
co-distributor or exclusive distributor, as
the case may be. ALS and Abbott
shall negotiate in good faith with each
other during such period. Such period
shall commence on the receipt of notice by
Abbott from ALS that ALS has
determined how a Product will be marketed
in any one or more specified countries
and specifying whether such marketing shall
be done by co-marketing,
co-distribution, or exclusive distribution.
If such ninety (90) day period
expires and a definitive agreement has not
been executed with respect to the
country or countries specified in such
notice, ALS shall thereafter have no
obligation to Abbott with respect to
co-marketing, co-distribution or exclusive
distribution in such country or
countries.
6. FINANCIALS.
6.1
MILESTONES. ALS shall make the following milestone payments to
Abbott within twenty (20) business days of
the following events:
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MILESTONE
PAYMENT
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The earlier to occur of October 31, 2005 or the $
5,000,000
commencement of clinical trials
(administration to first
patient) of Compound A or Compound B by
ALS
Submission of an NDA for Compound A or
Compound B for $
10,000,000
the United States. In the event that ALS
submits an NDA
for Compound A or Compound B to the
European Union prior
to submission in the United States, ALS
shall pay to
Abbott one half (1/2) of the milestone due
under this
term upon submission to the European Union
and the
balance of this milestone shall become due
upon
submission of an NDA for Compound A or
Compound B in the
United States.
Receipt of Regulatory Approval of Compound
A or Compound $ 30,000,000
B in the United States. In the event that
ALS receives
Regulatory Approval of Compound A or
Compound B in the
European Union prior to receipt of
Regulatory Approval
in the United States, ALS shall pay to
Abbott one half
(1/2) of the milestone due under this term
upon
Regulatory Approval in the European Union
and the
balance of this milestone shall become due
upon receipt
of Regulatory Approval of Compound A or
Compound B in
the United States.
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6.2
ROYALTY PAYMENTS.
(a) RUNNING
ROYALTY. Beginning with the First Commercial
Sale by ALS, any Affiliates or sublicensees of ALS, ALS
shall pay to Abbott, on a country-by-country basis, a
royalty of (i) nineteen percent (19%) on Net Sales, with
respect to which, but for the license granted hereunder,
the manufacture, use or sale of Product would infringe a
Valid Claim in such country. and (ii) nine and one-half
percent (9.5%) on Net Sales for all other countries;
provided, however, that ALS shall not be obligated to
pay any royalties for countries in which all Valid
Claims have expired; and provided further, however, that
(A) ALS shall only be obligated to make payments under
this Section 6.2(a)(ii), on a country-by-country basis
for a period of seven (7) years from the date of the
First Commercial Sale in each such country and (B) ALS
shall not be obligated to pay the nine and one-half
percent (9.5%) royalty established in Section 6.2
(a)(ii) in a given country in the event that all
Covering Claims are deemed invalid by the judicial
authority in such country effective as of the date that
the last Covering Claim is finally deemed invalid. For
purposes of this Section 6.2(a), the term "Covering
Claim" shall mean a claim contained in any of the
Patents that would be infringed but for the Exclusive
License granted hereunder.
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(b) ROYALTY
REPORTS AND PAYMENTS. Beginning with the First
Commercial Sale anywhere in the Territory, within
forty-five (45) days after the end of each calendar
quarter, ALS shall prepare and deliver to Abbott a
report detailing the calculation of Net Sales in the
Territory, on a country-by-country basis, for such just
ended quarter along with the calculation of royalties
due thereon pursuant to SECTION 6.2(a) above. Each
report shall be accompanied by full payment in U.S.
dollars of the royalties shown thereon to be due. In the
event that conversion from foreign currency is required
in calculating a royalty payment hereunder, the exchange
rate used shall be the average of the bid and ask rates
in effect at the end of the last business day of the
applicable quarter for which royalties are calculated,
as reported by THE WALL STREET JOURNAL (Midwest
Edition), or a substantially similar global publication
if THE WALL STREET JOURNAL (Midwest Edition) is no
longer published.
