Exhibit 10.36
EXECUTION VERSION
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:
ARTICLE 1
DEFINITIONS
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.
 

      *  
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.

 

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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.
6.2.3 [***].
(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:

                  Timing of signing a   Isis share of     OncoGenex share of  
sublicensing agreement   Non-Royalty Revenue     Non-Royalty Revenue  
 
               
(a) Prior to the initiation (i.e. first patient dosed) of a first Registration
Clinical Trial for a Product
    30 %     70 %
 
               
(b) After (a) but prior to enrolling 20% of the planned patients in the first
Registration Clinical Trial for a Product
    25 %     75 %
 
               
(c) After (b) but prior to obtaining marketing approval from a Regulatory
Authority
    20 %     80 %
 
               
(d) After (c)
    15 %     85 %

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.
Section 7.2 Publicity.
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
Section 8.1 Ownership.
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, 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; provided, however, that if the
Product has not been sublicensed to a Third Party and OncoGenex fails to bring
an action or proceeding within ninety (90) days following notice of such
infringement, or earlier notifies Isis in writing of its intent not to take such
steps, Isis will have the right to do so at its expense, and OncoGenex will have
the right, at its own expense, to be represented in any such action.
Notwithstanding the foregoing, if the infringement is likely to have a material
adverse effect on Isis’ economic interest in the Product’s development or
commercialization, Isis and OncoGenex will meet to determine whether to defend
against such infringement, and if the Parties mutually agree to proceed in
defending such infringement, OncoGenex will remove the infringement using
commercially appropriate steps, and Isis and OncoGenex will share in the
reasonable costs incurred relating to the removal of any such infringement on an
equal basis.
(e) Cooperation. The Party not enforcing the applicable Patent will provide
reasonable assistance to the other Party, including, but not limited to,
providing access to relevant documents and other evidence, making its employees
available at reasonable business hours, and joining the action to the extent
necessary to allow the enforcing Party to maintain the action.
8.3.2 Recovery. Any amounts recovered by either or both Parties, including Third
Party licensees in connection with or as a result of any action contemplated by
Section 8.3.1, whether by settlement or judgment, will be used to reimburse the
Parties, including Third Party licensees for their reasonable costs and expenses
in making such recovery (which amounts will be allocated pro rata if
insufficient to cover the totality of such expenses). Furthermore, if Isis is
enforcing Party under Section 8.3.1(a) or OncoGenex is the enforcing party,
after reimbursing the Parties in accordance with the preceding sentence,
OncoGenex will retain any remainder of the recovery as Net Sales and royalties
will be payable by OncoGenex to Isis with respect to such Net Sales in
accordance with this Agreement. If Isis is the enforcing party other than as set
forth in Section 8.3.1(a), after reimbursing the Parties in accordance with the
first sentence of this Section, any remainder will be kept by Isis.
Section 8.4 Third Party Litigation. In the event that a Third Party institutes a
patent infringement suit (including any suit alleging the invalidity or
unenforceability of the Patents of a Party) against either Party or Third Party
licensees during the Term of this Agreement, alleging that any of the activities
hereunder infringes one or more patent or other intellectual property rights
held by such Third Party (an “Infringement Suit”), the Parties will cooperate
with one another in defending such suit. Isis will have the sole right to
control any defense of any such claim involving alleged infringement of Third
Party rights by Isis’ activities at its own expense and by counsel of its own
choice, and OncoGenex will have the right, at its own expense, to be represented
in any such action by counsel of its own choice. OncoGenex will have the sole
right to control any defense of any such claim involving alleged infringement of
Third Party rights by OncoGenex’ activities, or that relates to the development,
manufacture, production, release and commercialization of the Product, at its
own expense and by counsel of its own choice, and Isis will have the right, at
its own expense, to be represented in any such action by additional counsel of
its own choice at its own expense.

 

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Section 8.5 No Challenge. During the term of this Agreement, OncoGenex, its
Affiliates and sublicensees will not, directly or indirectly, and will not
collaborate with, or otherwise authorize any Third Party to challenge any Isis
Patent Rights licensed by Isis to OncoGenex under this Agreement, including
through opposition, re-examination, nullity or revocation proceeding, or other
available administrative mechanism; provided, however, that, notwithstanding the
foregoing, OncoGenex, its Affiliates and sublicensees shall have the right to
comply with a subpoena duly issued in good faith by a Third Party, court or
administrative order, or similar legal process for testimony or the production
of documents.
ARTICLE 9
TERM AND TERMINATION
Section 9.1 Term. The term of this Agreement (the “Term”) will continue in
effect until such time as any Product is no longer being developed,
manufactured, produced, released or commercialized hereunder, or unless
terminated at an earlier date in accordance with the terms and conditions set
forth in this Article 9. Isis will have the right to terminate this Agreement
and/or any license granted by it hereunder solely in accordance with Article 12.
Section 9.2 Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by Isis to OncoGenex are, and will otherwise be
deemed to be, for purposes of Section 365(n) of the United States Bankruptcy
Code, licenses of rights to “intellectual property” as defined under Section 101
of the United States Bankruptcy Code. The Parties agree that OncoGenex, as a
licensee of such rights under this Agreement, will retain and may fully exercise
all of its rights and elections under the United States Bankruptcy Code. The
Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against Isis under the United States Bankruptcy Code, OncoGenex
will be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, which, if not already in OncoGenex’ possession, will be
promptly delivered to it (a) upon any such commencement of a bankruptcy
proceeding upon OncoGenex’ written request therefor, unless Isis elects to
continue to perform all of its obligations under this Agreement or (b) if not
delivered under clause (a) above, following the rejection of this Agreement by
or on behalf of Isis upon written request therefor by OncoGenex.
Section 9.3 Consequences of Expiration or Termination.
9.3.1 Licenses. Upon expiration of the Term of this Agreement in accordance with
Section Section 9.1 and payment of all amounts owed pursuant to this Agreement,
the licenses granted by Isis to OncoGenex hereunder will terminate.
9.3.2 Return of Information and Materials. Upon expiration of this Agreement
pursuant to Section Section 9.1 or upon termination of this Agreement in its
entirety by either Party pursuant to this Article 9, each Party, at the request
of the other Party, will return all data, files, records and other materials in
its possession or control relating to such other Party’s Technology, or
containing or comprising such other Party’s Information and Inventions or other
Confidential Information and, in each case, to which the returning Party does
not retain rights hereunder (except one copy of which may be retained for
archival purposes). Notwithstanding the foregoing, each Party may retain one
(1) copy of the other Party’s Confidential Information for its legal archives.

