Exhibit 10.1

Confidential Treatment Requested by Puma Biotechnology, Inc

COLLABORATION AND LICENSE AGREEMENT

THIS COLLABORATION AND LICENSE AGREEMENT (this “Agreement”), entered into as of
January 30th, 2018 (the “Effective Date”), is entered into by and between
CANbridgepharma Limited, a corporation organized and existing under the laws of
Hong Kong (“CANbridge”), and Puma Biotechnology, Inc., a corporation organized
and existing under the laws of the State of Delaware (“PUMA”).

INTRODUCTION

WHEREAS, prior to the Effective Date, PUMA has entered into a License Agreement
with Pfizer, Inc. (“Pfizer”) dated August 18, 2011, as amended (the “Pfizer
License Agreement”), pursuant to which PUMA received an exclusive, worldwide
license, with the right to grant sublicenses, to develop and commercialize
neratinib;

WHEREAS, prior to the Effective Date, PUMA has obtained regulatory approval of
neratinib in the United States; and

WHEREAS, CANbridge wishes to obtain from PUMA and PUMA wishes to grant to
CANbridge certain rights and licenses under intellectual property owned or
controlled by PUMA to Develop and Commercialize Licensed Products in the
Territory (each as defined below) subject to the terms and conditions set forth
herein.

NOW, THEREFORE, in consideration of the premises and the mutual promises and
conditions hereinafter set forth, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties, intending
to be legally bound, do hereby agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following terms will have the meanings set forth
below:

1.1“Accounting Standards” means, with respect to a Person, generally accepted
accounting principles as practiced in the United States (“GAAP”) or applicable
international standards followed by such Person.

1.2“Acquirer” has the meaning set forth in Section 14.2 (Acquisition
Transactions).

1.3“Acquired Party” has the meaning set forth in Section 14.2 (Acquisition
Transactions).

1.4“Acquisition Transaction” has the meaning set forth in Section 14.2
(Acquisition Transactions).

1.5“Action” means any claim, action, cause of action or suit (whether in
contract or tort or otherwise), litigation (whether at law or in equity, whether
civil or criminal),   assessment, arbitration, investigation, hearing, charge,
complaint, demand, notice or proceeding of, to, from, by or before any
Governmental Authority.

 

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1.6“Adverse Event” or “AE” has the meaning set forth in 21 C.F.R. § 312.32 and
generally means any untoward medical occurrence associated with the use of a
product in human subjects, whether or not considered related to such product. An
AE does not necessarily have a causal relationship with a product, that is, an
AE can be any unfavorable and unintended sign (including an abnormal laboratory
finding), symptom, or disease temporally associated with the use of such
product.

1.7“Adverse Ruling” has the meaning set forth in Section 12.3.1 (Termination for
Material Breach).

1.8“Affiliate” means, with respect to any Person, any Person controlling,
controlled by or under common control with such first Person, for as long as
such control exists. For purposes of this Section 1.8 (Affiliate), “control”
means (a) direct or indirect ownership of fifty percent (50%) or more of the
stock or shares having the right to vote for the election of directors of such
Person (or if the jurisdiction where such Person is domiciled prohibits foreign
ownership of such entity, the maximum foreign ownership interest permitted under
such Laws; provided, however, that such ownership interest provides actual
control over such Person), (b) status as a general partner in any partnership,
or (c) the possession, directly or indirectly, of the power to direct, or cause
the direction of, the management or policies of such Person, whether through the
ownership of voting securities, by contract or otherwise.

1.9“Alliance Manager” has the meaning set forth in Section 5.6.1 (Appointment).

1.10“Anti-Corruption Laws” means (a) the U.S. Foreign Corrupt Practices Act of
1977 (the “FCPA”), the U.K. Bribery Act 2010, (b) the criminal code of each
Region in the Territory, and (c) the domestic laws of the Territory.

1.11“Bankruptcy Code” has  the meaning set forth in  Section 2.6 (Bankruptcy  
Code §365(n) Election).

1.12“Blocking Third Party Patents Rights” means, with respect to a Licensed
Product in any Region in the Territory, any patent Controlled by a Third Party
that, absent a license thereunder, would be infringed by the Exploitation of
such Licensed Product in such Region.

1.13“Blocking Third Party Intellectual Property Costs” means any [***]
CANbridge, its Affiliates or its Sublicensees to a Third Party who Controls
Blocking Third Party Patent Rights for the right to Exploit Licensed Products
under such Blocking Third Party Patent Rights.

1.14“Breaching Party” has the meaning set forth in Section 12.3.1 (Termination
for Material Breach).

1.15“Business Day” means any day other than a Saturday or a Sunday on which the
banks in New York, New York and Beijing, China are open for business.

 

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1.16“Calendar Quarter” means each of the three month periods ending on March 31,
June 30, September 30, and December 31 of any Calendar Year; provided, however:
(a) the first Calendar Quarter of the Term shall extend from the Effective Date
to the end of the Calendar Quarter in which the Effective Date occurs; and (b)
the last Calendar Quarter shall extend from the beginning of the Calendar
Quarter in which this Agreement expires or terminates until the effective date
of such expiration or termination.

1.17“Calendar Year” means, for the first Calendar Year, the period beginning on
the Effective Date and ending on December 31, 2018, and for each Calendar Year
thereafter each twelve (12)-month period commencing on January 1, and ending on
December 31, except that the last Calendar Year shall commence on January 1 of
the year in which this Agreement expires or terminates and end on the effective
date of such expiration or termination.

1.18“CANbridge Indemnified Parties” has the meaning set forth in Section 10.1
(Indemnification by PUMA).

1.19“CANbridge Invention” has the meaning set forth in Section 7.1.2
(Ownership).

1.20“Clinical Trial Application” or “CTA” has the meaning set forth in Section
1.56 (“IND”).

1.21“CMC” means the Chemistry, Manufacturing and Controls portion of any
Regulatory Filing.

1.22“CMC Data” means any data included in the CMC portion of a Regulatory Filing
or in any supporting development reports thereto, in each case, with respect to
any Licensed Product in any country in the world.

1.23“Clinical Study” means a study in which human subjects or patients are dosed
with a drug, whether approved or investigational, including any Phase II
Clinical Study, Phase IIa Clinical Study, Phase III Clinical Study, or Phase
IIIb Clinical Study.

1.24“Clinical Trial Waiver” means the receipt of written confirmation from the
applicable Regulatory Authority that the data generated by PUMA and submitted to
such Regulatory Authority is sufficient for approval of an application for
Regulatory Approval for the First Indication without additional comparative
Clinical Study requirements

1.25“Commercialization”, “Commercializing” or “Commercialize” means any and all
activities related to the pre-marketing, launching, marketing, promotion
(including advertising and detailing), labeling, pricing and reimbursement,
distribution, storage, handling, offering for sale, selling, having sold,
importing and exporting for sale, having imported and exported for sale,
distribution, having distributed, customer service and support, and
post-marketing safety surveillance and reporting of a product (including a
Licensed Product), but not including Manufacturing.

1.26“Commercially Reasonable Efforts” means, in respect of a Party, the level of
efforts and resources (measured as of the time that such efforts and resources
are required to be used under this Agreement) that are commonly used by a
company in the industry of a similar size and profile

 

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as such Party to Develop, Manufacture or Commercialize, as the case may be, a
product owned by such company or to which it has rights, which product is at a
similar stage in its development or product life and is of a similar market and
profitability potential to the Licensed Product and taking into account all
relevant factors including, without limitation, the intellectual property
protection of the product, product labeling or anticipated labeling, market
potential, financial return, medical and clinical considerations, regulatory
environments and competitive market conditions, market exclusivity, and other
technical legal, scientific, medical or commercial factors that such a company
would reasonably deem to be relevant.

1.27 “Confidential Information” means (a) all trade secrets or confidential or
proprietary information (including any tangible materials embodying any of the
foregoing) of the disclosing Party or its Affiliates provided or disclosed to
the other Party or any of its Affiliates pursuant to this Agreement, (b)
“Confidential Information” (as defined in the Prior CDA) that was disclosed by a
Party or any of its Affiliates to the other Party or any of its Affiliates under
the Prior CDA, and (c) the terms and conditions of this Agreement; provided,
however, that Confidential Information will not include information that:

(i)has been published by a Third Party or otherwise is or hereafter becomes part
of the public domain by public use, publication, general knowledge or the like
through no wrongful act, fault or negligence on the part of the receiving Party
or its Affiliates;

(ii)has been in the receiving Party’s or its Affiliates possession prior to
disclosure by the disclosing Party without any obligation of confidentiality
with respect to such information (as evidenced by the receiving Party’s or such
Affiliate’s written records or other competent evidence);

(iii)is subsequently received by the receiving Party or its Affiliate from a
Third Party without restriction and without breach of any agreement between such
Third Party and the disclosing Party; or

(iv)has been independently developed by or for the receiving Party or its
Affiliates without reference to, or use or disclosure of, the disclosing Party’s
Confidential Information (as evidenced by the receiving Party’s or such
Affiliate’s written records or other competent evidence);

provided, further, that clauses (ii) through (iv) above will not apply to the
terms and conditions of this Agreement.

All Regulatory Filings owned by a Party will be deemed to be the Confidential
Information of such Party and such Party will be deemed to be the disclosing
Party and the other Party will be deemed to be the receiving Party with respect
thereto.

1.28“Compound” means the compound designated under the Pfizer License Agreement
as PF-05208767, also known as “neratinib,” “WAY 179272” or “HKI-272,” and [***].

 

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1.29“Contract Manufacturing Organization” or “CMO” means any Third Party
contract manufacturing organization.

1.30“Control” or “Controlled” means, with respect to any Know-How, Patent Right,
Regulatory Filing, Regulatory Approval or other property right, the legal
authority or right (whether by ownership, license (other than a license granted
pursuant to this Agreement) or otherwise) of a Person or its Affiliate, to grant
access, a license or a sublicense of or under such Know-How, Patent Right,
Regulatory Filing, Regulatory Approval or other property right, without
breaching the terms of any agreement with a Third Party.

1.31“Cover,” “Covering” or “Covered” means, when referring to a Licensed
Product:(a) with respect to a Patent Right, that, in the absence of a license
granted to a Person under an issued claim included in such Patent Right, the
practice by such Person of a specified activity with respect to such Licensed
Product would infringe such claim, or (b) with respect to an application for
Patent Rights, that, in the absence of a license granted to a Person under a
claim included in such application, the practice by such Person of a specified
activity with respect to such Licensed Product would infringe such claim if such
patent application were to issue as a patent.

1.32“Development” or “Develop” means non-clinical and clinical drug research and
development activities, whether before or after Regulatory Approval, including
drug metabolism and pharmacokinetics, translational research, toxicology,
pharmacology, test method development and stability testing, process and
packaging development and improvement, process validation, process scale-up,
formulation development, delivery system development, quality assurance and
quality control development, statistical analysis, conduct of Clinical Studies,
regulatory affairs, the preparation and submission of Regulatory Filings,
Clinical Study regulatory activities, and any other activities directed towards
obtaining Regulatory Approval of any Licensed Product. Development includes use
and importation of the relevant compound or Licensed Product to conduct such
Development activities. Development will not include Commercialization
activities.

1.33“Development Milestone Event” has the meaning set forth in Section 6.1.2(a)
(Development Milestone Payments).

1.34“Development Milestone Payment” has the meaning set forth in Section
6.1.2(a) (Development Milestone Payments).

1.35“Development Plan” has the meaning set forth in Section 3.2 (Development
Plan).

1.36“Dollars” or “$” means United States dollars.

1.37“Effective Date” has the meaning set forth in the preamble.

1.38“Executive Officers” means (a) with respect to PUMA, the Chief Executive
Officer of PUMA, and (b) with respect to CANbridge, the Chief Executive Officer
of CANbridge. If the position of any of the Executive Officers identified in
this Section 1.38 (Executive Officers) no longer exists due to a corporate
reorganization, corporate restructuring or the like that results in the
elimination of the identified position, the applicable title of the Executive
Officer set forth herein will be replaced with the title of another executive
officer with responsibilities and seniority

 

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comparable to the eliminated Executive Officer, and the relevant Party will
promptly provide notice of such replacement title to the other Party.

1.39 “Existing Third Party License Agreements” means the license agreements by
and between PUMA and Third Parties listed on Schedule 1.39 attached hereto.

1.40 “Exploit” or “Exploitation” means to import, have imported, export, have
exported, use, have used, sell, have sold, offer for sale or otherwise exploit,
including to Develop, Commercialize, register, modify, enhance, improve, hold,
or keep (whether for disposal or otherwise), or otherwise dispose of.

1.41 “FDA” means the United States Food and Drug Administration or any successor
agency thereto.

1.42 “FFDCA” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et
seq.

1.43“Field” means the diagnosis, treatment or prevention of disease in humans.

1.44“First Commercial Sale” means with respect to a Licensed Product in any
Region in the Territory, the first sale for monetary value for use or
consumption by the end user of such Licensed Product in such Region after the
receipt of the Marketing Authorization for such Licensed Product has been
obtained in such Region.

1.45“First Indication” means extended adjuvant HER2 overexpressing breast
cancer.

1.46“Force Majeure Event” has the meaning set forth in Section 14.10 (Force
Majeure).

1.47“GAAP” has the meaning set forth in Section 1.1 (Accounting Standards).

1.48“GCP” or “Good Clinical Practice” means all applicable then-current
standards for the design, conduct, performance, monitoring, auditing, recording,
analyses and reporting of Clinical Studies, including, as applicable, (a) as set
forth in the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use Harmonised Tripartite
Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines
for good clinical practice for trials on medicinal products, (b) the Declaration
of Helsinki (2013) as last amended at the 64th World Medical Association in
October 2013 and any further amendments or clarifications thereto, (c) U.S. Code
of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56
(Institutional Review Boards) and 312 (Investigational New Drug Application),
and (d) the equivalent applicable Laws in any relevant Region, 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.

1.49“Generic Competition” means, with respect to any Region in the Territory,
that any one or more Third Parties sell one or more Generic Products in such
Region that have, in the aggregate, achieved [***] or more of the aggregate
market share of Licensed Products and Generic Products (based on data provided
by IMS Health Incorporated, Fairfield, Connecticut) in any Calendar Quarter as
measured on an aggregate sales basis (in unit sales), or if

 

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such data is not available, a methodology to be mutually agreed upon by the
Parties for estimating the percentage of aggregate sales (in unit sales) based
on market share of Generic Products in such Region.

1.50“Generic Product” means, with respect to a Licensed Product, a [***].

1.51“GLP” or “Good Laboratory Practice” means all applicable then-current
standards for laboratory activities for pharmaceuticals, as set forth in the
FDA’s Good Laboratory Practice regulations as defined in 21 C.F.R. Part 58 or
the Good Laboratory Practice principles of the Organization for Economic
Co-Operation and Development (OECD), and such standards of good laboratory
practice as are required by the European Union and other organizations and
governmental agencies in countries in which a Licensed Product is intended to be
sold by the Party that is subject to such standards, to the extent such
standards are not less stringent than United States Good Laboratory Practice.

1.52“GMP” or “Good Manufacturing Practice” means all applicable then-current
standards for Manufacturing, including, as applicable, (a) the principles
detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. §§ 201,
211, 600 and 610 and all applicable FDA guidelines and requirements, (b)
European Directive 2003/94/EC for medicines and investigational medicines for
human use and the applicable guidelines stated in the Eudralex guidelines, (c)
the principles detailed in the applicable ICH guidelines, (d) the conduct of an
inspection by a Qualified Person and the execution by such Qualified Person of
an appropriate certification of inspection; and (e) the equivalent applicable
Laws in any relevant Region, each as may be amended and applicable from time to
time.

1.53“Governmental Authority” means any multinational, federal, national, state,
provincial, local or other entity, office, commission, bureau, agency, political
subdivision, instrumentality, branch, department, authority, board, court,
arbitral or other tribunal, official or officer, exercising executive, judicial,
legislative, police, regulatory, administrative or taxing authority or functions
of any nature pertaining to government.

1.54“Government Order” means any order, writ, judgment, injunction, decree,
stipulation, ruling, determination or award entered by or with any Governmental
Authority.

1.55“ICH” means the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use.

1.56“IND” means an application filed with a Regulatory Authority for
authorization to commence Clinical Studies, including (a) an Investigational New
Drug Application as defined in the FFDCA or any successor application or
procedure filed with the FDA, (b) any equivalent of a United States IND in other
countries or regulatory jurisdictions, including a Clinical Trial Application
(“CTA”) and (c) all supplements, amendments, variations, extensions and renewals
thereof that may be filed with respect to the foregoing.

 

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1.57“Indemnified Party” means a Person entitled to indemnification under ARTICLE
10 (Indemnification; Damages).

1.58“Indemnifying Party” means a Party from whom indemnification is sought under
ARTICLE 10 (Indemnification; Damages).

1.59“Indications” means, collectively, the First Indication and the Second
Indication.

1.60“Infringement Action” has the meaning set forth in Section 7.3.2
(Enforcement of Licensed Patents in the Territory).

1.61“Infringement Claim” has the meaning set forth in Section 7.4 (Claimed
Infringement).

1.62“Insolvent Party” has the meaning set forth in Section 2.6 (Bankruptcy Code
§ 365(n) Election).

1.63“International Chamber of Commerce” or “ICC” has the meaning set forth in
Section 13.2 (Arbitration).

1.64“Invention” has the meaning set forth in Section 7.1.1 (Inventorship).

1.65“Joint Know-How” means any Know-How that is first conceived or reduced to
practice jointly by the Parties or their Affiliates or others acting on behalf
of the Parties or their Affiliates in the conduct of Development, Manufacturing
or Commercialization of the Licensed Product under this Agreement during the
Term.

1.66“Joint Inventions” has the meaning set forth in Section 7.1.2 (Ownership).

1.67“Joint Patent Rights” means any Patent Rights that contain one or more
claims that claim any Joint Know-How or Joint Invention.

1.68“JSC” has the meaning set forth in Section 5.1 (Formation; Purposes and
Principles).

1.69“Know-How” means all chemical and biological materials and other tangible
materials, inventions, practices, methods, protocols, formulae, knowledge,
know-how, trade secrets, processes, procedures, assays, skills, experience,
techniques, data and results of experimentation and testing, including
pharmacological, toxicological and pre-clinical and clinical test data and
analytical and quality control data, patentable or otherwise.

1.70“Knowledge” means [***].

 

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1.71“Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders,
decrees, judgments or ordinances of any Governmental Authority, or any license,
permit or similar right granted under any of the foregoing, or any similar
provision having the force or effect of law.

1.72“Letter” means that letter agreement by and between CANbridge and PUMA dated
as of the Effective Date.

1.73“Licensed Know-How” means any and all Know-How Controlled by PUMA or its
Affiliates as of the Effective Date or during the Term (including any and all
information contained in Regulatory Filings, CMC Data, PUMA Inventions and
PUMA’s interest in the Joint Know-How and Joint Inventions) that is necessary or
useful to Exploit any Licensed Product in the Field and in the Territory.

1.74“Licensed Patents” means any and all Patent Rights Controlled by PUMA or its
Affiliates as of the Effective Date or during the Term (including (a) the Patent
Rights identified on Schedule 9.2.1 (Licensed Patents) and (b) PUMA’s interest
in the Joint Patent Rights), in each case, that are necessary or useful to
Exploit any Licensed Product in the Field and in the Territory.

1.75“Licensed Product” means any pharmaceutical product containing the Compound.

1.76“Licensed Trademark” means the NERLYNX® mark that is registered with the
U.S. Patent and Trademark Office under registration number 5311871, and all
other filings for the analogous trademark in jurisdictions outside the U.S.

1.77“Losses” means damages, losses, liabilities, costs (including costs of
investigation, defense), fines, penalties, taxes, expenses, or amounts paid in
settlement (in each case, including reasonable attorneys’ and experts’ fees and
expenses), in each case resulting from an Action by a Third Party.