(c) BOOKS AND
RECORDS/AUDIT RIGHTS. ALS shall keep, and
shall cause its Affiliates and sublicensees to keep,
books and records accurately showing all Products
manufactured, used or sold under the terms of this
Agreement. The relevant portions of such books and
records shall be open to inspection by representatives
of (i) Abbott and (ii) either or both of the two (2)
third parties that Abbott certifies that had as of the
Effective Date of the Option Agreement between Abbott
and ALS a legitimate financial interest in either of the
Compounds, at Abbott's cost, solely for the purposes of
determining the correctness of the royalties payable
under this Agreement. Such audit, conducted no more than
one time per calendar year, shall be during normal
business hours after reasonable advance notice and
subject to customary confidentiality provisions. In the
event an audit shows a deficiency to be due, ALS shall
immediately pay such deficiency along with the
reasonable costs and expenses of the audit if the
deficiency is more than five percent (5%) of the amount
due during such audited period. If the audit shows that
an excess was paid, ALS may deduct the amount of such
excess from the next payment due. Such books and records
shall be preserved for a period of at least three (3)
years after the date of the royalty payment to which
they pertain, and no audit may be conducted with respect
to royalties due in any calendar year that is more than
two (2) years preceding the calendar year in which the
audit is being conducted. Books and records for a given
calendar year may only be audited once. Any third party
exercising its audit rights under this Section 6.2 shall
enter into a confidentiality agreement with terms no
less stringent than those contained in this Agreement.
(d) WITHHOLDING
TAXES ON ROYALTIES. Where any sum due to be
paid to Abbott hereunder is subject to any withholding
or similar tax,
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the parties shall use reasonable efforts to do such acts
and things and to sign such documents as will enable
them to take advantage of any applicable double taxation
agreement or treaty. In the event there is no applicable
double taxation agreement or treaty, or if an applicable
double taxation agreement or treaty reduces but does not
eliminate such withholding or similar tax, ALS shall pay
such withholding or similar tax to the appropriate
government authority, deduct the amount paid from the
amount due Abbott and secure and send to Abbott the best
available evidence of such payment sufficient to enable
Abbott to obtain a deduction for such withheld taxes or
obtain a refund thereof.
7. REPRESENTATIONS, WARRANTIES
AND COVENANTS.
7.1
REPRESENTATIONS AND WARRANTIES OF ABBOTT. Abbott represents
and warrants that:
(a) it is duly
organized, validly existing and in good
standing under the laws of Illinois, that it has full
corporate power and authority to enter into this
Agreement and to carry out its provisions, and that
there are no outstanding agreements, assignments or
encumbrances in existence to which Abbott is a party or
otherwise bound that are inconsistent with the
provisions of this Agreement.
(b) the Patents
have not been, and will not be, knowingly
obtained by Abbott through any activity, omission or
representation that would limit or destroy the validity
of the Patents or cause the Patents to be deemed
unenforceable;
(c) there are no
actions pending or, to the knowledge of
Abbott, threatened against Abbott before any court,
relating to the Abbott Technology;
(d) Abbott has
no knowledge of the Abbott Technology being
infringed by others; and the Abbott Technology comprises
all of the patents and patent applications owned by or
licensed to Abbott or its Affiliates that claim either
Compound A or Compound B, their use or manufacture;
(e) all of the
Inventory to be purchased in accordance with
ARTICLE 4 hereof (i) was manufactured in accordance with
Abbott's internal specifications, (ii) when delivered
hereunder to ALS will meet Abbott's release
specifications for use in human clinical trials, and
(iii) was manufactured in accordance with FDA Current
Good Manufacturing Practices as defined in 21 C.F.R.
Part 210;
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(f) it has
authorized the execution and delivery this
Agreement and the performance of its obligations
hereunder and that the execution, delivery and
performance of this Agreement by it does not require the
consent, approval or authorization of or notice to, or
filing or registration with, any governmental agency or
Regulatory Authority;
(g) except for
the Compounds, it currently has not entered
in any stage of human clinical trials, any compound that
would fall in the ketolide antibiotic class as such term
is commonly used;
(h) it is the
sole owner or exclusive licensee of all patent
applications and patents within the Patents, provided
that no representation is made under this Section 7.1(h)
(i) regarding the content, scope