 

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Section 9.4 Accrued Rights; Surviving Obligations.
9.4.1 Accrued Rights. Termination or expiration of this Agreement for any reason
will be without prejudice to any rights or financial compensation that will have
accrued to the benefit of a Party prior to such termination or expiration. Such
termination or expiration will not relieve a Party from obligations that are
expressly indicated to survive the termination or expiration of this Agreement.
9.4.2 Survival. Articles 7, 10, 12 and 13 of this Agreement, and Sections 4.2.1,
6.10, 8.1, 9.3, 9.4 and 11.4 will survive expiration or termination of this
Agreement for any reason.
ARTICLE 10
INDEMNIFICATION AND INSURANCE
Section 10.1 Indemnification of Isis. OncoGenex will indemnify Isis, and their
respective directors, officers, employees and agents, and defend and hold each
of them harmless, from and against any and all losses, damages, liabilities,
costs and expenses (including reasonable attorneys’ fees and expenses) but only
to the extent arising from or occurring as a result of any and all liability
suits, investigations, claims, demands or actions by a Third Party
(collectively, “Losses” and each a “Loss”) to the extent arising from or
occurring as a result of (a) whether or not negligence is found, the
development, manufacture, use, handling, storage, sale or other
commercialization or disposition of OGX-011 or any Product by OncoGenex or its
Affiliates or licensees, (b) any material breach by OncoGenex of this Agreement,
or (c) the gross negligence or willful misconduct on the part of OncoGenex or
its licensees or sublicensees in performing any activity contemplated by this
Agreement, except for those Losses for which Isis has an obligation to indemnify
OncoGenex pursuant to Section 10.2, as to which Losses each Party will indemnify
the other to the extent of their respective liability for the Losses.
Section 10.2 Indemnification of OncoGenex. Isis will indemnify OncoGenex, and
their respective directors, officers, employees and agents, and defend and save
each of them harmless, from and against any and all Losses to the extent arising
from or occurring as a result of (a) any material breach by Isis of this
Agreement, or (b) the gross negligence or willful misconduct on the part of Isis
or its licensees or sublicensees in performing any activity contemplated by this
Agreement, except for those Losses for which OncoGenex has an obligation to
indemnify Isis pursuant to Section 9.1, as to which Losses each Party will
indemnify the other to the extent of their respective liability for the Losses.
Section 10.3 Indemnification Procedure.
10.3.1 Notice of Claim. The indemnified Party will give the indemnifying Party
prompt written notice (an “Indemnification Claim Notice”) of any Loss upon which
such indemnified Party intends to base a request for indemnification under
Section 10.1 or Section 10.2, but in no event will the indemnifying Party be
liable for any Losses that result from any delay in providing such notice. Each
Indemnification Claim Notice must contain a description of the Loss and the
nature and amount of such Loss (to the extent that the nature and amount of such
Loss are known at such time). The indemnified Party will furnish promptly to the
indemnifying Party copies of all papers and official documents received in
respect of such Loss. All indemnification claims in respect of a Party, its
Affiliates or their respective directors, officers, employees and agents
(collectively, the “Indemnitees” and each an “Indemnitee”) will be made solely
by such Party to this Agreement (the “Indemnified Party”).

 

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10.3.2 Third Party Claims. The obligations of an indemnifying Party under this
Article 10 with respect to Losses arising from claims of any Third Party that
are subject to indemnification as provided for in Section 10.1 or 10.2 (a “Third
Party Claim”) will be governed by and be contingent upon the following
additional terms and conditions:
(a) Control of Defense. At its option, the indemnifying Party may assume the
defense of any Third Party Claim by giving written notice to the Indemnified
Party within 30 days after the indemnifying Party’s receipt of an
Indemnification Claim Notice. The assumption of the defense of a Third Party
Claim by the indemnifying Party will not be construed as an acknowledgment that
the indemnifying Party is liable to indemnify any Indemnitee in respect of the
Third Party Claim, nor will it constitute a waiver by the indemnifying Party of
any defenses it may assert against any Indemnitee’s claim for indemnification.
Upon assuming the defense of a Third Party Claim, the indemnifying Party may
appoint as lead counsel in the defense of the Third Party Claim any legal
counsel selected by the indemnifying Party. In the event the indemnifying Party
assumes the defense of a Third Party Claim, the Indemnified Party will
immediately deliver to the indemnifying Party all original notices and documents
(including court papers) received by any Indemnitee in connection with the Third
Party Claim. Should the indemnifying Party assume the defense of a Third Party
Claim, the indemnifying Party will not be liable to the Indemnified Party or any
other Indemnitee for any legal expenses subsequently incurred by such
Indemnified Party or other Indemnitee in connection with the analysis, defense
or settlement of the Third Party Claim. In the event that it is ultimately
determined that the indemnifying Party is not obligated to indemnify, defend or
hold harmless an Indemnitee from and against the Third Party Claim, the
Indemnified Party will reimburse the indemnifying Party for any and all costs
and expenses (including attorneys’ fees and costs of suit) and any Losses
incurred by the indemnifying Party in its defense of the Third Party Claim with
respect to such Indemnitee.
(b) Right to Participate in Defense. Without limiting Section 10.3.2(a), any
Indemnitee will be entitled to participate in, but not control, the defense of
such Third Party Claim and to employ counsel of its choice for such purpose;
provided, however, that such employment will be at the Indemnitee’s own expense
unless (i) the employment thereof has been specifically authorized by the
indemnifying Party in writing, or (ii) the indemnifying Party has failed to
assume the defense and employ counsel in accordance with Section 10.3.2(a) (in
which case the Indemnified Party will control the defense).

 