1.78“Manufacture” or “Manufacturing” means all activities related to the
production of a Licensed Product, including the production of any of the
following to the extent used in a Licensed Product: any drug substance produced
in bulk form for use as an active pharmaceutical ingredient, drug product,
compounded or finished final packaged and labeled form, and in intermediate
states, including but not limited to the following activities: reference
standard preparation, cell bank preparation, mammalian cell production,
purification, formulation, scale- up, packaging, quality assurance oversight,
quality control testing (including in-process release and stability testing),
validation activities directly related to all of the foregoing, and data
management and recordkeeping related to all of the foregoing. References to a
Person engaging in Manufacturing activities will include having any or all of
the foregoing activities performed by a Third Party.

1.79“Marketing Authorization” means the grant of all necessary permits,
registrations, authorizations, licenses and approvals (or waivers) required for
the Manufacture and Commercialization of a Licensed Product for use in the Field
and in the Territory, including any Regulatory Approval for sale or marketing,
and, where required, Pricing and Reimbursement Approvals.

 

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1.80“New Drug Application” or “NDA” means a new drug application or product
license application or its equivalent filed with and accepted by the FDA after
completion of human clinical trials to obtain marketing approval for a Licensed
Product, or any comparable application filed with and accepted by the regulatory
authorities of a country or Region other than the U.S.

1.81“Net Sales” means the gross amount invoiced by or on behalf of CANbridge,
its Affiliates and their respective Sublicensees for sales of any Licensed
Product in the Territory (other than sales among CANbridge, its Affiliates or
its Sublicensees for subsequent resale in which case the first sale to a Third
Party that is not a Sublicensee shall be used for calculation of Net Sales),
less the following deductions if and to the extent they are (a) included in the
gross invoiced sales price of the Licensed Product or otherwise directly
incurred by CANbridge, its Affiliates and their respective Sublicensees with
respect to the sale of the Licensed Product, (b) normal and customary, and (c)
not otherwise deducted in computing other amounts hereunder: (i) rebates,
quantity and cash discounts, and other discounts to customers, (ii) taxes
(except income taxes) and tariffs or duties paid, absorbed or allowed which are
directly related to the sale of the Licensed Product, (iii) credits, allowances,
discounts and rebates to, and chargebacks for, spoiled, damaged, out-dated,
rejected or returned Licensed Product (including in connection with Licensed
Product withdrawals, expired Licensed Product and Licensed Product recalls),
(iv) actual freight and insurance costs, including without limitation the costs
of export licenses, shipping, postage and handling charges, incurred in
transporting the Licensed Product to customers, (v) discounts or rebates or
other payments required by applicable Law, including any governmental special
medical assistance programs, (vi) customs duties, surcharges and other
governmental charges incurred in connection with the exportation or importation
of the Licensed Product, and (vii) bad debts actually written off in connection
with such Licensed Products.

Subsections (i) through (vii) shall be collectively referred to as “Deductions”.
The following principles shall apply in the calculation of Net Sales:

In the case of any sale of Licensed Product which is not invoiced or is
delivered before invoice, Net Sales shall be calculated at the time of shipment
or when the Licensed Product is paid for, if paid for before shipment or
invoice.

In the case of any sale or other disposal of Licensed Product for non-cash
consideration, Net Sales shall be calculated as the fair market price of the
Licensed Product in the Region of sale or disposal. Notwithstanding the
foregoing, provision of the Licensed Product for the purpose of conducting
pre-clinical or clinical research shall not be deemed to be a sale. For clarity,
any Licensed Product provided as free samples or as charitable donations shall
not give rise to any Net Sales.

Net Sales shall be determined in accordance with the Accounting Standards.

1.82“Non-Breaching Party” has the meaning set forth in Section 12.3.1
(Termination for Material Breach).

1.83“Party” means either PUMA or CANbridge; “Parties” means PUMA and CANbridge,
collectively.

 

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1.84“Party Vote” has the meaning set forth in Section 5.5 (Decision-Making;
Escalation to Executive Officers).

1.85“Patent Rights” means the rights and interests in and to (a) all patents and
patent applications (including provisional applications), including all
divisionals, continuations, substitutions, continuations-in-part,
re-examinations, re-issues, additions, renewals, extensions, confirmations,
registrations, any other pre- or post-grant forms of any of the foregoing, (b)
any confirmation patent or registration patent or patent of addition, utility
models, patent term extensions, and supplemental protection certificates or
requests for continued examinations, foreign counterparts, and the like of any
of the foregoing, (c) any and all patents that have issued or in the future
issue from the foregoing patent applications, including author certificates,
utility models, petty patents, innovation patents and design patents and
certificates of invention.

1.86“Person” means any natural person, corporation, general partnership, limited
partnership, joint venture, proprietorship or other business organization or a
Governmental Authority.

1.87“Pfizer” has the meaning set forth in the Recitals hereto.

1.88“Pfizer License Agreement” has the meaning set forth in the Recitals hereto.

1.89“Phase II Clinical Study” means a clinical study in humans of the safety,
dose ranging and efficacy of a pharmaceutical product, as described in federal
regulation 21 C.F.R. § 312.21(b) or its foreign equivalents.

1.90“Phase IIa Clinical Study” means a Phase II Clinical Study specifically
designed to assess dosing range and requirements.

1.91“Phase III Clinical Study” means a controlled clinical study, or a portion
of a controlled study, in humans of the efficacy and safety of a Licensed
Product, which study (in its entirety or portion, as applicable), is
prospectively designed to demonstrate statistically whether such Licensed
Product is effective and safe for use in a particular indication in a manner
sufficient to file a Regulatory Approval Application to obtain Regulatory
Approval, as further defined in federal regulation 21 C.F.R. § 312.21(c) or its
foreign equivalents. For clarity, with respect to what is commonly called a
phase 2/3 study, the Phase III Clinical Study definition is met upon the first
patient, first visit in the portion of such study that is prospectively designed
to demonstrate statistically whether such Licensed Product is effective and safe
for use in a particular indication in a manner sufficient to file a Regulatory
Approval Application to obtain Regulatory Approval, as further defined in
federal regulation 21 C.F.R. § 312.21(c) or its foreign equivalents.

1.92“Pricing and Reimbursement Approval” means, with respect to a Licensed
Product, the governmental approval, agreement, determination or decision
establishing the price or level of reimbursement for such Licensed Product, in a
given jurisdiction in the Territory prior to the sale of such Licensed Product
in such jurisdiction in the Territory.

1.93“Prior CDA” means the Confidential Disclosure Agreement between PUMA and
CANbridge, dated October 31, 2017 (the “Prior CDA Effective Date”).

 

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1.94“Prior CDA Effective Date” has the meaning set forth in Section 1.93 (Prior
CDA).

1.95“Public Official or Entity” means (a) an individual or entity operating in
an official or public capacity on behalf of a Governmental Authority (including
physicians, hospital administrators, and other healthcare professionals working
for or on behalf of state-controlled healthcare organization), (b) any official
or employee of a quasi-public or non-governmental international organization,
(c) any employee or other person acting for or on behalf of any entity that is
wholly or partially government owned or controlled by a Governmental Authority,
(d) any person exercising legislative, administrative, judicial, executive, or
regulatory functions for or pertaining to a Governmental Authority (including
any independent regulator), (e) any political party official, officer, employee,
or other person acting for or on behalf of a political party and (f) any
candidate for public office.

1.96“PUMA Indemnified Parties” has the meaning set forth in Section 10.2
(Indemnification by CANbridge).

1.97“PUMA Inventions” has the meaning set forth in Section 7.1.2 (Ownership).

1.98“Qualified Person” or “QP” means a qualified person as defined in the
Clinical Trial Directive 2001/20/EC and Annex 13 to the European GMP Guide.

1.99“Redacted Pfizer License Agreement” means the terms and conditions of the
Pfizer License Agreement to the extent that the same appear in the redacted
version of the Pfizer License Agreement attached to the Letter.

1.100“Region” means each of mainland China, Hong Kong, Macao, and Taiwan.

1.101“Regulatory Approval Application” means an NDA or other equivalent
application to seek Regulatory Approval of a Licensed Product for sale or
marketing in any country(ies) or Region(s) outside the United States, as defined
in the applicable Laws and filed with the Regulatory Authority of such
country(ies) or Region(s).

1.102“Regulatory Approval” means the approval of the applicable Regulatory
Authority necessary for the marketing and sale of a Licensed Product in the
Field in a country(ies) or Region(s), excluding separate Pricing and
Reimbursement Approval that may be required.

1.103“Regulatory Authority” means any multinational, federal, national, state,
provincial or local regulatory agency, department, bureau or other Governmental
Authority with authority over the clinical development, manufacture, marketing
or sale of a Licensed Product in a Region, including FDA in the United States
and EMA in the EU.

1.104“Regulatory Filing” means any documentation comprising or relating to or
supporting any filing or application with any Regulatory Authority with respect
to a Licensed Product, including any documents submitted to any Regulatory
Authority, including INDs, Regulatory Approval Applications, and all
correspondence with any Regulatory Authority with respect to any Licensed
Product (including minutes of any meetings, telephone conferences or discussions
with any Regulatory Authority).

 

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1.105“Royalty Term” has the meaning set forth in Section 6.2.2 (Royalty Term).

 

1.106“Rules” has the meaning set forth in Section 13.2 (Arbitration).

 

1.107“Safety Data” means any Adverse Event information from human trials and all
results from non-clinical safety studies, including, but not limited to,
toxicology and carcinogenicity data (if any), with respect to a Licensed Product
required by one or more Regulatory Authorities to be collected or to be reported
to such Regulatory Authorities under applicable Laws, but excluding any
information related to the efficacy of the Licensed Product.

 

1.108“Sales Milestone Event” has the meaning set forth in Section 6.1.2(b)
(Sales Milestone Payments).

 

1.109“Sales Milestone Payment” has the meaning set forth in Section 6.1.2(b)
(Sales Milestone Payments).

 

1.110“Second Indication” means metastatic HER2 overexpressing breast cancer for
patients that have failed two or more lines of therapy.

 

1.111“Serious Adverse Event” or “SAE” has the meaning set forth in 21 C.F.R. §
312.32, and generally means any Adverse Event that (a) results in death, (b) is
life-threatening, (c) requires inpatient hospitalization or prolongation of
existing hospitalization, (d) results in persistent or significant disability or
incapacity or (e) is a congenital anomaly or birth defect.

 

1.112“Severed Clause” has the meaning set forth in Section 14.5 (Severability).

 

1.113“Sublicense” means a grant of rights from CANbridge to a Sublicensee under
any of the rights licensed to CANbridge by PUMA under Section 2.1 (License
Grant; Right of Reference) with respect to the Development or Commercialization
of any Licensed Product.

 

1.114“Sublicensee” means, with respect to a Party, a Third Party sublicensee of
rights granted to such Party under this Agreement or a Third Party licensee of
rights with respect to a Licensed Product which rights are retained by such
Party under this Agreement with respect to such Licensed Product.

 

1.115“Supply Agreement” has the meaning set forth in Section 4.1 (Supply Terms).

 

1.116“Term” has the meaning set forth in Section 12.1 (Term).

 

1.117“Territory” means the People’s Republic of China, including, for the
avoidance of doubt, each of the Regions.

 

1.118“Third Party” means any Person other than a Party or any of its Affiliates.

 

1.119“Third Party Claim” has the meaning set forth in Section 10.3.1 (Notice).

 

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1.120“Trademark” means all registered and unregistered trademarks, service
marks, trade dress, trade names, logos, insignias, domain names, symbols,
designs, and combinations thereof.

 

1.121“Tyrosine Kinase Inhibitor” means [***]. For the avoidance of doubt,
“Tyrosine Kinase Inhibitor” shall not include [***].

 

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

 

1.123“Valid Claim” means either: (a) a claim of an issued and unexpired patent
included within the Licensed Patents, which has not been permanently revoked or
declared unenforceable or invalid by an unreversed and unappealable or
unreversed and unappealed decision of a court or other appropriate body of
competent jurisdiction, or (b) a claim of a pending patent application included
within the Licensed Patents, which claim was filed in good faith, has not been
pending for more than [***] from its priority date, and has not been abandoned
or finally disallowed without the possibility of appeal or refiling of such
application.

 

ARTICLE 2

LICENSE GRANTS

 

2.1License Grant; Right of Reference.

2.1.1Exclusive License Grant. Subject to the terms and conditions of this
Agreement, PUMA hereby grants to CANbridge an exclusive (even with respect to
PUMA and its Affiliates), sublicensable (subject to Section 2.2.1 (CANbridge
Right to Sublicense)), royalty- bearing right and license under the Licensed
Patents, Licensed Know-How and, pursuant to Section 4.2.4(c) (Trademarks), the
Licensed Trademark, to (a) Develop, Commercialize and otherwise Exploit Licensed
Products in the Field in the Territory, including the right to co- administer
(but not co-formulate) Licensed Products with other pharmaceutical products in
the Territory, and (b) Develop Licensed Products outside of the Territory solely
for the purpose of Exploiting such Licensed Products in the Territory. For
clarity, this Section 2.1.1 does not grant any license to CANbridge under any
intellectual property rights Controlled by PUMA to Develop, Commercialize, and
otherwise Exploit, including the right to co-administer (but not co-formulate)
any product being developed or commercialized by or on behalf of PUMA, its
Affiliates or sublicensees other than Licensed Product.

2.1.2CANbridge Right of Access and Reference. Subject to the terms of this
Agreement, PUMA hereby grants CANbridge access to, and a right of reference with
respect to, (a) its and its Affiliates’ Regulatory Filings, Regulatory Approvals
and all corresponding documentation Controlled by PUMA or its Affiliates at any
time during the Term, and (b) all Safety Data and CMC Data contained or
referenced in any Regulatory Filings and all corresponding documentation
Controlled by PUMA or its Affiliates at any time during the Term, in each case
((a) and (b)), for the sole purpose of Developing, seeking and securing
Regulatory Approval for, Commercializing, and otherwise Exploiting Licensed
Products in the Territory. The foregoing rights include without limitation the
right for CANbridge and, to the extent permitted under this Agreement, its
Affiliates and Sublicensees, to make copies of and reproduce such

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documentation and information for the purposes set forth in this Section 2.1.2
(CANbridge Right of Access and Reference).

2.1.3PUMA Right of Reference. Subject to the terms of this Agreement, CANbridge
hereby grants PUMA, its Affiliates and sublicensees access to, and a right of
reference with respect to, (a) its and its Affiliates’ Regulatory Filings,
Regulatory Approvals and all corresponding documentation Controlled by CANbridge
or its Affiliates at any time during the Term, and (b) all Safety Data and CMC
Data contained or referenced in any Regulatory Filings and all corresponding
documentation Controlled by CANbridge or its Affiliates at any time during the
Term, in each case ((a) and (b)), for the sole purpose of Developing, seeking
and securing Regulatory Approval for, Commercializing, and otherwise Exploiting
Licensed Products outside the Territory. The foregoing rights include without
limitation the right for PUMA, its Affiliates and sublicensees, to make copies
of and reproduce such documentation and information for the purposes set forth
in this Section 2.1.3 (PUMA Right of Reference). Upon termination (but not
expiration) of this Agreement, and subject to Section 12.2 (Paid-Up License Upon
End of Royalty Term) of this Agreement, PUMA’s rights under this Section 2.1.3
shall apply on a worldwide basis.

 

2.1.4Delivery of Documentation. From time-to-time during the Term, upon
CANbridge’s reasonable request, Puma shall provide CANbridge with copies of all
data and information (including existing Regulatory Filings) relating to
Licensed Products that are (a) Controlled by PUMA, its Affiliates or its
sublicensees and (b) reasonably necessary to support Development of, or
Regulatory Approval for, Licensed Products in the Territory.

2.2Sublicensing and Subcontracting.

2.2.1CANbridge Right to Sublicense. CANbridge will have the right to grant
Sublicenses (through multiple tiers) in the Territory of any and all rights
granted to CANbridge by PUMA pursuant to Section 2.1 (License Grant; Right of
Reference) to (a) its Affiliates and (b) solely to the extent required by
applicable Law or any relevant Governmental Authority, Third Parties with the
identity of such Third Parties being subject to PUMA’s advance written consent,
not to be unreasonably withheld. In the event that CANbridge grants a Sublicense
pursuant to this Section 2.2.1 (CANbridge Right to Sublicense), CANbridge will
remain responsible for its obligations under this Agreement and will ensure that
each of its Sublicensees complies with all relevant provisions of this
Agreement.

2.2.2Sublicense Requirements. Each Sublicense granted by CANbridge to an
Affiliate or a Third Party pursuant to Section 2.2.1 (CANbridge Right to
Sublicense) will be in writing and will be consistent with the relevant
restrictions and limitations set forth in this Agreement. No Sublicense will
diminish, reduce or eliminate any obligation of either Party under this
Agreement.

2.2.3Performance by CANbridge Sublicensees. CANbridge will promptly provide PUMA
with a copy of any fully executed Sublicense agreement covering any Sublicense
granted hereunder. Any such Sublicense agreement entered into by CANbridge will
contain the following provisions: (a) a requirement that such Sublicensee submit
applicable sales or other reports to PUMA consistent with the reporting
requirements set forth in Section 6.3 (Royalty Payments and Reports); (b) an
audit requirement consistent with that set forth in Section 6.5

 

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(Financial Audits); (c) a requirement that such Sublicensee comply with the
confidentiality provisions and restrictions on use of Confidential Information
contained in Section 8.1 (Confidential Information) with respect to PUMA’s
Confidential Information; and (d) those provisions required by the Existing
Third Party License Agreements.

2.3Performance by Independent Contractors. CANbridge may contract or delegate
any portion of its obligations hereunder to a contractor subject to the terms
and condition of Section

14.9 (Affiliates, Sublicensees, and Contractors).

2.4Exclusivity Covenant. During the Term, neither Party nor its Affiliates will
directly or indirectly conduct, have conducted, engage in or fund any activity
that involves the Development, Manufacture or Commercialization of any Tyrosine
Kinase Inhibitor that [***] other than the Licensed Product pursuant to the
terms and conditions set forth in this Agreement.

2.5Reservation of Rights. No rights, other than those expressly set forth in
this Agreement, are granted to either Party under this Agreement, and no
additional rights will be deemed granted to either Party by implication,
estoppel or otherwise, with respect to any intellectual property rights. All
rights not expressly granted by either Party or its Affiliates to the other
under this Agreement are reserved.

2.6Bankruptcy Code § 365(n) Election. All rights and licenses now or hereafter
granted under or pursuant to this Agreement, are rights to “intellectual
property” (as defined in Section 101(35A) of Title 11 of the United States Code,
as amended (such Title 11, the “Bankruptcy Code”)). Each Party, as licensee of
such rights under this Agreement, will retain and may fully exercise all of its
rights and elections under the United States Bankruptcy Code. In the event of
the commencement of a bankruptcy proceeding by or against a Party under the
Bankruptcy Code (the “Insolvent Party”), the other Party will be entitled to a
complete duplicate of (or complete access to, as appropriate) any intellectual
property licensed to it under this Agreement and all embodiments of such
intellectual property (including all information related to such intellectual
property and rights of reference with respect to Regulatory Approvals), and
same, if not already in its possession, will be promptly delivered to it (a)
upon any such commencement of a bankruptcy proceeding upon its written request
therefor, unless the Insolvent Party continues to perform all of its obligations
under this Agreement, or (b) if not delivered or granted under (a) above,
following the rejection of this Agreement by or on behalf of the Insolvent Party
upon written request therefor by the other Party. The Parties hereto acknowledge
and agree that all payments by CANbridge to PUMA under this Agreement, other
than royalty payments pursuant to Section 6.2 (Royalties), do not constitute
royalties within the meaning of Bankruptcy Code

§365(n) or relate to licenses of intellectual property under this Agreement.

