exv10w35






Exhibit 10.35





EXECUTION COPY




[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT




DATED AS OF SEPTEMBER 7, 2010



BY AND AMONG



ONYX PHARMACEUTICALS, INC. AND



ONYX THERAPEUTICS, INC.



AND



ONO PHARMACEUTICAL CO., LTD.








 









 








TABLE OF CONTENTS




	 	 	 	 	 

	ARTICLE 1 DEFINITIONS
	 	 	- 1 -	 
	 
	 	 	 	 
	ARTICLE 2 LICENSES
	 	 	- 13 -	 
	 
	 	 	 	 
	2.1 Grant to Ono
	 	 	- 13 -	 
	2.2 Grant to Onyx
	 	 	- 13 -	 
	2.3 Tsu-jo Jisshiken Tohroku
	 	 	- 13 -	 
	2.4 Additional Licensing Provisions
	 	 	- 13 -	 
	2.5 Performance by Affiliates and Sublicensees
	 	 	- 15 -	 
	2.6 Exclusivity
	 	 	- 15 -	 
	2.7 Restrictive Covenants
	 	 	- 16 -	 
	 
	 	 	 	 
	ARTICLE 3 GOVERNANCE
	 	 	- 16 -	 
	 
	 	 	 	 
	3.1 Joint Development Committee
	 	 	- 16 -	 
	3.2 Joint Development Committee Membership
	 	 	- 17 -	 
	3.3 Joint Development Committee Meetings
	 	 	- 17 -	 
	3.4 Decision-Making
	 	 	- 18 -	 
	3.5 Limits on JDC and Committee Authority
	 	 	- 18 -	 
	3.6 Disbanding the JDC
	 	 	- 19 -	 
	3.7 Committees
	 	 	- 19 -	 
	3.8 Actions
	 	 	- 19 -	 
	3.9 Minutes of Committee Meetings
	 	 	- 19 -	 
	 
	 	 	 	 
	ARTICLE 4 DEVELOPMENT
	 	 	- 20 -	 
	 
	 	 	 	 
	4.1 Overview
	 	 	- 20 -	 
	4.2 Objectives Under the Development Plan
	 	 	- 20 -	 
	4.3 Development Plan
	 	 	- 21 -	 
	4.4 Development Costs
	 	 	- 22 -	 
	4.5 Records, Reports and Information
	 	 	- 23 -	 
	4.6 Development Diligence
	 	 	- 23 -	 
	4.7 Global Clinical Studies
	 	 	- 24 -	 
	 
	 	 	 	 
	ARTICLE 5 REGULATORY
	 	 	- 24 -	 
	 
	 	 	 	 
	5.1 Regulatory Data and Regulatory Materials
	 	 	- 24 -	 
	5.2 Regulatory Filings and Regulatory Approvals
	 	 	- 24 -	 
	5.3 Communications
	 	 	- 26 -	 
	5.4 No Other Regulatory Filings
	 	 	- 26 -	 
	5.5 Rights of Reference
	 	 	- 26 -	 
	5.6 Adverse Event Reporting; Safety Data Exchange and Medical Inquiries
	 	 	- 27 -	 
	5.7 Regulatory Authority Communications Received by a Party
	 	 	- 28 -	 
	5.8 Recall, Withdrawal, or Market Notification of Product
	 	 	- 29 -	 
	 
	 	 	 	 
	ARTICLE 6 COMMERCIALIZATION
	 	 	- 30 -	 





[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




i 









 






	 	 	 	 	 

	6.1 Commercialization in the Field in the Territory
	 	 	- 30 -	 
	6.2 Ono’s Performance
	 	 	- 30 -	 
	6.3 Commercialization Liaisons
	 	 	- 30 -	 
	6.4 Reports
	 	 	- 31 -	 
	6.5 Joint Marketing Meetings
	 	 	- 31 -	 
	6.6 Commercialization Compliance
	 	 	- 31 -	 
	6.7 Promotional Materials
	 	 	- 32 -	 
	6.9 Product Trademarks and Product Trade Dress; Ono Trademarks and Ono
Trade Dress
	 	 	- 33 -	 
	6.10 Global Branding Strategy
	 	 	- 35 -	 
	 
	 	 	 	 
	ARTICLE 7 SUPPLY
	 	 	- 35 -	 
	7.1 General
	 	 	- 35 -	 
	7.2 Carfilzomib Supply Agreements
	 	 	- 36 -	 
	7.3 0912 Supply Agreements
	 	 	- 38 -	 
	7.4 Supply Price Following Patent Term
	 	 	- 38 -	 
	7.5 Quality Agreement
	 	 	- 39 -	 
	7.6 Commercial Sample Supply Price
	 	 	- 39 -	 
	7.7 Non-Clinical Development Supply
	 	 	- 39 -	 
	 
	 	 	 	 
	ARTICLE 8 PAYMENTS
	 	 	- 39 -	 
	 
	 	 	 	 
	8.1 Upfront Payment
	 	 	- 39 -	 
	8.2 Milestone Payments
	 	 	- 39 -	 
	8.3 Royalties
	 	 	- 40 -	 
	8.4 Royalty Payments and Reports
	 	 	- 41 -	 
	8.5 Taxes and Withholding
	 	 	- 41 -	 
	8.6 Currency Conversion
	 	 	- 42 -	 
	8.7 Late Payments
	 	 	- 42 -	 
	8.8 Records; Audits
	 	 	- 42 -	 
	 
	 	 	 	 
	ARTICLE 9 INTELLECTUAL PROPERTY MATTERS
	 	 	- 43 -	 
	 
	 	 	 	 
	9.1 Ownership of Intellectual Property
	 	 	- 43 -	 
	9.2 Disclosures; Disputes Regarding Inventions
	 	 	- 44 -	 
	9.3 Patent Filings, Prosecution and Maintenance
	 	 	- 44 -	 
	9.4 Defense and Enforcement of Patents
	 	 	- 47 -	 
	9.5 Patent Term Extensions
	 	 	- 49 -	 
	9.6 Patent Marking
	 	 	- 50 -	 
	9.7 Patent Challenge
	 	 	- 50 -	 
	 
	 	 	 	 
	ARTICLE
10 REPRESENTATIONS, WARRANTIES AND COVENANTS
	 	 	- 50 -	 
	 
	 	 	 	 
	10.1 Mutual Representations and Warranties
	 	 	- 50 -	 
	10.2 Representations, Warranties and Covenants of Onyx
	 	 	- 51 -	 
	10.3 Representations, Warranties and Covenants of Ono
	 	 	- 52 -	 
	10.4 Disclaimer
	 	 	- 52 -	 
	10.5 No Other Representations or Warranties
	 	 	- 52 -	 





 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




ii 









 






	 	 	 	 	 

	ARTICLE
11 INDEMNIFICATION
	 	 	- 52 -	 
	 
	 	 	 	 
	11.1 Indemnification by Onyx
	 	 	- 52 -	 
	11.2 Indemnification by Ono
	 	 	- 53 -	 
	11.3 Indemnification Procedures
	 	 	- 53 -	 
	11.4 Limitation of Liability
	 	 	- 55 -	 
	11.5 Insurance
	 	 	- 55 -	 
	 
	 	 	 	 
	ARTICLE
12 CONFIDENTIALITY
	 	 	- 56 -	 
	 
	 	 	 	 
	12.1 Confidential Information
	 	 	- 56 -	 
	12.2 Confidentiality Obligations
	 	 	- 56 -	 
	12.3 Permitted Disclosure and Use
	 	 	- 57 -	 
	12.4 Notification
	 	 	- 57 -	 
	12.5 Publicity; Filing of this Agreement
	 	 	- 58 -	 
	12.6 Publication
	 	 	- 59 -	 
	12.7 Use of Names
	 	 	- 59 -	 
	12.8 Survival
	 	 	- 59 -	 
	 
	 	 	 	 
	ARTICLE
13 TERM AND TERMINATION
	 	 	- 59 -	 
	 
	 	 	 	 
	13.1 Term
	 	 	- 59 -	 
	13.2 Termination by Ono for Scientific or Commercial Reasons
	 	 	- 60 -	 
	13.3 Termination for Breach
	 	 	- 60 -	 
	13.4 Termination as a Result of Bankruptcy
	 	 	- 60 -	 
	13.5 Termination by Onyx
	 	 	- 60 -	 
	 
	 	 	 	 
	ARTICLE
14 EFFECTS OF EXPIRATION AND TERMINATION
	 	 	- 60 -	 
	 
	 	 	 	 
	14.1 Effects of Termination
	 	 	- 60 -	 
	14.2 Ono Rights Arising Under Section 13.3
	 	 	- 63 -	 
	14.3 Accrued Rights
	 	 	- 63 -	 
	14.4 Survival
	 	 	- 63 -	 
	14.5 Rights in Bankruptcy
	 	 	- 63 -	 
	 
	 	 	 	 
	ARTICLE
15 DISPUTE RESOLUTION
	 	 	- 64 -	 
	 
	 	 	 	 
	15.1 Disputes
	 	 	- 64 -	 
	15.2 Escalation of Disputes
	 	 	- 64 -	 
	15.3 Mediation
	 	 	- 64 -	 
	15.4 Arbitration
	 	 	- 64 -	 
	15.5 Litigation and Jurisdiction
	 	 	- 66 -	 
	15.6 Patent and Trademark Dispute Resolution
	 	 	- 66 -	 
	15.7 Injunctive Relief
	 	 	- 66 -	 
	 
	 	 	 	 
	ARTICLE
16 MISCELLANEOUS
	 	 	- 66 -	 
	 
	 	 	 	 
	16.1 Change of Control
	 	 	- 66 -	 
	16.2 Entire Agreement; Amendment
	 	 	- 67 -	 
	16.3 Force Majeure
	 	 	- 67 -	 
	16.4 Notices
	 	 	- 67 -	 




[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.





iii 









 






	 	 	 	 	 

	16.5 No Strict Construction; Interpretation
	 	 	- 68 -	 
	16.6 Assignment
	 	 	- 68 -	 
	16.7 Further Actions
	 	 	- 69 -	 
	16.8 Severability
	 	 	- 69 -	 
	16.9 No Waiver
	 	 	- 69 -	 
	16.10 Independent Contractors
	 	 	- 69 -	 
	16.11 English Language; Governing Law
	 	 	- 69 -	 
	16.12 Counterparts
	 	 	- 69 -	 






Schedules:




	 

	Schedule 1.3: CARFILZOMIB CHEMICAL STRUCTURE

	Schedule 1.51: ONX 0912 CHEMICAL STRUCTURE

	Schedule 3.2: INITIAL JDC MEMBERS

	Schedule 4.3.2: INITIAL DEVELOPMENT PLAN & [**]

	Schedule 4.4.1: CERTAIN GENERAL DEVELOPMENT ACTIVITIES

	Schedule 10.2.6: LICENSED PATENTS

	Schedule 16.1: ACQUIRERS TRIGGERING TERMINATION










[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.





iv 









 








LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT



This License, Development and Commercialization Agreement (this “Agreement”), dated as of September
7, 2010 (the “Effective Date”), is made by and among Onyx Pharmaceuticals, Inc., a Delaware
corporation, and Onyx Therapeutics, Inc., a Delaware corporation (together referred to as, “Onyx”),
and Ono Pharmaceutical Co., Ltd., a Japanese stock corporation (“Ono”). Onyx and Ono are sometimes
referred to herein individually as a “Party” and collectively as the “Parties.”




RECITALS



Whereas, Onyx has developed and is currently further developing pharmaceutical products
for the treatment of oncology indications;



Whereas, Ono has significant experience in the development and commercialization of
pharmaceutical products in the Territory; and



Whereas, Ono and Onyx desire to establish a collaboration for the further development and
commercialization of Product in the Field in the Territory.



Now Therefore, in consideration of the foregoing premises and the mutual promises,
covenants and conditions contained in this Agreement, the Parties agree as follows:




ARTICLE 1

DEFINITIONS



As used in this Agreement, the following initially capitalized terms shall have the meanings set
forth in this ARTICLE 1 or as otherwise defined elsewhere in this Agreement:




     1.1 “Affiliate” means any Person controlled by, controlling, or under common control with
another Person, where “control” means ownership, either direct or indirect, of more than fifty
percent (50%) of the equity interest entitled to vote for the election of directors or equivalent
governing body. An entity shall be considered an Affiliate only so long as such entity continues
to meet the foregoing definition.



     1.2 “Bulk Product” means, as applicable, either (i) the vial preparation with lyophilized drug
product containing Carfilzomib, or (ii) bulk capsule or tablet in final dosage form containing
ONX0912, in either case for Packaging and Labeling by Ono.



     1.3 “Carfilzomib” means [**], having the structure shown in Schedule 1.3.



     1.4 “Change of Control” means, with respect to a Party, (i) a merger, acquisition or
consolidation with a Third Party which results in the voting securities of such Party outstanding
immediately prior thereto ceasing to represent at least fifty percent (50%) of the combined voting
power of the surviving entity immediately after such merger, acquisition or consolidation, (ii) a
transaction or series of related transactions in which a Third Party, together with its Affiliates,
becomes the owner of fifty percent (50%) or more of the combined voting power of the


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




 









 




outstanding securities of such Party, (iii) the sale or other transfer to a Third Party of all
or substantially all of such Party’s business to which the subject matter of this Agreement
relates, (iv) the stockholders or equity holders of such Party shall approve a plan of complete
liquidation of such Party or an agreement for the sale or disposition by such Party of all or a
substantial portion of such Party’s assets, other than pursuant to the transaction as described
above or to an Affiliate, or (v) a change in the composition of such Party’s board of directors
(the “Board”) over a period of twelve (12) consecutive months or less such that a majority of the
Board members ceases by reason of one or more contested elections for Board membership to be
comprised of individuals whose election is endorsed by a majority of the members of the Board
immediately before the date of election. In the case of each of sub-clauses (i), (ii) and (iii),
such Third Party shall be referred to herein as “Acquirer”.




     1.5 “Commercialize”, “Commercializing” or “Commercialization” means all activities directed to
the marketing, promotion, selling or offering for sale of a Product for an indication, including
planning, market research, Pre-Marketing, advertising, educating, marketing, promoting, importing,
exporting, distributing and post-marketing safety surveillance and reporting. For clarity,
“Commercialization” shall not include any activities related to clinical research, Manufacturing or
Development of Product.



     1.6 “Commercially Reasonable Efforts” means, with respect to a Party’s obligations under this
Agreement, including to Develop or Commercialize Product, those efforts and resources consistent
with the usual practices of such Party in pursuing the development or commercialization of its own
pharmaceutical products that are of similar market potential and strategic value as such Product,
taking into account all relevant factors including product labeling or anticipated labeling,
present and future market potential, past performance of such Product and such Party’s other
pharmaceutical products that are of similar market potential, financial return, medical and
clinical considerations, present and future regulatory environment and competitive market
conditions, all as measured by the facts and circumstances at the time such efforts are due.
Without limiting the foregoing, Commercially Reasonable Efforts requires, with respect to such
obligations, that the Party apply efforts sufficient to carry out the given obligation in a
diligent and sustained manner without undue interruption, pause, or delay.



     1.7 “Competitive Product” means (i) with respect to the Parties, any product incorporating any
molecule or compound that is known, at the time a Party is [**] to [**] of such
product, to have [**] as its [**] of [**], other than Product
hereunder or (ii) with respect to an Acquirer, in the case of Section 16.1, any product
incorporating any molecule or compound that is known to have [**] as its [**]
of [**].



     1.8 “Compound(s)” means Carfilzomib and/or ONX 0912.



     1.9 “Control” means, when used in reference to intellectual property, other intangible
property, or materials, that a Party owns or has a license or sublicense to such intellectual
property, other intangible property or materials, and has the ability to grant a license or
sublicense or other right to use such intellectual property, other intangible property or
materials, as applicable, as provided for herein, without (i) requiring the consent of a Third
Party or (ii) violating the terms of any agreement or other arrangement with any Third Party.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




2









 





     1.10 “Develop”, “Developing” or “Development” means all activities relating to research,
non-clinical, preclinical and clinical trials, toxicology testing, statistical analysis and
reporting, necessary or reasonably useful or otherwise requested or required by a Regulatory
Authority as a condition or in support of obtaining or maintaining all Regulatory Approvals for
Product in the Field and all other development-related activities that are commercially useful, but
shall not include any activities related to Commercialization or Manufacture.



     1.11 “Development Activities” means those Development activities undertaken by or on behalf of
a Party or its Affiliates with respect to Product in the Field. For clarity, Ono shall be solely
responsible for conducting Development activities in the Territory in accordance with this
Agreement generally and ARTICLE 4 specifically.



     1.12 “Development Costs” means the costs and expenses incurred by a Party or its Affiliates
attributable to, or reasonably allocable to, the Development of Product, including costs of
conducting clinical trials (including Phase II Clinical Trials and other pre-Regulatory Approval
studies) and Phase IV Clinical Trials (as well as other post-Regulatory Approval studies (including
physician — initiated studies)). “Development Costs” shall include (i) [**] and (ii)
[**] that are attributable or reasonably allocable to the Development of Product. For
clarity, Development Costs shall [**] (but shall include [**]).



     1.13 “Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.



     1.14 “FDA” means the U.S. Food and Drug Administration or its successor.



     1.15 “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the
regulations promulgated thereunder.



     1.16 “Field” means the use of Product to treat (i) [**] indications and (ii) such other
indications as Onyx may decide, in its sole discretion, to pursue Regulatory Approval in any
territory; provided, however, that the inclusion of an indication in the “Field” pursuant to the
foregoing sub-clause (ii) shall be subject to Ono’s consent.



     1.17 “Finished Product” means Product in its full packaging and final presentation form ready
for release to end-users.



     1.18 “First Commercial Sale” means, with respect to a Product, the first sale of such Product
in the Territory by or on behalf of Ono, its Affiliates or its permitted distributors to a Third
Party, after receipt of Regulatory Approval (including Pricing Approval, to the extent required for
sale of a Product in the Territory, and any necessary labeling negotiations that may be required
after Regulatory Approval and such Pricing Approval) for such Product in the Territory.



     1.19 “General Development Activities” means all Development Activities other than Territory
Development Activities.



     1.20 “Generic Entry” means, with respect to a Product in the Field in the Territory, market
entry (i.e., [**]) of a Third Party pharmaceutical product that: (i) contains a [**], and (ii)


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




3









 




has been granted a marketing authorization by an [**] that relies [**] or [**] and [**]
generated for the [**] for such Product as determined by the applicable Regulatory Authority in the
Territory.




     1.21 “Good Clinical Practices” or “GCP” means all applicable Good Clinical Practice standards
for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of
clinical trials, including, as applicable, (i) those standards required by the MHLW, (ii) as set
forth in the International Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice
(CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal
products in the Territory, (iii) the Declaration of Helsinki (2004) as last amended at the 52nd
World Medical Association in October 2000 and any further amendments or clarifications thereto,
(iv) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56
(Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended
from time to time, and (v) the equivalent Laws in any relevant country, each as may be amended and
applicable from time to time and in each case, that provide for, among other things, assurance that
the clinical data and reported results are credible and accurate and protect the rights, integrity,
and confidentiality of trial subjects.



     1.22 “Good Laboratory Practices” or “GLP” means all applicable Good Laboratory Practice
standards, including, as applicable, (i) those standards required by the MHLW, (ii) as set forth in
the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined
in 21 C.F.R. Part 58, and (iii) the equivalent Laws in any relevant country, each as may be amended
and applicable from time to time.



     1.23 “Good Manufacturing Practices” or “GMP” means all applicable Good Manufacturing Practices
including, (i) those standards required by the MHLW, (ii) the principles detailed in the U.S.
Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601 and 610, (iii) the
principles detailed in the ICH Q7A guidelines, and (iv) the equivalent Laws in any relevant
country, each as may be amended and applicable from time to time.



     1.24 “Governmental Authority” means any multinational, federal, state, local, municipal or
other governmental authority of any nature (including any governmental division, prefecture,
subdivision, department, agency, bureau, branch, office, commission, council, court or other
tribunal), in each case, having jurisdiction over the applicable subject matter.



     1.25 “IND” means the equivalent application of an Investigational New Drug Application to the
MHLW, such as a clinical trial application or a clinical trial exemption, the filing of which is
necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such
jurisdiction.



     1.26 “Invented” means the acts of (an) inventor(s), as determined in accordance with Laws
relating to inventorship set forth in the patent Laws of the United States (Title 35, United States
Code), in discovering, conceiving and reducing to practice an Invention.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




4









 





     1.27 “Invention” means any writing, invention, discovery, improvement, technology or other
Know-How (in each case, whether patented or not) pertaining to Compound or Product in the Field,
that is not existing as of the Effective Date and is Invented under this Agreement during the Term.



     1.28 “JNDA” means (i) the single application or set of applications for approval and/or
pre-market approval to Manufacture and Commercialize in the Territory a pharmaceutical or biologic
product filed with the MHLW, and any related registrations with or notifications to the MHLW, and
(ii) all supplements and amendments that may be filed with respect to any of the foregoing.



     1.29 “Joint Development Committee” or “JDC” means the joint development committee formed by
the Parties as described in Section 3.1.



     1.30 “Joint Invention” means an Invention that is Invented jointly by an employee of, or
Person under an obligation of assignment to, each of Onyx and Ono or their respective Affiliates.



     1.31 “Joint Patents” mean any Patents claiming a Joint Invention.



     1.32 “JPY” means a Japanese Yen.



     1.33 “Know-How” means intellectual property including any asset that comprises any of the
following items and has a substantial value independent of the services of any individual:
inventions, formulae, processes, designs, patterns, or know-how; copyrights; trademarks, trade
names, or brand names; franchises; methods, programs, systems, procedures, campaigns, surveys,
studies, forecasts, estimates, customer lists, or technical data; and other similar items (whether
or not in documentary form and whether or not patentable, copyrightable or otherwise protectable
under applicable laws).



     1.34 “Laws” means all applicable laws, statutes, rules, regulations, directives, decisions,
ordinances, guidelines and other pronouncements of any Governmental Authority.



     1.35 “Licensed Technology” means any and all Patents (the “Licensed Patents”) and Know-How
(the “Licensed Know-How”) in existence and Controlled by Onyx as of the Effective Date that are
related to, embodied or incorporated in, or are used in conjunction with any Compound and/or
Product and/or the Development, Commercialization, or exploitation thereof. For clarity, “Licensed
Know-How” shall not include (i) any Onyx Manufacturing Technology, or (ii) the Licensed Patents.



     1.36 “Manufacture” or “Manufacturing” means all activities related to the manufacturing of
Bulk Product, or any ingredient thereof, including manufacturing for clinical use or commercial
sale, in-process and Bulk Product testing, handling and storage of Bulk Product and ongoing
stability tests related to any of the foregoing; provided, however, that for purposes of clarity
“Manufacture” shall include filling of Compound drug substance but shall exclude Packaging and
Labeling (whether in commercial or clinical packaging presentation).


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




5









 





     1.37 “Manufacturing Development Activities” means development of test methods, stability
testing, formulation development, process development, quality assurance activities, quality
control activities, qualification and validation activities, analytic process development,
manufacturing process validation, scale-up, and all other activities, including CMC-related
activities, necessary for or related to the Manufacture of Product for use in the Field.



     1.38 “Marketing Authorization Application” or “MAA” means an application to the appropriate
Regulatory Authority for approval to sell Product (but excluding Pricing Approval) in any
particular country or regulatory jurisdiction.



     1.39 “Medical Science Liaison” means an individual who is employed by or on behalf of Ono or
its Affiliates and who provides educational services and other educational efforts directed towards
the medical and/or scientific community.



     1.40 “MHLW” means the Japanese Ministry of Health, Labor and Welfare, or a successor agency
thereto.



     1.41 “Net Sales” means the gross amount [**] by [**] or [**] on account of sales of Product to
[**] Third Party in the distribution chain, less the following deductions [**] and [**] related to
Product, actually allowed and not separately charged to, and paid by, Third Parties:



          1.41.1 customary trade, cash or quantity discounts, returns in accordance with Ono’s standard
returned goods policy as consistently applied to Ono’s own products and rebates, chargebacks and
allowances actually given to [**] Third Party in the distribution chain, all the foregoing to the
extent actually paid to or granted to [**] Third Party in the distribution chain, and (i) not
already reflected in the amount invoiced and (ii) granted within the same [**];




          1.41.2 retroactive price reductions that are actually allowed or granted;




          1.41.3 a fixed amount of [**]% of gross sales allocated to outbound freight, insurance,
packing costs and other transportation charges; and




          1.41.4 mandatory sales-based or value added taxes and duties paid by Ono (and not reimbursed
by a Third Party) in relation to the Product and mandatory sales-based contributions actually made
by Ono for “Contributions for Drug Induced Suffering” and any sales-based contribution for
“Contribution for Measure for Drug Safety,” in the amount [**] and [**] to the Pharmaceuticals and
Medical Devices Agency (or “KIKO”) each as consistently applied by Ono to its products.



