Exhibit
10.6
License Agreement
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
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.
2.1
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).
3.1
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 14 th day after
the Effective Date (the “First Payment Date”), and the
subsequent installments due on the 90 th day, 180
th day, 270 th day, 360 th day,
450 th day, 540 th , and 630 th
day of the First Payment Date.
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.
3.3.1
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.
3.4.1
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
3.5.1
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.
3.6.1
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.
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Intellectual Property Rights
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Filing,
Prosecution and Maintenance of Licensed Patents
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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.
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Enforcement of Licensed
Patents.
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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 d