Exhibit 10.2
[*CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH
PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.]
EXECUTION VERSION
NON-EXCLUSIVE PATENT LICENSE
AGREEMENT
THIS NON-EXCLUSIVE PATENT LICENSE
AGREEMENT (“ Agreement ”), effective as of
February 12, 2009 (“ Effective Date ”) is
by and between, on the one hand, Hoffmann-La Roche Inc. with a
place of business at 340 Kingsland Street, Nutley, New Jersey 07110
and F. Hoffmann-La Roche Ltd with a place of business at
Grenzacherstrasse 124, 4070 Basel, Switzerland (collectively
“ Roche ”) and, on the other hand, MDRNA, Inc.
with a place of business at 3830 Monte Villa Parkway, Bothell,
Washington 98021 (“ MDRNA ”). Roche and MDRNA
are referred to in this Agreement individually as a “
Party ” and collectively as the “ Parties
”.
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I.
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BACKGROUND
OF AGREEMENT
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1.1
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Per a certain
Non-Exclusive License Agreement of [***], a copy of which has been
provided to Roche (the “[***] License Agreement”
), MDRNA controls certain patents and patent applications owned by
[***] (“ [***] ”) relating to siRNA constructs,
including [***].
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1.2
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MDRNA also owns
certain patent rights related to siRNA constructs, including
meroduplex technology, and chemical modifications of nucleic acids,
including unlocked nucleic acid technology (“ UNA
”).
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1.3
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Roche desires
to obtain from MDRNA a non-exclusive license under such patent
rights related to the dicer substrate, meroduplex and unlocked
nucleic acid technology.
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1.4
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MDRNA desires
to grant Roche such non-exclusive license on the terms and
conditions set forth herein.
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NOW THEREFORE, in consideration of
the foregoing premises, the mutual covenants and obligations
hereinafter contained, and other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:
II. DEFINITIONS
As used herein, the following terms
shall have the meanings set forth below:
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(a)
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any entity that
owns directly or indirectly, a Controlling Interest (defined below)
in a Party, by stock ownership or otherwise;
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(b)
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any entity in
which a Party owns a Controlling Interest, by stock ownership or
otherwise, or;
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(c)
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any entity under a common
Controlling Interest (defined below) with a
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1
[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS
TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS
BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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Party, directly or
indirectly.
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For purposes of this Agreement,
[***] (“ [***] ”) and its subsidiaries, and
[***] (“ [***] ”) and its subsidiaries ([***]
and its subsidiaries and [***] and its subsidiaries, each a “
Roche Entity ”), each shall not be deemed an Affiliate
of Roche, unless Roche opts for the inclusion of one or more Roche
Entity by giving written notice to MDRNA.
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2.2
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“
[***] Field ” means the use of a Licensed Product for
the treatment or prevention of disease in humans other than
[***].
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2.3
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“
[***] Patents ” mean Patents that are owned or
Controlled by [***] and licensed to MDRNA pursuant to the [***]
License Agreement.
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2.3
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“
Control ” means, with respect to intellectual
property, the ability to grant sublicenses under such intellectual
property.
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2.4
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“
Controlling Interest ” means the ownership, directly
or indirectly, of more than 50% of voting stock permitted to vote
for the election of the board of directors or any other arrangement
resulting in control of or the right to control the management and
the affairs of the entity or Party in question.
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2.5
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“
Insolvency Event ” shall mean circumstances under
which a Party (i) has a receiver or similar officer appointed
over all or a material part of its assets or undertaking;
(ii) passes a resolution for winding-up (other than a
winding-up for the purpose of, or in connection with, any solvent
amalgamation or reconstruction) or a court makes an order to that
effect or a court makes an order for administration (or any
equivalent order in any jurisdiction); (iii) enters into any
composition or arrangement with its creditors (other than relating
to a solvent restructuring); or (iv) ceases to carry on
business.
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2.6
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“
Licensed Product ” means all products for which the
development, manufacture, use, sale, importation, or offer for sale
of such product is covered by a Valid Claim.