2.7Not Inconsistent Third Party Agreements. During the Term, neither PUMA nor
any of its Affiliates will enter into any license of intellectual property
pursuant to which PUMA or any of its Affiliates grants to a Third Party rights
under or to any Know-How, Patent Rights or Licensed Trademarks, or otherwise
enters into any agreement, that would contravene or be inconsistent or in
conflict with the rights of CANbridge or the obligations of PUMA under this
Agreement. During the Term, neither PUMA nor any of its Affiliates will amend,
modify or terminate any in-license of Third Party intellectual property
(including, without limitation, any such in-license that is in effect as of the
Effective Date) without the prior written consent of

 

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CANbridge if such amendment, modification or termination would materially
adversely affect any of the rights that CANbridge or any of its Affiliates has
under this Agreement.

2.8The Pfizer License Agreement. CANbridge acknowledges that the rights granted
to CANbridge under this Agreement that constitute a sublicense under the Pfizer
License Agreement, in addition to being limited by and subject to the terms and
conditions of this Agreement, are further limited by the terms and conditions of
the Redacted Pfizer License Agreement. Notwithstanding ARTICLE 8
(Confidentiality and Publicity), pursuant to the Pfizer License Agreement,
CANbridge acknowledges that PUMA will furnish to Pfizer a true and complete copy
of this Agreement and any current and future amendments thereto, which Agreement
shall be redacted to omit any and all information not directly relevant to the
performance of PUMA’s obligations under the Pfizer License Agreement, within
[***] after the Effective Date of this Agreement or any amendments hereto have
been executed. To the extent requested by PUMA from time to time, CANbridge will
take reasonable steps (without requiring CANbridge to bear additional costs) to
support PUMA’s compliance with the Pfizer License Agreement.

 

ARTICLE 3

DEVELOPMENT

 

3.1Development Diligence; Development Responsibilities; Manner of Performance.

3.1.1Development Diligence. CANbridge (directly, or through its Affiliates,
Sublicensees and contractors) will use Commercially Reasonable Efforts to
Develop and seek Regulatory Approval for a Licensed Product for the Indications
in the Territory. For the avoidance of doubt, CANbridge’s Development diligence
obligations set forth in this Section 3.1.1 (Development Diligence) shall not be
deemed to require CANbridge to conduct a full comparative Phase III Clinical
Study, which, for clarity, does not include pharmacokinetic, safety or bridging
studies (i.e., any study that does not include a clinical comparative study for
efficacy), for any Licensed Product for the First Indication in the Territory.

3.1.2Development Responsibilities. Subject to the terms and conditions of this
Agreement, including this ARTICLE 3 (Development) and Section 5.2 (Specific
Responsibilities), CANbridge will have sole authority to, at its own expense,
Develop Licensed Product for the purpose of obtaining Regulatory Approval in the
Field and in the Territory, subject to PUMA’s written approval (such approval
not to be unreasonably withheld) of all protocols, study designs, and any
amendments thereto, for any Clinical Studies to be conducted by or on behalf of
CANbridge for the Licensed Product in the Field in the Territory. CANbridge will
be responsible for the day-to-day implementation of any Development activities
for which it (or any of its Affiliates) is assigned responsibility under this
Agreement and the Development Plan, and will keep PUMA reasonably informed as to
the progress of such activities.

3.1.3Manner of Performance. CANbridge will perform its Development obligations
under this Agreement in good scientific manner and in compliance with all
applicable Laws (including with respect to each such activity that will or would
reasonably be expected to be submitted to a Regulatory Authority in support of a
regulatory filing or Regulatory Approval Application in the Territory, and
then-current Good Laboratory Practice standards and Good Clinical Practices in
the Territory).

 

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3.2Development Plan. Any Development of Licensed Products in the Territory for
the Indications shall be conducted by CANbridge pursuant to a written plan
describing the Development activities to be performed by CANbridge with respect
to Clinical Studies for the Indications in the Territory (the “Development
Plan”). The Development Plan shall be mutually agreed to by the Parties through
the JSC pursuant to Section 5.2 (Specific Responsibilities). Any material
changes to the Development Plan, including the addition of any clinical trial
protocols (or any material changes to such protocols), shall be drafted by the
proposing Party and agreed upon by the JSC pursuant to Section 5.2 (Specific
Responsibilities), subject to the decision-making and escalation procedures set
forth in Section 5.5 (Decision-Making; Escalation to Executive Officers). In the
event of any proposed change to the Development Plan as a result of any
interaction with any Regulatory Authority, the JSC shall meet as promptly as
practicable to review and discuss any such proposed changes and determine an
appropriate revision (if any) to the Development Plan. For clarity, this Section
3.2 (Development Plan) shall not (a) supersede PUMA’s right to approve the
protocols, study designs, or any amendments thereto, for proposed Clinical
Studies for Licensed Product in the Field in the Territory pursuant to Section
3.1.2 (Development Responsibilities), or (b) prevent or limit CANbridge’s right
to pursue the Development of indications other than the Indications (including
the conduct of Clinical Trials), subject to the foregoing subsection (a).

3.3Development Records and Reporting.

3.3.1Records. CANbridge shall maintain complete and accurate records of all work
conducted by or on behalf of CANbridge in furtherance of the Development of the
Licensed Product and all material results, data and developments made in
conducting such activities. Such records shall be maintained in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes and in accordance with applicable Law.

3.3.2Reporting. CANbridge will provide to PUMA a written report at least [***],
in English, describing in reasonable detail CANbridge’s activities and progress
related to the Development of the Licensed Product in the Territory. CANbridge
shall promptly respond to PUMA’s reasonable questions or requests for additional
information relating to such Development activities.

3.4Regulatory Submissions and Approvals; Communications; Meetings.

3.4.1Regulatory Filings and Approvals. CANbridge, or its relevant Affiliates or
Sublicensees, will have the sole right to file and hold all Regulatory Filings,
and to apply for, own, and maintain all Regulatory Approvals, in each case for
all Licensed Products in the Territory at CANbridge’s cost and expense.

3.4.2Regulatory Communications.   Subject to applicable Law and this Section

3.4(Regulatory Submissions and Approvals; Communications; Meetings), CANbridge
will oversee, monitor and manage all interactions and communications with
Regulatory Authorities with respect to Licensed Products in the Territory.
CANbridge will have final decision-making authority regarding all regulatory
activities, including the labeling strategy and the content of Regulatory
Filings within the Territory, subject to the terms and conditions of this
Agreement. CANbridge will promptly notify PUMA of all material communications or
correspondence with Regulatory Authorities with respect to Licensed Products in
the Territory that are received by

 

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CANbridge from any Regulatory Authority or submitted by CANbridge to any
Regulatory Authority.

3.4.3Regulatory Meetings. Until such time as CANbridge obtains Regulatory
Approval for a Licensed Product in the Territory, to the extent legally
permissible and practicable, CANbridge shall provide PUMA with prior written
notice of all material meetings with Regulatory Authorities (including advisory
committee meetings and any other meeting of experts convened by a Regulatory
Authority) regarding the Licensed Product, such notice to be provided within
[***] after CANbridge receives notice of the scheduling of such meeting. PUMA
shall have the right to request to be present at (but not to participate in,
unless requested by CANbridge or the Regulatory Authority) all such meetings
with Regulatory Authorities to the extent permitted under applicable Laws, at
PUMA’s sole cost and expense, and CANbridge shall consider any such request in
good faith.

3.4.4Termination or Suspension of Clinical Studies. Notwithstanding anything to
the contrary in this Agreement or the Pharmacovigilance Agreement, CANbridge may
terminate or suspend any Clinical Study relating to the Licensed Product of
which it or its Affiliate or Sublicensee is the sponsor, without the approval or
consent of the JSC or PUMA, if (a) a Regulatory Authority, institutional review
board or safety data review board for such Clinical Study has required or
recommended such termination or suspension or (b) CANbridge believes in good
faith that such termination or suspension is warranted because of observed
safety risks to the study subjects or patients. In either case, CANbridge will
promptly notify PUMA in writing of such termination or suspension.

3.4.5Regulatory Investigation or Inquiry. If any Regulatory Authority (a)
contacts CANbridge or its Affiliate with respect to the alleged improper
Development, or Commercialization of any Licensed Product, (b) conducts, or
gives notice of its intent to conduct, an inspection at CANbridge’s or its
Affiliate’s facilities used in the Development of the Licensed Product, or (c)
takes, or gives notice of its intent to take, any other regulatory action with
respect to any activity of CANbridge or its Affiliate that could reasonably be
expected to adversely affect any Development or Commercialization activities
with respect to a Licensed Product in the Territory or outside of the Territory,
then CANbridge will promptly notify PUMA in writing of such contact, inspection
or notice.

3.5Pharmacovigilance. Within [***], the Parties shall define and finalize the
actions that the Parties shall employ with respect to Licensed Products to
protect patients and promote their well-being in a written pharmacovigilance
agreement (the “Pharmacovigilance Agreement”). These responsibilities shall
include mutually acceptable guidelines and procedures for the receipt,
investigation, recordation, communication, and exchange (as between the Parties)
of Adverse Event reports and any other information concerning the safety of any
Licensed Product, including recall and withdrawal responsibilities, processes
and procedures. Such guidelines and procedures shall be in accordance with, and
enable the Parties to fulfill, local and national regulatory reporting
obligations under applicable Laws. Furthermore, such agreed procedure shall be
consistent with relevant ICH guidelines, except where said guidelines may
conflict with existing local regulatory reporting safety reporting requirements,
in which case local reporting requirement shall prevail. CANbridge shall be
responsible for reporting quality complaints, Adverse Events and safety data
related to the Licensed Product to applicable Regulatory Authorities in the
Territory, as well as responding to safety issues and to all requests

 

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of Regulatory Authorities relating to Licensed Products in the Territory. PUMA
shall be responsible for reporting quality complaints, Adverse Events and safety
data related to Licensed Product to applicable Regulatory Authorities outside
the Territory, as well as responding to safety issues and to all requests of
Regulatory Authorities relating to Licensed Product outside the Territory. The
Pharmacovigilance Agreement shall also provide for a worldwide safety database
to be maintained by PUMA [***], which worldwide safety database will be
accessible by CANbridge, its Affiliates, Sublicensees and contractors to the
full extent necessary for CANbridge to exercise its rights under this Agreement,
comply with its obligations under this Agreement, and comply with all applicable
Laws. Each Party hereby agrees to comply with its respective obligations under
such Pharmacovigilance Agreement and to cause its Affiliates and permitted
sublicensees and contractors to comply with such obligations.

 

ARTICLE 4

MANUFACTURE AND COMMERCIALIZATION

 

4.1Manufacture Supply Terms. Except as otherwise expressly set forth in the
Supply Agreement, CANbridge hereby agrees to purchase any and all of its
requirements of clinical and commercial supply of the Licensed Product during
the Term from PUMA. The per unit supply price for each [***] of the Licensed
Product in [***] form shall be (a) $[***] for Licensed Product supplied for
clinical use, and (b) $[***] for Licensed Product supplied for commercial use.
Such prices shall be revised every [***] to account for any increase in the
relevant Producer Price Index applicable to the prior [***]. The Parties will
execute a supply agreement containing supply and quality terms and conditions
consistent with the principles set forth on Schedule 4.1 hereto (Supply
Agreement Key Terms) and typical for such agreements (the “Supply Agreement”).

4.2Commercialization.

4.2.1Commercialization Diligence. Upon receipt of Marketing Authorization for a
given Licensed Product in a given Region in the Territory for a given
Indication, CANbridge (directly, or through its Affiliates, Sublicensees or
contractors) shall use Commercially Reasonable Efforts to Commercialize such
Licensed Products in such Region for such Indication.

4.2.2Commercialization Responsibilities. CANbridge will be solely responsible
for at its expense, and subject to Section 4.2.4 (Coordination of Commercial
Activities), will have sole discretion with respect to, Commercializing Licensed
Product in the Territory.

4.2.3Manner of Performance. CANbridge will perform its Commercialization
obligations under this Agreement in good scientific manner and in compliance
with all applicable Laws.

4.2.4Coordination of Commercial Activities

(a)General. The Parties recognize that they may benefit from the coordination of
certain activities in support of the Commercialization of Licensed Products in
the Territory. As such, the Parties will coordinate such activities, where
appropriate, through the JSC. Following Regulatory Approval in a Region in the
Territory, CANbridge shall update PUMA in

 

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writing on a quarterly basis through the JSC of the expected timing of the
commercial launch of Licensed Product in such Region.

(b)Global Brand Elements. The Parties may, through their respective Alliance
Managers and the JSC, endeavor to develop and adopt the key distinctive colors,
logos, images, symbols, and trademarks to be used both in and outside of the
Territory in connection with the Commercialization of the Licensed Product. Each
Party shall own the rights in such global brand elements in its respective
territory and shall Commercialize the Licensed Product in its respective
territory in a manner consistent with the applicable global brand elements.

(c)Trademarks. Subject to Section 4.2.4(b) (Global Brand Elements), CANbridge
shall have the right to brand the Licensed Products in the Territory using
CANbridge related trademarks and any other trademarks and trade names it
determines appropriate for the Licensed Products, including, for the avoidance
of doubt, the Licensed Trademark, which branding may vary by Region or within a
Region. Except with respect to the Licensed Trademark, CANbridge shall own all
rights in such trademarks and register and maintain such trademarks in the
countries and regions within the Territory, where and how it determines
appropriate.

(d)Market Research and Materials. At each regularly scheduled JSC meeting, each
Party shall update the other Party regarding the material market research that
it is performing with respect to the Licensed Products, and shall provide the
other Party with a copy of such research upon request if such material market
research is necessary for the other Party to Commercialize the Licensed Products
in its respective territory or is otherwise requested by any Regulatory
Authority.

4.2.5Diversion. Each Party hereby covenants and agrees that it and its
Affiliates shall not, and it shall contractually obligate (and use Commercially
Reasonable Efforts to enforce such contractual obligation) its licensees,
sublicensees and contractors not to, directly or indirectly, actively promote,
market, distribute, import, sell or have sold any Licensed Product, including
via the Internet or mail order, to any Third Party or to any address or Internet
Protocol address or the like in the other Party’s territory. Neither Party shall
engage, nor permit its Affiliates, sublicensees or contractors to engage, in any
advertising or promotional activities relating to any Licensed Product for use
directed primarily to customers or other buyers or users of such product located
in any country, Region or jurisdiction in the other Party’s territory, or
solicit orders from any prospective purchaser located in any country, Region or
jurisdiction in the other Party’s territory.

4.2.6No Violation. Notwithstanding anything to the contrary contained herein,
CANbridge (including its Affiliates, Sublicensees and contractors) will not be
obligated to undertake or continue any Commercialization activities with respect
to Licensed Products if CANbridge (or its Affiliates, Sublicensees or
contractors, as applicable) reasonably determines that performance of such
Commercialization activity would violate applicable Law or infringe any Third
Party Patent Rights.

 

ARTICLE 5

GOVERNANCE; JOINT STEERING COMMITTEE

 

5.1Formation; Purposes and Principles. Promptly following the Effective Date,
but in no event later than [***] thereafter, PUMA and CANbridge will form a
joint steering

 

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committee (the “JSC”) to provide oversight and to facilitate information sharing
between the Parties with respect to the activities of the Parties under this
Agreement.

5.2Specific Responsibilities. In addition to its overall responsibility to
provide oversight and to facilitate information sharing between the Parties with
respect to the activities of the Parties under this Agreement, the JSC will:

(a)discuss and agree upon the initial Development Plan;

(b)review and approve changes to the Development Plan on an as-needed basis;

(c)coordinate and share information with respect to the Developmentand
Commercialization of Licensed Products, including as set forth in Section 4.2.4
(Coordination of Commercial Activities);

(d)keep each Party reasonably informed of the other Party’s Development and
Commercialization activities and interactions with Regulatory Authorities, by
receiving updates from the Party conducting such activities;

(e)coordinate and share information with respect to PUMA’s Manufacture and
supply of Licensed Products and activities associated therewith to the extent
relevant for Development and Commercialization of Licensed Products in the
Territory in accordance with this Agreement;

(f)attempt to resolve in the first instance all matters between the Parties that
are in dispute; and

(g)perform such other functions as are assigned to it in this Agreement or as
appropriate to further the purposes of this Agreement to the extent agreed to in
writing by the Parties.

 

5.3Membership.  The JSC will be composed of a total of [***] representatives,
[***] of which will be appointed by each of PUMA and CANbridge. Each individual
appointed by a Party as a representative to the JSC will be an employee or
contractor of such Party, or an employee or contractor of such Party’s
Affiliate. Each Party may replace any of its JSC representatives at any time
upon written notice to the other Party, which notice may be given by e-mail,
sent to the other Party’s co-chairperson. The JSC will be co-chaired by one
designated representative of each Party. The co-chairperson of the JSC will cast
its Party’s vote on the JSC and such designee will have the authority to make
decisions on behalf of such Party. Each co- chairperson will alternate being
responsible for each meeting for (a) calling meetings, (b) preparing and
circulating an agenda in advance of each meeting; provided, however, that the
applicable co- chairperson will include any agenda items proposed by either
Party on such agenda, and (c) preparing and issuing minutes of each meeting
promptly thereafter. Each JSC representative will be subject to confidentiality
obligations no less stringent than those in ARTICLE 8 (Confidentiality and
Publicity).

5.4Meetings; Reports. The JSC will hold meetings [***] during the Term for so
long as the JSC exists.       The JSC may meet in person or by audio or video
conference as its

 

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representatives may mutually agree. Other representatives of the Parties, their
Affiliates and Third Parties involved in the Development, Manufacture, or
Commercialization of Licensed Products may be invited by the members of the JSC
to attend meetings as non-voting observers; provided, however, that such
representatives are subject to confidentiality obligations no less stringent
than those set forth in ARTICLE 8 (Confidentiality and Publicity); and, provided
further, that each representative appointed by a Party to take action at a
meeting will have sufficient authority to execute such action on behalf of such
Party. No action taken at a meeting will be effective unless at least one
representative of each Party is present or participating. Neither Party will
unreasonably withhold attendance of at least one representative of such Party at
any meeting of the JSC for which reasonable advance notice was provided.

5.5Decision-Making; Escalation to Executive Officers. The Parties will endeavor
in good faith to reach unanimous agreement with respect to all matters within
the JSC’s authority. Each Party’s representatives on the JSC shall collectively
have one vote, (the “Party Vote”) and no action or decision shall be taken by
the JSC without unanimous Party Vote (i.e., the affirmative Party Vote of each
Party), which will be documented by a written consent signed by each Party’s
co-chairperson. Should the JSC not be able to reach agreement with respect to a
matter at a duly called meeting of the JSC, either Party may refer such matter
to the Executive Officers for resolution, and the Executive Officers will
attempt to resolve the matter in good faith. If the Executive Officers fail to
resolve such matter within [***] after the date on which the matter is referred
to the Executive Officers (unless a longer period is agreed to by the Parties),
then, (a) [***] shall have final decision-making authority with respect to the
[***], including any [***], subject to [***] right to [***], and (b) with
respect to all other such matters, [***]. Notwithstanding any provision of this
Section 5 (Governance; Joint Steering Committee) to the contrary, the JSC shall
not have the authority to amend the terms or conditions of this Agreement.

5.6Alliance Managers.

5.6.1Appointment. Each Party shall appoint a person to oversee interactions
between the Parties for all matters related to the Development and
Commercialization of Licensed Products between meetings of the JSC (each, an
“Alliance Manager”). The Alliance Managers will have the right to attend all
meetings of the committees as non-voting participants and may bring to the
attention of the JSC any matters or issues either Alliance Manager reasonably
believes should be discussed and will have such other responsibilities as the
Parties may mutually agree in writing. Each Party may replace its Alliance
Manager at any time or may designate different Alliance Managers with respect to
Development and Commercialization matters, respectively, by notice in writing to
the other Party.

