Exhibit 10.44





Exhibit 10.44




COLLABORATION AND LICENSE AGREEMENT




by and between




ONCOGENEX TECHNOLOGIES INC.




and




TEVA PHARMACEUTICAL INDUSTRIES LTD.






	 	 	 
	*	 	Certain information in this exhibit has been omitted as confidential, as indicated by [***]. This
information has been filed separately with the Commission.






 


 









 







TABLE OF CONTENTS




	 	 	 	 	 
	 	 	Page	 
	 
	 	 	 	 
	ARTICLE 1 DEFINITIONS
	 	 	2	 
	 
	 	 	 	 
	ARTICLE 2 GRANT OF RIGHTS
	 	 	29	 
	 
	 	 	 	 
	ARTICLE 3 TRANSITION; DEVELOPMENT AND COMMERCIALIZATION; REGULATORY MATTERS
	 	 	35	 
	 
	 	 	 	 
	ARTICLE 4 PAYMENTS AND STATEMENTS
	 	 	56	 
	 
	 	 	 	 
	ARTICLE 5 REPRESENTATIONS, WARRANTIES AND COVENANTS
	 	 	68	 
	 
	 	 	 	 
	ARTICLE 6 PATENT MATTERS
	 	 	76	 
	 
	 	 	 	 
	ARTICLE 7 CONFIDENTIALITY AND PUBLICITY
	 	 	88	 
	 
	 	 	 	 
	ARTICLE 8 TERM AND TERMINATION
	 	 	92	 
	 
	 	 	 	 
	ARTICLE 9 INDEMNIFICATION AND INSURANCE
	 	 	102	 
	 
	 	 	 	 
	ARTICLE 10 MISCELLANEOUS
	 	 	108	 





 


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THIS COLLABORATION AND LICENSE AGREEMENT (the “Agreement”) is made as of December 20, 2009
(“Effective Date”), by and between ONCOGENEX TECHNOLOGIES INC., a corporation incorporated under
the laws of Canada and having its principal office at 400 — 1001 West Broadway, Vancouver, British
Columbia, Canada V6H 4B1 (“OGX”), and TEVA PHARMACEUTICAL INDUSTRIES LTD., a limited liability
company organized and existing under the laws of Israel and having its principal office at Petah
Tiqva 49131, Israel (“Teva”).



B A C K G R O U N D:




OGX is engaged in the development and commercialization of new cancer therapies that address
treatment resistance in patients with cancer, and Controls the OGX Intellectual Property and is
currently developing a Licensed Compound (as such terms are hereinafter defined) for the treatment
of patients with cancer;



Teva and its Affiliates have experience in the development and commercialization of
pharmaceutical products; the Parties wish to collaborate to develop and commercialize Licensed
Compounds and Licensed Products; Teva desires to obtain the exclusive worldwide right and license
to further develop and thereafter commercialize Licensed Compounds and Licensed Products in the
Field (as such terms are hereinafter defined) and to grant OGX an option to co-promote Licensed
Products in the United States and Canada; and OGX desires to grant to Teva such exclusive worldwide
right and license and to obtain such option, all on the terms and conditions set forth below;


 


 









 





Concurrently with the execution of this Agreement, OGX’s parent, OncoGenex Pharmaceuticals
Inc. (“Parent”), and Teva are executing (a) a stock purchase agreement, and (b) a guaranty by
Parent of OGX’s obligations hereunder; and



OGX and Teva intend to execute after the Effective Date a pharmacovigilance agreement in
connection with development activities under this Agreement.



NOW, THEREFORE, in consideration of the mutual representations, warranties and covenants
herein contained, and for other good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties hereby agree as follows:



ARTICLE 1




DEFINITIONS




Unless specifically set forth to the contrary herein, the following terms, whether used in the
singular or plural, shall have the respective meanings set forth below:




1.1 “Act” means the United States Food, Drug, and Cosmetic Act of 1938, as
amended, and the rules and regulations promulgated thereunder, or any successor act, as the
same shall be in effect from time to time.




1.2 “Advanced Reimbursement” means the payment by Teva to OGX for actual
Development Expenses, as provided in Section 4.1(a) and Schedules 4.1 and 4.3.


 


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1.3 “Affiliate” means with respect to a Party: (a) any corporation or business
entity of which more than fifty percent (50%) of the securities or other ownership interests
representing the equity, the voting stock or general partnership interest entitled to elect
management of the entity (a “Controlling Interest”) are owned, controlled or
held, directly or indirectly, by the Party; (b) any corporation or business entity which,
directly or indirectly, owns, controls or holds a Controlling Interest of the Party; or (c)
any corporation or business entity of which, directly or indirectly, an entity described in
the immediately preceding subsection (b) controls or holds a Controlling Interest.




1.4 “Agreement Term” has the meaning set forth in Section 8.1(b).




1.5 “Anniversary Date” means an anniversary of the Effective Date.




1.6 “ASO” means an antisense oligonucleotide compound (reverse of/complementary
to 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.




1.7 “Authorized Generic Product” has the meaning set forth in Section 2.6.




1.8 “Authorized Generic Royalty Term” means, with respect to a particular
Licensed Product on a country by country basis, the period commencing on the date of the
first commercial sale of an Authorized Generic Product of such Licensed Product in the
applicable country and expiring on the date of the first commercial sale of the [***] of such
Licensed Product commercialized by Third Parties (for clarity, not including the Authorized
Generic Product) in such country.




1.9 “Bankruptcy Code” has the meaning set forth in Section 8.3.


 


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1.10 “Breaching Party” has the meaning set forth in Section 8.2(b)(i).




1.11 “Business Day” means any calendar day, except that if an activity to be
performed or an event to occur falls on a Friday, Saturday, Sunday or a day which is
recognized as a national holiday in the place of performance of an applicable activity or
occurrence of an applicable event, then the activity may be performed or the event may occur
on the next day that is not a Friday, Saturday, Sunday or such nationally recognized holiday.




1.12 “Calendar Quarter” means for each Calendar Year, each of the three (3)
consecutive month periods ending March 31, June 30, September 30 and December 31;
provided, however, that the (a) first Calendar Quarter of any period
specified under this Agreement shall extend from the commencement of such period to the end
of the first complete Calendar Quarter thereafter; and (b) last Calendar Quarter shall end
upon the expiration or termination of this Agreement.




1.13 “Calendar Year” means each successive period of twelve (12) months
commencing on January 1 and ending on December 31; provided, however, that
the (i) first Calendar Year shall commence on the Effective Date and end on December 31,
2009, and (ii) last Calendar Year shall end upon expiration or termination of this Agreement.




1.14 “C.F.R.” means the United States Code of Federal Regulations.


 


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1.15 “Change of Control” means with respect to a Party, the occurrence of any
related transactions that results in any of the following:



(a) any Third Party that was not, as of just prior to the transaction, the beneficial owner,
directly or indirectly, of more than fifty percent (50%) of the voting equity of the Party becomes
(after such transaction) the beneficial owner, directly or indirectly, of more than fifty percent
(50%) of the voting equity of the Party whether as a result of issuances, redemptions, repurchases
or transfers of voting equity or otherwise; or



(b) the Party consolidates with, or merges with or into, a Third Party or sells, assigns,
conveys, transfers, leases or otherwise disposes of all, or substantially all, of its assets to a
Third Party, or a Third Party consolidates with, or merges with or into, the Party, in any such
event pursuant to a transaction in which the outstanding voting equity of the Party is converted
into or exchanged for cash, securities, equity interests or other property and immediately after
such transaction the persons who were the beneficial owners of the outstanding voting equity of the
Party immediately prior to the transaction are not the beneficial owners, directly or indirectly,
of at least fifty percent (50%) of the total voting equity of the surviving or transferee entity.




1.16 “Clinical Development Plan” or “CDP” has the meaning set forth in
Section 3.5(a).




1.17 “Clinical Study” or “Clinical Studies” means any studies of a
Licensed Compound or a Licensed Product conducted on humans.




1.18 “Clusterin” means (a) the protein commonly known as clusterin, having the
official symbol CLU, and which is also referred to as Testosterone Repressed Prostatic
Message-2 (TRPM-2) and Sulphated Glycoprotein-2 (SGP-2), (b) the gene target, including its
[***], that codes for such protein known as clusterin, or (c) any form of RNA that codes for
the protein known as clusterin or is transcribed from the clusterin gene.


 


5









 






1.19 “CMC” means chemistry, manufacturing and controls as specified by the FDA,
EMEA or other Regulatory Authorities.




1.20 “Combination Product” means a Product in final form containing at least one
Licensed Compound as a pharmacologically active ingredient and one or more other active
pharmaceutical ingredients in all dosage forms, formulations, presentations, line extensions
and package configurations. For clarity, a Combination Product is considered a Licensed
Product. As used herein, the term “active pharmaceutical ingredient” means a
pharmacologically active ingredient and does not include excipients, controlled-release
compositions, materials to increase bioavailability, formulation compositions, and delivery
means.




1.21 “Commercialize” or “Commercialization” means to undertake
activities, or those activities undertaken, with respect to the promotion, marketing, sale,
supply, commercial manufacture, import, export, distribution and other commercialization of a
Licensed Compound or Licensed Product, and including any necessary educational, post-approval
Clinical Studies and pre-launch activities related to such commercial activities for the
Licensed Compound or Licensed Product.




1.22 “Commercially Reasonable Efforts” means:




(a) with respect to a task or obligation of Teva under this Agreement, exerting such
efforts and employing such resources as would normally be exerted or employed by Teva in
conducting such tasks or obligations for its other drug candidates and pharmaceutical
products of a comparable stage of development and commercial potential, taking into account
the cost effectiveness of efforts or resources, the competitiveness of
alternative compounds or products that are or are expected to be in the marketplace, the
patent and other proprietary position of the compound or product, the likelihood of
regulatory approval, the profitability of the compound or product and alternative compounds
or products and any other factors reasonably relevant to assessing the commercial
reasonableness of expending efforts and resources;



 


6









 






(b) with respect to a task or obligation of OGX under this Agreement, exerting such
efforts and employing such resources as would normally be exerted or employed by
biotechnology companies of reasonably similar size and resources in conducting such tasks or
obligations for other drug candidates and pharmaceutical products owned by such companies
that are of a comparable stage of development and commercial potential, taking into account
the cost effectiveness of efforts or resources, the competitiveness of alternative compounds
or products that are or are expected to be in the marketplace, the patent and other
proprietary position of the compound or product, the likelihood of regulatory approval, the
profitability of the compound or product and alternative compounds or products and any other
factors reasonably relevant to assessing the commercial reasonableness of expending efforts
and resources.




1.23 “Control” means, with respect to particular Know-How or Intellectual
Property rights, that the applicable Party (or its Affiliate) owns or has a license (or
sublicense) to such Know-How or Intellectual Property and has the ability to grant to the
other Party the rights and licenses under such Know-How or Intellectual Property as provided
for in this Agreement without violating the terms of any agreement or other binding
arrangement the granting Party has with any Third Party.


 


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1.24 “Co-Promotion Activities” means those activities undertaken by OGX pursuant
to the Co-Promotion Agreement in conducting or in support of the promotion of Licensed
Products in the United States and Canada, as contemplated and set forth in Section 3.7 and
Schedule 3.7.




1.25 “Co-Promotion Agreement” shall have the meaning set forth in Section
3.7(e).




1.26 “Co-Promotion Option” shall have the meaning set forth in Section 3.7(b).




1.27 “Co-Promotion Option Term” shall have the meaning set forth in Section
3.7(b).




1.28 “CRPC” means castrate resistant prostate cancer.




1.29 “Data” means any and all research data, pharmacology data, preclinical
data, clinical data, and CMC data generated with respect to the Licensed Compound or Licensed
Product.




1.30 “Data and Safety Monitoring Board” or “DSMB” means an independent
board set up specifically to review and monitor data throughout the duration of a Clinical
Study and for making recommendations concerning the continuation, modification and
termination of the study as it is being conducted.


 


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1.31 “Develop” or “Development” means to undertake activities, or those
activities undertaken, which are devoted to Clinical Studies of a Licensed Compound or
Licensed Product or are directed toward the research, quality issues, pre-clinical
issues, toxicology issues, publication, Regulatory Approval, formulation, production of
clinical trial materials or CMC of such Licensed Compound or Licensed Product, all with the
goal of seeking and obtaining Regulatory Approval of the Licensed Compound or Licensed
Product.




1.32 “Development Expenses” means (a) those out-of-pocket Development costs and
expenses paid by OGX to Third Parties pursuant to the Clinical Development Plan (including
any budgets promulgated thereunder and approved by the JSC), to the extent such costs and
expenses are approved by the JSC, (b) the direct costs incurred by OGX, measured at the FTE
Rate based on the FTEs actually applied by OGX for the OGX employees who perform those
activities related to the conduct of the Clinical Studies specified in the Clinical
Development Plan, in all cases in accordance with the budget approved by the JSC therefor, or
related to terminating a Clinical Study for safety or futility in accordance with Section
3.5(c)(iii), to the extent such costs are approved by the JSC, and (c) the actual costs
incurred by OGX prior to the Effective Date as set forth on Schedule 4.3, with all of the
foregoing (under subsections (a), (b) & (c) above) subject to receipt of appropriate
supporting documentation in form and substance reasonably acceptable to Teva.




1.33 “Disputed Claim” has the meaning set forth in Section 9.4(b).




1.34 “Dollar” or “$” means the lawful currency of the United States.




1.35 “Drug Approval Application” means an application for Regulatory Approval in
a regulatory jurisdiction, together with all subsequent submissions, supplements and
amendments thereto (which, for clarity, includes NDAs and MAAs).


 


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1.36 “Effective Date” has the meaning set forth in the Preamble of this
Agreement.




1.37 “EMEA” means the European Medicines Agency and any successor agency having
substantially the same functions or, if the mutual recognition procedure is used for the
Licensed Product in the EU, any governmental authority having the authority to regulate the
sale of medicinal or pharmaceutical products in any country in the EU.




1.38 “EMEA Approval” means all authorizations by the EMEA which are required for
the marketing of a Licensed Product in the EU.




1.39 “Estimated Launch Date” means the date, as estimated by Teva acting
reasonably and in good faith, that the First Commercial Sale in the U.S. of a Licensed
Product is predicted to occur.




1.40 “EU” means the European Union and all countries that are member states of
the European Union at any time during the Agreement Term.




1.41 “EU Market Payment Event” means on an indication-by-indication basis, the
earlier of (a) the date that is [***] after a First Commercial Sale of a Licensed Product for
the given indication in a Primary EU Market, provided Teva is still selling the Licensed
Product in the Primary EU Market at the end of such [***] period; or (b) the date on which
aggregate Net Sales of a Licensed Product for the given indication in the Primary EU Markets
exceeds [***] dollars [***].


 


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1.42 “EU [***]Approval” means, for a particular Licensed Product in a
given Primary EU Market, [***] and [***] approval for such Licensed Product by the
appropriate Regulatory Authority in such Primary EU Market.




1.43 “Existing IND” shall have the meaning set forth in Section 3.6(b).




1.44 “Expense Report” shall have the meaning set forth in Section 4.3.




1.45 “FDA” means the Food and Drug Administration of the United States
Department of Health and Human Services and any successor agency thereto having substantially
the same functions and authority.




1.46 “FDA Approval” means all authorizations by the FDA which are required for
the marketing of a Licensed Product in the United States as defined in 21 C.F.R. Section
314.105.




1.47 “Field” means the prevention, diagnosis or treatment of any disease or
medical condition in humans.




1.48 “First Commercial Sale” means, on a country by country and Licensed Product
by Licensed Product basis, the first sale to a Third Party, for end use or consumption by a
patient, of the applicable Licensed Product in the subject country for which payment is
received by Teva, its Affiliates or sublicensees after receipt of all Regulatory Approvals in
such country, excluding for purposes of clarity, registration samples, transfers (without
compensation) for compassionate use, use in Clinical Studies and so called “treatment IND
sales” and “named patient sales.”


 


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1.49 “FTE” means the actual work time of the particular individual applied to
the particular task.




1.50 “FTE Rate” means the FTE personnel cost on an hourly basis, by functional
area, incurred by OGX in connection with the Development activities as set forth on Schedule
1.50 and the Co-Promotion Activities as set forth in Schedule 3.7. Commencing January 1,
2011, the FTE Rate shall be changed annually by the JSC to reflect any year-to-year
percentage increase or decrease (as the case may be) in the Consumer Price Index for the US
City Average (all times) (the “CPI”), based on the change in the CPI from the most
recent index available as of the most recent such adjustment (or the Effective Date with
respect to the first such adjustment) to the most recent index available as of the date of
the calculation of such revised FTE Rate.




1.51 “GAAP” means generally accepted accounting principles in the United States,
consistently applied.




1.52 “Generic Competition” shall be deemed to exist, with respect to a
particular Licensed Product being sold in a particular country, if after the Generic Launch
Date in such country with respect to such Licensed Product the aggregate total Net Sales of
such Licensed Product in such country in any [***] after such Generic Launch Date are at
least [***] less than the aggregate total Net Sales of such Licensed Product in the [***]
completed just prior to the Generic Launch Date.




1.53 “Generic Competition Event” means the occurrence of Generic Competition.


 


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1.54 “Generic Competition [***]” means, with respect to a Generic Competition
Event, any one of [***] beginning on the first day of the [***] after the [***] in which the
Generic Competition Event occurred.




1.55 “Generic Launch Date” means, with respect to any Generic Product of a
particular Licensed Product, on a country-by-country basis, the date of the first sale by a
Third Party, for end use or consumption by a patient, of the applicable Generic Product in
the subject country.




1.56 “Generic Product” means, with respect to a Licensed Product in a country, a
Product sold by a Third Party (excluding, for clarity, sublicensees of Teva or its Affiliate)
in such country containing as an active pharmaceutical ingredient the same chemical compound
as the Licensed Compound that is an active pharmaceutical ingredient in such Licensed
Product, and that has been approved for sale or introduction into interstate commerce by
reference to such Licensed Compound or Licensed Product pursuant to (a) [***] or [***] of the
Act; (b) [***] or [***] of [***]; or (c) any similar approval in any other country, which
approval is based on reference to the Regulatory Approval for such Licensed Product in such
country (or, if applicable and permitted by Applicable Law in the country, such Regulatory
Approval(s) in another country), but excluding all Authorized Generic Products.




1.57 “[***]” means [***], a biotechnology company with a head office in [***].




1.58 “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976,
as amended.


 


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1.59 “HSR Rules” means the Premerger Notification Rules to the HSR Act.




1.60 “[***]” means [***], a biotechnology company with a head office in [***].




1.61 “Improvement” means any idea, invention, discovery, improvement and other
Know-How, patentable or otherwise, made, created, developed, conceived or reduced to practice
by a Party’s or its Affiliates’ employees, agents, contractors or other persons acting under
or pursuant to its or their authority, pursuant to activities relating to or contemplated by
this Agreement during the Agreement Term (including under or pursuant to the Clinical
Development Plan), that are based on, relate to, or result from access to OGX Intellectual
Property, Licensed Compounds and Licensed Products, including all Intellectual Property
therein. “Improvements” may include developments in the manufacture, formulation,
ingredients, preparation, presentation, means of delivery or administration, dosage,
indication, methods of use or packaging or sale relating to the Licensed Compounds or
Licensed Products, but shall exclude any such Know-How to the extent related solely to any
other proprietary compounds of OGX that are not Licensed Compounds or Licensed Products.




1.62 “IND” means an Investigational New Drug application, as described in 21
C.F.R. Section 312.23, filed for purposes of conducting Clinical Studies on a Licensed
Compound or Licensed Product in the Field in accordance with the requirements of the Act and
the regulations promulgated thereunder, including all supplements and amendments thereto, and
any analogous application and process required by a Regulatory Authority in a country or
regulatory jurisdiction elsewhere in the Territory in order to
conduct Clinical Studies on a Licensed Compound or Licensed Product in the Field in such
country or regulatory jurisdiction.


 


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1.63 “Insurance” has the meaning set forth in Section 9.6(a).




1.64 “Intellectual Property” means Patent Rights, Know-How and Trademarks
collectively, or any part thereof.




1.65 “Isis” means Isis Pharmaceuticals, Inc., a biotechnology company with a
head office in Carlsbad, California.




1.66 “Joint Improvement” has the meaning set forth in Section 6.1(a)(ii).




1.67 “Joint Steering Committee” or “JSC” has the meaning set forth in
Section 3.5(d)(i).




1.68 “Know-How” means all know-how, proprietary information and technology,
including trade secrets, inventions, developments, discoveries, methods, techniques,
formulations, data, results, reports, improvements and other information, whether or not
patentable.




1.69 “Knowledge” means, as attributed to a particular Party, the actual
knowledge of the senior executives of such Party or its Affiliates or of the management
employees of a Party or its Affiliates having principal direct responsibility for the
activities of the Party or its Affiliates to which the knowledge relates.


 


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1.70 “Label(ing)” shall have the same meaning as defined in the Act and as
interpreted by the FDA, and any analogous Laws as interpreted by the applicable Regulatory
Authorities elsewhere in the Territory.




1.71 “Laws” means all laws, statutes, rules, regulations, ordinances and other
pronouncements having the binding effect of law of any governmental authority and applicable
to the specific circumstance or situation.




1.72 “Licensed Compound” means (a) OGX-011, or (b) any other ASO that targets
Clusterin, in a manner that modulates the expression of Clusterin, and is claimed or covered
by (i) OGX Patent Rights listed on Schedule 1.88, or (ii) any additional Patent Rights that
are Controlled by OGX during the Agreement Term, and [***], but excluding, for clarity, the
OGX molecules referred to as OGX-427 and OGX-225.




1.73 “Licensed Product” means a Product containing a Licensed Compound as an
active pharmaceutical ingredient.




1.74 “Losses” means any and all damages, awards, settlement amounts,
assessments, fines, dues, penalties (including penalties imposed by any governmental
authority), costs, fees, liabilities, obligations, taxes, liens, losses, and expenses
(including court costs, interest and reasonable fees of attorneys, accountants and other
experts) awarded or otherwise paid or payable to Third Parties.




1.75 “MAA” means a marketing authorization application submitted to the EMEA to
obtain European commission approval for the marketing of the Licensed Product in the EU,
together with all subsequent submissions, supplements and amendments thereto.


 


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1.76 “NDA” means a new drug application, as described in 21 C.F.R. Section
314.50, submitted to the FDA to obtain approval for the marketing of a Licensed Product in
the U.S., together with all subsequent submissions, supplements and amendments thereto.




1.77 “Net Sales” means the gross sales amount (as invoiced or otherwise charged)
for the sale of Licensed Products, in any form or packaging, to Third Parties by Teva, its
Affiliates and sublicensees, less the following deductions (to the extent actually allowed or
incurred based on such sale and included in such gross sales amount):




(a) quantity and/or cash discounts off of the invoiced price;




(b) customs, duties, sales and similar taxes;



(c) amounts allowed or credited by reason of rejections, return of goods (including as a
result of recalls, market withdrawals and other corrective actions), and retroactive price
reductions or allowances specifically identifiable as relating to a Licensed Product including
allowances and credits related to inventory management or similar agreements with wholesalers;



(d) amounts incurred resulting from government (or any agency thereof) mandated rebate
programs in the Territory;



(e) Third Party rebates, patient discount programs, administrative fees and chargebacks or
similar price concessions related to the sale of a Licensed Product;


 


17









 





(f) bad debt allowed and recognized by Teva for accounting purposes as not collectible,
provided however that if a bad debt allowance is reduced in any subsequent Calendar
Quarter, such reduced amount will be added back to the gross sales amount for purposes of
calculating Net Sales);




(g) expenses for insurance, freight, packing, shipping and transportation; and



(h) to the extent agreed by the Parties in writing, such agreement not to be unreasonably
withheld, any other specifically identifiable appropriate allowances or deductions to the extent
such amounts are included in a Licensed Product’s gross sales amount and are credited and are
similar to those deductions listed above, all in accordance with GAAP.



All such discounts, allowances, credits, rebates and other deductions shall be fairly and equitably
allocated to the Licensed Product in accordance with GAAP. To the extent that the applicable
Licensed Product is sold in a bundle or other combination with other products or services of Teva
or its Affiliates or sublicensee such that the Licensed Products and such other products have
discounts, allowances, credits, rebates or other deduction applied as a group, then all such
discounts, allowances, credits, rebates and other deductions shall be fairly and equitably
allocated to the Licensed Product in a manner such that the Licensed Products do not bear a
disproportionate portion of all such deductions. For the avoidance of doubt, Net Sales shall not
include sales by Teva to its Affiliates or sublicensees for resale; provided that,
if Teva sells a Licensed Product to an Affiliate or sublicensee for resale, then the Net Sales
calculation shall include the amounts invoiced by such Affiliate or sublicensee to Third Parties on
the resale of such Licensed Product. For purposes of this Agreement, the term “sale” shall include
other commercial dispositions for value, but shall not include transfers or other distributions or
dispositions of a Licensed Product, at no charge, for regulatory purposes, clinical trials,
samples, free products or in connection with patient assistance programs administered by or on
behalf of Teva or its Affiliates or other charitable purposes or to physicians or hospitals for
promotional purposes or other similar uses. A Licensed Product shall be considered “sold” only
when billed or invoiced.



 


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1.78 “New Indication” means any indication in the Field that is not first-line
CRPC, second-line CRPC, or first-line non-small cell lung cancer.




1.79 “[***]” means [***], a global pharmaceutical company with a head office in [***].




1.80 “OGX-011” means the antisense inhibitor of Clusterin having the sequence
5’-MeCAGMeC AGC AGA GTC TTC A
MeU

MeCAMeU, where underlined residues are 2’-methoxyethylnucleosides (MOE)
and phosphorothioate linkages throughout, also referred to as OGX-011 or [***].




1.81 “OGX-225” means (a) the bi-specific antisense inhibitor of insulin-like growth
factor binding protein-2 and insulin-like growth factor binding protein-5 having the sequence
5’-CAGCAGCCGCAGCCCGGCTC-3’ where underlined residues are
2’-methoxyethylnucleosides (MOE) and phosphorothioate linkages throughout; and (b) any other
ASO that is covered by or based on any OGX intellectual property as at the Effective Date or
during the Agreement Term and primarily directly modulates the expression of insulin-like
growth factor binding protein-2 and insulin-like growth factor binding protein-5, solely or
as bi-specific inhibitors, but excluding compounds within the scope of OGX-
011, Licensed Compounds, Licensed Products, and OGX Product Specific Intellectual
Property.


 


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1.82 “OGX-427” means (a) the antisense inhibitor of heat shock protein 27 having
the sequence
5’-GGGAMeCGMeCGGMeCGMeCTMeCGGMeUMeCAMeU-3’
where underlined residues are
2’-methoxyethylnucleosides (MOE) and phosphorothioate linkages throughout; and (b) any other
ASO that is covered by or based on any OGX intellectual property as at the Effective Date or
during the Agreement Term and primarily directly modulates the expression of heat shock
protein 27, but excluding compounds within the scope of OGX-011, Licensed Compounds, Licensed
Products, and OGX Product Specific Intellectual Property.




[***]




1.84 “OGX Improvement” means any Improvement made, created, developed, conceived
or reduced to practice solely by OGX’s or its Affiliates’ employees, agents, contractors or
other persons acting under or pursuant to its or their authority.




1.85 “OGX Indemnified Parties” has the meaning set forth in Section 9.1.




1.86 “OGX Intellectual Property” means the OGX Patent Rights, OGX Know How, and
OGX Trademarks, including any OGX Improvements.




1.87 “OGX Know-How” means all Product Know-How that is Controlled by OGX or any
of its Affiliates as of the Effective Date and during the Agreement Term.


 


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1.88 “OGX Patent Rights” means all Product Patents that are Controlled by OGX or
any of its Affiliates as of the Effective Date and during the Agreement Term, including the
Patent Rights listed in Schedule 1.88.




1.89 “OGX Pharma Common Shares” has the meaning set forth in the stock purchase
agreement between Teva and Parent described in Section 4.5.




1.90 “OGX Product Specific Intellectual Property” means all OGX Intellectual
Property, OGX Improvements and OGX’s interest in Joint Improvements, the application of which
has utility only (or for all commercially practical purposes only) with respect to Licensed
Compound or Licensed Products, including the OGX Intellectual Property that is set forth on
Schedule 1.90. To the extent that any patent or patent application within the OGX Patent
Rights includes both (i) claims directed specifically to the Licensed Compound, or Licensed
Product as a composition of matter, or methods of using any of the foregoing, as well as (ii)
other claims (that do not meet the requirements of clause (i) above), then the Parties shall
(as part of the Prosecution efforts under Section 6.2(a)), but only if practicable, use
commercially reasonable efforts to divide such patents or patent applications (by all means
available under applicable Laws) such that the result is (x) one or more patents (or patent
applications, as applicable) in the OGX Patent Rights that have only claims directed
specifically to the Licensed Compound, or Licensed Product as a composition of matter, or
methods of using any of the foregoing, which patents and applications shall be deemed part of
the OGX Product Specific Intellectual Property, and (y) one or more other patents (or patent
applications, as applicable) in the OGX Patent Rights that do not have any claims directed
specifically to the Licensed Compound, or
Licensed Product as a composition of matter, or methods of using any of the foregoing,
which patents and applications shall not be OGX Product Specific Intellectual Property but
shall remain OGX Patent Rights to the extent such patents or applications meet the definition
thereof.


 


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1.91 “OGX Trademarks” means all Trademarks that are Controlled by OGX or any of
its Affiliates as of the Effective Date and during the Agreement Term that are specific to
the Licensed Compound or Licensed Product, including the Trademarks set forth on Schedule
1.91.




1.92 “Other Compound” has the meaning set forth in Section 2.5.




1.93 “Parent” has the meaning set forth in the Preamble.




1.94 “Parties’ Patent Rights” has the meaning set forth in Section 6.3(a).




1.95 “Party” means OGX or Teva.




1.96 “Patent Rights” means any and all patents, patent applications,
certificates of invention, or applications for certificates of invention and any supplemental
protection certificates, together with any extensions, registrations, confirmations,
reissues, substitutions, divisions, continuations or continuations-in-part, reexaminations or
renewals thereof, whenever submitted, filed, issued, received, or granted.




1.97 “Phase I Clinical Study” means a Clinical Study conducted in any country
that is intended to determine the metabolism and pharmacologic actions of the drug in humans,
the side effects associated with increasing doses, and, if possible, to gain early
evidence on effectiveness, that would satisfy the requirements of 21 C.F.R. Section
312.21(b), or an equivalent Clinical Study required by a Regulatory Authority in a
jurisdiction outside of the United States.


 


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1.98 “Phase II Clinical Study” means a Clinical Study conducted in any country
that is intended to explore a dose or variety of doses, rates of administration, dose
response, duration of effect or survival parameters in order to generate initial evidence of
clinical efficacy and additional evidence of safety in a target patient population, that
would satisfy the requirements of 21 C.F.R. Section 312.21(b), or an equivalent Clinical
Study required by a Regulatory Authority in a jurisdiction outside of the United States.




1.99 “Phase III Clinical Study” means an expanded Clinical Study conducted in
any country on a large patient population intended to confirm effectiveness of the drug in
humans, and to further evaluate its safety, including by gathering additional information to
evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for
physician labeling, that would satisfy the requirements of 21 C.F.R. Section 312.21(c), or an
equivalent Clinical Study required by a Regulatory Authority in a jurisdiction outside of the
United States, or that is consistent with any scientific advice provided by a Regulatory
Authority from time to time during such study as a basis for Regulatory Approval.




1.100 “Primary EU Markets” means the [***], [***], [***], [***] and [***].




1.101 “Prime Rate” has the meaning set forth in Section 4.7(a).




1.102 “Product” means any pharmaceutical or medicinal preparation in the form in
which it is sold (or, where the context so indicates, the form under development).