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2.7
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“ Net
Sales ” shall mean the gross amount invoiced by or on
behalf of Roche or a sublicensee of Roche on account of the sale,
use, transfer or other disposition or application of a Licensed
Product to or by a third party, less reasonable, customary and
documented deductions for any of the following:
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(i) rebates, allowances,
charge-backs or discounts (including, without limitation,
contractual discounts and allowances for Medicaid, Medicare,
Medi-Cal, managed care and third party insurance providers and the
like), to the extent actually granted;
(ii) allowances or credits actually
granted to customers on account of recall, rejection or return of
Licensed Products;
(iii) tariffs, duties, excise, sales
and value-added taxes and similar governmental charges actually
paid (except income taxes); and
(iv) to the extent actually paid by
seller, reasonable charges for shipping and
2
[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS
TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS
BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
insuring the shipment of Licensed
Product.
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2.8
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“
Patents ” means (1) the patents and patent
applications identified on Schedule A; (2) the patents and
patent applications covering any modification or improvement to any
inventions and/or technology that is the subject of the patent and
patent applications identified on Schedule A, but solely to the
extent such modification or improvement is (a) owned or
Controlled by MDRNA, and (b) developed, created or reduced to
practice during the period of time beginning on the Effective Date
and ending on the second anniversary thereof; (3) all
divisions, continuations, reissues, re-examinations, and extensions
of the patents and patent applications referred to in (1) and
(2); and (4) all foreign counterparts of (1), (2) and
(3). Schedule A shall be updated from time to time at the written
request of either Party.
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2.9
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“
Royalty Term ” means the period of time commencing on
the Effective Date and ending, on a country-by-country basis, upon
the expiration date of the last to expire of the [***] Patents in
such country.
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2.10
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“
Sublicensee ” means an entity to which Roche or its
Affiliates has licensed rights pursuant to this
Agreement.
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2.11
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“
Territory ” means worldwide.
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2.12
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“
Valid Claim ” shall, as applicable, mean a claim in
any (i) unexpired and issued Patents that have not been
disclaimed, revoked or held invalid by a final nonappealable
decision of a court of competent jurisdiction or government agency
or (ii) pending patent application in the Patents in any
country of the Territory that (a) is on file with the
applicable patent office and has shown evidence of reasonably
consistent activity to advance to issuance of a patent and
(b) which application has been on file with the applicable
patent office for no more than five (5) years from the
earliest date to which the patent application claims it earliest
priority. Notwithstanding the foregoing, with respect to the [***]
Patents, “Valid Claim” means any claim set forth in a
pending patent application or issued patent included in the [***]
Patents which (i) has not expired, been revoked or cancelled,
been declared invalid, unpatentable or unenforceable by a final
decision of a court or other government agency of competent
jurisdiction, from which decision no further appeal or other legal
recourse is possible, (ii) has not been withdrawn, disclaimed,
denied, admitted by the owner or its successor or assigns to be
invalid or unenforceable through reissue, re-examination,
disclaimer or otherwise, and (iii) with respect to any
particular pending patent application in the [***] Patents, has not
been pending in any country for more than [***].
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III.
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LICENSE
GRANT AND OPTION
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3.1
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MDRNA hereby grants to Roche and
its Affiliates in the Territory in the Field an irrevocable, fully
paid-up (other than that with regard to [***] Patents for which
a
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3
[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS
TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS
BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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royalty is due pursuant to
Section 4.3), non-exclusive license (or sublicense with
respect to the [***] Patents), with the right to sublicense (but
solely in connection with a third party collaboration for research,
manufacturing, development or commercialization of a pharmaceutical
product or otherwise in connection with the research,
manufacturing, development or commercialization of a Roche Licensed
Product), under the Patents to develop, make, import, use, offer
for sale or sell Licensed Product. As used herein,
“Field” means the field of therapeutics used in humans,
except that, with respect to the [***] Patents, the
“Field” means the [***] Field.
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3.2
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Notwithstanding
Section 3.1, above, Roche may only sublicense the license
rights granted to it hereby under the [***] Patents with the prior
written consent of [***], which [***] may withhold in its sole
discretion; provided that if the sublicense is made in connection
with the license by Roche (a) [***], or (b) in connection
with [***], by or on behalf of Roche, such consent by [***] shall
not be unreasonably withheld. [***] shall have [***] days after
receipt of a written request by Roche to approve a proposed
sublicense to either consent to or deny such request by Roche.
