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 XXXXXX LABORATORIES, an
Illinois corporation, with its principal office at 000 Xxxxxx Xxxx Xxxx, Xxxxxx
Xxxx, Xxxxxxxx 00000 ("ABBOTT"), and ADVANCED LIFE SCIENCES HOLDINGS, INC., a
Delaware corporation, with its principal office at 0000 Xxxxx Xxxx, Xxxxxxxxx,
Xxxxxxxx 00000 ("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 Xxxxxx'x 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.
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.
2
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.
3
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 XXXXXX 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 Xxxxxx'x 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 Xxxxxx'x 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
4
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
Xxxxxx'x 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
5
(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.
6
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 Xxxxxx'x 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 xxxxx Xxxxxx 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 xxxxx Xxxxxx 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:
7
MILESTONE PAYMENT
-------------------------------------------------------- ------------
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.
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.
8
(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 Xxxxxx'x 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,
9
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 XXXXXX. Xxxxxx 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
Xxxxxx'x internal specifications, (ii) when delivered
hereunder to ALS will meet Xxxxxx'x 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;
10
(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, validity or
enforceability of such applications or patents or any
intellectual property rights relating thereto or (ii)
that engagement in the activities described in such
applications or patents does not or would not infringe
the rights of any third party;
(i) none of its patent counsel, commercial counsel or
executive officers with responsibility for
pharmaceutical matters have knowledge (without having
conducted any investigation or inquiry) of any third
party rights necessary to develop, make, use or sell
Compound A or Compound B in the Territory; and
(j) it has not received written notice from any third party
that the manufacture or sale of the Compounds infringes
the rights of any third party.
7.2 REPRESENTATIONS AND WARRANTIES OF ALS. ALS represents and
warrants that:
(a) it is duly organized, validly existing and in good
standing under the laws of Delaware, 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 ALS is a party or
otherwise bound that are inconsistent with the
provisions of this Agreement;
(b) it has authorized the execution and delivery of this
Agreement and the performance of its obligations
hereunder; and
(c) 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.
11
7.3 INDEMNIFICATION BY ALS. ALS shall indemnify and hold Abbott,
its Affiliates and their respective directors, officers, employees and agents
harmless from and against any and all liabilities, actions, suits, claims,
demands, prosecutions, damages, costs, expenses or money judgments finally
awarded (including reasonable legal fees and costs of investigation and
litigation) (collectively, "LIABILITIES") incurred by or instituted or rendered
against or suffered by Abbott to the extent such Liabilities result from a third
party claim arising from the sale, distribution, transportation, handling or use
of Compound A or Compound B or Product(s) in the Territory by ALS, its
Affiliates, agents or sublicensees or any health care professional, patient or
other third party, or from the willful misconduct or the negligent acts or
omissions of ALS, its Affiliates, their agents or sublicensees or ALS's breach
of this Agreement, except to the extent such third party claims arise out of the
negligence or willful misconduct of Abbott, or any of its Affiliates or any of
their respective directors, officers, employees and agents. Abbott shall give
ALS prompt notice in writing of any such claim or lawsuit and permit ALS to
undertake sole control of the defense and settlement thereof at ALS's expense.
In any such claim or lawsuit:
(a) Abbott will cooperate in the defense by providing access
to witnesses and evidence available to it. Abbott shall
have the right to participate, at its expense, in any
defense to the extent that in its judgment Abbott may be
prejudiced by ALS's sole defense thereof.
(b) Any settlement for which Abbott intends to seek or has
sought indemnification hereunder from ALS shall not be
binding upon ALS without the written consent of ALS.
7.4 INDEMNIFICATION BY XXXXXX. Xxxxxx shall indemnify and hold
ALS, its Affiliates and their respective directors, officers, employees and
agents harmless from and against any and all Liabilities incurred by or
instituted or rendered against or suffered by ALS to the extent such Liabilities
result from a third party claim arising from the willful misconduct or the
negligent acts or omissions of Abbott, its Affiliates, their agents or
sublicensees, or Xxxxxx'x breach of this Agreement, except to the extent such
third party claims arise out of the negligence or willful misconduct of ALS, or
any of its Affiliates or any of their respective directors, officers, employees
and agents. ALS shall give Abbott prompt notice in writing of any such claim or
lawsuit and permit Abbott to undertake sole control of the defense and
settlement thereof at Xxxxxx'x expense. In any such claim or lawsuit:
(a) ALS will cooperate in the defense by providing access to
witnesses and evidence available to it. ALS shall have
the right to participate, at its expense, in any defense
to the extent that in its judgment ALS may be prejudiced
by Xxxxxx'x sole defense thereof.
(b) Any settlement for which ALS intends to seek or has
sought indemnification hereunder from Abbott shall not
be binding upon Abbott without the written consent of
Abbott.
12
7.5 REPORTABLE ADVERSE EVENTS. Each party warrants that it shall
advise the other of any serious adverse events relating in any way to the
Compounds or the Product as and when such serious adverse events are reported or
reportable by it to the Regulatory Authorities.
