AMENDED AND RESTATED LICENSE
AGREEMENT
THIS AMENDED AND RESTATED LICENSE
AGREEMENT (“Agreement”) is made and entered
into effective as of July 2, 2008 (the “Amendment
Effective Date”), by and between ONCOGENEX TECHNOLOGIES INC.,
having offices at #400 — 1001 West Broadway, Vancouver, B.C.
V6H 4B1 (“OncoGenex”) and ISIS PHARMACEUTICALS, INC.,
having principal offices at 1896 Rutherford Road, Carlsbad CA
92008-7208 (“Isis”). OncoGenex and Isis each may be
referred to herein individually as a “Party,” or
collectively as the “Parties.”
WHEREAS , the Parties entered into a Collaboration and
Co-Development Agreement dated November 16, 2001 (the
“Original Collaboration Agreement”) which collaboration
resulted in the development of OGX-011, a second generation
antisense inhibitor of Clusterin;
AND WHEREAS , the Parties now wish for OncoGenex to proceed
with unilateral development of OGX-011 and Products and in this
connection wish to enter into this Agreement to amend and restate
the Original Collaboration Agreement, as provided
herein.
NOW,
THEREFORE, the Parties do
hereby agree as follows:
Capitalized terms used in this Agreement and not
otherwise defined herein have the meanings set forth in
Appendix A.
ARTICLE 2
TERMINATION OF COLLABORATION
Section 2.1 Previous Collaboration. Pursuant to the Original Collaboration
Agreement, commencing November 16, 2001 the Parties
collaborated to jointly develop OGX-011 and the Products to the
present stage of development (the “Collaboration”). As
of the Amendment Effective Date, the Collaboration is
terminated.
ARTICLE 3
CESSATION OF OPERATION OF COLLABORATION
Section 3.1 Dissolution of Operating Committee.
Pursuant to Article 3 of the
Original Collaboration Agreement, the Parties established an
“Operating Committee” to oversee the Collaboration. As
of the Amendment Effective Date, the Operating Committee is hereby
dissolved and the Operating Committee will have no further
responsibility, authority or function.
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*
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Certain information in this exhibit has been
omitted as confidential, as indicated by [***]. This information
has been filed separately with the Commission.
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ARTICLE 4
LICENSE GRANT, TECHNOLOGY TRANSFER, DILIGENCE
Section 4.1 License Grant.
4.1.1 Nonexclusive License.
Subject to the terms and conditions
of this Agreement, Isis hereby grants to OncoGenex a worldwide,
nonexclusive license, with the right to grant sublicenses as set
forth in Section 4.1.2 below, under the Isis Core Technology,
Isis Core Technology Patents, Isis Manufacturing Technology and
Isis Manufacturing Patents to research, develop, make, have made,
use, gain regulatory approval, commercialize, sell, offer for sale,
have sold, export and import OGX-011 and Products for all
uses.
4.1.2 Sublicenses. The licenses granted to OncoGenex under this
Article 4 are sublicensable only in connection with a license
of OGX-011 or a Product to any Affiliate of OncoGenex or to any
Third Party, in each case for the continued Development and
Commercialization of OGX-011 or such Product in accordance with the
terms of this Agreement, provided that (i) such
Affiliate or Third Party will agree in writing to be bound by and
subject to all applicable terms and conditions of this Agreement in
the same manner and to the same extent as OncoGenex, and
(ii) OncoGenex will remain responsible for the performance of
this Agreement and will cause such Affiliate or Third Party to
comply with the applicable terms and conditions of this Agreement.
In addition to the requirements and limitations set forth above,
with respect to the Isis Manufacturing Technology, OncoGenex will
(a) name Isis as a third party beneficiary with the right to
directly enforce Article 7 (Confidentiality) of this Agreement
against such Affiliate or Third Party, (b) promptly notify
Isis in writing specifically identifying the Isis Manufacturing
Technology to be disclosed to such Third Party and identifying by
name such Third Party and (c) use appropriate precautions and
include provisions in such sublicense to protect the Isis
Manufacturing Technology such that the sublicensee will not use any
Isis Manufacturing Technology to manufacture any other ASOs for
Third Parties and in any event OncoGenex will not provide to any
Third Party manufacturer any batch record transferred by Isis to
OncoGenex under this Agreement.
4.1.3 Follow On/Back-up Compounds.
At OncoGenex’ request, Isis
and OncoGenex will negotiate in good faith a reasonable research
plan and corresponding budget, at the same FTE rate as set forth in
the Original Collaboration Agreement, to identify exclusively for
OncoGenex additional MOE Gapmers that modulate Clusterin
(“Follow-on Compounds”). In such event and after
OncoGenex has paid Isis pursuant to such research plan, the
definition of “Product” under this Agreement shall
include the Follow-on Compounds.