 


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1.103 “Product Know-How” means all Know-How that relates directly to a Licensed
Compound or Licensed Product and is necessary or reasonably useful for the research,
Development, use, or Commercialization of Licensed Compounds or Licensed Products in the
Field.




1.104 “Product Patent” means any Patent Right that claims the composition of
matter, manufacture or use of one or more Licensed Compounds or Licensed Products or that
otherwise would be infringed, absent a license, by the manufacture, use, importation or sale
of any Licensed Compound or Licensed Product.




1.105 “Proprietary Information” means, with respect to a Party, any and all
scientific, CMC, clinical, regulatory, marketing, financial and commercial Know-How, whether
communicated in writing, orally or by any other means, that is owned or otherwise Controlled
by such Party (or its Affiliate) and is provided by that Party to the other Party (or its
Affiliate) in connection with this Agreement, which includes (with respect to the applicable
disclosing Party) all applicable OGX Know-How and Teva Know-How disclosed under this
Agreement. The provisions and existence of this Agreement and its terms and conditions shall
be deemed to be confidential information of each Party that is subject to the protective
provisions of Article 7.




1.106 “Regulatory Approval” means approval by the relevant Regulatory Authority
of an NDA, MAA or other Drug Approval Application, and including any related health
registration, common technical document, regulatory submission, notice of compliance and any
other license or permit required (but excluding any pricing or reimbursement approval) for
the supply, manufacture, use, storage, distribution, import,
export, transport, promotion, marketing, and sale of a Licensed Product as a
pharmaceutical or medicinal Product in the applicable formulation or dosage form in a country
or other regulatory jurisdiction.


 


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1.107 “Regulatory Authority” means any governmental authority in a country or
other regulatory jurisdiction, including the FDA and the EMEA, that regulates the
Development, supply, manufacture, use, storage, distribution, import, export, transport,
promotion, marketing, sale and/or other Commercialization of a Licensed Product as a
pharmaceutical or medicinal Product in any formulation or dosage form.




1.108 “Regulatory Document Transfer Date” has the meaning set forth in Section
3.6(c).




1.109 “Regulatory Documents” has the meaning set forth in Section 3.6(c).




1.110 “Royalty Term” means, with respect to a specific Licensed Product in a
particular country in the Territory, the period commencing on the date of First Commercial
Sale of such Licensed Product in such country and expiring on the later of (a) expiration (as
the applicable Licensed Patent may be extended under applicable Laws) or invalidation of the
last Valid Claim covering such Licensed Product in such country, (b) expiration of all
periods of market exclusivity or data exclusivity granted by a Regulatory Authority in that
country for such Licensed Product, and (c) the date that is twelve (12) years after the date
of First Commercial Sale of such Licensed Product in such country; provided,
however, that in any event the Royalty Term for a particular Licensed Product in a
given country shall expire no later than fifteen (15) years after the date of First
Commercial Sale of such Licensed Product in such country.


 


25









 






1.111 “SEC” means the United States Securities and Exchange Commission and any
successor agency having substantially the same functions.




1.112 “Substantial Generic Competition” shall be deemed to exist, with respect
to a particular Licensed Product being sold in a particular country, if after the Generic
Launch Date in such country with respect to such Licensed Product the aggregate total Net
Sales of such Licensed Product in such country in any [***] after such Generic Launch Date
are at least [***] less than the aggregate total Net Sales of such Licensed Product in the
[***] completed just prior to the Generic Launch Date.




1.113 “Substantial Generic Competition Event” means the occurrence of
Substantial Generic Competition.




1.114 “Substantial Generic Competition [***]” means, with respect to a
Substantial Generic Competition Event, any one of the [***] during the [***] period beginning
on the first day of the [***] after the [***] in which the Substantial Generic Competition
Event occurred.




1.115 “Successor Entity” of a Party means such Party’s successor in interest.




1.116 “Territory” means the entire world.




1.117 “Teva Indemnified Parties” has the meaning set forth in Section 9.1.




1.118 “Teva Know-How” means all Product Know-How (including any Teva
Improvements necessary or reasonably useful for the research, Development, use or
Commercialization of Licensed Compounds and/or Licensed Products in the Field) that is
Controlled by Teva or any of its Affiliates as of the Effective Date and during the
Agreement Term.


 


26









 






1.119 “Teva Improvements” means any Improvement made, created, developed,
conceived or reduced to practice solely by Teva’s or its Affiliates’ employees, agents,
contractors or other persons acting under or pursuant to its or their authority.




1.120 “Teva Patent Rights” means all Product Patents (including Patent Rights
that claim or cover Teva Improvements) that are Controlled by Teva or any of its Affiliate(s)
as of the Effective Date and during the Agreement Term.




1.121 “Third Party” means a person or entity who or which is neither a Party nor
an Affiliate of a Party.




1.122 “Third Party Agreements” has the meaning set forth in Section 3.3(a).




1.123 “Third Party Claims” has the meaning set forth in Section 9.2.




1.124 “Third Party License Agreements” has the meaning set forth in Section
3.3(a).




1.125 “Trademarks” means registered or common law trademarks, service marks, and
trade names.




1.126 “UBC” means the University of British Columbia.




1.127 “United States” or “U.S.” means the United States of America, its
territories and possessions.


 


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1.128 “Upfront Payment” means that upfront payment set forth at Schedule 4.1(a).




1.129 “Valid Claim” means a claim of an issued and unexpired patent or pending
patent application within the OGX Patent Rights or the Teva Patent Rights that (a) in the
case of an issued patent, has not been disclaimed, revoked or held to be invalid or
unenforceable by a court or other authority of competent jurisdiction, from which decision no
appeal can be further taken, or has not been admitted to be invalid or unenforceable (in a
binding, enforceable manner by the party owning such claim), or (b) in the case of a pending
patent application, has not been canceled, expired, withdrawn from consideration, finally
determined to be unallowable (from which no appeal is or can be taken), or abandoned or
disclaimed; provided, however, that a Valid Claim will exclude any such
pending claim that (i) has not been granted within [***] following the filing of the
application containing such claim, or (ii) does not have a reasonable bona fide basis for
patentability (such reasonable bona fide basis to be determined by outside counsel selected
by the Parties in the event the Parties disagree as to whether there is such a reasonable
bona fide basis).




1.130 Additional Defined Terms. The following additional terms listed below
shall have the meanings ascribed thereto in the Section (or other provision hereof)
indicated:



	 	 	 
	Defined Term	 	Section or Provision
	AAA
	 	10.8(c)
	Burdened Product
	 	4.6(d)(i)
	CSR
	 	3.5(b)
	Field Infringement
	 	6.3(b)
	Indemnified Party
	 	9.4(a)






 


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	Defined Term	 	Section or Provision
	Indemnifying Party
	 	9.4(a)
	Infringement Claim
	 	6.4(a)
	Infringement Notice
	 	6.4(a)
	Invalidity Claim
	 	6.3(g)
	Inventions
	 	6.1(a)(ii)
	IP Transfer Date
	 	6.1(a)(i)
	Isis Agreement
	 	Schedule 3.3(a)
	Limits of Liability
	 	9.6(h)
	Manufacturing Resources
	 	8.4(g)
	OGX Disclosure Schedule
	 	5.2
	Other Product
	 	2.7
	Patent Challenge
	 	8.2(c)
	Prosecute or Prosecution
	 	6.2(a)
	Regulatory Correspondence
	 	3.6(a)(i)
	Required Third Party Rights
	 	4.6(d)(i)
	Sublicense Agreement
	 	2.1(b)(i)
	UBC Agreement
	 	Schedule 3.3(a)
	U.S./Canadian Commercialization
	 	Plan                      3.7(a)






ARTICLE 2


GRANT OF RIGHTS





2.1 Grants by OGX. (a) Subject to the terms and conditions of this Agreement,
OGX hereby grants to Teva an exclusive (even as to OGX, except as otherwise expressly
provided in this Agreement) right and license throughout the Territory, with the right to
grant sublicenses (subject to Sections 2.1(b) and (c)), under the OGX Intellectual Property:
(i) to Develop, have Developed, make, have made, and use the Licensed Compound and Licensed
Product in the Field, and (ii) to sell, offer for sale, register, Commercialize and otherwise
exploit the Licensed Product in the Field; provided that notwithstanding the
exclusive rights granted to Teva in the foregoing grant, OGX shall retain the limited right
to use the OGX Intellectual Property (i) to the extent necessary to perform its express
obligations under this Agreement (including the Clinical Development Plan), (ii) to
conduct the [***] subject to the approval of the JSC, and (iii) as otherwise agreed to
in writing by the Parties.


 


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(b) (i) The licenses and rights granted to Teva hereunder are sublicensable in connection with
the continued Development or Commercialization of any Licensed Compound or Licensed Product upon
notice provided by Teva to OGX. Teva shall provide OGX a copy of each agreement granting a
sublicense under the rights granted in Section 2.1(a) (each, a “Sublicense Agreement”)
promptly after execution thereof, provided that Teva may redact from such copy of
any Sublicense Agreement any financial or other information that is outside of the scope of and
does not relate to the license or other rights granted to Teva under this Agreement.




(ii) The grant of any sublicenses under this Section 2.1(b) shall not relieve either
Party of or reduce its obligations to the other Party under this Agreement. Notwithstanding
Teva’s grant of any such sublicense, Teva shall remain responsible to OGX for performing its
obligations under this Agreement and for the actions of its sublicensees, with the further
understanding that any action or omission by any such sublicensee that, if committed by Teva
would be a breach of this Agreement, will be deemed a breach by Teva of this Agreement (with
respect to those country(ies) in which such sublicensee is sublicensed) for which Teva is
responsible. The term of any sublicense shall be limited to the term of this Agreement and
will terminate upon the expiration or the termination of this Agreement for any reason
whatsoever, provided, however, that for each sublicensee, upon termination
of this Agreement, if the sublicensee is not then in breach of its Sublicense Agreement, and
provided that such sublicensee has financial and marketing capabilities
sufficient to perform the
Development (if applicable) and Commercialization at a commercially reasonable level in
those countries in which such sublicensee is sublicensed, then OGX shall, at the joint
request of the sublicensee and Teva, enter into a new license agreement with such
sublicensee on substantially the same terms as this Agreement (with Teva having no
obligations or liabilities thereunder, although not relieving Teva of any obligations or
liabilities accrued prior to the expiration or termination of this Agreement).


 


30









 






(iii) Teva shall, in each Sublicense Agreement, require the sublicensee to comply with
all applicable terms of the Third Party License Agreements and to provide to OGX (if this
Agreement and the Sublicense Agreement terminates) or to Teva (if only the Sublicense
Agreement terminates) the assignment and transfer of ownership and possession of all
Regulatory Documents and Regulatory Approvals held or possessed by such sublicensee (which
assignment could also be directly to Teva prior to any such termination). Each Sublicense
Agreement shall be subject to the applicable terms and conditions of this Agreement and any
Third Party License Agreements.



(c) Teva acknowledges and agrees that its sublicense rights with respect to intellectual
property licensed by OGX pursuant to the Isis Agreement and the UBC Agreement (as defined in
Schedule 3.3(a)) are at all times subject to the applicable terms and conditions of such
agreements, including the scope of rights licensed to OGX under such agreements. Teva acknowledges
that, pursuant to the Isis Agreement, OGX’s license under certain of the OGX Intellectual Property
is non-exclusive and, accordingly, the exclusivity of the sublicense granted to Teva in Section
2.1(a) hereof under such OGX Intellectual Property is subject to the applicable non-exclusivity
terms in the Isis Agreement. Teva covenants to comply with the terms of the Isis Agreement and the
UBC Agreement as applicable to sublicensees and consistent
with the provisions of this Agreement. This Agreement does not provide Teva with any rights
to use any Isis Manufacturing Technology (as defined in the Isis Agreement) to manufacture any ASO
(other than a Licensed Compound) for Third Parties.


 


31









 






2.2 Grants by Teva. Subject to the terms and conditions of this Agreement, Teva
hereby grants OGX a non-exclusive, non-sublicensable (except to subcontractors as permitted
under this Agreement, solely to permit such subcontractors to perform OGX’s assigned
responsibilities under the Clinical Development Plan), royalty-free, fully-paid right and
license, under the Teva Know-How and Teva Patent Rights, solely to the extent necessary to
conduct the activities assigned to OGX by the JSC under the Clinical Development Plan.




2.3 Negative Covenant. Each Party covenants that it will not knowingly use or
practice any of the other Party’s Intellectual Property licensed to it under this Article 2
except for the purposes expressly permitted in the applicable license grant.




2.4 No Implied Licenses; Limitations. Except as explicitly set forth in this
Agreement, neither Party grants to the other Party any license, express or implied, under its
intellectual property rights. For clarity, OGX retains exclusively all rights under the OGX
Intellectual Property for all purposes except as expressly licensed to Teva under this
Agreement.


 


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2.5 Exclusivity. In addition to the exclusive rights granted by OGX under
Section 2.1, OGX, together with its Affiliates, will not during the period commencing on the
Effective Date through the earlier of (a) the expiration of the first Royalty Term in (i) the
U.S., and (ii) any Primary EU Market, or (b) the expiration of the [***] Substantial
Generic Competition [***] following the [***] Substantial Generic Competition Event in
(i) the U.S., and (ii) any Primary EU Market: provided that at the time of such expiration
Substantial Generic Competition still exists in the U.S. or Primary EU Market, as applicable,
directly or indirectly (including through licenses, assignments, joint ventures and other
arrangements or transfer of rights), clinically develop after phase 2a (it being understood
that any pre-phase 2a and phase 2a Clinical Study or GLP toxicology IND-enabling studies on
Other Compounds shall require the prior consent of Teva, which consent shall not be
unreasonably withheld), register, market, sell, offer for sale, commercially distribute or
otherwise commercially exploit any molecule (or any Product containing such molecule) in the
Field (other than the Licensed Product or Licensed Compound) that directly acts to modulate
the expression of Clusterin (such molecule, an “Other Compound”), but excluding OGX-427 and
OGX-225. For clarity, the foregoing shall not apply to Products in the Field that do not
directly act on Clusterin, even if such action has the indirect effect of modulating the
expression of Clusterin. Further, if OGX undergoes a Change of Control with respect to a
Third Party, the foregoing negative covenant shall not apply to any active independent
program of such Third Party (or any of its affiliates) in existence prior to the date that
such Third Party initiated discussion with OGX of such Change of Control transaction.




2.6 Authorized Generic Products. Notwithstanding anything in this Agreement to
the contrary, if during the Agreement Term either Party believes in good faith that at any
time a launch of a Generic Product by a Third Party is imminent or likely in any country, the
Parties shall discuss the issue and whether it would be appropriate for Teva to launch an
Authorized Generic Product in such country. If the Parties so agree, or in any
event if a Generic Product actually is commercially launched in the country (but
excluding a “launch at risk”), then Teva shall have the right (but not the obligation) to
launch its own generic version of the applicable Licensed Product (an “Authorized Generic
Product”) in such country, subject to the provisions of Section 4.2(c).


 


33









 






2.7 Other Products. If Teva or its Affiliate sells, distributes or otherwise
commercializes, in a country during the Royalty Term applicable to such country, a Product
that contains an Other Compound (an “Other Product”), then for the period ending on the
earlier of the date that is (i) [***] ([***]) years from the First Commercial Sale of the
Other Product in such country or (ii) the earlier to occur of: (a) the [***] the Royalty
Term applicable to the [***] Licensed Product that is sold in such country under this
Agreement, and (b) the occurrence of Substantial Generic Competition in such country, Teva
shall pay OGX royalties on the net sales of such Other Products in such country (calculated
as if net sales of such Other Products are Net Sales of Licensed Products with such term
applied mutatis mutandis to the sales of such Other Products) at a rate equal to [***] of the
applicable ongoing royalty rate under Schedule 4.2. Notwithstanding the foregoing, in the
event that a Third Party is commercializing a Generic Product, nothing in this Agreement
shall prohibit Teva from manufacturing, distributing, promoting, marketing or selling such
product or the active pharmaceutical ingredient therein for or to a Third Party, and neither
Other Compounds nor Other Products will be deemed to include such product or ingredient
provided that such product or ingredient does not incorporate, and is not claimed or covered
by, any OGX Intellectual Property.


 


34









 





ARTICLE 3




TRANSITION; DEVELOPMENT AND COMMERCIALIZATION;

REGULATORY MATTERS





3.1 Overview. The Parties agree to collaborate under the terms of this
Agreement with respect to the Development of Licensed Compounds and Licensed Products in the
Field in the Territory. Such collaboration shall be under the direction of the JSC and
pursuant to the Clinical Development Plan. Subject to the remainder of this Article 3, each
Party shall be responsible for the activities allocated to it in the Clinical Development
Plan. As further described in this Agreement and in the Clinical Development Plan, (a) OGX
shall be primarily responsible for conducting a Phase III Clinical Study of Licensed Product
for second-line CRPC, and shall initially hold (under the direction and control of the JSC)
the Existing IND, and (b) Teva shall be primarily responsible for conducting a Phase III
Clinical Study of Licensed Product for first-line CRPC and a Phase III Clinical Study of
Licensed Product for first-line non-small cell lung cancer, and any other Clinical Studies
and Development reasonably necessary to obtain Regulatory Approvals in the Territory for
applicable indications.




3.2 Transfer of Technology.



(a) Information. OGX and its Affiliates shall, within [***] of the Effective Date or
as otherwise set forth in Schedule 3.2(a), provide access to Teva to all OGX Know-How set forth in
such Schedule 3.2(a). Upon Teva’s request, OGX shall use commercially reasonable efforts to
deliver to Teva promptly (but in any event within [***] of a request by Teva), at Teva’s cost and
expense, electronic or (if reasonably available) hard copies of OGX Know-How that is requested by
Teva from time to time hereafter and is necessary or reasonably useful for
Teva to continue the research, Development and Commercialization (including the manufacture)
of Licensed Compound and Licensed Product.


 


35









 





(b) Transfer of Materials. Within [***] of a request from Teva or as otherwise set
forth in Schedule 3.2(b), OGX and its Affiliates shall deliver to Teva, at Teva’s cost and expense,
reasonable quantities of the materials set forth in such Schedule 3.2(b).



(c) Technical Assistance. In addition to the foregoing, OGX shall use commercially
reasonable efforts to provide Teva with a reasonable amount of assistance, such assistance to be
without charge, as Teva may reasonably request from time to time during the [***] period after the
Effective Date in connection with or related to any or all of the foregoing disclosures and the
activities being undertaken by Teva in connection therewith. In addition, as soon as reasonably
practicable, OGX shall provide Teva the reports listed on Schedule 3.2(c), at no charge to Teva.
After the initial [***] period, OGX shall use commercially reasonable efforts to provide Teva with
a reasonable amount of assistance in connection with Teva’s establishment of manufacturing
facilities for Licensed Compounds or Licensed Products or the transfer of the Existing IND to Teva.
The assistance under this Section 3.2(c) may include making available at Teva’s place of
employment (or such other location as the Parties may mutually agree upon) the assistance of those
OGX employees involved with CMC activities, manufacturing and analytical development, Clinical
Studies, development or discovery of Licensed Compounds and Licensed Products, and the OGX
Intellectual Property. Other than such initial [***] of technical assistance and the completion of
the reports in Schedule 3.2(c) and the assistance in connection with the establishment of
manufacturing facilities and the transfer of the Existing IND, all such activities under this
Section 3.2(c) shall be at Teva’s cost and expense, including as applicable for FTEs in accordance
with the applicable FTE Rates, travel expenses in accordance with
Teva’s standard travel policies, and other out of pocket expenses approved in advance by Teva
and incurred by OGX in providing such assistance. OGX shall have a continuing obligation to
disclose and provide promptly and effectively to Teva from time to time any additional OGX
Intellectual Property developed or Controlled by OGX or its Affiliates during the Agreement Term to
the extent necessary or reasonably useful for Teva to Develop or Commercialize the Licensed
Compounds and Licensed Products in the Field.


 


36









 





(d) Alliance Managers. Each Party shall appoint an alliance manager, who shall serve
as the primary point of contact for that Party in connection with all matters under this Agreement
that are not expressly delegated to another individual or to the JSC hereunder. A Party may
replace its alliance manager at any time upon written notice to the other Party. As of the
Effective Date, the Parties’ alliance managers and contact details are:




For OGX:




[***]




For Teva:




[***]




3.3 Third Party Agreements.



(a) Attached hereto as Schedule 3.3(a) is a list of all contracts, licenses, and agreements
between OGX and any and all Third Parties that relate directly to the research, Development or
Commercialization of Licensed Compounds and Licensed Products (the “Third Party
Agreements”), including, as specifically identified on such schedule, all Third Party
Agreements under which OGX has in-licensed specific OGX Intellectual Property
(the “Third Party License Agreements”). Simultaneously with the execution of this
Agreement, OGX is delivering to Teva amendments to the UBC Agreement and the Isis Agreement, in
form and substance acceptable to Teva.


 


37









 





(b) Without Teva’s prior written consent, which shall not be withheld unreasonably, OGX shall
not terminate the Third Party Agreements or modify or amend the Third Party Agreements in a manner
that would adversely affect the rights granted to Teva hereunder, except as expressly provided in
this Agreement. Except as provided in the Clinical Development Plan or otherwise agreed by the
JSC, OGX shall not enter into any other contracts, agreements or other arrangements with Third
Parties regarding the Licensed Compound or the Licensed Products.



(c) Throughout the Agreement Term, OGX will use commercially reasonable efforts to maintain
and not to breach in any material manner any of the Third Party License Agreements.




3.4 Further Acts. The Parties shall use reasonable efforts to take such other
actions and execute such other instruments, assignments and documents as may be necessary or
reasonably useful to effect the transfer of rights hereunder to Teva, or to otherwise
effectuate the purposes of this Agreement.


 


38









 






3.5 Development and Commercialization.



(a) General. In connection with the Development of Licensed Compounds and Licensed
Products under this Agreement, each of the Parties shall use its Commercially Reasonable Efforts to
conduct the Development work assigned to it and to seek Regulatory
Approval for Licensed Products, as set forth in the clinical development plan to be agreed by
the JSC within [***] of the Effective Date (the “Clinical Development Plan”), a summary of
which is attached hereto as Exhibit A. Such Clinical Development Plan, under the direction
of the JSC, may be modified and reviewed from time to time pursuant to and in accordance with the
terms of this Agreement. Except for those activities allocated to OGX in the Co-Promotion
Agreement or under this Agreement (including activities designated in the Clinical Development
Plan), Teva shall have sole responsibility for the Development and Commercialization of Licensed
Compounds and Licensed Products in the Field in the Territory. The Parties shall conduct all such
activities in accordance with the terms and conditions of this Agreement and all applicable Laws.



(b) Clinical Development Plan. The Clinical Development Plan (as the same may be
modified from time to time pursuant to the terms of this Agreement) shall specify (i) to the extent
applicable, all technical, nonclinical, drug supply and clinical development activities, consistent
with requirements for Regulatory Approval, that will be conducted by the Parties in Developing the
Licensed Compounds and Licensed Products, and the Party responsible for each such activity; (ii)
protocols for all Clinical Studies to be conducted under the Clinical Development Plan; (iii)
clinical study reports (“CSRs”), summary activity reports, and budgetary reports to be
provided by the Parties, as well as timelines of dates for such reports to be provided; (iv)
scheduled budgets for the activities to be undertaken by OGX (including for activities to be
conducted by Third Parties on behalf of OGX); and (v) Development activities to be conducted by
Third Parties on behalf of either Party or the Parties jointly. The JSC shall review, amend and
supplement the Clinical Development Plan on a [***] basis or more often as the Parties mutually
deem appropriate, subject to the decision-making provisions under Section
3.5(d). As of the Effective Date, the Parties have agreed to protocols for the Phase III
Clinical Studies for first-line CRPC and second-line CRPC as set forth on Exhibit A. On a
[***] for the first-line non-small cell lung cancer Phase III Clinical Study to be conducted under
the Clinical Development Plan, which protocol shall be consistent with the patient population,
number of patients, and primary endpoint as summarized in Exhibit A.


 


39









 






(c) Specific Obligations




(i) Obligations of OGX. OGX shall, in accordance with and in furtherance of
the Clinical Development Plan:



(A) conduct the activities assigned to it under and pursuant to the Clinical Development Plan,
including the second-line CRPC Phase III Clinical Study, subject to Section 3.5(c)(iii); and



(B) spend $30 million in Development Expenses, subject however to early termination of
Clinical Trials under the provisions of Sections 3.5(c)(iii) or of the Agreement under Article 8
(which termination shall not relieve OGX from paying amounts due under any and all non-cancelable
arrangements entered into by OGX prior to the date of termination).




(ii) Obligations of Teva.



(A) Teva shall, in accordance with and in furtherance of the Clinical Development Plan,
conduct the activities assigned to it under and pursuant to the Clinical Development Plan with
respect to the three (3) Clinical Studies set forth therein, subject to Section 3.5(c)(iii).


 


40









 





(B) Teva shall be responsible for all expenses incurred by or on behalf of Teva under the
Clinical Development Plan or otherwise for Development of Licensed Compounds and Licensed Products
and, subject to Section 4.3, all Development Expenses exceeding the $30,000,000 in Development
Expenses incurred by OGX in accordance with the Clinical Development Plan.



(C) Teva shall use Commercially Reasonable Efforts to Develop and to Commercialize Licensed
Products in the Territory in accordance with the terms and conditions of this Agreement.




(iii) Deviations from Clinical Development Plan. A Party’s failure to complete
the Clinical Studies for which such Party is responsible, as set forth in Exhibit A,
once such Clinical Study is [***] shall not be deemed a breach of this Agreement solely to
the extent such failure results directly from (A) a determination on the part of [***] or
[***] as to the safety of the Licensed Product(s) and/or Licensed Compound in its then
current formulation, dosage form or dose level, (B) results of any futility analyses
performed by [***] as specified in the Clinical Study protocol or (C) the acts or omissions
of the other Party that materially prevent or impede such Party’s ability to conduct the
Clinical Studies that it is responsible for. A Party shall not be liable for any delay with
respect to the timelines set forth in the Clinical Development Plan to the extent such delay
is caused by (1) the acts or omissions of the other Party, or (2) an unexpected or
unforeseen event not in such Party’s control, including (x) any action, instruction or
guidance by a Regulatory Authority, or (y) lack of adequate or continuing supply of
Product(s) necessary for the manufacture of the Licensed Product, provided that such


 


41









 






Party
uses Commercially Reasonable Efforts to avoid the causes of the delay
and to perform such aspects of Development as it is able to perform notwithstanding
such events. Furthermore, Teva shall have the right not to [***] any of the three (3) Phase
III Clinical Studies, and therefore shall not be in breach of this Agreement, if
an unexpected or unforeseen event occurs or circumstance arises, that is not within the
control of Teva, and has a material adverse impact on (I) the OGX Patent Rights listed on
Schedule 1.88, or (II) safety issues attributable to OGX-011, provided that such
determination not to [***] the applicable Clinical Study, due to such event or circumstance,
is consistent with the decisions that would be made by global pharmaceutical companies in
the exercise of reasonable business judgment under similar facts and circumstances for drug
candidates and pharmaceutical products at a comparable stage of development and commercial
potential.



(d) Joint Steering Committee. (i) The Parties hereby establish a Joint Steering
Committee (“JSC”) to manage and oversee Development of all Licensed Products through all
Regulatory Approvals for each indication approved for Development by the JSC. The JSC shall have
an equal number of members from each Party, with a total of four (4) members initially (and the
Parties may change such total membership as needed and agreed upon in writing from time to time).
Each of OGX and Teva will appoint its member individuals to the JSC, each of whom will have
sufficient technical experience and seniority to make decisions within the scope of the JSC’s
responsibility. The initial members of the JSC shall be designated by the Parties prior to the
first JSC meeting described in subsection (d)(iv) hereof. Teva and OGX may each replace any or all
of its representatives on the JSC at any time upon written notice to the other Party. A Party may
designate a substitute to temporarily attend and perform the functions of such Party’s designee at
any meeting of the JSC. The JSC shall be chaired by
one of the representatives appointed by Teva (“chairperson”). On advance written notice to
the other Party, additional participants may be invited by any representative to attend JSC
meetings when appropriate, and the Parties intend that their respective alliance managers will
attend JSC meetings unless not practicable.


 


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(ii) The JSC shall be responsible for (A) planning, administering and monitoring all
significant and material aspects of Development, including reviewing, amending and approving
the Clinical Development Plan and all protocols for Clinical Studies of Licensed Products,
and the budgets thereunder; (B) proposing and adopting New Indications in the Field for
development of Licensed Compounds and Licensed Products; (C) all significant and material
aspects of seeking and obtaining Regulatory Approvals; and (D) performing such other
functions or establishing joint subcommittees as appropriate to further the purposes of this
Agreement as determined by the Parties.




(iii) The JSC may make decisions with respect to any subject matter that is subject to
the JSC’s decision-making authority and responsibilities as set forth in Section 3.5(d)(ii).
Regardless of the number of individuals attending any JSC meeting, Teva and OGX shall have
a single vote each. The JSC shall attempt in good faith to reach unanimity with respect to
matters that come before it for decision and shall give consideration to the views,
positions and recommendations of each Party on such matters. If the JSC is unable to reach
unanimity upon any issue or matter that is brought before it for decision, then the JSC
chairperson shall be entitled to make the final decision, which decision shall be binding
upon the Parties; provided, however:



(A) the JSC shall not have the right to decide not to commence or to discontinue any of the
three (3) Clinical Studies set forth in Exhibit A absent a decision by Teva not to
commence, or to discontinue (as applicable), the particular Clinical Study which decision is
consistent with the provisions of Section 3.5(c)(iii);




 


43









 






(B) under no circumstances shall the JSC and its chairperson have the right or authority to
allocate materially additional Development activities to OGX or to require OGX to incur any
expenses or costs or allocate any resources in excess of the amounts set forth in the Clinical
Development Plan or in Section 3.2(c) without the prior written consent of OGX;



(C) the JSC chairperson shall not have the right to amend the Clinical Development Plan or any
protocols for the first-line CRPC Clinical Study or the second-line CRPC Clinical Study described
in Exhibit A and the CDP, in a manner that would [***] without the prior written consent of OGX;
and



(D) with respect to the initial or any amended protocol for the first-line non-small cell lung
cancer Phase III Clinical Study to be conducted under the Clinical Development Plan, the JSC
chairperson shall not have the right to determine or modify the [***] without the written consent
of OGX.


 


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(iv) The chairperson of the JSC shall call meetings as reasonably requested by one of
the Parties; provided, however, that the JSC shall meet at least on a [***]
basis during the period prior to the first filing for Regulatory Approval of a Licensed
Product hereunder and at least [***] thereafter, unless otherwise required by this Agreement
or agreed to between the Parties, and further provided that the first
meeting of the JSC shall be held as soon as practicable, but no later than [***] after
the Effective Date, at a location mutually agreeable to the Parties, at which the Clinical
Development Plan contemplated by Section 3.5(b) and in accordance with Exhibit A shall be
approved. The chairperson shall establish the timing and agenda of all JSC meetings and
shall transmit notice of such meetings, including the agenda therefor, to all JSC members;
provided, however, either Party may request that specific items be included
on the applicable agenda and such topics shall be included on the agenda, and either Party
may request that additional meetings be scheduled as needed. Meetings may be held in
person, by telephone, or by video conference call and, except as set forth above, the
location of each meeting shall alternate between the Parties’ selected locations in [***] or
such other location as may be mutually agreed upon by the Parties. On advance written
notice to the other Party, additional participants may be invited by any representative to
attend meetings where appropriate. Each Party shall be responsible for all travel and
related costs and expenses for its members and other representatives to participate in or
attend committee meetings. Any Proprietary Information disclosed in any meeting of the JSC
or its subcommittees shall remain Proprietary Information of such Party.