7.6 COMPLIANCE WITH LAW. In its activities relating to this
Agreement, each party covenants to the other party that it shall comply with all
applicable laws, rules and regulations.
7.8 LIMITATION. EXCEPT FOR THE EXPRESS WARRANTIES IN THIS
ARTICLE 7, NEITHER PARTY MAKES ANY WARRANTIES, EXPRESS OR IMPLIED, IN FACT OR BY
OPERATION OF LAW, STATUTORY OR OTHERWISE. EACH PARTY SPECIFICALLY DISCLAIMS ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT
FOR AMOUNTS FINALLY AWARDED FOR INDEMNIFICATION FOR THIRD PARTY LIABILITIES
UNDER SECTIONS 7.3 AND 7.4 ABOVE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY HERETO OR TO ANY THIRD PARTY FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY OR
INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED PROFITS RELATING TO THE SAME)
ARISING FROM ANY CLAIM RELATING TO THIS AGREEMENT, WHETHER SUCH CLAIM IS BASED
ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED
REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF
SAME.
8. CONFIDENTIALITY AND NON-DISCLOSURE.
8.1 NONDISCLOSURE. Neither party shall use or disclose any
Confidential Information received by it from the other party pursuant to this
Agreement without the prior written consent of the other. This obligation will
continue for a period of seven (7) years after termination of this Agreement or
expiration of the Term.
8.2 RESTRICTION. Each party shall restrict dissemination of
Confidential Information of the other party to those of its employees,
Affiliates, contractors, agents and sublicensees (if any) who have a need
therefore in carrying out their functions. Neither party shall obtain any right
of any kind to the Confidential Information of the other party by virtue of this
Agreement, except as granted under this Agreement.
8.3 RESTRICTION EXEMPTIONS. Nothing contained in this ARTICLE 8 or
SECTION 1.4 shall be construed to restrict the parties from using or disclosing
Confidential Information solely to the extent and solely as required:
(a) for regulatory, tax or customs reasons;
(b) for audit purposes;
(c) by court order or other governmental order or request;
13
(d) to perform acts permitted by this Agreement, including
(i) disclosure by ALS to third parties undertaking
clinical trials and the like on behalf of ALS, so long
as such third parties are under a legal obligation to
ALS to protect the confidentiality of such Confidential
Information, (ii) disclosure by ALS to sublicensees, so
long as such sublicensees are under a legal obligation
to ALS to protect the confidentiality of such
Confidential Information or (iii) disclosure by ALS or
its sublicensees in connection with the marketing and
commercial sale of Product, to the extent required by
law; or
(e) as required by ALS in connection with a private or
public financing.
9. TERM AND TERMINATION.
9.1 The Term of this Agreement shall continue in effect until the
last to expire of the Patents unless earlier terminated as provided in this
ARTICLE 9. Upon the expiration of the Term, ALS shall have a non-exclusive,
perpetual and irrevocable license under Xxxxxx'x Know-How, without any further
payment obligation to Abbott, except for the payment obligations accruing prior
to such date and the indemnification obligations under SECTION 7.3.
9.2 ALS shall have the right, without cause, to terminate this
Agreement upon sixty (60) days' written notice, at the end of which the
termination shall be effective. Before such termination becomes effective, ALS
shall pay all payments and royalties which may have become due prior to the
effective date of such termination. Upon such termination, ALS shall assign and
deliver without charge, and Abbott shall be entitled to retain for its own use,
all materials (Compounds, bulk and processed clinical material), studies and
information relating to the Compounds.
9.3 Either party may terminate this Agreement by giving to the
other party prior written notice of not less than thirty (30) days in the case
of a monetary breach and of not less than ninety (90) days in the event the
other party shall commit a non-monetary material breach of this Agreement, and
such breaching party shall fail to cure such breach during such thirty (30) or
ninety (90) day period, as applicable. No such cancellation and termination
shall release the breaching party from any obligations hereunder incurred prior
thereto. If, in any dispute submitted for resolution pursuant to Section 13.8,
the neutral determines that there has been a material breach of the Agreement,
the breaching party shall not be entitled to an additional cure period, but
rather, the non-breaching party may immediately terminate this Agreement.
9.4 Either party may terminate this Agreement on thirty (30) days
notice if the other party passes a resolution or a court of competent
jurisdiction makes an order for its winding up; or ceases its business
operations.
14
9.5 Abbott may terminate this Agreement immediately if ALS,
directly or indirectly, commences or participates in any proceedings in order to
have any of the Patents declared invalid in any country.
9.6 Termination of this Agreement shall be without prejudice to
any rights of either party against the other which may have accrued up to the
date such termination becomes effective.
9.7 All causes of action accruing to either party under this
Agreement shall survive expiration or termination of this Agreement for any
reason.