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(c) Settlement. With respect to any Losses relating solely to the payment of
money damages in connection with a Third Party Claim and that will not result in
the Indemnitee’s becoming subject to injunctive or other relief or otherwise
adversely affect the business of the Indemnitee in any manner, and as to which
the indemnifying Party will have acknowledged in writing the obligation to
indemnify the Indemnitee hereunder, the indemnifying Party will have the sole
right to consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Loss, on such terms as the indemnifying Party, in its
sole discretion, will deem appropriate. With respect to all other Losses in
connection with Third Party Claims, where the indemnifying Party has assumed the
defense of the Third Party Claim in accordance with Section 9.3.2(a), the
indemnifying Party will have authority to consent to the entry of any judgment,
enter into any settlement or otherwise dispose of such Loss provided it obtains
the prior written consent of the Indemnified Party (which consent will not be
unreasonably withheld or delayed). The indemnifying Party will not be liable for
any settlement or other disposition of a Loss by an Indemnitee that is reached
without the written consent of the indemnifying Party. Regardless of whether the
indemnifying Party chooses to defend or prosecute any Third Party Claim, no
Indemnitee will admit any liability with respect to, or settle, compromise or
discharge, any Third Party Claim without the prior written consent of the
indemnifying Party.
(d) Cooperation. Regardless of whether the indemnifying Party chooses to defend
or prosecute any Third Party Claim, the Indemnified Party will, and will cause
each other Indemnitee to, cooperate in the defense or prosecution thereof and
will furnish such records, information and testimony, provide such witnesses and
attend such conferences, discovery proceedings, hearings, trials and appeals as
may be reasonably requested in connection therewith. Such cooperation will
include access during normal business hours afforded to the indemnifying Party
to, and reasonable retention by the Indemnified Party of, records and
information that are reasonably relevant to such Third Party Claim, and making
Indemnitees and other employees and agents available on a mutually convenient
basis to provide additional information and explanation of any material provided
hereunder, and the indemnifying Party will reimburse the Indemnified Party for
all its reasonable out-of-pocket expenses in connection therewith.
(e) Expenses. Except as provided above, the reasonable and verifiable costs and
expenses, including fees and disbursements of counsel, incurred by the
Indemnified Party in connection with any claim will be reimbursed on a calendar
quarter basis by the indemnifying Party, without prejudice to the indemnifying
Party’s right to contest the Indemnified Party’s right to indemnification and
subject to refund in the event the indemnifying Party is ultimately held not to
be obligated to indemnify the Indemnified Party.
Section 10.4 Insurance. OncoGenex shall maintain product liability insurance
with respect to the development, manufacture and sale of Products hereunder by
OncoGenex in such amount as OncoGenex customarily maintains with respect to the
development, manufacture and sale of its similar products, but at a minimum an
amount that is customarily maintained by similar companies in the life sciences
industry with respect to the development, manufacture and sale of similar
products. OncoGenex shall maintain such insurance for so long as it continues to
develop, manufacture or sell any Product, and thereafter for so long as
OncoGenex customarily maintains insurance covering the development, manufacture
or sale of its similar products. Upon Isis’ request, OncoGenex will provide Isis
with a certificate of insurance evidencing such insurance.

 

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ARTICLE 11
REPRESENTATIONS AND WARRANTIES
Section 11.1 Representations, Warranties and Covenants. Each Party hereby
represents, warrants and covenants to the other Party as of the Amendment
Effective Date as follows:
11.1.1 Corporate Authority. Such Party (a) has the power and authority and the
legal right to enter into this Agreement and perform its obligations hereunder,
and (b) has taken all necessary action on its part required to authorize the
execution and delivery of this Agreement and the performance of its obligations
hereunder. This Agreement has been duly executed and delivered on behalf of such
Party and constitutes a legal, valid and binding obligation of such Party and is
enforceable against it in accordance with its terms subject to the effects of
bankruptcy, insolvency or other laws of general application affecting the
enforcement of creditor rights and judicial principles affecting the
availability of specific performance and general principles of equity, whether
enforceability is considered a proceeding at law or equity.
11.1.2 Litigation. Such Party is not aware of any pending or threatened
litigation (and has not received any communication) that alleges that such
Party’s activities related to this Agreement have violated, or that by
conducting the activities as contemplated herein such Party would violate, any
of the intellectual property rights of any other party.
11.1.3 Consents, Approvals, etc. All necessary consents, approvals and
authorizations of all Regulatory Authorities and other parties required to be
obtained by such Party in connection with the execution and delivery of this
Agreement and the performance of its obligations hereunder have been obtained.
11.1.4 Conflicts. The execution and delivery of this Agreement and the
performance of such Party’s obligations hereunder (a) do not conflict with or
violate any requirement of Applicable Law or any provision of the articles of
incorporation, bylaws or any similar instrument of such Party, as applicable, in
any material way, and (b) do not conflict with, violate, or breach or constitute
a default or require any consent under, any contractual obligation or court or
administrative order by which such Party is bound.
11.1.5 No Default. Such Party is not aware of any breach by it of any
representation, warranty, or covenant in the Original Collaboration Agreement.
Section 11.2 Additional Representations and Warranties of Isis.
11.2.1 Isis represents and warrants to OncoGenex that Isis is a corporation duly
organized, validly existing and in good standing under the laws of the State of
Delaware, and has full corporate power and authority and the legal right to own
and operate its property and assets and to carry on its business as it is now
being conducted and as it is contemplated to be conducted by this Agreement.

 

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11.2.2 Isis represents and warrants to OncoGenex that the rights granted by Isis
to OncoGenex as set forth in Article 4 include all necessary rights of Isis’
technology, whether or not patented or patentable, which are owned or Controlled
by Isis on the Amendment Effective Date and which are necessary or reasonably
required for OncoGenex to research develop, make, have made, use, sell, offer
for sale, have sold and import the Product. Further, Isis represents and
warrants to OncoGenex that Isis has not knowingly [***] whether or not patented
or patentable, to develop, make or use OGX-011 under the Original Collaboration
Agreement, that Isis could not [***] of this Agreement or that (in the case of
broadly commercially available reagents, equipment and software) is not
otherwise available on commercially reasonable terms along with the purchase or
lease of such reagents, equipment and software.
11.2.3 Isis represents and warrants to OncoGenex that (i) Section 9.6 of the
[***] Agreement states that the sublicense granted by Isis to OncoGenex under
the [***] Agreement will survive termination of the [***] Agreement, and
(ii) Section 4.3(b) of the [***] Agreement provides that if the [***] Agreement
is terminated for any reason, then [***] will promptly negotiate in good faith a
direct license of the sublicensed rights, on terms substantially similar to
those contained in this Agreement, with OncoGenex, unless the actions or
omissions of OncoGenex were a cause for termination of the [***] Agreement.
Section 11.3 Additional Representations and Warranties of OncoGenex. OncoGenex
represents and warrants to Isis that OncoGenex is a corporation duly organized,
validly existing and in good standing under the laws of Canada, and has full
corporate power and authority and the legal right to own and operate its
property and assets and to carry on its business as it is now being conducted
and as it is contemplated to be conducted by this Agreement.
Section 11.4 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH
IN SECTIONS 11.1, 11.2 AND 11.3, ONCOGENEX AND ISIS MAKE NO REPRESENTATIONS AND
GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW,
BY STATUTE OR OTHERWISE, AND ONCOGENEX AND ISIS EACH SPECIFICALLY DISCLAIM ANY
OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE
OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
ARTICLE 12
BREACH
Section 12.1 Material Breach by Isis. Failure by Isis to comply with any of its
material obligations contained herein (including, without limitation, its
technology transfer obligations under Section 4.2) will entitle OncoGenex to
give Isis notice specifying the nature of the material breach, requiring Isis to
make good or otherwise cure such default, and stating its intention to trigger
the provisions of this Article 12 if such default is not cured. If such default
is not cured within ninety (90) days after the receipt of such notice (or, if
such default cannot be cured within such ninety (90) day period, if Isis does
not commence actions to cure such default within such period and thereafter
diligently continue such actions or if such default is not otherwise cured
within ninety (90) days after the receipt of such notice), then OncoGenex will
be entitled to appeal to the Courts to enforce specific performance upon Isis
without prejudice to any of its other rights conferred on it by this Agreement,
and in addition to any other remedies available to the Courts as remedy for the
breach and to continue to develop or commercialize the Product independently of
Isis in accordance with this Agreement.