(v) Minutes of each JSC meeting shall be transcribed and issued by a representative of
OGX within [***] after each meeting (or in any event at least [***] Business Days prior to
the date of the next scheduled meeting of such committee) and shall be deemed approved
unless any JSC member objects to the accuracy of such minutes within [***] after receipt of
such minutes from each such meeting. Such minutes shall include only key discussion points
and decisions made and provide a list of
any identified issues yet to be resolved, either within such committee or through the
relevant resolution process, if any.


 


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(vi) The Parties shall have the right to disband the JSC upon mutual agreement, and OGX
shall have the right to disband the JSC upon written notice to Teva at any time.
Additionally, if the JSC is not disbanded pursuant to the immediately preceding sentence,
and absent a mutual written agreement by the Parties to continue the JSC, the JSC shall be
automatically disbanded effective upon either [***] or mutual agreement of the Parties [***]
in each case in [***] and each [***] Drug Approval Applications for a Licensed Product for
each of [***] and [***]. Upon any such disbandment of the JSC (excluding, for clarity, due
to termination of the Agreement under Article 8), all powers that otherwise would have been
exercised by the JSC pursuant to this Section 3.5(d) shall be exercised by Teva.




(vii) The JSC shall have only the powers assigned to it in this Section 3.5(d). All
activities conducted by and decisions made by the JSC shall be consistent with and subject
to the provisions of this Agreement, and the JSC and the chairperson of the JSC shall not
have any power to take any action that conflicts with the terms of this Agreement or to
amend, modify or waive compliance with any of the terms of this Agreement.



(e) Reports. Each Party shall use commercially reasonable efforts to prepare and
timely provide to the JSC the reports, summaries and other work product allocated to such Party in
accordance with, and in a manner set forth in, the Clinical Development Plan, including CSRs,
summary activity reports, toxicology reports, pharmacokinetic reports, pre-clinical studies
reports, and budgetary reports. In addition, on a [***] basis, each Party shall provide the
JSC with a report detailing its Development activities since the last such report and the results
of such activities. Within [***] after the end of each Calendar Year during the Agreement Term,
Teva shall provide OGX with a written summary of Commercialization activities undertaken since the
previous such report, consistent with written reports issued by Teva in the ordinary course of its
business.


 


46









 





(f) Records. Each Party, in connection with its conducting Development under this
Agreement, shall maintain records of all such Development work and all results and Data generated
thereby, in sufficient detail and in good scientific manner appropriate for patent and regulatory
purposes and in accordance with good industry practice, which shall be complete and accurate in all
material respects and shall fully and properly reflect all work done and results achieved in the
performance of the Development, and in the form required by applicable Laws.



(g) Promotional Materials and Activities. Teva shall create and develop all
appropriate promotional materials and Labeling for the Licensed Products. Teva shall be
responsible for all submissions and interactions with Regulatory Authorities regarding Licensed
Product-related promotional materials and Labels that are required to be submitted to Regulatory
Authorities.



(h) Ownership of Copyrights and Trademarks. Teva shall have the sole right to brand
the Licensed Product and, except for the OGX Trademarks (which shall remain owned by OGX), Teva
shall own all right, title and interest in and to the copyrights, Trademarks and trade dress in all
marketing, sales, advertising or promotional materials used by Teva (or its Affiliates) in the
Commercialization of the Licensed Product. Teva shall be responsible for
searching, clearing and filing applications for registration of all such copyrights,
Trademarks and trade dress.


 


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(i) Sales of Licensed Product. All sales of Licensed Products shall be made,
recorded, invoiced and collected by Teva. All terms regarding Licensed Product sales, including
terms respecting credit, pricing, cash discounts, rebates, chargebacks, bad debt write-offs, and
other fees and charges, and returns and allowances shall be set solely by Teva.



(j) Supply of Licensed Product. Except as contemplated by and pursuant to the
Clinical Development Plan (including OGX using commercially reasonable efforts to achieve the
timely supply by OGX of all necessary drug supplies for the Clinical Studies to the extent
specified in the Clinical Development Plan), Teva shall use Commercially Reasonable Efforts to
supply, or cause to be supplied, during the Agreement Term, all requirements for the Licensed
Product in the Territory. To the extent OGX incurs any direct costs and expenses in carrying out
any transitional manufacturing activities authorized and approved in writing in advance by Teva,
Teva shall reimburse OGX for any pre-approved costs and expenses incurred in carrying out such
activities.


 


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3.6 Regulatory Matters.




(a) Rights and Responsibilities.




(i) Teva (or, solely with respect to the Existing IND described in Section 3.6(b), OGX
under the direction of the JSC) shall have the responsibility for the timely preparation,
filing and prosecution of all filings, submissions, authorizations or approvals related to
Drug Approval Applications for the applicable Licensed Product and
indication (“Regulatory Correspondence”) with Regulatory Authorities in the
applicable countries, and shall own and control all such filings, submissions,
authorizations and approvals, including any IND, NDA or other Drug Approval Application.
Teva (or, solely with respect to the Existing IND described in Section 3.6(b), OGX) shall
provide advance copies of all material Regulatory Correspondence to the other Party for
review and comment at least [***] in advance of submission to a Regulatory Authority, and
shall take into account, in good faith, any reasonable comments offered by such other Party
within [***] of provision to such other Party of such advance copies; provided,
however, that OGX shall not file any document with a Regulatory Authority until
reviewed and approved by the JSC or Teva. Teva shall keep OGX reasonably informed of the
status, progress and results of all regulatory activities under this Section 3.6.




(ii) Teva (or, solely with respect to the Existing IND described in Section 3.6(b),
OGX) shall be the primary contact with each applicable Regulatory Authority and shall be
solely responsible for all communications with each applicable Regulatory Authority that
relate to any IND, NDA, or other Drug Approval Application for the applicable Licensed
Product and indication, provided, however, that upon the reasonable request
of such Party and at least [***] notice, the other Party shall reasonably provide
appropriate personnel to participate in discussions with a Regulatory Authority regarding
the regulatory review process and shall reasonably assist and consult with Teva (or, solely
with respect to the Existing IND described in Section 3.6(b), OGX) in applying for
Regulatory Approval. In providing such assistance, such other Party shall not contact the
Regulatory Authorities without the prior written approval of Teva (or, solely with respect
to the Existing IND described in Section 3.6(b), OGX) and, if
contacted by a Regulatory Authority with respect to a Licensed Product, shall refer
such contact to Teva (or, solely with respect to the Existing IND described in Section
3.6(b), OGX).


 


49









 






(iii) From and after receipt of each Regulatory Approval or, with respect to the CRPC
indication in the United States, from and after the Regulatory Document Transfer Date, Teva
shall have exclusive authority and responsibility to submit all reports or amendments
necessary to maintain Regulatory Approvals and to seek revisions of the conditions of each
such Regulatory Approval and shall keep OGX promptly informed of any such actions. Without
limiting the generality of the foregoing, Teva shall have sole authority and responsibility
to seek and/or obtain any necessary Regulatory Authority approvals of any Product Label, or
Regulatory Authority-approved prescribing information, package inserts, monographs and
packaging used in connection with a Licensed Product, as well as promotional material and
Labels used in connection with a Licensed Product, and for determining whether the same
requires Regulatory Approval.



(b) Existing IND. OGX shall hold, under the direction and control of the JSC, the
U.S. IND for Licensed Products that exists as of the Effective Date (“Existing IND”), until
such time as either Teva or OGX requests such Existing IND to be transferred to Teva, at which time
OGX shall promptly transfer the Existing IND to Teva.


 


50









 





(c) Regulatory Filings, Approvals and Applications. Within [***] after (i) with
respect to the CRPC indication in the United States, the transfer of the Existing IND described in
Section 3.6(b), and (ii) with respect to all other countries and indications, the
Effective Date, OGX shall submit to the applicable Regulatory Authorities a letter authorizing
the transfer of ownership from OGX to Teva, and shall otherwise take action within its control to
transfer to Teva, all regulatory filings, approvals and applications, as well as protocol sign-offs
and approvals, relating to the Licensed Compound or Licensed Product for the applicable indication,
including all INDs (subject to Section 3.6(b)) and all Regulatory Approvals, Drug Approval
Applications and all related documentation and information, if any (the “Regulatory
Documents”), provided, however, that it is understood and agreed that OGX has
no obligation to transfer to Teva any physical copies of any Regulatory Documents that are made
available to Teva in electronic format (compatible with Teva’s systems), unless Teva pays for the
actual costs of effecting such transfer. Promptly after each such submission to a Regulatory
Authority, Teva shall execute and submit to the applicable Regulatory Authorities a letter,
accompanied by the transfer letter referred to in the preceding sentence, acknowledging Teva’s
assumption of ownership of and responsibility for the Regulatory Documents. The effective date of
the transfer of ownership of Regulatory Documents to Teva with respect to a Licensed Product,
indication and regulatory jurisdiction is referred to as the “Regulatory Document Transfer
Date” for such Licensed Product, indication and regulatory jurisdiction.



(d) Pharmacovigilance. The Parties’ responsibilities concerning adverse drug
reactions, safety information and compliance with regulatory requirements with respect thereto will
be detailed in a separate pharmacovigilance agreement to be mutually agreed upon by the Parties as
soon as practicable after the Effective Date. Such pharmacovigilance agreement shall have terms
that are commercially reasonable and typical for similar safety agreements in the industry, and
will provide that Teva shall be responsible for maintaining the global safety
database and for global safety monitoring for Clinical Studies commencing from and after the
Effective Date, except as prohibited by Law.


 


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(e) Recalls and Other Corrective Action. If any Regulatory Authority (i) threatens,
initiates or advises any action to remove any Licensed Product from the market in the Territory or
(ii) requires or advises Teva, OGX, their Affiliates, or their sublicensees to distribute a “Dear
Doctor” letter or its equivalent regarding use of such Licensed Product in the Territory, then Teva
or OGX, as applicable, shall notify the other Party of such event within [***] Business Days (or
sooner if required by Law) after such Party becomes aware of the action, threat, advice or
requirement (as applicable), and the appropriate members of each Party shall promptly discuss such
action, threat, advice or requirement. Teva shall have the sole responsibility for, and shall make
all final decisions with respect to, any recall, market withdrawal or any other corrective action
related to a Licensed Product, and nothing herein shall prohibit Teva from initiating or conducting
any recall or other corrective action mandated by a Regulatory Authority or applicable Law;
provided, however, that Teva shall consider in good faith all reasonable comments
of OGX with respect thereto. Teva shall conduct any recall, market withdrawals, or other
corrective action related to a Licensed Product at its expense. At Teva’s request and expense, OGX
shall provide all pertinent records of OGX that Teva may reasonably request to assist in effecting
such action. Except as set forth in this Section 3.6(e) or pursuant to the Parties’
indemnification obligations under this Agreement, neither Party shall have any obligation to
reimburse or otherwise compensate the other Party or its Affiliates for any consequential damages,
lost profits or income that may arise in connection with any recall, market withdrawal or
corrective action with respect to a Licensed Product.


 


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3.7 OGX Option to Co-Promote.



(a) US and Canadian Commercialization. The strategy for the commercial launch and
subsequent Commercialization of each Licensed Product in the United States and Canada shall be
described in a plan that describes the pre-launch, launch and subsequent Commercialization
activities for such Licensed Product in the United States and Canada (including pricing,
advertising, education, planning, marketing, sales force training and allocation) (each such plan,
a “US/Canadian Commercialization Plan”). The US/Canadian Commercialization Plan will
contain such information as Teva reasonably believes necessary for the successful commercial launch
of such Licensed Product in the United States and Canada. OGX shall have the right to evaluate the
US/Canadian Commercialization Plan as part of its determination whether to exercise the
Co-Promotion Option with respect to Licensed Products in the U.S. and Canada.



(b) The Co-Promotion Option. Pursuant to the terms set forth in this Section 3.7, OGX
shall have the option to co-promote Licensed Products with Teva in the United States and Canada
(the “Co-Promotion Option”). No later than [***] prior to the Estimated Launch Date for
the Licensed Product anticipated by Teva to be the first one launched in the U.S. or Canada, Teva
shall provide OGX with a then-current draft of the corresponding US/Canadian Commercialization Plan
for the particular Licensed Product. The Co-Promotion Option shall then be exercisable by OGX
until the later of (i) [***] after such draft US/Canadian Commercialization Plan is provided to OGX
and (ii) [***] prior to such Estimated Launch Date (“Co-Promotion Option Term”). If OGX
exercises the Co-Promotion Option under this Section 3.7(b), then the Parties shall cooperate in
the promotion and Commercialization of Licensed Product in the U.S. and Canada in accordance with a
Co-Promotion Agreement and Schedule 3.7. If OGX does not timely exercise its Co-Promotion Option,
or if the Co-Promotion
Agreement terminates, Teva shall be solely responsible for all promotion and Commercialization
activities with respect to the Licensed Product in the U.S. and Canada.


 


53









 





(c) Exercising the Co-Promotion Option. OGX may exercise the Co-Promotion Option by
providing written notice to Teva prior to the end of the Co-Promotion Option Term of OGX’s desire
to exercise the Co-Promotion Option. If OGX fails to exercise the Co-Promotion Option within the
Co-Promotion Option Term, then the Co-Promotion Option shall terminate and no longer be of any
force or effect; provided, however, that if Teva materially changes the US/Canadian
Commercialization Plan within [***] after the expiration of the Co-Promotion Option Term without
exercise of the Co-Promotion Option by OGX, then Teva shall provide such updated plan to OGX, the
Co-Promotion Option shall be reinstated, and OGX shall have [***] after receipt thereof to exercise
the Co-Promotion Option.



(d) Delegation of Co-Promotion Rights or Obligations. OGX [***] transfer, assign,
outsource or sublicense its co-promotion rights and obligations hereunder or under the Co-Promotion
Agreement without the prior written consent of Teva. Accordingly, OGX shall not use any persons
other than its (or its Affiliates’) employees to perform its obligations under the Co-Promotion
Agreement.


 


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(e) Co-Promotion Agreement. Within [***] after OGX exercises its Co-Promotion Option,
the Parties shall use their good faith efforts to enter into a written co-promotion agreement
specifying the terms of the co-promotion arrangement, including the performance of all Co-Promotion
Activities, which terms shall be consistent with the provisions outlined in Schedule 3.7 (the
“Co-Promotion Agreement”). The Parties shall negotiate the terms of the Co-Promotion
Agreement reasonably and in good faith. If the Parties cannot reach
agreement on the terms of the Co-Promotion Agreement by the end of such [***] period, then any
remaining issues in such negotiations shall be resolved using an accelerated arbitration process as
provided in Section 10.8(c), and, at OGX’s election, the Parties then shall complete such
negotiations based on such resolution and enter into the Co-Promotion Agreement as soon as
practicable thereafter or, alternatively, OGX shall have the right not to enter into the
Co-Promotion Agreement, which right must be exercised within [***] of the arbitration decision.



(f) Co-Promotion Term. Once executed by the Parties, the Co-Promotion Agreement shall
remain in effect for as long as Teva is selling Licensed Product in the United States or Canada,
unless earlier terminated pursuant to the terms of this Agreement or the Co-Promotion Agreement,
provided that Teva shall have the right to terminate the Co-Promotion Agreement
after [***] ([***]) years from the First Commercial Sale of a Licensed Product in the United States
or Canada. OGX shall have the right to terminate the Co-Promotion Agreement at any time on not
less than [***] written notice to Teva. OGX and Teva will cooperate in good faith throughout the
term of the Co-Promotion Agreement to ensure that the exercise and performance of the Co-Promotion
Activities and other co-promotion rights and obligations as described herein and in any
Co-Promotion Agreement shall be exercised by OGX in accordance with the terms of the Co-Promotion
Agreement.


 


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ARTICLE 4




PAYMENTS AND STATEMENTS





4.1 Upfront Payment, Advanced Reimbursement and Development Milestones.



(a) General. In partial consideration of the rights granted by OGX hereunder, Teva
shall pay OGX the Upfront Payment, the Advanced Reimbursement and development milestones set forth
in Schedule 4.1, contingent upon occurrence of the specified event, with each amount to be paid no
more than once (except for those milestones applicable to two (2) different indications) with
respect to the achievement of the respective event first giving rise to payment (but payable the
first time such event is achieved). Subject to Section 4.1(b), each development milestone fee
shall be deemed earned as of the achievement of the related milestone event and shall be paid by
Teva within [***] ([***]) Business Days after the achievement of each milestone event.



(b) Adjusted Milestone Payment Schedule. Notwithstanding Section 4.1(a) and Schedule
4.1, once Teva has paid the development milestones under ([***]), ([***]) and ([***]) of Schedule
4.1, Teva shall have no obligation to pay any development milestone under ([***]) of Schedule 4.1
unless and until either (1) [***] been granted for Licensed Products for [***], (2) [***] of a
Licensed Product for [***] indication has been granted, or (3) [***] have been achieved in the
[***], at which point the development milestone under ([***]) shall be due for each achievement of
the applicable event. Further, notwithstanding Section 4.1(a) and Schedule 4.1, once Teva has paid
the development milestones under ([***]), ([***]) and ([***]) of Schedule 4.1, Teva shall have no
obligation to pay any development milestones under ([***]) of Schedule 4.1 unless and until either
(1) [***] been granted for Licensed Products for [***], (2) [***] of a Licensed Product for [***]
indication has been granted, or (3) [***] have been achieved in the [***], at which point the
development milestone under ([***]) shall be due for each achievement of the applicable event.


 


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4.2 Royalties.



(a) Ongoing Royalties. Subject to any applicable adjustments under Sections 4.2(b)
and (e), for each Licensed Product being sold, during each Calendar Quarter throughout the
applicable Royalty Term, Teva shall, pursuant to Section 4.4(a), pay to OGX royalties as a
percentage of the Net Sales in the Territory using the royalty rates set forth in Schedule 4.2,
calculated according to the annual (Calendar Year) aggregate Net Sales throughout the Territory.




(b) Generic Competition.




(i) Reduction in Royalties. If prior to the expiration of the Royalty Term for
a particular Licensed Product in a country, Generic Competition occurs in such country with
respect to such Licensed Product, the royalty rates payable by Teva to OGX under Section
4.2(a) shall thereafter (except as otherwise provided in subclause (ii) below) be reduced by
[***] in such country for the sales of such Licensed Product (but not for other Licensed
Products). In addition, if prior to the expiration of the Royalty Term for a particular
Licensed Product in a country, Substantial Generic Competition occurs in the country with
respect to such Licensed Product, royalties shall thereafter no longer be owed by Teva to
OGX in the subject country for sales of such Licensed Product, except as otherwise provided
in subclause (iii) below.




(ii) Resumption of Royalties with Respect to Generic Competition.
Notwithstanding any reduction of royalties under Section 4.2(b)(i) for a given Licensed
Product in a given country due to Generic Competition, if, in any Generic Competition [***],
Net Sales of such Licensed Product in such country exceed [***] of the Net Sales of such
Licensed Product in the [***] completed just prior to the Generic Launch Date,
Teva shall resume payment of royalties consistent with Teva’s payment of royalties
prior to the Generic Competition Event. In the event that there is a subsequent Generic
Competition Event in such country, then Section 4.2(b)(i) shall again apply.


 


57









 






(iii) Resumption of Royalties with Respect to Substantial Generic Competition.
Notwithstanding any reduction of royalties under Section 4.2(b)(i) for a given Licensed
Product in a given country due to Substantial Generic Competition, if, in any Substantial
Generic Competition [***], Net Sales of such Licensed Product in such country exceed [***]
of the Net Sales of such Licensed Product in the [***] completed just prior to the Generic
Launch Date, Teva shall resume payment of royalties consistent with Teva’s payment of
royalties prior to the Substantial Generic Competition Event; provided that
if, for any [***] when Net Sales of such Licensed Product in such country do not exceed
[***] of the Net Sales of such Licensed Product in the [***] completed just prior to the
Generic Launch Date, then such royalty payments shall be at royalty rates that are reduced
by [***] in such country for the given sales of such Licensed Product (but not for other
Licensed Products). In the event that there is a subsequent Substantial Generic Competition
Event in such country, Section 4.2(b)(i) shall again apply.



(c) Royalties for Authorized Generic Products. In the event of a launch by or on
behalf of Teva or its Affiliate or its sublicensee of an Authorized Generic Product in any country
in accordance with Section 2.6, Teva shall pay OGX [***] of the net sales of such Authorized
Generic Products in such country during the applicable Authorized Generic Royalty Term (calculated
in the same manner as Net Sales with such term applied mutatis mutandis to the sales of such
Authorized Generic Products).


 


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(d) One Time Sales Threshold Royalties. In addition to the ongoing royalties pursuant
to Section 4.2(a), Teva shall pay OGX the additional one time sales threshold royalties as set
forth in Schedule 4.2, contingent upon occurrence of the specified event, with each such royalty to
be paid no more than once with respect to the achievement of the respective aggregate Net Sales
amount (but payable the first time such amount is achieved).



(e) Combination Products. If a Licensed Product is sold in the form of a Combination
Product, Net Sales of such Combination Product shall be determined by multiplying the actual Net
Sales of the Combination Product during the applicable royalty payment period (as determined under
Section 1.77) by the fraction [***] where [***] is the average [***] of the Licensed Product when
sold separately in the same dosage and [***] is the average [***] of the other pharmacologically
active ingredients when sold separately in the same dosage, in each case during the applicable
royalty payment period in the country in which the sale of the Combination Product was made, or if
sales of both the Licensed Product and the other active ingredients and components did not occur in
such period, then in the most recent royalty payment period in which sales of both occurred in such
country. In the event that the average [***] cannot be determined for either the Licensed Product
component of the Combination Product (when sold alone) or for all other pharmacologically active
ingredients included in the Combination Product, then the Parties shall discuss in good faith and
agree on the value of [***] that reasonably reflects the relative contribution of the Licensed
Compound to the total market value of the Combination Product.


 


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(f) Changes in Commercialization. The Parties agree that if changes in Teva’s (or its
Affiliate’s or sublicensee’s) Commercialization of Licensed Product in a particular country or
region, makes it impossible or impracticable to calculate Net Sales for such
Commercialization, then the Parties shall (at either Party’s request) meet and discuss
reasonably and in good faith and agree on a revised method of calculating the compensation to be
paid by Teva for such Commercialization of Licensed Products in such circumstances (in lieu of
paying royalties under this Section 4.2 for such Commercialized Licensed Products in the applicable
country or region while such circumstances remain), which method shall be commercially reasonable
and shall approximate the share of total value generated by such Commercialization, consistent with
OGX’s share of royalties under the royalty structure set forth in this Section 4.2. Such method
shall be implemented in a written amendment to this Agreement executed by the Parties as soon as
practicable.




4.3 Development Expenses. OGX shall charge all Development Expenses that it
incurs to a separate account created by it on its books and records solely for the purpose of
tracking Development Expenses. Within [***] days after the end of each Calendar Quarter
during the Agreement Term, OGX shall submit to Teva an itemized report of the Development
Expenses incurred by OGX during such Calendar Quarter (each, an “Expense Report”).
Each Expense Report shall detail the type, reason for, and amount of Development Expenses
incurred for such Calendar Quarter (including the calculation thereof consistent with the FTE
Rate) and shall include supporting documentation for such expenses in form and substance
reasonably acceptable to Teva. From and after the date on which OGX’s cumulative Development
Expenses exceed thirty million dollars ($30,000,000), Teva shall reimburse all Development
Expenses incurred in accordance with the Clinical Development Plan that exceed such amount,
provided that such expenses either are consistent with the then-current budget in the
Clinical Development Plan or otherwise have received the prior approval of the JSC before
being incurred. Teva shall
make such payment to OGX within [***] days after the receipt of the foregoing Expense
Reports (including appropriate supporting documentation). OGX’s cumulative Development
Expenses shall include those specific expenses incurred by OGX prior to the Effective Date
that are set forth on Schedule 4.3, which expenses shall be detailed in the first Expense
Report (including appropriate supporting documentation) provided by OGX to Teva hereunder.


 


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4.4 Royalty Payments and Reports.



(a) Royalty Payments. Within [***] days following the end of each Calendar Quarter
during the Royalty Term, Teva shall submit to OGX a written report containing, with respect to such
Calendar Quarter and for the then-current Calendar Year through the end of such Calendar Quarter,
an accounting on a country-by-country and Licensed Product-by-Licensed Product basis of gross
sales, the calculation of Net Sales and the royalties payable in accordance with Section 4.2 for
such Calendar Quarter, with a breakdown of all deductions taken in any such calculations, in
accordance with this Section 4.4(a). Any conversion to United States Dollars shall be calculated
in accordance with Section 4.6(c). In the event of any royalty reduction during any Calendar
Quarter due to Generic Competition or Substantial Generic Competition in any country in the
Territory, the report for such Calendar Quarter shall also show the basis for the determination of
such Generic Competition or Substantial Generic Competition, as the case may be. Royalties that
have accrued for each such Calendar Quarter shall be due and payable within [***] days following
the end of such Calendar Quarter.


 


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(b) Teva shall also furnish OGX a written report on a country-by-country and Licensed
Product-by-Licensed Product basis for the first Calendar Quarter after the expiration of
the Royalty Term in any country, and shall state the basis for the applicable Net Sales then
being free of royalty obligations hereunder. Teva shall thereafter have no further obligation to
include in any report submitted to OGX hereunder the Net Sales of such Licensed Product in such
country.



(c) Each Party shall keep and shall require its Affiliates to keep complete and accurate
records in sufficient detail to permit accurate determination of all amounts necessary for
calculation and verification of all payment obligations set forth in this Article 4.




4.5 Equity Investment. Simultaneously with the execution of this Agreement,
Teva is purchasing OGX Pharma Common Shares in accordance with the terms of that certain
stock purchase agreement by and between Teva and Parent, entered into simultaneously with
this Agreement, a copy of which is annexed hereto as Schedule 4.5.




4.6 General Payment Provisions.



(a) Payment Method. All payments under this Agreement shall be made in United States
Dollars by bank wire transfer in immediately available funds to an account designated by OGX in the
case of payments by Teva to OGX, or Teva in the case of payments by OGX to Teva, as applicable.


 


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(b) Withholding Taxes. Each Party may deduct from the amount of payments it owes the
other Party under this Agreement the amount of any taxes imposed on the other Party which are
required by applicable Laws to be withheld or collected by the withholding Party from amounts owing
from the withholding Party to the other Party hereunder. Any such taxes required to be withheld or
collected shall be an expense of the other Party. The withholding
Party shall pay such withholding taxes to the appropriate governmental authority on behalf of
the other Party, and the withholding Party shall promptly deliver to the other Party proof of
payment of such taxes and a certificate demonstrating the requirement for such withholding. The
Parties shall cooperate reasonably with each other to ensure that any amounts required to be
withheld by either Party are reduced to the fullest extent permitted by applicable Laws. The other
Party will give the withholding Party any information necessary to determine such taxes, levies or
other duties. No deduction shall be made, or a reduced amount shall be deducted, if the other
Party furnishes a document from the appropriate governmental authorities to the withholding Party
certifying that the payments are exempt from such taxes, levies or other duties or subject to
reduced tax rates, according to the applicable convention for the avoidance of double taxation.



(c) Currency Exchange. For purposes of computing royalties on Net Sales in any
country outside the United States, the Net Sales shall be converted to United States Dollars using
the exchange rate published in The Wall Street Journal for the last Business Day of the Calendar
Quarter for which royalties are due; provided, however, that if for any reason
conversion into United States Dollars cannot be made in a country in the Territory, then
notwithstanding the provisions of Section 4.6(a), payment may be in the currency of such country by
deposit in the name of OGX in a bank account designated by it in such country.


 


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(d) Obligations to Third Parties.




(i) Reduction for Third Party Royalties. If Teva must acquire rights to
intellectual property owned or Controlled by a Third Party in a country in order not to
infringe or violate such intellectual property when making, using, selling, offering for
sale, importing or otherwise exploiting in the country (A) the [***]; or (B) an [***] that
[***] or [***] that is [***] (but excluding, with respect to this subclause (B), any
such [***] required for any [***] or other [***] that is different from the [***] in [***]
(such [***], a [***] Teva shall have the right to acquire such rights in the applicable
country (the “[***]”) through a license with such Third Party or other similar transaction
as necessary to acquire such rights. If Teva acquires such [***] with respect to a
particular [***] in a country, then Teva shall be entitled to deduct from the royalties
payable to OGX under this Agreement with respect to the sales of such [***] in such country
[***] of the amounts paid by Teva to the Third Party based on the license or acquisition of
such Required Third Party Rights (including royalties on sales of the Licensed Product in
the country, milestone payments based upon development or commercialization of the Licensed
Product, license fees and similar consideration) and provided that if such license or
acquisition of rights from the Third Party applies to rights that are intended to be used by
Teva for any product or purpose other than for the [***], then Teva must exclude, from the
amounts deducted as above, the reasonable value of such rights licensed to or acquired by
Teva that are applicable to such other products and/or purposes, such value to be agreed by
the Parties reasonably and in good faith; and provided further,
however, that the royalties paid by Teva to OGX for such [***] in the particular
country in any Calendar Quarter shall not be reduced by more than [***] as a result of such
deductions. Any amount that Teva is entitled to deduct that is reduced by this limitation
on the deduction shall be carried forward and Teva may deduct such carried forward amounts
from subsequent royalty payments due to OGX with respect to sales of such [***] in such
country until the full amount that Teva was entitled to deduct (without any limitation) is
paid in full.


 


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(ii) OGX Obligations to Third Parties. OGX shall remain responsible for the
payment of royalty, milestone and other financial obligations, if any, due by OGX to Third
Parties with respect to any OGX Intellectual Property which has been licensed or assigned to
OGX and is licensed or sublicensed to Teva under this Agreement. All such payments shall be
made by OGX in accordance with the terms of its applicable agreement between OGX and such
Third Parties. If Teva actually pays to UBC or Isis any amounts that should have been paid
by OGX to UBC or Isis (or claimed by UBC or Isis to be payable) to cure a default under the
UBC Agreement or Isis Agreement, respectively, then without limiting any of its other rights
and remedies, Teva shall have the right to setoff such payments against any of its royalty,
milestone or other financial obligations to OGX under this Agreement.



(e) Except as otherwise defined herein, all financial calculations by either Party under this
Agreement shall be conducted in accordance with GAAP. In addition, all calculations shall give pro
rata effect to and shall proportionally adjust (by giving effect to the number of applicable days
in such Calendar Quarter) (i) for any Calendar Quarter that is shorter than a standard Calendar
Quarter or any Calendar Year that is shorter than four consecutive full Calendar Quarters, or (ii)
as a result of a determination, in accordance with the terms of this Agreement, that the first or
last day of such Calendar Quarter (including as a result of termination of this Agreement) shall be
deemed other than the actual first or last day of such Calendar Quarter, or that the first or last
day of such Calendar Year shall be deemed other than the actual first or last day of such Calendar
Year.


 


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4.7 Audits. Upon the written request of OGX, Teva shall permit an independent
certified public accounting firm of recognized standing, selected by OGX and
reasonably acceptable to Teva (provided that such accounting firm shall
not be retained or compensated on a contingency basis and shall have entered into a
confidentiality agreement with Teva), to have access not more than [***] in any Calendar
Year, during normal business hours, to such of the records of Teva as may be reasonably
necessary to verify the accuracy of the reports under Section 4.4 hereof for any year ending
not more than [***] months prior to the date of such request, provided that
the reports for any previous year may not be audited more than once. The accounting firm
shall disclose to OGX whether the reports are correct or incorrect, the specific details
concerning any discrepancies (including the accuracy of the calculation of Net Sales and the
resulting effect of such calculations on the amounts payable by Teva under this Agreement)
and such other information that should properly be contained in a report required under this
Agreement. Teva shall have reciprocal audit rights with respect to all Expense Reports
(including supporting documentation) regarding Development Expenses to be provided by OGX
pursuant to this Agreement (including those Development Expenses set forth in Schedule 4.3).



