Exhibit 10.1
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the “
Agreement ”) is made and entered into this 28th day of
August 2008 (the “ Effective Date ”), by and
between Aegera Therapeutics Inc., a company organized and existing
under the laws of Canada (“ Licensor ”), having
a principal place of business located at 810 chemin du Golf, Ile
des Soeurs, Québec H3E 1A8, Canada, and Neurologix, Inc., a
Delaware corporation (“ Licensee ”), having a
principal place of business located at One Bridge Plaza, Fort Lee,
NJ 07024, USA.
RECITALS
WHEREAS, Licensor is the owner of certain patents and
other intellectual property relating to the X-linked Inhibitor of
Apoptosis Protein (“ XIAP ”);
WHEREAS, Licensee desires to obtain an exclusive license
in the Field (as hereinafter defined) to develop and commercialize
products by using and practicing the Licensed Methods (as
hereinafter defined) and Licensed Patent Rights (as hereinafter
defined); and
WHEREAS , Licensor is willing to grant such a license to
Licensee on the terms set forth herein.
NOW THEREFORE , the parties agree as follows:
ARTICLE I
DEFINITIONS
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“
Accounting Standards ” shall mean United States
Generally Accepted Accounting Principles, as generally and
consistently applied throughout the applicable Person’s
organization.
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“
Affiliate ” means, with respect to a specified Person,
any other Person, (i) which is controlling, controlled by or under
common control with, such specified Person or (ii) in which such
specified Person owns 20% or more of the equity or other ownership
interests. For purposes of this Section 1.2, the term
“control” means possession, direct or indirect, of the
powers to direct, cause or direct or cause the direction of the
management and policies of a Person, whether through the ownership
of voting securities, by contract or otherwise.
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“
Confidential Information ” shall mean all technical
and scientific know-how and information, non-clinical and clinical
trial results, computer programs, knowledge, technology, means,
methods, processes, practices, formulas, techniques, procedures,
technical assistance, designs, drawings, apparatus, written and
oral representations of data, specifications, assembly procedures,
schematics and other valuable information of whatever nature and
all other scientific, clinical, regulatory, marketing, financial
and commercial information or data, whether communicated in
writing, verbally or electronically, which is provided by a party
to the other party in connection with this Agreement. For the
avoidance of doubt, the terms and conditions of this Agreement
shall be deemed the Confidential Information of both Licensor and
Licensee.
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“
Field ” means therapeutic or prophylactic use in the
treatment of Huntington’s Disease by Gene Therapy.
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“
First Commercial Sale ” means the first sale of any
Licensed Product (as hereinafter defined) by Licensee or any of its
Affiliates or Sublicensees following approval of its marketing to
the general public by the appropriate governmental agency for the
country in which the sale was made, and, where governmental
approval is not required, the first sale in that
country.
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“ Gene
Therapy ” means the treatment of certain disorders,
including, but not limited to those caused by genetic anomalies or
deficiencies, by introducing specific engineered genes into a
patient’s body.
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“
Improvements ” means any and all additions,
alterations, modifications, design changes and other improvements
to the Licensed Patent Rights, including subject art thereof, and
the Technology which are individually developed by Licensor,
Licensee, any Sublicensee or any Third Party during the
Term.
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“
License ” has the meaning set forth in Section
2.2.
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“
Licensed Method ” means any process or method that is
covered by a Valid Claim.
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“
Licensed Patent Rights ” means the patents and patent
applications listed in Schedule A hereto, including
divisionals, continuations and, to the extent entirely supported by
such patents and patent applications, continuation-in-part
applications, any patents issuing on said applications, including
reissues and reexaminations thereof, and any foreign counterparts
thereto.
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“
Licensed Product ” means a product, the manufacture,
use, offer for sale, sale or importation of which employs a
Licensed Method or the manufacture, use, offer for sale, sale or
importation of which is covered by a Valid Claim. Once a
product becomes a Licensed Product, such product shall remain a
Licensed Product for all purposes under this Agreement.