 

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Section 12.2 Breach by OncoGenex.
12.2.1 Failure to Pay. If OncoGenex is in material breach of OncoGenex’
obligation to make a payment to Isis under Article 6, then Isis may deliver
written notice of such breach to OncoGenex. OncoGenex will have thirty (30) days
following such notice to cure such breach. If OncoGenex receives written notice
of such breach and fails to cure such breach within the 30 day period, Isis may
declare a breach hereunder upon thirty (30) days advance written notice to
OncoGenex and such notice will effectively terminate this Agreement upon
expiration of such thirty (30) day period.
12.2.2 Discontinued Development. In the event of a Discontinuance or if
OncoGenex materially breaches its diligence obligations under Section 4.4 which
material breach is not cured by OncoGenex within ninety (90) days after receipt
of written notice from Isis describing such material breach in reasonably
specific detail, then in any such case, as Isis’ sole and exclusive remedy
therefor, Isis will have the right to terminate the [***] under [***] upon
thirty (30) days prior written notice to OncoGenex and in such case OncoGenex
will grant to Isis a worldwide license or sublicense, as the case may be, to the
OncoGenex Product-Specific Technology, OncoGenex Patents, OncoGenex Technology
and any Product-Specific Technology Patents assigned to OncoGenex under
Section 4.2.1 (in the case of OncoGenex Patents and OncoGenex Technology that
are the subject of one or more Third Party agreements, such license or
sublicense shall be subject to all restrictions and obligations (including
financial obligations) under such Third Party agreements) existing as of such
date solely to develop, make, have made, use, sell, offer for sale, have sold
and import Nonexclusive Clusterin ASOs (and any products containing such
Nonexclusive Clusterin ASOs). For purposes of this Section 12.2.2, “Nonexclusive
Clusterin ASOs” means ASOs that act predominantly by [***] Clusterin [***] or
that are [***] to Clusterin [***] provided, however that Nonexclusive Clusterin
ASOs will not include any ASO that (a) acts to modulate [***] Clusterin and
(b) either (i) has the same [***] as OGX-011 or (ii) at the time of such
Discontinuance or breach OncoGenex, its Affiliates or sublicensees had [***]
(each, an “Exclusive ASO”). Within ninety (90) days following the effectiveness
of any termination by Isis, pursuant to this Section 12.2.2, of the [***]
OncoGenex shall provide Isis with a list describing the [***].
ARTICLE 13
MISCELLANEOUS
Section 13.1 Force Majeure. Except for any failure to make any payment required
under Article 6, neither Party will be held liable or responsible to the other
Party or be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from events beyond the reasonable
control of the non-performing Party, including fires, floods, embargoes,
shortages, epidemics, quarantines, war, acts of war (whether war be declared or
not), insurrections, riots, civil commotion, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority. The non-performing Party will notify the other Party of
such force majeure within ten (10) days after such occurrence by giving written
notice to the other Party stating the nature of the event, its anticipated
duration, and any action being taken to avoid or minimize its effect. The
suspension of performance will be of no greater scope and no longer duration
than is necessary and the non-performing Party will use Commercially Reasonable
Efforts to remedy its inability to perform; provided, however, that in the event
the suspension of performance continues for one-hundred and eighty (180) days
after the date of the occurrence, the Parties will meet to discuss in good faith
how to proceed in order to accomplish the development and commercialization of
the Product as set forth in this Agreement.

 

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Section 13.2 Assignment. Without the prior written consent of the other Party
hereto, neither Party will sell, transfer, assign, delegate, pledge or otherwise
dispose of, whether voluntarily, involuntarily, by operation of law or
otherwise, this Agreement or any of its rights or duties hereunder; provided,
however, that (i) either Party hereto may assign or transfer this Agreement or
any of its rights or obligations hereunder without the consent of the other
Party to any Third Party with which it has merged or consolidated, or to which
it has transferred all or substantially all of its assets to which this
Agreement relates if in any such event the Third Party assignee or surviving
entity assumes in writing all of the assigning Party’s obligations under this
Agreement or (ii) Isis may assign or transfer its rights under Article 6 (but no
liabilities) to a Third Party in connection with a royalty (or payment)
factoring transaction. Any purported assignment or transfer in violation of this
Section will be void ab initio and of no force or effect.
Section 13.3 Severability. If any provision of this Agreement is held to be
illegal, invalid or unenforceable by a court of competent jurisdiction, such
adjudication will not affect or impair, in whole or in part, the validity,
enforceability, or legality of any remaining portions of this Agreement. All
remaining portions will remain in full force and effect as if the original
Agreement had been executed without the invalidated, unenforceable or illegal
part.
Section 13.4 Governing Law. This Agreement will be governed by and construed in
accordance with the laws of the Province of British Columbia without reference
to any rules of conflicts of laws.
Section 13.5 Notices. All notices or other communications that are required or
permitted hereunder will be in writing and delivered personally with
acknowledgement of receipt, sent by facsimile (and promptly confirmed by
personal delivery, registered or certified mail or overnight courier as provided
herein), sent by nationally-recognized overnight courier or sent by registered
or certified mail, postage prepaid, return receipt requested, addressed as
follows: If to OncoGenex, to:
OncoGenex Technologies Inc.
#400 — 1001 West Broadway
Vancouver, BC V6H 4B1
Attention: President
Facsimile: (604) 736-3687

 

