License Agreement
Exhibit
10.6
This
License Agreement (“Agreement”)
is
made and entered into effective as of February 8, 2005 (the “Effective
Date”),
by
and between Revaax
Pharmaceuticals LLC, an
Indiana corporation (“Licensor”),
and
Rexahn
Corporation, a
Delaware corporation (“Licensee”).
Licensor and Licensee each may be referred to herein individually as a
“Party,”
or
collectively as the “Parties.”
Recitals
A. Licensor
controls certain patents, and Licensee desires to obtain a license to such
patents for the purpose of developing and commercializing pharmaceutical
products.
B. Licensor
desires to grant Licensee such a license on the terms and conditions set forth
therein.
In
consideration of the foregoing premises, the mutual promises and covenants
set
forth in this Agreement, and other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, Licensor and Licensee hereby
agree as follows:
Agreement
|
1.
|
Definitions
|
When
used
in this Agreement, capitalized terms will have the meanings as defined below
and
throughout the Agreement.
1.1
“Affiliate”
means
a
legal entity that, directly or indirectly, through one or more intermediaries,
controls, is controlled by, or is under common control with an entity. For
purposes of this definition only, “control” and, with correlative meanings, the
terms “controlled by” and “under common control with” means (a) the possession,
directly or indirectly, of the power to direct the management or policies of
a
legal entity, whether through the ownership of voting securities or by contract
relating to voting rights or corporate governance, or (b) the ownership,
directly or indirectly, of more than 50% of the voting securities or other
ownership interest of a legal entity; provided,
that if
local law restricts foreign ownership, control will be established by direct
or
indirect ownership of the maximum ownership percentage that may, under such
local law, be owned by foreign interests.
1.2
“Controlled”
means,
with respect to any Know-How, Patent, or other intellectual property right,
possession of the right, whether directly or indirectly, and whether by
ownership, license or otherwise, to assign, or grant a license, sublicense
or
other right to or under, such Know-How, Patent or right as provided for herein
without violating the terms of any agreement or other arrangements with any
Third Party.
1.3
“FDA”
means
the United States Food and Drug Administration, or any successor
agency.
1.4
“Field”
means
the diagnosis, prognosis, prevention and treatment of human and non-human
diseases and conditions.
1.5
“IND”
means
an
Investigational New Drug Application filed with the FDA in conformance with
applicable laws and regulations,
or the
equivalent thereof in jurisdictions outside the United States.
1.6
“Know-How”
means
any knowledge, experience, technology, information, and data, including
pre-clinical and clinical data generated in connection with the research and
development of compounds, formulas and formulations, processes, techniques,
unpatented inventions, discoveries, ideas, and developments, test procedures,
results, and reports, together with all documents and files embodying the
foregoing.
1.7 “Licensed
Know-How”
means
any and all Know-How Controlled by Licensor as of the Effective Date or
developed by or on behalf of Licensor at any time during the Term.
1.8 “Licensed
Patent”
means
any Patent Controlled by Licensor as of the Effective Date or during the Term,
including the Patents listed in Exhibit A, and any Patent claiming Licensed
Know-How.
1.9 “Licensed
Product”
means
any product the manufacture, use or sale of which is covered by a Valid
Claim.
1.10
“Licensed
Technology”
means
the Licensed Patents and the Licensed Know-How.
1.11
“Marketing
Approval”
means
the approvals of any federal, state or local regulatory agency, department,
bureau or other government entity in a country, that are necessary to be
obtained prior to the commercial sale of a Licensed Product in that
country.
1.12
“Net
Expenditures”
means,
on a Licensed Product-by-Licensed Product basis, the cost of developing the
Licensed Product incurred by Licensee through the date of the first commercial
sale of the Licensed Product, including but not limited to: (a) direct material
costs, (b) direct labor costs, (c) overhead directly attributable to development
of the Licensed Product, all calculated in accordance with GAAP, and (d) all
other out-of-pocket costs, including but not limited to expenses for conducting
pre-clinical and clinical activities and developing a manufacturing process
and
any Technology Acquisition Payments to the extent not already deducted from
payments due to Licensor under this Agreement; but specifically excluding (i)
all license fees paid to Licensor under Section 3.1, and (ii) all milestone
payments paid to Licensor under Section 3.2. Direct material costs will include
the costs incurred in purchasing or manufacturing clinical trial materials,
including sales and excise taxes imposed thereon and customs duty and charges
levied by government authorities, and all costs of packaging components for
clinical trial materials. Direct labor will include the cost of employees and
consultants for the time they are engaged in direct development activities
for a
Licensed Product. Overhead attributable to the Licensed Product will include
a
reasonable allocation of indirect labor (not previously included in direct
labor), a reasonable allocation of administrative costs, and a reasonable
allocation of facilities costs.
1.13 “Net
Sales”
means
the total amount received by Licensee or its Affiliates from the sale of a
Licensed Product to Third Parties by Licensee or its Affiliates, less: (a)
credits, allowances, discounts and rebates to, and chargebacks from the account
of, such Third Parties for spoiled, damaged, out-dated and returned product;
(b)
freight and insurance costs for transporting such product; (c) sales,
value-added and other direct taxes on the sale of the product; (d) customs
duties, surcharges and other governmental charges incurred in connection with
the exportation or importation of such product; (e) trade, cash, and quantity
discounts off the invoiced price and similar promotional discounts or rebates
(such as management fees required by hospital buying groups or granted to
managed care organizations) off the invoiced price; (f) amounts reflecting
retroactive price adjustments on sale of products, to the extent not previously
deducted from Net Sales; (g) manufacturing and packing costs or the supply
price
paid to a Third Party manufacturer of the Licensed Product; (h) marketing and
promotional costs; (i) sales and detailing costs of Licensee’s or its
Affiliates’ sales force; and (j) any Technology Acquisition Payments to the
extent not already deducted from payments due to Licensor under this
Agreement.
1.14 “Patents”
means
(a) all patents and patent applications in any country or supranational
jurisdiction, and (b) any substitutions, divisions, continuations,
continuations-in-part, reissues, renewals, registrations, confirmations,
re-examinations, extensions, supplementary protection certificates and the
like,
and any provisional applications, of any such patents or patent applications.
1.15 “Pivotal
Trial”
means,
as
to a
specific pharmaceutical product, a Phase III clinical trial (or foreign
equivalent), or any controlled and lawful study in humans of the efficacy and
safety of such product, that is prospectively designed to demonstrate
with statistical significance that such
product
is
effective and safe for use
in a
particular indication in a manner sufficient to file for
Marketing Approval of such product.
1.16 “Sublicense
Agreement”
means
any license agreement under which Licensee grants a Third Party a sublicense
under any Licensed Technology for the purpose of allowing such Third Party
to
develop and commercialize one or more Licensed Products.
1.17
“Sublicense
Revenues”
means
any non-creditable upfront license fees or milestone payments received by
Licensee from any Sublicensee pursuant to a Sublicense Agreement and in
connection with the development and commercialization of a Licensed Product
by
such Sublicensee, less any Technology Acquisition Payments to the extent not
already deducted from payments due to Licensor under this Agreement, but
specifically excluding any Sublicense Royalty Revenues.