5.6.2Responsibility. The Alliance Managers, if appointed, will have the
responsibility of creating and maintaining a constructive work environment
within the JSC and between the Parties for all matters related to this
Agreement. Without limiting the generality of the foregoing, each Alliance
Manager will:

 

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(a)provide a single point of communication within the Parties’ respective
organizations and between the Parties with respect to this Agreement; coordinate
cooperative efforts, internal communications and external communications between
the Parties with respect to this Agreement; and

(b)take such other steps as may be required to ensure that meetings of the JSC
occur as set forth in this Agreement, that procedures are followed with respect
to such meetings (including the giving of proper notice and the preparation and
approval of minutes) and that relevant action items resulting from such meetings
are appropriately carried out or otherwise addressed.

ARTICLE 6

FINANCIAL PROVISIONS

 

6.1Upfront Payment; Milestone Payments.

6.1.1Upfront Payment. Subject to the terms and conditions of this Agreement,
CANbridge will pay PUMA a non-refundable, non-creditable payment in the amount
of thirty million Dollars ($30,000,000), which upfront payment will be due and
payable to PUMA within [***] following the Effective Date, or such longer period
of time as is required to effectuate the transfer of such upfront payment in
accordance with applicable Laws.

6.1.2Milestone Payments.

(a)Development Milestone Payments. Subject to the terms and conditions of this
Agreement, CANbridge will pay to PUMA the following non-refundable, non-
creditable one-time milestone payments (each, a “Development Milestone Payment”)
within [***] of achieving each of the following milestones in [***] (each a
“Development Milestone Event”):

 

 

Development Milestone Event

Development Milestone Payment

[***]

$[***]

[***]

$[***]

[***]

$[***]

 

Each Development Milestone Payment will be payable only one-time and only upon
the first achievement of the applicable Development Milestone Event in [***],
and no amounts would be due for subsequent or repeated achievements.

 

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(b)Sales Milestone Payments. Subject to the terms and conditions of this
Agreement, CANbridge will pay to PUMA the following non-refundable,
non-creditable one- time sales milestone payments (each, a “Sales Milestone
Payment”) within [***] during the Royalty Term in which the aggregate Net Sales
of Licensed Products by CANbridge and its Affiliates and Sublicensees in the
Territory achieves each of the following sales thresholds (each a “Sales
Milestone Event”):

 

Sales Milestone Event

Sales Milestone Payment

Aggregate Single Calendar Year Net Sales Greater than or Equal to $[***]

$[***]

Aggregate Single Calendar Year Net Sales Greater than or Equal to $[***]

$[***]

Aggregate Single Calendar Year Net Sales Greater than or Equal to $[***]

$[***]

Aggregate Single Calendar Year Net Sales Greater than or Equal to $[***]

$[***]

 

Each Sales Milestone Payment will be payable only one-time and only upon the
first achievement of the applicable Sales Milestone Event in the Territory, and
no amounts would be due for subsequent or repeated achievements. If a Sales
Milestone Event is achieved prior to the achievement of the preceding Sales
Milestone Event set forth in the relevant chart (i.e., if a lower- listed Sales
Milestone Event is achieved before a Sales Milestone Event that is listed higher
up in the relevant chart), then upon achievement of the relevant Sales Milestone
Event, [***].

 

6.1.3Milestone Event Notice. Within [***] after a Party becomes aware that a
Milestone Event was achieved, it will notify the other Party thereof in writing.

6.2Royalties.

6.2.1Royalty Rates. Subject to the terms and conditions in this Agreement, on a
Region-by-Region and Licensed Product-by-Licensed Product basis during the
applicable Royalty Term, CANbridge will pay to PUMA royalties on Net Sales of
Licensed Products in the Territory, as calculated by multiplying the applicable
royalty rates below by the corresponding amount of incremental Net Sales in the
Territory of all Licensed Products in each Calendar Year:

 

Annual Net Sales of Products

Royalty Rate

For that portion of aggregate annual Net Sales less than $[***]

[***]%

For that portion of aggregate annual Net Sales greater than or equal to

$[***] and less than $[***]

[***]%

For that portion of aggregate annual Net Sales greater than or equal to

$[***]

[***]%

 

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For example, if the Net Sales of Licensed Products in the Territory in a given
Calendar Year totaled $[***], CANbridge would pay to PUMA a [***] percent
([***]%) royalty on the first $[***] and a [***] percent ([***]%) royalty on the
next $[***], for a total royalty payment ([***]) equal to $[***].

 

6.2.2Royalty Term. Royalties will be due under this Section 6.2.2 (Royalty Term)
with respect to a given Licensed Product and given Region in the Territory
during the period commencing upon the earlier of (a) the first sale of such
Licensed Product for use in a named patient access program in such Region or (b)
the First Commercial Sale of such Licensed Product in such Region (the earlier
of (a) and (b) referred to herein as the “Royalty Commencement Date”), and
ending upon the later of (x) the expiration or abandonment of the last Valid
Claim within the Licensed Patents Covering such Licensed Product in such Region,
or (y) the earlier of (i) the time when Generic Competition first exists with
respect to such Licensed Product in such Region,   or

(ii) the 10th anniversary of the First Commercial Sale for such Licensed Product
in such Region (such period, the “Royalty Term”).

6.3Royalty Payments and Reports. CANbridge will pay to PUMA any amounts due
pursuant to Section 6.2.1 (Royalty Rates) within [***] after the end of each
Calendar Quarter, and will provide to PUMA concurrently with such payment a
statement setting forth (a) the monthly sales calculation of Net Sales on a
Licensed Products-by-Licensed Product and Region-by-Region basis in the
Territory during such Calendar Quarter (including such amounts expressed in
local currency and as converted to Dollars); (b) the type and amount of
permitted Deductions from gross sales to determine Net Sales and the total
amount of such Deductions; (c) the applicable royalty rates for each Licensed
Product in each Region in the Territory after applying any permitted Deductions
set forth above; and (d) a calculation of the royalties due to PUMA for such
Calendar Quarter.

6.4Payment Reduction for Blocking Third Party Intellectual Property. With
respect to a particular Region in the Territory, CANbridge will be entitled to
credit from royalty payments under Section 6.2 (Royalties) otherwise payable to
PUMA in such Region [***] of any Blocking Third Party Intellectual Property
Costs applicable to such Region. Notwithstanding the foregoing, in no event
shall such deductions reduce the royalties otherwise payable to PUMA by more
than [***] pursuant to this Section 6.4.

6.5Financial Audits.

6.5.1Record Keeping. CANbridge and its Affiliates will keep complete and
accurate records in accordance with its Accounting Standards of the items
underlying (a) the Sales Milestone Payments, (b) the Development Milestone
Payments, (c) Net Sales, (d) royalty payments, (e) any other payments under this
Agreement, and (f) CANbridge’s prosecution, maintenance and enforcement of
Patent Rights pursuant to this Agreement (collectively, “Relevant Records”).
CANbridge, and its Affiliates and Sublicensees, shall maintain the Relevant
Records for the longer of: (i) the period of time required by applicable Law or
(ii) [***] following expiration or termination of this Agreement. CANbridge
shall require its Sublicensees to provide to CANbridge (so that PUMA may provide
the same to Pfizer) copies of all Relevant Records relating to such
Sublicensees’ sale of Licensed Products as necessary to allow PUMA or, if
applicable, Pfizer (under the Pfizer License Agreement) to review such Relevant
Records when conducting an audit of CANbridge or PUMA, as applicable, pursuant
to this Section 6.5.1 (Record

 

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Keeping). Notwithstanding ARTICLE 8 (Confidentiality and Publicity), pursuant to
the Pfizer License Agreement, Pfizer will be allowed to review such Relevant
Records. PUMA will have the right [***], at its own expense, to have an
independent, certified public accountant, selected by PUMA and reasonably
acceptable to CANbridge, review any such records of CANbridge in the location(s)
where such records are maintained by CANbridge upon reasonable prior written
notice, during regular business hours and under obligations of confidentiality,
for the sole purpose of verifying the basis and accuracy of payments made under
this Agreement and to verify compliance with the terms of this Agreement, within
the prior [***] Calendar Year period. The records for any Calendar Year may be
audited no more than [***].

6.5.2Audit Report. The report prepared by the independent certified public
accounting firm pursuant to Section 6.5.1 (Record Keeping), a copy of which will
be sent or otherwise provided to each Party by such independent public
accountant at the same time, will contain the conclusions of such accounting
firm regarding the audit and will specify that the amounts paid pursuant thereto
were correct or, if incorrect, the amount of any underpayment or overpayment,
and the specific details regarding any discrepancies. No other information will
be provided to PUMA without the prior consent of CANbridge unless disclosure is
required by Law, regulation or judicial order, and if so determined by PUMA, it
will, if permitted, give CANbridge prior notice thereof reasonably sufficient
for CANbridge to seek a protective order against or limiting such disclosure. If
such report shows any underpayment, then CANbridge will remit to PUMA, within
[***] after receipt of such report, (a) the amount of such underpayment and (b)
if such underpayment exceeds [***] of the total amount owed for the period then
being audited, the [***] costs incurred by PUMA in conducting such review. For
the avoidance of doubt, payment of the underpayment will be considered a late
payment, subject to Section 6.9. If such report shows any overpayment, then the
overpaid amount will be deducted from future payments owed to PUMA. The Parties
mutually agree that all information subject to review under this Section 6.5.2
is Confidential Information of CANbridge and that PUMA will retain and cause the
accountant to retain all such information in confidence in accordance with
ARTICLE 8 (Confidentiality and Publicity).

6.5.3Audit Period. Upon the expiration of [***] following the end of any
Calendar Year, the audit rights set forth in this Section 6.5 shall no longer
apply to such Calendar Year and the calculation of amounts payable with respect
to such Calendar Year will be binding and conclusive.

6.6Tax Matters.

6.6.1Tax Responsibility. Any taxes imposed on CANbridge or with respect to
CANbridge’s business operations or activities hereunder, and any value added,
consumption, transfer, sales, use and other such taxes relating to the
transactions contemplated herein, including any imposed with respect to the
rights and obligations under Article III, shall be borne by CANbridge (and, for
the avoidance of doubt, all amounts stated in this Agreement exclusive of such
taxes), and CANbridge shall timely pay, and indemnify and hold harmless, PUMA
from and against all such taxes, including any penalties or interest associated
therewith. PUMA shall bear and be responsible for all taxes based on income to
PUMA.

6.6.2Tax Withholding; Gross Up. In the event any tax (other than any tax based
on income to PUMA) is required to be withheld and deducted from payments by
CANbridge

 

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pursuant to this Agreement under applicable Law, notwithstanding anything to the
contrary herein, CANbridge will make such deduction and withholding and shall
pay such additional amounts as may be necessary to ensure that PUMA receives the
amount it would have received had no such withholding applied (including any
withholding imposed in respect of such additional amounts), and any amounts so
withheld and deducted will be remitted by CANbridge on a timely basis to the
appropriate Governmental Authority for the account of PUMA and CANbridge will
provide PUMA reasonable evidence of the remittance within [***] thereof.

6.7Currency of Payments. All amounts payable and calculations under this
Agreement shall be in Dollars. As applicable, Net Sales and any royalty
reductions shall be translated into Dollars using the average of the applicable
daily foreign exchange rates published in the Wall Street Journal (or any other
qualified source that is acceptable to both Parties) for the last day of each
month of the Calendar Quarter in which such Net Sales occurred. All payments
under this Agreement will be paid in Dollars by wire transfer to an account
designated by the receiving Party (which account the receiving Party may update
from time to time in writing).

6.8Blocked Currency. Notwithstanding the provisions of Section 6.7 (Currency of
Payments), if by applicable Law or fiscal policy of a Region in the Territory,
conversion into Dollars or transfer of funds of a convertible currency to the
United States is restricted, forbidden or substantially delayed, then amounts
accrued in such Region under this ARTICLE 6 shall be paid to PUMA in Region in
local currency by deposit in a local bank designated by PUMA, unless the Parties
otherwise agree.

6.9Late Payments. Any late payment shall bear interest, to the extent permitted
by Law, at [***] above the Prime Rate of interest as reported in the Wall Street
Journal on the date payment is due.

 

ARTICLE 7

INTELLECTUAL PROPERTY OWNERSHIP,

PROTECTION AND RELATED MATTERS

 

7.1Ownership of Inventions.

7.1.1Inventorship. Ownership of inventions, improvements, developments or
discoveries, whether patentable or non-patentable, invented or otherwise
developed or generated by either Party or its Affiliates, or any of its or their
employees, sublicensees (where permitted), independent contractors or agents
during the Term, in the course of Developing, Manufacturing or Commercializing
any Licensed Product under this Agreement (“Inventions”), and any and all
intellectual property rights therein, will be determined based on the principles
of inventorship in accordance with United States patent Laws.

7.1.2Ownership. Subject to the remainder of this Section 7.1.2, any Invention
made, conceived, reduced to practice, or otherwise discovered solely by the
employees, independent contractors, or agents of PUMA (“PUMA Inventions”), and
all intellectual property rights therein, will, subject to the licenses granted
to CANbridge under this Agreement, be solely owned by PUMA. Subject to the
remainder of this Section 7.1.2, any Invention made, conceived, reduced to
practice or otherwise discovered by the employees, independent contractors or
agents of CANbridge (“CANbridge Inventions”), and all intellectual property
rights therein, will be solely

 

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owned by CANbridge. Subject to the remainder of this Section 7.1.2, any
Invention made, conceived, reduced to practice or otherwise discovered jointly
by the employees, independent contractors or agents of CANbridge and PUMA
(“Joint Inventions”), and all intellectual property rights therein, will be
owned jointly by PUMA and CANbridge. Notwithstanding anything to the contrary in
this Section 7.1.2, [***], including their [***] (“Licensed Product
Inventions”), and all intellectual property rights therein. Such Licensed
Product Inventions [***]. CANbridge hereby grants to PUMA a non-exclusive,
worldwide, transferable, royalty- free, fully paid-up, perpetual and irrevocable
license, with the right to sublicense through multiple tiers, under CANbridge
Inventions [***], to Develop, Commercialize and otherwise Exploit Licensed
Products in the Field outside the Territory. Upon termination (but not
expiration) of this Agreement, and subject to Section 12.2 (Paid-Up License Upon
End of Royalty Term) of this Agreement, PUMA’s rights under the foregoing
sentence shall apply on a worldwide basis. Each Party shall, and shall cause its
sublicensees and Affiliates, and all contractors, employees, and agents, to
cooperate with the other Party and take all reasonable actions and execute such
agreements, declarations, assignments, legal instruments and documents as may be
reasonably required to perfect the other Party’s joint right, title and interest
in and to all Joint Inventions and intellectual property rights therein. Subject
to: (a) the licenses granted to CANbridge and to PUMA in this Agreement; and (b)
the other terms and conditions of this Agreement, CANbridge and PUMA as joint
owners will each have the right to exploit and grant licenses under all Joint
Inventions, and to assign or otherwise dispose of their respective joint
interest in the Joint Inventions, without an accounting or obligation to, or
consent required from, the other Party. Each Party grants to the other Party a
nonexclusive, fully-paid, royalty-free, irrevocable, perpetual and sublicensable
(through multiple tiers) license under its interest in the Joint Inventions, and
intellectual property rights therein, to make, use, sell, offer for sale and
import all Joint Inventions, provided that: (i) PUMA’s rights in all Joint
Inventions shall remain subject to the licenses granted to CANbridge pursuant to
this Agreement; and (ii) CANbridge’s rights in all Joint Inventions shall remain
subject to the licenses granted to PUMA pursuant to this Agreement.

7.1.3Assignment Obligation. Each Party will cause all employees of such Party
who perform activities for such Party under this Agreement to be under an
obligation to assign their rights in any Patent Rights and Know-How, whether or
not patentable, resulting therefrom to such Party. With respect to any
activities of a Party under this Agreement that are contracted to a Person that
is not an employee, the Party retaining such contractor will use Commercially
Reasonable Efforts to include in the applicable contract an assignment to such
Party of all rights in Patent Rights and Know-How made by such contractor
resulting from such activities, and in any event will include in the applicable
contract a license to such Party that is sublicensable to the other Party under
this Agreement, of any Patent Rights and Know-How made by such contractor
resulting from such activities.

7.1.4Right to Practice Joint Patent Rights and Joint Know-How. The Parties will
jointly own any Joint Know-How and Joint Patent Rights. Subject to the licenses
granted to CANbridge under this Agreement, each Party is entitled to practice
the Joint Patent Rights and

 

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Joint Know-How for all purposes on a worldwide basis and license the Joint
Patent Rights and Joint Know-How without the consent of and without a duty of
accounting to the other Party. Each Party will: (a) grant and hereby does grant
all permissions, consents and waivers with respect to, and all licenses under,
the Joint Patent Rights and Joint Know-How, throughout the world, necessary to
provide the other Party with such rights of use and Exploitation of the Joint
Patent Rights and Joint Know-How, (b) execute documents as reasonably necessary
to accomplish the foregoing, and (c) reasonably cooperate with the other Party
to transfer to such other Party physical embodiments (or copies thereof) of any
Joint Know-How, at such other Party’s request and expense.

7.2Prosecution and Maintenance.

7.2.1Licensed Patents and Joint Patents. PUMA will have the first right, [***],
to prepare, file, prosecute and maintain the Licensed Patents and the Joint
Patent Rights [***] in all Regions in the Territory. PUMA will keep CANbridge
reasonably informed of all steps with regard to and the status of such
preparation, filing, prosecution, and maintenance of such Patent Rights,
including by providing CANbridge with (a) copies of all correspondence and
material communications it sends to or receives from any patent office or agency
in the Territory relating to the Licensed Patents or Joint Patent Rights, (b) a
draft copy of all applications sufficiently in advance of filing to permit
reasonable review and comment by CANbridge, and (c) a copy of applications as
filed, together with notice of its filing date and serial number. Before PUMA
submits any material filing, including a new patent application, or response to
such patent authorities with respect to the Licensed Patents or Joint Patent
Rights, PUMA will provide CANbridge with a reasonable opportunity to review and
comment on such filing or response and will take into account and consider in
good faith CANbridge’s reasonable and timely requests and suggestions regarding
the filing, prosecution and maintenance of the Licensed Patents and Joint Patent
Rights under this Section 7.2.1 (Licensed Patents and Joint Patents). The
Parties’ rights and obligations with respect to rights licensed to PUMA pursuant
to the Pfizer License Agreement that are sublicensed to CANbridge under this
Agreement are expressly subject to the terms of Section 7.4 of the Redacted
Pfizer License Agreement. The Parties agree to cooperate reasonably with Pfizer
with respect to matters described under this Agreement to the extent required by
the Redacted Pfizer License Agreement.

7.2.2Step-In Right. If PUMA elects not to continue to prosecute or maintain a
given Patent Right within the Licensed Patents or Joint Patent Rights [***] in
the Territory pursuant to Section 7.2.1 (Licensed Patents and Joint Patents),
then PUMA will give CANbridge notice thereof within a reasonable period (but not
less than [***]) prior to allowing such Patent Rights to lapse or become
abandoned or unenforceable, and only to the extent permitted under Section 7.4
of the Redacted Pfizer License Agreement and in accordance with Section 7.4 of
the Redacted Pfizer License Agreement, as applicable, CANbridge will have the
right to prosecute or maintain such Patent Right in the name of PUMA. CANbridge
will have the right, but not the obligation, to assume responsibility for
continuing the prosecution of such Patent Rights in such Region and paying any
required fees to maintain such Patent Rights in such Region or defending such
Patent Rights, [***], through patent counsel or agents of its choice. CANbridge
will not become an assignee of any such Patent

 

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Right as a result of its assumption of any such responsibility. Upon transfer of
PUMA’s responsibility for filing, prosecuting and maintaining any of the Patent
Rights to CANbridge under this Section 7.2.2 (Step-In Right), PUMA will promptly
deliver to CANbridge copies of all necessary files related to the Patent Rights
with respect to which responsibility has been transferred and will take all
actions and execute all documents reasonably necessary for CANbridge to assume
such prosecution, maintenance and defense.