9.8 Upon any termination or expiration of this Agreement, each
party shall promptly return to the other party all written Confidential
Information of such other party, and all copies thereof (retaining one copy of
the Confidential Information of the other in its confidential files for archival
purposes only), which is not covered by a paid-up license or other rights
specified herein surviving such termination or expiration. Further, upon
termination of this Agreement in whole or in part, except upon termination of
this Agreement by ALS pursuant to Sections 9.3 or 9.4 above, ALS shall act
promptly to ensure a smooth transition of rights to Abbott, including but not
limited to the transfer of any and all relevant Regulatory Approvals to Abbott.
10. INFRINGEMENT OF PATENTS BY THIRD PARTY. In the event of an actual or
suspected infringement of a Patent by a third party, the following shall apply:
10.1 NOTICE. Each party shall give the other written notice if one
of them becomes aware of any infringement by a third party of any Patent. Upon
notice of any such infringement, the parties shall promptly consult with one
another with a view toward reaching agreement on a course of action to be
pursued.
10.2 ALS'S RIGHT TO BRING INFRINGEMENT ACTION.
(a) ALS ELECTION. If a third party infringes any Patent,
Abbott shall have the first right, but not the
obligation, to institute and prosecute an action or
proceeding to xxxxx such infringement and to resolve
such matter by settlement or otherwise.
(i) Abbott shall notify ALS of its intention to bring
an action or proceeding prior to filing the same
and in sufficient time to allow ALS the
opportunity to discuss with Abbott the choice of
counsel for such matter. Abbott shall keep ALS
timely informed of material developments in the
prosecution or settlement of such action or
proceeding. Abbott shall be responsible for all
fees and expenses of any action or proceeding
against infringers which Abbott initiates. ALS
shall cooperate fully at its expense by joining
as a party plaintiff if reasonably requested to
do so
15
by Abbott or if required to do so by law to
maintain such action or proceeding and by
executing and making available such documents
as Abbott may reasonably request. ALS may be
represented by counsel in any such legal
proceedings, at ALS's own expense.
(ii) If Abbott elects not to exercise such first right
it shall notify ALS of its determination in
writing. Thereafter, ALS shall have the right, at
its discretion, to institute and prosecute an
action or proceeding to xxxxx such infringement
and to resolve such matter by settlement or
otherwise. ALS shall keep Abbott timely informed
of material developments in the prosecution or
settlement of such action or proceeding. ALS
shall be responsible for all fees and expenses of
any action or proceeding against infringers which
ALS initiates. Abbott shall cooperate fully by
joining as a party plaintiff if reasonably
requested to do so by ALS or if required to do so
by law to maintain such action and by executing
and making available such documents as ALS may
reasonably request. Abbott may be represented by
counsel in any such action, at its own expense.
(b) ALS'S USE OF PROCEEDS. All amounts of every kind and
nature recovered from an action or proceeding of
infringement brought by ALS shall belong to ALS, and
shall be used first to reimburse ALS for its documented
and actual costs of prosecution, including attorneys'
fees, expert fees and all other related expenses, second
to reimburse Abbott for its documented and actual costs
if it is represented by counsel in the proceedings, and
the balance shall thereafter be treated as Net Sales.
(c) XXXXXX'X USE OF PROCEEDS. All amounts of every kind and
nature recovered from an action or proceeding of
infringement brought by Abbott shall belong to Abbott,
and shall first be used to reimburse Abbott for its
documented and actual costs of prosecution, including
attorneys' fees, expert fees and all other related
expenses, second to reimburse ALS for its documented and
actual costs if it is represented by counsel in the
proceedings, and the balance shall thereafter belong to
Abbott.
11. INFRINGEMENT OF THIRD PARTY RIGHTS; ALS DEFENSE OF SUIT. If Abbott,
its Affiliates, ALS, its Affiliates, sublicensees, distributors or other
customers are sued or threatened with suit by a third party alleging
infringement in one or more countries of the Territory of such party's patents
or other intellectual property rights that are alleged to cover the manufacture,
use, sale, import. export or distribution of one or more Products, Abbott or
ALS, whichever is applicable, will promptly notify the other in writing and
provide a copy of the lawsuit or claim. The party being sued or threatened with
suit shall control the defense in any such claim or suit.
16
Such party shall have the right to settle any such suit, including the right to
grant one or more sublicenses with the other party's prior written approval,
which approval shall not unreasonably be withheld, provided that ALS shall not
otherwise have the right to surrender, limit or adversely affect any rights to
the Patents. ABBOTT MAKES NO WARRANTIES AND SPECIFICALLY DISCLAIMS ANY
WARRANTIES REGARDING THE NON-INFRINGEMENT BY THE PRODUCTS OF THIRD PARTY RIGHTS.
12. PATENT PROSECUTION AND MAINTENANCE; PATENT COSTS; PATENT TERM
EXTENSION.