1.18 “Sublicense
Royalty Revenues”
means
all cash payments received by Licensee from any Sublicensee pursuant to a
Sublicense Agreement based on the sales value of Licensed Products sold by
such
Sublicensee, less any Technology Acquisition Payments to the extent not already
deducted from payments due to Licensor under this Agreement.
1.19 “Sublicensee”
means
any Third Party that has entered into a Sublicense Agreement.
1.20 “Technology
Acquisition Agreement”
means
any agreement entered into before or after the Effective Date between Licensee
or its Affiliates and a Third Party under which Licensee or its Affiliate,
as
applicable, is granted a license to or is assigned (a) any of such Third Party’s
Patents that would be infringed, in the absence of such agreement, by the
manufacture, use or sale of a Licensed Product by Licensee or its Affiliates,
or
(b) any of such Third Party’s Know-How that covers or is useful with respect to
the composition, use, or manufacture of a Licensed Product.
1.21 “Technology
Acquisition Payments”
means
license fees, milestone payments, or royalties payable by Licensee or its
Affiliates to a Third Party under any Technology Acquisition Agreement in
connection with the development or commercialization of a Licensed
Product.
1.22 “Term”
has
the
meaning assigned to it in Section 7.1.
1.23 “Third
Party”
means
any party other than Licensor, Licensee, or their respective
Affiliates.
1.24 “Valid
Claim”
means
any claim of an issued and unexpired patent within the Licensed Patents which
has not been held unenforceable or invalid by a court or other governmental
agency of competent jurisdiction in an unappealed or unappealable decision,
and
which has not been disclaimed or admitted to be invalid or unenforceable through
reissue or otherwise.
|
2.
|
License
Grant; Diligence
|
2.1
Grant.
Licensor
hereby grants to Licensee an exclusive, worldwide, royalty-bearing license,
with
the
right to sublicense through multiple tiers of sublicenses,
under
the Licensed Technology to use and practice the Licensed Technology and to
research, develop, make, use, sell, offer for sale, and import Licensed Products
in the Field.
2.2
Technology
Transfer. Within
10
days after the Effective Date, Licensor will provide Licensee with copies of
all
tangible embodiments of the Licensed Know-How in Licensor’s possession or
control.
2.3
Diligence.
Licensee
will use its commercially reasonable efforts to develop and commercialize one
or
more Licensed Products in the Field during the Term. As between the Parties,
Licensee will be solely responsible for developing Licensed Products and seeking
regulatory approval for such Licensed Products (including, without limitation,
by preparing and filing any and all regulatory submissions relating to the
clinical development or Marketing Approval of a Licensed Product).
|
3.
|
Payments
|
3.1
Initial
License Fee. Licensee
will pay to Licensor an initial license fee of US$375,000, payable in 8
installments of US$46,875 each, with the first installment due on the
14th
day
after the Effective Date (the “First Payment Date”), and the subsequent
installments due on the 90th
day,
180th
day,
270th
day,
360th
day,
450th
day,
540th,
and
630th
day of
the First Payment Date.
|
3.2
|
Milestone
Payment.
|
3.2.1
Licensee
will pay to Licensor the following one-time milestone payments within 30 days
after the first achievement of the following milestone events by
Licensee:
(a) $500,000
with respect to the dosing of the first patient in the first Pivotal Trial
for a
Licensed Product, and $250,000 with respect to the dosing of the first patient
in the second, third, fourth and fifth Pivotal Trial, and $125,000 with respect
the dosing of the first patient in any subsequent Pivotal Trial;
provided, however, that
Licensee will not have any obligation to make any payments under this Section
3.2.1(a) with respect to any Pivotal Trial that is conducted for the same
Licensed Product and the same indication for which Licensee has previously
made
a milestone payment pursuant to this Section 3.2.1(a);
(b) $5,000,000
with respect to the receipt of the first Marketing Approval for a Licensed
Product, and $2,500,000 with respect to the receipt of the second, third, fourth
and fifth Marketing Approval for a Licensed Product, and $1,250,000 with respect
to any subsequent Marketing Approval;
provided, however, that
Licensee will not have any obligation to make any payments under this Section
3.2.1(b) with respect to any Marketing Approval that is for the same Licensed
Product and the same indication for which Licensee has previously made a
milestone payment pursuant to this Section 3.2.1(b).
3.2.2
Notwithstanding
anything in this Agreement, Licensee will have no obligation to make any
payments under this Section 3.2 with respect to any milestone events for which
Licensee receives Sublicense Revenues and thus has an obligation to make
payments under Section 3.4.1.
3.2.3
At
Licensee’s option, Licensee may elect to pay for up to 50% of any milestone
payment due under Section 3.2.1 above in common stock of Licensee with the
number of shares determined by dividing the amount of the portion of the
milestone payment to be paid in shares by the fair market value of one share
of
common stock of Licensee, as determined in good faith by Licensee’s board of
directors.
|
3.3
|
Royalties
on Net Sales.
|
3.3.1
Royalty
Rate. Subject
to the terms and conditions of this Agreement, Licensee will pay to Licensor
a
royalty on Net Sales of each Licensed Product as follows:
(a) 4%
of the
portion of aggregate Net Sales of such Licensed Product during a calendar year
that is equal to or less than $250,000,000;
(b) 5%
of the
portion of aggregate Net Sales of such Licensed Product during a calendar year
that is greater than $250,000,000 but equal to or less than $500,000,000;
(c) 6%
of the
portion of aggregate Net Sales of such Licensed Product during a calendar year
that is greater than $500,000,000 but equal to or less than $750,000,000; and
(d) 7%
of the
portion of aggregate Net Sales of such Licensed Product during a calendar year
that exceeds $750,000,000.
3.3.2
Royalty
Term.
Licensee’s royalty payment obligations under this Section 3.3 will expire on a
Licensed Product-by-Licensed Product basis and
a
country-by-country basis upon
the
expiration of the period (the “Royalty
Term”)
ending
upon the later of: (a) expiration of the last-to-expire Valid Claim that, but
for the licenses granted in this Agreement, would be infringed by the sale
of
such Licensed Product in
such
country,
and (b)
10 years after the first commercial sale of such Licensed Product by Licensee,
its Affiliates or Sublicensees anywhere
in the world.
3.3.3
Reduction
of Royalty Rate. Upon
expiration of the last Valid
Claim covering
a
particular Licensed Product in a particular country, each of the royalty rates
set forth in Section 3.3.1 will be reduced by 50% for the remainder of the
Royalty Term, resulting in royalty rates of 2%, 2.5%, 3%, and 3.5%, as
applicable.
3.3.4
No
Double Dipping.
For the
avoidance of doubt, Licensee will not be required to make any payments under
Section 3.3 with respect to any unit of Licensed Product for which Licensee
has
an obligation to make payments under Section 3.4.2.
|
3.4
|
Sublicense
Revenues.
|
3.4.1
Subject
to the terms and conditions of this Agreement, Licensee will pay to Licensor
25%
of Sublicense Revenues received by Licensee pursuant to any Sublicense
Agreement.