7.2.3Solely-Owned CANbridge Inventions. CANbridge shall have the sole right to
prepare, file, prosecute and maintain patents claiming the CANbridge Inventions
[***] on a worldwide basis.

7.2.4Cooperation. Each Party will, and will cause its Affiliates to, reasonably
cooperate, with the other Party with respect to the preparation, filing,
prosecution and maintenance of Licensed Patents pursuant to this Section 7.2
(Prosecution and Maintenance).

 

7.3

Third Party Infringement.

7.3.1Notice. Each Party will promptly notify the other in writing of any (a)
apparent, threatened or actual infringement by a Third Party of any Licensed
Patent, or (b) unauthorized use or misappropriation of any Licensed Know-How by
a Third Party of which it becomes aware, and, in each case, will provide the
other Party with all evidence in such Party’s possession or control supporting
such infringement or unauthorized use or misappropriation (each, an
“Infringement”).

7.3.2Enforcement of Licensed Patents in the Territory. CANbridge will have the
first right, but not the obligation, using counsel of its choosing and [***], to
institute any Action alleging Infringement of the Licensed Patents (including
the Joint Patent Rights) in the Territory (any such Action, an “Infringement
Action”). CANbridge will notify and keep PUMA apprised in writing of any such
Infringement Action and will consider PUMA’s reasonable interests and requests
regarding such Infringement Action; provided, that, if CANbridge does not intend
to prosecute an Infringement Action, or ceases to diligently pursue an
Infringement Action, (a) it will promptly inform PUMA in writing and (b) PUMA
shall have the right, but not the obligation, [***] to institute an Infringement
Action against the applicable Third Party infringer(s).

7.3.3Cooperation. In any Infringement Action brought under the Licensed Patents
pursuant to Sections 7.3.2 (Enforcement of Licensed Patents in the Territory)
each Party will, and will cause its Affiliates to, reasonably cooperate with
each other, in good faith, relative to the other Party’s efforts to protect the
Licensed Patents and will join such suit as a party, if requested by the other
Party. Furthermore, the Party initiating any Infringement Action pursuant to
Sections 7.3.2 (Enforcement of Licensed Patents in the Territory) will consider
in good faith all reasonable and timely comments from the other Party on any
proposed arguments asserted or to be asserted in litigation related to the
enforcement or defense of any such Patent Rights.

7.3.4Allocation of Recoveries. Any settlements, damages or monetary awards
recovered by either Party pursuant to any Infringement Action with respect to
the Licensed Patents will, after reimbursing the Parties for their reasonable
out-of-pocket expenses in making such

 

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recovery (which amounts will be allocated pro rata if insufficient to cover the
totality of such expenses), be allocated as follows: (a) if PUMA is the
enforcing Party, first to pay any amounts payable to Pfizer with respect to such
Infringement Action, and then [***] to PUMA and [***] to CANbridge or (b) if
CANbridge is the enforcing Party, first to pay any amounts payable to Pfizer
with respect to such Infringement Action, and then the remaining amount will be
[***].

 

7.4

Claimed Infringement.

7.4.1Claimed Infringement. Each Party will promptly notify the other Party if a
Third Party brings any Action alleging patent infringement by CANbridge or PUMA
or any of their respective Affiliates or sublicensees with respect to the
Development, Manufacture or Commercialization of any Licensed Product (any such
Action, an “Infringement Claim”). In the case of any Infringement Claim,
CANbridge will have the right, but not the obligation, to control the defense
and response to any such Infringement Claim in the Territory, and PUMA will have
the right, but not the obligation, to control the defense and response to any
such Infringement Claim outside of the Territory. Upon the request of the Party
controlling the response to the Infringement Claim, the other Party will
reasonably cooperate with the controlling Party in the reasonable defense of
such Infringement Claim. The other Party will have the right to consult with the
controlling Party concerning any Infringement Claim and to participate in and be
represented by independent counsel in any associated litigation. If the
Infringement Claim is brought against both Parties, then each Party will have
the right to defend against the Infringement Claim. The Party defending an
Infringement Claim under this Section 7.4 (Claimed Infringement) will (a)
consult with the other Party as to the strategy for the prosecution of such
defense, (b) consider in good faith any comments from the other Party with
respect thereto and (c) keep the other Party reasonably informed of any material
steps taken and provide copies of all material documents filed, in connection
with such defense. The Party controlling the defense against an Infringement
Claim will have the right to settle such Infringement Claim on terms deemed
reasonably appropriate by such Party, provided, that, unless any such settlement
includes a full and unconditional release from all liability of the other Party
and does not adversely affect the rights of the other Party, any such settlement
will be subject to the other Party’s prior written consent.

 

ARTICLE 8

CONFIDENTIALITY AND PUBLICITY

 

8.1Confidential Information.

8.1.1Confidentiality Obligation. During the Term and for a period of [***] after
any termination or expiration of this Agreement, each Party agrees to, and will
cause its Affiliates, sublicensees and contractors to, keep in confidence and
not to disclose to any Third Party, or use for any purpose, except to exercise
its rights or perform its obligations under this Agreement, any Confidential
Information of the other Party.

8.1.2Permitted Disclosures. Each Party agrees that it and its Affiliates will
provide or permit access to the other Party’s Confidential Information only to
the receiving Party’s employees, consultants, advisors and sublicensees, and to
the employees, consultants and advisors of the receiving Party’s Affiliates, in
each case on a need to know basis who are subject to obligations of
confidentiality and non-use with respect to such Confidential Information no  
less

 

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stringent than the obligations of confidentiality and non-use of the receiving
Party pursuant to this Section 8.1 (Confidential Information); provided,
however, that each Party will remain responsible for any failure by its
Affiliates and sublicensees, and its and its Affiliates’ respective employees,
consultants and advisors, to treat such Confidential Information as required
under this Section 8.1 (Confidential Information) as if such Affiliates,
employees, consultants, advisors and sublicensees were parties directly bound to
the requirements of this Section 8.1 (Confidential Information).

8.1.3Confidentiality Limitation. Notwithstanding anything to the contrary
herein, each Party may use and disclose the other Party’s Confidential
Information as follows: (a) under appropriate written confidentiality
obligations substantially equivalent to those in this Agreement, to its
Affiliates, potential and actual permitted sublicensees, contractors and any
other Third Parties, to the extent such use or disclosure is reasonably
necessary to perform its obligations or to exercise its rights under this
Agreement, (b) to the extent such use or disclosure is consistent with this
Agreement, is not prohibited by the Existing Third Party License Agreements and
is reasonably necessary for filing or prosecuting the Licensed Patents, (c) to
its advisors (including financial advisors, attorneys and accountants), actual
or potential acquisition partners, financing sources or investors and
underwriters on a need to know basis, in each case under appropriate
confidentiality obligations (which may include professional ethical obligations)
substantially equivalent to those in this Agreement; provided, however, that
each Party will remain responsible for any failure by any of the foregoing
individuals to treat such Confidential Information as required under Section 8.1
(Confidential Information) as if such individuals were parties directly bound to
the requirements of this Section 8.1, or (d) as required by any court or other
governmental body or as otherwise required by applicable Law (including any such
disclosures as are required by a Regulatory Authority in connection with seeking
Regulatory Approval for any Licensed Product in the Territory); provided, that,
notice is promptly given to the other Party and the disclosing Party cooperates
with reasonable requests from the other Party to seek a protective order or
other appropriate remedy to protect the Confidential Information.

8.1.4Secrecy of Licensed Know-How. PUMA will protect, and will cause its
Affiliates and its sublicensees and its and their respective officers,
directors, employees, and agents to protect, the secrecy and confidentiality of
the Licensed Know-How and PUMA’s interest in the Joint Know-How using at least
the same degree of care as it uses to prevent the disclosure of its own other
confidential information of like importance.

8.2Publicity.

8.2.1Initial Press Releases. Promptly following the Effective Date, the Parties
will issue a mutually agreed upon press release regarding the subject matter of
this Agreement, including a description of the financial terms, a high-level
description of the overall scope of the transaction and the scope of planned
Development and value of the Agreement in the form attached hereto as Schedule
8.2.1.

8.2.2Further Publicity; Publications. The Parties acknowledge the importance of
supporting each other’s efforts to publicly disclose results and significant
developments regarding the Licensed Product in the Field, and each Party may
make such disclosures from time to time, subject to this Section 8.2.2 (Further
Publicity; Publications). Such disclosures may include achievement of
milestones, significant events in the Development process with respect to
Licensed

 

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Products, Commercialization activities with respect to Licensed Products and the
like. Except for the initial press releases described in Section 8.2.1 (Initial
Press Releases):

(a)Whenever either Party elects to make any such public disclosure, it will
first notify the other Party of such planned press release or public
announcement and provide a draft for review no less than [***] in advance of
issuing such press release or making such public announcement (or, with respect
to press releases and public announcements that are required by applicable Law,
with as much advance notice as possible under the circumstances if it is not
possible to provide notice no less than [***] in advance). Each Party will have
the right to review and approve any such planned press release or public
announcement proposed by the other Party, including any oral presentation or
abstract, that contains clinical data or pertains to results of Clinical Studies
or other studies with respect to Licensed Products, or that includes
Confidential Information of the other Party; provided, however, that (i) the
reviewing Party will attempt to provide such approval as soon as reasonably
possible and will not unreasonably withhold such approval; (ii) the reviewing
Party will provide explanations of its disapproval of such press release; and
(iii) a Party desiring to make such public disclosure may issue such press
release or public announcement without such prior review by the other Party if
(A) the entire contents of such press release or public announcement have
previously been made public other than through a breach of this Agreement by
such Party, and (B) such press release or public announcement does not
materially differ from a previously issued press release or other publicly
available information; and provided, further, that the other Party will have the
right to review, but not approve, any press release or public announcement that
the proposing Party determines is required by applicable Law based on the advice
of counsel, which public disclosures are subject to Section 8.2 (Publicity;
Publications). The Party reviewing a press release provided under this Section
8.2.2(a) (Further Publicity) will review and approve or disapprove such press
release within [***] after its receipt thereof.

(b)The principles to be observed in such disclosures will include accuracy,
compliance with applicable Law and regulatory guidance documents, reasonable
sensitivity to potential negative reactions of Regulatory Authorities and the
need to keep investors informed regarding the business of the Party making such
public disclosure. Nothing in this Section 8.2 (Publicity) will restrict a Party
from making a disclosure required by Law as reasonably determined by such
Party’s counsel, including disclosures required by any laws or regulations
relating to the public sale of securities; provided, however, that such
disclosure will include the minimum amount of Confidential Information required
by such applicable laws and regulations, and the Parties will use reasonable
efforts to seek confidential treatment of Confidential Information to be
included in such disclosures.

(c)In the event that either Party proposes to publish or present the results of
Development or Commercialization carried out on a Licensed Product, such
publication or presentation will be subject to the prior review by the other
Party for patentability and protection of such other Party’s Confidential
Information. Each Party will provide to the other Party the opportunity to
review any proposed abstracts, manuscripts or summaries of presentations that
cover the results of Development or Commercialization of Licensed Products
during the Term. The other Party will respond in writing promptly and in no
event later than [***] after receipt of the proposed material with either
approval of the proposed material or a specific statement of concern, based upon
either the need to seek patent protection or concern   regarding

 

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competitive disadvantage arising from the proposal. In the event of any such
concern, the submitting Party agrees not to submit such publication or to make
such presentation that contains such information until the other Party is given
a reasonable period of time to seek patent protection for any material in such
publication or presentation that it believes is patentable or to resolve any
other issues, and the submitting Party will remove from such proposed
publication any Confidential Information of the other Party as requested by such
other Party. The Parties acknowledge that Pfizer has certain review and approval
rights with respect to publications relating to the Development of Licensed
Products under Section 14.2 of the Pfizer License Agreement, and the Parties
agree that such rights shall apply to any such publications under this
Agreement, provided that, PUMA shall be required to obtain any such approvals
from Pfizer within the [***] period required by this Section 8.2.2(c) (Further
Publicity; Publications).

 

ARTICLE 9

REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS

 

9.1Mutual Representations and Warranties. Each Party represents and warrants to
the other Party that, as of the Effective Date:

9.1.1Organization. It is a corporation duly organized, validly existing, and in
good standing under the laws of the jurisdiction of its organization, and has
all requisite power and authority, corporate or otherwise, to execute, deliver,
and perform this Agreement.

9.1.2Authority. It has full right, power and authority to enter into this
Agreement and to perform its respective obligations under this Agreement, it has
the right to grant to the other the licenses and sublicenses granted pursuant to
this Agreement, and this Agreement and the performance by such Party of this
Agreement do not violate such Party’s charter documents, bylaws or other
organizational documents.

9.1.3Consents. Except for any Marketing Authorizations, Regulatory Filings,
manufacturing approvals or similar approvals necessary for the Development,
Manufacture or Commercialization of Licensed Products, all necessary consents,
approvals and authorizations of all Governmental Authorities and other Persons
required to be obtained by it in connection with the execution, delivery and
performance of this Agreement have been obtained.

9.1.4No Conflict. It is not under any obligation, contractual or otherwise, to
any Person that would adversely affect the diligent and complete fulfillment of
obligations under this Agreement and the execution and delivery of this
Agreement by such Party, and the performance of such Party’s obligations under
this Agreement (as contemplated as of the Effective Date) and the licenses and
sublicenses to be granted by such Party pursuant to this Agreement (a) do not
conflict with or violate any requirement of Laws applicable to such Party, (b)
do not conflict with or violate any order, writ, judgment, injunction, decree,
determination, or award of any court or governmental agency presently in effect
applicable to such Party, and (c) do not conflict with, violate, breach or
constitute a default under any contractual obligations of such Party or any of
its Affiliates.

 

9.1.5Enforceability. This Agreement is a legal and valid obligation binding upon
it and is enforceable against it in accordance with its terms, subject to the
general principles of
equity  and  subject  to  bankruptcy,  insolvency,  moratorium,  judicial  principles  affecting  
the

 

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availability of specific performance and other similar Laws affecting the
enforcement of creditors’ rights generally.

9.2Additional  Representations  and  Warranties of PUMA.PUMA represents and
warrants to CANbridge that, as of the Effective Date:

9.2.1Licensed Patents. All Licensed Patents existing in the Territory as of the
Effective Date are listed in Schedule 9.2.1. Except as otherwise noted in
Schedule 9.2.1, PUMA is the sole and exclusive owner of the Licensed Patents,
all of which are free and clear of any claims, liens, charges or encumbrances.
With respect to Licensed Patents not solely owned by PUMA, PUMA licenses such
Licensed Patents pursuant to the Redacted Pfizer License Agreement. All Licensed
Patents owned by PUMA and, to PUMA’s Knowledge, all other Licensed Patents, are
(a) subsisting and in good standing and (b) being diligently prosecuted in the
applicable patent offices in accordance with Law, and have been filed and
maintained properly and correctly and all applicable fees have been paid on or
before the due date for payment. To PUMA’s Knowledge, all issued Licensed
Patents are valid and enforceable.

9.2.2Licensed Know-How. To PUMA’s Knowledge, the Development and Manufacture of
the Product by or on behalf of PUMA prior to the Effective Date did not
misappropriate the Know-How of any Third Party. PUMA owns or Controls the
Licensed Know- How, and to PUMA’s Knowledge, the Licensed Know-How is free and
clear of any claims, liens, charges or encumbrances. Except as otherwise set
forth in Schedule 9.2.2, PUMA has independently developed all Licensed Know-How.

9.2.3Delivery of Documentation. True, complete, and correct copies of all
material adverse information with respect to the safety and efficacy of the
Licensed Products in PUMA’s possession and control have been provided or made
available to CANbridge.

9.2.4Third Party Challenges. There are no claims, judgments, or settlements
against, or amounts with respect thereto, made against PUMA or any of its
Affiliates relating to the Licensed Patents or the Licensed Know-How. Except as
otherwise disclosed in writing to CANbridge, no claim or litigation has been
brought or, to PUMA’s Knowledge, threatened by any Person (a) alleging that the
Licensed Patents are invalid or unenforceable, (b) asserting the misuse, or
non-infringement of any of the Licensed Patents, (c) challenging PUMA’s Control
of the Licensed Patents or (d) alleging misappropriation of the Know-How used in
the Development and Manufacture of Licensed Products by or on behalf of PUMA
prior to the Effective Date.

9.2.5Non-Infringement of Third Party IP. To PUMA’s Knowledge, the Development
and Manufacture of Licensed Products, as conducted by PUMA, its Affiliates or
its sublicensees prior to the Effective Date, did not infringe any Patent Right
or misappropriate or otherwise violate any Know-How of any Person. To PUMA’s
Knowledge the Development, supply, or Commercialization of Licensed Products in
the Field and in the Territory as contemplated by this Agreement will not
infringe any Patent Right or misappropriate or otherwise violate any Know-How of
any Third Party. No claim of infringement of the Patent Rights or
misappropriation of the Know-How of any Third Party has been made, or to PUMA’s
Knowledge, threatened, against PUMA or any of its Affiliates with respect to the
Development, Manufacture or Commercialization of Licensed Products in the Field
and in the Territory.

 

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9.2.6Absence of Litigation. There are no judgments or settlements against or
owed by PUMA, its Affiliates or its sublicensees, or, to PUMA’s Knowledge,
pending litigation against PUMA, its Affiliates, or its sublicensees, or
litigation threatened against PUMA, its Affiliates, or its sublicensees, in each
case related to Licensed Products, including any such litigation any relating to
any Regulatory Filings Controlled by PUMA, its Affiliates or its sublicensees as
of the Effective Date.

9.2.7Maintenance of Regulatory Filings, Good Laboratory and Clinical Practices.
PUMA, its Affiliates, and its sublicensees have generated, prepared, maintained,
and retained all Regulatory Filings that are required to be maintained or
retained pursuant to and in material compliance with applicable Law, and have
conducted in material compliance with applicable Law, including GLP and GCP all
Development of Licensed Products in the Field conducted prior to the Effective
Date.

9.2.8Confidentiality of Know-How. To the Knowledge of PUMA, no material breach
of confidentiality has been committed by any Person with respect to the Licensed
Know- How that is maintained as a trade secret and PUMA has used reasonable
measures to protect the confidentiality thereof.

9.2.9Assignment of Third Party Rights; Third Party Consents.

(a)PUMA has obtained from each of its employees and agents, and from the
employees and agents of its Affiliates, who are participating in the
Exploitation of Licensed Products, rights to any and all Know-How created by
such employees and agents in the course of his or her employment by or
engagement with PUMA that relates to Licensed Products, such that CANbridge
will, by virtue of this Agreement, receive from PUMA, without payments beyond
those required by ARTICLE 6 (Financial Provisions), the licenses and other
rights granted to CANbridge under this Agreement.

(b)Each Person who has or has had any ownership rights in or to any Licensed
Patents purported to be owned solely by PUMA, has assigned and has executed an
agreement assigning its entire right, title, and interest in and to such
Licensed Patents to PUMA; to PUMA’s Knowledge, no current officer, employee,
agent, or consultant of PUMA or any of its Affiliates is in violation of any
term of any assignment or other agreement, in each case, regarding the
protection of the Licensed Patents.

(c)Prior to the Effective Date, PUMA has obtained all consents from Third
Parties necessary to grant CANbridge the licenses and rights PUMA purports to
grant to CANbridge under this Agreement.