12.1 DISCLOSURE OF PATENTS/APPLICATIONS TO ALS. Within thirty (30)
days following the Effective Date, Abbott shall, to the extent not previously
disclosed, disclose to ALS the complete text of, and all other information in
its possession or control directly related to (a) all patent applications
included in the Patents filed anywhere in the Territory; and (b) all patents
included in the Patents as well as all information in Xxxxxx'x, its Affiliates
and its patent counsel's possession concerning the institution or possible
institution of any interference, opposition, reexamination, reissue, revocation,
nullification or any official proceeding involving an issued patent included in
the Patents anywhere in the Territory. ABBOTT MAKES NO WARRANTIES AND
SPECIFICALLY DISCLAIMS ANY WARRANTIES REGARDING THE PATENTABILITY OF PENDING
PATENT APPLICATIONS.
12.2 PROSECUTION AND MAINTENANCE. Abbott shall file, prosecute and
maintain all of the Patents in Xxxxxx'x name, including oppositions and
interferences. In the event that Abbott determines to abandon any patent
application that is included in the Patents or to no longer maintain any patent
that is included within the Patents, Abbott shall give ALS ninety (90) days
prior written notice before taking any action or inaction in furtherance of such
determination during which time ALS shall have the right but not the obligation
to assume the prosection of such patent application or the maintenance of such
patent. Abbott and ALS shall consult and cooperate with each other, and Abbott
shall keep ALS reasonably informed, with respect to the prosecution and
maintenance of the Patents hereunder. Abbott will provide ALS with copies of all
material correspondence sent to or received from the United States Patent and
Trademark Office in connection with the prosecution and maintenance of the
Patents. Abbott shall provide copies in a timely manner to allow ALS an
opportunity, if it so elects, to review and comment on Xxxxxx'x proposed patent
strategy.
17
13. MISCELLANEOUS.
13.1 FORCE MAJEURE. If the performance by either party of any of
its obligations under this Agreement (except the obligation to pay money) shall
be prevented by circumstances beyond its reasonable control which could not have
been avoided by the exercise of reasonable diligence, then such party shall be
excused from the performance of that obligation for the duration of the event.
The affected party shall promptly notify the other party in writing should such
circumstances arise, give an indication of the likely extent and duration
thereof, and shall use commercially reasonable efforts to resume performance of
its obligations as soon as practicable.
13.2 NOTICES. Any notice required to be given or made under this
Agreement by one of the parties hereto to the other shall be in writing, by
personal delivery, registered U.S. mail or overnight courier, addressed to such
other party at its address indicated below, or to such other address as the
addressee shall have last furnished in writing to the addressor and shall be
effective upon the date of receipt.
If to ALS:
Advanced Life Sciences Holdings, Inc.
0000 Xxxxx Xxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attn: Xxxxxxx X. Xxxxxx, Ph.D.,
Chairman and Chief Executive Officer
With copy to: Winston & Xxxxxx, LLP
00 Xxxx Xxxxxx Xxxxx
Xxxxxxx, XX 00000
Attn: Xxxxxx X. Xxxxxxxxxx
If to Abbott: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxxxxxxxx 000; Building AP30
Xxxxxx Xxxx, Xxxxxxxx 00000-0000
With a copy to: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxxxxxxxx 000; Building AP6D
Xxxxxx Xxxx, Xxxxxxxx 00000-0000
Attn: Divisional Vice President, Domestic Legal
13.3 APPLICABLE LAW/COMPLIANCE. This Agreement shall be governed by
and construed in accordance with the laws of the State of
Illinois, excluding
its conflict of laws provision. Each party hereto shall comply with all
applicable laws, rules, ordinances, guidelines, consent decrees and regulations
of any federal, state or other governmental authority.
13.4 ENTIRE AGREEMENT. This Agreement and the attachments
(Exhibits) contain the entire understanding of the parties with respect to the
subject matter hereof. All express or implied agreements and understandings,
either oral or written, heretofore made are
18
expressly merged in and made a part of this Agreement. This Agreement may be
amended, or any term hereof modified, only by a written instrument duly executed
by both parties hereto.
13.5 COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
13.6 SEVERABILITY/HEADINGS. If any provision of this Agreement is
deemed unenforceable, the remainder of the Agreement will not be affected and,
if appropriate, the parties will attempt to replace the unenforceable provision
with a new provision that, to the extent possible, reflects the parties'
original intent. The captions and headings used in this Agreement are for
reference only and are not to be construed in any way as terms or used to
interpret the provisions of this Agreement.
13.7 ASSIGNMENT. Neither party may, without prior written consent
of the other, assign this Agreement or transfer its interest or any part thereof
under this Agreement to any third party except that either party may assign this
Agreement without such consent (i) to the surviving entity in a merger or
consolidation involving such party; (ii) to a third party that acquires all or
substantially all of the assets or the business of such party to which this
Agreement pertains; or (iii) to any Affiliate of that party and such party
hereby guarantees the performance by such Affiliate. A sale of shares of stock
shall not constitute an assignment in violation of this section. For purposes of
this Article 14, the term "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).