3.4.2
Subject
to the terms and conditions of this Agreement, Licensee will pay to Licensor
a
share of Sublicense Royalty Revenues received by Licensee, as
follows:
(a) 15%
of
all Sublicense Royalty Revenues, until such time as the Aggregate Discount
Amount (as defined in Section 3.4.3 below) reaches an amount equal to three
(3)
times the Net Expenditures;
(b) beginning
in the first full month after the Aggregate Discount Amount reaches an amount
equal to three (3) times the Net Expenditures:
(i) 25%
on
Sublicense Royalty Revenues corresponding to that portion of aggregate net
sales
of Licensed Products by a Sublicensee during a calendar year that is less than
or equal $500,000,000; and
(ii) 33%
on
Sublicense Royalty Revenues corresponding to that portion of aggregate net
sales
of Licensed Products by a Sublicensee during a calendar year that exceeds
$500,000,000.
3.4.3
For
purposes of this Section 3.4, the “Aggregate Discount Amount” will be equal to
the running total of all Annual Discount Amounts for the Term. For each calendar
year or portion thereof during the Term, the Annual Discount Amount (labeled
as
“X” in the equation below) will be calculated as follows:
X
= (0.1
* A) + (0.18 * B)
A
=
Sublicense Royalty Revenues received by Licensee corresponding to that portion
of aggregate net sales of Licensed Products by all Sublicensees during such
calendar year that is less than or equal $500,000,000
B
=
Sublicense Royalty Revenues corresponding to that portion of aggregate net
sales
of Licensed Products by all Sublicensees during such calendar year that exceeds
$500,000,000
|
3.5
|
Payments.
|
3.5.1
Payment
Timing. Licensee
will make royalty or sublicense payments to Licensor within 45 days of the
last
day of each calendar quarter for which such payments are due under Section
3.3
or 3.4, as the case may be. Each such payment will be accompanied by a written
report showing the cumulative Net Sales, Sublicense Revenues, and Sublicense
Royalty Revenues received by Licensee and its Affiliates during such calendar
quarter and the corresponding payments due under this Agreement. In addition,
in
connection with any payments pursuant to Section 3.4.2(a), Licensee will provide
the amount of Net Expenditures and the Aggregate Discount Amount.
3.5.2
Payment
Method.
All
amounts due hereunder will be paid in US Dollars by check or wire transfer
in
immediately available funds to an account designated by Licensor.
3.5.3
Currency
Conversion. For
any
currency conversion required in connection with any payment hereunder, or in
determining the amount of royalties due, such conversion will be made at the
prevailing commercial rate of exchange for purchasing the currency into which
an
amount is to be converted as published in the Eastern Edition of the
Wall
Street Journal (U.S.
Edition) on the day which is the last business day of the applicable quarterly
period for any payments made pursuant to Sections 3.3 or 3.4. For purposes
of
determining the payment due, the amount of Net Sales, Sublicense Revenues,
or
Sublicense Royalty Revenues, as the case may be, in any foreign currency will
be
computed by converting such amount into US Dollars as provided in this Section
3.5.3.
|
3.6
|
Records;
Audit.
|
3.6.1
Records
Retention.
Licensee
will maintain complete and accurate books, records and accounts in sufficient
detail to confirm the accuracy of any payments required hereunder, which books,
records and accounts will be retained by Licensee until three years after the
end of the period to which such books, records and accounts
pertain.
3.6.2
Audit.
Licensor
will have the right to have an independent certified public accounting firm
of
internationally recognized standing, reasonably acceptable to Licensee, to
have
access during normal business hours, and upon reasonable prior written notice,
to such of the records of Licensee as may be reasonably necessary to verify
the
accuracy of information needed to calculate payments required hereunder
(“Payment
Information”)
for
any calendar quarter ending not more than 36 months prior to the date of such
request; provided,
however,
that
Licensor will not have the right to conduct more than one such audit in any
12-month period. The accounting firm will disclose to Licensee and Licensor
whether such Payment Information is correct or incorrect and the specific
details concerning any discrepancies. Licensor will bear all costs of any such
audit.
3.6.3 Payment
of Additional Amounts.
If,
based on the results of any audit, additional payments are owed to Licensor
under this Agreement, Licensee will make such additional payments promptly
after
the accounting firm’s written report is delivered to both Parties and Licensee
will, in addition, reimburse Licensor’s expenses for conducting the audit if the
amount of the underpayment exceeds 5% of the total payment actually due. If,
based on the results of any audit, payments made pursuant to this Agreement
exceeded payments indicated by the audit as being due hereunder, such excess
will be credited against future amounts owed by Licensee under this Agreement.
3.6.4
Confidentiality.
Licensor
will treat all information subject to review under this Section 3.6 in
accordance with the confidentiality provisions of Section 6 and will cause
its
accounting firm to enter into a confidentiality agreement with Licensee
obligating such firm to maintain all such financial information in confidence
pursuant to such confidentiality agreement.
|
4.
|
Intellectual
Property Rights
|
|
4.1
|
Filing,
Prosecution and Maintenance of Licensed Patents.
|
4.1.1 Licensee
will be responsible for the filing and prosecution of the Licensed Patents,
and
for the maintenance of the Licensed Patents,
through
patent counsel of its choice.
4.1.2
The
costs
and expenses incurred by Licensee in connection with the filing, prosecution
and
maintenance of any Licensed Patent will be borne by Licensee.
4.1.3
Notwithstanding
anything in this Agreement, if Licensee wishes to discontinue the payment of
filing, prosecution or maintenance costs with respect to a particular Licensed
Patent, it will inform Licensor thereof in writing with 30 days prior notice,
and any Licensed Patents with respect to which Licensee has discontinued the
payment of such costs will be excluded from the licenses granted under this
Agreement, and will no longer be considered Licensed Patents as that term is
used in this Agreement.
4.2
Right
to Defend Infringement Claims.
If
the
manufacture, sale or use of a Licensed Product pursuant to this Agreement
results in, or may result in, any claim, suit, or proceeding by a Third Party
alleging patent infringement by Licensee (or its Affiliates or Sublicensees),
Licensee will promptly notify Licensor thereof in writing. Licensee or its
Affiliates or Sublicensees will have the exclusive right to defend and control
the defense of any such claim, suit or proceeding at its own expense (subject
to
Section Section 8.1), using counsel of its own choice;
provided, however, that
Licensee and its Affiliates and Sublicensees will not enter into any settlement
which admits or concedes that any aspect of Licensed Patents are invalid or
unenforceable without the prior written consent of Licensor. Licensee will
keep
Licensor reasonably informed of all material developments in connection with
any
such claim, suit, or proceeding. Licensee agrees to provide Licensor with copies
of all pleadings filed in such action and to allow Licensor reasonable
opportunity to participate in the defense of the claims.
|
4.3
|
Enforcement
of Licensed Patents.
|
4.3.1
Initiation.
Licensee
and Licensor will each promptly notify the other in writing of any alleged
or
threatened infringement of any Licensed Patent by a Third Party. Licensor and
Licensee will then confer and may agree jointly to prosecute any such
infringement. If the Parties do not agree on whether or how to proceed with
enforcement activity (i) within 60 days following the detection of the of
alleged infringement, or (ii) 10 business days before the time limit, if any,
set forth in appropriate laws and regulations for filing of such actions,
whichever comes first, then, Licensor may commence litigation with respect
to
the alleged or threatened infringement at its own expense. In the event that
Licensor does not commence litigation within five business days of the
above-specified date, Licensee may do so, at Licensee’s expense.
4.3.2
Cooperation.