For clarity, while not Ono’s practice as of the Effective Date, in the event that Ono [**] for the
[**] of a [**] including Product, or its Affiliates sell Product [**] of [**], such [**] 
shall be allocated to Product, for purposes of this Agreement, based on [**] sales to sales of all
of [**] sold in the Territory.




     1.42 “New Licensed Technology” means any and all Patents (the “New Licensed Patents”) and
Know-How (the “New Licensed Know-How”) arising from or developed on or after the Effective Date and
Controlled by Onyx, and subject to a license granted to Ono by


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




6









 




Onyx hereunder, that are related to, embodied or incorporated in, or are used in conjunction
with any Compound and/or Product and/or the Development, Commercialization, or exploitation
thereof. For clarity, “New Licensed Know-How” shall not include (i) any Onyx Manufacturing
Technology, (ii) the Licensed Patents, or (iii) the New Licensed Patents.




     1.43 “NHI” means the Japanese national health insurance system, or its successor system.



     1.44 “NHI Price” means the reimbursement price of Product for purposes of the NHI.



     1.45 “NHI Price Approval” means approval of the NHI Price by the MHLW.



     1.46 “Ono Fiscal Year” means the twelve (12) month period beginning on April 1 and ending on
March 31.



     1.47 “Ono Invention” means an Invention that is Invented, solely or jointly with a Third
Party, by an employee of Ono or its Affiliates or a Person under an obligation of assignment to Ono
or its Affiliates.



     1.48 “Ono Know-How” means all Know-How that is Controlled by Ono (or its Affiliates) as of the
Effective Date and/or during the Term (other than as a result of the licenses granted by Onyx to
Ono under this Agreement) that is necessary for the Development, Manufacture, use or
Commercialization of a Compound or Product, and including any Ono Invention.



     1.49 “Ono Patent” means any Patent that is Controlled by Ono (or its Affiliates) as of the
Effective Date and/or during the Term (other than as a result of the licenses granted by Onyx to
Ono under this Agreement) and that claims or covers any Ono Know-How.



     1.50 “Ono Technology” means the Ono Know-How and the Ono Patents.



     1.51 “ONX 0912” means [**], having the structure shown in Schedule 1.51.



     1.52 “Onyx Invention” means an Invention that is Invented, solely or jointly with a Third
Party, by an employee of Onyx or its Affiliates or a Person under an obligation of assignment to
Onyx or its Affiliates.



     1.53 “Onyx Manufacturing Know-How” means all Know-How that is (i) Controlled by Onyx (or its
Affiliates) as of the Effective Date and/or (ii) an Onyx Invention or a Joint Invention, in each
case of (i) and (ii) which is necessary for Manufacture of Product for Commercialization in the
Field in the Territory, including any CMC information.



     1.54 “Onyx Manufacturing Patent” means any Patent that is Controlled by Onyx (or its
Affiliates) as of the Effective Date and/or during the Term, in each case, which is necessary for
the Manufacture of Product for Commercialization in the Field in the Territory; provided, however,
that an “Onyx Manufacturing Patent” shall not include any Licensed Patent.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




7









 





     1.55 “Onyx Manufacturing Technology” means the Onyx Manufacturing Know-How and the Onyx
Manufacturing Patents.



     1.56 “Out-of-Pocket Costs” means costs and expenses paid to Third Parties (or payable to Third
Parties and accrued in accordance with generally accepted accounting standards in the U.S. or such
other national accounting standards as may be applicable to a Party hereunder), other than
Affiliates or employees, by either Party.



     1.57 “Patents” means any patents and patent applications and all substitutions, divisions,
continuations, any patent issued with respect to any such patent applications, any reissue,
reexamination, utility models or designs, renewal or extension (including any supplementary
protection certificate) of any such patent, and any confirmation patent or registration patent or
patent of addition based on any such patent, and all counterparts thereof in any country.



     1.58 “Patent Term Extension” means any term extensions, supplementary protection certificates,
Regulatory Exclusivity and equivalents thereof offering Patent protection beyond the initial term
with respect to any issued Patents.



     1.59 “Person” means any corporation, limited or general partnership, limited liability
company, joint venture, trust, unincorporated association, governmental body, authority, bureau or
agency, any other entity or body, or an individual.



     1.60 “Phase I Clinical Trial” means a clinical trial in humans, the principal purpose of which
is to make a preliminary determination of metabolism, pharmacokinetics, dose findings or
preliminary safety in healthy individuals or patients in the Japanese population.



     1.61 “Phase II Clinical Trial” means a clinical trial in humans, the principal purpose of
which is to make a preliminary determination that a given product is safe in the Japanese
population for its intended use and to obtain information about such product’s efficacy sufficient
to permit the design of further clinical trials, or if no further trials are necessary, to enable
an MAA filing.



     1.62 “Phase IV Clinical Trials” means post-marketing studies to delineate additional
information about a pharmaceutical product’s risks, benefits, and optimal use, commenced after
receipt of regulatory approval for a product in the indication for which such trial is being
conducted.



     1.63 “Pre-Marketing” means all sales and marketing activities undertaken prior to and in
preparation for the launch of Product in the Territory. Pre-Marketing shall include market
research, key opinion leader development, advisory boards, medical education, disease-related
public relations, health care economic studies, sales force training and other pre-launch
activities prior to the First Commercial Sale of Product in the Territory.



     1.64 “Pricing Approval” means the approval, agreement, determination or decision from a
Governmental Authority, including the NHI Price Approval, establishing the price and/or
reimbursement for Product for sale in a given country or regulatory jurisdiction, as required by


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




8









 




Laws in such country or other regulatory jurisdiction prior to the sale of Product in such
country or regulatory jurisdiction.




     1.65 “Product” means any pharmaceutical product, [**], incorporating a Compound.



     1.66 “Product Approval” means the approval of a Governmental Authority necessary for the
marketing and sale of Product in a given country or regulatory jurisdiction, which may include the
approval of an MAA (but shall not include any Pricing Approvals).



     1.67 “Product Complaint” means any written, verbal or electronic expression of dissatisfaction
regarding any Product sold by or on behalf of Ono (or any of its Affiliates or permitted
distributors) in the Territory, including reports of actual or suspected product tampering,
contamination, mislabeling or inclusion of improper ingredients.



     1.68 “Product Specifications” means those Manufacturing, performance, quality-control, and
Packaging and Labeling specifications for Product in the Territory, which are initially as set
forth in the applicable Product Approval for Product, as such specifications may be amended from
time to time pursuant to the terms of this Agreement.



     1.69 “Promotional Materials” means all written, printed, video or graphic advertising,
promotional, educational and communication materials (other than Product labels and package
inserts) for marketing, advertising and promoting of Product in the Field in the Territory, for use
(i) by a Sales Representative or a Medical Science Liaison or (ii) in advertisements, web sites or
direct mail pieces.



     1.70 “Quality Agreement” means the quality agreement relating to Product between Ono and Onyx.



     1.71 “Regulatory Approvals” means all necessary approvals (including INDs, JNDAs, Product
Approvals, Pricing Approvals, import permits, and, in each case any supplements and amendments
thereto), licenses, registrations or authorizations of any Governmental Authority, necessary for
the manufacture, distribution, use, promotion and sale of Product in a given country or regulatory
jurisdiction.



     1.72 “Regulatory Authority” means, in a particular country or regulatory jurisdiction, any
applicable Governmental Authority involved in granting Regulatory Approval in such country or
regulatory jurisdiction, including, in the Territory, the MHLW.



     1.73 “Regulatory Costs” means the costs and expenses incurred by a Party or its Affiliates
attributable to, or reasonably allocable to, the preparation, obtaining or maintaining of
Regulatory Materials and Regulatory Approvals for Product in the Field in the Territory, including
MAAs (other than Pricing Approval and Manufacturing-related Regulatory Approvals), including any
filing fees. “Regulatory Costs” shall include (i) [**] and (ii) [**] that are attributable or
reasonably allocable to the preparation of Regulatory Materials, and maintenance of Regulatory
Approvals, for Product in the Field in the Territory. For clarity, Regulatory Costs shall exclude
Development Costs.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




9









 





     1.74 “Regulatory Data” means any and all research data, pharmacology data, chemistry,
manufacturing and control data, preclinical data, clinical data and all other documentation
submitted, or required to be submitted, to Regulatory Authorities in association with regulatory
filings for Product (including any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing
and Control (“CMC”) data, or similar documentation).



     1.75 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights
conferred by any Governmental Authority with respect to Product other than a Patent right.



     1.76 “Regulatory Materials” means regulatory applications, submissions, notifications,
communications, correspondence, registrations, Regulatory Approvals and/or other filings made to,
received from or otherwise conducted with a Regulatory Authority that are necessary in order to
Develop, Manufacture, obtain marketing authorization, market, sell or otherwise Commercialize
Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs,
MAAs, JNDAs, Drug Master Files, presentations, responses, and applications for other Product
Approvals. For clarity, Regulatory Materials also include written minutes of any meeting with any
Regulatory Authorities, including minutes prepared by said Regulatory Authorities and those
prepared by Ono personnel.



     1.77 “Royalty Term” means, on a Product-by-Product basis in the Territory, the period of time
beginning on the First Commercial Sale of such Product and ending upon the latest of: (i) the
expiration of the last-to-expire Valid Claim covering or claiming [**] or [**] or [**] of the [**]
or [**] in the Territory, (ii) expiration of [**] in the Territory, or (iii) the [**] ([**])
anniversary of the First Commercial Sale of such Product.



     1.78 “Sales Representative” means an individual who is employed by or on behalf of Ono (or its
Affiliates) and who performs details and other promotional efforts with respect to Product.



     1.79 “Supply Shortfall” means, with respect to Bulk Product, (i) Onyx’s failure to deliver
[**] Bulk Product ordered by Ono for a period of [**] after the [**], (ii) Onyx providing notice to
Ono promptly after Onyx is aware that it will not be able to [**] supply Product in accordance with
the terms of this Agreement such that the requirements of the preceding sub-clause (i) are met, or
(iii) Onyx becoming insolvent or seeking relief from creditors under bankruptcy laws, or ceasing to
do business, and providing notice as described in the preceding sub-clause (ii).



     1.80 “Territory” means Japan.



     1.81 “Territory Development Activities” means those Development Activities that are (i)
necessary solely for obtaining or maintaining Regulatory Approval for Product in the Field in the
Territory and (ii) post-Regulatory Approval filing date Development Activities for Product in the
Field in the Territory.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




10









 





     1.82 “Third Party” means any Person other than Onyx or Ono or their respective Affiliates.



     1.83 “Trial Completion” means the date upon which data base lock occurs; provided that, to the
extent [**] is conducted and there is [**], then “Trial Completion” with respect to [**] shall be
deemed to have occurred upon [**] of the [**] of the [**]. For clarity, in the event that [**] is
conducted and [**] with respect to the [**] is required prior to entering [**] due to any
unexpected event (e.g, a serious adverse event occurred), then (i) the [**] shall be deemed to be
an [**] conducted [**], (ii) [**] shall be deemed to be an [**] conducted [**] and (iii) for
clarity, “Trial Completion” with respect to each such deemed [**] study shall occur upon [**] with
respect to each such deemed [**] study.



     1.84 “U.S.” means the United States of America and its possessions and territories.



     1.85 “Valid Claim” means a claim of a Patent, included within the Licensed Patents, New
Licensed Patents, or Joint Patents which would be infringed by, contribute to the infringement of,
or induce the infringement of, but for the license and rights granted to Ono hereunder, the
research, Development, Manufacture or Commercialization of Product in the Territory which claim (i)
has not been rejected, 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 (ii) has not been
finally abandoned, disclaimed or admitted to be invalid or unenforceable through reissue or
disclaimer[**].



     1.86 Interpretation. Except where expressly stated otherwise in this Agreement, the following
rules of interpretation apply to this Agreement: (i) “include”, “includes” and “including” are not
limiting; (ii) “hereof”, “hereto”, “herein” and “hereunder” and words of similar import when used
in this Agreement refer to this Agreement as a whole and not to any particular provision of this
Agreement; (iii) words of one gender include the other gender; (iv) words using the singular or
plural number also include the plural or singular number, respectively; (v) references to a
contract or other agreement mean such contract or other agreement as from time to time amended,
modified or supplemented; (vi) references to a Person are also to its permitted successors and
assigns; (vii) references to an “ARTICLE”, “Section”, “Exhibit” or “Schedule” refer to an ARTICLE
or Section of, or an Exhibit or Schedule to, this Agreement, unless expressly stated otherwise; and
(viii) references to a law include any amendment or modification to such law and any rules and
regulations issued thereunder, whether such amendment or modification is made, or issuance of such
rules and regulations occurs, before or after the date of this Agreement.



     1.87 Additional Definitions. The following terms have the meanings set forth in the
corresponding Sections of this Agreement:



	 	 	 	 	 
	Term	 	Section
	“0912 Supply Agreements”

	 	 	7.3	 
	“Acquirer”

	 	 	1.4	 
	“Agreement”

	 	Preamble

	“Audit”

	 	 	8.8	 





 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




11









 






	 	 	 	 	 
	Term	 	Section
	“Bankrupt Party”

	 	 	14.5	 
	“Board”

	 	 	1.4	 
	“Breaching Party”

	 	 	13.3	 
	“Carfilzomib Commercial Supply Agreement”

	 	 	7.2.1	 
	“Carfilzomib Product”

	 	 	7.2.1	 
	“Carfilzomib Development Supply Agreement”

	 	 	7.2.1	 
	“Carfilzomib Supply Agreements”

	 	 	7.2.1	 
	“CMC”

	 	 	1.74	 
	“Commercialization Liaison”

	 	 	6.3	 
	“Commercialization Plan”

	 	 	6.5.5	 
	“Committee”

	 	 	3.7	 
	“Confidential Information”

	 	 	12.1	 
	“Development Plan”

	 	 	4.3.1	 
	“Development Plan Event”

	 	 	4.6	 
	“Disbanding Notice”

	 	 	3.6	 
	“Disclosing Party”

	 	 	12.1	 
	“DMFs”

	 	 	1.74	 
	“Effective Date”

	 	Preamble

	“Executive Officer”

	 	 	15.2	 
	“Filing Party”

	 	 	9.2	 
	“Global Branding Strategy”

	 	 	6.10	 
	“ICC Rules”

	 	 	15.4	 
	“ICH”

	 	 	1.21	 
	“Indemnification Claim Notice”

	 	 	11.3.1	 
	“Indemnified Party” and “Indemnifying Party”

	 	 	11.3.1	 
	“Indemnitee” and “Indemnitees”

	 	 	11.3.1	 
	“Infringement Claim”

	 	 	9.4.1	(a)
	“Initial Development Plan”

	 	 	4.3.2	 
	“Joint Marketing Meeting” or “JMM”

	 	 	6.5	 
	“Licensed Know-How”

	 	 	1.35	 
	“Licensed Patents”

	 	 	1.35	 
	“Losses”

	 	 	11.1	 
	“Milestone Notification Notice”

	 	 	8.2	 
	“New Licensed Know-How”

	 	 	1.42	 
	“New Licensed Patents”

	 	 	1.42	 
	“Non-Filing Party”

	 	 	9.2	 
	“Ono”

	 	Preamble

	“Ono Promotional Materials”

	 	 	6.82	 
	“Ono Trade Dress”

	 	 	6.10.1	 
	“Ono Trademark”

	 	 	6.10.1	 
	“Onyx”

	 	Preamble

	“Onyx Promotional Materials”

	 	 	6.8.2	 
	“Packaging and Labeling”

	 	 	7.2.2	(b)





 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




12









 






	 	 	 	 	 
	Term	 	Section
	“Party” or “Parties”

	 	Preamble

	“Parallel Exportation”

	 	 	2.7.1	 
	“Patent Challenge”

	 	 	9.7	 
	“Product Trade Dress”

	 	 	6.9.1	 
	“Product Trademark”

	 	 	6.9.1	 
	“Receiving Party”

	 	 	12.1	 
	“Recovery”

	 	9.4.2	(c)(iii)
	“Redacted Agreement”

	 	 	12.5.2	 
	“Responsible Party”

	 	 	9.4.1	(a)
	“Royalty Rate”

	 	 	8.3	 
	“Second Source”

	 	 	7.2.2	(a)
	“Term”

	 	 	13.1	 
	“Third Party Claim”

	 	 	11.1	 
	“Third Party License”

	 	 	9.4.1	(b)
	“Upfront Payment”

	 	 	8.1	 






ARTICLE 2

LICENSES





	2.1	 	Grant to Ono.





          2.1.1 General Grants to Ono. Subject to the terms and conditions of this Agreement, Onyx
hereby grants to Ono during the Term:




               (a) The exclusive, payment-bearing right and license under the Licensed Technology to
Commercialize Products in the Field in the Territory, without the right to sublicense;



               (b) The exclusive payment-bearing right and license under the Licensed Technology to perform
Territory Development Activities, including the rights to use, store, import, export and
distribute, all for research and clinical purposes, Compound and/or Product and to conduct further
research and to further develop the Licensed Technology in the Territory for the purposes of
exercising the rights granted to it in Section 2.1.1(a), with the right to sublicense solely in
accordance with Section 2.5; and



               (c) Subject to Section 7.2.2(a), the non-exclusive, right and license under the Onyx
Manufacturing Technology to Manufacture Product anywhere in the world for the purposes of
exercising the rights granted to it in Section 2.1.1, with the right to sublicense solely in
accordance with Section 2.5.



          2.1.2 Additional Grants to Ono.




               (a) Subject to the terms and conditions of this Agreement, including in particular Section
6.9, Onyx hereby grants to Ono during the Term an exclusive license or sublicense, as applicable,
without the right to sublicense, to use Product Trademark and Product


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




13









 







Trade Dress solely to the extent necessary to (i) Commercialize Product in the Field in the
Territory and (ii) Package and Label Product for Development or Commercialization in the Field in
the Territory.



               (b) Subject to the terms and conditions of this Agreement, Onyx hereby grants to Ono during
the Term:



                    (i) The exclusive right and license under the New Licensed Technology to Commercialize
Product in the Field in the Territory, without the right to sublicense;



                    (ii) The exclusive, right and license under the New Licensed Technology to perform Territory
Development Activities, including the rights to use, store, import, export and distribute, all for
research and clinical purposes, Compound and/or Product and to conduct further research and to
further develop the New Licensed Technology in the Territory for the purposes of exercising the
rights granted to it in Section 2.1.2(b)(i), with the right to sublicense solely in accordance
with Section 2.5.



     2.2 Grant to Onyx. Subject to the terms and conditions of this Agreement, Ono hereby grants
to Onyx (i) in the Territory, a [**], [**], [**], [**] license or sublicense, as applicable, [**],
under (a) the Ono Inventions and Ono Patents, and (b) Ono’s interest in Joint Inventions and Joint
Patents and (ii) outside of the Territory, an [**], [**], [**], [**], license or sublicense, as
applicable, [**], under (a) Ono Inventions and Ono Patents (except to the extent that any Ono
Patents are [**] to Onyx and [**] Onyx Patents pursuant to Section [**]), and (b) Ono’s interest in
Joint Inventions and Joint Patents. Upon the request of Onyx, Ono shall execute and provide to
Onyx all documents and instruments of conveyance respecting the foregoing intellectual property
rights as may be appropriate to perfect Onyx’s legal title thereto. The absence of such documents
and instruments of conveyance shall not limit the rights of Onyx in Ono Inventions, Ono Patents,
Joint Inventions or Joint Patents. To the extent any of the Ono Inventions, Ono Patents, Joint
Inventions or Joint Patents cannot be licensed by Ono to Onyx, Ono hereby irrevocably waives and
agrees never to assert, anywhere in the world, such non-licensable intellectual property rights
against Onyx, Onyx’s Affiliates’, Onyx’s (or its Affiliates’) licensees or Onyx’s (or its
Affiliates’) successors, or its and their respective customers.



     2.3 Tsu-jo Jisshiken Tohroku. Upon Ono’s request, Onyx shall use Commercially Reasonable
Efforts, at Ono’s sole expense, to register a “Tsu-jo Jisshiken Tohroku” for Ono, with respect to
the Licensed Patents and New Licensed Patents owned by Onyx in the Territory, which shall be
transferred or assigned to Ono. Ono shall promptly request that Onyx cancel such registration of
Tsu-jo Jisshiken Tohroku in cooperation with Onyx, at Ono’s sole expense, in the event of the
expiration or termination of this Agreement for any reason or in the event that Ono ceases to
Commercialize the Product during the Term for any reason.



     2.4 Additional Licensing Provisions.



          2.4.1 Negative Covenant. Each Party covenants that it will not use or practice any of the
other Party’s Patent rights or other intellectual property rights licensed (or





 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




14









 







sublicensed, as applicable) to it under this ARTICLE 2 except for the purposes expressly
permitted in the applicable license grant.




          2.4.2 No Implied Licenses; Retained Rights. Except as explicitly set forth in this Agreement,
neither Party grants any license, express or implied, under its intellectual property rights to the
other Party, whether by implication, estoppel or otherwise.




     2.5 Performance by Affiliates and Sublicensees.



          2.5.1 The Parties recognize that each may perform some or all of its obligations under this
Agreement, or exercise its rights under this Agreement, through Affiliates; provided, however, that
each Party shall remain responsible for and be guarantor of the performance by its Affiliates and
shall cause its Affiliates to comply with the provisions of this Agreement in connection with such
performance. Each Party hereby expressly waives any requirement that the other Party exhaust any
right, power or remedy, or proceed against an Affiliate, for any obligation or performance
hereunder prior to proceeding directly against such Party. Wherever in this Agreement the Parties
delegate responsibility to Affiliates, the Parties agree that such entities may not make decisions
inconsistent with this Agreement, amend the terms of this Agreement (except as permitted under
Section 16.2) or act contrary to its terms in any way.




          2.5.2 Ono shall have the right to sublicense its rights under the licenses granted under
Sections 2.1.1(b), 2.1.1(c) and 2.1.2(b)(ii) only with respect to a contract research service
provider in the case of a sublicense under Sections 2.1.1(b) and 2.1.2(b)(ii) or contract
manufacturing service provider in the case of a sublicense under Section 2.1.1(c), and only in
order to enable its rights (under the applicable license grant) in the Territory; provided that,
with respect to each such sublicense, (i) Onyx shall be notified in writing regarding the identity
of each sublicense that Ono desires to enter prior to the execution of a contract with each such
sublicensee, (ii) Ono shall ensure that each of its sublicensees accepts and complies with all
applicable terms and conditions of this Agreement, and Ono shall remain responsible for, and shall
guarantee, the performance of its sublicensees hereunder, and (iii) any such sublicense shall
contain a provision prohibiting such sublicensee from further sublicensing.




     2.6 Exclusivity.



          2.6.1 Ono. Ono hereby covenants that it shall not (and shall cause its Affiliates not to),
during [**], [**] (including [**] any [**] for [**]), [**] or [**] any Competitive Product in the
Field in any territory, either on its own, with or through any Affiliate, or in collaboration with
a Third Party.




          2.6.2 Onyx. Onyx hereby covenants that it shall not (and shall cause its Affiliates not to),
during [**], (i) [**] (including [**] any [**] for [**]), [**] or [**] any Competitive Product in
the Field in the Territory, either on its own, with or through any Affiliate, or in collaboration
with a Third Party or (ii) cause any Third Party to Develop Product outside of the Field in the
Territory for purposes of Commercializing such Product outside of the Field in the Territory.





[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.





15









 







For clarity, to the extent that a Party realizes a given product is a Competitive Product while it
is in the process of [**] such product, then this Section 2.6 shall apply and the affected Party
shall cease [**] of such product.




          2.6.3 Jurisdictional Compliance. It is the desire and intent of the Parties that the
restrictive covenants contained in this Section 2.6 be enforced to the fullest extent permissible
under the Laws and public policies applied in each jurisdiction in which enforcement is sought.




     2.7 Restrictive Covenants.



          2.7.1 Ex-Territory Activities. Ono hereby covenants and agrees that it shall not (and shall
cause its Affiliates not to), either directly or indirectly, market or sell Product into countries
outside of the Territory. Without limiting the generality of the foregoing, with respect to such
countries outside of the Territory, Ono shall not (i) engage in any promotional activities relating
to Product directed solely to customers located in such countries, or (ii) solicit orders from any
prospective purchaser located in such countries. Ono will use Commercially Reasonable Efforts to
prevent Third Parties from purchasing Product from Ono and reselling it outside the Territory
(“Parallel Exportation”) and, if Ono becomes aware that any Third Party is engaging in Parallel
Exportation, Ono will use best efforts to induce such Third Party to cease and desist said Parallel
Exportation. Onyx will reciprocally use Commercially Reasonable Efforts to prevent resale of
Product by any Third Party inside the Territory, and if Onyx becomes aware that any Third Party is
selling Product inside the Territory, Onyx will use best efforts to induce such Third Party to
cease and desist said activity.




          2.7.2 Ex-Field Activities. Ono hereby covenants and agrees that it shall not (and shall
cause its Affiliates not to), either directly or indirectly, market, distribute or sell Product
for use outside of the Field. Without limiting the generality of the foregoing, Ono shall not (i)
engage in any promotional activities relating to Product directed to use outside of the Field, or
(ii) solicit orders from any prospective purchaser for use of Product outside of the Field in the
Territory.