(a) If such accounting firm concludes that additional amounts were owed during such year, and
the audited Party agrees with such conclusion, then the audited Party shall pay the additional
payments, together with interest calculated from the time that such payments were initially due at
the Prime Rate plus [***] (or, if lower, the maximum rate allowed under applicable Laws) on the
amount of such additional payments, within [***] of the date the auditing Party delivers to the
audited Party such accounting firm’s written report so concluding. In the event such accounting
firm concludes that amounts were overpaid by the



 


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audited Party during such period, the
auditing
Party shall repay the audited Party the amount of such
overpayment, together with interest at the Prime Rate plus [***] (or, if lower, the maximum
rate allowed under applicable Laws) on the amount of such overpayment, within [***] days of the
date the auditing Party delivers to the audited Party such accounting firm’s written report so
concluding; provided, however, that the audited Party can alternatively deduct such
overpayment from future payments due hereunder at the auditing Party’s option. The fees and
expenses of such accounting firm shall be paid by the auditing Party; provided,
however, that if an error in favor of the auditing Party of more [***] of the payments due
hereunder for the period being reviewed is discovered, then the fees and expenses of the accounting
firm shall be paid by the audited Party. As used herein, “Prime Rate” means, on the date
that the payment at issue first became due, the prime rate of Citibank, N.A. in New York, New York
(or any successor to the foregoing) as published in The Wall Street Journal computed on a daily
basis and shall change when and as the Prime Rate changes. If a Party disagrees with the
conclusion of any audit (whether based on an overpayment, an underpayment or otherwise), and the
Parties cannot resolve such disagreement after [***] days through good faith discussions between
them, then the Party disagreeing with such conclusion may avail itself of the dispute resolution
provisions of Section 10.8.



(b) Upon the expiration of [***] months following the end of any year for which Teva or OGX
has made payment in full of amounts payable with respect to such year, and in the absence of fraud,
negligence or willful misconduct of Teva or OGX or a contrary finding, or an ongoing, as yet
unconcluded audit, by an accounting firm pursuant to Section 4.7(a), or an ongoing dispute
regarding such amounts payable, such calculation shall be binding and conclusive upon Teva or OGX,
as applicable, and the applicable Party shall be released from any liability or accountability with
respect to royalties or other payments for such year.


 


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4.8 Late Payments. In the event that any milestone, royalty or other payment is
not received by a Party when due, the other Party shall pay interest charges on such late
amount at a rate equal to the Prime Rate plus [***] (or, if lower, the maximum rate allowed
under applicable Laws). Such interest shall be calculated from the date the payment was due
until the date such late amount is actually received by the other Party. The foregoing is in
addition to any other remedies available under this Agreement or by Law on account of such
late payment.



ARTICLE 5




REPRESENTATIONS, WARRANTIES AND COVENANTS





5.1 General Representations, Warranties and Covenants. Each Party hereby
represents, warrants, and covenants (as applicable) to the other Party as follows:



(a) Such Party is a corporation duly organized, validly existing and in good standing under
the laws of the jurisdiction of its incorporation or organization, is qualified to do business and
is in good standing as a foreign corporation or limited liability company in each jurisdiction in
which the conduct of its business or the ownership of its properties requires such qualification
and failure to have such qualification would prevent it from performing its obligations under this
Agreement;



(b) The execution, delivery and performance by such Party of this Agreement have been duly
authorized by all necessary corporate or limited liability company action and do not and will not
(i) violate any provision of any law, rule, regulation, order, writ, judgment, injunction, decree,
determination or award presently in effect having applicability to it or any
provision of its charter, operating agreement or bylaws; or (ii) conflict with or constitute a
default under any other agreement to which such Party is a party;


 


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(c) This Agreement has been duly executed by such Party and is (assuming valid execution and
delivery of the Agreement by the other Party) a legal, valid and binding obligation of such Party,
enforceable against it in accordance with the terms and conditions hereof, except as enforceability
may be limited by (i) any applicable bankruptcy, insolvency, reorganization, moratorium or similar
law affecting creditor’s rights generally, or (ii) general principles of equity, whether considered
in a proceeding in equity or at law;



(d) Such Party is not under any obligation to any person or entity, contractual or otherwise,
that would prevent such Party from performing its obligations under or complying with the terms of
this Agreement, nor shall such Party undertake any such obligation during the Agreement Term;



(e) Except as set forth on Schedule 5.1(e) by OGX, such Party has obtained all authorizations,
consents and approvals, governmental or otherwise, necessary for the execution and delivery of this
Agreement by such Party, and to otherwise perform such Party’s obligations under this Agreement
(except for Regulatory Approvals to be sought pursuant to this Agreement);



(f) Except as set forth on Schedule 5.1(f)(i) by OGX or Schedule 5.1(f)(ii) by Teva, neither
Party, nor any of its Affiliates, are a party to, or are otherwise bound by, any written contract
that will result in any person or entity obtaining any interest in, or that would give to any Third
Party any right to assert any claim in or with respect to, any of such Party’s or the other Party’s
rights under this Agreement;


 


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(g) In the course of the Development of Licensed Products, such Party has not (to its
Knowledge) used prior to the Effective Date and shall not knowingly use, during the Agreement Term,
any employee, agent or independent contractor who has been debarred by any Regulatory Authority or,
to such Party’s Knowledge, is the subject of debarment proceedings by a Regulatory Authority; and




(h) Such Party shall perform its obligations hereunder in accordance with all applicable Laws.




5.2 Additional OGX Representations, Warranties and Covenants. Subject to and
except as set forth on the disclosure schedule attached hereto as Schedule 5.2 (the “OGX
Disclosure Schedule”), OGX represents and warrants and covenants to Teva as of the
Effective Date as follows:



(a) to OGX’s Knowledge, (i) the [***] is not being infringed by any Third Party, (ii) no [***]
have been found by a court or administrative body of competent jurisdiction to be invalid or
unenforceable; (iii) the [***] are not subject to any pending or overtly threatened re-examination,
re-issue, opposition, interference, challenge or litigation proceeding, and OGX has received no
written threat or notice of the initiation of any of the foregoing proceedings; and (iv) each of
[***], and any other Third Party having responsibility for prosecuting any of the [***], as
applicable, has filed and prosecuted the patent applications within the [***] in good faith;



(b) to OGX’s Knowledge, neither [***] nor any other party to the agreements listed on Schedule
3.3(a) has committed any act, or failed to commit any required act, that likely will cause the
[***] or such agreements to expire prematurely or be declared invalid or
unenforceable, or that estops the respective owner of such rights from enforcing the [***]
against any Third Party;


 


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(c) all application, registration, maintenance and renewal fees in respect of the [***]
finally due prior to the Effective Date, and all necessary documents and certificates relating to
the prosecution of the [***] required to have been filed before the Effective Date to prevent
abandonment of any [***] (i) have been paid or filed, respectively, by OGX, in the case of [***]
owned and prosecuted by OGX, and (ii) have not, to OGX’s Knowledge, failed to have been timely paid
or filed, respectively, by the prosecuting Party, in the case of [***] owned and prosecuted by a
Third Party, in each case with the relevant agencies for the purpose of maintaining the [***];



(d) except as otherwise provided in the Third Party License Agreements or in Schedule 5.2(d),
(i) OGX is the sole and exclusive owner of, or Controls and has the sole right to enforce and
collect damages and/or royalties from, or obtain equitable relief with respect to, the [***]; (ii)
OGX has the right to use and disclose and to enable Teva to use and disclose (in each case under
appropriate conditions of confidentiality) the [***]; and (iii) the [***] solely owned by OGX is
not subject to any encumbrance, lien, license or claim of ownership by any Third Party that would
materially burden or interfere with Teva’s exercise of its license rights granted in Section
2.1(a);



(e) OGX has provided Teva with true, correct and complete copies of all Third Party
Agreements;



(f) to OGX’s Knowledge, the agreements listed on Schedule 3.3(a) are in full force and effect
in accordance with their terms (except as otherwise listed on Schedule 3.3(a)),
and OGX is not in default or breach in any material respect of the agreements listed on
Schedule 3.3(a), nor has it received any notice of any defaults, breaches or violation thereunder;


 


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(g) to OGX’s Knowledge, none of the [***] and or other information provided to Teva or its
Affiliates prior to the Effective Date by or on behalf of OGX related to the [***], [***], and
[***] is inaccurate in any material respect;



(h) to OGX’s Knowledge, there is no material [***] or other information that (i) is in OGX’s
possession or Control, (ii) relates to [***], [***] or [***], (iii) has not been disclosed by OGX
to Teva as of the Effective Date, and (iv) causes, due to such lack of disclosure, specific Data or
other information disclosed by OGX to Teva relating to [***], [***] or [***] to be misleading in
any material respect;



(i) to OGX’s Knowledge, OGX has provided Teva or its Affiliates with access to summaries of
all [***] known to OGX arising from Clinical Studies of the Licensed Compound as of [***], the last
[***] having been [***] the Licensed Compound in any Clinical Study as of [***];



(j) to OGX’s Knowledge, the [***] and [***] of a Licensed Compound or Licensed Product in the
Territory as contemplated under this Agreement will not infringe or misappropriate any patents or
other Intellectual Property right of any Third Party;


 


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(k) to OGX’s Knowledge, all of OGX’s employees and consultants and all contract research
organizations with whom OGX has contracted directly to perform any activities on OGX’s behalf in
connection with OGX’s research and development (including the clinical trials) of each Licensed
Compound or Licensed Product have assigned to OGX all of their rights
in any Intellectual Property conceived or reduced to practice by them that is relevant to
research, develop, test, import, export, make, have made, use, market, manufacture, sell, offer for
sale, register, record, have sold, sublicense, commercialize, distribute and otherwise exploit any
such Licensed Compounds or Licensed Products, except for any intellectual property related to a
contract research organization’s pre-existing intellectual property;



(l) OGX has received fully executed [***] and [***] from [***] for all right, title and
interest in and to the [***] and the [***] Patents, as those terms are defined in the [***]
Agreement;



(m) OGX is the owner of all existing (as of the Effective Date) Regulatory Documents in OGX’s
possession, other than those Regulatory Documents identified in Schedule 5.2(m);



(n) OGX has made available to Teva prior to the Effective Date, or will make available to Teva
within the timeframe set forth in Section 3.2, copies of all of its written records relating to
applications for or registrations of any OGX Patent Rights and OGX Trademarks, existing as of the
Effective Date that are related solely to Licensed Products and Licensed Compounds;



(o) to OGX’s Knowledge, OGX owns and possesses all right, title and interest in and to, or
possesses the valid right to use, the [***] necessary to carry out its obligations under this
Agreement;


 


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(p) to OGX’s Knowledge, the [***] and the [***] (as each is defined in Schedule 3.3(c)),
copies of which have been provided to Teva, are each in full force and effect.
To OGX’s Knowledge, the performance by OGX and Teva under this Agreement as contemplated as of
the Effective Date will not cause OGX to be in breach of any provisions of either such agreement;



(q) OGX’s assets located outside of the United States that are being exclusively licensed to
Teva pursuant to this Agreement have, on an aggregate basis, generated sales in or into the United
Sates of not more than [***] in Parent’s most recent fiscal year, as determined in accordance with
the HSR Rules. As of the Effective Date, Parent (i) is the “ultimate parent entity,” as such term
is defined under the HSR Rules, of OGX; (ii) had less than [***] in annual net sales in its most
recent fiscal year, as determined in accordance with Section 801.11 of the HSR Rules; and (iii)
holds less than [***] in total assets, as determined in accordance with Section 801.11 of the HSR
Rules; and



(r) to OGX’s Knowledge, there is no [***] in [***] or [***] that has [***] and that, [***],
would make the statements contained [***] of this Agreement [***].




5.3 Additional OGX Covenants.



(a) During the Agreement Term, OGX shall not grant to any Third Party any rights in or with
respect to the OGX Intellectual Property that conflict with the rights granted to Teva under this
Agreement (subject to the retained rights of OGX set forth in this Agreement), and shall not
encumber the OGX Intellectual Property in any manner that would materially negatively impact Teva’s
rights to use and exploit the rights granted to Teva under this Agreement; and


 


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(b) During the Agreement Term, OGX shall not assign or transfer the OGX Intellectual Property
except in a manner whereby such OGX Intellectual Property remains subject to the license rights
granted to Teva under Section 2.1(a).




5.4 Additional Teva Representations and Warranties. Teva represents and
warrants to OGX as of the Effective Date that:



(a) to Teva’s Knowledge, the [***] and [***] of a [***] in the Territory as contemplated under
this Agreement will not infringe or misappropriate any patents or other [***] right of [***];



(b) to Teva’s Knowledge, there is [***], [***] or [***] by [***] or [***] or [***] that is an
[***] ; and



(c) to Teva’s Knowledge, there is [***] that has [***] to [***] and that, [***], makes the
[***] and (b)[***].




5.5 Disclaimer of Additional Warranties. EXCEPT FOR THE EXPRESS WARRANTIES SET
FORTH IN SECTIONS 5.1, 5.2, AND 5.4 ABOVE, EACH PARTY HEREBY EXPRESSLY DISCLAIMS ALL
WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF
THIS AGREEMENT OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY,
NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE, EVEN IF EITHER PARTY HAS BEEN ADVISED
OF SUCH PURPOSE.


 


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ARTICLE 6




PATENT MATTERS





6.1 Ownership.



(a) Except as otherwise provided in and subject to the terms of this Agreement, as between the
Parties:




(i) Existing IP. OGX shall have and retain all right, title and interest in or
Control over, as applicable, all existing Intellectual Property owned or otherwise
Controlled by it on the Effective Date, subject only to the licenses and other rights
granted to Teva under this Agreement as to the applicable OGX Intellectual Property;
provided, however, that upon [***] and [***], if any, required under this
Agreement (“IP Transfer Date”), [***] the right to require [***] to [***], and [***] shall
thereupon [***], its [***]; and




(ii) Program IP. Each Party shall have and retain all right, title and
interest in [***] and [***] (including [***] claiming any inventions therein) that are
discovered, made, first conceived, reduced to practice, or generated [***] solely by such
Party’s or its Affiliates’ employees, agents, contractors or other persons acting under or
pursuant to its or their authority, as a result of the Development or otherwise during the
Agreement Term (collectively, “Inventions”) subject only to the licenses and other rights
granted to the other Party under the terms of this Agreement. The Parties shall jointly own
all right, title and interest in all Inventions made jointly by employees, agents or
contractors of each Party (collectively, “Joint Improvements”) in accordance with joint
ownership interests of co-inventors under U.S. patent laws (that is, each


 


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Party shall have
full rights to license, assign and exploit such Joint Improvements (and any patents
arising therefrom) anywhere in the world, without any requirement of gaining the consent of,
or accounting to, the other Party), subject in each case only to the licenses and other
rights granted to the other Party under this Agreement, and subject to any other
Intellectual Property held by such other Party (that is, no license in such other
Intellectual Property shall be deemed granted). Notwithstanding any of the preceding
provisions of this Section 6.1(a)(ii) to the contrary, Teva shall have and retain all right,
title and interest in and Control over all [***] (including all [***]) that is discovered,
made, first conceived, reduced to practice or generated during the Agreement Term, (a)
solely by OGX’s and its Affiliates’ employees, agents, contractors or other persons acting
under or pursuant to its or their authority, (b) solely by Teva’s and its Affiliates’
employees, agents, contractors or other persons acting under or pursuant to its or their
authority, or (c) jointly by Teva and OGX or by any combination of (a) or (b). Inventorship
shall be determined in accordance with U.S. patent laws; provided, however,
that, as provided above, Teva shall be deemed the sole owner and assignee of any and all of
the [***].



(b) Employees and Agents. OGX shall require all of its and its Affiliates’ employees
to assign to OGX all [***] including [***] (including all [***] arising thereunder) that is
discovered, made, first conceived, reduced to practice or generated under this Agreement as a
result of Development or otherwise pursuant to and in connection with this Agreement during the
Agreement Term, and OGX shall assign to Teva all of such [***] (including all Patent Rights arising
thereunder). Each Party shall use commercially reasonable efforts to require any Third Parties
engaged in Development or who receive materials relating to [***] from a Party, to assign or grant
a sublicenseable exclusive license on a fully paid-up, royalty-free basis to all
inventions and corresponding Product Patents that are developed, made or conceived by such
Third Parties during the Agreement Term to the Party that is contracting with such Third Party;
provided, however, that any such [***] made under this Agreement shall be assigned
to [***].


 


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6.2 Maintenance and Prosecution.



(a) OGX Patent Rights. Other than those [***] that [***] or other [***] has the sole
right, at its cost and expense and at its sole discretion, to obtain, prosecute and maintain under
the applicable [***], Teva shall have the first right, at its sole discretion, to file, prosecute
(including responding to correspondence from the relevant patent office, and conducting or
defending (as applicable) re-examination, reissue, opposition and other related proceedings) and
maintain (collectively, “Prosecute” or “Prosecution”) the [***] in [***] name,
using patent counsel selected by Teva and reasonably acceptable to OGX, and shall be responsible
for the payment of all patent prosecution and maintenance costs and expenses with respect to such
Prosecution; provided, however, that if Products other than Licensed Products or
Licensed Compounds are claimed by specific [***] and are being clinically Developed or
Commercialized by OGX, its Affiliates, or its other sublicensees (i.e., other than Teva and its
Affiliates and sublicensees) in a country where such [***] exist, then the Parties shall share
equally the actual Prosecution costs and expenses of such specific [***]. Teva agrees to keep OGX
fully informed of the course of such patent Prosecution or other proceedings relating to any [***]
for which Teva is responsible, including by providing OGX with copies of all material proposed
filings, patent office responses, office actions and other material communications from patent
offices relating to such prosecution efforts a reasonable time in advance of any proposed filing or
required response. OGX will have the right to comment on any and all such filings or responses,
and Teva shall in good faith give reasonable consideration to all timely



 


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received requests and
suggestions. Teva shall give OGX a reasonable opportunity to provide such comments on any and
all such filings or material responses relating to the Prosecution of any [***] for which Teva is
responsible. If Teva elects not to file, prosecute or maintain any patent application or patent
included in the [***] in the Territory for which Teva has the first right under this Section
6.2(a), Teva shall provide OGX with no less than [***] written advance notice (or such longer time
as Teva reasonably deems sufficient to avoid any loss or forfeiture of rights), and OGX shall have
the right, but not the obligation, at OGX’s sole expense, to file, prosecute or maintain such
[***], provided that OGX shall not knowingly take any action with respect to such
Patent Rights that OGX should reasonably expect could have an adverse effect on Teva’s rights under
this Agreement. For any such [***] that OGX elects to so file, prosecute and maintain, OGX agrees
to keep Teva fully informed of the course of such patent Prosecution or other proceedings relating
thereto. OGX shall give Teva a reasonable opportunity to provide comments on any and all filings
or material responses relating to the Prosecution of any [***] for which OGX is responsible, and
OGX shall, in good faith, give reasonable consideration to all suggestions and recommendations of
Teva with respect to such filings or responses.



(b) Teva Patent Rights. Teva shall have the right to make all decisions, in its sole
discretion, relating to the filing, prosecution and maintenance of the Teva Patent Rights in Teva’s
name, using patent counsel selected by Teva and shall be responsible for the payment of all patent
prosecution and maintenance costs. Teva shall keep OGX reasonably informed of the filing and
progress in prosecution of Teva Patent Rights that relate directly to Licensed Compounds or
Licensed Products.


 


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6.3 Third Party Infringement.



(a) Each Party shall promptly give the other Party notice of any actual or suspected
infringement or impending infringement by a Third Party in the Territory of any patent included in
the OGX Patent Rights or Teva Patent Rights (collectively, the “Parties’ Patent Rights” or
each a “Party’s Patent Right”), which comes to such Party’s attention. The Parties shall
thereafter consult and cooperate to seek to determine a course of action, including if appropriate
the commencement of legal action.



(b) If a Third Party is infringing (or believed by a Party to be infringing or planning to
infringe) an OGX Patent Right by the manufacture, use, import or sale of a Product that contains a
Licensed Compound (a “Field Infringement”), then, subject to and in accordance with the applicable
Third Party License Agreements, if any, Teva shall have the first right, in its sole discretion, to
initiate and/or prosecute a legal action against such Field Infringement at its own expense and in
the name of OGX, and OGX shall agree to be named as necessary for Teva to bring and conduct such
action, and Teva shall provide OGX with reasonable notice of any such action it commences, consider
all OGX’s reasonable comments thereto in good faith, seek to accommodate such comments in
initiating, conducting and/or prosecuting such action, and keep OGX reasonably informed of any
significant developments in such action. OGX shall render, at Teva’s expense, all reasonable
assistance as requested by Teva in connection with any such action initiated, conducted or
prosecuted by Teva. In any such action, OGX may participate using counsel of its choosing and at
its expense, provided, however, that the control of such action, including whether
to initiate any legal proceeding, what strategies to pursue or actions to take in prosecution of
any such legal proceeding, and/or the settlement thereof, shall solely be under the control of
Teva. Teva shall not settle any such action, claim or proceeding brought by
Teva in a manner that Teva should reasonably expect could have an adverse effect on OGX’s
rights under this Agreement or any OGX Patent Rights, or could result in more than a de minimis
monetary payment by or financial loss to OGX or which would subject OGX to any form of injunctive
or equitable relief, without OGX’s prior written consent, which shall not be unreasonably
withheld.


 


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(c) If Teva elects not to initiate and/or prosecute any legal action or proceeding against any
such Field Infringement in any country in the Territory as provided in Section 6.3(b) within [***]
days after having become aware of such infringement or potential infringement (or, in the case of
an infringement resulting from the submission of an ANDA under the Hatch-Waxman Act, [***] days
from the date Teva receives notice of such submission), then OGX may elect, subject to Teva’s
consent, which shall not be unreasonably withheld, to take such action that is reasonably necessary
and appropriate to terminate or prevent such infringement, including instituting an infringement
proceeding; provided, however, OGX shall not settle any such claim or proceeding in
a manner that OGX should reasonably expect could have an adverse effect on Teva’s rights under
this Agreement, or could result in more than a de minimis monetary payment by or financial loss to
Teva or which would subject Teva to any form of injunctive or equitable relief, without Teva’s
prior written consent, which shall not be unreasonably withheld.


 


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(d) With respect to any Third Party infringement (or actions that are believed by a Party to
be infringing or planning to infringe) of an OGX Patent Right by the manufacture, use, import or
sale of a Product that does not contain any Licensed Compound, OGX (or its other licensee) shall
have the sole right and authority, but not the obligation and at its sole discretion (except for
the following), to bring a suit or action or take any other steps with respect to such
infringement; provided, however, that OGX shall not file any lawsuit against
any such Third Party infringement based on an OGX Patent Right that relates primarily to or
otherwise materially impacts Licensed Compounds or Licensed Products without Teva’s consent, which
shall not be unreasonably withheld. OGX shall provide Teva with reasonable notice of any such
action it commences, consider all of Teva’s reasonable comments thereto in good faith, seek to
accommodate such comments in initiating, conducting and/or prosecuting such action, and keep Teva
reasonably informed of any significant developments in such action. In any such action, Teva may
participate using counsel of its choosing and at its expense, provided, however,
that the control of such action, including whether to initiate any legal proceeding, what
strategies to pursue or actions to take in prosecution of any such legal proceeding, and/or the
settlement thereof, shall solely be under the control of OGX. OGX shall not settle any such claim
or proceeding in a manner that OGX should reasonably expect could have an adverse effect on Teva’s
rights under this Agreement, or could result in more than a de minimis monetary payment by or
financial loss to Teva or which would subject Teva to any form of injunctive or equitable relief,
without Teva’s prior written consent, which shall not be unreasonably withheld.



(e) For any infringement action that any Party is unable to initiate, prosecute, conduct or
defend under Sections 6.3(b), (c) or (g) solely or jointly in its own name, the other Party will
join such action voluntarily at the expense of the Party initiating or pursuing the prosecution or
defense, and will execute all documents reasonably helpful or necessary for the Party to control to
the greatest extent possible the prosecution, defense and maintenance of such action. In
connection with any such action, the Parties will cooperate fully and will provide each other with
any reasonable information or assistance that either reasonably may request. For purposes of
clarification, Teva’s rights to initiate, prosecute, conduct or defend any action under
this Section 6.3 shall not apply to any OGX Patent Rights owned by [***], Isis, [***] or
another Third Party to the extent Teva is not permitted to enforce such OGX Patent Rights or may be
legally unable to participate as a named party due to Teva’s status as a sub-sublicensee or
otherwise.


 


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(f) Any recovery or award obtained by either Party as a result of any infringement action,
whether by a finding of damages, settlement or otherwise, under Sections 6.3(b) or (c) shall be
shared as follows:




(i) the Party that initiated, conducted, prosecuted, defended, maintained and/or
controlled the action shall recoup all of its costs and expenses (including reasonable
outside attorneys’ fees) incurred in connection with the action, whether the recovery is by
settlement or otherwise;




(ii) the other Party then shall, to the extent possible, recover its reasonably
documented costs and expenses (including reasonable outside attorneys’ fees) incurred in
connection with the action, to the extent not previously reimbursed or paid by the
prosecuting Party;




(iii) if OGX initiated, conducted, prosecuted, defended, maintained and/or controlled
the action, the amount of any recovery remaining then shall be allocated [***] to OGX and
[***] to Teva (which amounts shall not be included in Net Sales); and




(iv) if Teva initiated, conducted, prosecuted, defended, maintained and/or controlled
the action, the amount of any recovery remaining then shall be [***] under this Agreement,
and on which Teva shall [***] (with such [***] being deemed
received during the Calendar Quarter in which the applicable recovery was received by
Teva).


 


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(g) If any Third Party brings any declaratory judgment action, or asserts as a matter of a
defense or counterclaim in any other action to which a Party is a party, claiming that any OGX
Patent Rights are invalid, not infringed and/or unenforceable (an “Invalidity Claim”), then the
Party having knowledge of such Invalidity Claim shall give notice thereof to the other Party, and
the Parties shall promptly discuss the matter and seek to agree on the course of action to respond
to such Invalidity Claim. Unless the Parties otherwise agree, Teva shall have the initial right,
in its discretion, to respond to and defend against any such Invalidity Claim, provided
that Teva will consult reasonably with OGX as to all such defense against the Invalidity
Claim and shall consider in good faith all reasonable comments of OGX with respect thereto. If
Teva does not respond to or defend against any such Invalidity Claim, OGX shall have the right, in
its discretion and subject to Teva’s prior written consent, which shall not be unreasonably
withheld, to respond to and defend against any such Invalidity Claim (and may initiate such
response prior to any deadline that would cause a loss of, or would be a risk of loss of, rights in
the applicable OGX Patent Right), provided that OGX will consult reasonably with
Teva as to all such defense against the Invalidity Claim and shall consider in good faith all
reasonable comments of Teva with respect thereto.


 


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6.4 Third Party Intellectual Property.



(a) In the event that a Party becomes aware of any Third Party claim that the manufacture,
import, use, sale or other exploitation of Licensed Compounds or Licensed Products under this
Agreement infringes the Intellectual Property rights of any Third Party (an
“Infringement Claim”), such Party shall promptly (and in any event not later than [***]
Business Days after knowledge of the Infringement Claim), notify the other Party (“Infringement
Notice”). The Parties shall thereafter discuss the situation, and to the extent reasonably
necessary, attempt to agree on a course of action.



(b) If within [***] of receipt by a Party of the Infringement Notice, the Parties fail to
agree upon an appropriate course of action under Section 6.4(a), Teva (except as otherwise provided
below) shall have the first right, but not the obligation, after notifying OGX, to defend any
Infringement Claim, or to otherwise initiate, prosecute, conduct and/or maintain any appropriate
legal action related to the Intellectual Property rights of any Third Party in the name of Teva
and/or OGX. Teva shall keep OGX reasonably informed as to the progress of any such defense,
prosecution or maintenance of any such Infringement Claim or related legal action. OGX shall
render, at Teva’s expense, all assistance reasonably requested in connection with any action taken
by Teva, at Teva’s expense. If Teva elects (as above) to defend any Infringement Claim against OGX
or its Affiliate, Teva shall use good faith best efforts to resolve and defend such action
favorably for OGX and to avoid any liability, harm, judgment against or loss by OGX or its
Affiliate in the same manner and to the same extent as if such action were against Teva. If Teva
does not notify OGX in writing that it assumes such defense, within [***] of an Infringement
Notice, then OGX shall have the right at its expense, but not the obligation, to defend against
such claims; provided, however, that OGX shall obtain the written consent of Teva
prior to ceasing to defend, settling or otherwise compromising such claims in a manner that is
adverse to Teva’s interests under this Agreement, such consent not to be unreasonably withheld.
Except as to any Infringement Claim against OGX for which OGX assumes the defense as provided
above, the control of any such Infringement Claim suit or action, including



 


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whether to initiate any legal proceeding and/or the settlement thereof, shall solely be under
the control of Teva; provided that Teva shall not settle any such claim or
proceeding in a manner that likely will materially adversely affect OGX’s rights under this
Agreement or the OGX Patent Rights or which results in more than a de minimis monetary payment by
or financial loss to OGX or which would subject OGX to any form of injunctive or equitable relief,
without OGX’s written consent, which consent shall not be unreasonably withheld. Teva shall be
responsible for all costs and expenses incurred by Teva in any such action that Teva controls,
including all damages awarded or settlement payments made (including future royalty or similar
payments) to such Third Party.



(c) If Teva elects not to defend an Infringement Claim action in any country in the Territory
as provided in Section 6.4(b), and OGX elects to do so, which election shall be subject to the
prior written consent of Teva not to be unreasonably withheld, the cost of any agreed-upon course
of action, including the costs of any legal action commenced or any infringement action defended,
shall be borne solely by OGX, provided, however, that OGX shall not enter into any settlement or
compromise of any claim that likely will materially adversely affect Teva’s rights under this
Agreement, could result in more than a de minimis monetary payment by or financial loss to Teva, or
likely will subject Teva to any form of injunctive or equitable relief without the prior written
consent of Teva, which consent shall not be unreasonably withheld.



(d) For any Infringement Claim or other legal action or defense under this Section 6.4, in the
event that a Party is unable to initiate, prosecute, or defend such action solely in its own name
despite being entitled to under this Section 6.4, the other Party will join such action voluntarily
and will execute all documents reasonably necessary for the Party to
prosecute, defend and maintain such action, at the expense of the Party bringing or defending
such action. In connection with any such action, the Parties will reasonably cooperate fully and
will provide each other with any information or assistance that either reasonably may request.


 


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(e) The provisions of this Section 6.4 shall not limit any indemnity obligation of a Party, or
the rights of a Party to be defended and indemnified by the other Party, that may exist under
Article 9 as a result of any such Infringement Claim.




6.5 Patent Term Extensions. The Parties shall cooperate with each other in
obtaining patent term extensions or restorations or supplemental protection certificates or
their equivalents, for all Product Patents in any country in the Territory where applicable
and where desired by Teva or where reasonably beneficial to the commercial success of
Licensed Product, at Teva’s expense. Final decisions and elections with respect to obtaining
such extension or supplemental protection certificates shall be made in Teva’s reasonable
discretion; provided, however, if Teva elects not to pursue a patent term
extension or restoration or supplemental protection certificate or its equivalent for any
Product Patents owned or Controlled by OGX, it shall provide OGX with advance written notice,
and OGX shall have the right, subject to Teva’s prior written consent, not to be unreasonably
withheld, but not the obligation, at its sole expense, to pursue such patent term extension
or restoration or supplemental protection certificate. Any benefit accruing as a consequence
of either Party’s pursuit of patent term extension or restoration or supplemental protection
certificate or its equivalent under this Section 6.5 shall accrue to the benefit of both
Parties under and pursuant to this Agreement.