In
the
event a Party brings an infringement action, the other Party will cooperate
fully, including, if required to bring such action, the furnishing of a power
of
attorney or to join such action as a necessary party. If Licensee commences
litigation under this Section 4.3, it will receive a credit for one-half (50%)
of its reasonable and documented expenses of commencing and prosecuting said
litigation against payments due Licensor under Section 3 hereof. If Licensor
commences litigation under this Section 4.3 it will invoice Licensee quarterly
for one-half (50%) of its reasonable and documented expenses of commencing
and
prosecuting said litigation through each calendar quarter, and Licensee will
promptly pay said invoices. Neither Party will have the right to settle any
patent infringement litigation under this Section 4.3 in a manner that
diminishes the rights or interest of the other Party without the express written
consent of such other Party. The Party commencing the litigation will provide
the other Party with copies of all pleadings/documents filed with the court
and
will consider reasonable input from the other Party during the course of the
proceedings.
4.3.3
Recovery.
Except
as
otherwise agreed by the Parties as a cost sharing arrangement, any recovery
realized as a result of such litigation described in Section 4.3.1 (whether
by
way of settlement or otherwise) will be first allocated to reimbursement of
unreimbursed legal fees and expenses incurred by the Party initiating the
proceeding, then toward reimbursement of any of unreimbursed legal fees and
expenses of the other Party, then, if applicable, toward reimbursement of the
other Party for the amount of any credits taken by the Party initiating the
proceeding as permitted above, and then the remainder will be divided between
the Parties as follows: (i) if the award is based on lost profits, Licensee
will
receive the amount equal to the damages the court determines that Licensee
has
suffered as a result of the infringement less the amount of any royalties and
other payments that would have been due to Licensor on sales of Licensed
Products lost by Licensee as a result of the infringement had Licensee made
such
sales, and Licensor will receive an amount equal to the royalties and other
payments they would have received under Section 3 hereof if such sales had
been
made by Licensee; and (ii) as to awards other than those based on lost profits,
60% to the Party initiating such proceeding, and 40% to the other Party.
4.4
Patent
Term Extension and Supplementary Protection Certificate.
Upon
receiving Marketing Approval for a Licensed Product, the Parties agree to
coordinate the application for any patent term extension or supplementary
protection certificates that may be available in any country. The primary
responsibility of applying for any extension or supplementary protection
certificate will be the Party having the right to make the application under
the
applicable law. The Party responsible for filing the application will keep
the
other Party fully informed of its efforts to obtain such extension or
supplementary protection certificate. Each Party will provide prompt and
reasonable assistance, without additional compensation, to obtain such patent
extension or supplementary protection certificate. The Party filing such request
will pay all expenses in regard to obtaining the extension or supplementary
protection certificate.
|
5.
|
Representation
and Warranties; Covenants
|
5.1
Representations
of Licensor.
Licensor represents to Licensee that: (i) Licensor is the sole and exclusive
owner of, and has good and valid title to the Licensed Technology, free and
clear of any encumbrance, lien, mortgage, charge, restriction or liability,
whether equitable or legal, that would conflict with or impair the rights
granted to Licensee under this Agreement; (ii) to the best of Licensor’s
knowledge, practice of the inventions claimed in the Licensed Patents is not
infringing any Patent of a Third Party, and the Licensed Patents are not being
infringed by any Third Party; (iii) as of the Effective Date, all registration,
maintenance and renewal fees in connection with each Licensed Patent have been
paid; (iv) as of the Effective Date, Licensor has not, and during the term
of
this Agreement will not, grant any right to any Third Party relating to the
Licensed Technology that would conflict with or erode the rights granted to
Licensee under this Agreement; (v) as of the Effective Date, Licensor has not
received any statement or assertion that any claim in any of the Licensed
Patents is, or may be or become rendered, invalid or unenforceable; (vi)
Licensor has not been served with and has not received any notice of any
threatened complaint, claim, judgment or settlement relating to the breach
by
Licensor of any license agreement with any Third Party necessary to Control
the
Licensed Patents licensed under this Agreement; (vii) Licensor has not been
served with or received any notice of any threatened interference actions or
oppositions to any Patents within the Licensed Patents or other litigation
before any patent office, court, or any other governmental entity in any
jurisdiction in regard to the Licensed Patents; and (viii) it has not been
served with any complaint alleging infringement of a Third Party’s patents
arising from the practice of the claims in the Patents within the Licensed
Patents.
5.2
Reciprocal
Representations and Warranties.
Each
Party represents and warrants to the other Party that: (i) this Agreement is
a
legal and valid obligation binding upon its execution and enforceable against
it
in accordance with its terms and conditions; and (ii) the execution, delivery
and performance of this Agreement by such Party has been duly authorized by
all
necessary corporate action, and the person executing this Agreement on behalf
of
such Party has been duly authorized to do so by all requisite corporate
actions.
5.3
DISCLAIMER
OF WARRANTY.
EXCEPT
FOR THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 5.1 AND 5.2, EACH PARTY MAKES
NO REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN
FACT
OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND LICENSOR AND LICENSEE
EACH
SPECIFICALLY DISCLAIM ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS
OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY OR MERCHANTABILITY.
|
6.
|
Confidentiality
|
6.1
Definition.
During
the Term and subject to the terms and conditions of this Agreement, a Party
(a
“Disclosing
Party”)
may
communicate to another Party (a “Receiving
Party”)
information in connection with this Agreement or the performance of its
obligations hereunder, including, without limitation, certain scientific and
manufacturing information and plans, marketing and business plans, and financial
and personnel matters relating to a Party or its present or future products,
sales, suppliers, customers, employees, investors or business (collectively,
“Confidential
Information”).
Without limiting the foregoing, “Confidential Information” is hereby deemed to
include any and all information disclosed by one Party to the other Party
pursuant to any confidentiality agreement between the Parties executed prior
to
the Effective Date.
6.2
Exclusions.
Notwithstanding
the foregoing, information of a Disclosing Party will not be deemed Confidential
Information with respect to a Receiving Party for purposes of this Agreement
if
such information:
(a) was
already known to the Receiving Party or its Affiliates, other than under an
obligation of confidentiality or non-use, at the time of disclosure to the
Receiving Party;
(b) was
generally available or known to parties reasonably skilled in the field to
which
such information or know-how pertains, or was otherwise part of the public
domain, at the time of its disclosure to the Receiving Party;
(c) became
generally available or known to parties reasonably skilled in the field to
which
such information or know-how pertains, or otherwise became part of the public
domain, after its disclosure to the Receiving Party through no fault of or
breach of its obligations under this Section 6 by the Receiving
Party;
(d) was
disclosed to the Receiving Party other than under an obligation of
confidentiality or non-use, by a Third Party who had no obligation to the Party
that Controls such information and know-how not to disclose such information
or
know-how to others; or
(e) was
independently discovered or developed by the Receiving Party or its Affiliates,
as evidenced by their written records, without the use of, and by personnel
who
had no access to, Confidential Information belonging to the Party that Controls
such information and know-how.
6.3
Disclosure
and Use Restriction.
Except
as expressly provided herein, the Parties agree that, during the Term and for
five years thereafter, a Receiving Party and its Affiliates and sublicensees
will keep completely
confidential and will not publish or otherwise disclose and will not use for
any
purpose except for the purposes contemplated by this Agreement any Confidential
Information of a Disclosing Party, its Affiliates or sublicensees.
