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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, sc
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