4.1.4 Improvements . To the extent that Isis has the right to
license an Improvement, the Parties will negotiate in good faith
regarding the use of any such Improvement to research, develop,
make, have made, use, gain regulatory approval, commercialize,
sell, offer for sale, have sold, export and import OGX-011 and
Products for all uses. If OncoGenex gives to Isis written notice of
its desire to obtain a license to an Improvement, the Parties shall
negotiate in good faith and attempt to reach mutual agreement upon
a commercially reasonable agreement under which OncoGenex obtains a
license under such Improvement, and all patent and other
intellectual property rights therein and thereto, to research,
develop, make, have made, use, sell, offer for sale, have sold and
import Products. The license will be sublicensable in accordance
with Section 4.1.2. If requested by OncoGenex, Isis will give
to OncoGenex a written description of such Improvement in
reasonably specific detail, together with such data and information
as reasonably requested by OncoGenex.
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4.1.5 Exclusivity. Subject to Section 12.2.2, neither Isis nor
any of its Affiliates will (a) engage, on behalf of itself or
for any other party, in the research, development, manufacture,
production, release or commercialization of ASOs that act
predominantly by [***] Clusterin [***] or that are [***] Clusterin
[***] or products containing such ASOs, or (b) grant to any
other party any license, immunity or other right, in each case
other than a Permitted License or as otherwise set forth on
Appendix F, to do any of the foregoing. Isis represents and
warrants that all Permitted Licenses as of the Amendment Effective
Date are listed on Appendix F.
4.1.6 [***] and [***] Patents. Without
limiting OncoGenex’ obligations under Section 6.2.4,
Isis will timely pay in full all amounts required to be paid by
Isis, and timely perform in full all obligations required to be
performed by Isis, under the [***] Agreement and the [***]
Agreement. Without the prior express written consent of OncoGenex
(such consent not to be unreasonably withheld, conditioned or
delayed), Isis will not (and will take no action or make no
omission to) modify or waive any material provision of the [***]
Agreement or the [***] Agreement that could impair the value of the
sublicenses granted to OncoGenex under the [***] Agreement or the
[***] Agreement, or to terminate or have terminated the [***]
Agreement or the [***] Agreement.
Section 4.2 Assignment, Technology Transfer.
4.2.1 Assignment. Isis previously has assigned and transferred, or
will assign and transfer, and hereby does assign and transfer, to
OncoGenex or its designee, all rights, title, and interests in and
to the Product-Specific Technology and the Product-Specific
Technology Patents. Simultaneously with the execution of this
Agreement, Isis will execute and deliver a confirmatory assignment
relating to all Product-Specific Technology Patents listed on
Appendix G.
4.2.2 Isis Transfer of Technology.
Subject to the terms and conditions
of this Agreement, Isis will transfer to OncoGenex, or a Third
Party designate selected solely by OncoGenex, (a) all know-how
required to use and interpret the Release Methods, (b) all
software necessary for the conduct of the Release Methods,
(c) the Supply Chain Network necessary for the manufacture of
the Product, (d) any Isis Core Technology, (e) any
Product-Specific Technology and (f) the Isis Manufacturing
Technology, in each case Controlled by Isis on the Amendment
Effective Date. Isis will use Commercially Reasonable Efforts to
complete such transfer pursuant to this Section 4.2.1 within
120 days following the Amendment Effective Date. If
(i) such transfer requires more than [***] (ii) such
transfer is made to a Third Party manufacturer, or
(iii) OncoGenex reasonably requests further technical
assistance with respect thereto, then, in each case, OncoGenex will
pay to Isis the standard Isis FTE rate for the time to complete
such transfer or to provide such assistance. Any transfer made
under this Section 4.2.1 is subject to Section 4.1.2 and
Article 7.
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4.2.3 Transfer of Records.
Isis will provide to OncoGenex
promptly following OncoGenex’ written request, (a) all
batch records related to any Product, including but not limited to
corresponding release data, (b) toxicity and pharmacokinetic
data and reports related to such Product, (c) pharmacology
data and reports related to such Product, (d) Product and
OGX-011 characterization data, (e) Product and OGX-011
stability data, (f) any other records, including, but not
limited to, raw data or interim or final reports, related to such
Product or OGX-011, and (g) all Regulatory Documents, in each
case that are in the possession of Isis or its Affiliates, or any
third party engaged by Isis or any of its Affiliates. OncoGenex
will promptly share with Isis a summary of the data and results
related to each clinical trial conducted by OncoGenex that was
completed or commenced prior to the Amendment Effective Date in
substantially the form, and with substantially the content, of
OncoGenex’ regular reports provided to its board of directors
regarding such clinical trial, but in any event by the later of
(i) 60 days following the Amendment Effective Date and
(ii) the date OncoGenex comes into possession of such
information.