13.8 DISPUTE RESOLUTION. The parties hereto shall attempt to settle
any dispute arising out of or relating to this Agreement in an amicable way.
Except for claims for injunctive or other equitable relief, which may be brought
in any court of competent jurisdiction, any controversy, claim or right of
termination for cause which may arise under, out of, in connection with, or
relating to this Agreement, or any breach thereof, shall be settled according to
the Alternative Dispute Resolution provisions attached hereto as EXHIBIT C.
13.9 INDEPENDENT CONTRACTOR. It is understood that both parties
hereto are independent contractors and engage in the operation of their own
respective businesses and neither party hereto is to be considered the agent of
the other party for any purpose whatsoever and neither party has any authority
to enter into any contract or assume any obligation for the other party or to
make any warranty or representation on behalf of the other party. Each party
shall be fully responsible for its own employees, servants and agents, and the
employees, servants and agents of one party shall not be deemed to be employees,
servants and agents of the other party for any purpose whatsoever.
13.10 PUBLICITY. No press release or other public announcement shall
be made by either party concerning the execution of this Agreement or the fact
that ALS has licensed the Compounds from Abbott, without the prior written
consent of the non--disclosing party, which
19
consent may be withheld in the non-disclosing party's sole discretion. Neither
party shall use the name of the other party, its officers, employees or agents
without the other party's prior written consent, except where the name of the
other party must be disclosed as a matter of law. ALS anticipates that it will
make an initial public offering of its securities during the Option Term and
that disclosure of a summary of the terms of this Agreement may be required to
be included in a registration statement to be filed with the Securities and
Exchange Commission pertaining to such initial public offering. If, in good
faith, counsel for ALS determines that such disclosure is required, ALS shall
give Abbott written notice thereof not less than thirty (30) days prior to the
making of any such filing, together with a draft of the disclosure ALS intends
to make regarding this Agreement. Abbott shall have fifteen (15) days to review
and comment on the draft of the disclosure. ALS shall use all reasonable efforts
to incorporate Xxxxxx'x comments. Should either party wish to make a disclosure
or be required by law to make a disclosure under circumstances other than those
described above, the disclosing party shall submit a copy of the proposed
disclosure to the other party for review. The non--disclosing party shall have
three (3) weeks to review and comment on the content of such disclosure. In the
case of a disclosure required by law, the disclosing party, subject to legal
requirements, shall use all reasonable efforts to accommodate the
non--disclosing party's comments. For non--routine matters like an emergency,
special circumstance, or other situation where the law compels a disclosure in
less than three (3) week's time, the non-disclosing party agrees to use
commercially reasonable efforts to provide its review and comment in order to
meet the disclosing party's timetable.
[SIGNATURE PAGE FOLLOWS]
20
[SIGNATURE PAGE TO
LICENSE AGREEMENT ]
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the Effective Date.
XXXXXX LABORATORIES
ADVANCED LIFE SCIENCES
HOLDINGS, INC.
By: /s/ Xxxxxxx X. Leiden, Ph.D. By: /s/ Xxxxxxx X. Xxxxxx, Ph.D.
------------------------------------ ------------------------------------
Name: Xxxxxxx X. Leiden, M.D., Ph.D. Name: Xxxxxxx X. Xxxxxx, Ph.D.
Its: President and Chief Operating Officer, Its: Chairman and Chief Executive
Pharmaceutical Products Group Officer
21
EXHIBIT A
PATENTS AND PATENT APPLICATIONS
(SEE ATTACHED.)
A-1
EXHIBIT B
SCHEDULE OF RELEASE SPECIFICATION TESTS
1. Assay by HPLC Not less than 950 mcg/mg on the anhydrous basis
2. Impurities/Related Substances (by HPLC) Report results for 2-epimer (RRT About 0.91)
Not more than 2.00% of cis-A195773 (RRT about 1.10)
Not more than 5.00% total impurities
No other single unknown impurity greater that 1.00%
No other single known impurity greater than 1.50%
3. Moisture (Xxxx Xxxxxxx) Not more than 2.0%
4. X-Ray Diffraction Report pattern observed
5. Physical Examination Appearance: Powder; some soft lumps may be present
Color: White to light tan
B-1
EXHIBIT C
ALTERNATIVE DISPUTE RESOLUTION
The parties recognize that from time to time a dispute may arise relating to
either party's rights or obligations under this Agreement. The parties agree
that any such dispute shall be resolved by the Alternative Dispute Resolution
("ADR") provisions set forth in this Exhibit, the result of which shall be
binding upon the parties.
To begin the ADR process, a party first must send written notice of the dispute
to the other party for attempted resolution by good faith negotiations between
their respective presidents (or their designees) of the affected subsidiaries,
divisions, or business units within twenty-eight (28) days after such notice is
received (all references to "days" in this ADR provision are to calendar days).