          2.7.3 Jurisdictional Compliance. It is the desire and intent of the Parties that the
restrictive covenants contained in this Section 2.7 be enforced to the fullest extent permissible
under the Laws and public policies applied in each jurisdiction in which enforcement is sought.




ARTICLE 3

GOVERNANCE




     3.1 Joint Development Committee. The Parties shall have the right to establish the JDC
within [**] ([**]) [**] after the Effective Date. The JDC shall perform the following functions:



          3.1.1 [**] and [**] the Development Plan and any material amendments thereto, as well as
approve specifically any amendments to the Initial Development Plan;





[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.





16









 








          3.1.2 [**] and [**] any Phase IV Clinical Trials in the Territory, investigator-sponsored
studies in the Territory, and any other clinical studies to be conducted in the Territory that are
not described in the Development Plan;




          3.1.3 [**] any matters related to Regulatory Approvals for Product in the Field in the
Territory;




          3.1.4 [**] the progress of any other Committees;




          3.1.5 Resolve disputes and other matters referred to the JDC by any other Committee;




          3.1.6 Encourage and facilitate communication between the Parties regarding the progress and
results (whether preliminary or final) of the Parties’ respective Development Activities, and
future development plans and strategies, in their respective territories (for Ono in the
Territory, for Onyx outside the Territory) with respect to the Product; and




          3.1.7 Have such other responsibilities as may be assigned to the JDC pursuant to this
Agreement or as may be mutually agreed upon by the Parties in writing from time to time.




     3.2 Joint Development Committee Membership. Onyx and Ono shall each designate an equal number
of representatives (in any event, at least [**] ([**]) representatives) of sufficient experience
and authority to bind, as agents, their respective companies, to serve on the JDC by written notice
to the other Party. The initial JDC members are set forth on Schedule 3.2. Either Party
may designate substitutes for its representatives if one (1) or more of such Party’s designated
representatives are unable to be present at a meeting. Each Party may also designate non-voting
representatives to attend each meeting with the consent of the other, such consent not to be
unreasonably withheld. From time to time each Party may replace its representatives by written
notice to the other Party specifying the prior representative(s) and their replacement(s). The JDC
shall be co-chaired by a representative of each of Ono and Onyx; provided that, the Ono chairperson
shall be responsible for conducting the meetings of the JDC. One (1) member of the JDC shall serve
as secretary of the JDC at each JDC meeting, and the secretary shall alternate from meeting to
meeting between an Ono JDC member and an Onyx JDC member. The chairpersons shall be responsible
for (i) calling meetings, (ii) preparing and issuing minutes of each such meeting within [**]
([**]) [**] thereafter, and (iii) preparing and circulating an agenda for the upcoming meeting;
provided that, the chairpersons shall consider including any agenda items proposed by either Party
no less than [**] ([**]) [**] prior to the next scheduled JDC meeting.



     3.3 Joint Development Committee Meetings. The JDC shall hold meetings, (i) during the first
[**] ([**]) years following the Effective Date, at least [**] ([**]) times [**] and (ii) from and
after the [**] anniversary of the Effective Date, at least [**], or more or less frequently as
agreed by the JDC. The first JDC meeting shall be held at a mutually agreed venue and date
following the Effective Date. Meetings of the JDC shall be effective only if at least two (2)
representatives of each Party are present or participating. The JDC may meet either (a) in



 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




17









 




person at either Party’s facilities, with the location alternating between each Party’s
facilities, or at such locations as the Parties may otherwise agree or (b) by audio or video
teleconference; provided that, no less than [**] ([**]) meetings during each of the first [**]
([**]) years following the Effective Date, and [**] ([**]) meeting per year thereafter, shall be
conducted in person. Other representatives of each Party involved with Product may attend meetings
as non-voting participants, subject to the confidentiality provisions set forth in ARTICLE 12.
Additional meetings of the JDC may also be held with the consent of each Party, as required to
resolve disputes, disagreements or deadlocks in the other Committees or as otherwise required under
this Agreement, and neither Party shall unreasonably withhold its consent to hold such additional
meetings. Each Party shall be responsible for all of its own expenses incurred in connection with
participating in the JDC meetings or any of the other Committee meetings.




     3.4 Decision-Making. The JDC may make decisions with respect to any subject matter that is
subject to the JDC’s decision-making authority and functions as set forth in Section 3.1. All
decisions of the JDC shall be made by unanimous vote or written consent, with Ono and Onyx each
having, collectively, among its respective members, one (1) vote in all decisions. The JDC shall
use commercially reasonable efforts to resolve the matters within its roles and functions or
otherwise referred to it. In the event that the JDC is unable to resolve any matter unanimously,
such matter will be referred to the Executive Vice President and Head of Research and Development
of Onyx, and the Director of Development Headquarters of Ono, for attempted resolution in good
faith. If such officers are unable to resolve such matter, then Ono shall have the final decision
making authority with respect to Development of the Product in the Field in the Territory.
Notwithstanding the preceding allocation of decision making authority, Ono may exercise such
decision making authority only to the extent that such decision (i) could not reasonably be
expected to have a [**] on the [**], and the [**] for, or the [**] of the Product [**] and (ii)
does not modify the Initial Development Plan with respect to [**] or [**] described therein with
respect to which the [**] milestone payments pursuant to Section 8.2 will be paid, provided that,
notwithstanding the foregoing sub-clause (ii), Ono may exercise final decision-making authority to
amend the Initial Development Plan with respect to [**] described therein only to the extent
required to meet (a) [**], (b) [**], (c) the [**] of [**] or other [**] with respect to a
[**], [**], and [**], or (d) [**] of [**] and [**] (including [**], [**] and [**])
[**].



     3.5 Limits on JDC and Committee Authority. The JDC and any other Committee shall have only
the powers assigned expressly to it in this ARTICLE 3 and elsewhere in this Agreement, and shall
not have any power to amend, modify or waive compliance with this Agreement. In furtherance
thereof, each Party shall retain the rights, powers and discretion granted to it under this
Agreement and no such rights, powers or discretion shall be delegated or vested in the JDC and any
other Committee unless such delegation or vesting of rights is expressly provided for in this
Agreement or the Parties expressly so agree in writing. Without limiting the generality of the
foregoing, the JDC and any other Committee shall have no decision-making authority with respect to
any matters related to (i) approving (or otherwise making decisions with respect to) matters
related to obtaining, maintaining or enforcing Patent protection and market and data exclusivity
for Product in the Field in the Territory (which matters shall be governed by ARTICLE 9), (ii) the
Development of Product outside of the Field


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




18









 




or outside of the Territory, (iii) the Commercialization of Product outside of the Field or
outside of the Territory and (iv) the Manufacture of Product.




     3.6 Disbanding the JDC. At any time during the Term, and for any reason, either Party shall
have the right to disband the JDC (and any Committees existing as of such time) upon written notice
to the other Party, which notice shall be effective immediately upon receipt (“Disbanding Notice”).
Following the issuance of a Disbanding Notice and subject to this Section 3.6, (i) the JDC (and
any Committees existing as of such time) shall immediately cease meeting and (ii) all decisions,
obligations, rights and responsibilities within the purview of the JDC (and any Committees existing
as of such time) shall henceforth be handled directly between the Parties, and the Parties shall
work together in good faith to ensure the sharing of information previously under the purview of
the JDC. In the event of any dispute, Section 3.4 shall apply. If, at any time following the
issuance of a Disbanding Notice, the Party issuing the Disbanding Notice wishes to reestablish the
JDC, such Party shall notify the other Party in writing and, thereafter, the JDC shall be
reestablished and function in accordance with the provisions of this ARTICLE 3. For clarity, the
disbanding of the JDC by either Party under this Section 3.6 shall have no impact on the
consideration provided for or due to such Party under this Agreement.



     3.7 Committees. From time to time, the JDC may establish and delegate duties to other
sub-committees or directed teams (each, a “Committee”) to oversee particular projects or
activities. Each such Committee shall be constituted and shall operate as the JDC determines;
provided that, each Committee shall have equal representation from each Party. Committees may be
established on an ad hoc basis for purposes of a specific project, or on such other basis as the
JDC may determine. Each Committee and its activities shall be subject to the oversight, review and
approval of, and shall report to, the JDC. In no event shall the authority of a Committee exceed
that of the JDC. Without limiting the foregoing, the Parties agree to (i) appoint the
Commercialization Liaisons described in Section 6.3, (ii) timely establish the JMM and (iii)
establish an intellectual property committee to review and discuss the overall strategy for
prosecuting, maintaining, enforcing and defending Licensed Patents, New Licensed Patents, Ono
Patents and Joint Patents covering or claiming Compound or Product in the Field in the Territory,
taking into consideration the respective overall global patent strategy for such Patents.



     3.8 Actions. In developing strategies, making decisions and exercising its rights under this
Agreement (including acting through its representatives on any of the Committees and its
Commercialization Liaisons), each Party shall act in good faith and use its Commercially Reasonable
Efforts to achieve the goals of the then-current Development Plan or Commercialization Plan.



     3.9 Minutes of Committee Meetings. Within [**] ([**]) [**] after a Committee meeting, the
secretary of such Committee shall prepare and distribute to all members of such committee draft
minutes of the meeting. Such minutes shall provide a list of any issues yet to be resolved, either
within such Committee or through the relevant resolution process. Thereafter, definitive minutes
for each Committee meeting shall be finalized as soon as practicable after a given meeting, but in
any event [**] ([**]) [**] after the meeting to which the minutes pertain.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




19









 





ARTICLE 4

DEVELOPMENT




     4.1 Overview.



          4.1.1 Overview of Development. Ono shall conduct, in accordance with the Development Plan,
the Territory Development Activities, including bridging studies, clinical studies, Phase IV
Clinical Studies (and other post-Regulatory Approval studies). Ono shall perform the Territory
Development Activities so as to (i) enable obtaining Regulatory Approval in the Territory for
Product in the Field and (ii) maximize the commercial potential for Product in the Field in the
Territory.




          4.1.2 General Development Activities and Development Outside of the Territory or Outside of
the Field; Regulatory Approvals Outside of the Territory or Outside of the Field. The Parties
hereby agree and acknowledge that nothing contained herein shall limit or otherwise restrict the
ability of Onyx or its Affiliates or licensees to (i) perform the General Development Activities
as it sees fit and at its sole discretion, (ii) Develop Product for use or sale outside of the
Territory (whether or not in the Field) or (iii) obtain or maintain Regulatory Approvals for
Product outside of the Territory. Without limiting the generality of the foregoing, the
Development Plan shall not address (a) any General Development Activities, (b) any activities
which are necessary solely for obtaining or maintaining Regulatory Approval for Product in any
country outside of the Territory or (c) obtaining or maintaining Regulatory Approvals for Product
outside of the Territory.




          4.1.3 Manufacturing Related Activities. The Parties hereby agree and acknowledge that Onyx
shall be solely responsible for planning and performing all Manufacturing Development Activities.
For clarity, Manufacturing Development Activities shall not be set forth in the Development Plan.




          4.1.4 Certain Additional Restrictions. Ono agrees and acknowledges that it and its
Affiliates shall not conduct any Development of Product except in accordance with a Development
Plan established pursuant to this Agreement.




     4.2 Objectives Under the Development Plan.



          4.2.1 Development Activities. Ono shall use Commercially Reasonable Efforts to carry out the
Territory Development Activities set forth in the Development Plan in accordance with the time
frames set forth therein.




          4.2.2 Development Compliance. Ono shall conduct its Development Activities in accordance
with sound and ethical business and scientific practices, and in compliance with all Laws, GCPs
and GLPs. In addition, Ono shall not use in any capacity, in connection with its Development (or
Commercialization) of Product hereunder, any Person who has been debarred pursuant to Section 306
of the FD&C Act (or similar Laws outside of the U.S.), or who is the subject of a conviction
described in such section, and Ono shall inform Onyx in writing immediately if it or any Person
who is performing services for Ono hereunder


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




20









 






is debarred or is the subject of a conviction described in Section 306 (or similar Laws
outside of the U.S.), or if any action, suit, claim, investigation or legal administrative
proceeding is pending or, to Ono’s knowledge, is threatened, relating to the debarment of Ono or
any Person used in any capacity by Ono in connection with its Development (or Commercialization)
of Product hereunder.




     4.3 Development Plan.



          4.3.1 General. In connection with the Development of Product for use in the Field in the
Territory, Ono shall conduct Territory Development Activities pursuant to a comprehensive
development plan (the “Development Plan”). The Development Plan shall set forth, among other
things, the following:




               (a) any preclinical studies, Phase I Clinical Trials, Phase II Clinical Trials, and other
studies necessary for Regulatory Approval in the Territory. For clarity, and without limitation
of any other provisions herein, Onyx shall have the right to [**] and [**] on the protocols
pursuant to which any clinical trials using Product will be conducted; and



               (b) material elements of Ono’s regulatory plans for obtaining and maintaining Regulatory
Approvals in the Field in the Territory, and the [**] associated therewith.



          4.3.2 Initial Development Plan. The initial Development Plan for Product is attached hereto
as Schedule 4.3.2 (the “Initial Development Plan”), which plan describes among other
things the [**] and [**] with respect to which the [**] milestone payments pursuant to Section 8.2
will be paid. Without limitation of other provisions herein, to the extent any “national
meetings” with the Regulatory Authorities in the Territory provide guidance with respect to the
risk management plan or Development Activities, the Parties shall consider such guidance in
updating and amending the Development Plan pursuant to Section 4.3.3.




          4.3.3 Updating and Amending Development Plan; Additional Development Activities.




               (a) During the Term, on or before [**] of each year, the JDC shall [**] and [**], to the
extent applicable pursuant to Section 3.1.1, the Development Plan which shall cover the Territory
Development Activities to be conducted during the upcoming calendar year, and the JDC shall [**]
and [**] the then-current Development Plan to reflect any changes, reprioritizations of, or
additions to the Development Plan with the same frequency as the JDC meetings.



               (b) From time to time during the Term, either Party may submit to the JDC any proposed
expansion or other amendment of the Development Plan to cover additional Development Activities
(or otherwise amend the Development Activities) with respect to Product for use in the Field in
the Territory for the JDC’s [**] and [**]. Once [**] by the JDC, each [**] Development Plan shall
become effective and supersede the previous Development Plan as of the date of such approval or at
such other time as decided by the JDC.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




21









 





     4.4 Development Costs.



          4.4.1 General Development Activities. In consideration for the information and results
arising from the General Development Activities, which information and results may be useful for
obtaining Regulatory Approval in the Field in the Territory and would be delivered to Ono pursuant
to Section 5.1, the Parties shall share Development Costs incurred by Onyx from [**] through [**],
with respect to any General Development Activities, with Onyx bearing [**] percent ([**]%) of such
costs and Ono bearing (i.e., reimbursing Onyx for) the remaining [**] percent ([**]%) of such
costs (including, for clarity, [**] and [**]); provided that, Ono’s obligation to share in such
costs shall be capped at [**] Dollars ($[**]) per [**], and at a total of [**] Dollars ($[**]) for
such [**] ([**]) [**] period. From and after [**], Onyx shall be responsible for one hundred
percent (100%) of all Development Costs incurred by Onyx with respect to any General Development
Activities. In furtherance of the foregoing, within [**] following the end of each [**] after the
[**], Onyx shall prepare and deliver to Ono a [**] report detailing the Development Costs incurred
with respect to Development Activities during such period with such costs broken-down in
reasonable detail, as well as an invoice for the amount of such Development Costs which Ono is
responsible for pursuant to this Section 4.4.1; provided that, the [**] such invoice shall also
include [**] incurred by Onyx with respect to Development Activities [**] by Onyx [**]. Ono shall
pay the amount of such Development Costs within [**] ([**]) [**] of its receipt of each such
invoice and such [**] report; provided that, Onyx shall submit any additional information
reasonably requested by Ono related to such costs included in its report within [**] ([**]) [**]
of its receipt of such request. As of the Effective Date, the General Development Activities
include, among other things, the studies set forth on Schedule 4.4.1.




          4.4.2 Territory Development Activities. Subject to Section 4.4.3, Ono shall be solely
responsible for one hundred percent (100%) of all Development Costs incurred with respect to any
Territory Development Activities performed by or on behalf of Ono.




          4.4.3 Onyx’s Assistance. In further consideration for the Development Cost sharing required
by Section 4.4.1, upon reasonable request of Ono and subject to availability of appropriate
personnel, Onyx shall, at no additional expense to Ono other than the cost sharing described in
Section 4.4.1, (i) perform statistical re-analysis of data arising from non-clinical studies,
pre-clinical studies and/or clinical trials performed by Onyx, but only if required by Regulatory
Authorities in the Territory for the performance of Ono’s obligations hereunder, and (ii) provide
reasonable assistance to Ono to prepare the Regulatory Materials for Regulatory Approval and to
respond to Regulatory Authorities’ inquiries and investigation relating to analysis of data
arising from non-clinical studies, pre-clinical studies and/or clinical trials conducted by Onyx;
provided that, from and after [**], Onyx shall provide [**]  per [**]  for purposes of assisting Ono with Development Activities,
regulatory activities or related matters relating to Product in the Field in the Territory.






 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




22









 








     4.5 Records, Reports and Information.



          4.5.1 General. Each Party shall, to the extent applicable, maintain current and accurate
records of all work conducted by it under the Development Plan and all data and other information
resulting from such work (which records shall include, as applicable, books, records, reports,
research notes, charts, graphs, comments, computations, analyses, recordings, photographs,
computer programs and documentation thereof (e.g., samples of materials and other graphic or
written data generated in connection with the Development Activities)). Such records shall
properly reflect all work done and results achieved in the performance of the Development
Activities in sufficient detail and in good scientific manner appropriate for regulatory and
patent purposes. Each Party shall, to the extent applicable, document all preclinical studies and
clinical trials to be conducted pursuant to the Development Plan in formal written study reports
according to applicable national and international (e.g., ICH, GCP and GLP) guidelines. Each
Party shall, to the extent applicable and practicable, be given an adequate opportunity, in any
event not less than [**], to comment on the drafts of reports resulting from activities conducted
under the Development Plan; provided that, Ono will incorporate (or otherwise appropriately and
adequately address) any comments received from Onyx to the extent that a failure to so incorporate
(or otherwise appropriately and adequately address) any such comments could have an adverse effect
on the Product or Compound outside of the Territory.




          4.5.2 Status Updates in the Territory. Each Party shall, to the extent applicable, provide
the JDC with reports detailing its respective Development Activities under the Development Plan
and the results thereof at least [**] prior to any JDC meeting and with the same frequency as JDC
meetings. Without limiting the foregoing, each Party shall, to the extent applicable, promptly,
but in any event within [**] after receipt thereof, provide to the other Party copies of any
material documents or correspondence received from any Regulatory Authority related to Development
Activities under the Development Plan.




          4.5.3 Access to Records. Each Party shall have the right, not more than one (1) time per
calendar year, to review all records under the Development Plan maintained by the other Party at
reasonable times, upon written request; provided, however, that the other Party shall have the
right to redact any portions thereof not solely related to the Development of Product for use in
the Field.




     4.6 Development Diligence. If Ono fails to complete a development event as set forth in the
Development Plan (each, a “Development Plan Event”) [**] (including the Initial Development Plan,
to the extent applicable), then Onyx has the right to terminate this Agreement in accordance with
Section 13.5; provided that, such [**] period, and Onyx’s termination right related thereto, shall
be tolled for the duration of any Force Majeure event (as defined in Section 16.3, and including,
for clarity, unanticipated changes in regulations or Regulatory Authority’s order) that prohibits
Ono from timely completing a Development Plan Event. For the avoidance of doubt, “Development
Plan Event” does not refer to [**] but instead means a certain [**] as indicated in the
Development Plan.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




23









 





     4.7 Global Clinical Studies. Either Party may request that sites in the Territory be
included in a global clinical study. Following such request, the Parties shall discuss through
the JDC, or a specific Committee, the manner in which such request could be implemented and, in
particular, the clinical study protocols, clinical operations and Regulatory Approvals necessary
for such sites in the Territory. If the Parties mutually decide to conduct such global clinical
study with sites in the Territory, then Ono shall be responsible for Development Costs for such
global clinical study with respect to Development Activities inside the Territory, and Onyx shall
be, subject to Section 4.4.1, responsible for Development Costs for such global clinical study
with respect to Development Activities outside the Territory. Ono’s involvement in such study
shall include implementation activities, including arranging clinical sites within the Territory
for such clinical trials, meeting with and recruiting key opinion leaders in the Territory,
interfacing with Regulatory Authorities in the Territory and conducting other Development
Activities reasonably requested by Onyx and agreed to by both Parties. For clarity, in the event
that the Parties are not able to decide to conduct such global clinical study with sites in the
Territory, then Onyx shall not include sites in the Territory for such global clinical study.



ARTICLE 5

REGULATORY




     5.1 Regulatory Data and Regulatory Materials.



          5.1.1 Initial Transfer. Within [**] ([**]) [**] after the Effective Date, Onyx shall
provide, in electronic format, copies of the Regulatory Materials and Regulatory Data in its
possession that are necessary for Ono to perform its obligations hereunder, including IND #s
71,057 and 105,912, clinical study protocols and reports, analytical methods and pre-clinical data
existing as of the Effective Date.




          5.1.2 Regulatory Materials and Regulatory Data. During the Term, each Party shall provide to
the other, within [**] ([**]) [**], copies of any Regulatory Materials and Regulatory Data that it
may generate or otherwise acquire.




          5.1.3 Use of Data by Ono. Ono may use the Regulatory Materials and Regulatory Data provided
by Onyx hereunder or generated by Ono hereunder, and any other Licensed Technology (or New
Licensed Know-How), only for the purposes of (i) Developing Product in the Field in the Territory
pursuant to this Agreement, (ii) Commercializing Product in the Field in the Territory pursuant to
this Agreement and (iii) obtaining and maintaining Regulatory Approval for Product in the Field in
the Territory pursuant to this Agreement.




     5.2 Regulatory Filings and Regulatory Approvals.



          5.2.1 General Responsibilities; Ownership of Regulatory Approvals. Ono shall use
Commercially Reasonable Efforts to obtain Regulatory Approval for Product in the Field in the
Territory on the timelines described in the Development Plan. Subject to Section 5.2.5, Ono shall
be responsible for the preparation of all Regulatory Materials necessary or desirable for
obtaining and maintaining Regulatory Approvals in the Territory (including in


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




24









 






connection with Patient Information Leaflets, and labeling and packaging for Product in the
Field in the Territory) and Ono shall submit such Regulatory Materials, Regulatory Approvals and
MAA’s, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory
Approvals for Product in the Territory (other than those related solely to the Manufacture of
Product in the Territory, if any) shall be in the name of Ono, and Ono shall own all right, title
and interest in and to all such Regulatory Approvals and all related Regulatory Materials.




          5.2.2 Pricing Approvals. Notwithstanding the provisions of Section 5.2.1, to the extent that
it is necessary to obtain Pricing Approval for sale of Product in the Field in the Territory, Ono
shall (to the extent permitted by Laws) be solely responsible for (and shall use Commercially
Reasonable Efforts toward) obtaining and maintaining such Pricing Approvals in the Territory, in
its own name. Without limiting the foregoing, Ono shall use Commercially Reasonable Efforts to
apply for Pricing Approvals in the Territory as soon as reasonably possible following the receipt
of Product Approval in the Territory. Ono shall keep Onyx informed of Ono’s [**] for [**], and
the [**] it [**] in [**], such Pricing Approvals in the Territory, including [**] of [**] or [**]
with [**] regarding such Pricing Approval. To the extent permitted by Laws or the applicable
Regulatory Authority and subject to acceptance by Ono (such acceptance not to be unreasonably
withheld), Onyx shall be entitled to [**] with respect to obtaining or maintaining Pricing
Approvals for Product in the Field in the Territory.




          5.2.3 Cost of Regulatory Activities. Subject to Section 4.4.3, all Regulatory Costs incurred
in connection with the preparation by or on behalf of Ono of Regulatory Materials for, and
obtaining of Product Approvals in the Field in the Territory for Product shall be borne solely by
Ono. Ono shall be responsible for all Regulatory Costs involved in the maintenance of all
Regulatory Approvals for Product in the Field in the Territory.




          5.2.4 Reporting and Review. Ono shall keep Onyx reasonably and regularly informed in
connection with the preparation of all Regulatory Materials, Regulatory Authority review of
Regulatory Materials, and Regulatory Approvals, in each case with respect to Product for sale in
the Field in the Territory. Ono shall provide Onyx, within [**] ([**]) [**], with copies of all
notices, questions, and requests for information in tangible form which it receives from a
Regulatory Authority with respect to Product for sale in the Field; provided, however, that Ono
shall have the right to redact any information to the extent not related to Product.




