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Exhibit
10.2
LICENSE AGREEMENT
This license agreement is made by and
between Aquila Biopharmaceuticals, Inc., a Delaware corporation
having offices at 175 Crossing Boulevard, Framingham, MA 01702
(“Aquila”), Neuralab Limited, a company incorporated in
Bermuda, do EISL 1025 St. James Court, Flatts, Smiths, FLO4,
Bermuda (“Neuralab”) and Elan Biopharmaceuticals, Inc.,
a Delaware corporation having offices at 800 Gateway Boulevard,
South San Francisco, California 94080 (“Elan”), (each
singularly a “Party” and collectively the
“Parties”) with reference to the following:
RECITALS
WHEREAS, Aquila is performing research
and development in the field of purified saponins from the tree
Quillaja saponaria, and uses thereof as an immune adjuvant;
and
WHEREAS, Neuralab is performing research
and development in the field of vaccines and therapeutics for
Alzheimer’ s disease and is interested in licensing
Aquila’s rights to such purified saponins for use as an
immune adjuvant with such vaccines and therapeutics;
THEREFORE, the parties agree as
follows:
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1. |
Definitions . The following terms shall have the
following meanings for purposes of this Agreement: |
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1.1 |
“Adjuvant” means the compound or compounds
comprising [**] QS-21 isolated from the tree Quillaja
saponaria, [**] of [**]. |
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1.2 |
“Affiliate” means any corporation, firm,
partnership or other entity, whether de jure or de facto, which
directly or indirectly owns, is owned by, or is under common
ownership with a party to this Agreement to the extent of at least
fifty percent (50%) or greater of the equity (or such lesser
percentage which is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction) having the power to vote
on or direct the affairs of the entity and any person, firm,
partnership, corporation or other entity actually controlled by,
controlling, or under common control with a party to this
Agreement. Notwithstanding the foregoing, for the purposes of this
Agreement only Elan and its Affiliates shall be considered
Affiliates of Neuralab. |
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
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1.3 |
“Agreement” means this License Agreement,
including any exhibits, schedules or other attachments thereto, as
any of the foregoing may be validly amended from time to
time. |
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1.4 |
“Aquila” means Aquila Biopharmaceuticals,
Inc., a Delaware Corporation, it’s Affiliates, and its
successors and permitted assigns. |
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1.5 |
“Commercial Introduction” means on a
country-by-country basis the date of first commercial sale (other
than for purposes of obtaining regulatory approval) of a Licensed
Product by Neuralab or its Sublicensees in such
country. |
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1.6 |
“Effective Date” is November 23,
1999. |
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1.7 |
“Elan” means Elan Pharmaceuticals, Inc., a
Delaware corporation having offices at 800 Gateway Boulevard, South
San Francisco, California 94080, its Affiliates and its permitted
successors and assigns. |
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1.8 |
“FDA” means the United States Food and Drug
Administration. |
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1.9 |
“Field of Use” means the use of Licensed
Product for the prevention or treatment of Alzheimer’s
disease. |
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1.10 |
“Good Clinical Practice” means such
practices as are prescribed by the FDA’s “Good Clinical
Practice Consolidated Guideline.” |
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1.11 |
“Know-how” means materials, data, results,
formulae, designs, specifications, methods, processes,
improvements, techniques, ideas, discoveries, technical
information, process information, clinical information and any
other information. whether or not any of the foregoing is
patentable, known to and which is confidential (in accordance with
Section 9.1 hereof) and proprietary to Aquila now or hereafter
during the Term, to the extent that any of the foregoing relates to
any Licensed Patent Rights or the development, manufacture, use or
sale of Adjuvant in connection with the development, manufacture,
use or sale of any Licensed Product; provided however, that the
term “Know how” shall not include any of the foregoing
that is [**]. |
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1.12 |
“Licensed Patent Rights” means any and all
patent applications and patents (including inventor’s
certificates and utility models) throughout the world, including
any substitutions, extensions, reissues, reexaminations,
renewals, |
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
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divisions, continuations and
continuation-in-parts of the foregoing, which Aquila now or
hereafter during the Term owns or controls (solely or jointly) or
under which Aquila has the right to grant sublicenses (regardless
of any royalty or other payments to a Third Party required of
Aquila), to the extent that any of the foregoing covers, in whole
or in part, the [**] the development, manufacture, use,
importation, offer for sale, or sale of any Licensed Product.
“Licensed Patent Rights” shall include, without
limitation, the patents listed on Exhibit “A” attached
and incorporated into this Agreement.