 


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ARTICLE 7




CONFIDENTIALITY AND PUBLICITY





7.1 Non-Disclosure and Non-Use Obligations. All Proprietary Information
disclosed by one Party to the other Party hereunder shall be maintained in confidence and
shall not be disclosed to any Third Party or used for any purpose except as expressly
permitted herein without the prior written consent of the Party that disclosed the
Proprietary Information to the other Party during the Agreement Term and for a period of
[***] thereafter. The foregoing non-disclosure and non-use obligations shall not apply to
the extent that such Proprietary Information of the disclosing Party:



(a) is known by the receiving Party at the time of its receipt, and not through a prior
disclosure by the disclosing Party, as documented by records;



(b) is or becomes properly in the public domain or knowledge without breach of this Agreement
by the receiving Party;



(c) is subsequently disclosed to a receiving Party by a Third Party who may lawfully do so and
is not under an obligation of confidentiality to the disclosing Party; or



(d) is developed by the receiving Party independently of Proprietary Information received from
the disclosing Party and by persons without use of or reliance on such Proprietary Information, as
documented by records.


 


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7.2 Permitted Disclosure of Proprietary Information. Notwithstanding Section
7.1, a Party receiving Proprietary Information of another Party may disclose such Proprietary
Information:



(a) to governmental or other regulatory agencies in order to obtain patents pursuant to this
Agreement, or to gain approval to conduct Clinical Studies or to Commercialize Licensed Product,
but such disclosure may be only to the extent reasonably necessary to obtain such patents or
authorizations and in accordance with the terms of this Agreement or as otherwise requested by the
Regulatory Authorities;



(b) by either Party to its agents, consultants, sublicensees or Affiliates in connection with
the Development or Commercialization, or to otherwise enable the Party to fulfill its obligations
and responsibilities under this Agreement, on the condition that such entities agree to be bound by
confidentiality obligations consistent with this Agreement; or



(c) if required to be disclosed by Laws or court order, provided, that, notice
is promptly delivered to the non-disclosing Party in order to provide an opportunity to challenge
or limit the disclosure obligations.



(d) Certain Disclosures. The Parties agree to develop and distribute a joint press
release upon execution of this Agreement by the Parties. Except as set forth in this Agreement or
as required by applicable Laws, neither Party shall make any press release or other public
announcement or other disclosure to a Third Party concerning the existence of or terms of this
Agreement, the subject matter of this Agreement or the activities contemplated hereunder, without
the prior written consent of the other Party, which consent shall include agreement upon the nature
and text of such release, announcement or other disclosure and shall not be unreasonably withheld
or delayed. Each Party agrees to provide to the other Party a copy of any such press release or
other public announcement or disclosure as soon as reasonably practicable under the circumstances
prior to its



 


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scheduled release. Each Party shall have the right to
expeditiously (but in any event within [***]) review and recommend changes to any such press
release or other public announcement or disclosure; provided, however, that such
right of review and recommendation shall only apply for the first time that specific information is
to be disclosed, shall not apply to legally required disclosures (provided that the
disclosing Party shall give the other Party reasonable advance notice of same and the other Party
shall have the right to provide its comments), and shall not apply to the subsequent disclosure of
substantially similar information that has previously been disclosed unless there have been
material developments relating to the Licensed Compounds or the Licensed Product since the date of
the previous disclosure; provided, further, that each Party shall provide to the
other Party reasonable advance notice of any such subsequent disclosure. Without limiting the
generality of any of the foregoing, it is understood that the Parties or their Affiliates may make
disclosure of this Agreement and the terms hereof in any filings required by the SEC, other
governmental authority, or securities exchange, or as otherwise required by applicable Laws, may
file this Agreement as an exhibit to any filing with the SEC, other governmental authority, or
securities exchange, and may distribute any such filing in the ordinary course of its business,
provided, further, that to the maximum extent allowable by the rules and
regulations of the SEC, other governmental authority, or securities exchange, and except as
required by applicable Laws, OGX and Teva each shall seek to redact any confidential information
set forth in such filings, and each Party shall provide a draft of the redacted version of this
Agreement to the other Party no less than [***] prior to filing with the SEC, other governmental
authority, or securities exchange, and give reasonable consideration to the other Party’s comments
regarding any proposed redaction. Further, a Party may disclose this Agreement and the terms
hereof in confidence to its existing directors, investors and service providers and to bona fide
prospective investors, merger partners,
strategic partners, or acquirors and their respective professional advisors, in connection
with the negotiation, entry into and/or performance of a business transaction between such parties,
including the conduct of due diligence involved in such transaction, provided such parties agree to
be bound by (i) written confidentiality agreements typical for such transactions, or (ii) with
respect to attorneys, applicable ethical obligations.


 


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7.3 Publications. Except as set forth on Schedule 7.3, OGX shall not submit for
written or oral publication any manuscript, abstract or the like relating to the Licensed
Compound or Licensed Product, without the prior written approval or written request of Teva,
such approval not to be unreasonably withheld. If OGX desires to submit such publication, it
shall first deliver to Teva, for Teva’s prior written consent, the proposed publication or an
outline of the oral disclosure at least [***] prior to planned submission or presentation.
Teva shall provide OGX with [***] advance written notice (or a shorter period if appropriate
under the circumstances) of any written or oral publication relating to the Licensed Compound
or Licensed Product, including a copy of the proposed publication or an outline of the oral
disclosure. The Parties agree to acknowledge the other Party’s contributions, as
scientifically and commercially appropriate, in any publication, presentation (written or
oral) or other materials prepared with respect to the Development or Commercialization
activities, and the Parties shall ensure that the other Party’s scientists, researchers, and
other personnel are accorded similar credit, as scientifically and commercially appropriate,
in any such publications, presentations or other materials.


 


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ARTICLE 8




TERM AND TERMINATION





8.1 Term and Expiration.




(a) This Agreement shall be binding on the Parties as of the Effective Date.



(b) Unless terminated earlier pursuant to Section 8.2, this Agreement shall continue in effect
until the cessation of all payment obligations of each Party to the other under this Agreement (the
“Agreement Term”).



(c) On a country by country and Licensed Product by Licensed Product basis, upon expiration of
the Royalty Term for a Licensed Product in a particular country, the license granted to Teva by OGX
under Section 2.1(a) shall automatically be deemed fully paid up and non-exclusive with respect to
such Licensed Product in such country, and shall perpetually survive the expiration of the royalty
obligations with respect thereto (and any subsequent expiration or termination of the Agreement
Term); provided, however, that the license under the OGX Intellectual Property
covering such Licensed Product in such country shall remain exclusive until the later of (i)
expiration or invalidation of the last Valid Claim covering such Licensed Product in such country,
or (ii) expiration of all periods of market exclusivity or data exclusivity granted by a Regulatory
Authority in such country for such Licensed Product.


 


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8.2 Early Termination of Agreement Term.



(a) Termination by Teva. Commencing after (i) the completion, or early termination
under Section 3.5(c)(iii) due to safety issues or “futility” (as provided in Section 3.5(c)(iii)),
of all three (3) Phase III Clinical Studies as set forth in the initial Clinical
Development Plan, or (ii) a decision by Teva not to [***] any of such three (3) Phase III
Clinical Studies pursuant to Section 3.5(c)(iii), Teva may terminate this Agreement in its sole
discretion upon not less than three (3) months written notice of termination to OGX if such notice
is given prior to Regulatory Approval of a Licensed Product and upon not less than six (6) months
written notice if given after Regulatory Approval of a Licensed Product.




(b) Termination by Either Party.




(i) Breach. A Party may, without prejudice to any other rights or remedies
available to it under this Agreement or at law or in equity, terminate this Agreement prior
to expiration of the Agreement Term in the event that the other Party (as used in this
subsection, the “Breaching Party”) shall have materially breached this Agreement,
and has not cured such material breach within (i) [***] after notice of such breach is
provided to the Breaching Party in case the breach is a non-payment of any amount due under
this Agreement that is not being disputed in good faith (which shall be deemed a material
breach of a material obligation) and (ii) [***] after notice of such breach is provided to
the Breaching Party for other cases of breach (or, if such default cannot be cured within
such [***] period, if the Breaching Party does not commence and diligently continue actions
to cure such breach during such [***] period and cure the breach as soon as practicable but
in no event later than [***]. The termination shall become effective at the end of the (i)
[***] period in case the breach is a non-payment of any amount due under this Agreement that
is not being disputed in good faith if the Breaching Party has not cured such breach by such
date, or (ii) for other cases of breach, [***] period unless (a) the Breaching Party cures
such breach during such [***] period, or (b) if such breach is not susceptible to cure
within such [***] period, the Breaching


 


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Party has commenced and is diligently pursuing a cure (unless such breach, by its
nature, is incurable, in which case the Agreement may not be terminated unless the Breaching
Party fails to use its best commercially reasonable efforts to prevent a similar subsequent
breach) and cures such breach no later than [***] after the notice of breach. The right of
either OGX or Teva to terminate this Agreement as provided in this Section 8.2(b)(i) shall
not be affected in any way by such Party’s waiver or failure to take action with respect to
any previous breach or default.




(ii) Bankruptcy. Either Party may, without prejudice to any other rights or
remedies available to it under this Agreement or at law or in equity, terminate this
Agreement upon the filing or institution of bankruptcy, reorganization, liquidation or
receivership proceedings, or upon an assignment of a substantial portion of the assets for
the benefit of creditors by the other Party; provided, however, in the case
of any involuntary bankruptcy, reorganization, liquidation, receivership or assignment
proceeding such right to terminate shall only become effective if the Party consents to the
involuntary proceeding or such proceeding is not dismissed within [***] days after the
filing thereof.



(c) Termination by OGX. OGX shall have the right to terminate this Agreement upon
written notice to Teva, effective upon receipt, if Teva or any of its Affiliates directly or
indirectly: (i) initiates or requests an interference, opposition proceeding or request for ex
parte or inter-parties reexamination with respect to any OGX Patent Rights, (b) makes, files or
maintains any claim, demand, lawsuit or cause of action to challenge the validity or enforceability
of any OGX Patent Rights, or (c) opposes any patent term extension with respect to any OGX Patent
Rights (each, a “Patent Challenge”). Teva will include provisions in



 


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all
Sublicense Agreements providing that if the sublicensee or any of its Affiliates undertakes a
Patent Challenge, Teva may terminate all sublicenses under the OGX Patent Rights granted to such
sublicensee. If a sublicensee (or an Affiliate of such sublicensee) undertakes a Patent Challenge,
then Teva upon receipt of notice thereof from OGX, will terminate all sublicenses under the OGX
Patent Rights granted to such sublicensee in the applicable Sublicense Agreement. If Teva fails to
so terminate such sublicenses, then OGX may terminate this Agreement upon written notice to Teva,
effective upon receipt.




8.3 Rights Not Affected. All rights and licenses granted pursuant to this
Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title
11, U.S. Code (the “Bankruptcy Code”) licenses of rights to “intellectual property”
as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that Teva and
OGX shall retain and may fully exercise all of their respective rights, remedies and
elections under the Bankruptcy Code. The Parties further agree that, in the event of the
commencement of a bankruptcy or reorganization case by or against a Party under the
Bankruptcy Code, the other Party shall be entitled to all applicable rights under Section 365
(including Section 365(n)) of the Bankruptcy Code. Upon rejection of this Agreement by a
Party or a trustee in bankruptcy for such Party, pursuant to Section 365(n), the other Party
may elect (i) to treat this Agreement as terminated by such rejection or (ii) to retain its
rights (including any right to enforce any exclusivity provision of this Agreement) to
intellectual property (including any embodiment of such intellectual property) under this
Agreement and under any agreement supplementary to this Agreement for the duration of this
Agreement and any period for which this Agreement could have been extended by such other
Party.


 


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In the event that OGX is the party to a bankruptcy proceeding under
which the trustee in bankruptcy rejects this Agreement, and in such situation Teva
elects to retain its rights hereunder as provided above, then to the fullest extent permitted
by applicable law: (i) if such rejection occurs prior to OGX’s completion of its Development
work under the Clinical Development Plan and of its technology transfer to Teva relating to
manufacturing Know-How for OGX-011 manufacture, Teva’s royalty payment obligations and
milestone payment under this Agreement shall thereafter be reduced by [***]; (ii) if such
rejection occurs after OGX completes its Development work under the Clinical Development Plan
but before it completes the technology transfer to Teva relating to manufacturing Know-How
for OGX-011 manufacture, Teva’s royalty payment obligations and milestone payment under this
Agreement shall thereafter be reduced by [***], with all such reduced amounts deemed to be
royalties for purposes of Section 365(n) of the Bankruptcy Code; and (iii) if such rejection
occurs thereafter, there shall be no change to Teva’s economic obligations to OGX. Upon
written request to the trustee in bankruptcy or bankrupt Party, the trustee or Party, as
applicable, shall (i) provide to the other Party all OGX Intellectual Property or Teva
Intellectual Property, as applicable, (including any embodiment of such intellectual
property) held by the trustee or the bankrupt Party and shall provide to the other Party a
complete duplicate of (or complete access to, as appropriate) any such intellectual property,
and (ii) not interfere with the rights of the other Party to such intellectual property as
provided in this Agreement or any agreement supplementary to this Agreement, including any
right to obtain such intellectual property (or such embodiment or duplicates thereof) from a
Third Party.


 


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8.4 Effect of Expiration or Termination; Survival.



(a) If prior to first Regulatory Approval of a Licensed Product in the United States or a
Primary EU Market, this Agreement terminates for any reason other than by OGX
pursuant to Section 8.2(b)(i) for uncured material breach by Teva, OGX shall pay Teva an amount
equal to [***] of OGX’s Net Sales (calculated according to Section 1.77, substituting OGX for Teva)
on all Licensed Products. If following Regulatory Approval of a Licensed Product in the United
States or any Primary EU Market, this Agreement terminates for any reason, OGX shall pay Teva an
amount equal to [***] of OGX’s Net Sales (calculated according to Section 1.77, substituting OGX
for Teva) on all Licensed Products. Such amounts shall be due on a Licensed Product by Licensed
Product basis for a period beginning on the First Commercial Sale of each such Licensed Product on
a country by country basis, until the earlier of (i) [***] thereafter, or (ii) the expiration of
the [***] Substantial Generic Competition [***] following the [***] Substantial Generic Competition
Event in the given country, provided that at the time of such expiration Substantial Generic
Competition still exists in such country.



(b) Expiration or termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to such expiration or termination, including all accrued payment
obligations arising under Article 4 hereof. In addition to any other provisions of this Agreement
which by their terms continue after the expiration of this Agreement, the provisions of Article 7
and Article 9 shall survive the expiration or termination of this Agreement and shall continue in
effect after the date of expiration or termination. In addition, any other provisions required to
interpret and enforce the Parties’ rights and obligations under this Agreement shall also survive,
but only to the extent required for the full observation and performance of this Agreement. Any
expiration or early termination of this Agreement shall be without prejudice to the rights of any
Party against the other accrued or accruing under this Agreement prior to termination. Except
as expressly set forth herein, the rights to terminate as set forth herein shall be in addition to
all other rights and remedies available under this Agreement, at law, or in equity, or otherwise.


 


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(c) Payments of amounts owing to OGX under this Agreement as of its expiration or termination
shall be due and payable either (i) to the extent such amounts can be calculated and a fixed sum
determined at the time of expiration or termination of this Agreement, [***] days after the end of
the then Calendar Quarter, or (ii) to the extent such amounts cannot be calculated and a fixed sum
determined at the time of expiration or termination of this Agreement, [***] days after the end of
the Calendar Quarter in which such amounts can be calculated and a fixed sum determined.



(d) Upon termination, but not expiration, of this Agreement, (i) all rights and licenses
granted hereunder with respect to the OGX Intellectual Property shall immediately cease and
terminate and revert exclusively to OGX, subject only to the provisions of Section 8.3 and this
Section 8.4(d), and (ii) Teva shall immediately assign to OGX the entire right, title and interest
in and to all OGX Product Specific Intellectual Property that was assigned to Teva pursuant to the
terms of Section 6.1, and all such OGX Product Specific Intellectual Property shall be deemed the
Proprietary Information of OGX. Within [***] after the effective date of termination of this
Agreement, and subject to Section 8.4(g), Teva shall notify OGX of the amount of Licensed Product
Teva, its Affiliates and sublicensees then have on hand or in the process of manufacture. Except
in the case of termination by OGX under Section 8.2(b) or 8.2(c) (in which case Teva shall have no
right to continue to sell Licensed Products, and OGX shall have the right (at its discretion) to
buy all such remaining Licensed Product at actual cost), Teva shall have the



 


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right to sell in the
Territory (except with respect to any country in the
Territory in which Licensed Product has been withdrawn or there is no Regulatory Approval),
its remaining stock of Licensed Product for a period ending upon the earlier of: (i) Teva’s, its
Affiliates’ and sublicensees’ sale of all such remaining Licensed Product, or (ii) [***] after such
termination, and terms and conditions of this Agreement shall apply to such Licensed Product so
sold, including payment by Teva of all royalties owed on such sales under this Agreement (with the
assumption such sales were made during the Agreement Term). OGX hereby grants a non-exclusive
license to Teva as necessary to sell such Licensed Product in the Territory, subject to payment of
all related royalty amounts due under this Agreement. Any remaining quantities of Licensed Product
not sold during this period shall, at OGX’s election, either be destroyed by Teva at Teva’s cost or
sold to OGX at Teva’s procurement cost for such Licensed Product.



(e) In the event of termination of this Agreement pursuant to this Article 8, the following
shall also be applicable: (i) Teva shall promptly transfer, assign and return to OGX copies of all
Data, reports, records and other OGX Know-How and all materials in Teva’s possession or control
that relate solely to Licensed Compound or Licensed Product, and shall return to OGX all relevant
records and materials in Teva’s possession or control containing Proprietary Information of OGX
(provided that Teva may keep one copy of such Proprietary Information of OGX for
archival purposes only), at Teva’s expense; (ii) Teva shall assign and transfer to OGX ownership of
any and all INDs, Regulatory Approvals, Drug Approval Applications, all other Regulatory Documents
and any other regulatory filings or submissions made or filed for Licensed Product by Teva or its
designees; (iii) Teva shall reassign to OGX any Third Party Agreements that OGX had previously
assigned to Teva; (iv) Teva shall assign to OGX all right, title and interest in and to any
copyrights (including content in marketing, sales, advertising and



 


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promotional materials) used
exclusively with Licensed Products, Trademarks
and trade dress used exclusively (to the exclusion of all other Products) in connection with
the sale or marketing of Licensed Products; (v) Teva shall, at no cost to OGX (other than travel
and out of pocket expenses), provide reasonable consultation and assistance for a period of no more
than [***] for the purpose of transferring, at OGX’s request, all then-existing commercial
arrangements relating specifically to Licensed Compounds and Licensed Products that Teva is able,
using reasonable commercial efforts to, transfer or transition to OGX, in each case, to the extent
reasonably necessary or useful for OGX to commence or continue researching, Developing,
manufacturing, or Commercializing Licensed Products; (vi) except upon termination of this Agreement
by Teva under Sections 8.2(a) or 8.2(b)(i), Teva shall remain responsible for completion (it being
understood that Teva shall use its Commercially Reasonable Efforts to complete the Clinical Studies
referred to immediately below in accordance with the then-current Clinical Development Plan, that
OGX will have the ability to comment on such Clinical Studies, and that Teva shall in good faith
give reasonable consideration to all such timely received comments) or at its option payment to OGX
of all costs and expenses required to complete the three (3) Clinical Studies outlined on
Exhibit A commenced (first dosing of patients) prior to the date of the notice of
termination and of any other non-cancellable obligation, provided however OGX shall
remain responsible for the completion of all activities assigned to it under the Clinical
Development Plan and for payment of all Development Expenses (but not to exceed a total of
$30,000,000 in aggregate Development Expenses), except as otherwise provided in Section
3.5(c)(iii); and (vii) OGX shall promptly return to Teva all relevant records and materials in
OGX’s possession or control containing Proprietary Information of Teva (provided
that OGX shall have the right to keep possession of any such
Proprietary Information that is licensed to OGX under this Article 8, and may keep one copy of
all other such Proprietary Information of Teva for archival purposes only).


 


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(f) In the event of termination of this Agreement by Teva under Section 8.2(a) or by OGX under
Section 8.2(b)(i) or (ii), and subject to any payments due pursuant to Sections 8.2(a), at OGX’s
request, Teva hereby grants OGX, effective only upon such termination, a non-exclusive license in
the Territory, with the right to grant sublicenses under multiple tiers, under any Teva Patent
Rights and Teva Know-How solely for the purpose of, and to the extent necessary or reasonably
useful for, Development and/or Commercialization of the Licensed Compounds and Licensed Products.



(g) In the event of the termination of this Agreement after Teva commences manufacture of
Licensed Products, Teva shall at OGX’s cost and expense, until the earlier of [***] after notice of
such termination and such time as OGX determines in its commercially reasonable discretion that OGX
has established sufficient manufacturing resources to meet the requirements for such Licensed
Product in the Territory (“Manufacturing Resources”), provide OGX with such assistance as
OGX may reasonably request from time to time thereafter in connection with the development of
manufacturing capabilities and license of related Intellectual Property to OGX, its Affiliates or
its designee. In addition, Teva shall continue to supply, or cause to be supplied, at [***] and in
accordance with cGMP, the requirements for the Licensed Product in the Territory as reasonably
practical until the earlier of [***] after notice of such termination or such time as OGX has
developed and established Manufacturing Resources. OGX shall use commercially reasonable efforts
to expedite its development and establishment of Manufacturing Resources.


 


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ARTICLE 9




INDEMNIFICATION AND INSURANCE





9.1 Indemnity. For purposes of this Article 9, “OGX Indemnified
Parties” refers to OGX, its Affiliates and the officers, directors, employees,
shareholders, agents and successors, heirs and assigns of OGX and its Affiliates, and
“Teva Indemnified Parties” refers to Teva, its Affiliates and the officers,
directors, employees, shareholders, agents and successors, heirs and assigns of Teva and its
Affiliates.




9.2 Teva Indemnification. Teva shall defend the OGX Indemnified Parties from
and against all suits, claims, actions, demands, complaints, lawsuits or other proceedings
that are brought by a Third Party (collectively, “Third Party Claims”) against any
OGX Indemnified Party, and shall indemnify and hold harmless to the fullest extent permitted
by law the OGX Indemnified Parties from and against any and all Losses, to the extent
resulting from any such Third Party Claims, to the extent such Third Party Claims arise out
of or are attributable to (i) a Teva Indemnified Party’s negligence, recklessness or willful
misconduct in exercising or performing any of Teva’s rights or obligations under this
Agreement; (ii) a material breach by Teva of any of its obligations, representations,
warranties or covenants under this Agreement; (iii) any action taken by an OGX Indemnified
Party in connection with a Third Party Agreement at Teva’s request under Section 3.3; or (iv)
Teva’s or its Affiliates’, sublicensees’ or distributors’ Development, manufacture, storage,
handling, use, sale, offer for sale, importation, exportation and/or other Commercialization
of Licensed Products; provided, however, that Teva shall not be obligated
under this Section 9.2, to the extent it is shown by evidence acceptable in a court of law
having jurisdiction


 


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over the subject matter and meeting the appropriate degree of
proof for such Third Party Claim, that the Third Party Claim arose out of the negligence
or wrongdoing on the part of an OGX Indemnified Party or material breach by OGX of any of its
obligations, representations, warranties or covenants under this Agreement. For clarity, to
the extent OGX has any obligation to indemnify, defend or hold harmless a Third Party under a
Third Party License Agreement for Third Party Claims or Losses arising or resulting from an
act or omission by a Teva Indemnified Party within the scope of clauses (i)-(iv) above, such
obligation shall be deemed a Third Party Claim giving rise to an obligation of Teva under
this Section 9.2.




9.3 OGX Indemnification. OGX shall defend the Teva Indemnified Parties from and
against all Third Party Claims against a Teva Indemnified Party, and shall indemnify and hold
harmless to the fullest extent permitted by law the Teva Indemnified Parties from and against
any and all Losses that arise out of such Third Party Claims, to the extent such Third Party
Claims arise out of or are attributable to: (i) an OGX Indemnified Party’s negligence,
recklessness or willful misconduct in exercising or performing any of OGX’s rights or
obligations under this Agreement; (ii) a material breach by OGX of any of its obligations,
representations, warranties or covenants under this Agreement; or (iii) OGX’s or its
Affiliates’ research and Development of Licensed Compounds and Licensed Products before the
Effective Date; provided, however, that OGX shall not be obligated under this
Section 9.3, to the extent it is shown by evidence acceptable in a court of law having
jurisdiction over the subject matter and meeting the appropriate degree of proof for such
Third Party Claim, that the Third Party Claim arose out of the negligence or wrongdoing on
the part of a Teva Indemnified Party or material
breach by Teva of any of its obligations, representations, warranties or covenants under
this Agreement.


 


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9.4 Indemnification Procedure.



(a) Each Party shall promptly notify the other Party in writing of any Third Party Claim.
Concurrent with the provision of notice pursuant to this Section 9.4(a), the Party claiming
indemnity under this Article 9 (the “Indemnified Party”) shall provide to the Party from
whom indemnity is being sought (the “Indemnifying Party”) copies of any complaint, summons,
subpoena or other court filings or correspondence related to such Third Party Claim and will give
such other information with respect thereto as the Indemnifying Party shall reasonably request.
The Indemnifying Party and Indemnified Party shall meet to discuss how to respond to such Third
Party Claim. Failure to provide prompt notice shall not relieve an Indemnifying Party of the duty
to defend or indemnify unless such failure materially prejudices the defense of any matter. Each
Party agrees that it will take reasonable steps to minimize the burdens of the litigation on
witnesses and on the ongoing business of the Teva Indemnified Parties and OGX Indemnified Parties
including making reasonable accommodations to witnesses’ schedules when possible and seeking
appropriate protective orders limiting the duration and/or location of depositions.



(b) Should either Party dispute that any Third Party Claim or portion of a Third Party Claim
(“Disputed Claim”) of which it receives notice pursuant to Section 9.4(a), is an
indemnified Third Party Claim, it shall so notify the other Party providing written notice in
sufficient time to permit such other Party to retain counsel and timely appear, answer and/or move
in any such action. In such event, such other Party shall defend against such Third Party
Claim; provided, however, that the Indemnified Party shall not settle any
Third Party Claim which it contends is an indemnified Third Party Claim without providing the
Indemnifying Party [***] notice prior to any such settlement and an opportunity to assume the
defense and indemnification of such Third Party Claim pursuant to this Agreement. If it is
determined that a Disputed Claim is subject to indemnification, the Indemnifying Party will
reimburse the costs and expenses, including reasonable attorneys’ fees, of the Indemnified Party.


 


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9.5 Settlement of Indemnified Claims. The Indemnifying Party under Section 9.2
or Section 9.3, as applicable, shall have the sole authority to settle any Indemnified Claim
without the consent of the other Party, provided, however, that an Indemnifying Party shall
not, without the written consent of the other Party, as part of any settlement or compromise
(i) admit to liability on the part of the other Party; (ii) agree to an injunction against
the other Party; or (iii) settle any matter in a manner that separately apportions fault to
the other Party. The Parties further agree that as part of the settlement of any Indemnified
Claim, an Indemnifying Party shall obtain a full, complete and unconditional release from the
claimant on behalf of the Indemnified Parties.




9.6 Insurance.



(a) Each Party shall maintain, commencing as of the Effective Date, general liability
insurance (including coverage for product liability, bodily injury, property damage and personal
injury), in form and substance reasonably satisfactory to the other Party, with minimum limits of
$[***] or, in case of Clinical Studies as required by the relevant Laws, during the period when
such Clinical Studies are being conducted (the “Insurance”). However, if such Insurance is
written on a claims-made form, it shall continue for [***] following termination of this
Agreement either on a full form or a run-off. The Insurance shall have a retroactive date to
or coinciding with the Effective Date. Notwithstanding the foregoing, Teva may satisfy the
foregoing obligation with respect to the Insurance through self-insurance, to the extent it
self-insures for other liabilities relating to the development and commercialization of other
pharmaceutical products.


 


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(b) Such Insurance shall insure against all liability arising out of the manufacture, use,
sale, distribution, or marketing of Licensed Product in and for the Territory. During the
Agreement Term, each Party shall not permit such Insurance to be reduced, expired, materially
amended or canceled during the period of the Insurance and/or the Agreement without reasonable
prior written notice that shall be sent as set forth in Section 10.4. Prior to the commencement of
this Agreement, each Party shall provide certificates of insurance to the other Party evidencing
the coverage specified herein.



(c) Except as expressly stated herein, a Party’s liability to the other is in no way limited
to the extent of the Party’s insurance coverage.



(d) The Parties agree that neither Party shall be deemed to be an additional insured under the
terms of their respective insurance policies. The Parties further agree that neither Party shall be
deemed to be an additional insured vendor under such policies



(e) The Insurance shall contain an explicit clause, stating that each Party and its insurer
waive their rights of subrogation against the other Party and its directors, employees and/or any
one on its behalf with respect to the Insurance. Such waiver shall not apply in the event of a
malicious act.


 


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(f) The Insurance shall be primary, preliminary and non-contributory to any other insurance
maintained by each Party and each Party hereby waives any claim or demand as to participation in
any such other insurance.



(g) The Insurance shall be valid in any location regarding the activities performed by each
Party hereunder (including worldwide jurisdictions) for any destination or lawsuit which will be
served against the other Party.



(h) In case of a claim and/or a demand and/or knowledge related to erosion and/or exhaustion
of limits of liability of any of party’s insurance required under this Agreement (hereinafter, the
“Limits of Liability”) due to and/or a result from any event (whether paid or unpaid) each party
undertakes to purchase (promptly after the claim and/or a demand and/or knowledge related to
erosion and/or exhaustion as detailed above, the earlier) insurance to reinstate the Limits of
Liability as detailed in the Agreement.



(i) Both Parties’ obligations pursuant to this Section 9.6 including all the sub-clauses
hereof, constitute a fundamental condition of this Agreement and a breach of any of them shall be
deemed a fundamental breach of this Agreement.




9.7 Limitation of Liability. EXCEPT FOR FRAUD, GROSS NEGLIGENCE OR INTENTIONAL
MISCONDUCT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES
FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES
(INCLUDING LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR
ITS AFFILIATES, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT,
WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT OF THIS
AGREEMENT. THE FOREGOING SENTENCE SHALL NOT LIMIT THE OBLIGATIONS OF EITHER PARTY TO
INDEMNIFY AN INDEMNIFIED PARTY FROM AND AGAINST THIRD PARTY CLAIMS UNDER THIS ARTICLE 9.


 


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ARTICLE 10




MISCELLANEOUS





10.1 Force Majeure. Neither Party shall be held liable or responsible to the
other Party nor be deemed to have defaulted under or breached this Agreement for failure or
delay in fulfilling or performing any term of this Agreement (other than payment obligations)
during the period of time when such failure or delay is caused by or results from events
beyond the reasonable control of a Party, including fire, flood, earthquake, explosion,
storm, blockage, embargo, war, acts of war (whether war be declared or not), terrorism,
insurrection, riot, civil commotion, strike, lockout or other labor disturbance, failure of
public utilities or common carriers, act of God or act, omission or delay in acting by any
governmental authority or the other Party, provided that the affected Party
takes reasonable efforts to remove the condition causing the failure or delay (which efforts
may include delegating obligations under this Agreement to an Affiliate). The affected Party
shall notify the other Party of such force majeure circumstances as soon as reasonably
practicable.