          5.2.5 Notification and Consultation Prior to Regulatory Filings. Ono shall inform, and
consult with, Onyx regarding its strategy for pre-authorization activities (i.e., Regulatory
Authority meetings and MAA filing) and post-authorization activities, with respect to Regulatory
Approvals in the Territory for Product in the Field in the Territory prior to the filing thereof.
Without limitation of the foregoing, Ono shall provide Onyx at least [**] ([**]) [**], to the
extent possible, and in the event [**] ([**]) [**] is not possible, then the longest time
possible, to review all proposed Regulatory Materials for [**] and [**] prior to [**], and Ono
shall use good faith efforts to [**] any comments received from Onyx. Further, for clarity, in no
event shall Ono be obligated to delay filing Regulatory Materials as a result of Onyx’s
unreasonable delay in providing any comments (provided that Onyx shall be provided the [**] ([**])
[**] review period or such shorter review period that is the maximum allowed by the


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




25









 







Regulatory Authority receiving the filing). The materials to be provided to Onyx pursuant to
this Section 5.2.5 may be in Japanese, but Ono will use Commercially Reasonable Efforts to provide
Onyx with a summary, in English, of such materials, to the extent practicable.



     5.3 Communications. Each Party shall cooperate with the other in communicating with any
Regulatory Authority having jurisdiction regarding Product and Ono shall immediately notify Onyx in
the event that Ono communicates, or intends to communicate, either on its own initiative in
accordance with this Agreement or as a result of such a Regulatory Authority initiating contact
with Ono in connection therewith. Notwithstanding the foregoing, except as may be required by
Laws, Ono shall not, with respect to Product, communicate with (i) any Regulatory Authority having
jurisdiction outside of the Territory regarding Product or (ii) any Regulatory Authority with
respect to Product for use outside of the Field, in each case, unless explicitly provided for in
the Development Plan or requested or permitted in writing to do so by Onyx, or unless so ordered by
such Regulatory Authority, in which case Ono shall immediately notify Onyx of such order and shall,
to the extent permitted by Laws, not take any further actions or communicate with such Regulatory
Authority further until Onyx has provided instruction as to how to proceed. All communications
with Regulatory Authorities regarding Product in the Field in the Territory shall be undertaken as
provided in this Agreement.



     5.4 No Other Regulatory Filings. Except as otherwise expressly set forth in ARTICLE 5, Ono
(and its Affiliates) shall not file any Regulatory Materials or Regulatory Approvals for Product or
that are otherwise based on any Licensed Technology or any Joint Patents.



     5.5 Rights of Reference.



          5.5.1 Onyx shall use Commercially Reasonable Efforts to permit Ono (and its designees) to
access, and shall provide Ono (and its designees) with sufficient rights to reference and use, in
association with exercising Ono’s rights and performing its obligations under this Agreement,
Onyx’s Regulatory Materials and Regulatory Approvals outside of the Territory that are associated
with the Compounds and/or Product. Onyx shall transmit (or use Commercially Reasonable Efforts to
cause the transmission of) all necessary and appropriate letters to applicable Regulatory
Authorities advising such applicable Regulatory Authorities of such rights of reference and use.




          5.5.2 Ono shall permit Onyx (and its designees) to access, and shall provide Onyx (and its
designees) with sufficient rights to reference and use in association with exercising its rights
and performing its obligations under this Agreement, Ono’s Regulatory Materials and Regulatory
Approvals in the Territory that are associated with the Compounds and/or Product. Ono shall
transmit all necessary and appropriate letters to applicable Regulatory Authorities advising such
applicable Regulatory Authorities of such rights of reference and use.






 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




26









 








     5.6 Adverse Event Reporting; Safety Data Exchange and Medical Inquiries.



          5.6.1 Pharmacovigilance. Ono, as the holder of Product Approvals, shall be responsible for
the collection, review, assessment, tracking and filing of information related to adverse events
associated with Product in the Field in the Territory (whether or not Product Approval has been
achieved), in each case in accordance with Laws and this Agreement (and Ono shall ensure that, in
the Development and Commercialization of Product, it will record, investigate, summarize, notify,
report and review all adverse events in accordance with Laws). Onyx (or its designee) shall be
responsible for the collection, review, assessment, tracking and filing of information related to
adverse events associated with Product in the countries outside of the Territory. The safety
units from each of the Parties shall meet and agree upon written pharmacovigilance agreements for
exchanging adverse event and other safety information relating to (i) the Development of Product
within [**] ([**]) [**] of the Effective Date and (ii) the Commercialization of Product in
connection with the first MAA (including a JNDA in the Territory or its equivalent outside of the
Territory) for Product to be filed. Such written pharmacovigilance agreement shall ensure that
adverse event and other safety information is exchanged according to a schedule that will permit
each Party (and its designees or, solely with respect to Onyx, its sublicensees) to comply with
Laws and regulatory requirements in their respective markets.




          5.6.2 Global Safety Database. Onyx shall be responsible for maintaining the global safety
database for Product. The written pharmacovigilance agreement prescribed by Section 5.6.1 shall
ensure that adverse event and other safety information is exchanged according to a schedule that
will permit Onyx (and each of its designees and sublicensees, as applicable) to comply with Laws
and regulatory requirements in their respective markets. Onyx shall provide Ono with reasonable
access to such global safety database without any compensation to Onyx.




          5.6.3 Medical Inquiries for Product. Following the Effective Date, Ono, as the holder of
Product Approval in the Territory, shall be responsible for handling all medical questions or
inquiries in the Territory, including all Product Complaints, with regard to any Product sold by
or on behalf of Ono (or any of its Affiliates) (including setting up a call center in connection
therewith), in each case in accordance with Laws and this Agreement. Ono shall submit a copy of
any standardized responses to medical inquiries prior to use thereof for Onyx’s review and
comment. Onyx shall immediately forward any and all medical questions or inquiries which it
receives with respect to any Product sold by or on behalf of Ono (or any of its Affiliates) in the
Territory to Ono in accordance with all Laws and Ono shall immediately forward to Onyx any and all
medical questions or inquiries that it receives with respect to Product (i) not sold by or on
behalf of Ono (or any of its Affiliates) in the Territory or (ii) outside of the Territory, in
each case in accordance with all Laws. Notwithstanding the foregoing, Onyx shall be primarily
responsible for handling any Product Complaints related to the Manufacture of Product, and Ono
shall refer all such Product Complaints to Onyx, within [**] ([**]) [**] of receipt or otherwise
as soon as practicable after its receipt (or such other timing as may be specified in the
pharmacovigilance agreement). Further, Onyx shall submit a copy to Ono of its standardized
responses, and updated responses, to medical inquiries.



 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




27









 





     5.7 Regulatory Authority Communications Received by a Party.



          5.7.1 General. Each Party shall promptly inform the other of notification of any action by,
or notification or other information which it receives (directly or indirectly) from, any
Regulatory Authority whether inside the Territory or outside of the Territory which (i) raises any
material concerns regarding the safety or efficacy of Product; (ii) indicates or suggests a
potential material liability of either Party to Third Parties in connection with Product; (iii) is
reasonably likely to lead to a recall, market withdrawal or market notification with respect to
Product whether inside the Territory or outside of the Territory; or (iv) relates to expedited and
periodic reports of adverse events with respect to Product whether inside the Territory or outside
of the Territory, or Product Complaints, and which may have an adverse impact on Regulatory
Approval or the continued Commercialization of Product whether inside the Territory or outside of
the Territory. Ono shall be solely responsible for responding to any such communications relating
to Product in the Field in the Territory and the Parties shall reasonably cooperate with and
assist each other in complying with regulatory obligations, including by Onyx providing to Ono
such information and documentation which is in Onyx’s possession as may be necessary or reasonably
helpful for Ono to prepare a response to an inquiry from a Regulatory Authority in the Territory
with respect to Product in the Field. Ono shall also promptly provide Onyx with a copy of all
correspondence received from a Regulatory Authority whether inside the Territory or outside of the
Territory specifically regarding the matters referred to above. Onyx (or its designee) shall be
solely responsible for any communications relating to Product outside of the Territory.




          5.7.2 Disclosures. In addition to its obligations under this Agreement, each Party shall
disclose to the other Party the following regulatory information:




               (a) Regulatory Actions. All material information pertaining to actions taken by Regulatory
Authorities, whether inside the Territory or outside of the Territory, in connection with Product,
including any notice, audit notice, notice of initiation by Regulatory Authorities of
investigations, inspections, detentions, seizures or injunctions concerning Product, whether
inside the Territory or outside of the Territory, notice of violation letter (i.e., an untitled
letter), warning letter, service of process or other inquiry; provided, however, that the
disclosing Party shall be entitled to redact those portions thereof to the extent not related to
Product. Without limiting the generality of the foregoing, the disclosing Party shall promptly,
but in any event within [**] ([**]) [**], inform the other Party of any inspections, proposed
regulatory actions, investigations or requests for information or a meeting by any regulatory
Authority with respect to Product, whether inside the Territory or outside of the Territory.



               (b) Regulatory Non-compliance. All information pertaining to notices from Regulatory
Authorities, whether inside the Territory or outside of the Territory, of non-compliance with Laws
in connection with Product, including receipt of a warning letter or other notice of alleged
non-compliance from any Regulatory Authority relating to Product, whether inside the Territory or
outside of the Territory; provided, however, that the disclosing Party shall be entitled to redact
those portions thereof to the extent not related to Product.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




28









 





     5.8 Recall, Withdrawal, or Market Notification of Product.



          5.8.1 Notification and Determination. In the event that any Governmental Authority threatens
or initiates any action to remove Product from the market in the Field in the Territory, or one
Party otherwise determines that a recall, withdrawal or market notification in the Field in the
Territory is necessary, the Party receiving notice thereof, or such determining Party, shall
notify the other Party of such communication, or such determination, thereof immediately, but in
no event later than [**] ([**]) [**], after receipt thereof or such determination thereof.
Notwithstanding the foregoing, in all cases the Parties will together determine whether to
initiate any recall, withdrawal or market notification of Product in the Field in the Territory,
including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary
or permanent recall) or market notification by way of promptly discussing in good faith the
reasons therefor. In the event of any such recall, withdrawal or market notification, Ono, as the
distributor of Product in the Territory, shall determine the necessary actions to be taken, and
shall implement such actions to conduct such recall, withdrawal or market notification, with Onyx
providing reasonable input (which Ono shall in good faith consider and incorporate into any
recall, withdrawal or market notification strategy) and reasonable assistance. Without limiting
the foregoing, Onyx shall have the right to propose that a Product recall, withdrawal or market
notification should be initiated by Ono, but Ono, acting as the holder of Product Approval in the
Territory, shall make the final decision as to whether or not such a recall, withdrawal or market
notification in the Field in the Territory proposed by Onyx will be initiated. Ono shall at all
times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis,
customers within the Territory who have been supplied with Product of any particular batch, and to
recall such Product from such customers as set forth in this Section 5.8.1. In the event that any
Governmental Authority threatens or initiates any action to remove Product from the market in the
Field outside the Territory, or Onyx otherwise determines that such recall or withdrawal is
necessary or determines to recall or withdraw the Product outside of the Territory, Onyx shall
notify Ono of such communication or such determination thereof by Onyx immediately, but in no
event later than [**] ([**]) [**], after receipt thereof or such determination thereof by Onyx,
and the Parties shall promptly discuss whether to initiate any recall, withdrawal or market
notification of Product in the Field in the Territory (which would be conducted in accordance with
this Section 5.8.1).




          5.8.2 Cost Allocation. All direct costs and expenses associated with implementing a recall,
withdrawal or market notification with respect to Product in the Field in the Territory shall be
allocated between Onyx and Ono as follows:




               (a) in the event, and to the extent, that the recall, withdrawal or market notification
arises as a result of a material breach of this Agreement by Onyx, then Onyx shall bear the costs
and expenses, including all internal and Out-of-Pocket Costs of Ono for implementing the recall,
withdrawal or market notification; and



               (b) in the event, and to the extent, that the recall, withdrawal or market notification
arises out of the material breach of this Agreement by Ono, then Ono shall bear the costs and
expenses for implementing the recall, withdrawal or market notification; and


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




29









 





               (c) in all other cases, all costs and expenses incurred by either Party for implementing the
recall, withdrawal or market notification shall be borne equally by the Parties.



ARTICLE 6

COMMERCIALIZATION




     6.1 Commercialization in the Field in the Territory. During the Term, Ono shall be solely
responsible for Commercializing Product in the Territory for use in the Field. Ono shall be
responsible for one hundred percent (100%) of the expenses (including Pre-Marketing and other
Commercialization expenses) incurred in connection with the Commercialization of Product in the
Territory for use in the Field.



     6.2 Ono’s Performance.



          6.2.1 Specific Commercialization Obligations. Without limiting the generality of the
provisions of Section 6.1, in connection with the Commercialization of Product in the Territory
for use in the Field by Ono hereunder:




               (a) Ono shall (i) use Commercially Reasonable Efforts to Commercialize Product for use in the
Field in the Territory, (ii) maximize the commercial potential for Product in the Field in the
Territory, (iii) represent Product accurately and fairly, (iv) Commercialize Product so as to
reflect favorably on Product and the good name, goodwill and reputation of Onyx and (v) act in
good faith to maximize the economic value of Product.



               (b) Ono shall not (i) disparage, defame, discredit, or negatively comment to Third Parties in
any way about or concerning the Compounds, Product or Onyx (including Onyx’s activities,
operations or other products) nor permit its employees, officers or directors to do so, (ii)
utilize deceptive, misleading or unethical business practices, or (iii) take any action or
inaction that would reasonably be likely to prejudice the value of Product.



               (c) Ono shall be solely responsible for (i) receiving, accepting and filling orders for
Product in the Field in the Territory, (ii) handling all returns of Product in the Field in the
Territory, (iii) controlling invoicing, order processing and collection of accounts receivable for
the sales of Product in the Field in the Territory, and (iv) distributing and managing inventory
of Product in the Field in the Territory.



               (d) Ono shall launch Product in the Territory within [**] ([**]) [**] after all applicable
Regulatory Approvals for Product have been obtained. Ono shall ensure that, once launched,
Product remains commercially available throughout the Territory for the duration of the Royalty
Term.



     6.3 Commercialization Liaisons. At a mutually agreed time following the Effective Date
(provided that neither Party will unreasonably withhold its agreement thereto), each Party shall
designate an individual to serve as the main point of contact for each Party to exchange
information, facilitate communication and coordinate the Parties’ activities under this Agreement
relating to Commercialization of Products (each, a “Commercialization Liaison”),


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




30









 







including, for clarity, both in and outside of the Territory. For clarity, from
time-to-time, the Commercialization Liaisons shall have the right to request additional
information and updates regarding the other Party’s Commercialization activities.



     6.4 Reports. For the [**] period after the First Commercial Sale (and thereafter for each
[**] period following the [**] for Product in each [**]), Ono shall update Onyx, through the
Commercialization Liaisons, within [**] after the end of each Ono Fiscal Year regarding its
significant Commercialization activities involving Product. In addition, Ono shall provide
written [**] updates to Onyx, [**], with the content and form thereof being at Ono’s discretion
provided that such content reasonably addresses any specific requests from Onyx, summarizing its
Commercialization activities during the previous [**], for the [**] following [**].



     6.5 Joint Marketing Meetings. From time to time, each Party’s Commercialization Liaison
shall have the right to request that the Parties hold a joint marketing meeting (a “Joint
Marketing Meeting” or “JMM”), which may be attended by any senior representatives of the Parties
with responsibility for Commercializing Product. JMM shall be held in person or via video- or
tele- conference, as the Parties may agree. All decisions of the JMM shall be made by unanimous
vote or written consent, with Ono and Onyx each having collectively, among its respective members,
one (1) vote in all decisions. If the attendees of the JMM cannot reach consensus, then Ono shall
have the final decision making authority; provided that, Ono shall not have decision making
authority with respect to the following matters: (i) [**], (ii) global product positioning and
description as compared to competitor products (including Competitive Products), or (iii) public
disclosures of data by Onyx outside of the Territory. The JMM shall be responsible for, as
appropriate, discussing and overseeing:



          6.5.1 the [**] for Commercializing Product in the Field in the Territory, including [**];




          6.5.2 the Commercialization of Product in the Field in the Territory in the broader context
of Onyx’s Global Branding Strategy; and




          6.5.3 such other matters as the Parties may agree to discuss with respect to the
Commercialization of Product in the Field in the Territory.



Without limitation of the foregoing, at a date mutually agreed by the Parties during each Ono
Fiscal Year, for the [**] period after [**], Ono shall present to the JMM a commercialization plan
for the following [**] (the “Commercialization Plan”). From time to time during a given [**], Ono
shall update the JMM regarding its Commercialization activities, including, to the extent
applicable, such activities’ alignment with [**], and the Parties shall discuss such activities
and, to the extent applicable, [**] generally.




     6.6 Commercialization Compliance. Ono shall, in Commercializing Product in the Territory,
comply with all Laws, including MHLW requirements, and all applicable Regulatory Approvals for
Product, to the extent that those are applicable in the Territory.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




31









 





     6.7 Promotional Materials.



          6.7.1 Creation of Promotional Materials. Ono will create and develop Promotional Materials
for the Territory in accordance with the Regulatory Approvals and Laws, and shall provide samples
thereof to Onyx for its review and comment (and Ono shall consider any such comments in good
faith) prior to distributing such Promotional Materials. For clarity, such samples need only be
submitted for each different type of Promotional Material, as opposed to each item of Promotional
Material needing to be submitted. To the extent Ono includes any Onyx (or Onyx Affiliate)
trademarks in the Promotional Materials, Ono shall comply with Onyx’s (or Onyx’s Affiliate’s)
then-current guidelines for trademark usage.




          6.7.2 Supply of Onyx Promotional Materials. Onyx shall provide Ono with copies of written,
printed, video or graphic advertising, promotional, educational and communication materials (other
than Product labels and package inserts) created, developed and/or used in the US, Germany, UK,
France, Italy and Spain by Onyx or its Affiliates, and its licensees (provided that, with respect
to licensees, such provision of materials shall be subject to Onyx’s use of Commercially
Reasonable Efforts to obtain such rights) in Commercializing Product outside of the Territory in
the Field to support Ono’s Commercialization activities in the Territory, including materials
relating to marketing strategies for Product outside the Territory in the Field pursued by Onyx or
its Affiliates and its licensees and examples of core promotional materials used by Onyx or its
Affiliates and its licensees in Commercializing Product outside of the Territory in the Field
(“Onyx Promotional Materials”), promptly after such information becomes available during the Term.
Ono may use information contained in Onyx Promotional Materials for preparation of Promotional
Materials for use by Ono, or its Affiliate in connection with the Commercialization of the Product
in the Field in the Territory and for no other purpose.




          6.7.3 Inclusion of Logos on Packaging and Promotional Materials. To the extent permitted or
required by Laws and subject to obtaining necessary Regulatory Authority approvals, with respect
to Product to be sold by or on behalf of Ono (or any of its Affiliates) in the Territory, the Onyx
housemark (or Onyx’s designee’s housemark) and the Ono housemark shall be on all package inserts
utilized by Ono if practicable and appropriate in the Territory. Onyx hereby grants to Ono a
non-exclusive, royalty-free right and license during the Term to utilize the Onyx housemark
(including all trademarks, names and logos) in order to perform the Commercialization activities
required to be performed by Ono hereunder in accordance with the terms of this Agreement. Ono
hereby grants to Onyx (and its designees) a non-exclusive, royalty free right and license during
the Term to utilize the Ono housemark (including all trademarks, names and logos) in order to
perform the Manufacturing and other activities to be performed by or on behalf of Onyx under the
terms of this Agreement. Each Party shall only use the housemark of the other Party with the
necessary trademark designations, and each Party shall use the other Party’s housemarks in a
manner that does not derogate from such Party’s rights in its trademarks, names and logos. Each
Party shall submit representative samples of its use of the other Party’s housemark for review by
the other Party. Neither Party will take any action that will interfere with or diminish the
other Party’s rights in its respective trademarks, names and logos, and if a Party reasonably
believes that the use of its trademarks, names and logos by the other Party hereunder is
interfering with or diminishing its rights, such Party shall


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




32









 






notify the other Party thereof in writing and such other Party shall promptly cease use of
such trademarks, names or logos in such manner. Each Party agrees that all use of the other
Party’s trademarks, names and logos will inure to the benefit of such other Party, including all
goodwill in connection therewith.




          6.7.4 Ono Ownership of Promotional Materials. During the Term, Ono shall own all right,
title and interest in and to any Promotional Materials created by Ono hereunder relating to
Product in the Field in the Territory including copyrights, but excluding trademarks (including
Product Trademark), names, logos and other marks owned by or on behalf of Onyx or its Affiliates.




          6.7.5 Use of Promotional Materials Exclusively for Product. The Promotional Materials, and
any aspects of those uniquely tied to Product, shall be used by Ono exclusively in connection with
the Commercialization of Product in the Field in the Territory in accordance with the terms of
this Agreement, and Ono shall not use, or allow any other Person to use, any such Promotional
Materials except in accordance with this Agreement.




     6.8 Training. Ono shall be solely responsible for training, and all costs associated with
such training, its Sales Representatives and Medical Science Liaisons using Commercially
Reasonable Efforts and in all cases in accordance with Laws, including timely reporting of any
adverse events with respect to Product. To the extent that Onyx prepares, in its sole discretion,
any training materials with respect to the Commercialization of Product in the Field outside of
the Territory for the purpose of training Onyx’s own employees, Onyx shall provide Ono with copies
of such training materials.



     6.9 Product Trademarks and Product Trade Dress; Ono Trademarks and Ono Trade Dress.



          6.9.1 Trademark. Ono shall use Commercially Reasonable Efforts to select the same trademark
(and logo) and the same trade dress as Onyx is using for the Product outside of the Territory (the
“Product Trademark” and the “Product Trade Dress”, respectively) in order for Ono to Commercialize
the Product in the Field in the Territory. Notwithstanding the foregoing, in the event that Ono
believes that the use or registration of Product Trademark or the use of Product Trade Dress in
the Territory would be inappropriate due to linguistic or cultural particularities or against the
Laws of the Territory or by instruction of Regulatory Authority in the Territory, or in conflict
with any Third Party’s intellectual property rights in the Territory, based on a review of market
research, regulatory research, legal searches, investigation results, and any other relevant
information that may have been collected by either Party that is relevant to the clearance for use
and registration of a trademark or for use and registration of a trade dress, Ono shall present
such concern to Onyx, and Ono may select an alternative trademark and trade dress (the “Ono
Trademark” and the “Ono Trade Dress”) after due consultation with Onyx for use and registration in
the Territory; provided that, for clarity, Ono shall have no obligation to check the
registrability of such Ono Trademark or Ono Trade Dress outside of the Territory. Ono shall bear
all costs relating to the creation, legal clearance, filing, registration, and maintenance of any
Ono Trademark and Ono Trade Dress and shall own and employ any such Ono Trademarks or Ono Trade
Dress in the Territory.





 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




33









 







Onyx will have the right to file, register, maintain, and use any Ono Trademark and Ono Trade
Dress, at Onyx’s cost, outside the Territory, and Ono will have no obligation to investigate the
registrability of the Ono Trademark and/or Ono Trade Dress outside the Territory. For purposes of
this Agreement and as between the Parties, Onyx shall be the owner of the Ono Trademarks and Ono
Trade Dress outside of the Territory. For clarity, the Parties acknowledge and agree that it is
their mutual intention that Ono Commercialize Product in the Territory under the Product Trademark
and Product Trade Dress.




          6.9.2 Use and Ownership of Product Trademarks and Product Trade Dress. All uses of Product
Trademark and Product Trade Dress by Ono (and its Affiliates) to identify and/or in connection
with the Commercialization of Product in the Field in the Territory shall be in accordance with
Regulatory Approvals and all Laws, and shall be in accordance with Onyx’s quality control
guidelines for the Product Trademarks and the Product Trade Dress, as may be amended from time to
time. Ono (and its Affiliates) shall only use Product Trademark and Product Trade Dress pursuant
to the terms of this Agreement to identify and in connection with the Commercialization of Product
in the Territory for use in the Field, and Ono shall not (and shall cause its Affiliates not to)
use such Product Trademark or Product Trade Dress to identify or in connection with the marketing
of any other products. Onyx shall own and retain all rights to the Product Trademark and the
Product Trade Dress (in each case, together with all goodwill associated therewith throughout the
Territory), and Ono shall assign (and shall cause its Affiliates to assign), and hereby does
assign to Onyx, all of its right, title and interest in and to such Product Trademark and Product
Trade Dress, if any. Onyx shall also own rights to any Internet domain names incorporating
Product Trademark or any variation or part of such trademark as its URL address or any part of
such address; and Ono shall not establish any Internet domain name or URL incorporating such
Product Trademark without the prior written consent of Onyx; provided that Ono shall be
responsible for [**] with respect to such Internet domain names or URLs to the extent that Onyx
modifies or prepares any applicable website or website content to facilitate Ono’s
Commercialization of Product in the Territory. The Parties hereby agree and acknowledge that
nothing contained herein shall limit Onyx’s right to use Product Trademark or Product Trade Dress
outside of the Territory. For clarity, in the event that pursuant to Section 6.9.1, Ono registers
any Ono Trademark or uses Ono Trade Dress in the Territory, the provision of this Agreement with
respect to Product Trademark and Product Trade Dress shall not apply and Ono will not register any
Ono Trade Mark or uses Ono Trade Dress outside the Territory.