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1.13 |
“Licensed Product” means any product
comprising [**] or an [**] thereof (the [**] comprising at least
[**] from [**]) in combination with the Adjuvant. [**] is an
internal [** ] of [ **] termed [** ]
. |
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1.14 |
“Licensed Territory” means the
world. |
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1.15 |
“Net Sales” means the gross invoiced sales
price of all Licensed Products sold by Neuralab or its Sublicensees
to Third Party end users, after deduction of the following items to
the extent such items are incurred, taken or borne by the seller
thereof and do not exceed reasonable and customary amounts in the
market in which such sale occurred: (a) trade, cash or
quantity discounts or rebates; (b) credits or allowances given
or made for rejection or approved return of goods ; (c) taxes
or government charges, duties or tariffs (other than an income tax)
levied on the sale, transportation or delivery of a Licensed
Product. Sales between Neuralab and its Affiliates or Sublicensees
shall be excluded from the computation of Net Sales except where
such Affiliates or Sublicensees are end users, but Net Sales shall
include the subsequent final sales to Third Party end users by such
Affiliates or Sublicensees. |
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1.16 |
“Neuralab” mean a company incorporated in
Bermuda, do EISL 1025 St. James Court, Flatts, Smiths, FLO4,
Bermuda. |
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1.17 |
“Party” and “Parties” are
defined in the introductory paragraph. |
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1.18 |
“Sublicense” shall mean an agreement or
arrangement pursuant to which such a sublicense has been granted as
defined in Section 2.2. |
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
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1.19 |
“Sublicensee(s)” means a Third Party granted
a Sublicense. |
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1.20 |
“Term” is defined in Section 10.
1. |
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1.21 |
“Third Party” means any party other than a
party to this Agreement, the Supply Agreement, their respective
Affiliates and a Sublicensee. |
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1.22 |
“Valid Claim” means a claim in an issued,
unexpired patent in the Licensed Patent Rights, which has not been
held invalid, unpatentable or unenforceable in an unappealed or
unappealable decision of a court or other governmental body of
competent jurisdiction, which has not been rendered unenforceable
through disclaimer or otherwise, and which has not been lost
through an interference proceeding. |
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2.1 |
Grant of License Rights . Aquila hereby grants to
Neuralab an exclusive license within the Licensed Territory to use
the Know-how and practice the Licensed Patent Rights to develop,
make, have made, use, sell, offer for sale, import, and have sold
Licensed Products within the Field of Use. |
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2.2 |
Sublicenses . Neuralab shall have the right to grant
sublicenses of its rights under this Agreement with respect to
Licensed Products (Neuralab shall have no right to grant
sublicenses to the Adjuvant alone) only as follows: |
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(a) |
Neuralab may grant a sublicense to a Third Party for purposes
of manufacturing the Licensed Products developed by or under
continuing development by Neuralab; and |
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(b) |
Neuralab may grant a sublicense to a Third Party that enters
into a joint development, joint venture agreement or similar type
of arrangement with Neuralab in connection with Licensed Products
to be developed by Neuralab and the Third Party. |
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(c) |
Neuralab may grant a sublicense to a Third Party for purposes
of marketing the Licensed Products where local law requires a local
party to market the Licensed Products. |
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
Neuralab shall promptly
notify Aquila of the execution of each Sublicense and shall provide
Aquila with a copy of same. All such agreements shall constitute
proprietary information of Neuralab and Aquila shall maintain the
confidentiality of such agreements in accordance with the terms and
conditions of Section 9.
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2.3 |
[**] Transfer of [**] and [ ** ]. Aquila shall
promptly transfer to Neuralab existing [**] and [**] for purposes
of Neuralab’s research and development (including but not
limited to pre-clinical trials and human clinical trials but
excluding [**] relating to the [**] of the Adjuvant) with respect
to Licensed Products. On an [**] [**] the [**], Aquila shall [**]
and [**] to Neuralab [**] and [**] (exclusive of [**] to the [**]
the [**]) then [**], whether or not [**], and [**] and [**] then
[**]. |
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3. |
Schedule of Payments to Aquila . |
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3.1 |
Initial Payments . Neuralab has paid to Aquila a
one-time non-refundable license fee equal to [**] upon a signed
letter agreement for [**] (and Aquila acknowledges receipt
thereof). Neuralab shall pay Aquila an additional [**] within [**]
after the [**] of a [**]. |
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3.2 |
Milestones . Within [**] after achievement of each of
the milestones set forth below for each Licensed Product in the
Field of Use, Neuralab will pay to Aquila the milestone payments
set forth below: |
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(a) |
[**] upon [**] of the [**] in the [**] (or its
[**]). |
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(b) |
[**] upon [**] of the [**] in the [**] (or its
[**]). |
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(c) |
[**] upon the [**] (or [**]) with the [**] or the [**] in a
[**]; and |
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(d) |
[**] upon [**] of such [**] (or [**]) or the [**] in a
[**]. |
Neuralab shall promptly give
Aquila notice of the occurrence of each milestone. If any milestone
is achieved with respect to the Licensed Product, and at such time
any one or more of the previously listed milestones have not been
achieved with respect to such Licensed Product, then at the time of
the payment of the milestone payment for such achieved milestone,
Neuralab shall pay to Aquila the previously unpaid payments for
such unmet milestones.