9.2.10Statements to FDA and Other Regulatory Authorities. Neither PUMA nor any
of its Affiliates or sublicensees, nor, to PUMA’s knowledge, any of its or their
respective officers, employees, or agents has made an untrue statement of
material fact or fraudulent statement to the FDA or any other Regulatory
Authority with respect to the Development of Licensed Products, failed to
disclose a material fact required to be disclosed to the FDA or any other
Regulatory Authority with respect to the Development of Licensed Products, or
committed an act, made a statement, or failed to make a statement with respect
to the Development of Licensed Products that could reasonably be expected to
provide a basis for the FDA to invoke its

 

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policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and
Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and
any amendments thereto or any analogous laws or policies in the applicable
Territory.

9.2.11Compliance with Law. To PUMA’s Knowledge, all of the studies, tests and
pre-clinical and clinical trials of Licensed Products conducted prior to, or
being conducted as of, the Effective Date by or on behalf of PUMA have been and
are being conducted in all material respects in accordance with applicable Laws.

9.2.12In-licenses. Except as set forth in Schedule 1.39, there are no agreements
between PUMA or any of its Affiliates, on the one hand, and any Third Party, on
the other hand, pursuant to which PUMA has (a) in-licensed any Patent Rights or
Know-how owned or Controlled by such Third Party that are included as part of
the Licensed Patents or Licensed Know-How   or (b) agreed to provisions that
would require CANbridge to make any payments (including royalties) to any Third
Party or to undertake or observe any restrictions or obligations with respect to
the Development, Manufacture or Commercialization of Licensed Products in the
Field in the Territory.

9.3No Debarment. Each Party represents and warrants that neither it nor any of
its or its Affiliates’ employees or agents performing under this Agreement has
ever been, or is currently:(a) debarred under 21 U.S.C. § 335a; (b) excluded,
debarred, suspended, or otherwise ineligible to participate in federal health
care programs or in federal procurement or non-procurement programs; (c) listed
on the FDA’s Disqualified and Restricted Lists for clinical investigators;  
or(d) convicted of a criminal offense that falls within the scope of 42 U.S.C. §
1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise
declared ineligible. Each Party further covenants that if, during the Term of
this Agreement, it becomes aware that it or any of its or its Affiliates’
employees or agents performing under this Agreement is the subject of any
investigation or proceeding that could lead to that Party becoming a debarred
entity or individual, an excluded entity or individual or a convicted entity or
individual, such Party will promptly notify the other Party. This provision will
survive termination or expiration of this Agreement.

9.4Additional Representations and Warranties of CANbridge. CANbridge represents
and warrants to PUMA that, as of the Effective Date:

9.4.1There is no pending or, to CANbridge’s Knowledge, threatened claim,
litigation or any other proceeding brought by a Third Party against CANbridge
claiming that CANbridge’s or its Affiliates’ commercialization of any
pharmaceutical product constitutes or would constitute infringement of such
Third Party’s intellectual property right(s);

9.4.2To CANbridge’s Knowledge, neither CANbridge, nor any of its directors,
officers, employees, Affiliates, or any Person authorized to act on behalf of
CANbridge or its Affiliates, have violated any Anti-Corruption Law;

9.4.3Neither CANbridge nor its Affiliates, nor, to CANbridge’s Knowledge any
Person acting on behalf of CANbridge or its Affiliates, has offered, given,
authorized, or promised anything of value (as defined by applicable
Anti-Corruption Laws), either directly or indirectly, to any Person, including
to any Public Official or Entity, for the purpose of (a) improperly influencing
any official act or decision; (b) inducing performance or non-performance of any
act in violation

 

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of a lawful duty; or (c) securing an improper benefit or business advantage, in
each case ((a) – (c)) in any manner that violates the applicable Anti-Corruption
Laws;

9.4.4Neither CANbridge nor any of its Affiliates have received any written
notice, request, or citation from any Governmental Authority with respect to any
alleged or suspected violation of Anti-Corruption Laws;

9.4.5To CANbridge’s Knowledge, neither CANbridge nor any of its Affiliates are
under investigation or are being prosecuted by a Governmental Authority with
respect to any alleged or suspected violation of Anti-Corruption Laws;

9.4.6All due diligence materials that CANbridge has provided to PUMA are
accurate, truthful and complete; and

9.4.7To CANbridge’s Knowledge, no officer, director, or employee of CANbridge or
its Affiliates (an “Interested Person”), is a Public Official or Entity or
Governmental Authority.

9.5Covenants of CANbridge. CANbridge hereby covenants to PUMA that, during the
Term:

9.5.1CANbridge and its Affiliates shall, and shall ensure that its Sublicensees

and contractors, comply in all material respects with all applicable Laws with
respect to the performance of its and their activities pursuant to this
Agreement;

9.5.2Without limiting the generality of Section 9.5.1, CANbridge shall comply
with the Anti-Corruption Laws (as modified or amended), and CANbridge will not
directly or indirectly offer or pay, or authorize such offer or payment of, any
money, or transfer anything of value (as defined by applicable Anti-Corruption
Laws), for purposes of improperly seeking to influence any Public Official or
Entity or Governmental Authority in any manner that violates applicable
Anti-Corruption Laws in connection with this Agreement;

9.5.3All employees and officers of CANbridge and its Affiliates working under
this Agreement shall execute agreements requiring assignment to CANbridge of all
right, title and interest in and to their inventions and discoveries invented or
otherwise discovered or generated during the course of and as a result of their
association with CANbridge, whether or not patentable, to CANbridge, or its
applicable Affiliates, as the sole owner thereof;

9.5.4CANbridge shall, and shall cause its Affiliates, Sublicensees and
contractors to, reasonably cooperate with PUMA and PUMA’s Affiliates in ensuring
compliance with the Anti-Corruption Laws, Export Control Laws and all other
applicable Laws. CANbridge shall provide PUMA with any information reasonably
requested by PUMA in connection with its efforts to ensure compliance with
applicable Laws;

9.5.5CANbridge shall promptly notify PUMA if CANbridge becomes aware of any
material information that would reasonably suggest that there may be a violation
of the Anti- Corruption Laws, Export Control Laws or any other applicable Law in
connection with the performance of this Agreement or the sale of the Licensed
Product in the Territory;

 

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9.5.6CANbridge shall, promptly following discovery, notify PUMA if (a) any
Interested Person becomes a Public Official or Entity or Governmental Authority
or (b) any Public Official or Entity or Governmental Authority acquires a legal
or beneficial interest in CANbridge or any of its Affiliates or Sublicensees;
and

9.5.7On or prior to the date on which CANbridge first communicates with a
Regulatory Authority in connection with the Licensed Product, CANbridge shall
implement [***]. Within [***]. As part of its [***].

9.6No Other Warranties. EXCEPT AS EXPRESSLY STATED IN SECTION 9.1 (MUTUAL
REPRESENTATIONS AND WARRANTIES), SECTION 9.2 (ADDITIONAL REPRESENTATIONS AND
WARRANTIES OF PUMA), SECTION 9.3 (NO DEBARMENT) OR SECTION 9.4 (ADDITIONAL
REPRESENTATIONS AND WARRANTIES OF CANBRIDGE), NEITHER PARTY MAKES ANY
REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
TITLE, NON- INFRINGEMENT, VALIDITY, ENFORCEABILITY, MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE.

 

ARTICLE 10

INDEMNIFICATION; DAMAGES

 

10.1Indemnification by PUMA. PUMA will indemnify and hold harmless CANbridge,
its Affiliates and their respective directors, officers, employees and agents
(collectively, the “CANbridge Indemnified Parties”), from, against and in
respect of any and all Losses incurred or suffered by any CANbridge Indemnified
Party to the extent resulting from: (a) any breach of any representation or
warranty made by PUMA in this Agreement, or any breach by PUMA of any
obligation, covenant or agreement in this Agreement; (b) the negligence or
intentional misconduct of PUMA or any of its Affiliates, sublicensees, or
contractors, or any of their respective directors, officers, employees and
agents, in performing PUMA’s obligations or exercising PUMA’s rights under this
Agreement; (c) activities conducted by or on behalf of PUMA, its Affiliates or
its sublicensees or contractors related to the Development, Manufacture,
Commercialization or other Exploitation of Licensed Products anywhere in the
world prior to the Effective Date; and (d) activities conducted by or on behalf
of PUMA or its Affiliates, sublicensees or contractors related to the
Development, Manufacture, Commercialization or other Exploitation of Licensed
Products outside the Territory during the Term.

10.2Indemnification by CANbridge. CANbridge will indemnify and hold harmless
PUMA, its Affiliates and their respective directors, officers, employees and
agents (collectively,

 

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the “PUMA Indemnified Parties”), from, against and in respect of any and all
Losses incurred or suffered by any PUMA Indemnified Party to the extent
resulting from: (a) any breach of any representation or warranty made by
CANbridge in this Agreement, or any breach by CANbridge of any covenant or
agreement in this Agreement, (b) the negligence or intentional misconduct of, or
violation of Law by, CANbridge, any of its Affiliates, Sublicensees or
contractors, or any of their respective directors, officers, employees and
agents, in performing CANbridge’s obligations or exercising CANbridge’s rights
under this Agreement, or (c) the Development, Commercialization, Manufacture or
other Exploitation of any Licensed Product by or on behalf of CANbridge, its
Affiliates, Sublicensees or contractors in the Territory during the Term.

10.3Claims for Indemnification.

10.3.1  Notice.   An Indemnified Party entitled to indemnification under  
Sections 10.1 (Indemnification by PUMA) or 10.2 (Indemnification by CANbridge)
will give prompt written notification to the Indemnifying Party from whom
indemnification is sought of the commencement of any Action by a Third Party for
which indemnification may be sought (a “Third Party Claim”) or, if earlier, upon
the assertion of such Third Party Claim by a Third Party; provided, however,
that failure by an Indemnified Party to give notice of a Third Party Claim as
provided in this Section 10.3.1 (Notice) will not relieve the Indemnifying Party
of its indemnification obligation under this Agreement, except and only to the
extent that such Indemnifying Party is actually prejudiced as a result of such
failure to give notice.

10.3.2Defense. Within [***] after delivery of a notice of any Third Party Claim
in accordance with Section 10.3.1 (Notice), the Indemnifying Party may, upon
written notice thereof to the Indemnified Party, assume control of the defense
of such Third Party Claim with counsel reasonably satisfactory to the
Indemnified Party. If the Indemnifying Party does not assume control of such
defense, the Indemnified Party may control such defense. The Party not
controlling such defense may participate therein at its own expense.

10.3.3Cooperation. The Party controlling the defense of any Third Party Claim
will keep the other Party advised of the status of such Third Party Claim and
the defense thereof and will reasonably consider recommendations made by the
other Party with respect thereto. The other Party will reasonably cooperate with
the Party controlling such defense and its Affiliates and agents in defense of
the Third Party Claim, with all out-of-pocket costs of such cooperation to be
borne by the Party controlling such defense.

10.3.4Settlement. The Indemnified Party will not agree to any settlement of such
Third Party Claim without the prior written consent of the Indemnifying Party,
which consent will not be unreasonably withheld. The Indemnifying Party will
not, without the prior written consent of the Indemnified Party, which will not
be unreasonably withheld, agree to any settlement of such Third Party Claim or
consent to any judgment in respect thereof that does not include a complete and
unconditional release of the Indemnified Party from all liability with respect
thereto or that imposes any liability or obligation on the Indemnified Party.

10.4Insurance. Each Party, at its own expense, will maintain liability insurance
(or self- insure) with respect to its activities under this Agreement in an
amount consistent with industry standards. Each Party will provide a certificate
of insurance (or evidence of self-insurance) evidencing such coverage to the
other Party upon request.  Without limiting the foregoing, during

 

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the Term and thereafter for the period of time required below, each Party will
maintain on an ongoing basis comprehensive general liability insurance in the
minimum amount of [***] for [***]; provided, however, that (a) [***], and (b)
commencing not later than [***] prior to [***], and thereafter [***]. All of
such insurance coverage may be maintained through a self-insurance plan that
substantially complies with the foregoing limits and requirements and may be
satisfied through one or more policies, including an umbrella policy; provided,
however, that such self-insurance is determined to be investment quality by a
recognized rating agency such as Moody’s or Standard & Poor’s. Not later than
[***] following receipt of written request from a Party, the other Party will
provide to the requesting Party a letter(s) affirming appropriate self-insurance
or a certificate of insurance evidencing such coverage in accordance with this
Agreement. Each Party will maintain such insurance or self-insurance coverage
without interruption during the Term and for a period of [***] thereafter, and,
if applicable, will provide certificates or letters evidencing such insurance
coverage without interruption as reasonably requested during the period of time
for which such coverage must be maintained. Each Party will be provided at least
[***] prior written notice of any cancellation or material decrease in the other
Party’s insurance coverage limits described above. Notwithstanding the
foregoing, either Party’s failure to maintain adequate insurance will not
relieve that Party of its obligations set forth in this Agreement.

 

ARTICLE 11

LIMITATION OF LIABILITY

 

11.1No Consequential or Punitive Damages. EXCEPT AS SET FORTH IN SECTION

11.2(Exclusion from Liability Limitation), NEITHER PARTY NOR ANY OF ITS
AFFILIATES WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL,
EXEMPLARY, PUNITIVE OR MULTIPLE DAMAGES OR FOR ANY LOST PROFITS ARISING OUT OF
THIS AGREEMENT, IN EACH CASE HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE,
REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.

11.2 Exclusion from Liability Limitation. THE LIMITATIONS AND DISCLAIMER SET
FORTH IN SECTION 11.1 (No Consequential or Punitive Damages) WILL NOT APPLY TO A
CLAIM (A) FOR WILLFUL MISCONDUCT; (B) FOR A BREACH OF ARTICLE 8 (Confidentiality
and  Publicity);  OR  (C)  FOR  INDEMNIFIABLE  LOSSES  PURSUANT TO SECTION 10.1
(Indemnification by PUMA), OR SECTION 10.2 (Indemnification by CANbridge).

 

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ARTICLE 12

TERM AND TERMINATION

 

12.1Term. Unless terminated earlier in accordance with this ARTICLE 12 (Term and
Termination), this Agreement will become effective as of the Effective Date and
will continue in full force until the last to expire Royalty Term in the
Territory (the “Term”).

12.2Paid-Up License Upon End of Royalty Term. Upon the expiration of the Royalty
Term for a given Licensed Product in a given Region in the Territory, the
licenses and rights of reference granted to CANbridge pursuant to Section 2.1
(PUMA License Grant; Right of Reference) will become perpetual, irrevocable,
fully paid-up, and royalty free with respect to such Licensed Product in such
Region.

12.3Early Termination.

12.3.1Termination for Material Breach. Upon (a) any material breach of this
Agreement by PUMA or (b) any material breach of this Agreement by CANbridge (the
Party so allegedly breaching being the “Breaching Party”), the other Party (the
“Non-Breaching Party”) will have the right, but not the obligation, to terminate
this Agreement in its entirety (1) immediately upon written notice for any
material breach of Sections 9.4.2, 9.4.3, 9.4.4,9.4.5, 9.4.6, 9.5.2, or 9.5.5
that results in a material violation of the Anti-Corruption Laws by CANbridge  
or (2) by providing thirty (30) days’ written notice to the Breaching Party in
the case of any other material breach, which notice will, in each case (i)
expressly reference this Section 12.3.1 (Termination for Material Breach), (ii)
reasonably describe the alleged breach which is the basis of such termination,
and (iii) clearly state the Non-Breaching Party’s intent to terminate this
Agreement if the alleged breach is not cured within the applicable cure period.
Notwithstanding the foregoing, (A) if the alleged material breach by CANbridge
is that it has materially failed to satisfy its Development Diligence
obligations under Section 3.1.1 (Development Diligence) in a particular Region
in the Territory or has materially failed to satisfy its Commercialization
Diligence obligations under Section 4.2.1 (Commercialization Diligence) in a
particular Region in the Territory, then PUMA may only seek to terminate this
Agreement solely with respect to such Region (and not in its entirety); (B) if
such material breach (other than a payment breach), by its nature, is curable,
but is not reasonably curable within the applicable cure period, then such cure
period will be extended if the Breaching Party provides a written plan for
curing such breach to the Non-Breaching Party and uses Commercially Reasonable
Efforts to cure such breach in accordance with such written plan; provided,
however, that no such extension will    exceed sixty (60) days without the
written consent of the Non-Breaching Party; and (C) if the Breaching Party
disputes that it has materially breached this Agreement, the dispute will be
resolved pursuant to ARTICLE 13 (Dispute Resolution), and this Agreement may not
be terminated during the pendency of such dispute resolution procedure. The
termination will become effective at the end of the notice period unless the
Breaching Party cures such breach during such notice period; provided, however,
that the Non-Breaching Party may, by notice to the Breaching Party, designate a
later date for such termination in order to facilitate an orderly transition of
activities relating to Licensed Products.       If, as a result of the
application of such dispute resolution procedures, the

 

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Breaching Party is determined to be in material breach of this Agreement (an
“Adverse Ruling”), then if the Breaching Party fails to cure such material
breach within sixty (60) days after such ruling (whether or not such actions are
specified by the Adverse Ruling) (or ten (10) days after such ruling in the case
of a payment breach), then the Non-Breaching Party may terminate this Agreement
upon written notice to the Breaching Party as provided in this Section 12.3.1
(Termination for Material Breach).

12.3.2Termination by CANbridge for Convenience.  CANbridge may, upon [***] prior
written notice to PUMA, terminate this Agreement for convenience, without cause,
and for any or no reason.

12.3.3Termination for Bankruptcy. This Agreement may be terminated, to the
extent permitted by applicable Law, by either Party upon the filing or
institution of bankruptcy, reorganization, liquidation or receivership
proceedings, or upon an assignment of a substantial portion of the assets for
the benefit of creditors by the other Party; provided, however, that in the case
of any involuntary bankruptcy, reorganization, liquidation or receivership
proceeding such right to terminate shall only become effective if the Party
subject to such proceeding consents to the involuntary bankruptcy or such
proceeding is not dismissed within ninety (90) days after the filing thereof.

12.3.4Effect of Termination of the Pfizer License Agreement. In the event of
termination of the Pfizer License Agreement, PUMA will request that Pfizer grant
CANbridge a direct license in the Territory pursuant to the terms and conditions
of Section 13.6.4 of the Redacted Pfizer License Agreement.

12.4Effects of Termination.

12.4.1Effects of Termination Generally. Upon termination of this Agreement in
its entirety pursuant to Section 12.3 (Early Termination), the Parties’ rights
and obligations under this Agreement will terminate and neither Party will have
any further rights or obligations under this Agreement from and after the
effective date of termination, except as set forth in this Section

12.4(Effects of Termination); provided, however, that, if this Agreement is
terminated with respect to a particular Region only, then such rights and
obligations will terminate only to the extent they relate solely to the
terminated Region.

12.4.2Accrued Obligations. Expiration or termination of this Agreement for any
reason will not release either Party from any obligation or liability which, on
the effective date of such expiration or termination, has already accrued to the
other Party or which is attributable to a period prior to such expiration or
termination.