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with a copy to:
Doug Seppala
DuMoulin Black LLP
10th Floor, 595 Howe Street
Vancouver, British Columbia V6C 2T5
Facsimile: (604) 687-3635
If to Isis, to:
Isis Pharmaceuticals, Inc.
1896 Rutherford Road
Carlsbad, California 92008-7208
Attention: Executive Vice President
Facsimile: (760) 268-4922
with a copy to:
Attention: General Counsel
Facsimile: (760) 603-2707
or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such
communication will be deemed to have been given (i) when delivered, if
personally delivered or sent by facsimile on a Business Day, (ii) on the
Business Day after dispatch, if sent by nationally-recognized overnight courier,
and (iii) on the third business day following the date of mailing, if sent by
mail. It is understood and agreed that this Section 13.6 is not intended to
govern the day-to-day business communications necessary between the Parties in
performing their duties, in due course, under the terms of this Agreement.
Section 13.6 Entire Agreement; Modifications. This Agreement sets forth and
constitutes the entire agreement and understanding between the Parties with
respect to the subject matter hereof and all prior agreements, understanding,
promises and representations, whether written or oral, with respect thereto are
superseded hereby, including without limitation the Original Collaboration
Agreement. For clarity, the Parties acknowledge and agree that the Original
Collaboration Agreement remains in effect in accordance with its terms with
respect to the period between the Start Date and the Amendment Effective Date.
Each Party confirms that it is not relying on any representations or warranties
of the other Party except as specifically set forth herein. No amendment,
modification, release or discharge will be binding upon the Parties unless in
writing and duly executed by authorized representatives of both Parties.
Section 13.7 Relationship of the Parties. It is expressly agreed that the
Parties will be independent contractors of one another and that the relationship
between the Parties will not constitute a partnership, joint venture or agency.
Neither Party will have the authority to make any statements, representations or
commitments of any kind, or to take any action, which will be binding on the
other, without the prior written consent of the other to do so. All persons
employed by a Party will be employees of such Party and not of the other Party
and all costs and obligations incurred by reason of any such employment will be
for the account and expense of such Party.

 

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Section 13.8 Cooperation. Isis will provide reasonable assistance to OncoGenex
in respect of partnering discussions, financing activities and regulatory
filings to support the development and commercialization of the Product.
Notwithstanding the foregoing, Isis will not be required to modify or waive any
provision of this Agreement in connection with partnering discussions or
financing activities to support the development and commercialization of the
Product.
Section 13.9 Waiver. Any term or condition of this Agreement may be waived at
any time by the Party that is entitled to the benefit thereof, but no such
waiver will be effective unless set forth in a written instrument duly executed
by or on behalf of the Party waiving such term or condition. The waiver by
either Party hereto of any right hereunder or of the failure to perform or of a
breach by the other Party will not be deemed a waiver of any other right
hereunder or of any other breach or failure by said other Party whether of a
similar nature or otherwise.
Section 13.10 Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which will be deemed an original, but all of which
together will constitute one and the same instrument.
Section 13.11 No Benefit to Third Parties. The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of
the Parties hereto and their successors and permitted assigns, and they will not
be construed as conferring any rights on any other parties.
Section 13.12 Further Assurance. Each Party will duly execute and deliver, or
cause to be duly executed and delivered, such further instruments and do and
cause to be done such further acts and things, including the filing of such
assignments, agreements, documents and instruments, as may be necessary or as
the other Party may reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes, or to better assure and
confirm unto such other Party its rights and remedies under this Agreement.
Section 13.13 References. Unless otherwise specified, (a) references in this
Agreement to any Article, Section, Schedule or Exhibit will mean references to
such Article, Section, Schedule or Exhibit of this Agreement, (b) references in
any section to any clause are references to such clause of such section, and
(c) references to any agreement, instrument or other document in this Agreement
refer to such agreement, instrument or other document as originally executed or,
if subsequently varied, replaced or supplemented from time to time, as so
varied, replaced or supplemented and in effect at the relevant time of reference
thereto.
Section 13.14 Construction. Except where the context otherwise requires,
wherever used, the singular will include the plural, the plural the singular,
the use of any gender will be applicable to all genders and the word “or” is
used in the inclusive sense (and/or). The captions of this Agreement are for
convenience of reference only and in no way define, describe, extend or limit
the scope or intent of this Agreement or the intent of any provision contained
in this Agreement. The term “including” as used herein will mean including,
without limiting the generality of any description preceding such term. The
language of this Agreement will be deemed to be the language mutually chosen by
the Parties and no rule of strict construction will be applied against either
Party hereto. Appendices to this Agreement, or added hereto according to the
terms of this Agreement, are made part of this Agreement.

 

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Section 13.15 Dispute Resolution Regarding Diligence.
13.15.1 General. The Parties will negotiate in good faith and use reasonable
efforts to settle any dispute, controversy or claim arising regarding whether
(i) OncoGenex has satisfied its diligence obligations under Section 4.4 of this
Agreement or (ii) in the event of an OncoGenex Mandate, Isis has refused to
remove the applicable infringement using commercially appropriate steps, by
first referring such dispute to the Chief Executive Officers of each of the
Parties (or their respective designees) who will use their good faith efforts to
mutually agree upon the resolution of the dispute. If any dispute is not
resolved by the Chief Executive Officers of the Parties (or their designees)
within 30 days after such dispute is referred to them, and a Party wishes to
pursue the matter, each such dispute, controversy or claim will be finally
resolved by binding arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association (“AAA”), and judgment on the
arbitration award may be entered in any court having jurisdiction thereof. The
arbitration will be conducted by a panel of three persons experienced in the
pharmaceutical business: within 30 days after initiation of arbitration, each
party will select one person to act as arbitrator and the two party-selected
arbitrators will select a third arbitrator within 30 days of their appointment.
If the arbitrators selected by the parties are unable or fail to agree upon the
third arbitrator, the third arbitrator will be appointed by the AAA. No
individual shall be appointed to arbitrate a dispute pursuant to this Agreement
unless he or she agrees in writing to be bound by the provisions of this
Section 13.15. The place of arbitration will be Seattle, Washington. Either
Party may apply to the arbitrators for interim injunctive relief until the
arbitration award is rendered or the controversy is otherwise resolved.
13.15.2 Expenses. Except as expressly provided herein, each Party will bear its
own costs and expenses and attorneys’ fees and an equal share of the
arbitrators’ and any administrative fees of arbitration. The arbitrators shall
have the authority to grant specific performance and to allocate between the
Parties the costs of arbitration in such equitable manner as they determine.
Notwithstanding the foregoing, if a Party has been found to be in material
breach of this Agreement, the defaulting Party will be responsible for both
Parties’ costs and expenses (including the costs of the arbitrators and any
administrative fees of arbitration) and the reasonable attorneys’ fees of the
non-defaulting Party.

 

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13.15.3 Procedure. Except to the extent necessary to confirm an award or as may
be required by law, neither a Party nor an arbitrator may disclose the
existence, content, or results of an arbitration without the prior written
consent of both Parties. In no event will an arbitration be initiated after the
date when commencement of a legal or equitable proceeding based on the dispute,
controversy or claim would be barred by the applicable Province of British
Columbia statute of limitations.
13.15.4 Speedy Resolution. The Parties intend, and shall take all reasonable
action as is necessary or desirable to ensure, that there be a speedy resolution
to any dispute which becomes the subject of arbitration, and the arbitrators
shall conduct the arbitration so as to resolve the dispute as expeditiously as
possible.
13.15.5 Awards. All awards shall be in writing and shall state reasons. Executed
copies of all awards shall be delivered by the arbitrators to the Parties as
soon as is reasonably possible. All awards of the arbitrators shall be final and
binding on the Parties, and there shall be no appeal of any such award
whatsoever. The Parties undertake to satisfy any award without delay.
13.15.6 Except as otherwise specified in the first sentence of Section 13.15.1,
no other disputes, controversies or claims shall be subject to this
Section 13.15.
The remainder of this page intentionally left blank.