          6.9.3 Maintenance of Product Trademark. During the Term, Ono will use Commercially
Reasonable Efforts to establish, maintain and enforce Product Trademark in the Territory and will
bear all costs and expenses relating thereto, including with respect to Ono Trademarks and Ono
Trade Dress.




          6.9.4 Infringement of Product Trademark or Ono Trademark. In the event that either Party
becomes aware of any infringement of Product Trademark or Ono Trademark by a Third Party in the
Territory, such Party shall promptly notify the other Party and the Parties shall consult with
each other in good faith with respect thereto. Ono shall, at its sole discretion, have the first
right to determine how to proceed with respect to such infringement, including by the institution
of legal proceedings against such Third Party, in


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




34









 






which case all costs and awards relating to such legal proceedings will be borne exclusively
by Ono. If requested to do so, Onyx shall reasonably cooperate with any and all action initiated
by Ono, including by joining legal proceedings as a party at Ono’s expense. If Ono elects not to
take action or initiate legal proceedings against an instance of infringement to Product Trademark
or Ono Trademark in the Territory, Onyx shall have the right at its own and sole discretion to
take action or initiate legal proceedings against such instance of infringement to Product
Trademark or Ono Trademark in the Territory, in which case all costs and awards relating to such
legal proceeding will be borne exclusively by Onyx. If requested to do so, Onyx shall reasonably
cooperate with any and all action initiated by Ono in connection therewith, including, by joining
legal proceedings as a party at Onyx’s expense.




          6.9.5 Trademark Acknowledgments. Each Party acknowledges the sole ownership by the other
Party and validity of all trademarks, trade dress, logos and slogans owned by the other Party and
used or intended to be used in connection with the Commercialization of Product for the Field in
the Territory. Each Party agrees that it will not at any time during or after the Term assert or
claim any interest in, or do anything which may adversely affect the validity or enforceability
of, any copyright, trademark, trade dress, logo or slogan owned by the other Party and used or
intended to be used on or in connection with the marketing or sale of Product. Neither Party will
register, seek to register or cause to be registered any copyrights, trademarks, trade dress,
logos or slogans owned by the other Party and used or intended to be used on or in connection with
the marketing or sale of Product or any variation thereof, under any Laws providing for
registration of copyrights, trademarks, service marks, trade names or fictitious names (including
as an Internet domain name) or similar Laws, without the other Party’s prior written consent (in
its sole discretion).




     6.10 Global Branding Strategy. Onyx shall have the right, from time to time during the Term,
to implement (and thereafter modify and update) a global branding strategy, including global
messaging, for Product for use in the Field throughout the world (the “Global Branding Strategy”).
To the extent Onyx determines to utilize such Global Branding Strategy, Ono shall use Commercially
Reasonable Efforts to adhere to the Global Branding Strategy in its Commercialization of Product,
including with respect to any Promotional Materials; provided, that, in the event that Ono believes
that the application of the Global Branding Strategy in the Territory would be inappropriate
because of linguistic or cultural particularities, because it is against the Laws of the Territory
or because Ono reasonably determines it would be inconsistent with Ono’s obligation to use
Commercially Reasonable Efforts to Commercialize Product in the Territory, Ono shall present such
concern to Onyx, and the Parties shall discuss whether appropriate revisions to the Global Branding
Strategy may make it appropriate for use in the Territory. Nothing in this Section 6.10 shall be
construed to derogate from Ono’s ultimate right and responsibility to use Commercially Reasonable
Efforts to Commercialize Product in the Territory in accordance with the terms and conditions of
this Agreement.



ARTICLE 7

SUPPLY




     7.1 General. Onyx will use Commercially Reasonable Efforts to Manufacture (or have
Manufactured) and supply reasonable quantities of the Bulk Product for clinical and


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




35









 




commercial use in the Field in the Territory, in each case in accordance with the terms of the
Carfilzomib Supply Agreements and 0912 Supply Agreements described in Section 7.2 and the Quality
Agreement.




     7.2 Carfilzomib Supply Agreements.



          7.2.1 The Parties will negotiate in good faith to execute, within [**] of the Effective Date,
a clinical supply agreement to provide for Ono’s requirements for Bulk Product incorporating
Carfilzomib (the “Carfilzomib Product”, and the “Carfilzomib Development Supply Agreement”,
respectively) during Development. Thereafter, the Parties will negotiate in good faith to execute
a commercial supply agreement to provide for Ono’s Commercialization requirements for the
Carfilzomib Product (the “Carfilzomib Commercial Supply Agreement”) within [**] of the Effective
Date. The Carfilzomib Development Supply Agreement and Carfilzomib Commercial Supply Agreement
(collectively, the “Carfilzomib Supply Agreements”) will govern the terms under which Ono will
obtain its supply requirements of the Bulk Product incorporating Carfilzomib.




          7.2.2 The Parties acknowledge and agree that the Carfilzomib Supply Agreements will each
contain, as appropriate, the following terms and conditions, in addition to such other terms and
conditions as are standard for the industry for such agreements and as the Parties may otherwise
agree:




               (a) A requirement that Ono will obtain Bulk Product incorporating Carfilzomib exclusively
from Onyx; provided that, in the event that [**] with respect to [**], then Ono may establish a
separate supply source from among [**] suppliers for [**] (solely as such Product was being
Manufactured by Onyx at the time [**] occurred; i.e., Ono has no right to change the formulation
or specifications for Product), subject to consultation with Onyx and compliance with all Laws and
Regulatory Approvals, until such time as Onyx is again able to [**]. Without limitation of the
foregoing, within [**] ([**]) [**] of [**], Onyx shall provide Ono with any required Licensed
Know-How and Onyx Manufacturing Know-How (including technical documentation and contractual
support (i.e., support with respect to Third Party contracting and analytical testing) subject to
receipt of any necessary Third Party consents with respect thereto) necessary to enable Ono to
establish a separate supply source, subject to Ono’s ongoing obligation to obtain its supply
exclusively through Onyx as described above. If Ono requests Onyx to provide technical assistance
for Manufacturing [**] in connection with such establishment of a separate supply source, then
Onyx and Ono will separately negotiate in good faith a commercially reasonable fee for such
technical assistance. The Parties acknowledge and agree that such Ono-managed second source will
only be activated and commence clinical or commercial manufacturing activities, as the case may
be, in the event that Onyx suffers [**] and such [**] continues (i.e., such Ono-managed second
source shall cease Manufacturing after Onyx [**] and supplying such Bulk Product to Ono, provided
that, the Parties acknowledge and agree that the contractual relationship between Ono and such
Ono-managed second source may require a “tail period” after Onyx’s resumption of manufacturing
Product during which such Ono-managed second source will exhaust its supply of Product, provided,
further, that Ono shall use Commercially Reasonable Efforts to obtain as minimal a “tail period”
(and as easily terminated an agreement) as possible with any such Ono-managed second source, which
“tail


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




36









 







period” shall in any event not exceed [**]. For clarity, for so long as Onyx is using
Commercially Reasonable Efforts to establish a second (i.e., redundant) Onyx-managed supply source
(“Second Source”), and Onyx is providing contractual support sufficient to enable Ono access to
Bulk Product manufactured by such Onyx Second Source supplier if Onyx [**], then Onyx will have no
obligation to provide technical assistance for Manufacturing to Ono. In addition to the above,
(i) Onyx shall, at any time more than [**] ([**])[**] after the execution of the Carfilzomib
Development Supply Agreement, keep a quantity of Compound necessary to Manufacture [**] ([**])
[**] requirements of Product based on the most recent [**] forecast (and **] requirements in the
event that Onyx is not actively pursuing a Second Source) and (ii) Ono shall keep a quantity of
Product in accordance with Ono’s storage policy for its own (and other) products, which as of the
Effective Date would require an average stockpile of [**] of Carfilzomib Product supply.



               (b) In accordance with the procedures set forth in the Quality Agreement, Ono or its
designated Third Party shall be responsible (at its sole cost and expense) for all final product
labeling and packaging, and handling, storage, quality control, quality assurance, and the testing
and release of Product in connection with the foregoing (collectively, “Packaging and Labeling”).
Ono or its designated Third Party shall ensure that all such Packaging and Labeling shall comply
with Laws, GMPs and the Regulatory Approvals for Product in the Territory, including Product
Specifications; provided that, Onyx shall have the right, but not the obligation, to review any
single or collective element of Packaging and Labeling at any time and Ono shall give good faith
consideration to any comments received from Onyx. For clarity, Onyx shall provide Ono with copies
of all reasonably requested analytical methods, and transfer the related Licensed Know-How,
including providing Ono with such reasonable technical assistance as is necessary to enable Ono to
fulfill its obligations to release finished packaged Bulk Product under this Section 7.2.2(b) for
distribution in the Field in the Territory under ARTICLE 6.



               (c) Forecasting and ordering, pricing and invoicing procedures, which will in any event
provide that (i) with respect to the Development Supply Agreement, (A) a supply price equal to
Onyx’s cost therefor (including Onyx’s [**] and [**]), plus [**] percent ([**]%), but not to
exceed Three Hundred Dollars ($[**]) per [**] unit of Bulk Product incorporating Carfilzomib), and
(B) that Onyx will supply in total [**] ([**]) units of Bulk Product incorporating Carfilzomib in
[**] shipments of (X) [**] ([**]) units of Bulk Product incorporating Carfilzomib [**] and (Y)
[**] units of Bulk Product incorporating Carfilzomib in the [**], subject in each case to (1) a
successful GMP-compliant engineering run during [**] and (2) there being no changes required in
the Territory to the Bulk Product incorporating Carfilzomib specifications, excipients, suppliers,
manufacturers or container closure systems (provided that, the Parties may choose to negotiate an
interim supply agreement to govern the transfer of the initial clinical batches described by the
foregoing sub-clause (B)) and (ii) with respect to the Commercial Supply Agreement, a supply price
[**]. The Parties expect as of the Effective Date that this price will [**] ($[**]) per [**] vial
once [**] have been [**], but each Party acknowledges that such expectation may not be met. Onyx
shall also provide Ono, at [**], from time-to-time within [**] of written request therefor, with a
quantity of secondary reference standard not to exceed [**]/calendar year and related substance
not to exceed [**]/calendar year, necessary for testing of Product for clinical and commercial
purposes in the


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




37









 







Territory; provided that, the initial supply of such materials described in Schedule
4.3.2 will be provided as set forth in such Schedule.



               (d) Ono shall provide Onyx with a [**] forecast with the first [**] of each forecast becoming
firm and the remaining [**] to be used for planning purposes. In all cases the required
quantities of Bulk Product shall not be more than [**] percent ([**]%) of the total quantity
forecasted for any [**] period. Should any Purchase Order seek to purchase Bulk Product in amounts
up to [**] percent ([**]%) of the amounts set forth in the most recent [**] forecast provided by
Ono to Onyx or should Ono desire to increase the amount of Bulk Product to be manufactured
pursuant to any Purchase Order already submitted, then Onyx shall use reasonable commercial
efforts to comply with such requested changes; but Onyx shall not be liable to Ono for any
inability, despite its use of Commercially Reasonable Efforts, to manufacture such excess
quantities of Bulk Product. Notwithstanding the foregoing, until the [**] of the First Commercial
Sale of any Product, the required quantities of Bulk Product shall not be more than [**] percent
([**]%) of the total quantity forecasted for any [**] period.



               (e) Onyx will disclose to Ono detailed cost-breakdown information with respect to the price
of clinical supply, and the Parties will in good faith negotiate appropriate adjustments of such
clinical supply price if necessary to maximize the economic potential of the Product.



               (f) From and after the second anniversary of the Effective Date, Onyx shall deliver to Ono
Carfilzomib Product and/or Product containing ONX 0912 for commercial purposes, of which the
remaining shelf-life shall be determined by the Parties during the negotiation of the Carfilzomib
Commercial Supply Agreement and 0912 Supply Agreements, taking into consideration the period of
ordering, lead-time, release testing and storage requirements, as well as approved shelf-life of
the Product pursuant to the U.S. Regulatory Materials for Product.



     7.3 0912 Supply Agreements. In the event that Ono elects to advance ONX 0912 into Development
in the Territory, the Parties will (i) jointly agree to timing for executing a Development supply
agreement and a commercial supply agreement for Product incorporating ONX 0912 (the “0912 Supply
Agreements”) based upon the development plan for the Territory such that, in any event, a
commercial supply agreement will be executed prior to JNDA filing and (ii) subsequently negotiate
the 0912 Supply Agreements, on terms that the Parties agree to negotiate in good faith.



     7.4 Supply Price Following Patent Term. On a Product-by-Product basis, [**] prior to the
expected end of Royalty Term with respect to such Product, the Parties shall discuss and determine
in good faith, including by reference to competitive alternative supply prices offered by generic
competitors reasonably capable of meeting Ono’s quality, capacity, and customer service standards
for similar products, an appropriate supply price for such Product following the expiration of the
Royalty Term. In the event that Ono and Onyx fail to reach an agreement on lower supply price
despite such good faith negotiation, Onyx shall grant to Ono a royalty-free, perpetual and
worldwide license(s) under the Onyx Manufacturing Patents and Onyx Manufacturing Know-How, with the
right to sublicense, to manufacture or have


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




38









 




manufactured such Product, and shall, at Ono’s expense, provide Ono or its designated third
party supplier with technology transfer and other assistance reasonably required by Ono to enable
Ono to manufacture or have manufactured such Product, on terms to be mutually agreed upon by the
Parties in good faith.




     7.5 Quality Agreement. The Quality Agreement will set forth the Parties’ quality and
compliance obligations with respect to Manufacture of Product. Ono and Onyx agree to comply with
the requirements and provisions set forth in the Quality Agreement. The Quality Agreement will set
forth in greater detail many of the responsibilities and obligations set forth herein. In the
event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the
terms of this Agreement shall prevail. The Parties shall execute the Quality Agreement within [**]
([**]) [**] of the Effective Date.



     7.6 Commercial Sample Supply Price. Onyx shall separately supply Ono with Product (on an [**]
basis) for distribution as free samples in the Territory for Commercialization purposes to be used,
after obtaining Regulatory Approval for the Product in the Territory, as a specimen for display or
provided to doctors in accordance with the Law relating to such specimen and [**]; provided that,
(i) Onyx shall not be obligated to provide more than [**] ([**]) units of Product for free sample
purposes per calendar year and (ii) under no circumstances shall such samples be used for the
treatment of patients or subjects.



     7.7 Non-Clinical Development Supply. Onyx shall supply Ono, at [**], with Compound drug
substance and its related materials, including deuterated Compound, (i) as described in
Schedule 4.3.2, and (ii) as may otherwise be mutually agreed by the Parties from
time-to-time and within [**] of written request therefor.



ARTICLE 8

PAYMENTS




     8.1 Upfront Payment. In consideration for the rights and licenses granted to Ono hereunder
and the documentation delivery to be performed hereunder, Ono shall remit to Onyx an upfront amount
equal to Five Billion Yen (JPY 5B) (the “Upfront Payment”) by wire transfer of immediately
available funds into an account designated in writing by Onyx, on the date that is the later of (i)
fifteen (15) business days after the Effective Date or (ii) ten (10) business days after the
receipt by Ono of the tax documentation delivered by Onyx and expressly described in Section 8.5
(including the timeframe for delivery of such documentation as described in Section 8.5). Onyx
shall provide Ono with an invoice for the Upfront Payment. Such Upfront Payment shall be
nonrefundable and noncreditable against any other payments due hereunder.



     8.2 Milestone Payments. Ono shall remit to Onyx the milestone payments described in this
Section 8.2 following achievement (first occurrence) of the corresponding milestone event and
provision by Onyx to Ono of an invoice for the given milestone payment. A Party shall promptly
notify the other Party in writing of, but in no event later than [**] after, the achievement of
each such milestone event (each, a “Milestone Notification Notice”) achieved by it, Ono shall remit
the applicable milestone payment by wire transfer of immediately available


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




39









 




funds into an account designated by Onyx on [**] after the achievement (first occurrence) of
the applicable Milestone Event; provided, however, that in no event shall a failure to deliver a
Milestone Notification Notice relieve Ono of its obligation to pay Onyx the milestone payments
described in this Section 8.2. Each such milestone payment is nonrefundable and noncreditable
against any other payments due hereunder.




	 	 	 
	Milestone Event	 	Milestone Payment
	Development Milestones

	1. Upon Trial Completion of the [**] for Product in the Territory,
[**]

	 	JPY [**]
	2. Upon Trial Completion of the [**] for Product in the Territory (or, if
there is no [**], upon [**]), [**]

	 	JPY [**]
	3. Upon acceptance of [**] of the [**] for Product by [**]

	 	JPY [**]
	4. Upon the [**] of a [**] for Product, [**]

	 	JPY [**]
	 
	[**] Milestones

	1. Upon the [**] achievement of [**] of Product [**]
in the Territory

	 	JPY [**]
	2. Upon the [**] achievement of [**] of Product [**] in
the Territory

	 	JPY [**]





For clarity, (i) each milestone payment shall be payable to Onyx only one time upon the first
achievement of such milestone, regardless of subsequent or repeated achievement of such milestone
by any Compound or Product, (ii) in the event that any given milestone payment is not paid for any
reason, such milestone shall become due and immediately payable upon the occurrence of the next
milestone being accomplished, and (iii) with respect to the first and second milestones, where [**]
is performed, the first milestone shall become due and payable upon Trial Completion of the [**]
and the second milestone shall become due and payable upon Trial Completion of [**]; provided,
however, that, in event that [**] is conducted and data base lock with respect to the [**] is
required prior to entering the [**] due to any unexpected event (e.g, a serious adverse event
occurred), then (a) the [**] shall be deemed to be an [**] conducted [**], (b) the [**] of such
[**] shall be deemed to be an [**] conducted [**] and (c) for clarity, “Trial Completion” with
respect to each such deemed [**] shall occur upon data base lock with respect to each such deemed
[**] study.




     8.3 Royalties. As further consideration for the rights and licenses granted to Ono under this
Agreement, Ono shall pay to Onyx, on Product-by-Product basis, until the expiration of the Royalty
Term with respect to such Product, a royalty equal to [**] percent ([**]%) (the “Royalty Rate”) of
Net Sales of Product in the Territory.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




40









 





     8.4 Royalty Payments and Reports. Ono shall calculate all royalty payments payable to Onyx
pursuant to Section 8.3 with respect to Net Sales at the end of each calendar quarter. Ono shall
remit to Onyx the royalty payment due for Net Sales during a given calendar quarter on the date
that is [**] ([**]) [**] after the end of such calendar quarter; provided, however, that if the
[**] ([**]) [**] falls on a non-business day then such royalty payment shall be remitted on the
previous business day. Notwithstanding the timing for royalty payments, Ono shall provide an [**]
report to Onyx within [**] ([**]) [**] after the end of each calendar quarter (which [**]
report will include [**] for the applicable calendar quarter and [**] of the Net Sales of Product
for the applicable calendar quarter based on the preceding calendar quarter’s deductions from gross
sales to arrive at Net Sales during such preceding calendar quarter) and an [**] report to Onyx
within [**] after the end of each calendar quarter, which report shall show (i) a statement of the
amount of [**] of Product in the Territory during the applicable calendar quarter (including such
amounts expressed in local currency and as converted to Dollars at the exchange rate for conversion
of JPY into Dollars posted by [**] on the [**] of such applicable calendar quarter), (ii) a
statement of the amount of [**] for in the [**] during such calendar quarter [**] and (iii) a
statement of the amount of the royalty payment due on such Net Sales for such calendar quarter.
Without limiting the generality of the foregoing, Ono shall require its Affiliates to account for
their respective Net Sales and to provide such reports with respect thereto as if such sales were
made by Ono.



     8.5 Taxes and Withholding.



          8.5.1 Tax Matters. The Parties acknowledge and agree that that no withholding taxes are
anticipated with respect to the Upfront Payment, milestone payment or royalties, as a result of
the tax treaty in place between Japan and the U.S as of the Effective Date subject to submission
of taxation documents necessary for obtaining the withholding tax exemption. If Ono’s future
payment to Onyx of a milestone payment or royalties is subject to a deduction of withholding tax
by Japanese tax authorities, the sum payable by Ono (in respect of which such withholding is
required to be made) shall be made to Onyx after deduction of the amount required to be so
withheld by Japanese tax authorities, which withheld amount shall be remitted to the Japanese tax
authorities in accordance with Laws and shall be an expense of, and borne solely by Onyx. In the
event that any taxes other than those described in the first two sentences of this Section, or any
transfer, excise, franchise, property, documentary, sales, use, stamp, registration, recording,
value added, goods and services, harmonized sales, or other such similar taxes or fees are imposed
in the Territory in connection with any payments to be made by Ono to Onyx under this Agreement,
the Parties shall discuss in good faith to reach agreement on which Party should bear such taxes
or fees in the light of nature of such tax.




          8.5.2 Tax Cooperation. To the extent Ono is required by the Japanese tax authorities to
deduct and withhold taxes on any payments to Onyx, Ono shall pay the amounts of such taxes to the
proper Japanese tax authorities in a timely manner and transmit to Onyx an official tax
certificate or other evidence of such withholding sufficient to enable Onyx to claim such payments
of taxes promptly after it is available. Onyx shall provide to Ono any taxation documents (Form 3
and Form 17), and the Residency Certificate of Onyx issued by the U.S. Internal Revenue Service
(which Residency Certificate is effective for three (3) years after its issuance to a public
company) that may be reasonably necessary in order for Ono not to


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




41









 






withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax
treaty. Onyx shall use reasonable efforts to provide any such taxation documents and the
Residency Certificate of Onyx to Ono at least [**] ([**]) [**] (to the extent possible) prior to
the due date for any payments for which Onyx desires that Ono apply a reduced withholding rate;
provided, however, that in the event that Onyx is not able to provide such taxation documents and
the Residency Certificate of Onyx to Ono at least [**] ([**]) [**] prior to the due date for any
payments, such payment shall be remitted to Onyx [**] ([**]) [**] after receipt by Ono of such
taxation documents and the Residency Certificate of Onyx. Each Party shall provide the other with
reasonable assistance to enable the recovery, as permitted by Laws, of withholding taxes or
similar obligations resulting from payments made under this Agreement, such recovery to be for the
benefit of the Party bearing such withholding tax.




     8.6 Currency Conversion. All payments hereunder shall be made in Dollars. All such payment
shall be converted into U.S. Dollars at the exchange rate for conversion of JPY into Dollars posted
by the Bank of Tokyo-Mitsubishi UFJ, Ltd. on the date on which Ono will make the applicable payment
hereunder, provided that no deduction from any amount shall be made in respect of bank fees or
charges.



     8.7 Late Payments. Any amount required to be paid by Ono hereunder which is not paid on the
date due shall bear interest at a rate equal to the thirty (30) day U.S. Dollar LIBOR rate
effective for the date that payment was first due as reported by The Wall Street Journal, plus two
percent (2%). Such interest shall be computed on the basis of a year of three hundred sixty (360)
days for the actual number of days payment is delinquent.



     8.8 Records; Audits. Ono and its Affiliates shall keep full, true and accurate records and
books of account containing all particulars that may be necessary for the purpose of confirming the
accuracy of, and calculating, as applicable, all royalty payments and other amounts payable to Onyx
hereunder (including records of Net Sales), and any other records reasonably required to be
maintained with respect to Ono’s obligations under this Agreement, for a minimum period of [**]
([**]) [**] or such longer period as required by Laws. Onyx shall have a right to cause an
independent, certified public accountant of internationally recognized standing selected by Onyx,
and reasonably acceptable to Ono, to audit such records of Ono, and its Affiliates in order to
confirm the accuracy of the foregoing (an “Audit”) for a period covering not more than the
preceding [**] ([**]) [**]. Such audits may be conducted during normal business hours upon
reasonable prior written notice to Ono, but no more than frequently than once per year. Ono shall
make personnel reasonably available during regular business hours to answer queries on all such
books and records required for the purpose of the Audit. Any underpayments by Ono shall be paid to
Onyx within [**] ([**]) [**] of notification of the results of such inspection. Onyx shall cause
the accounting firm to execute a reasonable written confidentiality agreement with Ono, which shall
provide that such accounting firm will disclose to Onyx only such information as is reasonably
necessary to provide Onyx with information regarding any actual or potential discrepancies between
amounts reported or paid and amounts payable under this Agreement and not disclose to Onyx any
information, financial or otherwise, unrelated to sales of the Product, including any financial
information regarding any of Ono’s products other than the Product. The accounting firm will send
a copy of the report it prepares for Onyx to Ono at the same time such report is delivered to Onyx.
The report sent to Ono will


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




42









 




include the methodology and calculations used to determine the results. Prompt adjustments
shall be made by the Parties to reflect the results of such audit. Any overpayments made by Ono
shall be refunded by Onyx within [**] ([**]) [**] of notification of the results of such
inspection. Onyx shall bear the cost of any such Audit, unless the Audit reveals that the actual
royalties payable, Net Sales, and/or any other applicable amount Audited hereunder to be different,
by more than [**] ([**]), than the amounts as previously calculated by Ono. Onyx shall treat all
financial information subject to review under this Section 8.8 in accordance with the
confidentiality and non-use provisions of this Agreement. Ono shall be free, including in any
instance wherein Ono disputes the results, findings or methodologies of Onyx’s auditor, to engage a
suitable auditor, at Ono’s own cost to review the work of Onyx’s auditor and Onyx shall use
Commercially Reasonable Efforts to cause its auditor to meet with Ono and Ono’s auditor and provide
to Ono and Ono’s auditor all relevant documents and information reasonably related to any issues
concerning royalty and milestone payments, and Onyx and Ono shall meet in good faith to resolve any
and all such issues.