6.4
Authorized
Disclosure.
A
Receiving Party may disclose Confidential Information of a Disclosing Party
to
the extent that such disclosure is:
6.4.1
made
in
response to a valid order of a court of competent jurisdiction or other
governmental or regulatory body of competent jurisdiction; provided,
however,
that
such Receiving Party will first have given notice to the Disclosing Party and
given the Disclosing Party a reasonable opportunity to quash such order and
to
obtain a protective order requiring that the Confidential Information and
documents that are the subject of such order be held in confidence by such
court
or governmental or regulatory body or, if disclosed, be used only for the
purposes for which the order was issued; and provided,
further
that
if a
disclosure order is not quashed or a protective order is not obtained, the
Confidential Information disclosed in response to such court or governmental
order will be limited to that information which is legally required to be
disclosed in response to such court or governmental order;
6.4.2 otherwise
required by law; provided,
however,
that
the Disclosing Party will provide the Receiving Party with notice of such
disclosure in advance thereof to the extent practicable;
6.4.3
made
by
such Party to the regulatory authorities as required in connection with any
filing of an IND or an application for Marketing Approval, or similar
applications or requests; provided,
however,
that
reasonable measures will be taken to assure confidential treatment of such
information;
6.4.4
made
by a
Receiving Party, in connection with the performance of this Agreement, to
Affiliates, employees, consultants, representatives or agents, each of whom
prior to disclosure must be bound by obligations of confidentiality and non-use
at least equivalent in scope to those set forth in this Section 6;
6.4.5
made
by a
Receiving Party to existing or potential acquirers or merger candidates;
potential sublicensees or collaborators (to the extent contemplated hereunder);
investment bankers; existing or potential investors, venture capital firms
or
other financial institutions or investors for purposes of obtaining financing;
or Affiliates, each of whom prior to disclosure must be bound by obligations
of
confidentiality and non-use at least equivalent in scope to those set forth
in
this Section 6;
6.4.6
made
by
the Receiving Party with the prior written consent of the Disclosing
Party.
6.5
Use
of Name.
Neither
Party may make public use of the other Party's name except (a) in connection
with announcements and other permitted disclosures relating to this Agreement
and the activities contemplated hereby, (b) as required by applicable law,
and
(c) otherwise as agreed in writing by such other Party.
|
6.6
|
Press
Releases.
|
6.6.1
Licensee
may make a press release regarding the execution of this Agreement, the final
form of which will be submitted to Licensor for review and comment not less
than
five full business days prior to its release to the public. For subsequent
press
releases and other written public disclosures relating to this Agreement or
the
Parties’ relationship hereunder (each, a “Proposed
Disclosure”),
each
Party will use reasonable efforts to submit to the other Party a draft of such
Proposed Disclosures for review and comment by the other Party at least five
full business days prior to the date on which such Party plans to release such
Proposed Disclosure, and in any event will submit such drafts at least 24 hours
prior to the release of such Proposed Disclosure, and will review and consider
in good faith any comments provided in response.
6.6.2
If
a
Party is unable to comply with the foregoing 24-hour notice requirement because
of a legal obligation or stock exchange requirement to make more rapid
disclosure, such Party will not be in breach of this Agreement but will in
that
case give telephone notice to a senior executive of the other Party and provide
a draft disclosure with as much notice as possible prior to the release of
such
Proposed Disclosure.
6.6.3 A
Party
may publicly disclose without regard to the preceding requirements of this
Section 6.6 information that was previously disclosed in a Proposed Disclosure
that was in compliance with such requirements.
6.7
Terms
of Agreement to be Maintained in Confidence. Subject
to the provisions of this Section 6, including the exception for any public
disclosures made in compliance with the terms of Section 6.6, the Parties agree
that the terms of this Agreement are confidential and will not be disclosed
by
either Party to any Third Party (except to a Party's professional advisor)
without prior written permission of the other Party; provided,
however,
that
either Party may make any filings of this Agreement required by law or
regulation in any country so long as such Party uses its reasonable efforts
to
obtain confidential treatment for portions of this Agreement as available,
consults with the other Party, and permits the other Party to participate,
to
the extent practicable, in seeking a protective order or other confidential
treatment; and provided,
further,
that
either Party may disclose the terms of this Agreement to a Third Party (and
its
professional advisors) when such disclosure is reasonably necessary in
connection with (i) the grant of a license or sublicense of the Licensed Patents
to such Third Party, (ii) a merger, acquisition, placement, investment, or
other
such transaction with such Third Party, or (iii) the sale of securities to
or
other financing from such Third Party or a financing underwritten by such Third
Party, in which case disclosure may be made to any person or entity to whom
such
Third Party sells such securities (and its professional advisors). Prior written
permission for disclosure will not be required when a Party is ordered to
disclose information concerning the Agreement by a competent tribunal or such
disclosures are required by law, regulation, or stock exchange rules, except
that such Party will make all reasonable efforts to limit any disclosure as
may
be required in the course of legal proceedings by entry of an appropriate
protective and confidentiality order, and will provide the other Party with
as
much advance notice of such circumstances as is practicable.
|
7.
|
Term
and Termination
|
7.1
Term.
The
term of this Agreement will commence as of the Effective Date and, unless
earlier terminated in accordance with this Section 7, will expire upon the
expiration of the Royalty Term for all Licensed Products in all countries (the
“Term”).
|
7.2
|
Termination
for Material Breach.
|
7.2.1
Any
material failure by a Party (“Breaching
Party”)
to
comply with any of its material obligations contained in this Agreement (such
failure a “Material
Breach”)
will
entitle the other Party (“Non-Breaching
Party”)
to
give to the Breaching Party written notice specifying the nature of the Material
Breach, requiring the defaulting Party to make good or otherwise cure such
Material Breach.
7.2.2 If
such
Material Breach is not cured within 60 days after the receipt of notice pursuant
to Section 7.2.1 above, the Non-Breaching Party will be entitled to terminate
this Agreement on written notice to the Breaching Party and without prejudice
to
any of its other rights conferred on it by this Agreement; provided,
however,
that if
the Breaching Party disputes the existence of a Material Breach, the matter
will
be submitted for resolution in accordance with Section 10.4, and this Agreement
cannot be terminated by the Non-Breaching Party until a court of competent
jurisdiction in accordance with Section 10.4.3 in a final decision from which
no
further appeal can be taken has found such Material Breach to
exist.
7.3
Termination
at Will. Licensee
may terminate this Agreement in its entirety at any time upon 90 days’ prior
written notice to Licensor. Licensor may terminate this Agreement in its
entirety, upon written notice to Licensee effective immediately, (i) if Licensee
is declared bankrupt by a court of competent jurisdiction, (ii) if a voluntary
or involuntary petition in bankruptcy is filed in any court of competent
jurisdiction against Licensee and such petition is not dismissed within ninety
(90) days after filing, or (iii) if Licensee makes or executes an assignment
of
substantially all of its assets for the benefit of creditors.
|
7.4
|
Consequences
of Expiration and
Termination.
|
7.4.1
Expiration.