12.4.3Survival. This Section 12.4.3 (Survival), the provisions set forth in the
following Sections, as well as, to the extent applicable, any other Sections or
defined terms referred to in such Sections or Articles or necessary to give them
effect, will survive any expiration or termination of this Agreement in its
entirety: Sections 2.1.3, 3.3.1 (until the earlier of (a) one (1) year following
any termination hereof, or (b) completion of the technology transfer activities
set forth in Section 12.4.8), 3.4.5 (for so long as CANbridge remains the holder
of the Marketing Authorizations for any Licensed Products in the Territory), 6.5
(for the time period provided therein), 6.6 (to the extent applicable to
payments becoming due during the Term), 6.7, 6.8, 6.9 (to

 

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the extent applicable to payments becoming due during the Term), 7.1, 7.2
(solely with respect to Joint Patent Rights), 8.1 (during the [***] period set
forth therein), 12.2 (if applicable), and

12.4and ARTICLE 10 (as to Sections 10.1 - 10.3, solely to the extent applicable
to activities conducted during the Term pursuant to this Agreement, and as to
Section 10.4, for the time period provided therein), ARTICLE 11, ARTICLE 13, and
ARTICLE 14. Furthermore, any other provisions required to interpret the Parties’
rights and obligations under this Agreement, including applicable definitions in
ARTICLE 1 (Definitions), will survive to the extent required. Except as
otherwise expressly provided in this Agreement, all rights and obligations of
the Parties under this Agreement, including any licenses granted under this
Agreement, will terminate upon expiration or termination of this Agreement in
its entirety or solely with respect to the terminated Region, as the case may
be, for any reason.

12.4.4Inventory. Upon termination of this Agreement, CANbridge shall have the
right to sell its remaining inventory of Licensed Products following the
termination of this Agreement so long as CANbridge has fully paid, and continues
to fully pay when due, any and all royalties and milestone payments owed to PUMA
under ARTICLE 6, and CANbridge is otherwise not in material breach of this
Agreement.

12.4.5Transfer of Regulatory Filings and Regulatory Approvals. Following the
effectiveness of any termination of this Agreement pursuant to Section 12.3
(Early Termination), as promptly as practicable after PUMA’s written request and
unless prohibited by applicable Law, CANbridge will, to the extent permitted by
applicable Law and relevant Regulatory Authorities and at PUMA’s sole cost and
expense (unless the applicable termination giving rise to PUMA’s rights under
this Section 12.4.5 was for CANbridge’s material breach pursuant to Section
12.3.1, in which case such transfer shall be at CANbridge’s sole cost and
expense), assign and transfer to PUMA all Regulatory Filings, filings for
Pricing and Reimbursement Approval and Marketing Authorizations for Licensed
Products that are held by or under authority of CANbridge or its Affiliates or
Sublicensees as of the effective date of termination, with respect to the
terminated Region in the Territory, as the case may be, and will take such
actions and execute such other instruments, assignments and documents as may be
necessary to effect the transfer of rights under such Regulatory Filings,
filings for Pricing and Reimbursement Approval and Marketing Authorizations to
PUMA. If applicable Law or relevant Regulatory Authorities prevent or delay the
transfer of ownership of any such Regulatory Filing, filing for Pricing and
Reimbursement Approval and Marketing Authorizations to PUMA, then CANbridge will
grant, and hereby does grant, to PUMA an exclusive and irrevocable right of
access and right of reference to such Regulatory Filing, filing for Pricing and
Reimbursement Approval and Marketing Authorizations for Licensed Products in the
Territory or the terminated Region, as the case may be, and will reasonably
cooperate with PUMA, at PUMA’s expense (unless the applicable termination giving
rise to PUMA’s rights under this Section 12.4.5 was for CANbridge’s material
breach pursuant to Section 12.3.1, in which case such transfer shall be at
CANbridge’s sole cost and expense), to make the benefits of such Regulatory
Filings, filings for Pricing and Reimbursement Approval and Marketing
Authorizations available to PUMA or its designee(s).

12.4.6Licenses Upon Termination. Upon any termination of this Agreement pursuant
to Section 12.3 (Early Termination), CANbridge will grant, and hereby does grant
to PUMA: (a) a non-exclusive, fully paid-up, royalty-free, worldwide,
transferable, perpetual and irrevocable license, with the right to sublicense,
under all intellectual property rights   Controlled

 

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by CANbridge claiming Inventions that are necessary or reasonably useful to
make, use, sell, offer for sale, or import the Licensed Products as they exist
at the time of such termination of this Agreement to make, use, sell, offer for
sale, or import the Licensed Products and (b) a fully paid- up, royalty-free,
worldwide, transferable, sublicensable, perpetual and irrevocable license to use
Trademarks specifically identifying the Licensed Products, excluding for clarity
all Trademarks also used in connection with CANbridge’s business other than with
respect to Licensed Product, for the purpose of manufacturing, marketing,
distributing, selling, and otherwise Developing and Commercializing, such
Licensed Product.

12.4.7Return of Confidential Information. Within [***] after the effective date
of termination (but not expiration) of this Agreement in its entirety, and
subject to Section 12.2 (Paid-Up License Upon End of Royalty Term), each Party
will, and cause its Affiliates to (a) destroy, all tangible items solely
comprising, bearing or containing any Confidential Information of the other
Party that are in such first Party’s or its Affiliates’ possession or Control,
and provide written certification of such destruction, or (b) prepare such
tangible items of the other Party’s Confidential Information for shipment to
such other Party, as such other Party may direct, at the first Party’s expense;
provided, however, that, in any event, (i) each Party may retain one (1) copy of
the Confidential Information of the other Party to the extent necessary to
perform its obligations that survive expiration or termination of this
Agreement; and (ii) such first Party may retain one copy of such Confidential
Information of the other Party for its legal archives.

12.4.8Third-Party Agreements; Transfer of Know-How. Within [***] following the
termination (but not expiration) of this Agreement, and subject to Section 12.2
(Paid- Up License Upon End of Royalty Term) of this Agreement, at PUMA’s written
request, CANbridge shall and shall cause its Affiliates to assign all of its
right, title and interest in and to any Third Party agreements that solely
relate to the Licensed Product and not to another product (“Third Party
Agreement”) to PUMA [***]. Promptly following the termination (but not
expiration) of this Agreement, and subject to Section

12.2 (Paid-Up License Upon End of Royalty Term) of this Agreement, CANbridge
shall provide copies to PUMA or its designee of any Know-How in CANbridge’s
possession or control that  is

(a)reasonably useful or necessary to make, use, sell, offer for sale, or import
the Licensed Products and (b) developed by CANbridge in the course of performing
its obligations and exercising its rights under this Agreement. Such Know-How
shall include without limitation customer lists, but only to the extent such
customer lists relate solely to the Licensed Product and not another product.

12.4.9 Cooperation. Each Party will cause its Affiliates, sublicensees and
contractors to comply with the obligations in this Section 12.4 (Effects of
Termination).

 

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ARTICLE 13

DISPUTE RESOLUTION

 

13.1Dispute Resolution; Escalation. The Parties recognize that disputes as to
certain matters arising out of or in connection with this Agreement may arise
from time to time. It is the objective of the Parties to establish procedures to
facilitate the resolution of disputes arising under this Agreement in an
expedited manner by mutual cooperation. To accomplish this objective, any and
all disputes between the Parties arising out of or in connection with this
Agreement will first be referred to the JSC for resolution. Should the JSC not
be able to reach agreement at a duly called meeting of the JSC within [***]
after the date on which the matter is referred to the JSC, then either Party may
refer such matter to the Executive Officers for resolution and the Executive
Officers will attempt to resolve the matter in good faith. If the Executive
Officers fail to resolve such matter within [***] after the date on which the
matter is referred to the Executive Officers (unless a longer period is agreed
to by the Parties), then either Party may submit the dispute to the [***] for
final resolution by binding arbitration in accordance with Section 13.2
(Arbitration).

13.2Arbitration. Except as set forth in this Section 13.2 (Arbitration), each
dispute, difference, controversy or claim arising in connection with or related
or incidental to, or question occurring under, this Agreement or the subject
matter hereof will be referred to and finally resolved by arbitration in
accordance with the Rules of Arbitration (the “Rules”) of the [***], by an
arbitral tribunal composed of three arbitrators, all of whom will have previous
judicial experience, with each Party appointing one arbitrator and the third
arbitrator to be selected by mutual agreement of the two arbitrators appointed
by the Parties. The foregoing arbitration proceedings may be commenced by either
Party by notice to the other Party. Unless otherwise agreed by the Parties
hereto, all such arbitration proceedings will be held in [***]; provided,
however, that proceedings may be conducted by telephone conference call with the
consent of the Parties and the arbitrator(s). All arbitration proceedings will
be conducted in the English language. The arbitrator(s) will consider grants of
equitable relief and orders for specific performance as co-equal remedies along
with awards of monetary damages. The arbitrator(s) will have no authority to
award punitive damages. The allocation of expenses of the arbitration, including
reasonable attorney’s fees, will be [***]. The Parties hereby agree that the
arbitrator(s) has authority to issue rulings and orders regarding all procedural
and evidentiary matters that the arbitrator(s) deem reasonable and necessary
with or without petition therefore by the Parties as well as the final ruling
and judgment. All rulings by the arbitrator(s) will be final. Notwithstanding
any contrary provision of this Agreement, any Party may seek equitable measures
of protection in the form of attachment of assets or injunctive relief
(including, without limitation, specific performance and injunctive relief) in
any matter relating to the proprietary rights and interests of either Party from
any court of competent jurisdiction, pending a decision by the arbitral tribunal
in accordance with this Section 13.2 (Arbitration). The Parties hereby exclude
any right of appeal to any court on the merits of such matter. The provisions of
this Section 13.2 (Arbitration) may be enforced and judgment on the award
(including without limitation equitable remedies) granted in any arbitration
hereunder may be entered in any court having jurisdiction over the award or any
of the Parties or any of their respective assets. Except  to the extent
necessary to confirm an award or as may be required by Law, neither a Party nor
an arbitrator may disclose the existence, content, or results of an arbitration
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consent of both Parties. The Parties agree that, in the event of a dispute over
the nature or quality of performance under this Agreement, neither Party may
terminate this Agreement until final resolution of the dispute through
arbitration or other judicial determination. Nothing in this Section 13.2 will
preclude either Party from seeking interim or provisional relief from a court of
competent jurisdiction, including a temporary restraining order, preliminary
injunction or other interim equitable relief, concerning a dispute either prior
to or during any arbitration if necessary to protect the interests of such Party
or to preserve the status quo pending the arbitration proceeding.
Notwithstanding the Parties’ agreement to arbitrate, unless the Parties agree in
writing in any particular case, claims and disputes between the Parties relating
to or arising out of, or for which resolution depends in whole or in part on a
determination of the interpretation, scope, validity, enforceability or
infringement of, Patent Rights shall not be subject to arbitration under this
Agreement, and the Parties may pursue whatever rights and remedies may be
available to them under law or equity, including litigation in a court of
competent jurisdiction, with respect to such claims and disputes.

13.3Jury Waiver. EACH PARTY, TO THE EXTENT PERMITTED BY LAW, KNOWINGLY,
VOLUNTARILY, AND INTENTIONALLY WAIVES ITS RIGHT TO A TRIAL BY JURY IN ANY ACTION
OR OTHER LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT AND THE
TRANSACTIONS IT CONTEMPLATES TO ARBITRATE AS SET FORTH IN SECTION 13.2
(Arbitration). THIS WAIVER APPLIES TO ANY ACTION OR LEGAL PROCEEDING, WHETHER
SOUNDING IN CONTRACT, TORT OR OTHERWISE.

 

ARTICLE 14

MISCELLANEOUS

 

14.1Assignment; Successors.

14.1.1Assignment. This Agreement and the rights and obligations of each Party
under this Agreement will not be assignable, delegable, transferable, pledged or
otherwise disposed of by either Party without the prior written consent of the
other Party; provided, however, that either Party may assign or transfer this
Agreement together with all of its rights and obligations hereunder, without
such consent (but with written notice to the other Party), (a) to an Affiliate
or

(b)to a successor in interest in connection with the transfer or sale of all or
substantially all of its business or assets to which this Agreement relates, or
in the event of its merger or consolidation, reorganization or similar
transaction, subject to the assignee agreeing in writing to be bound by the
terms and conditions of this Agreement. Any assignment in violation of this
Section 14.1.1 (Assignment) shall be null and void.

14.1.2Successors. Any permitted assignment of the rights and obligations of a
Party under this Agreement will be binding on, and inure to the benefit of and
be enforceable by and against, the successors and permitted assigns of the
assigning Party. The permitted assignee or transferee will assume all
obligations of its assignor or transferor under this Agreement. Any assignment
or attempted assignment by either Party in violation of the terms of this
Section 14.1.2 (Successors) will be null, void and of no legal effect.

14.2Acquisition Transactions. Notwithstanding anything to the contrary in this
Agreement, in the event of an acquisition of a Party or its business (an
“Acquired Party”) by a

 

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Third Party (an “Acquirer”) after the Effective Date, directly or indirectly,
whether by merger, asset purchase or otherwise (each, an “Acquisition
Transaction”), then, as to any such   Acquirer, (a) any Patent Rights, Know-How,
or Regulatory Approvals that are held at the time of such acquisition by the
Acquirer, or any Affiliate of the Acquirer that becomes an Affiliate of the
Acquired Party as a result of such acquisition, will be deemed not to be
Controlled by the Acquired Party, and (b) such Acquirer (including its
Affiliates, but excluding the acquired Party) will not be obligated to comply
with the covenants in Section 2.4 (Exclusivity Covenant).

14.3Choice of Law. This Agreement will be governed by and interpreted under the
laws of the State of New York, without referring to conflicts of law principles;
provided, however, that all questions concerning (a) inventorship of Patent
Rights under this Agreement will be determined in accordance with Section 7.1
(Ownership of Inventions) and (b) the construction or effect of Patent Rights
will be determined in accordance with the laws of the country, Region or other
jurisdiction in which the particular patent within such Patent Rights has been
filed or granted, as the case may be. Any communication or proceedings resulting
of disputes under this Agreement shall be in English language. The Parties agree
to exclude the application to this Agreement of the United Nations Conventions
on Contracts for the International Sale of Goods.

14.4Notices. Any notice or report required or permitted to be given or made
under this Agreement by one Party to the other will be in writing and will be
deemed to have been delivered (a) upon personal delivery, (b) on the second
Business Day (at the place of delivery) next following deposit with a reputable,
internationally recognized overnight courier that maintains records of delivery
and (c) in the case of notices provided by telecopy (which notice will be
followed immediately by an additional notice pursuant to clause (a) or (b) above
if the notice is of a default under this Agreement), upon completion of
transmission, with transmission confirmed, to the addressee’s facsimile machine,
as follows (or at such other addresses or facsimile numbers as may have been
furnished in writing by a Party to the other as provided in this Section 14.4
(Notices)). This Section 14.4 (Notices) is not intended to govern the day-to-day
business communications necessary between the Parties in performing their
obligations under the terms of this Agreement.

 

If to PUMA:

Puma Biotechnology, Inc.

 

10880 Wilshire Blvd., Suite 2150 Los Angeles, CA 90024, USA Attention: [***]

 

Fax: [***]

 

 

With copies to:

Latham & Watkins

 

650 Town Center Drive, 20th Floor Costa Mesa CA 92626-1925, USA

 

Attention: [***]

 

Fax: [***]

 

 

 

Latham & Watkins 140 Scott Drive

 

Menlo Park, CA 94025-1008, USA

 

Attention: [***]

 

Fax: [***]

 

 

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If to CANbridge:

CANbridgepharma Limited

 

Sterling Centre No.11

 

Cheung Yue Street, Kowloon

 

Hong Kong

 

Attn: [***]

 

Fax: [***]

 

 

With copies to:

CANbridge Life Sciences Ltd.

 

303A, Building E

 

Wangjing Pioneer Park

 

No. 2 LizeZhongEr Road

 

Chaoyang District, Beijing, China

 

Attn: [***]

 

Fax: [***]

 

 

 

Ropes & Gray LLP 800

 

Boylston Street

 

Prudential Tower

 

Boston, Massachusetts 02199-3600

 

Attn: [***]

 

Fax: [***]

 

14.5Severability. In the event that one or more provisions of this Agreement is
held invalid, illegal or unenforceable in any respect, then such provision shall
not render any other provision of this Agreement invalid or unenforceable, and
all other provisions shall remain in full force and effect and shall be
enforceable, unless the provisions that have been found to be invalid or
unenforceable shall substantially affect the remaining rights or obligations
granted or undertaken by either Party. The Parties agree to attempt to
substitute for any invalid or unenforceable provision a provision which achieves
to the greatest extent possible the economic objectives of the invalid or
unenforceable provision.

14.6Integration. This Agreement, together with all schedules and exhibits
attached hereto, constitutes the entire agreement between the Parties with
respect to the subject matter of this Agreement and supersedes all previous
arrangements between the Parties with respect to the subject matter hereof,
whether written or oral, including the Prior CDA. In the event of a conflict
between the Development Plan or any schedules or attachments to this Agreement,
on the one hand, and this Agreement, on the other hand, the terms of this
Agreement will govern. Each Party confirms that it is not relying on any
representations or warranties of the other Party except as specifically set
forth in this Agreement.

14.7Waivers and Amendments. The failure of any Party to assert a right under
this Agreement or to insist upon compliance with any term or condition of this
Agreement will not constitute a waiver of that right or excuse a similar
subsequent failure to perform any such term or

 

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condition by the other Party. The exercise by any Party of any right or election
under the terms or covenants herein shall not preclude or prejudice any Party
from exercising the same or any other right it may have under this Agreement,
irrespective of any previous action or proceeding taken by the Parties
hereunder. Notwithstanding the authority granted to the JSC under this
Agreement,

(a) no waiver will be effective unless it has been given in writing and signed
by the Party giving such waiver, and (b) no provision of this Agreement may be
amended or modified other than by a written document signed by authorized
representatives of each Party.

14.8Independent Contractors; No Agency. Neither Party will have any
responsibility for the hiring, firing or compensation of the other Party’s or
such other Party’s Affiliates’ employees or for any employee benefits with
respect thereto. No employee or representative of a Party or its Affiliates will
have any authority to bind or obligate the other Party for any sum or in any
manner whatsoever, or to create or impose any contractual or other liability on
such other Party, without such other Party’s written approval. For all purposes,
and notwithstanding any other provision of this Agreement to the contrary, each
Party’s legal relationship under this Agreement to the other Party will be that
of independent contractor, and the relationship between the two Parties will not
constitute a partnership, joint venture, or agency, including for all tax
purposes.

14.9Affiliates, Sublicensees, and Contractors. To the extent that this Agreement
imposes obligations on Affiliates, sublicensees or contractors of a Party, such
Party will cause its Affiliates and its sublicensees and contractors to perform
such obligations. Either Party may use one or more of its Affiliates,
sublicensees or contractors to perform its obligations and duties or exercise
its rights under this Agreement; provided, however, that (a) each such
Affiliate, sublicensee or contractor will perform any such obligations delegated
to it in compliance with the applicable terms and conditions of this Agreement,
(b) the performance of any obligations of a Party’s by its Affiliates,
sublicensees or contractors will not diminish, reduce or eliminate any
obligation of such Party under this Agreement, and (c) subject to such Party’s
assignment to an Affiliate pursuant to Section 14.1 (Assignment; Successors),
such Party will remain liable under this Agreement for the prompt payment and
performance of all of its obligations under this Agreement.

14.10Force Majeure. Neither Party will be responsible to the other for, or be
deemed to have defaulted under or breached this Agreement for, any failure or
delay in performing any of its obligations under this Agreement or for other
nonperformance under this Agreement (excluding, in each case, the obligation to
make payments when due) if such delay or nonperformance is caused by or results
from events beyond the reasonable control of the non-performing Party, including
strike, fire, flood, earthquake, hurricanes, accident, war, acts of war (whether
war be declared or not), insurrections, riots, civil commotion, strikes,
lockouts, or other labor disturbances (whether involving the workforce of the
non-performing Party or of any other Person), act of terrorism, act of God or
acts, omissions or delays in acting of the government of any country or Region
or of any local government, or by cause unavoidable or beyond the reasonable
control of such Party (except to the extent such delay results from the breach
by the non-performing Party or any of its Affiliates of any term or condition of
this Agreement) (a “Force Majeure Event”). In such event, the Party affected
will promptly (and, in any event, within [***]) notify the other Party in
writing of such Force Majeure Event, stating the nature of the event, its
anticipated duration, and any action being taken to avoid or minimize its
effect.  The suspension of performance will be of   no

 

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greater scope and no longer duration than is necessary and the non-performing
Party and will use Commercially Reasonable Efforts to resume performance of its
obligations.