If the matter has not been resolved within twenty-eight (28) days of the notice
of dispute, or if the parties fail to meet within such twenty-eight (28) days,
either party may initiate an ADR proceeding as provided herein. The parties
shall have the right to be represented by counsel in such a proceeding.
1. To begin an ADR proceeding, a party shall provide written notice to the
other party of the issues to be resolved by ADR. Within fourteen (14) days
after its receipt of such notice, the other party may, by written notice to
the party initiating the ADR, add additional issues to be resolved within
the same ADR.
2. Within twenty-one (21) days following receipt of the original ADR
notice, the parties shall select a mutually acceptable neutral to preside
in the resolution of any disputes in this ADR proceeding. If the parties
are unable to agree on a mutually acceptable neutral within such period,
either party may request the President of the CPR Institute for Dispute
Resolution ("CPR"), 000 Xxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx
00000, to select a neutral pursuant to the following procedures:
(a) The CPR shall submit to the parties a list of not less than five
(5) candidates within fourteen (14) days after receipt of the request,
along with a CURRICULUM VITAE for each candidate. No candidate shall
be an employee, director, or shareholder of either party or any of
their subsidiaries or affiliates.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her
impartiality.
(c) Each party shall number the candidates in order of preference
(with the number one (1) signifying the greatest preference) and shall
deliver the list to the CPR within seven (7) days following receipt of
the list of candidates. If a party believes a conflict of interest
exists regarding any of the candidates, that party shall provide a
written explanation of the conflict to the CPR along with its list
C-1
showing its order of preference for the candidates. Any party failing
to return a list of preferences on time shall be deemed to have no
order of preference.
(d) If the parties collectively have identified fewer than three (3)
candidates deemed to have conflicts, the CPR immediately shall
designate as the neutral the candidate for whom the parties
collectively have indicated the greatest preference. If a tie should
result between two candidates, the CPR may designate either candidate.
If the parties collectively have identified three (3) or more
candidates deemed to have conflicts, the CPR shall review the
explanations regarding conflicts and, in its sole discretion, may
either (i) immediately designate as the neutral the candidate for whom
the parties collectively have indicated the greatest preference, or
(ii) issue a new list of not less than five (5) candidates, in which
case the procedures set forth in subparagraphs 2(a) - 2(d) shall be
repeated.
3. No earlier than twenty-eight (28) days or later than fifty-six (56) days
after selection, the neutral shall hold a hearing to resolve each of the
issues identified by the parties. The ADR proceeding shall take place at a
location agreed upon by the parties. If the parties cannot agree, the
neutral shall designate a location other than the principal place of
business of either party or any of their subsidiaries or affiliates.
4. At least seven (7) days prior to the hearing, each party shall submit
the following to the other party and the neutral:
(a) a copy of all exhibits on which such party intends to rely in any
oral or written presentation to the neutral;
(b) a list of any witnesses such party intends to call at the hearing,
and a short summary of the anticipated testimony of each witness;
(c) a proposed ruling on each issue to be resolved, together with a
request for a specific damage award or other remedy for each issue.
The proposed rulings and remedies shall not contain any recitation of
the facts or any legal arguments and shall not exceed one (1) page per
issue.
(d) a brief in support of such party's proposed rulings and remedies,
provided that the brief shall not exceed twenty (20) pages. This page
limitation shall apply regardless of the number of issues raised in
the ADR proceeding.
Each party shall be permitted to take up to a maximum of two (2)
depositions of no more than five (5) hours each. Notwithstanding the
foregoing, except as expressly set forth in subparagraphs 4(a) - 4(d) no
further discovery shall be required or permitted by any means, including
depositions, interrogatories, requests for admissions, or production of
documents.
C-2
5. The hearing shall be conducted on two (2) consecutive days and shall be
governed by the following rules:
(a) Each party shall be entitled to five (5) hours of hearing time to
present its case. The neutral shall determine whether each party has
had the five (5) hours to which it is entitled.
(b) Each party shall be entitled, but not required, to make an opening
statement, to present regular and rebuttal testimony, documents or
other evidence, to cross-examine witnesses, and to make a closing
argument. Cross-examination of witnesses shall occur immediately after
their direct testimony, and cross-examination time shall be charged
against the party conducting the cross-examination.
(c) The party initiating the ADR shall begin the hearing and, if it
chooses to make an opening statement, shall address not only issues it
raised but also any issues raised by the responding party. The
responding party, if it chooses to make an opening statement, also
shall address all issues raised in the ADR. Thereafter, the
presentation of regular and rebuttal testimony and documents, other
evidence, and closing arguments shall proceed in the same sequence.
(d) Except when testifying, witnesses shall be excluded from the
hearing until closing arguments.
(e) Settlement negotiations, including any statements made therein,
shall not be admissible under any circumstances. Affidavits prepared
for purposes of the ADR hearing also shall not be admissible. As to
all other matters, the neutral shall have sole discretion regarding
the admissibility of any evidence.