ARTICLE 9

INTELLECTUAL PROPERTY MATTERS




     9.1 Ownership of Intellectual Property.



          9.1.1 General. Subject to the provisions of this Section 9.1.1 and except as expressly set
forth otherwise in this Agreement, (i) Onyx shall solely own, and it alone shall have the right to
apply for, Patents covering or claiming Onyx Inventions within and outside of the Territory and
have the right to apply for Patents covering or claiming Onyx Inventions, (ii) Ono shall, subject
to Sections 2.2 and 9.3.2(b), own all Ono Inventions within and outside of the Territory, and have
the right to apply for Patents covering or claiming Ono Inventions, and (iii) the Parties shall
jointly own all Joint Inventions within and outside of the Territory and each Party shall have the
right to apply for Patents covering or claiming Joint Inventions in accordance with Section 9.3.3.
Each Party shall promptly disclose to the other Party all Onyx Inventions, Ono Inventions and
Joint Inventions, as applicable, made by it during the Term. The determination of inventorship
for such Inventions shall be made in accordance with applicable Laws relating to inventorship set
forth in the patent Laws of the United States (Title 35, United States Code) or in its equivalent
foreign patent Laws where each of Inventions is originally discovered, made, conceived, or reduced
to practice. For clarity, subject to the rights granted to each Party under this Agreement, all
Joint Inventions shall be owned jointly by the Parties in accordance with joint ownership
interests of co-inventors under U.S. patent laws, with each Party having the unrestricted right to
use, license and grant rights to sublicense each such Joint Invention in the Territory.




          9.1.2 Employees. Each Party will require all of its and its Affiliates’ employees to assign
all Inventions that are discovered, made, conceived, or reduced to practice by such employees
according to the ownership principles described in Section 9.1.1, free and clear of all liens,
encumbrances, charges, security interests, mortgages or other similar restrictions. Each Party
will also use its Commercially Reasonable Efforts to require any agents or independent contractors
performing an activity pursuant to this Agreement to assign all Inventions that are discovered,
made, conceived or reduced to practice by such agents or


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




43









 






independent contractors to Onyx and/or Ono according to the ownership principles described in
Section 9.1.1 free and clear of all liens, encumbrances, charges, security interests, mortgages or
other similar restrictions, and to facilitate any actions necessary or useful to perfect the
Parties’ intellectual property rights in such inventions.




     9.2 Disclosures; Disputes Regarding Inventions. Each Party (the “Filing Party”) shall,
before filing a new Patent application in the Territory (including any priority claims) claiming
an Invention, promptly disclose such Invention to, and provide the other Party (the “Non-filing
Party”) with a copy of (i) the proposed patent application or (ii) the abstract of the claim of
proposed patent application, at least [**] ([**]) [**] to the extent practicable, and in any event
no less than [**] ([**]) [**], before filing such application or such shorter time as may be
required to preserve Patent rights, including the avoidance of a statutory bar or prior
publication. If the Non-filing Party provides any comments on either (i) or (ii) within ([**])
[**] after receipt thereof, the Filing Party shall use commercially reasonable efforts to
incorporate such comments made by the Non-filing Party into the Patent application. If the
Non-filing Party believes that such Filing Party’s proposed Patent application discloses
Confidential Information of such Non-filing Party, the Non-filing Party shall so notify the Filing
Party within [**] ([**]) [**] after receipt thereof, and shall amend its proposed application to
comply with the confidentiality provisions of this Agreement. If the Parties are in agreement as
to the designation of the Invention as an Onyx Invention, Joint Invention or Ono Invention, as
applicable, they shall continue as set forth in Section 9.3. If the Parties disagree as to
whether an Invention is an Onyx Invention, Joint Invention or Ono Invention, and are unable to
reach agreement within [**] ([**]) [**] after commencing discussions, then the provisions of
ARTICLE 15 shall apply to such dispute.



     9.3 Patent Filings, Prosecution and Maintenance.



          9.3.1 Licensed Patents and New Licensed Patent. Subject to Section 9.2, Onyx shall have the
first right to prepare, file, prosecute and maintain all Licensed Patents and New Licensed Patents
(including those covering or claiming Onyx Inventions), at its own cost and expense within and
outside of the Territory. Onyx shall keep Ono informed of the status of Licensed Patents and New
Licensed Patents and will provide Ono with copies, in English, of all substantive documentation
submitted to, or received from, the patent office in the Territory and in the United States in
connection therewith. The Parties shall cooperate reasonably in the prosecution of all Licensed
Patents and New Licensed Patents and shall share all material information relating thereto
promptly after receipt of such information. If, during the Term, Onyx (a) intends to allow any
Licensed Patent or New Licensed Patent to which Ono has an exclusive license under this Agreement
to expire or intends to otherwise abandon any such Licensed Patent or New Licensed Patent, or (b)
decides not to prepare or file patent applications covering or claiming Onyx Inventions in the
Territory to which Ono would otherwise have an exclusive license under this Agreement, Onyx shall
notify Ono of such intention or decision at least [**] ([**]) [**] (or as soon as possible if less
than [**] ([**]) [**]) prior to any filing or payment due date, or any other date that requires
action, in connection with such Licensed Patent and New Licensed Patents. In such case, such
Licensed Patent and New Licensed Patent shall be assigned to Ono at Ono’s expense, and Ono shall
have the right to prepare, file, prosecute and maintain, at Ono’s expense and in the name of Ono,
such Licensed Patent and


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




44









 






New Licensed Patent as assigned to Ono. The aforementioned assigned Licensed Patents and New
Licensed Patents shall be deemed Ono Patents; provided that, Onyx shall not be obligated to, and
Ono shall not be able to cause Onyx to, assign any given Licensed Patent or New Licensed Patent to
the extent that such an assignment could have an adverse effect on Onyx’s worldwide strategy with
respect to Product (including any such effect with respect to Onyx’s intellectual property
portfolio).




          9.3.2 Ono Patents




               (a) Subject to Section 9.2, Ono shall have the first right to prepare, file, prosecute and
maintain all Ono Patents (including those covering or claiming Ono Inventions), at its own cost
and expense in and outside the Territory. Ono shall keep Onyx informed of the status of Ono
Patents and will provide Onyx with copies of all substantive documentation submitted to, or
received from, the patent offices in connection therewith. The Parties shall cooperate reasonably
in the prosecution of all Ono Patents, in accordance with Section 9.3.2(c), and shall share all
material information relating thereto promptly after receipt of such information. If, during the
Term, Ono (a) intends to allow Ono Patents to expire or intends to otherwise abandon any such Ono
Patent, or (b) decides not to prepare or file patent applications covering or claiming Ono
Inventions in and/or outside the Territory, Ono shall notify Onyx of such intention or decision at
least [**] ([**]) [**] (or as soon as possible if less than [**] ([**]) [**]) prior to any filing
or payment due date, or any other date that requires action, in connection with such Ono Patents.
In such case, if Onyx desires to prepare, file, prosecute and maintain such Ono Patent, then such
Ono Patent shall be assigned to Onyx at Onyx’s expense, and Onyx shall have the right to prepare,
file, prosecute and maintain, at Onyx’s expense and in the name of Onyx, such Ono Patent as
assigned to Onyx, which assigned Ono Patents shall be deemed Onyx Patents.



               (b) With respect to the Ono Patents outside of the Territory, Ono shall notify Onyx before
entering such Ono Patent into national phase filings, and if Onyx notifies Ono that Onyx desires
to prepare, file, prosecute and maintain (at its own expense) such Ono Patent, said patent will be
[**], after completion of national phase filing, to Onyx at Onyx’s expense, without any
compensation to Ono, and Onyx shall have the right at Onyx’s expense to prepare, file, prosecute
and maintain such Ono Patent as [**] to Onyx, and such patent will [**]. If Onyx does not notify
Ono that Onyx desires to do so, then such Ono Patent may be abandoned.



               (c) The Parties’ patent representatives will develop a process to coordinate the filing,
prosecution, and defense of all Ono Inventions and Patents covering or claiming such Ono
Inventions in the Territory; provided that, in the event the Parties cannot resolve disagreements
regarding the filing, prosecution, and defense with respect to Ono Inventions, the Parties will
retain a neutral and disinterested Third Party patent counsel, acceptable to both Ono and Onyx (in
each Party’s sole discretion), to decide the dispute with reference to the goal of maximizing the
overall value of the Products. Notwithstanding anything to the contrary contained herein, the
Parties agree that the Parties’ patent representatives shall together have the right to vary the
terms of this Section 9.3.2, provided that


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




45









 







any variance to the terms will be mutually agreed to in writing between the Parties’ patent
representatives.



          9.3.3 Joint Patents




               (a) Outside of the Territory, subject to Section 9.3.3(c), Onyx shall have the first right to
prepare, file, prosecute and maintain Joint Patents, at its own cost and expense after good faith
consultation of such Joint Patents with Ono. Onyx shall keep Ono informed of the status of Joint
Patents outside of the Territory and will provide Ono with copies, in English, of all substantive
documentation submitted to, or received from, the patent offices in connection therewith; provided
that, Ono shall have the right to provide input with respect to such matters. The Parties shall
cooperate reasonably in the prosecution of all Joint Patents, in accordance with section 9.3.3(c),
and shall share all material information relating thereto promptly after receipt of such
information. If, during the Term, Onyx (a) intends to allow any Joint Patent outside of the
Territory to expire or intends to otherwise abandon any such Joint Patent, or (b) decides not to
prepare or file patent applications covering or claiming Joint Inventions outside of the
Territory, Onyx shall notify Ono of such intention or decision at least [**] ([**]) [**] (or as
soon as possible if less than [**] ([**]) [**]) prior to any filing or payment due date, or any
other date that requires action, in connection with such Joint Patent outside of the Territory and
Ono shall thereupon have the right, but not the obligation, to assume responsibility for the
preparation, filing, prosecution, or maintenance thereof, at its sole cost and expense, in the
name of Ono.



               (b) In the Territory, subject to Section 9.3.3(c), Ono shall have the first right to prepare,
file, prosecute and maintain Joint Patents, at its own cost and expense. Ono shall keep Onyx
informed of the status of Joint Patents in the Territory and will provide Onyx with copies, in
either Japanese or English, of all substantive documentation submitted to, or received from, the
patent offices in connection therewith; provided that, Onyx shall have the right to provide input
with respect to such matters. The Parties shall cooperate reasonably in the prosecution of all
Joint Patents if practicably possible and shall share all material information relating thereto
promptly after receipt of such information. If, during the Term, Ono (a) intends to allow any
Joint Patent in the Territory to expire or intends to otherwise abandon any such Joint Patent in
the Territory, or (b) decides not to file patent applications covering or claiming Joint
Inventions in the Territory, Ono shall notify Onyx of such intention or decision at least [**]
([**]) [**] (or as soon as possible if less than [**] ([**]) [**]) prior to any filing or payment
due date, or any other date that requires action, in connection with such Joint Patent in the
Territory, and Onyx shall thereupon have the right, but not the obligation, to assume
responsibility for the preparation, filing, prosecution or maintenance thereof at its sole cost
and expense, in the name of Onyx.



               (c) The Parties’ patent representatives will develop a process to coordinate the filing,
prosecution, and defense of all Joint Inventions and Patents covering or claiming such Joint
Inventions in and outside the Territory; provided that, in the event that the Parties cannot
resolve disagreements regarding the filing, prosecution, and defense with respect to Joint
Inventions, the Parties will retain a neutral and disinterested Third Party patent counsel,
acceptable to both Ono and Onyx (in each Party’s sole discretion), to decide the dispute with


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




46









 







reference to the goal of maximizing the overall value of the Products. Notwithstanding
anything to the contrary contained herein, the Parties agree that the Parties’ patent
representatives shall together have the right to vary the terms of this Section 9.3.3, provided
that any variance to the terms will be mutually agreed to in writing between the Parties’ patent
representatives.



          9.3.4 Cooperation. The Parties agree to cooperate in the preparation, filing, prosecution
and maintenance of all Patents under this Section 9.3, including obtaining and executing necessary
powers of attorney and assignments by the named inventors, providing relevant technical reports to
the filing Party concerning the Invention disclosed in such Patent, obtaining execution of such
other documents which are needed in the filing and prosecution of such Patent, and, as requested
by a Party, updating each other regarding the status of such Patent, and shall cooperate with the
other Party so far as reasonably necessary with respect to furnishing all information and data in
its possession reasonably necessary to obtain or maintain such Patents.




          9.3.5 Patent Expenses. Any expenses incurred by a Party in connection with the preparation,
filing, prosecution and maintenance of any Licensed Patents, Joint Patents or Ono Patents, as
applicable, shall be borne by the Party incurring such expenses.




     9.4 Defense and Enforcement of Patents.



          9.4.1 Infringement of Third Party Patents.




               (a) Each of the Parties shall promptly, but in any event no later than [**] ([**]) [**] after
receipt of notice thereof, notify the other Party in writing in the event of any claims by a Third
Party of alleged patent infringement by Ono or Onyx or any of their respective Affiliates or,
solely with respect to Onyx, its licensees and sublicensees, with respect to the research,
development, manufacture, use, sale, offer for sale or importation of a Compound or Product (each,
an “Infringement Claim”). If each of the Parties cannot settle such Infringement Claim with the
appropriate Third Parties within [**] ([**]) [**] after the receipt of the notice pursuant to this
Section 9.4.1, then in the Territory Ono shall be deemed the “Responsible Party”, and outside the
Territory Onyx shall be deemed the “Responsible Party” with respect to controlling the defense of
such Infringement Claim, in which case, such Responsible Party shall be responsible for the costs,
including attorney fees, related to such Infringement Claim. If such Responsible Party declines
to assume control of the defense of such Infringement Claim, then such Responsible Party shall
provide an explanation to the other Party regarding its decision to decline to assume control, and
such other Party shall have the right to assume such defense, at such other Party’s expense. Upon
request of the Party controlling the defense of any such action, the other Party may join in any
such litigation and will have the obligation to reasonably cooperate with the controlling Party
(including giving testimony and producing documents lawfully requested, and using its reasonable
efforts to make available to the other such employees who may be helpful with respect to such
suit, investigation, claim or other proceeding). The controlling Party shall have the exclusive
right to settle any Infringement Claim, with the other Party’s consent, which shall not be
unreasonably withheld.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




47









 





               (b) Subject to the provisions of Sections 9.4.1(a) above, in the event that the research,
development, manufacture, use, sale, offer for sale or importation of a Compound or Product is
deemed by a court of competent jurisdiction to infringe a claim of a patent(s) owned or controlled
by a Third Party in the Territory and Ono or its Affiliate obtains a license under such patent(s)
in settlement of such claims with the consent of Onyx, or as Ono may determine, with the consent
of Onyx, that it is commercially necessary to pay royalties or other fees to a Third Party to
obtain a license to practice any Third Party’s rights in order to practice Licensed Patents or New
Licensed Patents and/or use Licensed Know-How or New Licensed Know-How licensed to Ono hereunder
in the Territory in order to avoid the infringement of a claim of a patent(s) owned or controlled
by a Third Party in the Territory and the infringement of such patent cannot reasonably be avoided
by Ono (“Third Party License”), during the Royalty Term, Ono may deduct up to [**] percent ([**]%)
of the total royalties for such Third Party Licenses due to such Third Parties (or such amounts
expended by Ono in settlement of such infringement actions with Onyx’s consent) from the royalties
due to Onyx with respect to Net Sales of such Product in the Territory under Section 8.3; provided
that, in no event shall the royalties payable by Ono pursuant to Section 8.3 be reduced by more
than [**] percent ([**]%) than the amounts that would have otherwise been payable to Onyx in any
given quarter.



          9.4.2 Prosecution of Infringers.




               (a) Notice. If either Party (i) receives notice of any patent nullity actions, any
declaratory judgment actions or any alleged or threatened infringement of patents or patent
applications or misappropriation of intellectual property in the Territory comprising the (w)
Licensed Technology, (x) New Licensed Technology or (y) Ono Technology, or (z) Joint Technology,
or (ii) learns that a Third Party is infringing or allegedly infringing any Patent within the
Licensed Patents, New Licensed Patents, Ono Patents or Joint Patents, in each case, in the
Territory, or if any Third Party claims that any such Patent is invalid or unenforceable, in each
case, in the Territory, it will promptly notify the other Party thereof, including providing
evidence of infringement or the claim of nullity, validity or unenforceability reasonably
available to such Party.



               (b) Enforcement of Patents. Onyx (or its designee) will have the first right (but not the
obligation) to take the appropriate steps to enforce or defend any Patent within (a) the Licensed
Patents or New Licensed Patents anywhere in the world and (b) the Ono Patents or Joint Patents
(outside of the Territory) against infringement by a Third Party. Onyx may take steps including
the initiation, prosecution and control of any suit, proceeding or other legal action by counsel
of its own choice. Within the Territory the Parties shall jointly share, and outside the
Territory Onyx shall solely bear, the costs of such enforcement or defense, as applicable. If,
pursuant to this Section 9.4.2(b), Onyx fails to institute such litigation or otherwise take steps
to remedy such infringement within [**] ([**]) [**] of the date one Party has provided notice to
the other Party pursuant to Section 9.4.2(a) of such infringement or claim, then Ono will have the
right (but not the obligation), at its own expense, to bring any such suit, action or proceeding
by counsel of its own choice, and Onyx will have the right, at its own expense, to be represented
in any such action by counsel of its own choice. Notwithstanding anything to the contrary
contained herein, in no event shall Ono have any right


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




48









 




to bring any suit, action or proceeding with respect to any matter involving infringement of
an Onyx Manufacturing Patent, or any Patent outside of the Territory or outside of the Field.




               (c) Cooperation; Damages.



                    (i) If one Party brings any suit, action or proceeding under Section 9.4.2(b), the other
Party agrees to be joined as party plaintiff if necessary to prosecute the suit, action or
proceeding and to give the first Party reasonable authority to file and prosecute the suit, action
or proceeding; provided, however, that neither Party will be required to transfer any right, title
or interest in or to any property to the other Party or any other party to confer standing on a
Party hereunder.



                    (ii) The Party not pursuing the suit, action or proceeding hereunder will provide reasonable
assistance to the other Party, including by providing access to relevant documents and other
evidence and making its employees available, subject to the other Party’s reimbursement of any Out
of Pocket Costs incurred by the non-enforcing or defending Party in providing such assistance.



                    (iii) Any settlements, damages or other monetary awards (a “Recovery”) recovered pursuant to
a suit, action or proceeding brought pursuant to Section 9.4.2(b) will be allocated first to the
costs and expenses of the Party taking such action, and second, to the costs and expenses (if any)
of the other Party, with any remaining amounts (if any) to be allocated as follows: (i) to the
extent that such Recovery is a payment for lost sales of Product in the Field in the Territory,
any such Recovery will be paid to Ono and added to Net Sales for the quarter in which Recovery is
received, and (ii) all Recoveries related to Product outside of the Field or outside of the
Territory shall be payable to Onyx, and (iii) all remaining Recoveries shall be payable to the
Party taking such action to the extent such remaining Recoveries relate solely to Product in the
Field in the Territory.



               (d) Infringement and Defense of Licensed Patents Outside of the Territory or Outside of the
Field. For clarity, with respect to any and all infringement or defense of any Licensed Patent,
New Licensed Patent, Ono Patent or Joint Patent anywhere outside of the Territory or outside of
the Field, Onyx (or its designee) shall have the sole and exclusive right to bring an appropriate
suit or other action against any Person engaged in such infringement or defense of any such
Licensed Patents, New Licensed Patents, Ono Patents or Joint Patents, in its sole discretion and
Ono shall have no rights with respect thereto.



     9.5 Patent Term Extensions. As between Onyx and Ono, Onyx shall have the exclusive right, but
not the obligation, to seek, in Ono’s name if so required, Patent Term Extensions (including any
supplemental protection certificates and the like available under applicable Law) in the Territory
in relation to the Licensed Patents, Ono Patents or Joint Patents. Ono and Onyx shall cooperate in
connection with all such activities. Onyx, its agents and attorneys will give due consideration to
all suggestions and comments of Ono regarding any such activities, but in the event of a
disagreement between the Parties, Onyx will have the final decision making authority.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




49









 





     9.6 Patent Marking. Ono shall mark Product marketed and sold by Ono (or its Affiliate or
distributor) hereunder with appropriate patent numbers or indicia to the extent not prohibited by
Laws.



     9.7 Patent Challenge. Onyx will be permitted to terminate this Agreement upon written notice
to Ono, effective upon receipt, if Ono or any of its Affiliates, directly or indirectly, (i)
initiate or request an interference or opposition proceeding with respect to, (ii) make, file or
maintain any claim, demand, lawsuit or cause of action to challenge the validity or enforceability
of, or (iii) oppose any extension of, or the grant of a supplementary protection certificate with
respect to, any Licensed Patent, New Licensed Patent or Onyx Manufacturing Patent (each of clause
(i) or (ii), a “Patent Challenge”).



ARTICLE 10

REPRESENTATIONS, WARRANTIES AND COVENANTS




     10.1 Mutual Representations and Warranties. Each Party hereby represents and warrants (as
applicable) to the other Party as follows, as of the Effective Date:



          10.1.1 Corporate Existence and Power. It is a company or corporation duly organized, validly
existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and
has full corporate power and authority and the legal right to own and operate its property and
assets and to carry on its business as it is now being conducted and as contemplated in this
Agreement, including the right to grant the licenses granted by it hereunder.




          10.1.2 Authority and Binding Agreement. (i) It has the corporate power and authority and the
legal right to enter into this Agreement and perform its obligations hereunder, (ii) it has taken
all necessary corporate action on its part required to authorize the execution and delivery of
this Agreement and the performance of its obligations hereunder, and (iii) this Agreement has been
duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding
obligation of such Party that is enforceable against it in accordance with its terms, except as
enforcement may be affected by bankruptcy, insolvency or other similar laws and by general
principles of equity.




          10.1.3 No Conflicts. The execution, delivery and performance of this Agreement by it does
not (i) conflict with any agreement, instrument or understanding, oral or written, to which it is
a party and by which it may be bound or (ii) violate any Laws of any Governmental Authority,
including any applicable Regulatory Authority, having jurisdiction over it.




          10.1.4 All Consents and Approvals Obtained. Except with respect to Regulatory Approvals for
the Development, Manufacturing or Commercialization of Product or as otherwise described in this
Agreement, (i) all necessary consents, approvals and authorizations of, and (ii) all notices to,
and filings by such Party with, all Governmental Authorities and other Persons required to be
obtained or provided by such Party as of the Effective Date in connection with the execution,
delivery and performance of this Agreement


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




50









 






have been obtained and provided, except for those approvals, if any, not required at the time
of execution of this Agreement.




     10.2 Representations, Warranties and Covenants of Onyx. Onyx hereby represents, warrants and
covenants to Ono that, as of the Effective Date:



          10.2.1 Onyx has not filed any Marketing Authorization Applications with a Governmental
Authority in the Territory for the sale of Product in the Territory.




          10.2.2 To its knowledge after reasonable investigation, Onyx, or its Affiliate, is the owner
or licensee of the Licensed Patents and Licensed Know-How, all of which are free and clear of any
liens, charges and encumbrances (other than liens for taxes not yet due and payable or statutory
mechanics liens and other liens of a similar nature), and no Person or Governmental Authority, has
or shall have any claim of ownership whatsoever with respect to the Licensed Patents and Licensed
Know-How.




          10.2.3 Neither Onyx nor, to the knowledge of Onyx after reasonable investigation, its
subcontractors, has received written notice of any negative proceedings pending before or
threatened by any Regulatory Authority with respect to the Compounds or Product which would have a
materially adverse effect on Product in the Field in the Territory.




          10.2.4 To the knowledge of Onyx after reasonable investigation, the exercise of the license
granted to Ono under the Onyx Patent and Onyx Know-How do not interfere with or infringe any
intellectual property rights owned or possessed by any Third Party;




          10.2.5 To the knowledge of Onyx after reasonable investigation, no Third Party has challenged
the scope, duration, validity, enforceability, priority, or Onyx’s right to use or license any
Licensed Technology.




          10.2.6 Schedule 10.2.6 contains a complete and correct list of the Licensed Patents
that are Controlled by Onyx (or its Affiliates) as of the Effective Date.




          10.2.7 In the course of the Development of the Compounds and Product, to its knowledge, Onyx
has not used any employee that is debarred by the FDA under the Generic Drug Enforcement Act of
1992 (or by any analogous agency or under any analogous Laws in the Territory).




