exv10w36






Exhibit 10.36




     EXECUTION COPY


CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT MARKED WITH [***] HAS BEEN OMITTED AND
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.




LICENSE AGREEMENT




     This License Agreement (the “Agreement“) is entered into on November 6, 2009 (the
“Effective Date“) between Nippon Kayaku Co., Ltd., a Japanese corporation with its
principal place of business at 11-2, Fujimi 1-chome, Chiyoda-ku,
Tokyo 102-8172, Japan (“NK”), and Spectrum Pharmaceuticals, Inc., a
Delaware corporation with its principal place of business at 157 Technology Drive, Irvine, CA 92618
(“Spectrum“). Spectrum and NK are sometimes referred to herein individually as a “Party” and
collectively as the “Parties.”



RECITALS




     Whereas, Spectrum has developed certain intellectual property relating to the use of
Apaziquone for treatment of bladder cancer;



     Whereas, Spectrum has granted the right to develop and commercialize certain products
containing Apaziquone outside of Asia to Allergan, Inc. and its affiliates, under a License,
Development, Supply and Distribution Agreement by and among Allergan Sales, LLC, Allergan USA,
Inc., Allergan, Inc. and Spectrum, effective October 28, 2008 (the Allergan entities collectively,
together with any successors or assigns of Allergan with respect to such agreement with Spectrum,
“Allergan”, such agreement, the “Allergan Agreement” and such date, the “Allergan Agreement
Effective Date”);



     Whereas, NK has substantial expertise in the research, development, manufacture,
distribution, sales and marketing of pharmaceutical products in Japan and in the distribution,
sales and marketing of pharmaceutical products through distributors in Asia; and



     Whereas, Spectrum desires to grant to NK, and NK desires to obtain, the right to
develop, manufacture and commercialize product(s) containing Apaziquone for certain indications in
all countries and territories of Asia except for Korea, all on the terms and conditions set forth
herein.



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



 









 





ARTICLE 1




DEFINITIONS



     As used in this Agreement, the following initially capitalized terms, whether used in the
singular or plural form, shall have the meanings set forth in this Article 1.



     1.1 “Affiliate” means, with respect to a particular Party, a person, corporation, partnership,
or other entity that controls, is controlled by or is under common control with such Party. For
the purposes of this definition, the word “control” (including, with correlative meaning, the terms
“controlled by” or “under the common control with”) means the actual power, either directly or
indirectly through one or more intermediaries, to direct or cause the direction of the management
and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting
stock of such entity, or by contract or otherwise.



     1.2 “Apaziquone” means the compound having the structure set forth on Exhibit A attached
hereto.



     1.3 “Asia” means Bangladesh, Bhutan, Brunei, Burma (Myanmar), Cambodia, China, Hong Kong,
India, Indonesia, Japan, Laos, Macao, Malaysia, Maldives, Mongolia, Nepal, North Korea, Pakistan,
Philippines, Qatar, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam, as their
boundaries are defined as of the Allergan Agreement Effective Date, and including any successors of
the foregoing countries to the extent within the boundaries of the countries set forth above as of
the Allergan Agreement Effective Date.



     1.4 “Closed-System Packaging” means a packaging system that allows reconstitution of drug
product with diluent in a closed system in a manner that does not expose the individual performing
the reconstitution to any direct contact with either lyophilized or reconstituted Apaziquone.



     1.5 “Commercialization” with a correlative meaning for “Commercialize” and “Commercializing”,
means all activities undertaken before and after obtaining Regulatory Approvals relating
specifically to the pre-launch, launch, promotion, detailing, medical education and medical liaison
activities, marketing, pricing, reimbursement, sale, and distribution of the Product, including:
(a) strategic marketing, sales force detailing, advertising, medical education and liaison, and
market and Product support; (b) any postmarketing clinical studies for use in generating data to
be submitted to Regulatory Authorities (and all associated reporting requirements); and (c) all
customer support, Product distribution, invoicing and sales activities.