Failure of [***] to answer within such [***] day period shall
conclusively be deemed to constitute consent by [***] to such
proposed sub-license. Roche agrees that any permitted sublicense
granted by it shall provide that the obligations of Roche pursuant
to Sections 3.3, 6.1 and 7.4 and Article 5 of this Agreement shall
be binding upon the Sublicensee, for the benefit of MDRNA, as if it
was a party to this Agreement. Roche hereby agrees not to
(i) seek the sublicense of, or otherwise grant a sublicense
to, the [***] Patents except in connection with [***], or
(ii) [***], provided Roche may assign this Agreement without
prior written consent (a) to an Affiliate of Roche, or
(b) to a third party (other than Roche or MDRNA) in connection
with a merger, sale or transfer of all or substantially all of the
assigning Roche entity’s pharmaceutical business related to
RNAi technology.
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3.3
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In connection
with its exercise of its rights set forth in this Agreement, Roche
shall comply with all applicable U.S. and foreign laws and
regulations.
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3.5
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Notwithstanding
anything contained in this Agreement to the contrary, it is
understood and agreed that the obligations of [***] set forth in
Section 3.4 of this Agreement shall not be binding on any
assignee of [***].
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IV.
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LICENSING
CONSIDERATION
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4.1
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In
consideration of the rights granted by MDRNA to Roche and its
Affiliates under this Agreement, Roche shall pay MDRNA the
consideration set out in this Article IV.
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4.2
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As of the Effective Date, a
one-time non-refundable execution fee in U.S. currency of five
million dollars (US$5,000,000) is due by Roche to MDRNA. Roche
shall pay
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4
[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS
TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS
BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
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such fee on the Effective Date
provided that Roche receives an invoice in such amount from MDRNA
on the Effective Date.
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4.3
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For sales of
Licensed Product made by or on behalf of Roche, its Affiliates or
Sublicensees during the Royalty Term for such Licensed Product,
Roche shall pay to [***] a royalty on Net Sales of such Licensed
Product equal to [***] percent ([***]%) of such Net
Sales.
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V.
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PAYMENTS,
REPORTS AND RECORDS
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5.1
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Roche shall
keep true and accurate records, and shall ensure that its
Affiliates and Sublicensees keep true and accurate records, of Net
Sales and the royalties payable to [***] under Section 4.3
hereof and Roche shall deliver to [***] (with a copy to MDRNA) a
written statement thereof within [***] days following the end of
each [***] (or any part thereof in the first or last [***] of this
Agreement) for such [***] (“Royalty Statement”). Each
Royalty Statement shall set forth for each product, the amount of
Net Sales during that [***].
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5.2
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All amounts due
under this Agreement shall be paid in U.S. dollars. When
calculating the Adjusted Gross Sales for countries other than the
United States of America, Roche shall convert the amount of such
sales in currencies other than Swiss Francs into Swiss Francs using
for internal foreign currency translation Roche’s then
current standard practices actually used on a consistent basis in
preparing its audited financial statements. Upon converting the
amount of Adjusted Gross Sales into Swiss Francs, Roche shall
convert into US Dollars (or other currency), using the average
[***] rate (currently Reuters) for the applicable [***]. All
payments shall be made by wire transfer to a designated [***]
account within [***] days after the end of each [***].
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5.3
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Any income or
other taxes which Roche is required by law to pay or withhold
(ultimately) on behalf of MDRNA or [***] with respect to royalties
and any other moneys payable to MDRNA or [***] under this Agreement
shall be deducted from the amount of such royalties and moneys due.
Roche shall furnish MDRNA or [***], as applicable, with proof of
such payments. Any such tax required to be paid or withheld shall
be an expense of and borne by MDRNA or [***], as applicable. Roche
shall promptly provide MDRNA or [***], as applicable, with a
certificate or other documentary evidence to enable MDRNA to
support a claim for a refund or a foreign tax credit with respect
to any such tax so withheld or deducted by Roche. The Parties and
[***], if applicable, will reasonably cooperate in completing and
filing any documents required under the provisions of any
applicable tax treaty or under any other applicable law, in order
to enable Roche to make such payments to MDRNA or [***], as
applicable, without any deduction or withholding.
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5.4
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[***] shall have the right to
nominate an independent certified public accountant who shall have
access during Roche’s annual auditing period, on
reasonable
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5
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