 


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10.2 Assignment. This Agreement may not be assigned or otherwise transferred
without the prior written consent of the other Party, not to be unreasonably withheld;
provided, however, that either Party may assign this Agreement to an
Affiliate, or to its successor in interest in connection with the transfer or sale of its
business or all or substantially all of its assets, or in the event of a merger,
consolidation, change in control or similar corporate transaction, without such consent;
provided further, however, that such assignment shall not relieve the
Party of its responsibilities for performance of its obligations under this Agreement and
shall be subject to the provisions of Section 10.8. Furthermore, the foregoing restriction
on assignment shall not apply to a divestiture by Teva as may be ordered by a court or
administrative agency of competent jurisdiction, or otherwise required by Law. This
Agreement shall be binding upon and inure to the benefit of the successors and permitted
assigns of the Parties. Any assignment not in accordance with this Agreement shall be void.




10.3 Severability. In the event that any of the provisions contained in this
Agreement are held invalid, illegal or unenforceable in any respect, the validity, legality
and enforceability of the remaining provisions contained herein shall not in any way be
affected or impaired thereby, unless the absence of the invalidated provision(s) adversely
affects the substantive rights of the Parties. In such event, the Parties covenant and agree
to renegotiate any such term, covenant or application thereof in good faith in order to
provide a reasonably acceptable alternative to the term, covenant or condition of this
Agreement or the application thereof that is invalid or unenforceable, it being the intent of
the Parties that the basic purposes of this Agreement are to be effectuated.


 


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10.4 Notices.



(a) Correspondence, reports, documentation, and any other communication between the Parties in
the course of ordinary implementation of this Agreement (but not including any notice required by
this Agreement) shall be in writing and delivered by hand, sent by facsimile, email, or by
overnight express mail (e.g., FedEx) to any one (1) representative designated by the Party which is
to receive such written communication.




if to OGX to:




ONCOGENEX TECHNOLOGIES, INC.

400-1001 West Broadway

Vancouver, British Columbia,

Canada V6H 4B1

[***]

Fax No.: (604) 736-3687

[***]




With copies to:




ONCOGENEX PHARMACEUTICALS, INC.

1522 217th Place SE, Suite 100

Bothell, WA 98021

[***]

[***]




if to Teva to:




TEVA PHARMACEUTICAL INDUSTRIES LTD.

5 Basel Street

P.O. Box 3190

Petah Tiqva 49131

Israel




[***]


 


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(b) Extraordinary notices and communications (including but not limited to notices of
termination, force majeure, material breach, change of address, or any other notices required by
this Agreement) shall be in writing and shall be deemed to have been given when delivered in
person, or sent by overnight courier service (e.g., FedEx), postage prepaid, or by facsimile
confirmed by prepaid registered or certified air mail letter or by overnight express mail (e.g.,
FedEx), or sent by prepaid certified or registered air mail, return receipt requested, to the
following addresses of the Parties (or to such other address or addresses as may be specified from
time to time in a written notice), and shall be deemed to have been properly served to the
addressee upon receipt of such written communication, to the following addresses of the Parties:




if to OGX to:




ONCOGENEX TECHNOLOGIES, INC.

400-1001 West Broadway

Vancouver, British Columbia, Canada V6H 4B1

[***]

Fax No.: (604) 736-3687




With a copy (which shall not constitute notice) to:




[***]

Dorsey & Whitney LLP

701 Fifth Avenue, Suite 6100

Seattle, WA 98104-7043

Fax No.: (206) 903-8820




if to Teva to:




TEVA PHARMACEUTICAL INDUSTRIES LTD.

5 Basel Street

P.O. Box 3190

Petah Tiqva 49131

Israel




[***]


 


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With a copy to:




TEVA NEUROSCIENCE, INC.

901 E. 104th Street

Kansas City, MO 64131




[***]




With a second copy to:




TEVA NEUROSCIENCE, INC.

901 E. 104th Street

Kansas City, MO 64131




[***]



or to such other address as the Party to whom notice is to be given may have furnished to the other
Parties in writing in accordance herewith. Any such communication shall be deemed to have been
given when delivered if personally delivered or sent by facsimile on a Business Day, upon confirmed
delivery by nationally-recognized overnight courier if so delivered, and on the third Business Day
following the date of mailing if sent by registered or certified mail.




10.5 Specific Performance. Each of the Parties acknowledges and agrees that the
other Party may be damaged irreparably in the event any of the provisions of this Agreement
are not performed in all material respects or otherwise are materially breached.
Accordingly, and notwithstanding anything herein to the contrary, each of the Parties agrees
that the other Party shall be entitled to seek injunctive relief to prevent breaches of the
provisions of this Agreement, and/or to seek to enforce specifically this Agreement and the
terms and provisions hereof, in any action instituted in any court or tribunal having
jurisdiction over the Parties and the matter, without posting any bond or other security, and
that such injunctive relief shall be in addition to any other remedies to which such
Party may be entitled, at law or in equity.


 


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10.6 Further Assurances. Each of the Parties shall use reasonable efforts to
take such further reasonable actions as shall be necessary or desirable in order to
effectuate the respective rights and obligations hereunder.




10.7 Change of Control. Notwithstanding anything in this Agreement to the
contrary, in the event of a Change of Control of OGX, (a) Teva will not be obligated to
disclose any [***] to the Successor Entity during the remainder of the Agreement Term (but
shall continue to provide the royalty reports required under this Agreement and shall provide
reasonable summaries of Development and Commercialization status and efforts), and Teva may
request the immediate return or destruction of [***] previously disclosed to OGX; and (b) OGX
shall use reasonable efforts to [***], in substantially [***] had been providing [***] as of
the Effective Date, until at least [***] after the closing of the Change of Control (provided
such obligation shall in any event terminate [***] after OGX transfers the existing IND to
Teva as contemplated in Section 3.6). Further, notwithstanding anything in this Agreement to
the contrary, within ninety (90) days of the date of any Change of Control of OGX, Teva may:
(c) terminate the JSC in its sole discretion (d) terminate the Co-Promotion Option if not
then exercised by OGX, in Teva’s sole discretion; (e) terminate the Co-Promotion Option,
after exercise by OGX but prior to execution of a Co-Promotion Agreement, in Teva’s sole
discretion; and/or (f) terminate the Co-Promotion Agreement, if in Teva’s commercially
reasonable judgment co-promotion with OGX’s successor-in-interest would be adverse to Teva’s
interests.


 


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10.8 Applicable Law, Venue and Dispute Resolution.



(a) This Agreement shall be governed by the laws of the State of New York, U.S. The United
Nations Convention on Contracts for the International Sale of Goods shall not apply in any action,
suit or proceeding arising out of or relating to this Agreement.



(b) All actions, suits or proceedings arising out of or relating to this Agreement (but not
originating from the JSC) shall be heard and determined in any state or federal court having
jurisdiction of the Parties and the subject matter of the dispute, sitting in the Southern District
of New York, and the Parties hereto hereby irrevocably submit to the exclusive jurisdiction of such
courts in any such action or proceeding and irrevocably waive any defense of an inconvenient forum
to the maintenance of any such action or proceeding.



(c) Matters referred pursuant to Section 3.7(e) shall be resolved through binding arbitration
in accordance with this Section 10.8(c) and under the Commercial Arbitration Rules of the American
Arbitration Association (“AAA”) then in effect, including application of the “Expedited Procedures”
(sections E-1, et al) of the Commercial Arbitration Rules of the AAA. The proceedings and
decisions of the arbitrator shall be confidential, final and binding on the Parties, and judgment
upon the award of such arbitrator may be entered in any court having jurisdiction thereof. The
arbitration shall take place in New York City and will be conducted by one (1) arbitrator who shall
be reasonably acceptable to the Parties and who shall be appointed in accordance with AAA rules.
If the Parties are unable to select an arbitrator within ten (10) days of the notice that initiated
the arbitration, then the arbitrator shall be appointed in accordance with AAA rules. Any
arbitrator chosen hereunder shall have educational training and industry
experience sufficient to demonstrate a reasonable level of scientific, financial, medical and
industry knowledge relevant to the particular dispute.


 


114









 






10.9 Entire Agreement. This Agreement, including the exhibits and schedules
hereto, and the stock purchase agreement and guaranty referred to in the recitals hereof,
contains the entire understanding of the Parties with respect to the subject matter. All
express or implied agreements and understandings, either oral or written, heretofore made,
including any offering letters, letters of intent, or term sheets, are expressly superseded
by this Agreement. This Agreement may be amended, or any term hereof modified, only by a
written instrument duly executed by all Parties hereto.




10.10 Independent Contractors. It is expressly agreed that the Parties shall be
independent contractors and that the relationship between the Parties shall not constitute a
partnership, joint venture or agency. Neither Party shall have the authority to make any
statements, representations or commitments of any kind, or to take any action, which shall be
binding on the other Party, without the prior consent of such other Party.




10.11 Waiver. The waiver by a Party hereto of any right hereunder or the
failure to perform or of a breach by another Party shall 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.




10.12 Headings; References. The captions to the several Articles and Sections
hereof are not a part of this Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Sections hereof. Any reference in this
Agreement to an Article, Exhibit, Schedule or Section shall, unless otherwise specifically
provided, be to
an Article, Exhibit, Schedule or Section of this Agreement. The words “including”,
“includes” and “such as” are used in their non-limiting sense and have the same meaning as
“including without limitation” and “including but not limited to.” “Hereunder” and “hereto”
means under or pursuant to any provision of this Agreement.


 


115









 






10.13 Interpretation. Both Parties have had the opportunity to have this
Agreement reviewed by an attorney; therefore, neither this Agreement nor any provision hereof
shall be construed against the drafter of this Agreement.




10.14 Counterparts. This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and
the same instrument. Signatures to this Agreement transmitted by fax, by email in “portable
document format” (“.pdf”) or by any other electronic means intended to preserve the original
graphic and pictorial appearance of this Agreement shall have the same effect as physical
delivery of the paper document bearing an original signature.




10.15 No Third Party Beneficiaries. Except as specifically set forth herein,
none of the provisions of this Agreement shall be for the benefit of or enforceable by any
Third Party, including any creditor of either Party hereto. No such Third Party shall obtain
any right under any provision of this Agreement or shall by reasons of any such provision
make any claim in respect of any debt, liability or obligation (or otherwise) against either
Party hereto.


 


116









 






10.16 Delegation. Each Party may delegate the full or partial discharge of its
covenants, agreements, obligations and liabilities under this Agreement including the due and
punctual payment of all amounts which are or may become due and payable by such
Party hereunder to any Affiliate of such Party at the time of such delegation, if, but
only if, such delegation does not result in the imposition of greater tax withholding than
would otherwise be imposed under Section 4.6(b) or any payment by deposit of local currency
under Section 4.6(c). Each Party hereby guarantees the performance by its Affiliates of such
Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the
provisions of this Agreement in connection with such performance. Any breach by a Party’s
Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by
such Party, and the other Party may proceed directly against such Party without any
obligation to first proceed against such Party’s Affiliate.



[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]



 


117









 





IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth
above.



	 	 	 	 	 
	ONCOGENEX TECHNOLOGIES INC.	 	 
	 
	 	 	 	 
	By:
	 	/s/ Scott Cormack	 	 
	 

	 	 

Name: Scott Cormack
	 	 
	 

	 	Title:   President & CEO	 	 
	 
	 	 	 	 
	TEVA PHARMACEUTICAL INDUSTRIES LTD.	 	 
	 
	 	 	 	 
	By:

	 	/s/ Moshe Manor
 

Name: Moshe Manor
	 	  
	 

	 	Title: Group VP — Global Branded Products	 	
	 
	 	 	 	 
	By:

	 	/s/ Chen Schor
 

Name: Chen Schor
	 	 
	 

	 	Title: VP, Business Developmemt
Global
Branded Products	 	 







 


118











 




SCHEDULES AND EXHIBITS




Schedule 1.50 — FTE Rates by Functional Area

Schedule 1.88 — OGX Patent Rights

Schedule 1.90 — OGX Product Specific Intellectual Property

Schedule 1.91 — OGX Trademarks

Schedule 3.2(a) — Information to Be Transferred to Teva

Schedule 3.2(b) — Materials to Be Transferred to Teva

Schedule 3.2(c) — Reports to Be Provided by OGX

Schedule 3.3(a) — Third Party Agreements

Schedule 3.7 — Outline of Terms and Conditions for Co-Promotion Agreement

Schedule 4.1 — Milestone Fees

Schedule 4.2 — Royalties

Schedule 4.3 — Development Expenses Incurred Prior to Effective Date

Schedule 4.5 — Stock Purchase Agreement

Schedule 5.1(e) — Exceptions to 5.1(e)

Schedule 5.1(f)(i) (OGX); Schedule 5.1(f)(ii) (Teva) — Third Party Claims on Rights Under Agreement

Schedule 5.2 — OGX Disclosure Schedule

Schedule 7.3 — OGX Publications

Schedule 10.7 — OGX Employees




Exhibit A: Clinical Development Plan Summary






	 	 	 
	*	 	Certain information in this exhibit has been omitted as confidential, as indicated by [***]. This
information has been filed separately with the Commission.




 


 









 





SCHEDULE 1.50




FTE RATES BY FUNCTIONAL AREA




	 	 	 
	Position	 	FTE Rate
	Level 2 (Director — Clinical Research, Data Management, CMC and IP)

	 	$[***]/ hr
	Level 3 (Clinical Research Associate, SAS Programmer and Data Manager)

	 	$[***]/ hr








	 	 	 
	*	 	Note: Should other resources than the levels set forth in the above table be required, the JSC
shall have the discretion to include such resources at a rate or rates to be mutually agreed by the Parties.




 


2









 





SCHEDULE 1.88




OGX PATENT RIGHTS




Pursuant to the License Agreement dated November 15, 2001 (commencing Nov. 1, 2001) between OGX and
the University of British Columbia, OGX has an exclusive license to the following patents and
patent applications:



	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	FILE	 	FILE	 	 	 	 	 	 	 	 
	DOCKET	 	TITLE	 	INVENTORS	 	TYPE	 	DATE	 	PATENT/PUB #	 	SERIAL #	 	STATUS	 	NOTES
	[***]

	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]






 


3









 





Pursuant to the Amended and Restated License Agreement effective July 2, 2008 between OGX and Isis
Pharmaceuticals, Inc., the following [***] have been assigned to OGX:



[***] PATENTS




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***] compositions
	[***]

	 	[***]
	 	[***]
	 	EP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***] compositions
	[***]

	 	[***]
	 	[***]
	 	JP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***] compositions
	[***]

	 	[***]
	 	[***]
	 	JP
	 	[***]
	 	 	 	[***]
	 	[***]
	 	[***] compositions






Pursuant to the Amended and Restated License Agreement effective July 2, 2008 between OGX and Isis
Pharmaceuticals, Inc., OGX has a non-exclusive license to the following patents and patent
applications, provided that such patents and patent applications are required for the Product (as
defined in the Amended and Restated License Agreement):



[***] PATENTS




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

	 	N/A
	 	United States
	 	[***]
	 	[***]
	 	[***]





 


4









 





[***] PATENTS




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

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	European Patent Convention (FR, GB, DE, IE, NL, CH, SE, BE, DK)
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	European Patent Convention (FR, GB, DE, JP, CH)
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Patent Cooperation Treaty (AU, CA, EP, JP)
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Patent Cooperation Treaty
	 	[***]
	 	[***]
	 	[***]
	[***]
	 	 	 	 	 	 	 	 	 	 
	 

	 	[***]
	 	European Patent Convention (AT, BE, DK, FI, FR, GB, DE, IE, IT, NL, CH, ES, SE)
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Canada
	 	[***]
	 	[***]	 	 
	 

	 	[***]
	 	Japan
	 	[***]
	 	[***]	 	 
	 

	 	[***]
	 	New Zealand
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Australia
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]






 


5









 





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

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Canada
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Australia
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	[***]
	 	 	 	 	 	 	 	 	 	 
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]






[***] PATENTS




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

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Great Britain
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Germany
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Switzerland
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Belgium
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Great Britain
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Germany
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Switzerland
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Sweden
	 	[***]
	 	[***]
	 	[***]






 


6









 





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

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Canada
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Europe
	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Great Britain
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Ireland
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	France
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Germany
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Belgium
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Switzerland
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Italy
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Portugal
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Spain
	 	[***]
	 	[***}
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Canada
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Japan
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	 	 	 	 	[***]	 	 






 


7









 





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

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Canada
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Germany
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Spain
	 	[***]
	 	[***}
	 	[***]
	 

	 	[***]
	 	France
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Great Britain
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	Italy
	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	European Patent Convention
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	 

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	United States
	 	[***]
	 	[***]
	 	[***]
	[***]

	 	[***]
	 	Patent Cooperation Treaty
	 	[***]
	 	[***]
	 	[***]





 


8









 





SCHEDULE 1.90




[***]




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	DOCKET	 	TITLE	 	INVENTORS	 	FILE TYPE	 	FILE DATE	 	PATENT/PUB #	 	SERIAL #	 	STATUS	 	NOTES
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US CIP (1)
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Combination composition
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	AU
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Composition
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	CA
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Composition
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	EP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Composition
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	HU
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	IL
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Composition
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	JP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	KR
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	KR Divisional
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Composition






 


9









 





	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	DOCKET	 	TITLE	 	INVENTORS	 	FILE TYPE	 	FILE DATE	 	PATENT/PUB #	 	SERIAL #	 	STATUS	 	NOTES
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	NO
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	NZ
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Composition
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US CIP (2)
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Compound
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US CON
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US CON
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Composition
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	AU
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	CA
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	EP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method






 


10









 





	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	DOCKET	 	TITLE	 	INVENTORS	 	FILE TYPE	 	FILE DATE	 	PATENT/PUB #	 	SERIAL #	 	STATUS	 	NOTES
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	IL
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	JP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	KR
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	NO
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	NZ
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method for treating
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method for treating
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	AU
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method for treating
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	CA
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method for treating
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	EP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method for treating
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	JP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	Method for treating
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	US
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]

compositions
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	EP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]

compositions
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	JP
	 	[***]
	 	[***]
	 	[***]
	 	[***]
	 	[***]

compositions
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[***]

	 	[***]
	 	[***]
	 	JP
	 	[***]
	 	 	 	[***]
	 	[***]
	 	[***]

compositions





 


11









 





SCHEDULE 1.91




OGX TRADEMARKS




Trademarks or Tradename





None



Registered Domain Names





custirsen.ca

custirsen.com

custirsensodium.ca

custirsensodium.com



USAN Name for OGX-011





Custirsen


 


12









 





SCHEDULE 3.2(a)




INFORMATION TO BE TRANSFERRED TO TEVA




Electronic or hard copies of the following will be made available to Teva within the timeframe
outlined below:




Within [***] following the Effective Date:




	 	1.	 	All documents related to Licensed Compounds or Licensed Products (including without
limitation all Third Party Agreements) in the electronic data room as of [***], 2009 and
any additions up to the Effective Date.







Within [***] following the Effective Date (to the extent not provided in the
electronic data room and transferred pursuant to the above):




	 	1.	 	To the extent not included in the above, all documents provided during the on-site due
diligence and listed on the OncoGenex due diligence document index dated [***], 2009







	 	2.	 	All available clinical trial SAS datasets







	 	3.	 	CRFs from OncoGenex-sponsored trials







	 	4.	 	Current SAE narratives for all studies







	 	5.	 	Current SAS summary tables of safety data for all studies







	 	6.	 	Current SAS summary tables for all studies







	 	7.	 	All regulatory documents and correspondence, including:







	 	(i)	 	All the IND’s in existence and contents ([***]).

	 
	 	(ii)	 	All [***] contact reports and meeting minutes.

	 
	 	(iii)	 	A list of all ongoing activities that eventually need to be filed to
the IND.

	 
	 	(iv)	 	All [***] documents and correspondence, including:







[***]




	 	8.	 	All IP related materials, including agreements with any other company or university
from which any IP was licensed







	 	9.	 	All preclinical reports in OncoGenex’ possession







	 	10.	 	All preclinical published material on OGX-011 or its precursors.







	 	11.	 	Drug Substance (DS):







	 	(i)	 	[***] executed batch records for batch [***]

	 
	 	(ii)	 	Analytical raw data for batch [***] release





 


13









 





	 	(iii)	 	COA for [***] batch

	 
	 	(iv)	 	Raw materials COAs for [***] batch ([***] and [***])

	 
	 	(v)	 	Raw materials analyses — release raw data

	 
	 	(vi)	 	Analytical methods, all available development reports etc

	 
	 	(vii)	 	Comparability report and raw data performed between [***] and [***]

	 
	 	(viii)	 	Stability data — tables and raw data for all DS batches

	 
	 	(ix)	 	Any available chemical development reports

	 
	 	(x)	 	Reference standard qualification report







	 	12.	 	Drug Product (DP):







	 	(i)	 	Documentation from [***] and previous vendors: executed formula records
of all DP batches

	 
	 	(ii)	 	COAs of all DP batches ([***])

	 
	 	(iii)	 	Stability data of all DP batches







	 	13.	 	Nonclinical studies and related documents:







	 	(i)	 	[***] repeated administration in [***] (study report [***])

	 
	 	(ii)	 	[***] repeated administration in [***] (study report [***])

	 
	 	(iii)	 	[***] assay (study report [***])

	 
	 	(iv)	 	[***] ([***])

	 
	 	(v)	 	[***] assay ([***])

	 
	 	(vi)	 	Updated toxicology plan for the development of OGX-011 (2009)







	 	14.	 	PK/ADME documents:







	 	(i)	 	The toxicokinetic report of [***] study report: A [***] of [***] in the
[***] with a [***] Recovery Period. [***].

	 
	 	(ii)	 	The toxicokinetic report of [***] study report: A [***] in the [***]
with a [***] Recovery Period. [***].







	 	15.	 	OGX-011-07 and OGX-011-05 Studies: Current patient profiles







	 	16.	 	Phase II study OGX-011-06 in combination with Docetaxel in advanced Breast Cancer-
Final [***] report





 


14









 





Note: All documents in OncoGenex’ possession that have original signatures (such as clinical
studies approvals, investigator’s sign off, regulatory CMC, etc.) should be transferred to Teva.




As soon as reasonably practicable (to the extent not provided in the electronic data room
and transferred pursuant to the above):




	 	1.	 	CRFs from the [***] Sponsored Study OGX-011-03 when available from [***] (if CRFs are
required from other [***] studies, copies must [***] with [***]).







	 	2.	 	CRFs from the OncoGenex Sponsored Studies that are collected from the clinical sites
more than 60 days after the Effective date







	 	3.	 	For DS later stage:







	 	(i)	 	BRs of DS batches :[***]

	 
	 	(ii)	 	COA and release analyses raw data for DS batches :[***]







	 	4.	 	Phase 1 Study with PK components OGX-011-02 ([***]) — Final Signed off







	 	5.	 	Pharmacokinetic data for investigator sponsored study OGX-011-04





 


15









 





SCHEDULE 3.2(b)




MATERIALS TO BE TRANSFERRED TO TEVA





	 	1.	 	[***] of OGX-011 API manufactured by [***] for toxicology studies, OncoGenex Lot [***].

	 
	 	2.	 	[***]of OGX-011 API manufactured by [***], batch [***].

	 
	 	3.	 	[***] vials of liquid reference standard (0.1 mg/mL, 1 mL fill in single use vials) to
be provided to Teva after qualification and receipt by OGX of materials on order.

	 
	 	4.	 	[***] of OGX-011[***] used for the [***] of [***] and such other [***], including [***]
of OGX-011, as approved to be ordered by the JSC.

	 
	 	5.	 	Such quantities and number of raw material [***] (not exclusive to OncoGenex) as
approved to be ordered by the JSC and as available from [***].





 


16









 





SCHEDULE 3.2(c)




REPORTS TO BE PROVIDED BY OGX




OncoGenex will provide, as soon as reasonably practicable, final and complete clinical study
reports (suitable for regulatory submission) for the following studies:



	 	 	 
	Phase 1 Study 

OGX-011-01

NCIC Sponsored

	 	Open-label, Phase 1,
dose-escalation, safety,
pharmacokinetic and pharmacodynamic
study of weekly doses of custirsen
in combination with neoadjuvant
hormone therapy (NHT) in patients
with localized prostate carcinoma
prior to radical prostatectomy.
	 
	 	 
	Phase 1 Study 

OGX-011-02

NCIC Sponsored

	 	Open-label, non-blinded, Phase 1
dose escalation, safety and
pharmacokinetic study of custirsen
in combination with docetaxel in
patients with solid tumors that were
known to over express clusterin.
	 
	 	 
	Phase 2 Study 

OGX-011-03

NCIC Sponsored

	 	Randomized, non-blinded study
evaluating weekly custirsen in
combination with docetaxel and
prednisone compared to docetaxel and
prednisone alone for first-line
chemotherapy treatment in patients
with metastatic hormone refractory
prostate cancer (HRPC).
	 
	 	 
	Phase 2 Study 

OGX-011-04

Investigator Sponsored

	 	Open-label, non-blinded study
evaluating the combination of NHT
and custirsen prior to radical
prostatectomy in patients with
localized prostate carcinoma. The
study was a two-stage design; only
stage 1 was conducted.
	 
	 	 
	Phase 1/2 Study 

OGX-011-05

OncoGenex Sponsored

	 	Open-label, non-blinded, Phase 1/2
study of custirsen in combination
with a gemcitabine/platinum-based
regimen (gemcitabine/cisplatin or
gemcitabine/carboplatin) in
chemotherapy-naïve patients with
advanced non-small cell lung cancer
(NSCLC). The Phase 2 dose of
custirsen in combination with
gemcitabine/cisplatin.
	 
	 	 
	Phase 2 Study 

OGX-011-07

OncoGenex Sponsored

	 	This study is evaluating custirsen
in combination with second-line
chemotherapy (either mitoxantrone or
docetaxel) in patients with HRPC who
were previously treated with
docetaxel and progressed on or
within 6 months of treatment. The
protocol was amended and additional
patients were added in the docetaxel
plus custirsen arm.






OncoGenex will also provide the final clinical study report as prepared by the NCIC:



	 	 	 
	Phase 2 Study 

OGX-011-06

NCIC Sponsored

	 	Phase 2 study of custirsen in combination with docetaxel in
advanced breast cancer. The study was a two stage design.
14 patients were to be entered into Stage 1, Stage 2 was
not conducted.





 


17









 





SCHEDULE 3.3(a)




THIRD PARTY AGREEMENTS




1. Section 85 Transfer Agreement made [***] between [***] and OGX.



2. Letter of understanding dated [***] addressed to [***] of the [***] at [***] and [***] pursuant
to which, under certain circumstances, OGX would arrange to provide [***] on a cost recovery basis
in support of the [***]. The subject matter of this letter of understanding relate to [***] for
which OGX has provided [***] and the [***] have been publicly presented and provided to Teva.



3. License Agreements





	 	(a)	 	UBC — License Agreement dated November 15, 2001 (commencing Nov. 1, 2001) between OGX and the
University of British Columbia pursuant to which OGX is granted an exclusive, world-wide,
royalty-bearing license to certain intellectual property related to antisense inhibitors of
Clusterin together with Amending Agreement dated August 30, 2006, August 7, 2008 and December
20, 2009.







	 	(b)	 	Isis — Amended and Restated License Agreement effective July 2, 2008 between OGX and Isis
Pharmaceuticals, Inc. regarding the unilateral development of OGX-011 together with Amendment
No. 1 to Amended and Restated License Agreement dated December 19, 2009. This agreement and
amendment supercedes the License and Co-development Agreement effective November 16, 2001.






4. Pre-Clinical




Work performed under Pre-Clinical has been completed and is listed below under “Expired
Contracts”



5. Drug Formulation




Contract relating to Drug Formulation has been terminated and is listed below under “Expired
Contracts”.



6. Pharmacokinetics & Toxicology





[***] dated [***] between [***] and OGX, now known as [***]




	 	(b)	 	[***] effective [***] which expires [***] with [***] together with Quotation dated [***]
regarding [***] in [***].






7. Manufacturing





	 	(a)	 	[***] between [***] and OGX commencing on the date of execution being [***]
with respect to the [***] for [***].







	 	(b)	 	[***] signed as of [***] between OGX and [***] together with Change Orders
dated [***], [***] and [***]; and [***] dated [***], [***] and [***].





 


18









 






	 	(c)	 	[***] with [***] effective [***] together with Quotation dated [***] regarding
[***] of [***] used in [***] manufacture.







	 	(d)	 	[***] effective [***] between Laureate Pharma, Inc. and OGX to which is
attached as [***] the [***]; together with [***] dated [***]. [***] dated [***]
regarding [***] of OGX-011 [***]. [***] dated [***] which adds [***] as product to the
[***] agreement.







	 	(e)	 	[***] and [***] dated [***] with Avecia Biotechnology Inc. regarding OGX-011
together with [***] entered into [***] and [***] dated [***], [***] and [***].







	 	(f)	 	[***] and [***] effective [***] with [***].






8. Clinical Trial Agreements





	 	(a)	 	[***] effective [***] between OGX, [***] and [***] with respect to [***].







	 	(b)	 	[***] dated [***] between OGX, [***], owner and operator of [***] and [***]
with respect to [***], together with [***] dated [***].







	 	(c)	 	[***] effective [***] between OGX, [***] and [***] with respect to [***].







	 	(d)	 	[***] effective [***] between [***], the [***], [***] and OGX regarding for the
[***] entitled [***].







	 	(e)	 	[***] effective [***] between OGX and [***] and [***] with respect to [***].

	 
	 	(f)	 	[***] effective [***] between OGX, BC [***] and [***] with respect to [***].







	 	(g)	 	[***] dated [***] between [***] at [***] in the style and cause of the [***]
and OGX with respect to [***]. [***] study.







	 	(h)	 	[***] effective [***] between OGX, [***] and [***] with respect to [***].







	 	(i)	 	[***] effective [***] between OGX and [***] and [***] with respect to [***] and
Amendment thereto effective [***].







	 	(j)	 	[***] effective [***] between OGX and [***] at [***] and [***] with respect to
[***].







	 	(k)	 	[***] dated [***] between [***] at [***] in the style and cause of the [***]
and OGX with respect to [***] study.







	 	(l)	 	[***] effective [***] between OGX and [***] of [***] and [***] with respect to
[***].





 


19









 






	 	(m)	 	[***] effective [***] between OGX, [***] with respect to [***] together with
[***] effective [***].







	 	(n)	 	[***] effective [***] between OGX and [***] and [***] with respect to [***].







	 	(o)	 	[***] dated [***] between OGX and [***] and [***] with respect to protocol
[***].







	 	(p)	 	[***] dated [***] between OGX and [***] and [***] with respect to protocol
[***].







	 	(q)	 	[***] dated [***] between OGX and [***] regarding grant for OGX-011 together
with the [***] dated [***] which amends the schedule of payment together with the [***]
dated [***] which amends the terms set out in the [***] and [***]. The subject matter
of this [***] relate to [***], a [***] the [***] and [***] of OGX-011 in combination
with [***] in patients with [***], for which OGX has provided OGX-011 and the study
results have been publicly presented and provided to Teva.






9. Contract Research Agreement





	 	(a)	 	[***] dated [***] between [***] at [***] and OGX.







	 	(b)	 	[***] dated [***] between [***] at [***] and OGX.







	 	(c)	 	[***] effective [***] between [***], [***] and OGX regarding [***] an [***] to
evaluate [***] using [***] of OGX-011 in [***] and [***].







	 	(d)	 	[***] with [***] dated [***] regarding the development of a [***] to support a
[***] of an [***] product.






10. Clinical Agreements





	 	(a)	 	[***] with [***] and [***] for [***] effective [***] regarding [***].







	 	(b)	 	[***] with [***] and [***] for [***] effective [***] regarding [***].






11. CRO





	 	(a)	 	[***] for [***] and [***] effectively dated [***] between [***] and OGX
together with Amendment #1 dated [***].







	 	(b)	 	[***] effective [***] between [***] and OGX together with Statement of Work #1
regarding [***] and Statement of Work #2 for [***] dated [***].