14.11No Third Party Beneficiary Rights. The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of
the Parties and their successors and permitted assigns, and they shall not be
construed as conferring any rights on any other Person. This Agreement is not
intended to and will not be construed to give any Third Party any interest or
rights (including any third party beneficiary rights) with respect to or in
connection with any agreement or provision contained herein or contemplated
hereby, other than, to the extent provided in ARTICLE 10 (Indemnification;
Damages), the Indemnified Parties.

14.12Non-exclusive Remedy. Except as expressly provided herein, the rights and
remedies provided herein are cumulative and each Party retains all remedies at
law or in equity, including the Parties’ ability to receive legal damages or
equitable relief, with respect to any breach of this Agreement. Neither Party
will be required to terminate this Agreement due to a breach of this Agreement
by the other Party.

14.13Interpretation. The Article and Section headings used herein are for
reference and convenience only, and will not enter into the interpretation of
this Agreement. Except as otherwise explicitly specified to the contrary, (a)
references to an Article, Section, Exhibit or Schedule means an Article or
Section of, or a Schedule or Exhibit to this Agreement and all subsections
thereof, unless another agreement is specified; (b) references in any Section to
any clause are references to such clause of such Section; (c) references to any
agreement, instrument, or other document in this Agreement refer to such
agreement, instrument, or other document as originally executed or, if
subsequently amended, replaced, or supplemented from time to time, as so
amended, replaced, or supplemented and in effect at the relevant time of
reference thereto; (d) references to a particular Law mean such Law as in effect
as of the relevant time, including all rules and regulations thereunder and any
successor Law in effect as of the relevant time, and including the then-current
amendments thereto; (e) words in the singular or plural form include the plural
and singular form, respectively; (f) unless the context requires a different
interpretation, the word “or” has the inclusive meaning that is typically
associated with the phrase “and/or”; (g) the terms “including,” “include(s),”
“such as,” “e.g.” and “for example” mean including the generality of any
description preceding such term and will be deemed to be followed by “without
limitation”; (h) whenever this Agreement refers to a number of days, such number
will refer to calendar days unless Business Days are specified, and if a period
of time is specified and dates from a given day or Business Day, or the day or
Business Day of an act or event, it is to be calculated exclusive of that day or
Business Day; (i) “monthly” means on a calendar month basis, (j) “quarter” or
“quarterly” means on a Calendar Quarter basis; (k) “annual” or “annually” means
on a Calendar Year basis; (l) “year” means a 365 day period unless Calendar Year
is specified; (m) references to a particular Person include such Person’s
successors and assigns to the extent not prohibited by this Agreement; (n) all
words used in this Agreement will be construed to be of such gender or number as
the circumstances require; (o) a capitalized term not defined herein but
reflecting a different part of speech than a capitalized term which is defined
herein will be interpreted in a correlative manner; (p)any definition of or
reference to any agreement, instrument or other document herein will be
construed as referring to such agreement, instrument or other document as from
time to time amended, supplemented or otherwise modified (subject to any
restrictions on such amendments, supplements or modifications set forth herein);
(q) the words “hereof,” “herein,” “hereby” and

 

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derivative or similar words refer to this Agreement (including any Exhibits or
Schedules); (r) neither Party or its Affiliates will be deemed to be acting “on
behalf of” the other Party under this Agreement, except to the extent expressly
otherwise provided; (s) there will be no double-counting in calculating
Development costs or any components thereof; (t) provisions that require that a
Party, or the JSC hereunder “agree”, “consent” or “approve” or the like will be
deemed to require that such agreement, consent or approval be specific and in
writing in a written agreement, letter or approved minutes, but, except as
expressly provided herein, excluding e-mail and instant messaging; and (u) the
word “will” shall be construed to have the same meaning and effect as the word
“shall”.

14.14Further Assurances. Each Party will duly execute and deliver, or cause to
be duly executed and delivered, such further instruments and do and cause to be
done such further acts and things, including the filing of such assignments,
agreements, documents, and instruments, as may be necessary or as the other
Party may reasonably request in connection with this Agreement or to carry out
more effectively the provisions and purposes hereof, or to better assure and
confirm unto such other Party its rights and remedies under this Agreement.

14.15Ambiguities; No Presumption. Each of the Parties acknowledges and agrees
that this Agreement has been diligently reviewed by and negotiated by and
between them, that in such negotiations each of them has been represented by
competent counsel and that the final agreement contained herein, including the
language whereby it has been expressed, represents the joint efforts of the
Parties hereto and their counsel. Accordingly, in interpreting this Agreement or
any provision hereof, no presumption will apply against any Party as being
responsible for the wording or drafting of this Agreement or any such provision,
and ambiguities, if any, in this Agreement will not be construed against any
Party, irrespective of which Party may be deemed to have authored the ambiguous
provision.

14.16Execution in Counterparts; Facsimile Signatures. This Agreement may be
executed in counterparts, each of which counterparts, when so executed and
delivered, will be deemed to be an original, and all of which counterparts,
taken together, will constitute one and the same instrument even if both Parties
have not executed the same counterpart. Signatures provided by facsimile
transmission or in Adobe™ Portable Document Format (PDF) sent by electronic mail
will be deemed to be original signatures.

 

14.17Export Control. This Agreement is made subject to any restrictions
concerning the export of products or technical information from the U.S. or
other countries which may be imposed upon or related to the Parties from time to
time (“Export Control Laws”). Each Party agrees that it will not export,
directly or indirectly, any technical information acquired from the other Party
under this Agreement or any products using such technical information to a
location or in a manner that at the time of export requires an export license or
other governmental approval, without first obtaining the written consent to do
so from the appropriate agency or other Governmental Authority.

 

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IN WITNESS WHEREOF, each Party has caused this Agreement to be duly executed by
its authorized representative under seal, in duplicate on the Effective Date.

 

PUMA BIOTECHNOLOGY, INC.

 

/s/ Alan Auerbach

Name: Alan Auerbach

Title: CEO/President

 

 

CANBRIDGEPHARMA  LIMITED

 

/s/ Xue James Qun

Name: Xue James Qun

Title: Director

Jan. 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[Signature Page to Collaboration and License Agreement]

 

 

 

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Schedule 1.39

 

Existing Third Party License Agreements

 

The Pfizer License Agreement

 

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Schedule 4.1

Supply Agreement Key Terms

 

The Supply Agreement shall incorporate the following key terms and conditions:

 

 

•

Supply Price

 

°

The per unit supply price for each [***] of the Licensed Product in [***] form
shall be (a) $[***] for Licensed Product supplied for clinical use, and (b)
$[***] for Licensed Product supplied for commercial use. Such prices shall be
revised every [***] to account for any increase in the relevant [***] applicable
to the prior [***]. [***].

 

•

Forecasting / Delivery Against Forecasts

 

°

CANbridge shall provide to PUMA a rolling [***] forecast setting forth its
estimated requirements for Licensed Product (the “Rolling Forecast”), and shall
update such forecast [***]. The first [***] of each Rolling Forecast shall be
binding on both Parties (the “Binding Forecast”). The last [***] of each Rolling
Forecast shall be used for planning purposes only. PUMA shall supply CANbridge
with its requirements for Licensed Product as set forth in each Binding
Forecast, and CANbridge shall be obligated to purchase the amount of Licensed
Product set forth in each Binding Forecast.

 

°

If at any time during the Term, PUMA believes that it will not be able to meet
CANbridge’s requirements for Licensed Product, as set forth in any Rolling
Forecast, then PUMA shall provide notice to CANbridge within [***] of becoming
aware of such anticipated supply shortfall. Promptly following any such notice,
the Parties will discuss strategies for addressing any potential shortfall.

 

•

Initial Supply and Back-Up Supply

 

°

The Parties shall agree to forecasting and delivery mechanics with the intent to
[***].

 

•

Remedies for Supply Failures and Shortfalls

 

°

PUMA shall maintain [***] qualified third party contract manufacturing
organization for the supply of Licensed Product (“Third Party CMO”). In the
event of a Supply Failure (to be defined in the Supply Agreement), CANbridge
shall have the right to source Licensed Product for the CANbridge Territory
directly from any such Third Party CMO for the duration of such Supply Failure
and PUMA shall use commercially reasonable efforts to enable such direct
sourcing relationship.

 

°

In the event of any supply shortfall, PUMA may supply the US market first, but
shall distribute available Licensed Product to all other countries (or regions,
as applicable) in the world on a proportionate basis, to be determined by [***],
and [***].

 

°

The Parties shall discuss and agree upon additional remedies in the event of any
Supply Failure.

 

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Schedule 8.2.1

 

Form of Initial Press Release

 

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CANbridge Press Release

Puma Biotechnology and CANbridge Life Sciences Enter into Exclusive Licensing
Agreement to Commercialize NERLYNX® (neratinib) in Greater China

CANbridge Life Sciences, a biopharmaceutical company focused on developing
Western drug candidates in China and North Asia, announced today that it has
exclusively licensed the rights to develop and commercialize NERLYNX®
(neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China)
from Puma Biotechnology, Inc (Nasdaq: PBYI).

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July
2017 for the extended adjuvant treatment of adult patients with early stage
HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is
marketed in the United States as NERLYNX® (neratinib) tablets.

“We are very proud to be partnering with Puma.  By addressing a significant
unmet medical for the extended adjuvant treatment of patients with early stage
HER2-positive breast cancer following adjuvant trastuzumab-based therapy, we
believe that NERLYNX will transform the lives of patients. We are honored to
have been selected by Puma to develop and commercialize this important therapy
which we believe has significant commercial potential in greater China in
HER2-postive cancers including gastric cancer where CANbridge will be leading
the development in greater China.” said James Xue, Chief Executive Officer of
CANbridge Life Sciences. “This transformative collaboration is an important
demonstration of our capabilities as a leading biopharmaceutical company and
partner of choice in the greater China region. We will work closely with Puma
and regulatory authorities toward earliest market approval of NERLYNX.”

“CANbridge was selected to be our partner in greater China because of the
strength and depth of the team and we are confident in CANbridge’s capabilities
to make NERLYNX® a commercial success in greater China.” stated Alan H.
Auerbach, Chief Executive Officer and President of Puma.

 

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[g201805102022569083588.jpg]

News Release

Puma Biotechnology and CANbridge Life Sciences Enter into

Exclusive Licensing Agreement to Commercialize NERLYNX® (neratinib)

in  Greater China

 

LOS ANGELES, Calif., Jan. XX, 2018 – Puma Biotechnology, Inc. (Nasdaq: PBYI), a
biopharmaceutical company, and CANbridge
Life  Sciences,  a  biopharmaceutical  company focused on developing Western
drug candidates in China and North Asia, have entered into an exclusive
agreement under which CANbridge will commercialize NERLYNX® (neratinib) in
China, Taiwan, Hong Kong, and Macau (greater China).

 

NERLYNX is not approved currently for commercialization outside of the United
States. CANbridge will be responsible for seeking the requisite regulatory
approval and, once approved, for commercializing NERLYNX in greater China. Puma
will receive an upfront payment of $30 million and other potentially near term
regulatory milestone payments totaling an additional $40 million. In addition,
Puma will receive significant double digit royalties on NERLYNX sales in greater
China and sales-based milestones may be realized in later years.

 

“Puma is committed to providing access to NERLYNX to patients around the world
and greater China represents a very large market opportunity,” stated Alan H.
Auerbach, Chief Executive Officer and President of Puma. “While we continue to
focus our commercial resources on the U.S. market, we are confident this new
partnership with CANbridge will help patients in greater China access NERLYNX at
the earliest opportunity.”

 

“We are excited about the opportunity to provide this therapy to women in our
region. We plan to engage our local regulatory authorities in greater China to
expedite commercial access to NERLYNX in parts of greater China by mid-2019.”
said James Xue, Chief Executive Officer of CANbridge Life Sciences. “We are
honored to have been selected by Puma to develop and commercialize this
important therapy which we believe has significant commercial potential in
greater China in HER2-postive cancers, including gastric cancer, where CANbridge
will  be  leading the clinical development in greater China.”

 

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July
2017 for the extended adjuvant treatment of adult patients with early stage
HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is
marketed in the United States  as NERLYNX® (neratinib) tablets.

 

About HER2-Positive Breast Cancer

 

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein.
HER2- positive breast cancer is often  more aggressive than other types of
breast cancer, increasing the   risk of disease progression and death. Although
research has shown that trastuzumab can reduce the risk of early stage
HER2-positive breast cancer returning after surgery, up to 25% of patients
treated with trastuzumab experience recurrence.

 

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IMPORTANT SAFETY INFORMATION

 

NERLYNX ® (neratinib) tablets, for oral use

 

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended
adjuvant treatment of adult patients with early-stage HER2
overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based
therapy.

 

CONTRAINDICATIONS: None

 

WARNINGS AND PRECAUTIONS:

 

 

•

Diarrhea: Aggressively manage diarrhea occurring
despite  recommended  prophylaxis  with additional antidiarrheals, fluids, and
electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing
severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients
experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea  that occurs after maximal
dose reduction.

 

•

Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of
treatment, then every 3 months while on treatment and as clinically indicated.
Withhold NERLYNX   in patients experiencing Grade 3 liver abnormalities and
permanently discontinue NERLYNX in patients experiencing Grade 4 liver
abnormalities.

 

•

Embryo-Fetal Toxicity: NERLYNX  can  cause  fetal harm.  Advise  patients  of
potential risk to a fetus and to use effective contraception.

 

ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea,
nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite,
muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin,
abdominal distention, epistaxis, weight decreased  and urinary tract infection.

 

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-
844-NERLYNX (1-844-637-5969) and   www.NERLYNX.com or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch

 

DRUG INTERACTIONS:

 

 

•

Gastric acid reducing agents: Avoid concomitant use with proton pump  inhibitors
(PPI) and H2-receptor antagonists. Separate NERLYNX by 3 hours after antacid
dosing.

 

•

Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.

 

•

Strong or moderate CYP3A4 inducers: Avoid concomitant use.

 

•

P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of
narrow  therapeutic  agents that are P-gp substrates when used concomitantly
with  NERLYNX.

 

USE IN SPECIFIC POPULATIONS:

 

 

•

Lactation: Advise women not to breastfeed.

 

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Please see Full Prescribing Information for additional safety  information.

 

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once
daily with food, continuously for one year. Antidiarrheal prophylaxis should be
initiated with the first dose of NERLYNX and continued during the first 2 months
(56 days) of treatment and as needed  thereafter.

 

To help ensure patients have access to NERLYNX, Puma has implemented the Puma
Patient Lynx support program to assist patients and healthcare providers with
reimbursement support and  referrals to resources that can help with financial
assistance. More information  on  the  Puma Patient Lynx program can be found at
www.NERLYNX.com or 1-855-816-5421.

 

About Puma Biotechnology

 

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the
development and commercialization of innovative products to enhance cancer care.
The Company in-licenses the global development and commercialization rights to
three drug candidates — PB272 (neratinib (oral)), PB272 (neratinib
(intravenous)) and PB357. NERLYNX® (neratinib) is approved for commercial use by
prescription in the United States as extended adjuvant therapy for early stage
HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is
marketed as NERLYNX. Neratinib is a potent irreversible tyrosine kinase
inhibitor that blocks signal transduction through the epidermal growth factor
receptors, HER1, HER2 and HER4. Currently,  the Company is primarily focused on
the commercialization of NERLYNX and the continued development of its other
advanced drug candidates directed at the treatment of HER2-positive  breast
cancer. The Company believes that NERLYNX has clinical application in the
potential treatment of several other cancers that over-express or have a
mutation in HER2.

 

Further information about Puma Biotechnology can be found
at  www.pumabiotechnology.com.

 

About CANbridge Life Sciences

 

CANbridge Life Sciences, Ltd. is a clinical-staged bio-pharmaceutical company
accelerating development and commercialization of specialty healthcare products
for serious and critical  medical conditions in China and North Asia (Korea and
Taiwan). CANbridge  develops  partnerships with Western bio-pharmaceutical
companies with clinical-stage pharmaceutical, medical device or diagnostic
products that are either unavailable in China/North Asia or address medical
needs that are underserved in the region. CANbridge also licenses, or obtains
exclusive rights to commercialize, drug and device products that are approved in
their home markets for commercialization in China and North Asia. Led
and  backed  by a  highly-seasoned  executive team, with extensive Chinese drug
development experience, CANbridge has the  capability  to select, acquire,
develop and commercialize future therapeutics and diagnostics targeting the
unmet medical needs of Chinese and East Asian patients with serious or critical
conditions.   CANbridge   is privately-held and headquartered in Beijing, China.

 

Additional information can be found at  http://www.canbridgepharma.com/.

 

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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Confidential Treatment Requested by Puma Biotechnology, Inc.

 

Forward-Looking Statements

 

This press release contains forward-looking statements, including statements
regarding the commercialization and commercial availability of NERLYNX® in
Greater China; the registration of, and regulatory approval of, NERLYNX in the
region; the expected milestone payments and royalties payable under the
agreement with CANbridge Pharma Ltd.; the benefits of NERLYNX and neratinib; the
Company’s clinical trials; and the announcement of data relative to those
trials.

All forward-looking statements included in this press release involve risks and
uncertainties that could cause the Company’s actual results to differ materially
from the anticipated results and expectations expressed in these forward-looking
statements. These statements are based on current expectations, forecasts and
assumptions, and actual outcomes and results could differ materially from these
statements due to a number of factors, which include, but are not limited to,
the fact that the Company has only recently commenced commercialization and
shipment of its only FDA approved product; the Company’s dependence upon the
commercial success of NERLYNX (neratinib); the Company’s history of operating
losses and its expectation that it will continue to incur losses for the
foreseeable future; risks and uncertainties related to the Company’s ability to
achieve or sustain profitability; the Company’s ability to predict its future
prospects and forecast its financial performance and growth; failure to obtain
sufficient capital to fund the Company’s operations; the effectiveness of sales
and marketing efforts; the Company’s ability to obtain FDA approval or other
regulatory approvals in the United States or elsewhere for other indications for
neratinib or other product candidates; the challenges associated with conducting
and enrolling clinical trials; the risk that the results of clinical trials may
not support the Company’s drug candidate claims; even if approved, the risk that
physicians and patients may not accept or use the Company’s products; the
Company’s reliance on third parties to conduct its clinical trials and to
formulate and manufacture its drug candidates; risks pertaining to securities
class action, derivative and defamation lawsuits; the Company’s dependence on
licensed intellectual property; and the other risk factors disclosed in the
periodic and current reports filed by the Company with the Securities and
Exchange Commission from time to time, including the Company’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2017. Readers are cautioned not
to place undue reliance on these forward-looking statements, which speak only as
of the date hereof. The Company assumes no obligation to update these
forward-looking statements, except as required by law.

 

Contact:

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500
info@pumabiotechnology.com

ir@pumabiotechnology.com

 

David Schull or Amiad Finkelthal, Russo Partners, +1-212-845-4271
david.schull@russopartnersllc.com

amiad.finkelthal@russopartnersllc.com

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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Confidential Treatment Requested by Puma Biotechnology, Inc.

 

Schedule 9.2.1

 

Licensed Patents

 

A.Hong Kong, Macau & Taiwan

 

[***]

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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Confidential Treatment Requested by Puma Biotechnology, Inc.

 

 

B.China

 

[***]

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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Confidential Treatment Requested by Puma Biotechnology, Inc.

Page 2

 

 

 

 

 

Schedule 9.2.2

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.