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“ Net
Sales ” means the total amount invoiced by Licensee or
its Affiliates or Sublicensees from the sale or distribution of
Licensed Products in the Territory, less the sum of the following
deductions where applicable, determined in accordance with the
Accounting Standards: sales, use, tariff, import/export duties or
other excise taxes imposed upon particular sales, transportation
charges, allowances or credits to customers because of rejections
or returns and actual amounts credited for uncollectible amounts on
previously sold Licensed Products. Sales between or
among Licensee and its Affiliates or Sublicensees shall be excluded
from the computation of Net Sales, except where such Affiliates or
Sublicensees are end users (i.e., where such sale is the last sale
to the consumer), but Net Sales shall include the subsequent final
sales to Third Parties by such Affiliates or
Sublicensees.
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To the extent
that any amount that would otherwise qualify as a deduction in the
calculation of Net Sales is paid by a Third Party pursuant to a
separate charge or invoice, such amount shall not be deducted in
the calculation of Net Sales. In the case of any sale or
other disposal of a Licensed Product between or among a party and
its Affiliates, or Sublicensees, for resale, Net Sales shall be
calculated as above only on the value charged or invoiced on the
first arm’s-length sale thereafter to a Third
Party. In the case of any sale or other disposal for
value, such as barter or counter-trade, of any Licensed Product, or
part thereof, other than in an arm’s length transaction
exclusively for money, Net Sales shall be calculated as above on
the value of the non-cash consideration received or the fair market
price (if higher) of the Licensed Product in the country of sale or
disposal.
Transfers of
samples of the Licensed Product, such as for physician samples and
indigent patient and similar programs (including registration
samples), will not be included for purposes of determining Net
Sales; provided that no compensation beyond the cost
of goods of any such transferred Licensed Product is received, such
sampling and other programs are conducted in a manner consistent
with Licensee’s, its Affiliate’s or it
Sublicensee’s normal practices applied across all of its
products and no non-cash consideration or other benefits (e.g.,
concessions or agreements with respect to products other than the
Licensed Product) is obtained in exchange for such transferred
Licensed Product.
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“
Ottawa License Agreement ” means the License Agreement
between University of Ottawa and Aegera (as successor to Apoptogen
Inc.), made as of November 30, 1995, as amended as of October 10,
2000.
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“
Person ” means an individual, sole proprietorship,
partnership, limited partnership, limited liability partnership,
corporation, limited liability company, business trust, joint stock
company, trust, unincorporated association, joint venture or other
similar entity or organization, including without limitation, a
government or political subdivision, department or agency of a
government.
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“
Royalty Term ” means the period that commences on the
Effective Date and terminates, on a country-by-country basis, with
respect to each Licensed Product, on the later to occur of (a) the
expiration of the last to expire Valid Claim within the Licensed
Patent Rights covering such Licensed Product, (b) ten (10) years
after the First Commercial Sale of such Licensed Product in such
country or (c) the full prosecution of any claims under a properly
filed patent application.
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“
Sublicensee ” means any Third Party sublicensed by
Licensee to make, have made, use, offer for sale, sell, have sold,
import or have imported Licensed Products.
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“
Territory ” means the entire world except for the
People’s Republic of China.
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“
Third Party ” means any Person other than Licensee,
Licensor or any of their respective Affiliates.
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“
Third Party License ” means any agreement under which
a license to the Licensed Patent Rights or Technology is granted by
a Third Party to Licensor.
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“
Technology ” means any and all proprietary processes,
trade secrets, technical information and know-how claimed in or
relating to the Licensed Patent Rights, that is necessary or useful
to make, use, offer for sale, sell or import Licensed Products in
the Field and that is owned or controlled by Licensor as of the
Effective Date.
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“
Valid Claim ” means (a) any claim of an issued,
unexpired patent included in the Licensed Patent Rights, which
claim has not lapsed, been abandoned, been revoked or been held to
be invalid or unenforceable by a final judgment of a court of
competent jurisdiction or other governmental agency from which no
appeal can be or is taken within the time allowed for appeal and
which has not been admitted to be invalid or unenforceable through
reissue, re-examination, disclaimer or otherwise; or (b) any claim
of a patent application included in the Licensed Patent Rights that
has been pending for less than seven (7) years and which has not
been withdrawn, cancelled, abandoned, or finally held to be
unallowable.