     1.6 “Commercially Reasonable Efforts” means those efforts consistent with the exercise of
prudent scientific and business judgment in an active and ongoing program as applied by a Party to
the development and commercialization of its own pharmaceutical products at a similar stage of
development and with similar market potential. Commercially Reasonable Efforts requires that a
Party, at a minimum, assigns responsibility for such obligations to qualified employees, sets
annual goals and objectives for carrying out such obligations, and allocates resources designed to
meet such goals and objectives.



2.









 





     1.7 “Confidential Information” means, with respect to a Party, all reports and other
Information of such Party that is disclosed to the other Party under this Agreement, whether in
oral, written, graphic, or electronic form. All Information disclosed by either Party pursuant to
the Mutual Confidentiality Agreement between the Parties dated April 16, 2009, shall be deemed to
be such Party’s Confidential Information disclosed hereunder.



     1.8 “Control” means, with respect to any material, Information, or intellectual property
right, that a Party owns or has a license to such material, Information, or intellectual property
right and, in each case, has the ability to grant to the other Party access, a license, or a
sublicense (as applicable) to the foregoing on the terms and conditions set forth in this Agreement
without violating the terms of any then-existing agreement or other arrangement with any Third
Party.



     1.9 “Cost of Goods Sold” means the cost incurred by Spectrum in manufacturing the Product
(including the production of the active ingredient and the fill and finish of the Product) supplied
to NK under this Agreement and transporting such Product to the airport(s) where such Product will
be exported to NK, including material costs, labor costs and overhead costs (including allocated
facility costs, testing costs and delivery costs). In the event Spectrum engages any Third Party
contract manufacturer for the manufacture and supply of the Products, Cost of Goods Sold shall mean
Spectrum’s costs actually incurred in such engagement, the procurement of such Products from such
Third Party and transporting such Product to such airport(s).



     1.10 “Develop” or “Development” means all activities relating to preparing and conducting
preclinical testing, toxicology testing, human clinical studies, and regulatory activities (e.g.,
regulatory applications) with respect to the Product, together with the manufacturing of the
Product for the purpose of conducting the foregoing activities.



     1.11 “Development Costs” means the internal costs and out-of-pocket costs incurred as an
expense in accordance with generally accepted accounting principles by or on behalf of a Party or
its Affiliates in carrying out the Development of the Product in accordance with the approved
Development Plan, including, without limitation, (i) the costs of clinical trials (including costs
of procuring the Product(s), placebos and comparator drugs used in such clinical trials), (ii)
filing fees and other costs associated with any Regulatory Filings; (iii) costs related to
manufacturing development; and (iv) all other costs that are directly attributable and reasonably
allocable to the Development activities for the Products. For purposes of this definition: (a)
out-of-pocket costs mean the actual expense incurred with respect to a Third Party for specific
Development activities relating to the Products; and (b) internal costs means the applicable FTE
Rate multiplied by the number of FTE hours expended in carrying out the Development activities in
accordance with the Development Plan. For clarity, the costs associated with attending or
participating in meetings of the JPT are expressly excluded from this definition.



     1.12 “Development Plan” has the meaning set forth in Section 4.2(a).



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



3.









 





     1.14 “FDA” means the United States Food and Drug Administration and any successors thereof.



     1.15 “Field” means the intravesical treatment of non-muscle invasive bladder cancer in humans.



     1.16 “First Commercial Sale” means the first sale to a Third Party of a Product in a given
regulatory jurisdiction after Regulatory Approval has been obtained in such jurisdiction.



     1.17 “Generic Product” means, with respect to a Product in the Field in a particular country
in the NK Territory, another pharmaceutical product that is: (a) a Product; (b) approved for use in
such country by the Regulatory Authority; and (c) commercialized by a Third Party who has not
obtained the right or access to such product (through sublicense, subcontract or chain of
distribution) from NK or its Affiliates or sublicensees.



     1.18 “Governmental Authority” means any multi-national, federal, state, local, municipal,
provincial or other government authority of any nature (including any governmental division,
prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or
other tribunal).