          10.2.8 Onyx, or its Affiliate, shall comply with all Laws in all material respects, in
connection with the performance of its provisions, obligations and rights pursuant to this
Agreement (including without limitation, its obligations and rights relating to Licensed
Know-How), including all Laws in the U.S., Japan and any other relevant nation.




          10.2.9 To its knowledge after reasonable investigation, Onyx, or its Affiliate, has obtained
assignments from the inventors of all inventorship rights relating to the Licensed Patents.






 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




51









 








          10.2.10 To Onyx’s knowledge after reasonable investigation it has provided to Ono, in
writing, prior to the Effective Date, data summaries and other material information relating to
pre-clinical and clinical studies, safety profile, commercial utility and manufacturing of the
Compound and the Product that are materially accurate and responsive in all material respects to
requests received from Ono.




     10.3 Representations, Warranties and Covenants of Ono. Ono hereby represents, warrants and
covenants to Onyx that, as of the Effective Date,



          10.3.1 Ono is solvent and has the ability to pay and perform all of its obligations as and
when such obligations become due, including payment obligations and other obligations under this
Agreement.




          10.3.2 There are no Ono Patents or Ono Know-How.




          10.3.3 Ono shall comply with all Laws in all material respects, in connection with the
performance of its provisions, obligations and rights pursuant to this Agreement (including
without limitation, its obligations and rights relating to Licensed Know-How), including laws and
regulations in the U.S., Japan and any other relevant nation, as well as all applicable Regulatory
Approvals.




     10.4 Disclaimer. Ono understands that the Compounds and Product are the subject of ongoing
clinical research and development and that Onyx cannot ensure the safety or usefulness of the
Compounds or Product or that any Product will receive Regulatory Approval. In addition, Onyx makes
no warranties except as set forth in this ARTICLE 10 concerning the Licensed Technology.



     10.5 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO
REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF
THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. EXCEPT AS
EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY
OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.



ARTICLE 11

INDEMNIFICATION




     11.1 Indemnification by Onyx. Onyx hereby agrees to save, indemnify, defend and hold Ono, its
Affiliates, and their respective directors, officers, agents and employees harmless from and
against any and all losses, damages, liabilities, costs and expenses (including reasonable
attorneys’ fees and expenses) (collectively, “Losses”) arising in connection with any and all
charges, complaints, actions, suits, proceedings, hearings, investigations, claims, demands,
judgments, orders, decrees, stipulations or injunctions by a Third Party (each a “Third


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




52









 




Party Claim”) resulting or otherwise arising from (i) any breach by Onyx of any of its
representations, warranties, covenants or obligations pursuant to this Agreement, or (ii) the
negligence or willful misconduct by Onyx or its Affiliates or their respective officers, directors,
employees, agents or consultants in performing any obligations under this Agreement, or (iii) any
matter related to the development, manufacturing, packaging and labeling or commercialization of
Product (including, for clarity, any product liability Losses resulting therefrom) by Onyx, its
Affiliates, licensees or sublicensees or their respective officers, directors, employees, agents or
consultants; in each case except to the extent that such Losses are subject to indemnification by
Ono pursuant to Section 11.2.




     11.2 Indemnification by Ono. Ono hereby agrees to save, indemnify, defend and hold Onyx, its
Affiliates, and their respective directors, agents and employees harmless from and against any and
all Losses arising in connection with any and all Third Party Claims resulting or otherwise arising
from (i) any breach by Ono of any of its representations, warranties, covenants or obligations
pursuant to this Agreement, (ii) the negligence or willful misconduct by Ono or its Affiliates or
their respective officers, directors, employees, agents or consultants in performing any
obligations under this Agreement, or (iii) any matter related to the Development, Packaging and
Labeling or Commercialization of Product hereunder (including, for clarity, any product liability
Losses resulting therefrom) by Ono or its Affiliates or their respective officers, directors,
employees, agents, sublicensees or consultants; in each case except to the extent that such Losses
are subject to indemnification by Onyx pursuant to Section 11.1.



     11.3 Indemnification Procedures.



          11.3.1 Notice of Claim. All indemnification claims in respect of any indemnitee seeking
indemnity under Section 11.1 or 11.2, as applicable (collectively, the “Indemnitees” and each an
“Indemnitee”) will be made solely by the corresponding Party (the “Indemnified Party”). The
Indemnified Party will give the indemnifying Party (the “Indemnifying Party”) prompt written
notice (an “Indemnification Claim Notice”) of any Losses and any legal proceeding initiated by a
Third Party against the Indemnified Party as to which the Indemnified Party intends to make a
request for indemnification under Section 11.1 or 11.2, as applicable, but in no event will the
Indemnifying Party be liable for any Losses that result from any delay in providing such notice
which materially prejudices the defense of such proceeding. Each Indemnification Claim Notice
shall contain a description of the claim and the nature and amount of such Loss (to the extent
that the nature and amount of such Loss are known at such time). Together with the
Indemnification Claim Notice, the Indemnified Party will furnish promptly to the Indemnifying
Party copies of all notices and documents (including court papers) received by any Indemnitee in
connection with the Third Party Claim.




          11.3.2 Control of Defense. At its option, the Indemnifying Party may assume the defense of
any Third Party Claim subject to indemnification as provided for in Section 11.1 or 11.2, as
applicable, by giving written notice to the Indemnified Party [**] ([**]) [**] after the
Indemnifying Party’s receipt of an Indemnification Claim Notice. Upon assuming the defense of a
Third Party Claim, the Indemnifying Party may appoint as lead counsel in the defense of the Third
Party Claim any legal counsel it selects, and such Indemnifying Party shall thereafter continue to
defend such Third Party Claim in good faith. Should the Indemnifying


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




53









 






Party assume the defense of a Third Party Claim (and continue to defend such Third Party
Claim in good faith), the Indemnifying Party will not be liable to the Indemnified Party or any
other Indemnitee for any legal expenses subsequently incurred by such Indemnified Party or other
Indemnitee in connection with the analysis, defense or settlement of the Third Party Claim, unless
the Indemnifying Party has failed to assume the defense and employ counsel in accordance with this
Section 11.3.




          11.3.3 Right to Participate in Defense. Without limiting Section 11.3.2, any Indemnitee will
be entitled to participate in the defense of a Third Party Claim for which it has sought
indemnification hereunder and to employ counsel of its choice for such purpose; provided, however,
that such employment will be at the Indemnitee’s own expense unless (i) the employment thereof has
been specifically authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party
has failed to assume the defense (or continue to defend such Third Party Claim in good faith) and
employ counsel in accordance with this Section 11.3, in which case the Indemnified Party will be
allowed to control the defense at the indemnifying Party’s expense.




          11.3.4 Settlement. With respect to any Losses relating solely to the payment of money
damages in connection with a Third Party Claim and that will not result in the Indemnitee becoming
subject to injunctive or other relief or otherwise adversely affect the business of the Indemnitee
in any manner, and as to which the Indemnifying Party will have acknowledged in writing the
obligation to indemnify the Indemnitee hereunder, the Indemnifying Party will have the sole right
to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such
Loss, on such terms as the Indemnifying Party, in its reasonable discretion, will deem appropriate
(provided, however, that such terms shall include a complete and unconditional release of the
Indemnified Party from all liability with respect thereto), and will transfer to the Indemnified
Party all amounts which said Indemnified Party will be liable to pay prior to the time of the
entry of judgment. With respect to all other Losses in connection with Third Party Claims, where
the Indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section
11.3.2, the Indemnifying Party will have authority to consent to the entry of any judgment, enter
into any settlement or otherwise dispose of such Loss, provided it obtains the prior written
consent of the Indemnified Party (which consent will be at the Indemnified Party’s reasonable
discretion). The Indemnifying Party that has assumed the defense of (and continues to defend) the
Third Party Claim in accordance with Section 11.3.2 will not be liable for any settlement or other
disposition of a Loss by an Indemnitee that is reached without the written consent of such
Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, no Indemnitee will admit any liability with respect to, or settle,
compromise or discharge, any Third Party Claim without first offering to the Indemnifying Party
the opportunity to assume the defense of the Third Party Claim in accordance with Section 11.3.2.




          11.3.5 Cooperation. If the Indemnifying Party chooses to defend or prosecute any Third Party
Claim, the Indemnified Party will, and will cause each other Indemnitee to, cooperate in the
defense or prosecution thereof and will furnish such records, information and testimony, provide
such witnesses and attend such conferences, discovery proceedings,


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




54









 






hearings, trials and appeals as may be reasonably requested in connection with such Third
Party Claim. Such cooperation will include access during normal business hours afforded to the
Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and
information that are reasonably relevant to such Third Party Claim, and making Indemnitees and
other employees and agents available on a mutually convenient basis to provide additional
information and explanation of any material provided hereunder, and the Indemnifying Party will
reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in
connection with such cooperation.




          11.3.6 Expenses of the Indemnified Party. Except as provided above, the reasonable and
verifiable costs and expenses, including fees and disbursements of counsel, incurred by the
Indemnified Party in connection with any Third Party Claim will be reimbursed on a calendar
quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and subject to refund in the event the
Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.




     11.4 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
CONSEQUENTIAL, INCIDENTAL, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS
AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE
FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE
INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 or 11.2, OR DAMAGES AVAILABLE
FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 12. EXCEPT AS EXPRESSLY SET
FORTH IN ANY REPRESENTATION OR WARRANTY IN ARTICLE 10, ONO ACKNOWLEDGES AND AGREES THAT ONYX HAS
MADE NO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO, AND ONO SHALL HAVE NO CLAIM OR RIGHT
(INCLUDING WITH RESPECT TO INDEMNIFICATION PURSUANT TO THIS ARTICLE 11 (OR OTHERWISE)) WITH RESPECT
TO, ANY INFORMATION, DOCUMENTS OR MATERIALS FURNISHED TO OR FOR ONO BY ONYX, ANY OF ITS AFFILIATES,
OR ANY OF ITS OR THEIR OFFICERS, DIRECTORS, EMPLOYEES, AGENTS OR ADVISORS, INCLUDING ANY
INFORMATION, DOCUMENTS OR MATERIAL MADE AVAILABLE TO ONO IN ANY FORM IN EXPECTATION OF THE
TRANSACTION AND COLLABORATION CONTEMPLATED HEREBY.



     11.5 Insurance. Each Party shall (provided that either Party shall be allowed to self insure)
procure and maintain insurance, including clinical trials insurance and product liability
insurance, adequate to cover its obligations hereunder and which is consistent with normal business
practices of prudent companies similarly situated at all times during which Product is being
clinically tested in human subjects or commercially distributed or sold by such Party pursuant to
this Agreement, and such insurance coverage shall be (i) with respect to Onyx, [**], in no event
less than, [**] and (ii) with respect to Ono, [**], and in no event less than [**]. It is
understood that such insurance shall not be construed to create a limit of either Party’s liability
with respect to its indemnification obligations under this ARTICLE 11. Each Party shall provide


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




55









 




the other Party with written evidence of such insurance upon request of the other Party and
upon expiration of any one coverage. Each Party shall provide the other Party with written notice
at least [**] ([**]) [**] prior to the cancellation, nonrenewal or material change in such
insurance or self — insurance which materially adversely affects the rights of the other Party
hereunder.




ARTICLE 12

CONFIDENTIALITY




     12.1 Confidential Information. As used in this Agreement, the term “Confidential Information”
means all information, whether it be written or oral, including all production schedules, lines of
products, volumes of business, processes, new product developments, product designs, formulae,
technical information, laboratory data, clinical data, patent information, know-how, trade secrets,
financial and strategic information, marketing and promotional information and data, and other
material relating to any products, projects or processes of one Party (the “Disclosing Party”) that
is provided to, or otherwise obtained by, the other Party (the “Receiving Party”) in connection
with this Agreement (including information exchanged prior to the date hereof in connection with
the transactions set forth in this Agreement, including any information disclosed by either Party
pursuant to the Mutual Disclosure Agreement between the Parties dated March 15, 2010).
Notwithstanding the foregoing sentence, Confidential Information shall not include any information
or materials that:



          12.1.1 were already known to the Receiving Party (other than under an obligation of
confidentiality), at the time of disclosure by the Disclosing Party, to the extent such Receiving
Party has documentary evidence to that effect;




          12.1.2 were generally available to the public or otherwise part of the public domain at the
time of disclosure thereof to the Receiving Party;




          12.1.3 became generally available to the public or otherwise part of the public domain after
disclosure or development thereof, as the case may be, and other than through any act or omission
of a Party in breach of such Party’s confidentiality obligations under this Agreement;




          12.1.4 were disclosed to a Party, other than under an obligation of confidentiality, by a
Third Party who had no obligation to the Disclosing Party not to disclose such information to
others; or




          12.1.5 were independently discovered or developed by or on behalf of the Receiving Party
without the use of the Confidential Information belonging to the other Party, to the extent such
Receiving Party has documentary evidence to that effect.




     12.2 Confidentiality Obligations. Each of Ono and Onyx shall keep all Confidential
Information received from or on behalf of the other Party with the same degree of care with which
it maintains the confidentiality of its own Confidential Information, but in all cases no less than
a reasonable degree of care. Neither Party shall use such Confidential Information for any purpose
other than in performance of this Agreement or disclose the same to any other Person


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




56









 




other than to such of its and its Affiliates’ directors, officers, managers, employees,
independent contractors (e.g., CRO, SMO, and investigational sites), agents, consultants or, solely
with respect to Onyx, its licensees or sublicensees who have a need to know such Confidential
Information to implement the terms of this Agreement or enforce its rights under this Agreement;
provided, however, that a Receiving Party shall advise any of its and its Affiliates’ directors,
officers, managers, employees, independent contractors (e.g., CRO, SMO, and investigational sites),
agents, consultants or, solely with respect to Onyx, its licensees or sublicensees, who receives
such Confidential Information of the confidential nature thereof and of the obligations contained
in this Agreement relating thereto, and the Receiving Party shall ensure (including, in the case of
a Third Party, by means of a written agreement with such Third Party having terms at least as
protective as those contained in this ARTICLE 12) that all such directors, officers, managers,
employees, independent contractors (e.g., CRO, SMO, and investigational sites), agents, consultants
or, solely with respect to Onyx, its licensees or sublicensees comply with such obligations. Upon
termination of this Agreement, the Receiving Party shall return or destroy all documents, tapes or
other media containing Confidential Information of the Disclosing Party that remain in the
possession of the Receiving Party or its directors, officers, managers, employees, independent
contractors (e.g., CRO, SMO, and investigational sites), agents, consultants or, solely with
respect to Onyx, its licensees or sublicensees, except that the Receiving Party may keep one copy
of the Confidential Information in the legal department files of the Receiving Party, solely for
archival purposes. Such archival copy shall be deemed to be the property of the Disclosing Party,
and shall continue to be subject to the provisions of this ARTICLE 12. It is understood that
receipt of Confidential Information under this Agreement will not limit the Receiving Party from
assigning its employees to any particular job or task in any way it may choose, subject to the
terms and conditions of this Agreement.




     12.3 Permitted Disclosure and Use. Notwithstanding Section 12.2, (i) either Party may
disclose Confidential Information belonging to the other Party only to the extent such disclosure
is reasonably necessary to: (a) comply with or enforce any of the provisions of this Agreement; (b)
comply with Laws; or (c) disclose Confidential Information belonging to Ono related to the
Compounds or a Product only to the extent such disclosure is made to a Governmental Authority,
including Regulatory Authority, and is reasonably necessary to obtain or maintain Regulatory
Approval of a Product, as applicable. If a Party deems it necessary to disclose Confidential
Information of the other Party pursuant to this Section 12.3, such Party shall give advance written
notice of such disclosure to the other Party sufficient to permit such other Party reasonable
opportunity to object to such disclosure or to take measures to ensure confidential treatment of
such information, including seeking a protective order or other appropriate remedy.
Notwithstanding Section 12.2, Onyx may also disclose Confidential Information belonging to Ono
related to the Compounds and Product to Third Parties in connection with financing activities or
the development or commercialization of the Compounds and Product outside of the Field in the
Territory, or outside of the Territory (provided that such Third Parties are bound by written
agreements having terms at least as protective as those contained in this ARTICLE 12 with respect
to keeping such Confidential Information confidential).



     12.4 Notification. The Receiving Party shall notify the Disclosing Party promptly upon
discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




57









 




Information, and will cooperate with the Disclosing Party in any reasonably requested fashion
to assist the Disclosing Party to regain possession of such Confidential Information and to prevent
its further unauthorized use or disclosure.




     12.5 Publicity; Filing of this Agreement.



          12.5.1 Publicity. The press releases to be issued by each Party in connection with the
transactions described herein shall be provided to the other Party for comment prior to issuance
thereof and each Party shall incorporate any comments received from such other Party to the extent
practicable. Except as otherwise provided in this Section 12.5, each Party shall maintain the
confidentiality of all provisions of this Agreement, and without the prior written consent of the
other Party, which consent shall not be unreasonably withheld, neither Party nor its respective
Affiliates shall make any press release or other public announcement of or otherwise disclose the
provisions of this Agreement to any Third Party, except for: (i) disclosure to those of its
directors, officers, managers, employees, accountants, attorneys, underwriters, lenders and other
financing sources, potential strategic partners, advisors, agents and, solely with respect to
Onyx, its licensees or sublicensees whose duties reasonably require them to have access to this
Agreement, provided that such directors, officers, managers, employees, accountants, attorneys,
underwriters, lenders and other financing sources, advisors, agents or, solely with respect to
Onyx, its licensees or sublicensees are required to maintain the confidentiality of this
Agreement, (ii) disclosures required by NASDAQ regulation or any listing agreement with a national
securities exchange, in which case the disclosing Party shall provide the non-disclosing Party
with at least forty eight (48) hours’ notice unless otherwise not practicable, but in any event no
later than the time the disclosure required by such NASDAQ regulation or listing agreement is
made, (iii) disclosures as may be required by Laws, in which case the disclosing Party shall
provide the non-disclosing Party with prompt advance notice of such disclosure and cooperate with
the non-disclosing Party to seek a protective order or other appropriate remedy, including a
request for confidential treatment in the case of a filing with the Securities and Exchange
Commission, (iv) the report on Form 8-K, which may be filed by an Onyx or an Affiliate of Onyx
setting forth the press release referred to above, and/or this Agreement in redacted form as
provided in Section 12.5.2, (v) disclosures that are consistent with or complementary to those
described in clause (i) of this Section but which do not contain any Confidential Information of
the other Party; and (vi) other disclosures for which consent has previously been given. A Party
may publicly disclose without regard to the preceding requirements of this Section 12.5 any
information that was previously publicly disclosed pursuant to this Section 12.5. In any case,
the disclosing Party shall provide the non-disclosing Party with a copy of such any press release
or other public announcement when officially released.




          12.5.2 Redacted Agreement. Onyx shall have the right to prepare a redacted copy of this
Agreement (“Redacted Agreement”) which it shall submit to Ono for review and comment, which
comments Onyx shall in good faith, and with due consideration of the impact on Ono’s business,
consider incorporating into the final Redacted Agreement; provided that, Onyx shall have final
discretion with regards to the content of the Redacted Agreement. In the event Ono is obligated
to file this Agreement it shall file the Redacted Agreement as filed by Onyx.






 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




58









 








     12.6 Publication. Each Party recognizes that the publication of papers regarding results of
research and clinical studies and other information regarding the Compound and/or the Product,
including oral presentations and abstracts, may be beneficial to both Parties. Notwithstanding the
foregoing, Ono shall submit copies of each proposed academic, scientific, medical and other
publication or presentation that contains or refers to the Licensed Technology, the Ono Technology
or otherwise relates to the Compounds or Product to Onyx at least [**] ([**]) [**] in advance of
submitting such proposed publication or presentation to a publisher or other Third Party in order
to reasonably control and protect Confidential Information and to otherwise provide approve such
publication. Onyx shall make reasonable efforts to expedite review of such proposed publication or
presentation and shall return such items as soon as practicable to Ono with appropriate comments,
if any, but in no event later than [**] ([**]) [**] from the receipt of proposed publication or
presentation by Onyx. Ono shall redact or otherwise modify the proposed publication or
presentation to remove any such Confidential Information of Onyx and as otherwise necessary to be
responsive to any comments provided by Onyx. Without limitation of the foregoing, Ono also agrees
to delay any submission for publication or other public disclosure for a period of at least
additional [**] ([**]) [**] for the purpose of allowing the preparation and filing of appropriate
patent applications. In addition, in the event that the document includes data, information, or
material generated by Onyx’s scientists, and professional standards for authorship would be
consistent with including Onyx’s scientists as co-authors of the document, the names of such
scientists will be included as co-authors. For clarity, in the event that Onyx proposes any
publication that contains references to an Ono Invention (which is not covered or claimed by a
Patent that has been [**] to Onyx), then this provision shall apply mutatis mutandis, substituting
references to “Ono” with references to “Onyx” and vice versa. It is also agreed by Onyx that Onyx
shall, to the extent practicable in advance of a given publication, provide Ono with a copy of such
publication, with respect to the Compound or the Product, made by or on behalf of Onyx.



     12.7 Use of Names. Except as otherwise set forth in this Agreement, neither Party shall use
the name of the other Party in relation to this transaction in any public announcement, press
release or other public document without the written consent of such other Party, which consent
shall not be unreasonably withheld; provided, however, that subject to Section 12.5, either Party
may use the name of the other Party in any document filed with any Regulatory Authority or
Governmental Authority, including the Securities and Exchange Commission.



     12.8 Survival. The obligations and prohibitions contained in this ARTICLE 12 as they apply to
Confidential Information shall survive the expiration or termination of this Agreement for a period
of ten (10) years.



ARTICLE 13

TERM AND TERMINATION




     13.1 Term. This Agreement shall become effective on the Effective Date and, unless earlier
terminated pursuant to this ARTICLE 13, shall remain in effect, on a Product-by-Product basis,
until the expiration of the Royalty Term for such Product (the “Term”). Upon expiration (as
opposed to termination) of this Agreement, the licenses granted to Ono under Section 2.1 shall
become fully paid-up, perpetual, non-exclusive licenses. From and after the expiration of


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




59









 




this Agreement, Ono shall have the exclusive, royalty-free right in the Territory to use the
Product Trademark and the Product Trade Dress pursuant to the license granted under Section 6.10 to
the extent necessary for Ono to Commercialize Product in the Field in the Territory.




     13.2 Termination by Ono for Scientific or Commercial Reasons. Ono shall have the right to
terminate this Agreement [**] for scientific or commercial reasons consistent with the usual
practice followed by Ono in pursuing the commercialization of its other pharmaceutical products of
similar commercial value, by giving [**] advance written notice, provided that Ono shall timely
provide Onyx with such reason for termination.



     13.3 Termination for Breach. Either Party may, without prejudice to any other remedies
available to it at law or in equity, terminate this Agreement upon written notice to the other
Party in the event that the other Party (the “Breaching Party”) shall have materially breached any
representation, warranty, covenant, terms or provision of the Agreement or defaulted in the
performance of any of its obligations. The Breaching Party shall have [**] ([**]) [**] ([**]
([**]) [**] in the event of non-payment) after written notice thereof was provided to the Breaching
Party by the non-breaching Party to remedy such default. Unless the Breaching Party has cured any
such breach or default prior to the expiration of such [**] ([**]) [**] period ([**] ([**]) [**]
period for non-payment), such Termination shall become effective upon receipt of the written notice
of termination by the Breaching Party to be given within [**] ([**]) [**] of the end of the [**]
([**]) [**] period ([**] ([**]) [**] period for non-payment).



     13.4 Termination as a Result of Bankruptcy. Each Party shall have the right to terminate this
Agreement upon written notice as a result of 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 that such
termination shall be effective only if such proceeding is not dismissed within [**] ([**]) [**]
after the filing thereof.



     13.5 Termination by Onyx. Without limitation of its rights under this ARTICLE 13, Onyx may
also terminate this Agreement in its entirety pursuant to the provisions of Sections 4.6, 9.7 and
16.1.



ARTICLE 14

EFFECTS OF EXPIRATION AND TERMINATION




     14.1 Effects of Termination. Without limiting any other legal or equitable remedies that a
Party may have, if this Agreement is terminated prior to its natural expiration, then the following
provisions shall apply (for clarity, on a Product-by-Product basis to the extent applicable and
feasible):



          14.1.1 Termination of Licenses. All rights and licenses granted to Ono hereunder shall
immediately terminate and be of no further force and effect and Ono shall cease Developing,
Commercializing and Manufacturing Product (except as otherwise set forth in Section 14.1.4).