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ARTICLE II
GRANT
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Subject to the
terms and conditions of this Agreement and the Ottawa License
Agreement, Licensor hereby grants to Licensee and its Affiliates in
the Territory an exclusive license, under the Licensed Patent
Rights to make, have made, use, offer for sale, sell, have sold,
import and have imported Licensed Products in the Field in the
Territory (the “ Product License ”) during the
Term.
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Subject to the
terms and conditions of this Agreement and the Ottawa License
Agreement, Licensor hereby grants to Licensee and its Affiliates an
exclusive license to use and have used the Technology in connection
with the manufacture, use, offer for sale, sale and importation of
Licensed Products in the Field in the Territory (the “
Technology License ” and, together with the Product
License, the “ License ”) during the
Term.
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Licensor shall
retain ownership of any Improvements to the inventions claimed in
the Licensed Patent Rights and to the Technology that are developed
or invented by or on behalf of it, its Affiliates or Third Parties
(“ Licensor Improvements ”). Licensor
shall promptly notify Licensee, in writing, of any Licensor
Improvements in the Field in the Territory. In the event
that Licensor, its Affiliates or Third Parties, makes any such
Improvements, and Licensor and Licensee are able to determine
commercially reasonable terms for a license of such Improvements,
Licensor, shall grant to Licensee an exclusive license, with the
right to grant sublicenses, to make, have made, use, offer for
sale, sell, have sold, import and have imported the Licensor
Improvements in the Field in the Territory.
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Licensee shall
retain ownership of any improvements to the inventions claimed in
the Licensed Patent Rights and to the Technology that are developed
or invented by or on behalf of Licensee, its Affiliates and
Sublicensees (“ Licensee Improvements
”). Licensee shall promptly notify Licensor, in
writing, of any Licensee Improvements. In the event that
Licensee, or its Affiliates, makes any Improvements to the
inventions claimed in the Licensed Patent Rights or to the
Technology, and Licensor and Licensee, or its Affiliates, are able
to determine commercially reasonable terms for a license of such
Improvements, Licensee, or its Affiliates, shall grant to Licensor
a non-exclusive license, with the right to grant sublicenses, to
make, have made, use, offer for sale, sell, have sold, import and
have imported the Licensee Improvements; provided that,
during the Term, such license shall not permit the manufacture,
use, offer for sale, sale or importation of Licensed Products in
the Field in the Territory.
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ARTICLE III
SUBLICENSES
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Licensee shall
have the right to grant exclusive and/or non-exclusive sublicenses
(each a “ Sublicense ”) of the License to Third
Parties. The granting by Licensee of a Sublicense shall
not relieve Licensee of any of its obligations
hereunder.
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Licensee shall
furnish Licensor with an unredacted copy of any Sublicense within
15 days after the execution thereof; provided that
the existence and terms of any such Sublicense shall constitute
Confidential Information of Licensee.
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Licensee shall
provide to Licensor a copy of all information submitted to Licensee
by Sublicensees that is relevant to the computation of the payments
due from Licensee to Licensor under this Agreement.
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Licensee shall
obtain from its Affiliates and Sublicensees all licenses and access
to information and documents necessary for Licensee to grant to
Licensor the rights and licenses set forth in Section
2.4.
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The Sublicense
shall be consistent with all the relevant terms of this Agreement,
including Section 2.4, this Article III and Articles VI, IX, X, XI,
XV and XVI.
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In the event of
a material default of a Sublicense by any Sublicensee, Licensee
will promptly inform Licensor of such
default. Notwithstanding any such material default,
Licensee shall remain responsible for the satisfaction of all
obligations of Licensee, its Affiliates and Sublicensees under this
Agreement.
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ARTICLE IV
INITIATION and MAINTENANCE
FEES
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On the
Effective Date, Licensee shall pay to Licensor a non-refundable
initiation fee of ########.* This fee is not intended to be, and
shall not be construed as, an advance against Royalties (as
hereinafter defined).
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* ######## = Material omitted pursuant to a
request for Confidential Treatment and filed separately with the
Commission on the date of filing of this Form 8-K.