Section 4.3 Supply of Existing OGX-011. Isis will supply
OncoGenex, and OncoGenex will purchase from Isis, the [***] grams
of OGX-011 API in Isis’ possession as of the Amendment
Effective Date for a purchase price of $1,356,000, in accordance
with the terms and conditions of Purchase Order No. 184, dated
February 14, 2006, issued by OncoGenex to Isis (including
without limitation the specifications, warranties and other
obligations set forth in the Terms and Conditions of Purchase
attached thereto, other than the purchase price and payment terms),
with the same effect, and to the same extent, as if such supply and
purchase had been made pursuant to such Purchase Order. In
connection therewith, Isis shall deliver to OncoGenex an updated
Certificate of Analysis dated not more than ninety (90) days
prior to the date of delivery to OncoGenex. OncoGenex acknowledges
and agrees that in order to perform the testing necessary to
provide the updated certificate of analyses, Isis will need to use
approximately [***] grams of such API. Within ninety (90) days
following the receipt by OncoGenex of such API and such Certificate
of Analysis, each provided in accordance herewith, OncoGenex shall
pay to Isis the purchase price set forth in this Section 4.3
and take delivery of the API purchased by OncoGenex hereunder plus
approximately [***] grams of API previously purchased by
OncoGenex.
Section 4.4 Diligence. OncoGenex will use Commercially Reasonable
Efforts to develop and commercialize OGX-011 and
Products.
ARTICLE 5
DEVELOPMENT & COMMERCIALIZATION
Section 5.1 Development, Commercialization and Regulatory
Responsibilities. OncoGenex will have sole responsibility,
including without limitation sole responsibility for all funding,
resourcing and decision making, for all further development and
commercialization with respect to OGX-011 and Products. OncoGenex
hereby assumes all regulatory responsibilities in connection with
OGX-011 and Products, including sole responsibility for all
Regulatory Documents and for obtaining all regulatory approvals.
OncoGenex will comply with all Applicable Laws in connection with
the development and commercialization of OGX-011 and Products. All
INDs, NDAs, MAAs and other regulatory filings for OGX-011 and
Products will be owned by OncoGenex.
4
Section 5.2 Reports by OncoGenex. At Isis’ request, after the first
anniversary of the Amendment Effective Date, OncoGenex will provide
an annual report to Isis summarizing OncoGenex’ development
and commercialization activities over the past year regarding the
Product in substantially the form, and with substantially the
content, of OncoGenex’ regular reports provided to its board
of directors regarding the Product. In addition, OncoGenex will
promptly respond to any reasonable follow-up questions Isis may
have regarding such reports solely to the extent necessary to
determine whether OncoGenex is in compliance with its obligations
to use Commercially Reasonable Efforts under Section 4.4. Isis
shall have the right to use such reports solely to reasonably
determine whether OncoGenex is in compliance with its obligations
to use Commercially Reasonable Efforts under
Section 4.4.
Section 5.3 Safety Database. Isis maintains a database that includes
information regarding the safety and tolerability of its drug
compounds, individually and as a class, including information
discovered during pre-clinical and clinical development (the
“Isis Database”).
5.3.1 To the extent OncoGenex and its Affiliates have
collected data and information specifically regarding Products, and
subject to Applicable Law, including, without limitation, all
applicable privacy laws, rules and regulations (such as the Health
Insurance Portability Accountability Act), any applicable informed
consents, and any obligations or restrictions imposed by Third
Party clinical sites relating to dissemination or use of such data
and information, in an effort to maximize understanding of the
safety profile and pharmacokinetics of Isis compounds, OncoGenex
will provide Isis with the following: (a) copies of [***] and
[***] summary reports, and [***] final reports, in each case
specifically regarding Products, and (b) in connection with
any reported [***] (including any follow-up or amended reports)
specifically regarding a Product, the following [***] regarding the
applicable Product: (i) [***]; (ii) [***] usage;
(iii) particulars of [***]; (iv) [***] history [***]; and (v)
[***]. All such data and information disclosed by OncoGenex to Isis
in connection with this Section 5.3, together with any data
and information related to the [***] of each Product and any [***],
will be OncoGenex’ Confidential Information. Isis shall use
such Confidential Information solely for the purpose of populating
the Isis Database, and for no other purpose. Isis shall not
disclose any such Confidential Information to any Third Party;
provided, however , that Isis may conduct analyses to keep
Isis and its partners informed regarding class generic safety and
pharmacokinetic properties of ASOs so long as Isis does not
disclose to such Third Parties the identity of the applicable
Product, Clusterin as the target, OncoGenex or its Affiliates (or
any information that would foreseeably reveal the identity of the
applicable Product, Clusterin as the gene target, OncoGenex or its
Affiliates) or any patient identifying information.