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
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3.3 |
Royalties and Sublicense fees . Subject to the other
terms of this agreement, Neuralab shall pay to Aquila royalties and
Sublicense fees as follows: |
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(a) |
During the term of the Agreement, Neuralab will pay to Aquila
during each calendar year a royalty of [**] of Net Sales of
Licensed Product until Net Sales of such Product [**] reach [**]
; thereafter until the end of [**], Neuralab will pay to
Aquila a royalty equal to [**] of subsequent Net Sales of Licensed
Product. Neuralab will pay to Aquila a royalty equal to [**
] of subsequent Net Sales of Licensed Product. Neuralab will
make royalty payments on a country-by-country basis for the longer
of (i) [**] from first commercial sale of Licensed Product, or
(ii) if a Valid Patent for the Licensed Product is issued in
that country, until the expiration of the last to expire of the
Valid Patents. |
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(b) |
In the event that Neuralab should enter into a Sublicense for
Licensed Product, Neuralab will pay to Aquila [** ] of all
Sublicense fees received by Neuralab from its Sublicensees for
Licensed Products up until [**] of the [**], which shall be
understood to [**], [**] of [**] and [**], and [**] but [**] all
[**] or [**], co-[**,**] and [**]. |
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3.4 |
Excluded Products . Notwithstanding any other provision
of this Agreement, Neuralab shall not be obligated to pay Aquila
milestone, royalty or other types of payments with respect products
developed or acquired by Neuralab within the Field of Use which do
not constitute Licensed Products, including but not limited to,
[**] or [**], [**] without an [**], [**] with [**] other than [**],
and other [**] of [**] an [**] to [**]. If Licensed Products are
used for [**] to [**] for use in [**], such [**] are not
[**]. |
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4. |
Royalty Payments, Reports and Records . |
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4.1 |
Commercial Introduction . Neuralab shall promptly give
Aquila notice of the occurrence of Commercial Introduction of the
Licensed Products. |
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
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(a) |
Payments: Deduction of Taxes . After the date of
Commercial Introduction of the first Licensed Product, a royalty
report and payment under this Agreement on Net Sales will be due
and payable from Neuralab to Aquila within [**] after [**], [**
] and [** ] of each calendar year. Payments due under
Section 3.3(b) attributable to Sublicense fees shall be made
at the end of the quarter when such license fees are payable.
Neuralab will remit any such payment due to Aquila under this
Agreement by check payable to Aquila. Any tax paid or required to
be withheld by Neuralab on account of royalties payable to Aquila
under this Agreement shall be deducted from the amount of royalties
otherwise due. Neuralab shall make applicable withholding payments
due on behalf of Aquila and shall promptly provide Aquila with
written documentation of any such taxes withheld and paid by
Neuralab or its Sublicensees for the benefit of Aquila. |
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(b) |
Foreign Currency Conversion . For sales of any Licensed
Product that occur in a currency other than United States dollars
(‘foreign currency sales’), the quarterly royalty
payment will be calculated as follows: |
[**] = United States dollars
royalty payment on foreign currency sales, where
[**] = foreign currency Net
Sales per quarter
[**] = foreign exchange
conversion rate, expressed in local currency per United States
dollar (using as the applicable foreign exchange conversion rate
the average of the rate published in the Wall Street Journal or any
other mutually agreed-upon source for the last business day of each
of the [**] of the quarter); and
[**] = the royalty rate
applicable to such Net Sales under Section 12.
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4.3 |
Royalty Reports . After the date of Commercial
Introduction of the first Licensed Product Neuralab shall render to
Aquila, together with the royalty payment due under
Section 4.2 for a given calendar quarter, within [**] of the
end of such quarter, a written account for such calendar quarter
showing (a) total gross sales and Net Sales, and the
total |
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
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gross royalty and license fee
revenues paid to Neuralab by any Sublicensee(s) during such
calendar quarter, and (b) a calculation of the royalty rate
and royalties payable under Section 3.3 (including, in the
case of foreign currency sales, the total foreign currency Net
Sales during such calendar quarter, the applicable foreign exchange
conversion rate(s) and the total United States dollar royalty
payment amount).