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Commencing on
January 1, 2009, and on each subsequent January 1 during the Term,
Licensee shall pay an annual maintenance fee (the “
Maintenance Fee ”) of ########* to Licensor. The
Maintenance Fee for each calendar year shall be offset against
Royalties (as hereinafter defined) payable to Licensor based on Net
Sales occurring in the same calendar year.
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ARTICLE V
ROYALTIES
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Within sixty
(60) days after the end of each calendar quarter during an
applicable Royalty Term in which Net Sales occur, Licensee shall
pay to Licensor earned royalties on the Net Sales during such
calendar quarter (“ Royalties ”). The
Royalties due for any calendar quarter shall be determined as
follows:
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On the first
######## during such calendar year, Licensee shall pay Royalties in
an amount equal to ########;
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On the next
######## during such calendar year, Licensee shall pay Royalties in
an amount equal to ########;
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On Net Sales
during such calendar year in excess of ########, Licensee shall pay
Royalties in an amount equal to ########;
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Royalties shall
be payable only once with respect to Net Sales regardless of the
number of Licensed Patent Rights which cover the Licensed
Product;
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On a Licensed
Product-by-Licensed Product and country-by-country basis, for Net
Sales of a Licensed Product in a country made during any portion of
the applicable Royalty Term in which no Valid Claim covers such
Licensed Product in such country, the royalty rates set forth in
Sections 5.1.1 through 5.1.3 above applicable to such Net Sales
shall be reduced to ########.
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To the extent
that Licensee or any of its Affiliates or Sublicensees determines
that it is required to obtain in any jurisdiction a license from a
Third Party to patent rights covering XIAP (excluding, for the
avoidance of doubt, patent rights covering any delivery vector that
may be incorporated into a Licensed Product) in order to make, use,
offer for sale, sell or import a Licensed Product in the Field in
such jurisdiction, then ######## in such jurisdiction may be
deducted from royalties otherwise payable to Licensor;
provided that in no event shall the aggregate
royalties payable to Licensor in any calendar quarter based on Net
Sales in such jurisdiction be reduced by ######## as a result of
any such deduction; provided further that any
excess deduction remaining as a result of such limitation may be
carried forward to subsequent periods.
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* ######## = Material omitted pursuant to a
request for Confidential Treatment and filed separately with the
Commission on the date of filing of this Form 8-K.
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In addition to
the Royalties payable pursuant to Section 5.1, Licensee shall pay
Licensor the following milestone payments for each Licensed Product
(collectively, “ Milestone Payments ”), each of
which shall be paid only once for each Licensed Product:
########*
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Royalties shall
be payable on a Licensed Product-by-Licensed Product and
country-by-country basis during the applicable Royalty
Term.
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All monies due
to Licensor under this Agreement shall be payable in United States
dollars by wire transfer to an account to be established by
Licensor. Licensee shall be responsible for all bank transfer
charges. When Licensed Products are sold for monies
other than United States dollars, the Royalties will first be
determined in the foreign currency of the country in which such
Licensed Products were sold and then converted into United States
dollars at the exchange rate established by Capital One Bank on the
last day of the applicable calendar quarter.
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Any tax for the
account of Licensor required to be withheld by Licensee under the
laws of any foreign country shall be promptly paid by Licensee for
and on behalf of Licensor to the appropriate governmental
authority, provided that Licensee and Licensor shall use reasonably
and legal efforts to cooperate to minimize such withholding taxes
(e.g., by taking advantage of applicable tax treaties) and Licensee
shall use reasonable commercial efforts to furnish Licensor with
proof of payment of any such tax. Nothing herein shall
require Licensee to be responsible for or pay any taxes payable by
Licensor, including taxes on the income of Licensor.
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If at any time
legal restrictions prevent the prompt remittance to Licensor of
part or all Royalties by Licensee with respect to any country where
a Licensed Product is sold, Licensee shall have the right and
option to make such payments by depositing the amount thereof in
local currency in Licensor ‘s bank account or other
depository in such country.
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* ######## = Material omitted pursuant to a
request for Confidential Treatment and filed separately with the
Commission on the date of filing of this Form 8-K.