     1.19 “Immediate Instillation Indication” means the intravesical instillation of a Product into
the bladder for the treatment of non-muscle invasive bladder cancer, administered immediately after
transurethral resection of bladder tumor (TUR-BT).



     1.20 “Information” means any data, results, technology, business information and information
of any type whatsoever, in any tangible or intangible form, including, without limitation,
know-how, trade secrets, practices, techniques, methods, processes, inventions, developments,
specifications, formulations, formulae, materials or compositions of matter of any type or kind
(patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test
data (including pharmacological, biological, chemical, biochemical, toxicological, preclinical and
clinical test data), analytical and quality control data, stability data, other study data and
procedures.



     1.21 “Joint Inventions” has the meaning set forth in Section 9.1.



     1.22 “Joint Patent” has the meaning set forth in Section 9.1.



     1.23 “Joint Product Team” or “JPT” means the Product team formed by the Parties as described
in Section 3.2.



     1.24 “Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements
having the effect of law of any federal, national, multinational, state, provincial, county, city
or other political subdivision, domestic or foreign.



     1.25 “Major Markets” means each of the following countries: (a) Japan; (b) mainland China; (c)
Taiwan; (d) Hong Kong; (e) Singapore; and (f) India.



4.









 





     1.26 “Multiple Instillation Indication” means the intravesical instillation of a Product into
the bladder for the treatment of non-muscle invasive bladder cancer, administered as multiple
instillations. For clarity, multiple instillations shall mean a repeat and/or sequential dosing
regimen which may include an immediate instillation dose as part of such regimen.



     1.27 “Net Sales” means, with respect to a particular time period, the total amounts invoiced
by NK, its Affiliates and their respective sublicensees for sales of Products made during such time
period to unrelated Third Parties, less the following deductions to the extent actually allowed or
incurred with respect to such sales:



          (a) reasonable and customary discounts, including cash and quantity discounts, charge-back
payments, administrative fees incurred directly in such discounting, and rebates actually granted
to trade customers and distributors (including wholesalers);




          (b) reasonable and customary credits or allowances actually granted for damaged, outdated,
spoiled, returned or rejected Products, including, without limitation, in connection with recalls;
and




          (c) Taxes, tariffs, duties or other governmental charges (other than income taxes) levied on,
absorbed or otherwise imposed on sales of the Product in the NK Territory, as adjusted by any
refunds, provided that such Taxes, tariffs, duties or other government charges are included in the
applicable invoiced amount and identified in the applicable invoice.



Notwithstanding the foregoing, amounts billed by NK, its Affiliates, or their respective
sublicensees for the sale of Products among NK, its Affiliates or their respective sublicensees for
resale, or for use in clinical development (at or below cost incurred for procuring and shipping
the Product), shall not be included in the computation of Net Sales hereunder. A sale of Products
by NK, its Affiliates or their respective sublicensees to a wholesaler shall be regarded as the
sale of Product to unrelated Third Parties for the purpose of calculating Net Sales. For purposes
of determining Net Sales, the Products shall be deemed to be sold when shipped and a “sale” shall
not include reasonable transfers or dispositions, at no cost, as samples or for charitable
purposes, or transfers or dispositions at no cost for preclinical, clinical or regulatory purposes.



Each of the deductions set forth above shall be reasonable and customary, and in accordance with
accounting principles generally accepted in Japan. NK, its Affiliates, and their respective
sublicensees will sell Products as stand-alone products and will not sell such Products as part of
a bundle with other products or offer packaged arrangements to customers that include Products,
except with the prior written consent of Spectrum.




     1.28 “NK Know-How” means all Information that is Controlled by NK or its Affiliates as of the
Effective Date or during the Term and is necessary or reasonably useful for the Development,
manufacture and/or Commercialization of the Product in the Field in accordance with the terms of
this Agreement. For clarity, NK Know-How excludes rights granted under the NK Patents. For further
clarity, NK Know-How includes (i) all data, results and other Information generated from or
obtained by the Development conducted by or for NK in the NK Territory under this Agreement, (ii)
all data, results and other Information generated from or obtained by the clinical Development
conducted by or for NK in South Korea pursuant



5.