6. Within seven (7) days following completion of the hearing, each party
may submit to the other party and the neutral a post-hearing brief in
support of its proposed rulings and remedies, provided that such brief
shall not contain or discuss any new evidence and shall not exceed ten (10)
pages. This page limitation shall apply regardless of the number of issues
raised in the ADR proceeding.
7. The neutral shall rule on each disputed issue within fourteen (14) days
following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the parties on each
disputed issue but may adopt one party's proposed rulings and remedies on
some issues and the other party's proposed rulings and remedies on other
issues. The neutral shall not issue any written opinion or otherwise
explain the basis of the ruling.
8. The neutral shall be paid a reasonable fee plus expenses. These fees and
expenses, along with the reasonable legal fees and expenses of the
prevailing party (including all
C-3
expert witness fees and expenses) the fees and expenses of a court
reporter, and any expenses for a hearing room, shall be paid as follows:
(a) If the neutral rules in favor of one party on all disputed issues
in the ADR, the losing party shall pay 100% of such fees and expenses.
(b) If the neutral rules in favor of one party on some issues and the
other party on other issues, the neutral shall issue with the rulings
a written determination as to how such fees and expenses shall be
allocated between the parties. The neutral shall allocate fees and
expenses in a way that bears a reasonable relationship to the outcome
of the ADR, with the party prevailing on more issues, or on issues of
greater value or gravity, recovering a relatively larger share of its
legal fees and expenses.
9. The rulings of the neutral and the allocation of fees and expenses shall
be binding, non-reviewable, and non-appealable, and may be entered as a
final judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the existence
of the dispute, any settlement negotiations, the ADR hearing, any
submissions (including exhibits, testimony, proposed rulings, and briefs),
and the rulings shall be deemed Confidential Information. The neutral shall
have the authority to impose sanctions for unauthorized disclosure of
Confidential Information.
C-4
FIRST AMENDMENT TO
LICENSE AGREEMENT
This FIRST AMENDMENT TO
LICENSE AGREEMENT (this "Amendment") is entered
into as of this 27th day of April, 2005 by and between
Advanced Life Sciences
Holdings, Inc., a Delaware corporation ("ALS') and Xxxxxx Laboratories, an
Illinois corporation ("Abbott") to amend the terms of that certain
License
Agreement dated December 13, 2004 between Abbott and ALS (the "Agreement").
BACKGROUND
A. The Agreement provides that certain amounts are to be paid by ALS
to Abbott in the months of May and June 2005.
B. ALS has requested, and Abbott has agreed to a change in the payment
terms for such amounts.
C. The parties wish to amend the Agreement to reflect the change in
the payment terms.
1. INCORPORATION OF AGREEMENT. All capitalized terms which are not
defined herein shall have the same meanings as set forth in the Agreement,
and the Agreement, to the extent not inconsistent with this Amendment is
incorporated herein by this reference as though the same was set forth in its
entirety. To the extent any terms and provisions of the Agreement are
inconsistent with the amendment set forth in Paragraph 2 below, such terms
and provisions shall be deemed superseded hereby. Except as specifically set
forth herein, the Agreement shall remain in full force and effect and its
provisions shall be binding on the parties hereto.
2. AMENDMENT OF THE AGREEMENT. Paragraph 4.2(a) shall be replaced in
its entirety as follows:
(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) Eight Million Dollars
($8,000,000) on the earlier to occur of: (i) five (5) days
after the closing of ALS' initial public offering of
securities or, (ii) September 1, 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 (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.
3. EFFECTUATION. The amendment to the Agreement contemplated by this
Amendment shall be deemed effective as of the date first written above upon
the full execution of this Amendment and without any further action required
by the parties hereto. There are no conditions precedent or subsequent to the
effectiveness of this Amendment.
4. COUNTERPARTS. This Amendment may be executed in two or more
counterparts, each of which shall be deemed to be an original, but all of
which together shall constitute one and the same instrument. One or more
counterparts of this Amendment may be delivered by facsimile, with the
intention that delivery by such means shall have the same effect as delivery
of an original counterpart thereof.
IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment
as of the date first above written.
XXXXXX LABORATORIES
ADVANCED LIFE
SCIENCES HOLDINGS, INC.
By: /s/ Xxxxx X. Xxxxx By: /s/ Xxxxxxx X. Xxxxxx, M.D.
------------------ ---------------------------
Name: Xxxxx X. Xxxxx Name: Xxxxxxx X. Xxxxxx, M.D.
Its: Vice President, Global Licensing/ Its: Chairman and Chief
New Business Development Executive Officer
AMENDED AND RESTATED
SECOND AMENDMENT TO
LICENSE AGREEMENT
This SECOND AMENDMENT TO THE
LICENSE AGREEMENT (this "AMENDMENT") is
entered into as of this 2nd day of August, 2005 by and between
Advanced Life
Sciences Holdings, Inc., a Delaware corporation ("ALS") and Xxxxxx
Laboratories, an
Illinois corporation ("ABBOTT") to amend the terms of that
certain
License Agreement dated December 13, 2004 between Abbott and ALS (the
"AGREEMENT"). This Amendment amends and restates that certain Second
Amendment to
License Agreement, dated as of August 1, 2005, in its entirety.
