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 November 6, 2006, a copy of
which has been provided to Roche (the “COH License
Agreement ”), MDRNA controls certain patents and patent
applications owned by City of Hope (“ COH ”)
relating to siRNA constructs, including the dicer
substrate.
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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:
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
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[*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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(c)
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any entity
under a common Controlling Interest (defined below) with a 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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“ COH
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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“ COH
Patents ” mean Patents that are owned or Controlled by
COH and licensed to MDRNA pursuant to the COH 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,
[*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.]
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 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 COH 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 COH
Patents, “Valid Claim” means any claim set forth in a
pending patent application or issued patent included in the COH
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 COH Patents, has not
been pending in any country for more than [***].
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[*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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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 COH
Patents for which a royalty is due pursuant to Section 4.3),
non-exclusive license (or sublicense with respect to the COH
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 COH Patents, the “Field” means the COH
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 COH Patents with the prior
written consent of COH, which COH 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 COH shall not
be unreasonably withheld. COH 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 COH to
answer within such [***] day period shall conclusively be deemed to
constitute consent by COH 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 COH 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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3.4
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For the period of time beginning
on the Effective Date and ending [***] thereafter, MDRNA hereby
grants to Roche, at no cost to Roche, a right of first negotiation
related to [***]. Roche shall have a period of [***] ([***]) days
to exercise such right after its receipt from MDRNA of written
notice and a summary of the applicable financial terms; and if,
within the [***] ([***]) day period, the Parties do not agree upon
the license or sublicense, or Roche responds that it does not
desire to obtain the license or sublicense or fails to respond,
then Roche’s rights relating to such intellectual property
shall terminate and MDRNA shall be free to
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[*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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practice such intellectual
property itself and/or in collaboration with a third party (on an
exclusive basis or otherwise). The provisions of this
Section 3.4 shall survive the termination of this
Agreement.
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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 MDRNA set forth in
Section 3.4 of this Agreement shall not be binding on any
assignee of MDRNA.
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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 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 COH 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 COH under Section 4.3
hereof and Roche shall deliver to COH (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 COH account
within [***] days after the end of each [***].
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[*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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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 COH with respect to royalties
and any other moneys payable to MDRNA or COH under this Agreement
shall be deducted from the amount of such royalties and moneys due.
Roche shall furnish MDRNA or COH, 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 COH, as applicable. Roche shall
promptly provide MDRNA or COH, 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 COH, 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 COH, as applicable, without any deduction or
withholding.
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5.4
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COH shall have
the right to nominate an independent certified public accountant
who shall have access during Roche’s annual auditing period,
on reasonable notice, to the records of Roche and/or its Affiliates
and/or its Sublicensees during reasonable business hours for the
purpose of verifying the royalties payable as provided in this
Agreement for the [***] preceding years. This right may not be
exercised more than [***]. The accountant shall disclose to COH
only information for the purpose of verifying the accuracy of the
royalty report and the royalty payments made according to this
Agreement. The public accountant shall not interpret the Agreement.
The audit report shall be shared by both parties at the same time.
Any adjustment required by such audit shall be made within [***]
days after the determination by the accountants. If the adjustment
payable to COH is greater than [***] percent ([***]%) of the amount
paid for the relevant period, then the cost to COH for the audit
shall be paid by Roche. The failure of COH to request verification
of any royalty calculation within the period for which
corresponding records must by maintained will be deemed to be
acceptance of the royalty reporting for such period. Any disputes
as to the determination or amount of Net Sales shall be resolved
between Roche and COH; and MDRNA shall have no obligation or
liability to Roche or COH with respect to any such
dispute.
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5.5
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Notwithstanding
the other provisions of this Section 5, with respect to any
royalties due (or claimed to be due) by Roche to COH pursuant to
Section 4 of this Agreement, the provisions of Sections 3.7
and 3.8 of the COH License Agreement are incorporated herein by
reference as if fully set forth herein, and Roche hereby agrees to
be bound, for the benefit of COH and MDRNA, by all of the
provisions therein to the same extent that MDRNA is bound thereby.
In the event of a conflict or inconsistency between the provisions
of this Agreement and the provisions of Sections 3.7 and 3.8 of the
COH License Agreement, the provisions of Sections 3.7 and 3.8 of
the COH License Agreement shall prevail.
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[*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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VI.
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PATENTS AND
INFRINGEMENT OF THIRD PARTIES’ RIGHTS
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6.1
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In the event
that any infringement of any of the Patents comes to the attention
of MDRNA, Roche and/or its Affiliates, the Party with knowledge
thereof shall promptly notify the other Party thereof in writing.
With respect to all Patents other than the COH Patents:
(i) [***] shall have the right, but not the obligation to
initiate patent infringement proceedings against any third parties
suspected of infringing a claim within the Patents; (ii) [***]
shall have exclusive control over the content of such patent
litigation proceedings, including the right to settle or compromise
such proceedings; (iii) if [***] wishes to do so it shall at
its sole discretion undertake an infringement suit and/or settle
the case with the infringing party which shall be binding on [***]
and/or its Affiliates; and (iv) [***] will be informed about
the undertaken steps by [***].
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VII.
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REPRESENTATIONS AND WARRANTIES
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7.1
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MDRNA
represents and warrants that it has the power, authority and the
legal right to enter into this Agreement and has the ability to
grant to Roche the license provided herein without violating the
terms of any agreement with either COH or any other third party.
Roche represents and warrants that it has the power, authority and
the legal right to enter into this Agreement without violating the
terms of any agreement with any other third party.
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7.2
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MDRNA
represents and warrants that by Roche complying with the terms and
conditions of this Agreement, MDRNA will be in compliance with the
terms and conditions of the COH License (as supplemented by the
letter agreement, dated as of the Effective Date, between COH and
MDRNA). EXCEPT AS SPECIFICALLY SET FORTH IN THIS AGREEMENT, MDRNA
MAKES NO EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY OF ANY KIND
OR NATURE.
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7.3
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MDRNA
represents and warrants that it has obtained the written agreement
of COH that in the event of either (i) termination of this
Agreement by Roche pursuant to Section 8.3 or
Section 8.5, or (ii) termination of the COH License
Agreement, Roche will have the right to obtain from COH a direct
license of the same rights previously sublicensed to Roche and its
Affiliates by the Company upon the same terms and conditions set
forth in the COH License Agreement, except that the terms and
conditions of the COH License Agreement shall be modified to
provide that: (i) the sublicensing right of Roche shall be as
set forth in this Agreement and (ii) the royalty rate shall be
[***] percent ([***]%) royalty with respect to Net Sales of
Licensed Products; and Roche shall have no other financial
obligation to COH except for the $[***] milestone payment
obligation set forth in Section 3.6(c) of the COH License
Agreement.
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[*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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7.4
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Except in case
of a breach by MDRNA of its representations and warranties under
this Article VII, MDRNA shall have no liability whatsoever to
Roc
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