 




to Section 2.1(a)(ii), and (iii) NK’s interest in the data, results and other Information
generated from or obtained by the clinical Development conducted by NK and Korean Partner pursuant
to Section 2.1(a)(ii).




     1.29 “NK Patent” means any Patent that (a) is Controlled by NK or its Affiliates as of the
Effective Date or at any time during the Term (excluding NK’s interest in any Joint Patents), and
(b) claims the Products or their use, composition, formulation, preparation, method of
administration or manufacture.



     1.30 “NK Technology” means the NK Patents and NK Know-How.



     1.31 “NK Territory” means all countries and territories in Asia, excluding North Korea and
South Korea.



     1.32 “Patents” means (a) pending patent applications, issued patents, utility models and
designs; (b) reissues, substitutions, confirmations, registrations, validations, re-examinations,
additions, continuations, continued prosecution applications, continuations-in-part, or divisions
of or to any patents, patent applications, utility models or designs; and (c) the equivalent or
counterpart of the foregoing.



     1.33 “Product” means any formulation that includes Apaziquone that is suitable for use in
treating non-muscle invasive bladder cancer via intravesical instillation.



     1.34 “Regulatory Approval” means, with respect to a Product in any country or jurisdiction,
all approvals (including, where required, pricing and reimbursement approvals), registrations,
licenses or authorizations from the relevant Regulatory Authority in a country or jurisdiction that
is specific to Product and necessary to market and sell such Product in such country or
jurisdiction.



     1.35 “Regulatory Authority” means, in a particular country or regulatory jurisdiction, any
applicable Governmental Authority involved in granting Regulatory Approval and/or, to the extent
required in such country or regulatory jurisdiction, pricing or reimbursement approval of a Product
in such country or regulatory jurisdiction.



     1.36 “Regulatory Exclusivity” means market exclusivity granted by a Governmental Authority
designed to prevent the entry of Generic Product(s) onto the market in the Field, including new
chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan
drug exclusivity, pediatric exclusivity and 180-day generic product exclusivity, or any equivalent
of the foregoing in the NK Territory.



     1.37 “Regulatory Filings” means, with respect to the Products, any submission to a Regulatory
Authority of any appropriate regulatory application specific to Products, and shall include,
without limitation, any submission to a regulatory advisory board and any supplement or amendment
thereto.



     1.38 “Retained Territory” means all countries and territories in the world outside the NK
Territory.



6.









 





     1.39 “Sole Inventions” has the meaning set forth in Section 9.1.



     1.40 “Spectrum Know-How” means all Information that is Controlled by Spectrum or its
Affiliates as of the Effective Date or during the Term and is necessary or reasonably useful for
the Development, manufacture and/or Commercialization of the Product in the Field in accordance
with the terms of this Agreement. For clarity, Spectrum Know-How includes all data, results and
other Information generated from or obtained by clinical studies and other tests conducted under
the Allergan Agreement and any Information described in Regulatory Filings filed with any
Regulatory Authority in the Retained Territory with respect to the Product, in each case to the
extent Controlled by Spectrum or its Affiliates. For further clarity, Spectrum Know-How excludes
rights granted under the Spectrum Patents. Notwithstanding the foregoing, Spectrum Know-How shall
not include Information controlled by an acquiror or merger partner of Spectrum that: (a) existed
as of the date of closing of such acquisition or merger; or (b) was developed after the date of
closing of such acquisition or merger without using Spectrum Know-How or inventions claimed in
Spectrum Patents.



