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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: ABBOTT LABORATORIES | ADVANCED LIFE SCIENCES HOLDINGS, INC You are currently viewing:
This License Agreement involves

ABBOTT LABORATORIES | ADVANCED LIFE SCIENCES HOLDINGS, INC

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Title: LICENSE AGREEMENT
Governing Law: Illinois     Date: 4/28/2005
Law Firm: Winston Strawn    

LICENSE AGREEMENT, Parties: abbott laboratories , advanced life sciences holdings  inc
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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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<Table>

<Caption>

MILESTONE PAYMENT

-------------------------------------------------------- ------------

<S> <C>

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.

</Table>

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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