 

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their duly authorized representatives as of the date first above written.

                      OncoGenex Technologies Inc.       ISIS Pharmaceuticals,
Inc.    
 
                   
Per:
  /s/ Scott Cormack
 
Scott D. Cormack,       Per:   /s/ B. Lynne Parshall
 
B. Lynne Parshall    
 
  President & CEO           COO and CFO    

 

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APPENDIX A
Definitions
“Affiliate” of a party means any other party that, directly or indirectly,
through one or more intermediaries, controls, is controlled by, or is under
common control with such first party. For purposes of this definition only,
“control” and, with correlative meanings, the terms “controlled by” and “under
common control with” will mean (a) the possession, directly or indirectly, of
the power to direct the management or policies of a party, whether through the
ownership of voting securities or by contract relating to voting rights or
corporate governance, and (b) the ownership, directly or indirectly, of more
than fifty percent (50%) of the voting securities or other ownership interest of
a party; provided that, if local law restricts foreign ownership, control will
be established by direct or indirect ownership of the maximum ownership
percentage that may, under such local law, be owned by foreign interests. In
addition, Regulus Therapeutics, LLC will not be considered an Affiliate of Isis.
“Applicable Law” means the applicable laws, rules, and regulations, including
any rules, regulations, guidelines, or other requirements of the Regulatory
Authorities, that may be in effect from time to time.
“ASO” means an antisense oligonucleotide compound (reverse of the sense strand
messenger RNA), or analog, mimic or mimetic thereof, having a sequence that is
at least 6 bases long and that modulates expression of a gene target via the
binding, partially or wholly, of such compound to a mRNA or pre-mRNA of such
gene target.
“Business Day” means any day, other than Saturday, Sunday or any statutory
holiday in the Province of British Columbia or the United States.
“Calendar Year” means each successive period of 12 months commencing on January
1 and ending on December 31.
“Clusterin” means the gene target, official symbol CLU, which is also referred
to as Testosterone Repressed Prostatic Message -2 (TRPM-2), and Sulphated
Glycoprotein-2 (SGP-2).
“Commercialization Agreement” has the meaning set forth in 6.2.2.
“Commercially Reasonable Efforts” means, with respect to the research,
development, manufacture, release or commercialization of the Product, efforts
and resources commonly used in the biotechnology industry for products of
similar commercial potential at a similar stage in its lifecycle, taking into
consideration their safety and efficacy, cost to develop, priority in relation
to other products under development by the other Party, the competitiveness of
alternative products, proprietary position, the likelihood of regulatory
approval, profitability, and all other relevant factors.

 

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“Competing Product” means a product containing an ASO that (i) acts
predominantly by [***] Clusterin [***] or that is [***] Clusterin [***] (ii)
[***] covered by a Valid Claim within the Product-Specific Technology Patents in
the relevant country, but for the expiration, invalidity, revocation or
unenforceability of such Product-Specific Technology Patents (such invalidity,
revocation or unenforceability as determined by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed), and
(iii) [***] by a Valid Claim within the Isis Core Technology Patents in the
relevant country.
“Confidential Information” means all information and know-how and any tangible
embodiments thereof provided by or on behalf of one Party to the other Party
either in connection with the discussions and negotiations pertaining to this
Agreement or in the course of performing this Agreement, including data;
knowledge; practices; processes; ideas; research plans; engineering designs and
drawings; research data; manufacturing processes and techniques; scientific,
manufacturing, marketing and business plans; and financial and personnel matters
relating to the disclosing Party or to its present or future products, sales,
suppliers, customers, employees, investors or business. For purposes of this
Agreement, notwithstanding the Party that disclosed such information or
know-how, all information or know-how of OncoGenex will be Confidential
Information of OncoGenex, and all information and know-how of Isis will be
Confidential Information of Isis.
Notwithstanding the foregoing, information or know-how of a Party will not be
deemed Confidential Information for purposes of this Agreement if such
information or know-how:
(a) was already known to the receiving Party, other than under an obligation of
confidentiality or non-use, at the time of disclosure to such receiving Party;
(b) was generally available or known to parties reasonably skilled in the field
to which such information or know-how pertains, or was otherwise part of the
public domain, at the time of its disclosure to, or, with respect to know-how,
discovery or development by, such receiving Party;
(c) became generally available or known to parties reasonably skilled in the
field to which such information or know-how pertains, or otherwise became part
of the public domain, after its disclosure to such receiving Party through no
fault of the receiving Party;
(d) was disclosed to such receiving Party, other than under an obligation of
confidentiality or non-use, by a Third Party who had no obligation to the Party
that Controls such information and know-how not to disclose such information or
know-how to others; or
(e) was independently discovered or developed prior to disclosure by such
receiving Party, as evidenced by their written records, without the use of
Confidential Information belonging to the Party that Controls such information
and know-how.

 

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Specific aspects or details of Confidential Information will not be deemed to be
within the public domain or in the possession of a Party merely because the
Confidential Information is embraced by more general information in the public
domain or in the possession of such Party. Further, any combination of
Confidential Information will not be considered to be in the public domain or in
the possession of a Party merely because individual elements of such
Confidential Information are in the public domain or in the possession of such
Party unless the combination and its principles are in the public domain or in
the possession of such Party.
“Control” means, with respect to any Patent or other intellectual property
right, possession of the right (whether by ownership, license or otherwise), to
assign, transfer, or grant a license, sublicense or other right to or under,
such Patent or right as provided for herein without violating the terms of any
agreement or other arrangement with any Third Party.
“Discontinuance” means OncoGenex voluntarily elects to abandon [***] developing
OGX-011 and/or Products, as evidenced by a written communication from an
authorized officer of OncoGenex to Isis.
“FDA” means the United States Food and Drug Administration and any successor
agency thereto.
“FTE” means the equivalent of the work of one employee full time for one year
(consisting of at least a total of 45.5 weeks or 1,820 hours per year (excluding
vacations and holidays) of work on or directly related to the Agreement),
carried out by an Isis employee. The FTE rate will be (i) [***] (U.S.) per FTE
for any of the following activities: drug substance manufacturing; analytical
chemistry; process chemistry; formulation; raw material ordering and handling;
quality control; or manufacturing technology transfer; and (ii) [***] (U.S.) per
FTE for any of the following activities: toxicology;
pharmacokinetics/metabolism; regulatory; clinical development; or data
management. These FTE rates will be adjusted upward on a Calendar Year basis
commencing January 1, 2009 (and on January 1 of each year thereafter during the
Term of this Agreement) by a factor which reflects [***] for [***] during the
Term of the Agreement when compared to the [***] in the preceding year.
“GAAP” means generally accepted accounting principles of the United States
consistently applied.
“Generic Product(s)” means a product or products containing an active ingredient
having the same or substantially the same chemical structure as the applicable
ASO targeting Clusterin that is the active ingredient contained in the
applicable Product, whether approved under an NDA, ANDA, an application under
505(b)(2), or any equivalent thereof, or otherwise by a Regulatory Authority
within the applicable country.
[***] means [***], a biotech company with head office in [***].
[***]
[***] means those patents listed in Appendix B.