5.3.2 To the extent that [***] OncoGenex under this
Agreement collects safety and tolerability data or information
specifically regarding a Product, OncoGenex shall use commercially
reasonable efforts to obtain from such sublicensee (a) the
right to provide to Isis (whether through OncoGenex or its
Affiliate, or directly from such sublicensee) the [***] described
in [***] and (b) the right of Isis to [***] for the purposes
described in [***]. Only sublicensees that agree to provide such
[***] and grant Isis the right to use such [***] as set forth
herein, will have the right to access the results of any queries
requested by OncoGenex. If and when Isis identifies safety,
pharmacokinetic or other related issues that may be relevant to a
Product [***] Isis will promptly inform OncoGenex of such issues,
and if requested, provide the data and information supporting
Isis’ conclusions regarding such issues. In addition, at
OncoGenex’ reasonable request and at no cost to OncoGenex,
Isis will [***] the Isis Database to provide OncoGenex information
regarding [***] or other related issues.
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5.3.3 To the extent OncoGenex or its Affiliate obtains
safety and tolerability data or information specifically regarding
a Product, and such data or information is subject to any
restrictions or obligations imposed by a Third Party clinical site,
OncoGenex shall use commercially reasonable efforts to obtain from
such Third Party clinical site (a) the right to provide to
Isis the data and information described in this Section 5.3,
and (b) the right of Isis to use such data and information for
the purposes described in this Section 5.3.
ARTICLE 6
FINANCIAL PROVISIONS
Section 6.1 Initial Payment by OncoGenex.
The Parties acknowledge and agree
that OncoGenex paid to Isis $500,000 (U.S.) under section 5.1 of
the Original Collaboration Agreement.
Section 6.2 Royalty Payments by OncoGenex; Royalty
Term.
6.2.1 Royalty Rate. In consideration of Isis’ collaborative
efforts under the Original Collaboration Agreement and the licenses
and assignments granted hereunder, OncoGenex will pay Isis a base
royalty of [***]% of the Net Sales of a Product. In addition,
OncoGenex will pay Isis [***]% of Royalty Revenue in excess of
[***]% of Net Sales of Third Parties to a maximum additional
royalty payable to Isis of [***]% of Net Sales of Third
Parties.
6.2.2 [***] . Notwithstanding anything to the
contrary in this Agreement, if (i) OncoGenex has an agreement
with a Third Party for the further development or commercialization
of a Product pursuant to which such Third Party is selling the
Product (a “Commercialization Agreement”),
(ii) under such Commercialization Agreement the [***] by such
Third Party to OncoGenex [***] of such Product under such
Commercialization Agreement [***] and (iii) a [***] in any
country would not be infringed by the making, using or selling of a
Product in such country by an unauthorized party, then with respect
to such Product in such country, (a) the applicable [***]%
base royalty rate, and the [***]% threshold for and [***]% cap on
the additional royalty, under Section 6.2.1 above shall be
[***] as such [***] and (b) the aggregate royalty owing to
Isis shall not exceed [***] of the Royalty Revenue retained by
OncoGenex.
(a) Notwithstanding anything to the contrary in this
Agreement, subject to Section 6.2.3(c), if (i) OncoGenex
has a Commercialization Agreement, and (ii) under such
Commercialization Agreement the [***] to OncoGenex on the [***]
under such agreement because [***] then with respect to such
Product, the applicable [***]% royalty rate, and the [***]%
threshold and the [***] on the additional royalty under
Section 6.2.1 above shall be reduced in the same manner and in
the same proportion as such [***].
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(b) Notwithstanding anything to the contrary in this
Agreement, subject to Section 6.2.3(c) if (i) OncoGenex
does not have a Commercialization Agreement, and (ii) in any
quarter, there are one or more [***] OncoGenex may [***] above on a
country-by-country and Product-by-Product basis by [***] represents
of the [***] in such country as reported by IMS plus (b) [***] in
such country, in each case in such quarter. By way of example, if
in any quarter the [***] in a country represents 50% of the [***]
of the Product plus all [***] OncoGenex may reduce the royalties
due to Isis under Section 6.2.1 by [***] in such country.
Nothing in this Section 6.2.3 shall modify the obligations of
OncoGenex under [***] required pursuant to the [***] Agreement and
the [***] Agreement.
(c) This Section will not apply to [***] by Isis or
a Third Party in a country under a license granted by Isis pursuant
to Section 12.2.2, unless a Valid Claim within the
Product-Specific Technology Patents, Isis Core Technology Patents,
Isis Manufacturing Patents or Joint Patents in such country would
not be infringed by the making, using or selling of such Product in
such country by an unauthorized party.
6.2.4 Third Party Payments.
In addition to the royalty set forth
in Section 6.2.1, OncoGenex will pay to Isis (i) a
royalty of [***]% of Net Sales of such Product to the extent
required pursuant to the [***] Agreement; and (ii) a royalty
of [***]% of Net Sales of such Product to the extent required
pursuant to the [***] Agreement. In the event that Isis negotiates
a reduction or elimination of the royalties with [***] or [***]
following the Amendment Effective Date, the royalties due under the
referenced license agreements will still be paid to
Isis.