 


20









 






	 	(c)	 	[***] with [***] Effective [***] regarding the application for [***] to [***]
terminating [***] together with [***] dated [***] for work to be completed by
approximately [***].







	 	(d)	 	[***] with [***] dated [***] regarding [***] together with Statement of Work
for [***] dated [***] and Statement of Work for [***].







	 	(e)	 	[***] with [***], together with non-binding Agreement in Principle dated [***].







	 	(f)	 	[***] dated [***] and [***] with [***], a division of [***] together with Scope
of Work No. 1 regarding [***] submission and Scope of Work No. 3 for [***] regarding
[***] operations.







	 	(g)	 	[***] with [***] regarding [***] and/or [***] services effective [***] together
with Work Order number [***].






12. Material Transfer Agreements




	 	 	 	 	 
	 	 	Date of	 	 
	Name of Party	 	Agreement	 	Research Project
	[***]

	 	[***]
	 	Analysis of [***] in [***] and [***] and its involvement in the
[***] of the [***]
	 
	 	 	 	 
	[***]

	 	[***]
	 	[***] evaluating the therapeutic potential of [***] for [***]
cancer [***] and similar mode systems).
	 
	 	 	 	 
	[***]

	 	[***]
	 	To evaluate in detail the potential of [***] in the modulation of
[***] of human [***] and [***] (revised [***])
	 
	 	 	 	 
	[***]

	 	[***]
	 	[***] study of the effects of [***] in [***]
	 
	 	 	 	 
	[***]

	 	[***]
	 	[***] and [***] of [***] in [***] with & w/o [***]
	 
	 	 	 	 
	[***]

	 	[***]
	 	Characterisation of [***] in [***]; Toxicity of [***] in [***];
Down-regulation of [***] expression by [***]; Uptake of [***] in
the [***]; [***] characterization of [***] expression.
	 
	 	 	 	 
	[***]

	 	[***]
	 	Determine whether [***] is able to [***] various [***] or [***],
using [***] and [***]. Determine biological significance of
combining [***] with [***] in [***] of [***].






 


21









 





	 	 	 	 	 
	 	 	Date of	 	 
	Name of Party	 	Agreement	 	Research Project
	[***]

	 	[***]
	 	[***] and control [***] into [***] to: (i) further confirm the
[***] and [***] of [***]; and (ii) test the molecular mechanisms of
[***] in [***].
	 
	 	 	 	 
	[***]

	 	[***]
	 	Evaluate if [***] of [***] obtained by treatment with [***] may
modify the response to [***] in [***].
	 
	 	 	 	 
	[***]

	 	[***]
	 	Assess influence of [***] in [***] & [***] by which [***] develops
against [***]
	 
	 	 	 	 
	[***]

	 	[***]
	 	Determine whether [***] can sensitize [***] to [***] and [***] in
[***] and [***]
	 
	 	 	 	 
	[***]

	 	[***]
	 	Investigating [***] and [***]in relation to [***] in [***] and [***]
	 
	 	 	 	 
	[***]

	 	[***]
	 	Experiment part of larger project involving [***] underlying [***].
As part of this, [***] of [***] is being explored
	 
	 	 	 	 
	[***]

	 	[***]
	 	Determine the effects of [***] on [***] in [***] after [***]
administration.
	 
	 	 	 	 
	[***]

	 	[***]
	 	The study will focus on the role of [***] during the [***] of a
[***]. [***] was [***] in [***] and may play a [***] during [***]
	 
	 	 	 	 
	[***]

	 	[***]
	 	Investigating role of [***] and [***] in the [***] of [***].
	 
	 	 	 	 
	[***]

	 	[***]
	 	Find out whether [***] will be [***] by [***].
	 
	 	 	 	 
	[***]

	 	[***]
	 	Study the [***] activity of [***] in combination with [***] such as
[***] and [***] such as [***] and whether [***] enhances the [***]
of [***].





 


22









 





10. Consulting Agreements





	 	(a)	 	Consulting Agreement with [***] dated [***] together with amendments dated
[***] and [***] regarding [***], [***] and [***].







	 	(b)	 	Consulting Agreement between [***] and OGX dated [***] regarding [***] and
[***], together with Consulting Amending Agreement dated [***] which extends term of
agreement for [***] and then renews on [***] basis.







	 	(c)	 	Consulting Agreement between [***] and OGX dated [***] which sets out the terms
for providing [***] and [***] services together with Consulting Amending Agreement
dated [***] which extends term of agreement for [***] and then renews on [***].







	 	(d)	 	Consulting Agreement as of [***] between [***] and OGX together with Consulting
Amending Agreement dated [***] and Second Consulting Amending Agreement dated [***]
which extends term of agreement for [***] and then renews on [***].







	 	(e)	 	Consulting Agreement dated [***] between [***] and OGX with respect to [***]
together with Consulting Amending Agreement dated [***]; Second Consulting Amending
Agreement; and Third Consulting Amending Agreement (terms expires [***]).







	 	(f)	 	Consulting Agreement with [***] for [***] effective [***] together with
Consulting Amending Agreement extending term until [***].







	 	(g)	 	Consulting Agreement with [***] for [***] effective [***] together with
Consulting Amending Agreement renewing until [***] and then automatically renews until
[***].







	 	(h)	 	Consulting Agreement with [***] effective [***] with respect to [***] together
with Consulting Amending Agreement dated [***]; and Second Consulting Amending
Agreement dated [***] extending term to [***].







	 	(i)	 	Consulting Agreement with [***] for [***] effective [***] together with
Consulting Amending Agreement dated [***] and Second Consulting Amending Agreement
dated [***] extending term until [***].







	 	(j)	 	Consulting Agreement with [***] dated [***] as [***] for [***]. Agreement
renews [***].





 


23









 






	 	(k)	 	Consulting Agreement with [***] dated [***] as [***] for [***]. Agreement
renews [***].







	 	(l)	 	Consulting Agreement with [***] as [***]. Agreement renews [***].







	 	(m)	 	Consulting Agreement with [***] dated [***] as [***]. Agreement renews [***].







	 	(n)	 	Consulting Agreement with [***] dated [***] as [***]. Agreement renews [***].







	 	(o)	 	Consulting Agreement effective [***] with [***] regarding [***] related to
[***]. ([***] term)







	 	(p)	 	Consulting Agreement effective [***] with [***] regarding [***] for [***] for
[***] together with Consulting Amending Agreement dated [***] terminating on [***].







	 	(q)	 	Consulting Agreement effective [***] with [***] together with First Amendment
to Consulting Agreement dated [***].







	 	(r)	 	Consulting Agreement with [***] effective [***] for a [***] term regarding
[***].







	 	(s)	 	Consulting Agreement with [***] effective [***] for [***] term.







	 	(t)	 	Consulting Agreement with [***] dated [***] for [***] term.







	 	(u)	 	Consulting Agreement with [***] dated [***] regarding [***] of [***] expires
[***].






11. [***] dated [***] regarding performing functions associated with [***] for a term of [***].



12. [***] dated [***] between OGX and [***]




[***]





Pre-Clinical




	 	(a)	 	[***] dated [***] between [***] and OGX. The Study(s) performed under this
[***] has been [***].







	 	(b)	 	[***] between [***] and OGX dated [***] which provides general terms related to
the provision of services for [***]. This agreement has [***] and is [***] due to
[***] in [***].







Drug Formulation




	 	(c)	 	[***] entered into as of [***] with [***] together with [***] letter dated
[***]. This agreement has [***] and is [***] due to [***] in [***].





 


24









 





Manufacturing





	 	(d)	 	Agreement dated [***] between [***] and [***] pursuant to which [***] of OGX’s
product, [***] will be conducted and to which OGX is responsible for [***] of [***]
associated thereto to [***]. This agreement has [***] and is [***] due to [***] in
[***].







	 	(e)	 	[***] between [***] and OGX commencing on the date of execution being [***]
with respect to the [***] for [***]. This agreement has [***] and is [***] due to
[***] in [***].







	 	(f)	 	[***] with [***] dated [***] now known as [***] (see [***]







Contract Research Agreement




	 	(g)	 	Collaborative Research Agreement dated [***] between OGX, [***] and [***] and
[***] pursuant to which the projects for [***] and [***]; [***] and [***]; [***] and
[***] are outlined AND Amendment #1 to the agreement dated [***]; Amendment #2 dated
[***]; Amendment #3 dated [***], Amendment #4 dated [***] and Amendment #5 dated [***].
This agreement has [***] and is [***] due to [***] in [***].





 


25









 





SCHEDULE 3.7




OUTLINE OF KEY PROVISIONS FOR

CO-PROMOTION AGREEMENT





	1)	 	Definitions. Capitalized terms used in this Schedule 3.7 and not otherwise defined
here, shall have the respective meanings set forth in the Agreement to which this Schedule is
attached. The following definitions are intended to be instructive only for purposes of this
outline, and the actual detailed definitions may be modified in the definitive Co-Promotion
Agreement as such agreement is negotiated by the Parties, provided that such actual
definitions shall be substantively equivalent to the definitions set forth below.







	 	a)	 	“Brand Management Team” means a team of individuals created, organized and
directed by Teva that manages, directs and leads activities relating to and supporting
branding for the Licensed Products in the U.S. and Canada (or such other functional group
as designated by Teva that manages substantially the same activities).







	 	b)	 	“Canadian Brand Management Team” means a team of individuals created, organized
and directed by Teva, that manages, directs and leads the sales representatives and
associated sales management teams for the promotion and sale of Licensed Products in
Canada, as well as the Medical Director and Medical Liaisons (or such other functional
group as designated by Teva that manages substantially the same activities).







	 	c)	 	“Medical Director” means an individual hired and employed by OGX to support
activities under the Co-Promotion Agreement, whose primary function is to provide a
rigorous scientific and medical foundation for widespread usage and acceptance of Licensed
Products in the U.S. and/or Canada; to foster relationships and partnerships with
scientific experts, professional organizations, and academic and clinical centers in the
U.S. and/or Canada; and to serve as an internal resource for Teva relating to the
professional education, and regulatory, training and commercial functions for Licensed
Products in the U.S. and/or Canada.







	 	d)	 	“Medical Liaison” is the Canadian equivalent of a PESM or such other
medical/education field-focused person as mutually agreed by the Parties.







	 	e)	 	“Professional Education Science Manager” or “PESM” means an individual,
hired and employed by OGX to support activities under the Co-Promotion Agreement, whose
primary function is to provide a scientific resource to the Parties, and to develop and
implement relevant scientific and clinical education programs, and foster successful
relationships with healthcare providers and managed care organizations, in support of the
Commercialization of Licensed Products in the U.S.





 


26









 






	2)	 	OGX Obligations. Pursuant to the Co-Promotion Agreement, OGX will, under the
direction of the Brand Management Team, conduct and/or be responsible for the following
Co-Promotion Activities (along with such marketing, advertising, detailing and operational
aspects as provided for in the US/Canadian Commercialization Plan):







	 	a)	 	OGX will provide [***] for the U.S. and Canadian markets ([***]) who will use
commercially reasonable efforts to carry out the functions, duties and responsibilities
contemplated by the Parties, as well as participating in all official meetings of the Brand
Management Team in which the Licensed Products will be discussed (or the part of such
meeting dedicated to Licensed Products).







	 	b)	 	OGX will provide a sufficient number of PESMs throughout the U.S. as set forth in the
US/Canadian Commercialization Plan and as reasonably necessary in order to carry out the
functions, duties and responsibilities contemplated by the Parties. The Parties
contemplate that initially there will be [***] PESMs.







	 	c)	 	OGX will use commercially reasonable efforts to provide a sufficient number of sales
representatives and associated sales managers in Canada to successfully Commercialize
Licensed Products in Canada (collectively, the “Canadian Sales Force”) in a manner and at a
level consistent with the relevant portion of the US/Canadian Commercialization Plan. All
such sales representatives and associated sales managers in Canada will be OGX employees
working under the guidance of Teva’s Canadian Brand Management Team.







	 	d)	 	OGX will provide a sufficient number of Medical Liaisons throughout Canada as set forth
in the US/Canadian Commercialization Plan and as reasonably necessary in order to carry out
the functions, duties and responsibilities contemplated by the Parties. The Parties
contemplate that initially there will be [***] Medical Liaisons.







	 	e)	 	OGX shall have the right to appoint one individual to act as an OGX representative
member of the Brand Management Team and one individual to act as an OGX representative
member of the Canadian Brand Management Team (or such other entities as determined by Teva
that perform substantially the same function), each of whom may be from the [***] or [***]
functions. Such OGX representative members may be appointed by OGX within [***] of the
Effective Date, and OGX may replace such members upon written notice to Teva; provided,
however, that if OGX does not timely exercise the Co-Promotion Option, the OGX
representative member may be removed from the Brand Management Team and Canadian Brand
Management Team by Teva, and OGX shall no longer have the right to appoint or retain an OGX
representative member on the Brand Management Team or Canadian Brand Management Team.





 


27









 






	3)	 	Teva Obligations. Pursuant to the Co-Promotion Agreement, Teva will provide and
otherwise be responsible for the following:







	 	a)	 	Teva shall provide regulatory support, copy approval, sales and promotional materials,
field based sales training, distribution management support, and other similar managerial
and administrative support for the promotion and Commercialization of Licensed Products in
the U.S. and Canada as Teva considers reasonably necessary.







	 	b)	 	Teva shall provide OGX, in accordance with Teva’s normal annual workplan development
timeline, updates of the US/Canadian Commercialization Plan.







	 	c)	 	Teva shall compensate OGX for the Medical Directors, PESMs, Medical Liaisons and all
members of the Canadian Sales Force, on an FTE basis at [***] not to exceed [***], such
rate to be adjusted based on [***] of such employees’ efforts being allocated to promotion
of the Licensed Products.







	 	d)	 	Teva shall compensate OGX for reasonable travel expenses to attend sales training
meetings and sales meetings called by or at the direction of Teva, in accordance with
Teva’s travel policies then in place.







	4)	 	Activities Under Teva’s Direction and Control. All functions and activities carried
out under the Co-Promotion Agreement shall be under the direction and control of Teva, and
shall be governed or guided in accordance with all commercial plans, strategies, guidelines
and other policies established or adopted by Teva, from time to time, in Teva’s commercially
reasonable discretion.







	5)	 	Costs and Expenses. Except as expressly provided in Section 3 above, any costs and
expenses incurred by OGX under the Co-Promotion Agreement shall be its responsibility.
Notwithstanding anything to the contrary, under no circumstances shall Teva be responsible for
any start-up costs or expenses incurred by OGX in support of recruiting and hiring personnel
necessary for OGX to carry out its Co-Promotion Activities; all such costs and expenses shall
be borne by OGX.







	6)	 	Other Provisions. Detailed definitions, termination provisions, representations,
warranties and other covenants and provisions typical for similar co-promotion agreements, all
to be commercially reasonable, will be negotiated in good faith by the Parties and
incorporated in the definitive Co-Promotion Agreement.





 


28









 





SCHEDULE 4.1




MILESTONE FEES




	 	 	 	 	 
	Upfront Fees
	 	 	 	 
	 
	 	 	 	 
	(a)

	 	Upfront Payment by December 24,
2009 (close of business Israel
time):
	 	$20 million
	 
	 	 	 	 
	(b)

	 	Advanced Reimbursement by December
24, 2009 (close of business Israel
time):
	 	$30 million
	 
	 	 	 	 
	Development 

Milestones
	 	 	 	 
	 
	 	 	 	 
	 

	 	For first-line CRPC:	 	 
	 
	 	 	 	 
	(c)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(d)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(e)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(f)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	 

	 	For second-line CRPC:	 	 
	 
	 	 	 	 
	(g)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(h)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(i)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(j)

	 	[***]
	 	$[***]






 


29









 





	 	 	 	 	 
	 

	 	For non-small cell lung cancer:	 	 
	 
	 	 	 	 
	(k)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(l)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(m)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(n)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	 

	 	For [***] additional indications (other than
CRPC and non-small cell lung cancer) approved
for investigation by the JSC:	 	 
	 
	 	 	 	 
	(o)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(p)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(q)

	 	[***]
	 	$[***]
	 
	 	 	 	 
	(r)

	 	[***]
	 	$[***]





 


30









 





SCHEDULE 4.2




ROYALTIES




	 	 	 	 	 
	Ongoing 

Royalties

	 	Aggregated for all Licensed Products throughout Territory	 	 
	 
	 	 	 	 
	(i)

	 	On the portion of aggregate annual Net Sales ≤$[***]:
	 	[***]%
	 
	 	 	 	 
	(ii)

	 	On the portion of aggregate annual Net Sales >$[***]
but ≤[***]:
	 	[***]%
	 
	 	 	 	 
	(iii)

	 	On the portion of aggregate annual Net Sales >$[***]
but ≤$[***]:
	 	[***]%
	 
	 	 	 	 
	(iv)

	 	On the portion of aggregate annual Net Sales
>$[***]but ≤$[***]:
	 	[***]%
	 
	 	 	 	 
	(v)

	 	On the portion of aggregate annual Net Sales >$[***]:
	 	[***]%
	 
	 	 	 	 
	One Time 

Sales 

Threshold 

Royalties
	 	 	 	 
	 
	 	 	 	 
	(vi)

	 	Upon the first occurrence of aggregate annual Net
Sales of $[***] in a Calendar Year:
	 	One-time royalty of
[***]% of Net Sales
of $[***]
	 
	 	 	 	 
	(vii)

	 	Upon the first occurrence of aggregate annual Net
Sales of $[***] in a Calendar Year:
	 	One-time royalty of
[***]% of Net Sales
of $[***]
	 
	 	 	 	 
	(viii)

	 	Upon the first occurrence of aggregate annual Net
Sales of $[***] in a Calendar Year:
	 	One-time royalty of
[***]% of Net Sales
of $[***]





 


31









 





Each of the royalty rates set forth in subclauses (i) through (v) above in this Schedule 4.2, but
solely for the applicable country or region (as provided below) shall be lowered by [***]
percentage points (e.g., if a particular affected royalty rate is [***]%, it would be lowered to
[***]%) for all Net Sales of any Licensed Product sold in the applicable country or region, in the
following circumstances: (i) for Net Sales of Licensed Products sold in [***] prior to Regulatory
Approval of such Licensed Product by the [***] for any [***] in [***] patient populations (e.g.,
[***] and [***]); (ii) for Net Sales of Licensed Products sold in [***] prior to Regulatory
Approval of such Licensed Product by the [***] for any [***] in [***] patient populations; or (iii)
for Net Sales of Licensed Products sold in [***] prior to Regulatory Approval of such Licensed
Product by the [***] for any [***] in [***] patient populations. Notwithstanding the number of
[***] approved by the [***], [***] or the [***], no reduction in royalties will be applied after
the first Calendar Year that aggregate annual Net Sales of Licensed Products exceed $[***]. In
addition, no such reduction shall be applied at any time in any country outside the [***], [***] or
[***].


 


32









 





SCHEDULE 4.3




DEVELOPMENT EXPENSES INCURRED

PRIOR TO EFFECTIVE DATE




	 	 	 	 	 
	 	 	 	 	Amount Paid
	Activity	 	Vendor	 	to [***]
	 
	 	 	 	 
	[***]
	 	 	 	 
	[***]
	 	 	 	 
	Manufacture of ~ [***] of API
	 	[***]	 	[***]
	Drug Product fill /finish of [***] API
	 	[***]	 	[***]
	Release testing for DP and placebo
	 	[***]	 	[***]
	Stability studies DP and Placebo — [***]
	 	[***]	 	[***]
	Placebo Manufacture
	 	[***]	 	[***]
	 
	 	 	 	 
	Vials — min [***]
	 	[***]	 	[***]
	Media Fill
	 	[***]	 	[***]
	[***] method transfer/Qualification (DP and API)
	 	[***]	 	[***]
	[***]
	 	[***]	 	[***]
	 
	 	 	 	 
	[***]
	 	 	 	 
	Development [***] batch [***]
	 	[***]	 	[***]
	Development [***] batch [***]
	 	[***]	 	[***]
	Raw materials for [***]
	 	[***]	 	[***]
	Raw materials for [***]
	 	[***]	 	[***]
	Manufacture ~[***]
	 	[***]	 	[***]
	Procurement and qualification of [***]
	 	[***]	 	[***]
	Stability Studies API
	 	[***]	 	[***]
	[***] study API first manufacture [***]
	 	[***]	 	[***]
	Drug Product fill /finish of [***]
	 	[***]	 	[***]
	Release testing for DP and placebo
	 	[***]	 	[***]
	Stability studies DP and Placebo — [***]
	 	[***]	 	[***]
	 
	 	 	 	 
	[***] Studies
	 	 	 	 
	 
	 	 	 	 
	Develop an [***]
	 	[***]	 	[***]
	Validation of [***]
	 	[***]	 	[***]
	[***] Study
	 	[***]	 	[***]
	[***] Study
	 	[***]	 	[***]
	 
	 	 	 	 
	[***]
	 	 	 	 
	 
	 	 	 	 
	[***]
	 	[***]	 	[***]
	[***]
	 	[***]	 	[***]
	[***]
	 	[***]	 	[***]
	[***] System Setup
	 	[***]	 	[***]
	[***] system setup
	 	[***]	 	[***]
	[***],[***]and [***]
	 	[***]	 	[***]
	[***]
	 	[***]	 	[***]
	[***] Submission Consulting
	 	[***]	 	[***]
	[***] Registration
	 	[***]	 	[***]
	 
	 	 	 	 
	 
	 	 	 	 
	[***]
	 	 	 	[***]
	 
	 	 	 	 





 


33









 





SCHEDULE 4.5




STOCK PURCHASE AGREEMENT



 


34









 





STOCK PURCHASE AGREEMENT




This STOCK PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of
December 20, 2009 (the “Effective Date”), by and between OncoGenex Pharmaceuticals, Inc., a
Delaware corporation (the “Company”), and Teva Pharmaceutical Industries Limited, a limited
liability company incorporated under the laws of Israel (the “Purchaser”).



Recitals




The Company and the Purchaser are executing and delivering this Agreement in reliance upon the
exemption from securities registration afforded by Section 4(2) under the Securities Act of 1933,
as amended (the “1933 Act”), and the provisions of Regulation D, as promulgated by the U.S.
Securities and Exchange Commission (the “SEC”) under the 1933 Act.



The Purchaser wishes to purchase, and the Company wishes to sell and issue to the Purchaser,
upon the terms and subject to the conditions stated in this Agreement, 267,531 shares (the
“Shares”) of its common stock, par value $0.001 per share (the “Common Stock”), for
cash consideration of Ten Million United States Dollars (the “Purchase Price”).



Contemporaneous with the execution and delivery of this Agreement, the Purchaser and OncoGenex
Technologies Inc., a wholly-owned subsidiary of the Company (“OTI”), are executing a License and
Co-Development Agreement (the “License and Co-Development Agreement”).



Agreement




NOW, THEREFORE, in consideration of the mutual representations, warranties and covenants
contained in this Agreement, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Company and the Purchaser agree as follows:



1. DEFINITIONS. IN ADDITION TO THOSE TERMS DEFINED ABOVE AND ELSEWHERE IN THIS AGREEMENT,
FOR THE PURPOSES OF THIS AGREEMENT, THE FOLLOWING TERMS SHALL HAVE THE MEANINGS HEREIN SET FORTH:



1.1 “1934 Act” means the Securities Exchange Act of 1934, as amended.



1.2 “Affiliate” means, with respect to any Person, any other Person that directly or
indirectly through one or more intermediaries controls, is controlled by or is under common control
with, such Person, as such terms are used in and construed under Rule 144 under the 1933 Act.



1.3 “Beneficially Own” has the meaning set forth in the Company’s Amended and Restated
Rights Agreement dated July 24, 2002, as amended.



1.4 “Business Day” means any day other than Saturday, Sunday or any other day on which
commercial banks in the City of New York are authorized or required by law to remain closed.


 


35









 





1.5 “Closing” means the closing of the purchase and sale of the Shares pursuant to
Section 2.1.



1.6 “IP Rights” means all vested, contingent and future intellectual property rights
including, but not limited to: (a) all inventions, compounds, compositions, substances, methods,
processes, techniques, know-how, technology, data, information, discoveries and other results of
whatsoever nature, and any patents, copyrights, proprietary intellectual or industrial rights
directly or indirectly deriving therefrom, as well as provisionals, patent applications (whether
pending or not), and patent disclosures together with all reissuances, continuations, continuations
in part, revisions, extensions, and reexaminations thereof; (b) all trademarks, service marks,
copyrights, designs, trade styles, logos, trade dress and corporate names, including all goodwill
associated therewith; (c) any work of authorship, regardless of copyrightability, all compilations,
all copyrights and (d) all trade secrets, confidential information and proprietary processes.



1.7 “knowledge of the Company” means the actual knowledge of Scott Cormack and Stephen
Anderson.



1.8 “Lien” means any lien, charge, claim, security interest, encumbrance, right of
first refusal or other restriction.



1.9 “Material Adverse Effect” means a material adverse effect on (a) the condition
(financial or otherwise), business, assets or results of operations of the Company, taken as a
whole, (b) the Company’s ability to perform any of its obligations under the terms of the
Transaction Documents in any material respect, or (c) the rights and remedies of the Purchaser
under the Transaction Documents; provided, however, that in determining whether a Material Adverse
Effect has occurred, any effect to the extent attributable to the following will not be considered:
(i) a change in the Company’s stock price; (ii) a material adverse effect resulting from an event,
occurrence or condition disclosed to the Purchaser in the Transaction Documents; (iii) the
announcement of the Transaction Documents; and (iv) any changes resulting from general economic or
market conditions or conditions affecting the biotechnology or biopharmaceutical industry in
general.



1.10 “Person” means an individual, corporation, partnership, limited liability
company, trust, business trust, association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, governmental authority or any other form of
entity not specifically listed herein.



1.11 “Subsidiaries” means any Person in which the Company, directly or indirectly,
owns capital stock or holds an equity or similar interest.



1.12 “Trading Market” means any of the New York Stock Exchange, the NYSE Amex, the
NASDAQ Global Select Market, the NASDAQ Global Market, the NASDAQ Capital Market or the
Over-the-Counter Bulletin Board, or any other national securities exchange, market or trading or
quotation facility on which the Common Stock is then listed or quoted.



1.13 “Transaction Documents” means this Agreement, the License and Co-Development
Agreement and any other agreement entered into, now or in the future, by the Company in connection
with this Agreement or any of the other Transaction Documents.


 


36









 





1.14 List of Additional Definitions. The following is a list of additional terms used
in this Agreement and a reference to the Section hereof in which such term is defined:



	 	 	 
	Term	 	Section
	Agreement

	 	Preamble
	Closing Date

	 	2.2 
	Common Stock

	 	Recitals
	Company

	 	Preamble
	Effective Date

	 	Preamble
	License and Co-Development Agreement

	 	Recitals
	OTI

	 	Recitals
	Purchaser

	 	Preamble
	Purchase Price

	 	Recitals
	Reports

	 	3.9 
	SEC

	 	Recitals
	Shares

	 	Recitals
	1933 Act

	 	Recitals






2. PURCHASE AND SALE OF SHARES.




2.1 Purchase of Shares. Subject to the terms and conditions of this Agreement and on
the basis of the representations and warranties made herein, at the Closing the Company hereby
agrees to sell and issue to the Purchaser, and the Purchaser hereby agrees to purchase from the
Company, the Shares for Purchase Price.



2.2 Time and Place of Closing. The Closing and delivery of all items to be delivered
hereunder shall take place at the offices of Loeb & Loeb LLP, 345 Park Avenue, New York, New York
10154, or by electronic means, on (i) Thursday, December 24, 2009, provided that each of the
conditions to the obligations of the parties to consummate the transaction contemplated hereby have
been satisfied, or (ii) if such conditions have not been satisfied as of Thursday, December 24,
2009, the second Business Day after the date on which each of the conditions to the obligations of
the parties to consummate the transaction contemplated hereby have been satisfied (such date, the
“Closing Date”).



2.3 Closing Deliveries.



(a) At the Closing, the Company shall deliver or cause to be delivered to the Purchaser the
following:




(i) a true and correct copy of the irrevocable instructions delivered by the Company as
of the Closing Date to its transfer agent, directing the transfer agent to deliver to
Purchaser a stock certificate, free and clear of all restrictive legends (except as
expressly provided in Sections 5.1(a) and (b)), evidencing the Shares, registered in the
name of the Purchaser;


 


37









 






(ii) the executed License and Co-Development Agreement; and




(iii) any other documents reasonably requested by the Purchaser or its counsel in
connection with the Closing, including, without limitation, certified copies of the
Company’s certificate of incorporation, certificates of good standing and customary
officers’ and secretary’s certificates.



(b) At the Closing, the Purchaser shall deliver or cause to be delivered to the Company the
following:



(i) the Purchase Price, by wire transfer of immediately available funds to the account of the
Company; and




(ii) the executed License and Co-Development Agreement.




2.4 Conditions to Closing.



(a) Conditions Precedent to the Obligations of the Purchaser. The obligation of the
Purchaser to acquire the Shares at the Closing is subject to the satisfaction or waiver by the
Purchaser, at or before the Closing, of each of the following conditions:




(i) Representations and Warranties. The representations and warranties of the
Company contained in the Transaction Documents shall be true and correct in all material
respects as of the date when made and as of the Closing Date as though made on and as of
such date;




(ii) Performance. The Company shall have performed, satisfied and complied in
all material respects with all covenants, agreements and conditions required by the
Transaction Documents to be performed, satisfied or complied with by it at or prior to the
Closing;




(iii) No Injunction. No statute, rule, regulation, executive order, decree,
ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court
or governmental authority of competent jurisdiction that prohibits the consummation of any
of the transactions contemplated by the Transaction Documents; and




(iv) No Material Adverse Effect. Since the date of execution of this Agreement,
no event or series of events shall have occurred that would reasonably be expected to have
or result in a Material Adverse Effect.



(b) Conditions Precedent to the Obligations of the Company. The obligation of the
Company to sell the Shares at the Closing is subject to the satisfaction or waiver by the Company,
at or before the Closing, of each of the following conditions:




(i) Representations and Warranties. The representations and warranties of the
Purchaser contained in the Transaction Documents shall be true and correct in all material
respects as of the date when made and as of the Closing Date as though made on and as of
such date;


 


38









 






(ii) Performance. Purchaser shall have performed, satisfied and complied in all
material respects with all covenants, agreements and conditions required by the Transaction
Documents to be performed, satisfied or complied with by it at or prior to the Closing;




(iii) No Injunction. No statute, rule, regulation, executive order, decree,
ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court
or governmental authority of competent jurisdiction that prohibits the consummation of any
of the transactions contemplated by the Transaction Documents; and




(iv) the Closing shall not violate the 1933 Act or any other applicable securities
laws, or the rules or regulations of the applicable Trading Market.



3. REPRESENTATIONS AND WARRANTIES OF THE COMPANY. THE COMPANY HEREBY MAKES THE FOLLOWING
REPRESENTATIONS AND WARRANTIES TO THE PURCHASER. IN ADDITION, THE PARTIES ACKNOWLEDGE AND AGREE
THAT AS A FURTHER INDUCEMENT FOR THE PURCHASER TO ENTER INTO THIS AGREEMENT AND TO PURCHASE THE
SHARES HEREUNDER, THE COMPANY’S REPRESENTATIONS AND WARRANTIES UNDER THE LICENSE AND
CO-DEVELOPMENT AGREEMENT ARE INCORPORATED HEREIN BY REFERENCE.



3.1 Subsidiaries. The Company’s only Subsidiary is OTI. The Company owns (either
directly or indirectly) beneficially and of record all of the issued and outstanding capital stock
of its Subsidiary, free and clear of all Liens (other than transfer restrictions under applicable
securities laws), pledges, options, agreements or limitations on the Company’s or such other
Subsidiary’s voting rights, and does not own an equity interest in any other corporation,
partnership or entity other than OTI. The Company’s former Subsidiary, OncoGenex, Inc., a
Washington corporation, has been dissolved.