 

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“Improvements” means any enhancement or improvement (in each case, whether or
not patented or patentable) to the Isis Core Technology or the Isis
Manufacturing Technology.
“Isis Core Technology” means any discovery, invention, composition, method,
process, procedure, data, information, know-how or other technology (in each
case, whether or not patented or patentable) that is Controlled by Isis as of
the Amendment Effective Date and that either (i) was not conceived, discovered,
developed or otherwise made under or in connection with the Original
Collaboration Agreement, and the application of which has utility only with
respect to Products, or (ii) is necessary or useful for the development or
commercialization of Products, and the application of which has utility both
with respect to Products and other compositions. Isis Core Technology excludes
the Isis Manufacturing Technology and Product-Specific Technology.
“Isis Core Technology Patents” means Patents Controlled by Isis that claim the
Isis Core Technology on the Amendment Effective Date; provided however that Isis
Core Technology Patents excludes the Isis Manufacturing Patents and
Product-Specific Technology Patents. The Isis Core Technology Patents include,
but are not limited to, the patents listed on Appendix D attached hereto.
“Isis Manufacturing Patents” means Patents Controlled by Isis that claim the
manufacturing production and release processes (a) that were used to manufacture
MOE Gapmers on the Amendment Effective Date and embodied in the [***], or
(b) that are Controlled by Isis on or after the Amended Effective Date and
otherwise are necessary, or are required by a Regulatory Authority, to be used
in the manufacture of a Product. The Isis Manufacturing Patents are listed on
Appendix E attached hereto. Manufacturing for this purpose includes synthesis,
purification and analysis.
“Isis Manufacturing Technology” means (a) the Isis Manufacturing Patents,
(b) the Release Method, and (c) all other trade secret, know-how or other
information or technology (i) that is Controlled by Isis as of the Amendment
Effective Date and is applicable to the manufacture, production or release
processes for the Product and embodied in the [***] or (ii) that is Controlled
by Isis after the Amendment Effective Date and otherwise is necessary, or is
required by a Regulatory Authority, to be used in the manufacture of a Product.
“Isis Patent Rights” means Isis Core Technology Patents and Isis Manufacturing
Patents.
“Joint Patents” means all Patents that claim, cover or disclose the Joint
Technology.
“Joint Technology” means any discovery, invention, composition, method, process,
procedure, data, information, trade secret, know-how or other technology (in
each case, whether or not patented or patentable) which is conceived,
discovered, developed or otherwise made jointly by Isis and OncoGenex (as
determined in accordance with U.S. patent law). Joint Technology excludes the
Product-Specific Technology.

 

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“MOE Gapmer” means “2’MOE Gapmers” or an antisense phosphorothioate
oligonucleotide of 15-30 nucleotides wherein all of the backbone linkages are
modified by adding a sulfur at the non-bridging oxygen (phosphorothioate) and a
stretch of at least 10 consecutive nucleotides remain unmodified (deoxy sugars)
and the remaining nucleotides contain an O’-methyl O’-ethyl substitution at the
2’ position (MOE).
“Net Sales” means the gross invoice price of the Product sold by OncoGenex and
sublicensees to a Third Party which is not a sublicensee of the selling party
(unless such sublicensee is the end user of the Product, in which case the
amount billed therefor will be deemed to be the amount that would be billed to a
Third Party in an arm’s-length transaction) for sales of such Product to such
end users less the following items, as allocable to such Product (if not
previously deducted from the amount invoiced): (i) cash, quantity and trade
discounts, credits, allowances or other price reductions for such Product given
to such end user, (ii) credits, discounts, rebates, chargebacks or allowances
additionally granted (A) upon returns, rejections or recalls (except where any
such recall arises out of the Party or its sublicensee’s gross negligence,
willful misconduct or fraud) or (B) for nonconforming, damaged, out-dated and
returned Product, (iii) freight, shipping and insurance charges, (iv) taxes,
duties, tariffs, surcharges or other governmental charges (other than income
taxes), (v) government mandated rebates, and (vi) a reasonable allowance for
uncollectible or bad debts determined in accordance with generally accepted
accounting principles consistently applied.
“Nonexclusive Clusterin ASO” has the meaning set forth in Section 12.2.2.
“Non-Royalty Revenue” means all Revenue received by OncoGenex with the exception
of Royalty Revenue and OncoGenex Direct Sales.
[***]
[***]
[***]
“OGX-011” means an antisense inhibitor of Clusterin having the sequence [***]
where underlined residues are 2’-methoxyethylnucleosides (MOE) and
phosphorothioate linkages throughout, also referred to as OGX-011 or ISIS
112989.
“OncoGenex Direct Sales” means Net Sales made by OncoGenex to a Third Party
which is not a sublicensee of OncoGenex.
“OncoGenex Patent Rights” means any Patents Controlled by OncoGenex.

 