6.2.5 Noncumulative Relief.
If the conditions described in
Sections 6.2.2 and 6.2.3 have been met such that, under both
provisions, OncoGenex would be entitled to [***] OncoGenex may
[***] by applying the greater of the [***] such that under no
circumstances will Sections 6.2.2 and 6.2.3 work together to
cumulatively [***].
Section 6.3 Royalty Term. Royalties payable under Section 6.2 will be
payable for each Product on a country-by-country basis from the
first commercial sale of a Product in such country until the date
that is the later of (i) [***] after the first commercial sale of a
Product in such country or (ii) the expiration of the last to
expire Valid Claim within the Product-Specific Technology Patents,
Isis Core Technology Patents, Isis Manufacturing Technology or
Joint Patents which would be infringed by the making, using or
selling of the applicable Product in the applicable country by an
unauthorized party.
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Section 6.4 Timing of Royalty Payments; Preliminary
Report.
6.4.1 The royalties calculated in Sections 6.2 or
6.3 will become due and payable within 40 days after each
respective Royalty Due Date and will be calculated in respect of
the Net Sales in the calendar quarter period ending with the
applicable Royalty Due Date; provided, however , that if the
royalties are adjusted in accordance with Section 6.2.3, then
such royalties will become due and payable within the later of
(a) forty (40) days after each respective Royalty Due
Date, and (b) fifteen (15) days after the applicable IMS
data is available for the applicable quarter as necessary to fully
calculate the royalty reduction under Section 6.2.3.
Furthermore, OncoGenex agrees to supply Isis the information Isis
reasonably requires to comply with any third party payments under
Section 6.3. In the event the applicable IMS data is no longer
available, the Parties agree to negotiate in good faith a
reasonable, mutually-acceptable data source to be used in place of
IMS data for purposes of calculating the royalty reduction under
Section 6.2.3. In the event the applicable IMS data (or other
reasonable, mutually-acceptable data described above) is only
available on a date that is significantly later than forty
(40) days after the respective Royalty Due Date, the Parties
agree to negotiate in good faith a reasonable, mutually-acceptable
mechanism providing for the payment by OncoGenex, within forty
(40) days after the respective Royalty Due Date, of the
estimated royalty payment for a quarter based on commercially
reasonable assumptions, and the prompt true-up (in the form of an
additional payment, repayment or credit, as applicable) of such
estimated payment once the actual royalty payment for such quarter
may be calculated.
6.4.2 In addition, during the Term following the first
commercial sale of any Product, within 10 Business Days after the
Royalty Due Date, OncoGenex will provide Isis a preliminary
non-binding quarterly royalty report estimating the total Net Sales
of Product and royalty payable for such calendar quarter. Unless
required by applicable law or OncoGenex has already publicly
disclosed such information, Isis shall not directly or indirectly
in any manner whatsoever, publicly disclose the information
contained in the preliminary royalty report estimate without first
confirming such information against the payment made by OncoGenex
under Section 6.4.1 above for the applicable period, and
without expressly acknowledging that such information is a
preliminary non-binding estimate only. Notwithstanding anything to
the contrary in this Agreement, (a) any breach by Isis of its
obligations under Section 6.4.2 shall constitute a material
breach under this Agreement, and (b) OncoGenex will not be
liable to Isis for any Loss Isis may suffer as a result of Isis
publicly disclosing information contained in such a preliminary
non-binding quarterly royalty report estimate.
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Section 6.5 Non-Royalty Revenue Payments by
OncoGenex. Non-Royalty
Revenue will be allocated between the Parties based on the timing
of when OncoGenex signs a sublicensing agreement with a Third Party
for the Product as follows:
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Timing of
signing a
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Isis share of
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OncoGenex share of
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sublicensing
agreement
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Non-Royalty
Revenue
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Non-Royalty
Revenue
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(a) Prior to the initiation (i.e. first
patient dosed) of a first Registration Clinical Trial for a
Product
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30
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%
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70
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%
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(b) After (a) but prior to enrolling
20% of the planned patients in the first Registration Clinical
Trial for a Product
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25
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%
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75
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%
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(c) After (b) but prior to obtaining
marketing approval from a Regulatory Authority
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20
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%
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80
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%
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15
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%
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85
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%
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6.5.1 Third Party Payments on Non-Royalty
Revenue. Isis will be
solely responsible for passing through the Third Party Payments
owing to [***] and [***] on Non-Royalty Revenue, if any.
Section 6.6 Timing of Non-Royalty Revenue
Payments. Isis share of
Non-Royalty Revenue calculated in Section 6.5 will become due
and payable within twenty-one (21) days after receipt of the
applicable Non-Royalty Revenue by OncoGenex.