BACKGROUND
X. Xxxxxx and ALS entered into the Agreement on December 13, 2004 (the
"EFFECTIVE DATE").
B. The Agreement provides ALS with an exclusive worldwide license (except
in Japan) to certain patent applications and patents relating to the
Compounds.
X. Xxxxxx has requested and ALS has agreed to delete all references to
Compound B throughout the entire Agreement along with any associated
rights or obligations.
D. The Agreement provides that certain amounts are to be paid by ALS to
Abbott upon achieving certain milestone events.
E. Both ALS and Abbott desire to change the payment terms for those
amounts due upon certain milestone events.
F. The Agreement provides that ALS shall pay to Abbott royalty payments
on Net Sales of any Product.
G. ALS has requested and Abbott has agreed to change the amount of that
certain royalty on Net Sales.
H. The parties wish to amend the Agreement to, among other things,
reflect the changes outlined above.
1. INCORPORATION OF THE AGREEMENT. All capitalized terms which are not
defined herein shall have the same meanings as set forth in the Agreement, and
the Agreement, to the extent not inconsistent with this Amendment, is
incorporated herein by this reference as though the same was set forth in its
entirety. To the extent any terms and provisions of the Agreement are
inconsistent with the amendments set forth in Paragraph 2 below, such terms and
provisions shall be deemed superseded hereby. Except as specifically set forth
herein, the Agreement shall remain in full force and effect and its provisions
shall be binding on the parties hereto.
2. AMENDMENT OF THE AGREEMENT. The Agreement is hereby amended as follows:
a. CHANGE IN DEFINITIONS.
i. Section 1.4 is hereby deleted in its entirety.
ii. All references to Compound B in Sections 1.5, 1.6, 1.10,
1.14, 1.15, and 1.16 are hereby deleted.
b. CHANGE IN LICENSE GRANT. SECTION 2 of the Agreement is
hereby deleted in its entirety and shall be replaced with
the following:
"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 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, Compound A
and Product(s)."
c. CHANGE IN REFERENCES TO COMPOUND B. All references to
Compound B in Sections 3, 6, and 7 any Exhibits attached to
the Agreement are hereby deleted along with any associated
rights or obligations.
d. CHANGE IN MILESTONE PAYMENTS. SECTION 6.1 of the Agreement
is hereby deleted in its entirety and shall be replaced with
the following:
"The milestone payments are independent, nonrefundable, and
are not creditable against any other amounts due under the
agreement:
MILESTONE PAYMENT
The earlier to occur of October 31, 2005 or the commencement of $5,000,000
clinical trials (administration to first patient) of Compound A by ALS
Submission of an NDA for Compound A for the United States. In the $10,000,000
event that ALS submits an NDA for Compound A 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 in the United States.
Receipt of Regulatory Approval of Compound A in the United States. $30,000,000
In the event that ALS receives Regulatory Approval of Compound A 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 in the United States.
Upon reaching Net Sales of $200,000,000 for the Product. $2,500,000
Upon reaching Net Sales of $400,000,000 for the Product. $5,000,000"
e. CHANGE IN ROYALTY PAYMENTS. SECTION 6.2(a)(i) of the
Agreement is hereby deleted in its entirety and shall be
replaced with the following:
"nineteen percent (19%) on Net Sales of up to $100,000,000;
eighteen percent (18%) on Net Sales of $100,000,000.01 to
$200,000,000; and seveteen percent (17%) on Net Sales of
$200,000,000.01 and above, 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"
3. EFFECTUATION. The amendment to the Agreement contemplated by this
Amendment shall be deemed effective as of the date first written above
upon the full execution of this Amendment and without any further
action required by the parties hereto. There are no conditions
precedent or subsequent to the effectiveness of this Amendment.
4. COUNTERPARTS. This Amendment may be executed in two or more
counterparts, each of which shall be deemed to be an original, but all
of which together shall constitute one and the same instrument. One or
more counterparts of this Amendment may be delivered by facsimile,
with the intention that delivery by such means shall have the same
effect as delivery of an original counterpart thereof.
[SIGNATURE PAGE FOLLOWS]
[SIGNATURE PAGE TO AMENDED AND RESTATED SECOND AMENDMENT
TO THE LICENSE AGREEMENT]
IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment as
of the date first above written.
XXXXXX LABORATORIES
ADVANCED LIFE SCIENCES HOLDINGS, INC.
By: /s/ Xxxxx X. Xxxxx By: /s/ Xxxxxxx X. Xxxxxx, Ph.D.
------------------------------ -------------------------------------
Name: Xxxxx X. Xxxxx Name: Xxxxxxx X. Xxxxxx, Ph.D.
Its: Vice President, Global Its: Chairman and Chief Executive Officer
Licensing/New Business
Development