Upon
expiration of the Term pursuant to Section 7.1, Licensee will have an
exclusive, irrevocable, perpetual, worldwide, fully-paid license, with the
right
to sublicense through multiple tiers of sublicenses, under
the
Licensed Technology to research, develop, make, use, sell, offer for sale,
and
import Licensed Products in the Field.
7.4.2
Early
Termination. Upon
termination of this Agreement pursuant to Sections 7.2 or 7.3, all licenses
granted by Licensor to Licensee under this Agreement will terminate;
provided,
however,
that in
such event, Licensee may sell all Licensed Products then in its inventory,
subject to the payment of the royalties set forth in Section 3.3 of this
Agreement.
7.4.3
Survival
of Certain Sublicenses.
Sublicenses granted by Licensee will survive termination of Licensee's license
hereunder, provided that (a) such Affiliate or Sublicensee is not the cause
of
the default, (b) such Affiliate or Sublicensee is not in breach of, and
continues to fully perform all obligations under, its sublicense agreement,
and
(c) Licensor continues to receive from such Affiliate or Sublicensee all
payments set forth in Section 3 due on account of Sublicense Revenues generated
by such Affiliate.
7.4.4
Survival.
Expiration or termination of this Agreement will not relieve the Parties of
any
obligation accruing prior to such expiration or termination. The provisions
of
Sections 5.3, 6, 7.4, 8, 9, and 10 will survive any termination or expiration
of
this Agreement.
|
8.
|
Indemnification
and Insurance
|
8.1
Indemnification
by Licensor. Licensor
will indemnify Licensee, its Affiliates, sublicensees, and their respective
directors, officers, employees and agents, and defend and hold each of them
harmless, from and against any and all losses, damages, liabilities, costs
and
expenses (including reasonable attorneys’ fees and expenses) (collectively,
“Losses”)
in
connection with any and all liability suits, investigations, claims or demands
by Third Parties (“Third
Party Claims”)
to the
extent arising from or occurring as a result of or in connection any breach
by
Licensor of its representations, warranties or obligations under this Agreement,
except to the extent that such Losses arise out of or result from (i) the
negligence or willful misconduct of a party seeking indemnification hereunder,
or (ii) a breach by a party seeking indemnification hereunder of any
provision of this Agreement.
8.2
Indemnification
By Licensee. Licensee
will indemnify Licensor, its Affiliates, and their respective directors,
officers, employees and agents, and defend and save each of them harmless,
from
and against any and all Losses in connection with any and all Third Party Claims
arising out of any theory of product liability (including, but not limited
to,
actions in the form of tort, warranty or strict liability) concerning a Licensed
Product that is developed or commercialized by Licensee, its Affiliates or
sublicensees pursuant to any right or license granted under this Agreement,
except to the extent that such Losses arise out of or result from (i) the
negligence or willful misconduct of a party seeking indemnification hereunder,
or (ii) a breach by a party seeking indemnification hereunder of any provision
of this Agreement.
|
8.3
|
Indemnification
Procedure.
|
8.3.1
Notice
of Claim.
The
indemnified Party will give the indemnifying Party (the “Indemnifying
Party”)
prompt
written notice (an “Indemnification
Claim Notice”)
of any
Losses or discovery of fact upon which such Indemnified Party intends to base
a
request for indemnification under Section 8.1 or Section 8.2, but in no event
will the Indemnifying Party be liable for any Losses that result from any delay
in providing such notice. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to the extent
that the nature and amount of such Loss are known at such time). The indemnified
Party will furnish promptly to the indemnifying Party copies of all papers
and
official documents received in respect of any Losses. All indemnification claims
in respect of a Party, its Affiliates or their respective directors, officers,
employees and agents (collectively, the “Indemnitees”
and
each an “Indemnitee”)
will
be made solely by such Party to this Agreement (the “Indemnified Party”).
8.3.2
Control
of Defense.
At its
option, the Indemnifying Party may assume the defense of any Third Party Claim
by giving written notice to the Indemnified Party within 30 days after the
Indemnifying Party’s receipt of an Indemnification Claim Notice. Upon assuming
the defense of a Third Party Claim, the Indemnifying Party may appoint as lead
counsel in the defense of the Third Party Claim any legal counsel selected
by
the Indemnifying Party. In the event the Indemnifying Party assumes the defense
of a Third Party Claim, the Indemnified Party will immediately deliver to the
Indemnifying Party all original notices and documents (including court papers)
received by any Indemnitee in connection with the Third Party Claim. Should
the
Indemnifying Party assume the defense of a Third Party Claim, the Indemnifying
Party will not be liable to the Indemnified Party or any other Indemnitee for
any legal expenses subsequently incurred by such Indemnified Party or other
Indemnitee in connection with the analysis, defense or settlement of the Third
Party Claim.
8.3.3
Right
to Participate in Defense.
Without
limiting Section 8.3.2 above, any Indemnitee will be entitled to participate
in,
but not control, the defense of such Third Party Claim and to employ counsel
of
its choice for such purpose; provided,
however,
that
such employment will be at the Indemnitee’s own expense unless (i) the
employment thereof has been specifically authorized by the Indemnifying Party
in
writing, or (ii) the Indemnifying Party has failed to assume the defense and
employ counsel in accordance with Section 8.3.2 (in which case the Indemnified
Party will control the defense).
8.3.4
Settlement.
With
respect to any Losses relating solely to the payment of money damages in
connection with a Third Party Claim and that will not result in the Indemnitee’s
becoming subject to injunctive or other relief or otherwise adversely affect
the
business of the Indemnitee in any manner, and as to which the Indemnifying
Party
will have acknowledged in writing the obligation to indemnify the Indemnitee
hereunder, the Indemnifying Party will have the sole right to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of such
Loss, on such terms as the Indemnifying Party, in its sole discretion, will
deem
appropriate, and will transfer to the Indemnified Party all amounts which said
Indemnified Party will be liable to pay prior to the time prior to the entry
of
judgment. With respect to all other Losses in connection with Third Party
Claims, where the Indemnifying Party has assumed the defense of the Third Party
Claim in accordance with Section 8.3.2, the Indemnifying Party will have
authority to consent to the entry of any judgment, enter into any settlement
or
otherwise dispose of such Loss provided it obtains the prior written consent
of
the Indemnified Party (which consent will be at the Indemnified Party’s sole and
absolute discretion). The Indemnifying Party will not be liable for any
settlement or other disposition of a Loss by an Indemnitee that is reached
without the written consent of the Indemnifying Party. Regardless of whether
the
Indemnifying Party chooses to defend or prosecute any Third Party Claim, no
Indemnitee will admit any liability with respect to, or settle, compromise
or
discharge, any Third Party Claim without the prior written consent of the
Indemnifying Party.
8.3.5
Cooperation.
The
Indemnified Party will, and will cause each other Indemnitee to, cooperate
in
the defense or prosecution thereof and will furnish such records, information
and testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals as may be reasonably requested in
connection with the defense or prosecution of any Third Party Claim. Such
cooperation will include access during normal business hours afforded to the
Indemnifying Party to, and reasonable retention by the Indemnified Party of,
records and information that are reasonably relevant to such Third Party Claim,
and making Indemnitees and other employees and agents available on a mutually
convenient basis to provide additional information and explanation of any
material provided hereunder, and the Indemnifying Party will reimburse the
Indemnified Party for all its reasonable out-of-pocket expenses in connection
therewith.