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In the event
that any patent or any claim thereof included within the Licensed
Patent Rights shall be held invalid or unenforceable in a final
decision by a court of competent jurisdiction from which no appeal
has or can be taken, any such claim so adjudicated shall thereupon
cease to constitute a Valid Claim. Licensee shall not,
however, be relieved from paying any Royalties that accrued before
such decision or that are based on another patent or claim not
involved in such decision.
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ARTICLE VI
DUE DILIGENCE
Licensee shall use, or shall cause its
Affiliates or Sublicensees to use, commercially reasonable efforts
to develop and commercialize the Licensed Products throughout the
Territory, including, without limitation, in accordance with the
milestones set forth in Schedule B attached
hereto.
ARTICLE VII
PATENT FILING, PROSECUTION AND
MAINTENANCE
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Licensor shall
have the first right to prepare, file, prosecute and maintain the
Licensed Patent Rights in the United States and in all foreign
countries within the Territory with counsel selected by Licensor at
Licensor’s expense. Licensor shall (i) promptly
provide Licensee and its counsel with copies of any official
communications from the United States and any foreign patent office
relating to the Licensed Patent Rights, and (ii) provide Licensee
and its counsel with advance copies of all written communications
addressed to the United States or any foreign patent office
relating to the Licensed Patent Rights. In the event
that Licensor determines not to prepare, file, prosecute or
maintain any patent rights constituting Licensed Patent Rights,
Licensor shall promptly notify Licensee in writing, and, subject to
Licensor’s pre-existing contractual obligations to Third
Parties, Licensee shall have the right to prepare, prosecute and
maintain any such application or right that is relevant to the
Field in Licensor’s name and at Licensee’s expense;
provided that , Licensor’s abandonment of a
particular patent application in favor of a continuation,
divisional or other substitute application shall not give rise to
the foregoing Licensee step-in right. Licensee shall
have reasonable opportunities to participate in decisions with
respect to the filing, prosecution and maintenance of patents and
patent applications in the Licensed Patent Rights, to the extent
such decisions are material to the protection of Licensed Products
in the Field. Licensor shall consider in good faith any
comments timely provided by Licensee with respect to the filing,
prosecution and maintenance of patents and patent applications in
the Licensed Patent Rights, to the extent such comments are
relevant to Licensed Products in the Field.
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In the event
that Licensor advises Licensee in writing that it has determined to
abandon, any patent application or issued patent licensed under
this Agreement, and Licensee thereafter exercises its step-in
rights with respect to the preparation, prosecution and maintenance
thereof as set forth in Section 7.1 above, Licensee’s license
under such abandoned Licensed Patent Rights set forth in Section
2.1 shall convert to, and thereafter be, a fully paid-up,
non-royalty-bearing license.
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ARTICLE VIII
PATENT
INFRINGEMENT
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In the event
that Licensee learns of the substantial infringement in the Field
of any patent in the Licensed Patent Rights, Licensee shall so
notify Licensor, in writing, and shall provide Licensor with
evidence of such infringement to the extent reasonably available to
Licensee (such notice is hereinafter referred to as an “
Infringement Notice ”). Licensor
shall have the right, but not the obligation, to prosecute at its
own expense the alleged infringement described in an Infringement
Notice; provided that, within thirty (30) days after receipt
by Licensor of an Infringement Notice, Licensor shall notify
Licensee, in writing, whether it intends to prosecute the alleged
infringement described in the Infringement Notice (such notice is
hereinafter referred to as an “ Infringement Reply
Notice ”).
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Licensee shall
have the right to prosecute at its own expense any substantial
infringement in the Field described in an Infringement Notice, and
Licensee shall be entitled to retain any recovery obtained by such
prosecution, including any portion of such recovery to which
Licensor might otherwise be entitled pursuant to this
Agreement, in the event that:
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Licensor fails
timely to deliver an Infringement Reply Notice to Licensee in
response to such Infringement Notice;
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Licensor’s Infringement Reply Notice
indicates Licensor’s intention not to take reasonable actions
to eliminate any substantial infringement in the Field described in
such Infringement Notice; or
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