 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




60









 








          14.1.2 Assignments. Ono will promptly, in each case within [**] ([**]) [**] after receipt of
Onyx’s request, and [**] to Onyx:




               (a) assign to Onyx all of Ono’s right, title and interest in and to any agreements (or
portions thereof) between Ono and Third Parties that relate to the Development or
Commercialization of Product;



               (b) assign to Onyx all of Ono’s right, title and interest in and to any (i) Promotional
Materials, (ii) copyrights and trademarks (including Product Trademarks), including any goodwill
associated therewith, and any registrations and design patents for the foregoing, and (iii) any
Internet domain name registrations for such trademarks and slogans, all to the extent solely
related to Product; provided, however, in the event Onyx exercises such right to have assigned
such Promotional Materials, Ono shall grant, and hereby does grant, a royalty-free right and
license to any housemarks, trademarks, names and logos of Ono contained therein for a period of
[**] ([**]) [**] in order to use such Promotional Materials in connection with the
Commercialization of Product;



               (c) assign to Onyx, the management and continued performance of any clinical trials for
Product ongoing hereunder as of the effective date of such termination in respect of which Onyx
shall assume full financial responsibility from and after the effective date of such termination;



               (d) transfer to Onyx all of, if any, Ono’s right, title and interest in and to any and all
regulatory filings, Regulatory Approvals and other Regulatory Materials for Product in respect of
which Onyx shall assume full financial responsibility;



               (e) transfer to Onyx all of Ono’s right, title and interest in and to any and all
Commercialization-related Data Controlled by Ono for Product; and



               (f) provide a copy of (i) the material tangible embodiments of the foregoing and (ii) any
other material books, records, files and documents Controlled by Ono solely to the extent related
to Product and which may be redacted to exclude Confidential Information of Ono;



               (g) provided, however, that to the extent that any agreement or other asset described in this
Section 14.1.2 is not assignable by Ono, then such agreement or other asset will not be assigned,
and upon the request of Onyx, Ono will take such steps as may be reasonably necessary to allow
Onyx to obtain and to enjoy the benefits of such agreement or other asset. For purposes of
clarity, (i) Onyx shall have the right to request that Ono take any or all of the foregoing
actions in whole or in part, or with respect to all or any portion of the assets set forth in the
foregoing provisions and (ii) to the extent Onyx requests Ono to transfer its right, title and
interest in the items set forth in this Section 14.1.2 to Onyx, Ono shall also cause its
Affiliates to transfer and assign to Onyx all of such Affiliates’ right, title and interest in and
to the foregoing items set forth in this Section 14.1.2.


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




61









 





          14.1.3 Disclosure and Delivery of Ono Know-How.




               (a) Ono will promptly transfer to Onyx copies of any physical embodiment of any Ono Know-How,
to the extent then used in connection with the Development or Commercialization of Product; such
transfer shall be effected by the delivery of material documents, to the extent such Ono Know-How
is embodied in such documents, and to the extent that Ono Know-How is not fully embodied in such
documents, Ono shall make its employees and agents who have knowledge of such Ono Know-How in
addition to that embodied in documents available to Onyx for interviews, demonstrations and
training to effect such transfer in a manner sufficient to enable Onyx to practice such Ono
Know-How but only in a manner as set out as follows in this Section 14.1.3. The appropriate
technical teams at Onyx and Ono will meet to plan transfer for the Ono Know-How as follows: (i)
Ono’s designated representative(s) for Product will meet with representatives from Onyx to answer
questions with respect to the Ono Know-How and establish a plan for the transfer for such Ono
Know-How; (ii) Ono will allocate adequate appropriately qualified representatives to work with
Onyx to review the Ono Know-How to enable the completion of the transfer [**] of the completion of
the initial transfer planning meetings to the extent reasonable, but in any event no longer than
[**] ([**]) [**] thereafter.



               (b) To the extent that this Agreement is terminated by Onyx pursuant to Section 13.3 because
of Ono’s uncured breach, then Ono shall, and shall cause its Affiliates to, also transfer and
assign, and hereby does assign, to Onyx its entire right, title and interest in and to any Ono
Technology and Joint Patents; provided that, Onyx hereby grants Ono a non-exclusive license under
such transferred and assigned rights, to develop, manufacture and commercialize products other
than (and which do not incorporate) the Compounds or Product. In furtherance of the foregoing,
Ono shall execute, and shall cause its Affiliates to execute, any documents reasonably required to
confirm Onyx’s sole ownership of Ono Technology and Joint Patents, and any documents required to
apply for, maintain and enforce any Patent or other right in the Ono Technology or Joint Patents.



          14.1.4 Disposition of Inventory. Ono and its Affiliates will be entitled, during the period
ending on the last day of the [**] following the effective date of such termination, to sell any
inventory of Product affected by such termination that remains on hand as of the effective date of
the termination, so long as Ono pays to Onyx the royalty payments and other amounts payable
hereunder (including milestones) applicable to said subsequent sales, with respect to sales in the
Territory, as applicable, in accordance with the terms and conditions set forth in this Agreement
and otherwise complies with the terms set forth in this Agreement.




          14.1.5 Disposition of Commercialization Related Materials. Ono will promptly deliver to Onyx
in electronic, sortable form (i) a list identifying all wholesalers and other distributors
involved in the Commercialization of Product in the Territory as well as any customer lists (e.g.,
purchasers) related to the Commercialization of Product in the Territory, and (ii) all Promotional
Materials as well as any items bearing Product Trademark and/or any trademarks or housemarks
otherwise associated with Product or Onyx.



 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




62









 





     14.2 Ono Rights Arising Under Section 13.3.



          14.2.1 Without limiting any other legal or equitable remedies that Ono may have, if Ono has
the right to terminate this Agreement in accordance with Section 13.3 because Onyx is the
breaching Party, then Ono shall have the option, in its sole discretion, to allow this Agreement
to remain in full force and effect in lieu of exercising such termination right.




          14.2.2 Notwithstanding the foregoing or anything to the contrary contained herein, in the
event that this Agreement has been terminated by Ono pursuant to Section 13.3 because of Onyx’s
uncured breach, then (i) Onyx shall be responsible for [**] in the process of accomplishing the
transfer described in Section 14.1.2(d) and (ii) Onyx shall pay royalties to Ono on any [**] of
Product booked by Onyx in the Territory as follows: if such for-cause termination occurs (a) after
[**], then Onyx shall pay Ono royalties equivalent to [**], or (b) before [**], then Onyx shall
pay Ono royalties equivalent to [**]. For purposes of this Section, [**] shall be calculated in
the same manner as [**] is pursuant to [**], substituting “Onyx” for each reference to “Ono” in
such Section.




     14.3 Accrued Rights. Termination or expiration of this Agreement for any reason will be
without prejudice to any rights that will have accrued to the benefit of a Party prior to the
effective date of such termination. Such termination or expiration will not relieve a Party from
obligations that are expressly indicated to survive the termination or expiration of this
Agreement.



     14.4 Survival. Notwithstanding anything to the contrary contained herein, the following
provisions shall survive any expiration or termination of this Agreement: ARTICLES: 1, 10, 11
(other than Section 11.5), 12 (subject to Section 12.8), 14, and 15 (with respect to any dispute
then in progress) and Sections 2.2, 2.3, 4.5.1 (to the extent required by Law), 5.7.1, 5.8, 6.9.2,
7.4, 8.5.3, 8.8 (until the third anniversary after the date of early termination or expiration of
the Agreement), 9.1.1, 13.1 (in the event of expiration (as opposed to termination) of this
Agreement), 16.2, 16.4, 16.5, 16.11 and 16.12. Except as set forth in this ARTICLE 14 or otherwise
expressly set forth herein, upon termination or expiration of this Agreement all other rights and
obligations of the Parties shall cease.



     14.5 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this
Agreement by Onyx and Ono are, and shall otherwise be deemed to be, for purposes of Section 365(n)
of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section
101 of the U.S. Bankruptcy Code. The Parties agree that each Party, as licensee of certain rights
under this Agreement, shall retain and may fully exercise all of its rights and elections under the
U.S. Bankruptcy Code. The Parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against a Party (such Party, the “Bankrupt Party”) under the U.S.
Bankruptcy Code, (i) the other Party shall be entitled to a complete duplicate of (or complete
access to, as appropriate) any intellectual property licensed to such other Party and all
embodiments of such intellectual property, which, if not already in such other Party’s possession,
shall be promptly delivered to it (x) upon any such commencement of a bankruptcy proceeding upon
such other Party’s written request therefor, unless the Bankrupt Party elects to continue to
perform all of its obligations under this Agreement or (y) if not


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




63









 




delivered under clause (x), following the rejection of this Agreement by the Bankrupt Party
upon written request therefore by the other Party and (ii) the Bankrupt Party shall not
unreasonably interfere with the other Party’s rights to intellectual property and all embodiments
of intellectual property, and shall assist and not unreasonably interfere with the other Party in
obtaining intellectual property and all embodiments of intellectual property from another entity.
The “embodiments” of intellectual property include all tangible, intangible, electronic or other
embodiments of rights and licenses hereunder, including all compounds and products embodying
intellectual property, Products, filings with Regulatory Authorities and related rights and
Licensed Technology, New Licensed Technology, Onyx’s interests in Joint Patents and Joint
Inventions in the case that Onyx is the Bankrupt Party, and Ono Technology and Ono’s interest in
Joint Patents and Joint Inventions in the case that Ono is the Bankrupt Party.




ARTICLE 15

DISPUTE RESOLUTION




     15.1 Disputes. The Parties recognize that, from time to time during the Term, disputes may
arise as to certain matters which relate to either Party’s rights and/or obligations hereunder. It
is the objective of the Parties to establish procedures to facilitate the resolution of disputes
arising under this Agreement in an expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in
this ARTICLE 15 to resolve any controversy or claim arising out of, relating to or in connection
with any provision of this Agreement (other than a dispute addressed in Section 3.4).



     15.2 Escalation of Disputes. With respect to all disputes arising between the Parties,
including any alleged failure to perform, or breach, of this Agreement, or any issue relating to
the interpretation or application of this Agreement, if the Parties are unable to resolve such
dispute within [**] ([**]) [**] after such dispute is first identified by either Party in writing
to the other, the Parties shall refer such dispute to the Chief Executive Officers of each of the
Parties, or a designee from senior management with decision-making authority (the Chief Executive
Officer or such designee, the “Executive Officer”) for attempted resolution by good-faith
negotiations within [**] ([**]) [**] after such notice is received.



     15.3 Mediation. Except to the extent that final decision-making authority is specifically
provided in any provision in this Agreement, if the Executive Officers are unable to resolve the
dispute pursuant to Section 15.2, then the Parties shall attempt in good faith to resolve such
dispute through mediation with a mutually agreed mediator. If the mediation of such dispute does
not commence within [**] ([**]) [**] (or such other period of time mutually agreed upon by the
Parties) of the receipt of a written request for such mediation by the other Party, or if the
dispute is not resolved within [**] ([**]) [**] (or such other period of time mutually agreed upon
by the Parties) of commencing such mediation, or if the Parties are unable to agree upon a
mediator, then either Party may proceed to arbitration under Section 15.4.



     15.4 Arbitration. If the Parties are unable to resolve the dispute following the procedures
set forth in Sections 15.2 and 15.3, then the dispute for arbitration shall be submitted in San
Francisco, California in case Ono demands arbitration and in Osaka, Japan in case Onyx


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




64









 




demands arbitration in accordance with the Rules of Conciliation and Arbitration of the
International Chamber of Commerce (the “ICC Rules”) then in effect. Notwithstanding the foregoing,
in all events, the provisions contained herein shall govern over any conflicting rules which may
now or hereafter be contained in the ICC Rules. Any judgment upon the award rendered by the panel
of the arbitrators shall be entered in any court having jurisdiction over the subject matter
thereof. The panel of the arbitrators shall have the authority to grant any equitable and legal
remedies that would be available if any judicial proceeding was instituted to resolve said dispute.
The final decision of such panel of the arbitrators, as entered by a court of competent
jurisdiction, will be furnished by such panel of the arbitrator in writing and will constitute a
final, conclusive and non-appealable determination of the issue in question, binding upon the
Parties, and an order with respect thereto may be entered in any court of competent jurisdiction.
Notwithstanding anything in this ARTICLE 15, neither Party shall have the right to submit for
arbitration any claim that any Invention is unpatentable or any Patent is invalid or unenforceable.
A dispute regarding the scope of a Patent covering or claiming Licensed Know-How, New Licensed
Know-How, Onyx Inventions, Joint Inventions, Ono Inventions or Ono Know-How, or whether a
particular Product is covered or claimed by a Licensed Patent, New Licensed Patent, Joint Patent or
Ono Patent, may be submitted for arbitration under this ARTICLE 15.




          15.4.1 Any such arbitration will be conducted before a panel of three (3) persons who will be
compensated for his or her services at a rate to be determined by the Parties or by ICC, but based
upon reasonable hourly or daily consulting rates for the arbitrator in the event the Parties are
not able to agree upon his or her rate of compensation.




          15.4.2 Each Party shall select one person to act as arbitrator and the two Party-selected
arbitrators shall select a third arbitrator within [**] ([**]) [**] of their appointment. If the
arbitrators selected by the Parties are unable or fail to agree upon the third arbitrator, the
third arbitrator shall be appointed by the ICC.




          15.4.3 No arbitrator shall have any past or present family, business or other relationship
with the Parties or any Affiliate, director or officer thereof, unless following full disclosure
of all such relationships, the Parties agree in writing to waive such requirement with respect to
an individual in connection with any dispute. In addition, unless otherwise agreed to between the
Parties, (i) the arbitrators in any dispute related to the performance or non-performance of Ono’s
obligations under the Development Plan shall have at least [**] ([**]) [**] of experience in the
development of cancer pharmaceuticals and interactions with Regulatory Authorities; and (ii) the
arbitrators in any dispute involving a Patent shall be a current or former patent attorney with at
least [**] ([**]) [**] of experience; provided, however, that, if ICC is not able to provide
arbitrators for such arbitration with the requisite experience the Parties will agree on
arbitrators with as to close such experience as is practicable.




          15.4.4 The panel of the arbitrators shall be instructed to hold an up to a [**] ([**])- [**]
hearing (or [**] ([**]) [**] in the event of a dispute relating to the scope of a Patent claim)
regarding the disputed matter within [**] ([**]) [**] of his designation and to render an award
(without written opinion) no later than [**] ([**]) [**] after the conclusion of such


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




65









 






hearing (or such longer time as is permitted under ICC Rules), in each case unless otherwise
mutually agreed in writing by the Parties.




          15.4.5 No discovery other than an exchange of relevant documents may occur in any arbitration
commenced under the provisions of this ARTICLE 15. The Parties agree to act in good faith to
promptly exchange relevant documents.




          15.4.6 The Parties will each pay fifty percent (50%) of the initial compensation to be paid
to the arbitrator in any such arbitration and fifty percent (50%) of the costs of transcripts and
other normal and regular expenses of the arbitration proceedings; provided, however, that: (i) the
prevailing Party in any arbitration will be entitled to an award of attorneys’ fees and costs; and
(ii) all costs of arbitration, other than those provided for above, will be paid by the losing
Party, and the arbitrator will be authorized to determine the identity of the prevailing Party and
the losing Party.




          15.4.7 The panel of the arbitrators chosen in accordance with these provisions will not have
the power to alter, amend or otherwise affect the terms of these arbitration provisions or any
other provisions contained in this Agreement.




     15.5 Litigation and Jurisdiction. If an error is found in the procedure of the arbitration,
or the dispute relates to the validity, patentability or enforceability of any Licensed Patent, New
Licensed Patent, Ono Patent or Joint Patent then either Party shall have right to pursue any legal
or equitable remedy available to it under Laws; provided that, any litigation arising under this
Agreement shall be brought in the State of California in the USA if Ono is the defendant, and
Osaka, Japan if Onyx is the defendant. Each Party hereby agrees to the exclusive jurisdiction of
such court and waives any objections as to the personal jurisdiction or venue of such court.



     15.6 Patent and Trademark Dispute Resolution. Notwithstanding anything to the contrary in
this ARTICLE 15, any dispute, controversy or claim relating to the validity, enforceability or
infringement of any Licensed Patent, New Licensed Patent, Ono Patent or Joint Patent shall be
submitted to a court of competent jurisdiction in any country in which such patent or trademark
rights were granted or arose.



     15.7 Injunctive Relief. Nothing herein may prevent either Party from seeking a preliminary
injunction or temporary restraining order, in any court of competent jurisdiction, so as to prevent
any Confidential Information from being disclosed in violation of this Agreement.



ARTICLE 16

MISCELLANEOUS




     16.1 Change of Control. In the event of a Change of Control of Ono in which the Acquirer is
developing or commercializing any Competitive Product in the Field, then such Competitive Product
will be divested within [**] ([**]) [**] of the effective date of such Change of Control; provided,
however, that in the event that (i) such divesture is not completed within such [**] ([**])- [**]
period or (ii) the Acquirer is one of the Persons set forth on Schedule 16.1,


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




66









 




then Onyx shall have the right to immediately terminate this Agreement upon written notice to
Ono. For clarity, in the event that Onyx undergoes a Change of Control, there will be no change in
Ono’s or Onyx’s rights and obligations under this Agreement or any ancillary agreement related
hereto; provided, however, that following such a Change of Control affiliates of the Acquirer shall
not be Affiliates of Onyx hereunder.




     16.2 Entire Agreement; Amendment. This Agreement, including the Exhibits and Schedules
hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises,
agreements, warranties, representations, conditions and understandings between the Parties hereto
with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior
agreements and understandings between the Parties with respect to the subject matter hereof,
including the Confidential Disclosure Agreement between the Parties dated March 15, 2010 (which
shall remain effective prior to the Effective Date). There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or written, between the
Parties other than as are set forth herein and therein. No subsequent alteration, amendment,
change or addition to this Agreement shall be binding upon the Parties unless reduced to writing
and signed by an authorized representative of each Party.



     16.3 Force Majeure. A Party shall be excused from the performance of its obligations under
this Agreement to the extent that such performance is prevented by force majeure and the
nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse
shall be continued so long as the condition constituting force majeure continues and the
nonperforming Party makes reasonable efforts to remove the condition. For purposes of this
Agreement, force majeure shall include conditions beyond the control of the Parties, including an
act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or
default of public utilities or common carriers, destruction of production facilities or materials
by fire, earthquake, storm or like catastrophe. For clarity, a Party shall not be released from
making payments owed hereunder because of force majeure affecting such Party; provided that, a
Party shall be entitled to defer a specific payment to the extent that its banking institution is
closed as a result of a force majeure event; provided further that, any such deferred payments
shall be made to the other Party as promptly as practicable once any such force majeure ends up.



     16.4 Notices. Any notice required or permitted to be given under this Agreement shall be in
writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate
Party at the address specified below or such other address as may be specified by such Party in
writing in accordance with this Section 16.4, and shall be deemed to have been given for all
purposes (i) when delivered, if hand-delivered or sent by facsimile on a business day, (ii) on the
third (3rd) business day after mailing if sent by a reputable international overnight
courier service, or (iii) on the seventh (7th) business day after mailing, if mailed by
first-class certified or registered airmail, postage prepaid, return receipt requested. Unless
otherwise specified in writing, the mailing addresses of the Parties shall be as described below:



	 	 	 	 	 
	 

	 	If to Onyx:
	 	Onyx Pharmaceuticals, Inc.
	 

	 	 	 	2100 Powell St. 
	 

	 	 	 	Emeryville, CA 94608





 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




67









 






	 	 	 	 	 
	 

	 	 	 	Attention: Dr. Juergen Lasowski
	 

	 	 	 	Senior Vice President of Corporate Development
	 

	 	 	 	Fax: +1 (510) 597-6603
	 
	 	 	 	 
	 

	 	 	 	Onyx Therapeutics, Inc.
	 

	 	 	 	2100 Powell St. 
	 

	 	 	 	Emeryville, CA 94608
	 

	 	 	 	Attention: Suzanne Shema
	 

	 	 	 	Corporate Officer and Secretary
	 

	 	 	 	Fax: +1 (510) 597-6603
	 
	 	 	 	 
	 

	 	With a copy to:
	 	Morgan, Lewis & Bockius LLP
	 

	 	 	 	502 Carnegie Center 
	 

	 	 	 	Princeton, New Jersey 08540
	 

	 	 	 	Attention: Randall B. Sunberg
	 

	 	 	 	Fax: +1 (609) 919-6701
	 
	 	 	 	 
	 

	 	If to Ono:
	 	Ono Pharmaceutical Co., Ltd.
	 

	 	 	 	8-2, Kyutaromachi 1-chome 
	 

	 	 	 	Chuo-ku, Osaka 541-8564, Japan
	 

	 	 	 	Attention: [**]
	 

	 	 	 	Fax: [**]
	 
	 	 	 	 
	 

	 	With a copy to:
	 	Ono Pharma USA, Inc.
	 

	 	 	 	2000 Lenox Drive 
	 

	 	 	 	Lawrenceville, NJ 08648, USA
	 

	 	 	 	Attention: [**]
	 

	 	 	 	Fax: [**]






     16.5 No Strict Construction; Interpretation. This Agreement has been prepared jointly and
shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall
not be construed against any Party, irrespective of which Party may be deemed to have authored the
ambiguous provision. The headings of each ARTICLE and Section in this Agreement have been inserted
for convenience of reference only and are not intended to limit or expand on the meaning of the
language contained in the particular ARTICLE or Section.



     16.6 Assignment. Neither Party may assign or transfer this Agreement or any rights or
obligations hereunder without the prior written consent of the other, except that (A) Onyx may make
such an assignment, in whole or in part, without Ono’s consent to (i) Affiliates, or (ii) a
successor to a material interest in this Agreement or substantially all of the business of Onyx to
which this Agreement relates, whether in a merger, sale of stock, sale of assets or other
transaction and (B) subject to Section 16.1, Ono may make such an assignment, in whole or in part,
without Onyx’s consent to (i) Affiliates, or (ii) a successor to substantially all of the business
of Ono to which this Agreement relates, whether in a merger, sale of stock, sale of assets or other
transaction. Any permitted assignment shall be binding on the successors of the


 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




68









 




assigning Party. Any assignment or attempted assignment by either Party in violation of the
terms of this Section 16.6 shall be null, void and of no legal effect.




     16.7 Further Actions. Each Party agrees to execute, acknowledge and deliver such further
instruments, and to perform all such other acts, as may be necessary or appropriate in order to
carry out the purposes and intent of this Agreement.



     16.8 Severability. If any one or more of the provisions of this Agreement are held to be
invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is
taken, such provision or provisions shall be considered severed from this Agreement and shall not
serve to invalidate any remaining provisions hereof. The Parties shall make a good-faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement may be realized.



     16.9 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver as
to a particular default or other matter shall not constitute a waiver of such Party’s rights to the
future enforcement of its rights under this Agreement, except with respect to an express written
and signed waiver relating to a particular matter for a particular period of time.



     16.10 Independent Contractors. Each Party shall act solely as an independent contractor, and
nothing in this Agreement shall be construed to give either Party the power or authority to act
for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the
relationship of partners, principal and agent, or joint-venture partners between the Parties.



     16.11 English Language; Governing Law. This Agreement was prepared in the English language,
which language shall govern the interpretation of, and any dispute regarding, the terms of this
Agreement. This Agreement and all disputes arising out of or related to this Agreement or any
breach hereof shall be governed by and construed under the laws of the State of New York, without
giving effect to any choice of law principles that would require the application of the laws of a
different state.



     16.12 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument.



[Signature Page follows]








 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




69









 







In Witness Whereof, the Parties have executed this Agreement by their duly authorized
representatives as of the Effective Date.




	 	 	 	 	 	 	 	 	 	 	 

	Ono Pharmaceutical Co., Ltd.	 	 	 	Onyx Pharmaceuticals, Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Gyo Sagara
 

	 	 
	 	By:
	 	/s/ N. Anthony Coles
 

	 	 
	Name: Gyo Sagara	 	 	 	Name: N. Anthony Coles	 	 
	Title: President,
Representative Director and CEO	 	 	 	Title: President & CEO	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Onyx Therapeutics, Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 
	 	By:
	 	/s/ Suzanne M. Shema
 

	 	 
	 	 	 	 	 	 	Name: Suzanne M. Shema	 	 
	 	 	 	 	 	 	Title: Officer — Secretary	 	 










 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




 









 








Schedule 1.3

CARFILZOMIB CHEMICAL STRUCTURE



Molecular formula: [**]



Molecular Mass: [**]



Molecular Structure: [**]








 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




 









 








Schedule 1.51

ONX 0912 CHEMICAL STRUCTURE



Molecular formula: [**]



Molecular Mass: [**]



Molecular Structure: [**]








 [ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.




 









 








Schedule 3.2

INITIAL JDC MEMBERS



ONYX:




     [**]


ONO:




     [**]






[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.





 









 








Schedule 4.3.2

INITIAL DEVELOPMENT PLAN

& [**]





	A.	 	Development Plan for Carfilozmib as of the Effective Date
	 
	 	 	[**]
	 
	B.	 	Development Plan for ONX 0912 as of the Effective Date
	 
	 	 	[**]








[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.





 









 








Schedule 4.4.1

CERTAIN GENERAL DEVELOPMENT ACTIVITIES



[**]







[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.





 









 








Schedule 10.2.5

LICENSED PATENTS



[**]







[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.





 









 








Schedule 16.1

ACQUIRERS TRIGGERING TERMINATION




     [**]



[ ** ] = Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.