8.4
Expenses.
Except
as provided above, the reasonable and verifiable costs and expenses, including
fees and disbursements of counsel, incurred by the Indemnified Party in
connection with any claim will be reimbursed on a calendar quarter basis by
the
Indemnifying Party, without prejudice to the Indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and subject to refund
in the event the Indemnifying Party is ultimately held not to be obligated
to
indemnify the Indemnified Party.
8.5
Insurance.
Each
Party will have and maintain such types and amounts of liability insurance
as is
normal and customary in the industry generally for parties similarly situated,
and will upon request provide the other Party with a copy of its policies of
insurance in that regard, along with any amendments and revisions
thereto.
|
9.
|
Limitation
of Liability
|
IN
NO
EVENT WILL EITHER PARTY BE LIABLE FOR LOST PROFITS, LOSS OF DATA, OR FOR ANY
SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER
CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION
AND ARISING IN ANY WAY OUT OF THIS AGREEMENT. THE FOREGOING LIMITATIONS WILL
NOT
APPLY TO AN AWARD OF ENHANCED DAMAGES AVAILABLE UNDER THE PATENT LAWS FOR
WILLFUL PATENT INFRINGEMENT AND WILL NOT LIMIT EITHER PARTY'S OBLIGATIONS TO
THE
OTHER PARTY UNDER SECTIONS 6 AND 8 OF THIS AGREEMENT.
|
10.
|
Miscellaneous
|
|
10.1
|
Rights
in Bankruptcy; Change of Control.
|
10.1.1
All
rights and licenses granted under or pursuant to this Agreement by Licensor
to
Licensee are, and will otherwise be deemed to be, for purposes of Section 365(n)
of the United States Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101 of the United States Bankruptcy Code. The
Parties agree that Licensee, its Affiliates and sublicensees, as the licensee
or
sublicensees of such rights under this Agreement, will retain and may fully
exercise all of their rights and elections under the United States Bankruptcy
Code. The Parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against Licensor under the United States Bankruptcy
Code, Licensee will be entitled to a complete duplicate of (or complete access
to, as appropriate) any such intellectual property and all embodiments of such
intellectual property, which, if not already in Licensee’s possession, will be
promptly delivered to it (a) upon any such commencement of a bankruptcy
proceeding upon Licensee’s written request therefor, unless Licensor subject to
such proceeding continues to perform all of its obligations under this
Agreement, or (b) if not delivered under clause (a) above, following the
rejection of this Agreement by or on behalf of Licensor upon written request
therefor by Licensee.
10.1.2
In
the
event of a Change of Control of Licensor, Licensor will provide written notice
to Licensee promptly following such Change of Control. As used in this Section
10.1.2, “Change of Control” means (a) a sale, lease, license or other
disposition of all or substantially all of the assets of a Party; (b) any
consolidation or merger of a Party with or into any other corporation or other
entity or person, or any other corporate reorganization, in which the capital
stock of a Party immediately prior to such consolidation, merger or
reorganization, represents less than 50% of the voting power of the surviving
entity (or, if the surviving entity is a wholly owned subsidiary, its parent)
immediately after such consolidation, merger or reorganization; or (c) any
transaction or series of related transactions to which a Party is a party in
which in excess of fifty percent (50%) of a Party’s voting power is transferred;
provided,
that a
Change of Control will not include (i) any consolidation or merger effected
exclusively to change the domicile of a Party, or (ii) any transaction or series
of transactions principally for bona fide equity financing purposes in which
cash is received by a Party or any successor, or indebtedness of such Party
is
cancelled or converted, or a combination thereof.
10.2
Assignment.
Neither
Party will sell, transfer, assign, delegate, pledge or otherwise dispose of,
whether voluntarily, involuntarily, by operation of law or otherwise, this
Agreement or any of its rights or duties under this Agreement; provided,
however,
that
either Party may assign or transfer this Agreement or any of its rights or
obligations under this Agreement to an Affiliate and to any Third Party with
which it merges or consolidates, or to which it transfers all or substantially
all of its assets to which this Agreement relates;
and
provided, further,
that the
relevant assignee or surviving entity assumes in writing all of the assigning
Party’s obligations under this Agreement. The assigning Party (except if it is
not the surviving entity) will remain jointly and severally liable with the
relevant Third Party assignee under this Agreement. Any purported assignment
or
transfer in violation of this Section 10.2 will be void ab
initio
and of
no force or effect.
10.3
Severability.
If any
provision of this Agreement is held to be illegal, invalid or unenforceable
under any present or future law, and if the rights or obligations of either
Party under this Agreement will not be materially and adversely affected
thereby, (a) such provision will be fully severable, (b) this Agreement will
be
construed and enforced as if such illegal, invalid or unenforceable provision
had never comprised a part hereof, (c) the remaining provisions of this
Agreement will remain in full force and effect and will not be affected by
the
illegal, invalid or unenforceable provision or by its severance herefrom, and
(d) in lieu of such illegal, invalid or unenforceable provision, there will
be
added automatically as a part of this Agreement a legal, valid and enforceable
provision as similar in terms to such illegal, invalid or unenforceable
provision as may be possible and reasonably acceptable to the Parties herein.
To
the fullest extent permitted by applicable law, each Party hereby waives any
provision of law that would render any provision prohibited or unenforceable
in
any respect.
|
10.4
|
Governing
Law; Dispute Resolution.
|
10.4.1
This
Agreement, all disputes between the Parties related to or arising out of this
Agreement, the Parties’ relationship created hereby, and/or the negotiations for
and entry into this Agreement, including any dispute concerning its conclusion,
binding effect, amendment, coverage, or termination, will be governed by the
laws of the State of New York without reference to any choice of law principles
thereof that would cause the application of the laws of a different
jurisdiction.
10.4.2
The
Parties will try to settle their differences amicably between themselves. In
the
event of any controversy or claim arising out of or relating to any provision
of
this Agreement or the performance or alleged non-performance of a Party of
its
obligations under this Agreement (“Dispute”),
a
Party may notify the other Party in writing of such Dispute. If the Parties
are
unable to resolve the Dispute within 20 days of receipt of the written notice
by
the other Party, such dispute will be referred to the Chief Executive Officers
of each of the Parties (or their respective designees) who will use their good
faith efforts to resolve the Dispute within 30 days after it was referred to
the
Chief Executive Officers. Notwithstanding the foregoing, no Dispute relating
to
Section 6 will be subject to this Section 10.4.2. In addition, nothing in this
Section 10.4 will limit either Party’s right to seek immediate injunctive or
other equitable relief whenever the facts or circumstances would permit a Party
to seek such relief in a court of competent jurisdiction.
10.4.3
Any
Dispute that is not resolved as provided in Section 10.4.2, whether before
or
after termination of this Agreement, will be resolved by litigation in the
courts of competent jurisdiction located in New York, New York. Each Party
hereby agrees to such jurisdiction and waives any objections as to the personal
jurisdiction or venue of such courts.
10.5
Notices.
All
notices or other communications that are required or permitted hereunder will
be
in writing and delivered personally, sent by facsimile (and promptly confirmed
by personal delivery or overnight courier as provided herein), or sent by
internationally-recognized overnight courier addressed as follows:
If
to
Licensor, to:
Revaax
Pharmaceuticals LLC
X.X.