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4.4 |
Neuralab’s Recordkeeping and Inspection . After
the date of Commercial Introduction of the first Licensed Product,
Neuralab shall keep for at least [**] records of all sales of
Licensed Products in sufficient detail to permit Aquila to confirm
the accuracy of Neuralab’s royalty calculations. At the
request of Aquila no more frequently than [**], upon at [**] prior
written notice to Neuralab from Aquila, and at the expense of
Aquila (except as otherwise provided below), Neuralab shall permit
a nationally recognized, independent certified public accountant
selected by Aquila and acceptable to Neuralab to inspect, during
regular business hours, any such Neuralab records for the
then-preceding [**] solely to the extent necessary to verify such
calculations, provided that such accountant in advance has entered
into a confidentiality agreement with Neuralab [(**] to the[**] of
[**)] limiting the disclosure of such information to[**] of the
[**]. Results of any such inspection shall be made available to
both Parties. If such inspection reveals a deficiency in the
calculation of royalties resulting in an underpayment to Aquila
[**] or more, Neuralab shall pay all reasonable costs and expenses
of such inspection. |
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5.1 |
Maintenance of License . In order to maintain the
license granted pursuant to Section 2.1 with respect to a
designated Licensed Product, Neuralab, Elan and their sublicensees
collectively, shall, commencing [**], either: |
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(a) |
[**]of [**] than [**], or |
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(b) |
Achieve the following objectives: |
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(i) |
[**] a [**] for a [**] within [**] after the Effective
Date. |
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
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(ii) |
[**] a [**] within [**] of the Effective Date. |
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(iii) |
[**] for a [**] within [**] after the Effective
Date. |
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(iv) |
[**] and [**] of a [**] within [**] after the Effective
Date. |
If Neuralab shall fail to
achieve any of the above objectives and such failure shall remain
unremedied for a period of [**] after notice of such failure to
Neuralab by Aquila (the “Grace Period”), this license
shall [**] the [**] of [**]. Notwithstanding the foregoing, if such
failure is a result of Neuralab not having obtained a third party
license necessary to make, use or sell Licensed Products and
reasonable evidence is submitted by Neuralab to Aquila that such
license can be obtained in a reasonable period of time, Neuralab
may request that the Grace Period be extended for a period of time
set forth in the request. Aquila shall not unreasonably withhold
its consent to such extension but in no event shall the Grace
Period exceed [**]. Aquila shall not unreasonably withhold its
consent to any reasonable revision in the preceding schedule
requested in writing by Neuralab and supported by reasonable
evidence of technical difficulties or delays in the clinical
studies or regulatory process that could have not have been
reasonably anticipated or avoided. Notwithstanding the foregoing,
Aquila shall not have the right to terminate the license for
failure of Neuralab to meet a goal if such failure is a result of
(i) Aquila’s failure to meet its obligations hereunder,
or (ii) an action brought by a third party claiming that the
use of the Adjuvant in Licensed Products infringed a patent of such
third party.
If Neuralab elects to stop
development of Licensed Products, this license shall automatically
terminate.
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5.2 |
Pre-Clinical and Clinical Programs . Neuralab shall
conduct the human clinical trials in accordance with Good Clinical
Practice, reporting adverse events to Aquila and the FDA. Neuralab
agrees, subject to regulatory guidelines and restrictions, to
provide Aquila with all safety information developed during the
course of its studies in humans on the Licensed Products. Neuralab
shall provide Aquila with a [**] of the [**] involving the Adjuvant
and consider |
[**] = Portions of this exhibit have
been omitted pursuant to a confidential treatment request. An
unredacted version of this exhibit has been filed separately with
the Commission.
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in good faith
Aquila’s comments on such [**] involving the Adjuvant.
Neuralab also agrees to provide Aquila with a [**] of the [**] and
to [**] the [**] in accordance with the [**]. Neuralab shall
prepare and deliver to Aquila a copy of a [**] to be used in
connection with [**] involving the Adjuvant. Neuralab or its
Sublicensees shall be solely responsible for the conduct of
preclinical and human clinical testing, regulatory filings,
applications and approvals, and expenses in connection with such
clinical development plan. All such information shall constitute
proprietary information of Neuralab and Aquila shall maintain the
confidentiality of such agreements in accordance with the terms and
conditions of Section 9 below. Without limiting the generality
of the foregoing, Aquila warrants that it shall maintain
confidential the [**].
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In connection with all of the
foregoing:
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(a) |
Aquila Cooperation . Aquila shall cooperate with and
assist Neuralab, its Affiliates andlor Sublicensees in the
preparation and filing of information with r |
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