Section 6.7 Payment Method. Any amounts due to Isis pursuant to this
Agreement will be paid in U.S. dollars by wire transfer in
immediately available funds to an account designated by Isis. Any
payments or portions thereof due hereunder which are not paid on
the date such payments are due under this Agreement will bear
interest at a rate equal to the lesser of the prime rate as
published in The Wall Street Journal , Eastern Edition, on
the first day of each calendar quarter in which such payments are
overdue, plus two percent (2%), or the maximum rate permitted by
law, whichever is lower, calculated on the number of days such
payment is delinquent, compounded monthly.
Section 6.8 Currency; Foreign Payments.
If any currency conversion will be
required in connection with any payment hereunder, such conversion
will be made by using the daily noon buying rates as published by
the Federal Reserve Bank of New York on the last business day of
the calendar quarter to which such payments relate. If at any time
legal restrictions prevent the prompt remittance of any payments in
any jurisdiction, OncoGenex may notify Isis and make such payments
by depositing the amount thereof in local currency in a bank
account or other depository in such country in the name of Isis or
its designee, and OncoGenex will have no further obligations under
this Agreement with respect thereto.
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Section 6.9 Taxes. OncoGenex may deduct from any amounts it is
required to pay to Isis pursuant to this Agreement an amount equal
to that withheld for or due on account of any taxes (other than
taxes imposed on or measured by net income) or similar governmental
charge imposed on Isis by a jurisdiction of OncoGenex
(“Withholding Taxes”). OncoGenex will provide Isis a
certificate evidencing payment of any Withholding Taxes hereunder
within 30 days of such payment. OncoGenex will notify Isis as
soon as practicable once OncoGenex has determined it will deduct
the amount of any Withholding Taxes from its payments to Isis under
this Section 6.9. Each Party agrees to cooperate with the
other Party in claiming refunds or exemptions from such deductions
or withholdings under any relevant agreement or treaty which is in
effect. The Parties shall discuss applicable mechanisms for
minimizing such taxes to extent possible in compliance with
Applicable Law. In addition, the Parties shall cooperate in
accordance with Applicable Law to minimize indirect taxes (such as
value added tax, sales tax, consumption tax and other similar
taxes) in connection with this Agreement.
Section 6.10 Records Retention; Audit.
6.10.1 Regulatory Records.
With respect to the subject matter
of this Agreement, OncoGenex will maintain, or cause to be
maintained, records of its research, development, manufacturing and
commercialization activities, including all Regulatory
Documentation, pursuant to its standard operating procedures. All
Regulatory Documentation will be retained for a period at least as
may be required by Applicable Law.
6.10.2 Record Retention. OncoGenex will maintain (and will ensure that
its sublicensees will maintain) complete and accurate books,
records and accounts that fairly reflect Revenue and the royalties
payable to Isis under this Agreement (including the calculation of
Net Sales and any adjustments under Section 6.2) with respect
to the Product in sufficient detail to confirm the accuracy of any
payments required hereunder and in accordance with GAAP, which
books, records and accounts will be retained until the later of
(i) 3 years after the end of the period to which such
books, records and accounts pertain, and (ii) the expiration
of the applicable tax statute of limitations (or any extensions
thereof), or for such longer period as may be required by
Applicable Law.
6.10.3 Audit. Isis will have the right to have an independent
certified public accounting firm of nationally recognized standing,
reasonably acceptable to OncoGenex, have access during normal
business hours, and upon reasonable prior written notice, to such
of the records of OncoGenex as may be reasonably necessary to
verify the accuracy of Revenues for any calendar quarter or
calendar year ending not more than 24 months prior to the date
of such request; provided, however , that Isis will not have
the right to conduct more than one such audit in any Calendar Year
except as provided below. Isis will bear the cost of such audit
unless the audit reveals a variance of more than 5% from the
reported results, in which case OncoGenex will bear the cost of the
audit. Isis will have the right to audit previous years, if such
years have not been previously audited, if the audit reveals a
variance of more than 5% from the reported results. Isis will bear
the cost of such previous year audits unless such audits reveal a
variance of more than 5%. The results of such accounting firm will
be final and binding upon each of Isis and OncoGenex, absent
manifest error.
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6.10.4 Payment of Additional Amounts.
If, based on the results of such
audit, additional payments are owed by OncoGenex under this
Agreement, OncoGenex will make such additional payments, with
interest from the date originally due at the rate of 1% per month,
within 60 days after the date on which such accounting
firm’s written report is delivered to OncoGenex.
6.10.5 Confidentiality. Isis will treat all information subject to
review under this Section 6.10 as OncoGenex’
Confidential Information in accordance with the confidentiality
provisions of Article 7 and will cause its accounting firm to
enter into a reasonably acceptable confidentiality agreement with
OncoGenex obligating such firm to maintain all such financial
information in confidence pursuant to such confidentiality
agreement. The accounting firm will disclose to Isis only whether
the reports are correct or not and the amount of any discrepancy.
No other information will be shared.