Xxx
00000
Xxxxxxxxxxxx,
XX 00000
Attention:
Chief Executive Officer
Facsimile:
__________________
If
to
Licensee, to:
Rexahn
Corporation
0000
Xxxxxxx Xxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx,
XX 00000
Attention:
Chief Business Officer
Facsimile:
000-000-0000
or
to
such other address as the Party to whom notice is to be given may have furnished
to the other Party in writing in accordance herewith. Any such communication
will be deemed to have been given (i) when delivered, if personally delivered
or
sent by facsimile on a business day, and (ii) on the second business day after
dispatch, if sent by internationally-recognized overnight courier. It is
understood and agreed that this Section 10.5 is not intended to govern the
day-to-day business communications necessary between the Parties in performing
their duties, in due course, under the terms of this Agreement.
10.6
Entire
Agreement; Modifications. This
Agreement sets forth and constitutes the entire agreement and understanding
between the Parties with respect to the subject matter hereof and all prior
agreements, understanding, promises and representations, whether written or
oral, with respect thereto. Each Party confirms that it is not relying on any
representations or warranties of the other Party except as specifically set
forth herein. No amendment or modification of this Agreement will be binding
upon the Parties unless in writing and duly executed by authorized
representatives of both Parties.
10.7
Relationship
of the Parties. It
is
expressly agreed that the Parties' relationship under this Agreement is strictly
one of licensor-licensee, and that this Agreement does not create or constitute
a partnership, joint venture, or agency. Neither
Party will have the authority to make any statements, representations or
commitments of any kind, or to take any action, which will be binding (or
purport to be binding) on the other. All persons employed by a Party will be
employees of such Party and not of the other Party and all costs and obligations
incurred by reason of any such employment will be for the account and expense
of
such Party.
10.8
Waiver.
Any term
or condition of this Agreement may be waived at any time by the Party that
is
entitled to the benefit thereof, but no such waiver will be effective unless
set
forth in a written instrument duly executed by or on behalf of the Party waiving
such term or condition. The waiver by either Party hereto of any right hereunder
or of claims based on the failure to perform or a breach by the other Party
will
not be deemed a waiver of any other right hereunder or of any other breach
or
failure by said other Party whether of a similar nature or
otherwise.
10.9
Counterparts.
This
Agreement may be executed in two or more counterparts, each of which will be
deemed an original, but all of which together will constitute one and the same
instrument.
10.0
No
Benefit to Third Parties.
The
representations, warranties, covenants and agreements set forth in this
Agreement are for the sole benefit of the Parties hereto and their successors
and permitted assigns, and they will not be construed as conferring any rights
on any other parties.
10.11
Further
Assurance.
Each
Party will duly execute and deliver, or cause to be duly executed and delivered,
such further instruments and do and cause to be done such further acts and
things, including the filing of such assignments, agreements, documents and
instruments, as may be necessary or as the other Party may reasonably request
in
connection with this Agreement or to carry out more effectively the provisions
and purposes, or to better assure and confirm unto such other Party its rights
and remedies under this Agreement.
10.12
Construction.
Except
where the context otherwise requires, wherever used, the singular will include
the plural, the plural the singular, and the use of any gender will be
applicable to all genders. Unless used in combination with the word “either,”
the word “or” is used throughout this Agreement in the inclusive sense (and/or).
Unless expressly provided otherwise, references to Sections are references
to
Sections of this Agreement. The captions of this Agreement are for convenience
of reference only and in no way define, describe, extend or limit the scope
or
intent of this Agreement or the intent of any provision contained in this
Agreement. The term “including” as used in this Agreement will mean including,
without limiting the generality of any description preceding such term.
No
rule
of strict construction will be applied against either Party.
[Remainder
of page intentionally left blank. Signature page follows.]
In
Witness Whereof,
the
Parties have executed this License Agreement by their respective authorized
representatives as of the date first written above.
|
Revaax
Pharmaceuticals LLC
|
|
|
By:
|
/s/
Xxxx Xxxxxx
|
|
Name:
|
Xxxx
Xxxxxx
|
|
Title:
|
Vice
President
|
|
Rexahn
Corporation
|
|
|
By:
|
/s/
Xxxxxx X. Xxxxxxxxx
|
|
Name:
|
Xxxxxx
X. Xxxxxxxxx
|
|
Title:
|
Chief
Business Officer
|
Attachments:
Exhibit A
Exhibit
A
|
Issued
Patents
|
Issue
Date
|
Title
|
|
US
No. 6,426,342
|
30-Jul-2002
|
Use
Of Β-Lactamase Inhibitors As Neuroprotectants
|
|
US
No. 6,627,625
|
30-Sep-2003
|
Neurotherapeutic
Composition And Method
|
|
US
No. 6,610,681
|
26-Aug-2003
|
Neurotherapeutic
Clavulanate Composition And Method
|
|
US
No. 6,489,319
|
03-Dec-2002
|
Neurotherapeutic
Use Of Carboxypeptidase Inhibitors
|
|
NZ
No. 517662
|
29-Mar-2004
|
Neurotherapeutic
Formulations
|
|
Pending
Patent
|
Filing
Date
|
Title
|
|
US-
10/658667
|
09-Sep-2003
|
Neurotherapeutic
Compositions And Method
|
|
EP
- 00955580.6
|
16-Aug-2000
|
Pharmaceutical
Compositions Comprising Clavulanic Acid Or Derivative Thereof For
The
Treatment Of Behavioral Diseases
|
|
CA
-2380820
|
16-Aug-2000
|
Pharmaceutical
Compositions Comprising Clavulanic Acid Or Derivative Thereof For
The
Treatment Of Behavioral Diseases
|
|
AU
- 67763/00
|
16-Aug-2000
|
Pharmaceutical
Compositions Comprising Clavulanic Acid Or Derivative Thereof For
The
Treatment Of Behavioral Diseases
|
|
JP
- 2001-516530
|
16-Aug-2000
|
Neurotherapeutic
Composition And Method
|
|
CA
- 2383522
|
16-Aug-2000
|
Neurotherapeutic
Composition And Method
|
|
EP
- 00959244.5
|
16-Aug-2000
|
Neurotherapeutic
Composition And Method
|
|
MX
-PAa20002001667
|
16-Aug-2000
|
Neurotherapeutic
Composition And Method
|
|
US
- 10/114174
|
02-Apr-2002
|
Neurotherapeutic
Compositions
|
|
XX
- 000000
|
16-Aug-2000
|
Pharmaceutical
Compositions Comprising Clavulanic Acid Or Derivative Thereof For
The
Treatment Of Behavioral Diseases
|
|
US-10/224124
|
20-Aug-2002
|
Neurotherapeutic
Composition And Method Therefor
|
|
US-10/175092
|
18-Jun-2002
|
Therapeutic
Treatment For Sexual Dysfunction
|
|
US-10/620221
|
15-Jul-2003
|
Neurotherapeutic
Clavulanate Composition And Method
|
|
US-10/467185
|
05-Aug-2003
|
Antibiotic
Composition And Method
|
|
PCT
- US2004/027451
|
24-Aug-2004
|
Oral
Neurotherapeutic Cefazolin Compositions
|