3.2 Organization and Good Standing. The Company and its Subsidiary are validly
existing and in good standing under the laws of the State of Delaware and under the federal laws of
Canada, respectively, and have all requisite power and authority to carry on their businesses as
presently conducted and to own and use their properties and assets. The Company and its Subsidiary
are authorized to conduct business as foreign corporations and are in good standing in each
jurisdiction where the conduct of their businesses or their ownership of property requires such
qualification, except where the failure to be so qualified and in good standing would not,
individually or in the aggregate, reasonably be expected to have or result in a Material Adverse
Effect.



3.3 Authorization; Enforcement. The Company has the requisite corporate power and
authority to enter into and to consummate the transactions contemplated by each of the Transaction
Documents and otherwise to carry out its obligations hereunder and thereunder. The execution and
delivery of each of the Transaction Documents by the Company and the consummation by it of the
transactions contemplated hereunder and thereunder have been duly authorized by all necessary
action on the part of the Company and no further action is required by the Company in connection
therewith. Each Transaction Document has been (or upon delivery will have been) duly executed by
the Company and, when delivered in accordance with
the terms hereof, will constitute the legal, valid and binding obligation of the Company
enforceable against the Company in accordance with its terms.


 


39









 





3.4 No Conflicts. The execution, delivery and performance of the Transaction Documents
by the Company and the consummation by the Company of the transactions contemplated hereby and
thereby do not and will not (a) conflict with or violate any provision of the Company’s certificate
of incorporation, bylaws or other organizational or charter documents, (b) conflict with, or
constitute a default (or an event that with notice or lapse of time or both would become a default)
under, or give to others any rights of termination, amendment, acceleration or cancellation (with
or without notice, lapse of time or both) of, any agreement, credit facility, debt or other
instrument (evidencing a Company debt or otherwise) or other understanding to which the Company is
a party or by which any property or asset of the Company is bound or affected, or (c) result in a
violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of
any court or governmental authority to which the Company is subject (assuming the accuracy of the
Purchaser’s representations and warranties and compliance by the Purchaser with its respective
covenants as set forth in this Agreement), including federal and state securities laws and
regulations and the rules and regulations of any self-regulatory organization to which the Company
or its securities are subject, or by which any property or asset of the Company is bound or
affected.



3.5 Issuance of the Shares. The Shares have been duly authorized and, when issued and
paid for in accordance with the terms of this Agreement, will be validly issued, fully paid and
nonassessable, free and clear of all Liens imposed by the Company other than restrictions on
transfer provided for in this Agreement and, provided that the Purchaser at all times will
Beneficially Own less than 15% of the outstanding shares of common stock of the Company, shall not
be subject to preemptive or similar rights. Assuming the validity of the Purchaser’s
representations and warranties contained in Section 4, the offer, issuance and sale of the
Shares to the Purchaser pursuant to this Agreement is exempt from registration requirements of the
1933 Act.



3.6 Capitalization. The aggregate number of shares and type of all authorized, issued
and outstanding capital stock, options and other securities of the Company and its Subsidiary
(whether or not presently convertible into or exercisable or exchangeable for shares of capital
stock of the Company) is set forth in Schedule 3.6. All of the outstanding shares of
capital stock of the Company and its Subsidiary are duly authorized, validly issued, fully paid and
nonassessable and have been issued in compliance with all applicable securities laws. Except as set
forth in Schedule 3.6, there are no options, warrants, convertible securities,
subscriptions, stock appreciation rights, phantom stock plans or stock equivalents or other rights,
agreements, arrangements or commitments (contingent or otherwise) of any character issued or
authorized by the Company or its Subsidiary relating to the issued or unissued capital stock of the
Company or its Subsidiary or obligating the Company or its Subsidiary to issue or sell any shares
of capital stock of, or options, warrants, convertible securities, subscriptions or other equity
interests in, the Company or its Subsidiary.



3.7 Absence of Litigation. Except as set forth in Schedule 3.7, there is no
action, suit, inquiry, notice of violation, proceeding or investigation pending or, to the
knowledge of the Company, threatened against or affecting the Company, any of the Company’s
officers or directors in their capacities as such and any of the Company’s properties before or by
any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state,
county, local or foreign) which (a) adversely affects or challenges the legality, validity or
enforceability of any of the Transaction Documents or the Shares or (b) could, if there were an
unfavorable decision, individually or in the aggregate, have or result in a Material Adverse
Effect. No judgment, injunction, writ, award, decree or order has been issued by any court or other
governmental authority against the Company.


 


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3.8 Reporting Company. The Company is a publicly held company subject to reporting
obligations pursuant to Section 13 of the 1934 Act and has a class of common equity registered
pursuant to Section 12(b) of the 1934 Act.



3.9 Information Concerning Company. The Company’s Form 10-K for the year ended
December 31, 2008 as filed with the SEC, together with all subsequently filed Forms 10-Q and 8-K,
and all other filings made with the SEC since August 21, 2008 (collectively, the
“Reports”) contain all material information relating to the Company and its operations and
financial condition as of their respective dates that is required to be disclosed therein. Since
December 31, 2008, there has not been a Material Adverse Effect. The Reports do not contain any
untrue statement of a material fact or omit to state a material fact required to be stated therein
or necessary to make the statements therein not misleading in light of the circumstances under
which they were made.



3.10 Compliance. The Company (i) is not in default under or in violation of (and no
event has occurred that has not been waived that, with notice or lapse of time or both, would
result in a default by the Company under), nor has the Company received notice of a claim that it
is in default under or that it is in violation of, any indenture, loan or credit agreement or any
other agreement or instrument to which it is a party or by which it or any of its properties is
bound (whether or not such default or violation has been waived), (ii) is not in violation of any
order of any court, arbitrator or governmental body, or (iii) is not, nor has it been in the past
in violation of any statute, rule or regulation of any governmental authority, including without
limitation all foreign, federal, state and local laws relating to taxes, environmental protection,
occupational health and safety, product quality and safety and employment and labor matters, except
in each case as would not reasonably be expected to have a Material Adverse Effect.



3.11 Transactions with Affiliates and Employees. None of the officers or directors of
the Company, nor any of the employees of the Company, is presently a party to any transaction with
the Company (other than for services as employees, officers and directors), including any contract,
agreement or other arrangement providing for the furnishing of services to or by, providing for
rental of real or personal property to or from, or otherwise requiring payments to or from any
officer, director or such employee or, to the knowledge of the Company, any entity in which any
officer, director, or any such employee has a substantial interest or is an officer, director,
trustee or partner.



3.12 Title to Assets. The Company has valid title to or leasehold rights for all real
property that is material to the business of the Company and good and marketable title in all
personal property owned by it that is material to the business of the Company, in each case free
and clear of all Liens, except for Liens disclosed in Schedule 3.12. Any real property and
facilities held under lease by the Company are held by it under valid, subsisting and enforceable
leases of which the Company is in compliance.


 


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3.13 Company Employees. To the best knowledge of the Company, none of its respective
employees, officers, directors, agents or consultants is (i) subject to confidentiality
restrictions in favor of any third Person the breach of which could subject the Company to any
liability, or (ii) obligated under any contract (including licenses, covenants or commitments of
any nature) or other agreement, or subject to any judgment, decree or order of any court or
administrative agency, that would interfere with their duties to the Company or that would conflict
with the Company’s business as presently proposed to be conducted. Each employee and officer of and
consultant to the Company has executed a proprietary information and inventions agreement (a
standard form of which has been provided to Purchaser). The Company does not use or rely on any IP
Rights made or developed by any current or former employee or officer of or consultant to the
Company prior to his or her employment or relationship with the Company that have not been assigned
or licensed to the Company.



3.14 Registration Rights. Except as described in Schedule 3.14, the Company
has not granted or agreed to grant to any Person any rights to have any securities of the Company
registered with the SEC or any other governmental authority that have not been satisfied or waived.



3.15 Disclosure. All disclosures provided to the Purchaser regarding the Company, its
business and the transactions contemplated hereby (including the Schedules to this Agreement)
furnished by or on behalf of the Company are true and correct in all material respects and do not
contain any untrue statement of a material fact or omit to state a material fact required to be
stated therein or necessary to make the statements therein not misleading in light of the
circumstances under which they were made. Except for the transactions contemplated by the
Transaction Documents, no material event or circumstance has occurred, and no information exists
with respect to the Company or its business, properties, prospects, operations or financial
conditions, that, under applicable law, rule or regulation, requires public disclosure or
announcement by the Company on or prior to the date hereof but which has not been so publicly
announced or disclosed.



4. REPRESENTATIONS AND WARRANTIES OF THE PURCHASER. THE PURCHASER HEREBY MAKES THE
FOLLOWING REPRESENTATIONS AND WARRANTIES TO THE COMPANY.



4.1 Organization: Authority. The Purchaser is an entity duly organized, validly
existing and in good standing under the laws of the State of Israel. The Purchaser has the
requisite corporate power and authority to enter into and to consummate the transactions
contemplated by the Transaction Documents to which it is a party and otherwise to carry out its
obligations hereunder and thereunder. The execution, delivery and performance by the Purchaser of
the Transaction Documents to which it is a party have been duly authorized by all necessary action
on the part of the Purchaser. Each Transaction Document to which the Purchaser is a party has been
(or upon delivery will have been) duly executed by the Purchaser and, when delivered by the
Purchaser in accordance with terms hereof, will constitute the valid and legally binding
obligations of the Purchaser, enforceable against it in accordance with its terms.


 


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4.2 No Conflicts. The execution, delivery and performance of the Transaction Documents
by the Purchaser and the consummation by the Purchaser of the transactions contemplated hereby and
thereby do not and will not (a) conflict with or violate any provision of
the Purchaser’s certificate of incorporation, bylaws or other organizational or charter
documents, (b) conflict with, or constitute a default (or an event that with notice or lapse of
time or both would become a default) under, or give to others any rights of termination, amendment,
acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement,
credit facility, debt or other instrument (evidencing a Purchaser debt or otherwise) or other
understanding to which the Purchaser is a party or by which any property or asset of the Purchaser
is bound or affected, or (c) result in a violation of any law, rule, regulation, order, judgment,
injunction, decree or other restriction of any court or governmental authority to which the
Purchaser is subject (assuming the accuracy of the Company’s representations and warranties and
compliance by the Company with its respective covenants as set forth in this Agreement), including
federal and state securities laws and regulations and the rules and regulations of any
self-regulatory organization to which the Purchaser or its securities are subject, or by which any
property or asset of the Purchaser is bound or affected.



4.3 The Purchaser’s Status. At the time the Purchaser was offered the Shares, it was,
and at the date hereof it is: an “accredited investor” as defined in Rule 501(a) under the 1933
Act. The Purchaser is not a broker-dealer, or required to be registered as a broker-dealer, under
Section 15 of the 1934 Act.



4.4 Investor as Principal. The Purchaser is purchasing the Shares as principal, the
acquisition cost of the Shares to the Purchaser is not less than CDN$150,000 paid in cash at
Closing and the Purchaser was not created or used solely to purchase or hold the Shares in reliance
on the exemptions from the prospectus and dealer registration requirements in Sections 2.10(1) and
3.10(1) of National Instrument 45-106 of the Canadian Securities Administrators.



4.5 Experience of the Purchaser. The Purchaser, either alone or together with its
representatives, has such knowledge, sophistication and experience in business and financial
matters so as to be capable of evaluating the merits and risks of the prospective investment in the
Shares, and has so evaluated the merits and risks of such investment, and the Purchaser has had
available such information with respect to the Company as the Purchaser deems necessary or
appropriate to make such evaluation and an informed investment decision with respect thereto. The
Purchaser is able to bear the economic risk of an investment in the Shares and, at the present
time, is able to afford a complete loss of such investment.



4.6 Investment Decision. Purchaser’s decision to purchase the Shares was based solely
upon the representations and warranties set forth herein, and the Purchaser has not relied upon any
other information or representations made by or on behalf of the Company.



4.7 General Solicitation. The Purchaser is not purchasing the Shares as a result of
any advertisement, article, notice or other communication regarding the Shares published in any
newspaper, magazine or similar media or broadcast over television or radio or presented at any
seminar or any other general solicitation or general advertisement.



4.8 No Public Sale or Distribution; Investment Intent. The Purchaser is acquiring the
Shares in the ordinary course of business for its own account for investment purposes only and not
with a view towards, or for resale in connection with, the public sale or distribution thereof, and
the Purchaser does not have a present intention nor a present arrangement to effect any
distribution of the Shares to or through any Person or entity; provided, however, that by making
the representations herein, the Purchaser is not agreeing to hold any of the Shares for any
minimum or other specific term and reserves the right to dispose of the Shares at any time in
accordance with or pursuant to an effective registration statement or an exemption under the 1933
Act and other applicable securities laws.


 


43









 





4.9 Other Applicable Securities Laws. The acquisition of the Shares by, and the
issuance and delivery of the Shares to, the Purchaser does not and will not contravene any of the
applicable laws in the jurisdiction in which the Purchaser resides and does not give rise to any
obligation of the Company to prepare and file a registration statement, prospectus or similar
document or to register any of the Shares, or to be registered with or to file any report or notice
with or obtain any approval from any governmental or regulatory authority in such jurisdiction.



4.10 Beneficial Ownership of Company Securities. Taking into effect the transactions
contemplated hereby, the Purchaser will, upon Closing, Beneficially Own less than 15% of the
outstanding shares of common stock of the Company.



5. COVENANTS AND AGREEMENTS.





5.1 Transfer Restrictions.



(a) Until such time as the resale of the Shares may be registered under the 1933 Act or such
time as the Shares may be transferred pursuant to the provisions of Rule 144 under the 1933 Act, to
the extent applicable, each certificate or other document evidencing any of the Shares shall be
endorsed with the legend set forth below, and the Purchaser covenants that, except to the extent
such restrictions are waived by the Company, the Purchaser shall not transfer the Shares
represented by any such certificate, other than to its Affiliates in compliance with applicable
securities laws to the satisfaction of the Company, acting reasonably, without complying with the
restrictions on transfer described in the following legend endorsed on such certificate:




THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE
“SECURITIES ACT”) OR ANY STATE SECURITIES LAWS IN RELIANCE UPON AN EXEMPTION FROM
REGISTRATION UNDER THE SECURITIES ACT, AND, ACCORDINGLY, MAY NOT BE OFFERED, SOLD,
TRANSFERRED OR OTHERWISE DISPOSED OF UNLESS REGISTERED UNDER THE SECURITIES ACT AND UNDER
APPLICABLE STATE SECURITIES LAWS OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A
TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN
COMPLIANCE WITH APPLICABLE STATE SECURITIES OR BLUE SKY LAWS. THE COMPANY MAY REQUIRE AN
OPINION OF COUNSEL REASONABLY SATISFACTORY TO THE COMPANY TO THE EFFECT THAT ANY PROPOSED
OFFER, SALE, TRANSFER OR OTHER DISPOSITION IS IN COMPLIANCE WITH THE SECURITIES ACT AND ANY
APPLICABLE STATE SECURITIES LAWS.


 


44









 





Any such legend may be removed if the Purchaser delivers to the Company or its transfer agent the
certificate(s) evidencing the Shares together with an opinion of counsel reasonably satisfactory to
the Company and its transfer agent to the effect that such legend is not required
under applicable requirements of the 1933 Act (including judicial interpretations and
pronouncements issued by the Staff of the SEC) and state securities laws. Following such time, the
Company will use commercially reasonable efforts to deliver or cause to be delivered to the
Purchaser a certificate representing the Shares that is free from all restrictive and other
legends.



(b) The certificates representing the Shares will bear, as of the Closing Date, a legend
substantially in the following form and with the necessary information inserted:




UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE
THE SECURITY BEFORE                     , 2010. <INSERT DATE THAT IS FOUR (4) MONTHS AND ONE
(1) DAY AFTER THE CLOSING DATE>



5.2 Listing or Quotation of Shares. At such time as the Shares are eligible to be
traded on the Trading Market, the Company shall, to the extent required under the rules and
regulations of the applicable Trading Market, (i) in the time and manner required by the Trading
Market, prepare and file with the Trading Market an additional shares listing application or other
required notification covering all of the Shares issued or issuable under the Transaction
Documents, (ii) take all steps necessary to cause such Shares to be approved or designated for
listing or quotation on the Trading Market as soon as possible thereafter, (iii) provide to the
Purchasers evidence of such listing or quotation, and (iv) as long as the Company’s Common Stock is
listed or quoted on the Trading Market, maintain the listing or quotation of such Shares on the
Trading Market.



5.3 Reports and Filing. Upon execution of this Agreement, the Company shall fully
cooperate with the Purchaser in preparing, drafting and filing the reports the Purchaser must file
with the relevant government authorities, agencies, offices and other institutions in connection
with the acquisition of foreign securities by the Purchaser. The Purchaser shall fully cooperate
with the Company in preparing, drafting and filing any reports and documents pursuant to the
relevant securities laws and regulations.



5.4 General Indemnity. The Company shall indemnify and hold harmless the Purchaser and
its directors, officers, Affiliates, agents, successors and permitted assigns from an against any
and all losses, liabilities, deficiencies, costs, damages and expenses (including, without
limitation, reasonable attorneys’ fees, charges and disbursements) incurred by the Purchaser as a
result of any inaccuracy in or breach of the representations, warranties or covenants made by the
Company herein. The Purchaser shall indemnify and hold harmless the Company and its directors,
officers, Affiliates, agents, successors and permitted assigns from and against any and all losses,
liabilities, deficiencies, costs, damages and expenses (including, without limitation, reasonable
attorneys’ fees, charges and disbursements) incurred by the
Company as a result of any inaccuracy in or breach of the representations, warranties or
covenants made by the Purchaser herein.


 


45









 





5.5 Compliance with Laws. So long as the Purchaser Beneficially Owns any of the
Shares, the Company will use reasonable efforts to comply with all applicable laws, rules,
regulations, orders and decrees of all governmental authorities, except to the extent noncompliance
(in one instance or in the aggregate) would not have a Material Adverse Effect.



6. MISCELLANEOUS.




6.1 Entire Agreement. The Transaction Documents, together with the Exhibits and
Schedules thereto, contain the entire understanding of the parties with respect to the subject
matter hereof and supersede all prior agreements and understandings, oral or written, with respect
to such matters, which the parties acknowledge have been merged into such documents, exhibits and
schedules.



6.2 Notices. Any and all notices or other communications or deliveries required or
permitted to be provided hereunder shall be in writing and shall be deemed given and effective on
the earliest of (a) the date of transmission, if such notice or communication is delivered via
facsimile at the facsimile number specified in this Section 6.2 prior to 5:30 p.m. (New
York City time) on a Business Day, (b) the Business Day after the date of transmission, if such
notice or communication is delivered via facsimile at the facsimile number specified in this
Agreement later than 5:30 p.m. (New York City time) on any date, (c) the Business Day following the
date of mailing, if sent by nationally recognized overnight courier service, or (d) upon actual
receipt by the party to whom such notice is required to be given. The address for such notices and
communications shall be as follows:



	 	 	 
	If to the Company:

	 	Oncogenex Pharmaceuticals, Inc.
	 

	 	1522 217th Place S.E.
	 

	 	Bothell, Washington
	 

	 	Attn: Chief Executive Officer
	 

	 	Fax No.: 604-736-3687
	 
	 	 
	With a copy to:

	 	Dorsey & Whitney LLP
	 

	 	701 Fifth Avenue, Suite 6100
	 

	 	Seattle, WA 98104-7043
	 

	 	Attn: Christopher Doerksen
	 

	 	Fax No.: 206.260.9072
	 
	 	 
	If to the Purchaser:

	 	Teva Pharmaceutical Industries Limited
	 

	 	5 Basel Street
	 

	 	Petah Tiqva 49131, Israel
	 

	 	Attn: Chief Executive Officer
	 

	 	Fax No.: 972-3-926-7472
	 
	 	 
	With a copy to:

	 	Teva Pharmaceutical Industries Ltd.
	 

	 	5 Basel Street
	 

	 	Petah Tiqva 49131, Israel
	 

	 	Attention: General Counsel, Legal Department
	 

	 	Fax No.: 972-3-926-7429






; or such other address as may be designated in writing hereafter, in the same manner, by such
Person.


 


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6.3 Amendments; Waivers. No provision of this Agreement may be waived or amended
except in a written instrument signed by the parties hereto. No waiver of any default with respect
to any provision, condition or requirement of this Agreement shall be deemed to be a continuing
waiver in the future or a waiver of any subsequent default or a waiver of any other provision,
condition or requirement hereof, nor shall any delay or omission of either party to exercise any
right hereunder in any manner impair the exercise of any such right.



6.4 Construction. The headings herein are for convenience only, do not constitute a
part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof. The
language used in this Agreement will be deemed to be the language chosen by the parties to express
their mutual intent, and no rules of strict construction will be applied against any party.



6.5 Successors and Assigns. Except as otherwise expressly provided herein, the
provisions hereof shall be binding upon and inure to the benefit of the parties and their
successors and permitted assigns.



6.6 No Third-Party Beneficiaries. This Agreement is intended for the benefit of the
parties hereto and their respective successors and permitted assigns and is not for the benefit of,
nor may any provision hereof be enforced by, any other Person, except that each party able to be
indemnified pursuant to Section 5.4 is an intended third party beneficiary.



6.7 Governing Law; Venue; Waiver Of Jury Trial. All questions concerning the
construction, validity, enforcement and interpretation of this agreement shall be governed by and
construed and enforced in accordance with the laws of the State of New York, without regard to
conflicts of laws principles. Each party hereby irrevocably submits to the exclusive jurisdiction
of any federal or state court located in the City of New York, County of New York, for the
adjudication of any dispute hereunder or in connection herewith or with any transaction
contemplated hereby or discussed herein (including with respect to the enforcement of any of the
transaction documents), and hereby irrevocably waives, and agrees not to assert in any suit, action
or proceeding, any claim that it is not personally subject to the jurisdiction of any such court,
or that such suit, action or proceeding is improper. Each party hereby irrevocably waives personal
service of process and consents to process being served in any such suit, action or proceeding by
mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of
delivery) to such party at the address in effect for notices to it under this Agreement and agrees
that such service shall constitute good and sufficient service of process and notice thereof.
Nothing contained herein shall be deemed to limit in any way any right to serve process in any
manner permitted by law. the company and the purchaser hereby waive all rights to a trial by jury.



6.8 Execution. This Agreement may be executed in two or more counterparts, all of
which when taken together shall be considered one and the same agreement and shall become effective
when counterparts have been signed by each party and delivered to the other party, it being
understood that both parties need not sign the same counterpart. In the event that any
signature is delivered by facsimile transmission or e-mail, such signature shall create a
valid and binding obligation of the party executing (or on whose behalf such signature is executed)
with the same force and effect as if such facsimile or e-mail signature page were an original.


 


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6.9 Severability. If one or more provisions of this Agreement are held to be
unenforceable under applicable law, such provisions shall be excluded from this Agreement and the
balance of the Agreement shall be interpreted as if such provision were so excluded and shall be
enforceable in accordance with its terms.



6.10 Replacement of Shares. If any certificate or instrument evidencing any Shares is
mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and
substitution for and upon cancellation thereof, or in lieu of and substitution therefor, a new
certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company
of such loss, theft or destruction and customary and reasonable indemnity, if requested.



6.11 Remedies. In addition to being entitled to exercise all rights provided herein or
granted by law, including recovery of damages, the Purchaser and the Company will be entitled to
specific performance under the Transaction Documents. The parties agree that monetary damages may
not be adequate compensation for any loss incurred by reason of any breach of obligations described
in the foregoing sentence and hereby agree to waive in any action for specific performance of any
such obligation the defense that a remedy at law would be adequate.



6.12 Adjustments in Share Numbers and Prices. In the event of any stock split,
subdivision, dividend or distribution payable in shares of Common Stock (or other securities or
rights convertible into, or entitling the holder thereof to receive directly or indirectly shares
of Common Stock), combination or other similar recapitalization or event occurring after the date
hereof and prior to the Closing, each reference in this Agreement to a number of shares or a price
per share shall be amended to appropriately account for such event.



[Signature page follows]



 


48









 





IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above
written.



	 	 	 	 	 
	 	ONCOGENEX PHARMACEUTICALS, INC.

 	 
	 	By:  	/s/
Scott Cormack	 
	 	 	Name:  	Scott Cormack	 
	 	 	Title:  	President
&
CEO	 
	 	 	 
	 	By:  	
/s/ Stephen Anderson	 
	 	 	Name:  	Stephen Anderson	 
	 	 	Title:  	CFO	 
	 	 	 
	 	TEVA PHARMACEUTICAL INDUSTRIES LIMITED

 	 
	 	By:  	/s/ Moshe
Manor	 
	 	 	Name:  	Moshe
Manor	 
	 	 	Title:  	Group
VP — Global Branded Products	 
	 	 	 
	 	By:  	
/s/ Chen Schor	 
	 	 	Name:  	Chen Schor	 
	 	 	Title:  	VP,
Business Development, Global Branded Products	 



[Signature page to Stock Purchase Agreement]




 


49









 





SCHEDULE 5.1(e)




EXCEPTIONS TO 5.1(e)




5.1(e) — [***]



 


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SCHEDULE 5.1(f)(i)




THIRD PARTY CLAIMS — OGX




OGX is a party to the License Agreement dated November 15, 2001 (commencing Nov. 1, 2001) with the
University of British Columbia pursuant to which OGX is granted an exclusive, world-wide,
royalty-bearing license to certain intellectual property related to antisense inhibitors of
Clusterin together with Amending Agreement dated August 30, 2006, August 7, 2008 and December 20,
2009.



OGX is a party to the Amended and Restated License Agreement effective July 2, 2008 with Isis
Pharmaceuticals, Inc. regarding the unilateral development of OGX-011 pursuant to which OGX is
granted a world-wide, royalty-bearing license to certain intellectual property related to antisense
inhibitors of Clusterin together with Amendment No. 1 to Amended and Restated License Agreement
dated December 19, 2009.


 


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SCHEDULE 5.1(f)(ii)




THIRD PARTY CLAIMS — TEVA




None



 


52









 





SCHEDULE 5.2




OGX DISCLOSURE SCHEDULE




In connection with that certain Collaboration and License Agreement, dated as of December 20, 2009,
by and between OncoGenex Technologies Inc., a corporation organized under the laws of British
Columbia, Canada (the “Company”), and Teva Pharmaceutical Industries Ltd., a corporation organized
under the laws of Israel (the “Agreement”), the Company hereby delivers this Disclosure Schedule
relating to the Company’s representations and warranties given in the Agreement. This Disclosure
Schedule and the information and disclosures contained herein are intended only to (i) provide
certain information specified in the Agreement, or (ii) qualify and limit the representations,
warranties and covenants of the Company contained in the Agreement, and shall not be deemed to
expand in any way the scope or effect of any of such representations, warranties or covenants. The
section numbers in this Disclosure Schedule correspond to the section numbers in the Agreement;
provided, however, that any information disclosed herein under any section number shall be deemed
to be disclosed and incorporated in any other section of the Agreement where such disclosure would
be appropriate and reasonably apparent on its face. Disclosure of any information or document
herein is not a statement or admission that it is material or required to be disclosed herein.
References to any document do not purport to be complete and are qualified in their entirety by the
document itself. Capitalized terms used but not defined herein shall have the same meanings given
them in the Agreement.



5.2(a)(ii) — Certain [***] have been [***] in [***].



5.2(b); 5.2(c)(ii); and 5.2(h)




[***] patent [***]. The patent [***].



5.2(k)




Capitalized terms used in this Schedule have the meanings ascribed to them in the agreements to
which they relate.



Pursuant to the [***] and [***] dated [***] with [***] regarding [***] shall provide OGX an [***]
with [***] to [***] interest in any Intellectual Property specific to [***] and use of Product.



Pursuant to the [***] effective [***] between OGX and [***] and [***] with respect to clinical
study [***], any [***] that are [***] to, [***], or (where applicable) [***] or [***] of the [***]
or [***] that arise from performance of [***]; or occur [***] and based or subject to claims of
[***] are the sole property of [***]. Any [***] arising out of [***] solely by the [***] that are
not covered by provisions above are the sole property of the [***]. OGX has the [***] to [***] an
[***] to such [***] arising out of [***].


 


53









 





Pursuant to the [***] and [***] effective [***] with [***], [***] that [***] and [***] to [***] or
[***] shall be [***] to [***] an [***] accompanied by [***] of such [***] at [***].



5.2(m)




Capitalized terms used in this Schedule have the meanings ascribed to them in the agreements to
which they relate.



Pursuant to the [***] effective [***] between [***], the [***], [***] and OGX, the [***] is the
[***] for the [***] referenced in the agreement and all [***] in and to any [***] is the exclusive
property of [***]. Under the License Agreement dated November 15, 2001 with UBC, OGX has an
exclusive license to the technology pertaining to the Study Drug.



Pursuant to the [***] effective [***] between [***] at [***] in the style and cause of the [***]
with respect to [***] study. OGX and its Affiliates have the [***]. [***] or [***] made by [***]
which [***] to [***] are the property of [***] and [***] shall [***] the [***] for [***] and [***].



Pursuant to the [***] dated [***] between [***] at [***] in the style and cause of the [***] with
respect to [***] study, OGX and its Affiliates have the [***]. [***] or [***] made by [***] which
[***] to [***] are the property of [***] and [***] shall [***] the [***] for [***] and [***].


 


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SCHEDULE 7.3




OGX PUBLICATIONS




Planned Publications for [***] based on [***].



[***]


 


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SCHEDULE 10.7




OGX EMPLOYEES




A senior employee with sufficient knowledge and experience to perform the [***] designated by the
[***] for [***].



A senior employee with sufficient knowledge and experience to perform the [***] designated by the
[***] for [***].




 


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EXHIBIT A: Summary of Clinical Development Plan 




This Exhibit is aimed to present a summary of the near term Clinical Development Plan as agreed
upon by the Parties. It is agreed by the Parties that following the Effective Date, pursuant to
the terms of the Agreement, the Parties will initiate three Phase III Clinical Studies to be run in
parallel:




	1.	 	A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Clinical Benefit
of Adding Custirsen to Docetaxel Retreatment/Prednisone as an Option for Second-line Therapy
in Men with Castrate Resistant Prostate Cancer. This study is expected to be initiated in
[***]2010, initiated by OncoGenex. The study referenced above is Study OGX-011-10 dated [***]
and approved by FDA under the Special Protocol Assessment process on April 21, 2009. The
primary endpoint is based on durable pain palliation as compared to the control arm. The
secondary endpoint is based on a longer time to pain progression as compared to the control
arm. The study sample size is approximately 292 patients.







	2.	 	A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to
Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate
Resistant Prostate Cancer. This study is expected to be initiated in [***]2010, initiated by
Teva. The study referenced above is Study OGX-011-11 dated [***] approved by FDA under the
Special Protocol Assessment process on June 12, 2009. The primary endpoint is based on longer
survival time distribution compared to the control arm. The secondary endpoint is based on
higher proportion of patients having a milestone Day 140 status of alive without event
compared to the control arm. The study sample size is approximately 800 patients.







	3.	 	Proposed NSCLC Protocol: A Randomized Phase 3 Study Comparing Standard First-Line [***] to
[***] in Combination with Custirsen (OGX-011) in Subjects with Advanced, Unresectable NSCLC.
This study is expected to be initiated in [***]2011, initiated by Teva. The protocol for the
study referenced above will be [***]. The primary endpoint will be based on longer survival
time distribution compared to the control arm. The secondary endpoint is to be [***]. The
study sample size will be at least approximately 700 patients.







 


57