ARTICLE 7
CONFIDENTIALITY
Section 7.1 Disclosure and Use Restriction.
Except as expressly provided herein,
the Parties agree that, for the Term and for five (5) years
thereafter, each Party will keep completely confidential and will
not publish, submit for publication or otherwise disclose, and will
not use for any purpose except for the purposes contemplated by
this Agreement, any Confidential Information received from the
other Party.
7.1.1 Authorized Disclosure.
Each Party may disclose Confidential
Information of the other Party to the extent that such disclosure
is:
(a) made in response to a valid order of a court of
competent jurisdiction; provided, however , that such Party
will first have given notice to such other Party and given such
other Party a reasonable opportunity to quash such order and to
obtain a protective order requiring that the Confidential
Information and documents that are the subject of such order be
held in confidence by such court or agency or, if disclosed, be
used only for the purposes for which the order was issued; and
provided further that if a disclosure order is not quashed or a
protective order is not obtained, the Confidential Information
disclosed in response to such court or governmental order will be
limited to that information which is legally required to be
disclosed in response to such court or governmental
order;
(b) otherwise required by law; provided,
however , that the disclosing Party will provide such other
Party with notice of such disclosure in advance thereof to the
extent practicable;
(c) made by such Party to the Regulatory Authorities
as required in connection with any filing, application or request
for Regulatory Approval; provided, however , that reasonable
measures will be taken to assure confidential treatment of such
information;
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(d) made by such Party, in connection with the
performance of this Agreement, to permitted sublicensees,
licensors, directors, officers, employees, consultants,
representatives or agents, each of whom prior to disclosure must be
bound by obligations of confidentiality and non-use at least
equivalent in scope to those set forth in this Article 7;
or
(e) made by such Party to existing or potential
acquirers; existing or potential pharmaceutical collaborators (to
the extent contemplated hereunder); investment bankers; existing or
potential investors, merger candidates, partners, venture capital
firms or other financial institutions or investors for purposes of
obtaining financing; or, bona fide strategic potential partners;
each of whom prior to disclosure must be bound by obligations of
confidentiality and non-use at least equivalent in scope to those
set forth in this Article 7.
7.2.1 Press Releases Regarding
Agreement. Upon execution
of this Agreement, the Parties shall issue a joint press release
announcing the existence of this Agreement in a form and substance
agreed to in writing by the Parties. Each Party agrees not to issue
any other press release or other public statement disclosing other
information relating to this Agreement or the transactions
contemplated hereby without the prior written consent of the other
Party, except for those communications required by Applicable Law
or court order, disclosures of information for which consent has
previously been obtained, and information of a similar nature to
that which has been previously disclosed publicly with respect to
this Agreement, each of which will not require advance approval,
but will be provided to the other Party as soon as practicable
after the release or communication thereof.
7.2.2 Press
Releases Regarding Products.
(a) OncoGenex may publish, present or otherwise
disclose results regarding OGX-011 or Product to the public at its
sole discretion; however , any press release or other
similar public communication by either Party related to a
Product’s efficacy or safety data and/or results, will be
submitted to the other Party for review at least 4 Business Days in
advance of such proposed public disclosure. Notwithstanding the
foregoing, if the Party is making a disclosure that is reasonably
required by applicable law, regulation or court order and cannot
practically submit the disclosure to the other Party within the 4
Business Day advance notice period above, the disclosing Party may
provide the other Party the disclosure [***] advance notice as is
practical under the circumstances, but in any event at least [***]
written notice. OncoGenex may satisfy its notice obligation under
this Section 7.2.2(a) by emailing and telephoning either
Isis’ Chief Executive Officer or Chief Operating Officer, and
Isis may satisfy its notice obligation under this
Section Section 7.2.2(a) by emailing and telephoning
OncoGenex’ Chief Executive Officer.
(b) In addition, each Party will immediately notify
(and provide as much advance notice as possible to) the other of
any event materially related to Product (including any regulatory
approval) so that the Parties may analyze the need to or
desirability of publicly disclosing or reporting such
event.
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ARTICLE 8
TECHNOLOGY AND PATENTS
8.1.1 Ownership of Technology and
Patents.
(a) As between OncoGenex and Isis, Isis will solely
own all right, title and interest to the Isis Core Technology, Isis
Core Technology Patents, Isis Manufacturing Technology and Isis
Manufacturing Patents.
(b) As between OncoGenex and Isis, OncoGenex will
solely own all right, title and interest to the OncoGenex
Technology and OncoGenex Technology Patents.