A-5

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“OncoGenex Technology” means any discovery, invention, composition, method,
process, procedure, data, information, trade secret, know-how or other
technology (in each case, whether or not patented or patentable) that is
Controlled by OncoGenex and that is or relates to an ASO targeting Clusterin or
a method of using an antisense inhibitor of Clusterin, or otherwise is necessary
or useful for the development, manufacture, production or commercialization of
Products. OncoGenex Technology excludes Product-Specific Technology.
“OncoGenex Technology Patents” means all Patents that claim, cover or disclose
the OncoGenex Technology.
“Patents” will include (i) all U.S. patents and patent applications, (ii) any
substitutions, divisions, continuations, continuations-in-part, reissues,
renewals, registrations, confirmations, re-examinations, extensions,
supplementary protection certificates and the like, and any provisional
applications, of any such patents or patent applications, and (iii) any foreign
or international equivalent of any of the foregoing.
“Permitted License” means a license under the Isis Core Technology Patents or
the Isis Manufacturing Patents (but not under the Product-Specific Technology
Patents) (i) granted by Isis to a Third Party to use ASOs solely to conduct such
Third Party’s own internal Research, or (ii) granted by Isis to a Third Party
(provided that such Third Party is [***] and neither such Third Party nor any of
its Affiliates is [***] to manufacture ASOs solely for unaffiliated third
parties; provided, however, in each case, any such ASOs are not specified in
such license or a related document to be ASOs (a) that act predominantly by
[***] Clusterin [***] or (b) that are [***] Clusterin [***] or products
containing such ASOs. For purposes of clarification, a Permitted License shall
not permit Isis or its Affiliates to supply to a Third Party ASOs that act
predominantly by [***] Clusterin [***] or that are [***] Clusterin [***] or
products containing such ASOs.
“Product” means any pharmaceutical preparation (in intravenous, subcutaneous,
oral or any other formulation) containing as the sole active pharmaceutical
ingredient either (a) OGX-011, or (b) any other ASO targeting Clusterin that
either (i) was identified under the Original Collaboration Agreement or (ii) is
identified under Section 4.1.3. For clarity, the Product may be used in
association with other products such as chemotherapy, hormone ablation therapy
and radiation therapy and the immediately preceding sentence does not limit such
intended use.
“Product-Specific Technology” means any discovery, invention, composition,
method, process, procedure, data, information, trade secret, know-how or other
technology (in each case, whether or not patented or patentable) which is
conceived, discovered, developed or otherwise made solely by Isis or OncoGenex,
or jointly by Isis and OncoGenex, under or in connection with the Original
Collaboration Agreement or this Agreement, and the application of which has
utility only with respect to Products. For purposes of clarification
Product-Specific Technology excludes the Isis Manufacturing Technology and Isis
Core Technology.
“Product-Specific Technology Patents” means all Patents that claim, cover or
disclose Product-Specific Technology. Product-Specific Technology Patents
include, but are not limited to the patents listed on Appendix G attached
hereto. For purposes of clarification, any Product-Specific Technology Patents
assigned to OncoGenex as set forth in Section 4.2.1 or 8.2.2 will still be
considered Product-Specific Technology Patents for determining the royalty term
and applicable royalty rates under Article 6.

 

A-6

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“Qualified Partner” means a corporation or other entity (a) whose primary
business is the commercialization of pharmaceutical products, (b) which, on its
own or in connection with a Third Party, does not operate a contract
oligonucleotide manufacturing business and (c) is approved as Qualified Partner
by Isis at the request of OncoGenex (or its Affiliate), such approval not to be
unreasonably withheld.
“Registration Clinical Trial” means a clinical study (whether or not denominated
as a “Phase III” clinical study under applicable regulations) in human patients
that is of size and design appropriate to establish that the Product is safe and
effective for its intended use, to define warnings, precautions and adverse
reactions that are associated with the Product in the dosage range to be
prescribed, and to support approval from the applicable Regulatory Authority
sufficient for the manufacture, distribution, use and sale of the Product in
such jurisdiction in accordance with Applicable Laws.
“Regulatory Authority” means any applicable government entities regulating or
otherwise exercising authority with respect to the development and
commercialization of the Product.
“Regulatory Documentation” means all applications, registrations, licenses,
authorizations and approvals (including all regulatory approvals), all
correspondence submitted to or received from Regulatory Authorities (including
minutes and official contact reports relating to any communications with any
Regulatory Authority), all supporting documents and all clinical studies and
tests, including the manufacturing batch records, relating to the Product, and
all data contained in any of the foregoing, including all regulatory drug lists,
advertising and promotion documents, adverse event files and complaint files.
“Release Method” means the methods used by Isis as at the Amendment Effective
Date for the release of OGX-011 utilizing liquid chromatography – mass
spectrometry and specified in Specification outlined in [***].
“Research” means in vitro or in vivo research, excluding any and all uses in
humans.
“Revenue” means all revenues, receipts, monies, and the fair market value of all
other consideration directly or indirectly collected or received whether by way
of cash or credit or any barter, benefit, advantage, or concession received
OncoGenex relating to the sale, license or any other commercial transaction
involving the Product, with the exception of the following: (i) any
consideration received for the reimbursement for research and development
activities and (ii) any consideration received for the fair market portion of
any sale of equity or quasi-equity securities including, without limitation,
common shares and preferred shares.

 

A-7

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“Royalty Due Date” means March 31, June 30, September 30 and December 31 of each
year during the term of this Agreement.
“Royalty Revenue” means, with respect to a Product in a country, all Revenue
received by OncoGenex that is based on a percentage of Net Sales of such Product
by a Third Party sublicensed to sell such Product in such country.
“Start Date” means November 16, 2001.
“Supply Chain Network” will include the names, contact information, and supply
description of all providers, whether currently used or alternative preferred
suppliers as of the Amendment Effective Date, and who supply modified and
unmodified nucleotides, solid support and other reagents and raw materials
specified in the Isis Manufacturing Technology.
“Third Party” means any party other than Isis or OncoGenex.
“Third Party Payments” means royalties, milestones, and other payments owing to
Third Parties, including payments as set forth in Section 6.3 and Section 6.5.
“Valid Claim” means either (a) a claim of an issued and unexpired patent
included within the Isis Patent Rights, which has not been held permanently
revoked, unenforceable or invalid by a decision of a court or other governmental
agency of competent jurisdiction, unappealable or unappealed within the time
allowed for appeal, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise or (b) a claim of a
pending patent application included within the Isis Patent Rights, which was
filed in good faith and has not been abandoned, finally rejected or expired
without the possibility of appeal or refiling, provided however, that Valid
Claim will exclude any such pending claim in an application that has not been
granted within (x) [***] years following the earliest filing date for such
application in the United States (unless and until such claim is granted), and
(y) [***] years following the earliest filing date for such application outside
of the United States (unless and until such claim is granted).

 

A-8

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APPENDIX B
[***]

                                  Patent/             Docket #   Country/Treaty
  Application #   Title   Issue Date
[***]
                   
 
  [***]   [***]   [***]   [***]   [***]

 

B-1

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APPENDIX C
[***]

                                  Patent/         Assignee   Docket #  
Country/Treaty   Application #   Title   Issue Date
[***]
                   
 
  [***]   [***]   [***]   [***]   [***]

 

C-1

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APPENDIX D
Isis Core Technology Patents

                                  Patent/         Assignee   Docket #  
Country/Treaty   Application #   Title   Issue Date
ISIS
                   
 
  [***]   [***]   [***]   [***]   [***]

 

D-1

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APPENDIX E
Isis Manufacturing Patents

                                  Patent/         Technology   Docket #  
Country/Treaty   Application #   Title   Filing Date
[***]
  [***]   [***]   [***]   [***]   [***]

 

E-1

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APPENDIX F
[***]

 

F-1

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APPENDIX G
Product-Specific Technology Patents

                              Patent/             Docket No.   Country  
Applicaion #   Filing Date   Issue Date   Title
[***]
  [***]   [***]   [***]   [***]   [***]

 

G-1