(c) Except as otherwise set forth in clauses
(a) and (b) above, and in Section 4.2.1, as between
OncoGenex and Isis, (i) OncoGenex will solely own all right,
title and interest in all discovery, invention, data, information,
trade secret, know-how or other technology (the
“Technology”) conceived or reduced to practice solely
by employees or agents of OncoGenex, together with all patents and
other intellectual property rights therein and thereto;
(ii) Isis will solely own all right, title and interest in and
to all Technology conceived or reduced to practice solely by
employees or agents of Isis, together with all patents and other
intellectual property rights therein and thereto; and
(iii) OncoGenex and Isis will jointly own all right, title and
interest in all Joint Technology, together with all patents and
other intellectual property rights therein and thereto. Each party
will have the right, subject to the provisions of this Agreement,
to freely exploit, transfer, license or encumber its rights in any
Joint Patents without the consent of, or payment or accounting to,
the other party.
8.1.2 Ownership of Regulatory
Documentation. All
Regulatory Documentation with respect to the Product will be owned
by OncoGenex.
Section 8.2 Prosecution of Patents.
8.2.1 Isis Rights. Isis will have the sole right, at its cost and
expense and at its sole discretion, to obtain, prosecute and
maintain throughout the world the Isis Patent Rights, including,
but not limited to the Isis Core Technology Patents and the Isis
Manufacturing Patents, but excluding the Product-Specific
Technology Patents and the Joint Patents. Isis will keep OncoGenex
informed of the status of all Isis Core Technology Patents and Isis
Manufacturing Patents by way of an annual listing and reasonably
detailed written status report.
8.2.2 OncoGenex Rights. OncoGenex will have the sole right, at its cost
and expense and at its sole discretion, to file, obtain, prosecute
and maintain throughout the world any OncoGenex Technology Patents,
Product-Specific Technology Patents and the Joint
Patents.
8.2.3 Cooperation. Each Party will cooperate in the preparation,
filing, prosecution, and maintenance of the other Party’s
Patents, the Product-Specific Technology Patents and the Joint
Patents, as required. Such cooperation includes promptly executing
all papers and instruments and requiring employees to execute such
papers and instruments as reasonable and appropriate so as to
enable such other Party, to file, prosecute, and maintain its
Patents in any country.
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Section 8.3 Enforcement of Patents.
8.3.1 Rights and Procedures.
If Isis or OncoGenex determines that
any Isis Patent Rights or OncoGenex Patent Rights are being
infringed by a Third Party’s activities and that such
infringement could affect the exercise by OncoGenex of its rights
under this Agreement, it will promptly notify the other Party in
writing and provide such other Party with any evidence of such
infringement that is reasonably available.
(a) Isis Core Technology Patents and Isis
Manufacturing Patents. Subject to 8.3.1(e) Isis will have the sole
right, but not the obligation, at its own expense, to remove
infringement of Isis Core Technology Patents and Isis Manufacturing
Patents using commercially appropriate steps, including the filing
of an infringement suit or taking other similar action, and
OncoGenex or a Third Party licensee of the Product will have the
right, at its own expense, to be represented in any such action;
provided, however , that (i) if Isis fails to bring an
action or proceeding within ninety (90) days following notice
of such infringement, or earlier notifies OncoGenex or a Third
Party licensee of the Product in writing of its intent not to take
such steps, and (ii) the infringement is likely to have a
material adverse effect on OncoGenex’ or a
sub-licensee’ development, manufacture, production, release
or commercialization of the Product, then OncoGenex and/or the
Third Party licensee of the Product will meet with Isis to
determine whether to defend against such infringement, and if the
Parties mutually agree in writing to proceed in defending such
infringement, Isis will remove the infringement using commercially
appropriate steps, and OncoGenex or the Third Party will share in
the reasonable costs incurred relating to the removal of any such
infringement on an equal basis. If however, (i) the Parties
cannot mutually agree in writing to proceed in removing such
infringement, (ii) the product in question is a Competing
Product, and (iii) OncoGenex requests in writing that Isis
remove such infringement (an “OncoGenex Mandate”), then
Isis (at OncoGenex’ sole expense) will remove the
infringement using commercially appropriate steps. In either case,
Isis may not settle, or otherwise consent to an adverse judgment
in, such infringement that diminishes the rights or interests of
OncoGenex without the prior express written consent of
OncoGenex.
(b) In the event of an (i) OncoGenex Mandate
(ii) Isis refuses to remove the infringement in a country
using commercially appropriate steps (as determined, if necessary,
in accordance with the dispute resolution provisions in
Section 13.15) and (iii) such Competing Product is
actually being sold in such country, then the [***].
(c) OncoGenex Technology
Patents. Subject to
8.3.1(e) OncoGenex will have the sole right, but not the
obligation, at its own expense, to remove infringement of OncoGenex
Technology Patents using commercially appropriate steps, including
the filing of an infringement suit or taking other similar action,
and Isis will have the right, at its own expense, to be represented
in any such action.
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(d) Product-Specific Technology Patents and
Joint Patents. Subject to
8.3.1(e) OncoGenex will have the sole right, but not the
obligation, at its own expense, to remove infringement of
Product-Specific Technology Patents and Joint Patents using
commercially appropriate steps, includi
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