     1.41 “Spectrum Patents” means all Patents in the NK Territory that (a) are Controlled by
Spectrum or its Affiliates as of the Effective Date or at any time during the Term (excluding
Spectrum’s interest in any Joint Patents), and (b) but for the licenses granted herein, would be
infringed by the developing, making, using and/or selling of the Products by NK, its Affiliates or
sublicensees in the Field in the NK Territory. Notwithstanding the foregoing, Spectrum Patents
shall not include Patents controlled by an acquiror or merger partner of Spectrum that: (a) existed
as of the date of closing of such acquisition or merger; or (b) were developed after the date of
closing of such acquisition or merger without using Spectrum Know-How or inventions claimed in
Spectrum Patents. The Spectrum Patents existing as of the Effective Date in the NK Territory are
set forth on Exhibit B attached hereto.



     1.42 “Spectrum Technology” means the Spectrum Patents and Spectrum Know-How.



     1.43 “Taxes” means taxes (other than income taxes), duties, tariffs or other governmental
charges levied on the sale of Products, including, without limitation, consumption taxes.



     1.44 “Term” means the term of this Agreement, as determined in accordance with Article 13.



     1.45 “Third Party” means any person or entity other than Spectrum or NK or an Affiliate of
either of them.



     1.46 “TPP” means the target product profile of the Product existing as of the Effective Date
and attached to this Agreement as Exhibit C.



     1.47 “Valid Claim” means, with respect to any country: (a) a claim of an issued and unexpired
patent (as may be extended through supplementary protection certificate or patent term extension or
the like) included within the Spectrum Patents to the extent such claim has not been revoked, held
invalid or unenforceable by a patent office, court or other governmental agency of competent
jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken
within the allowable time period) and which claim has not been



7.









 




disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination
or disclaimer or otherwise; and (b) a claim of a pending patent application included within the
Spectrum Patents.




ARTICLE 2




LICENSES AND EXCLUSIVITY



     2.1 License to NK under Spectrum Technology.



          (a) License.




               (i) Subject to the terms of this Agreement, Spectrum hereby grants NK: (A) an exclusive,
royalty-bearing license, with the right to grant sublicenses at one or more tier(s) subject to
Section 2.1(c) below, under the Spectrum Technology, to research, Develop, use, sell, offer for
sale, have sold, import and otherwise Commercialize the Products in the Field in the NK Territory;
and (B) a non-exclusive license under the Spectrum Technology to make and have made the Products in
the NK Territory and have made the Products in the Retained Territory, solely for use or sale of
such Products pursuant to Section 2.1(a)(i)(A).



               (ii) The Parties acknowledge that Spectrum is actively seeking a licensee for the Product in
South Korea (such licensee, the “Korean Partner”). Spectrum hereby grants to NK a co-exclusive
license (with such Korean Partner) under the Spectrum Technology to conduct clinical Development
activities (but not seek Regulatory Approval) in South Korea with respect to the Products solely to
support NK’s or its sublicensees’ Regulatory Filings in the NK Territory. Promptly after the
Effective Date or the execution of a license agreement between Spectrum and such Korean Partner
granting such Korean Partner the right to develop and commercialize the Products in Korea,
whichever is later, NK shall discuss in good faith with such Korean Partner to coordinate the
Development activities for the Products in South Korea. Further, the Parties acknowledge that in
order to facilitate the Regulatory Filings in the NK Territory, it is essential for NK to conduct
clinical Development in South Korea and, therefore, the Parties agree that, in the event such
license agreement between Spectrum and such Korean Partner is not executed by the expiration of a
period of [***] after the Effective Date: (A) North Korea and South Korea shall be included in the
NK Territory hereunder; (B) South Korea shall be included as an additional Major Market hereunder;
and (C) NK shall deliver to Spectrum a payment in the amount of $[***] as a consideration for such
inclusion.



          (b) Spectrum Retained Rights.




               (i) Notwithstanding the licenses granted to NK under Section 2.1, Spectrum retains the right
to practice the Spectrum Technology in the NK Territory to fulfill its obligations under this
Agreement.



               (ii) Subject to Section 2.5 below, Spectrum retains the right to practice and license the
Spectrum Technology outside the scope of the license granted to NK in Section 2.1(a)(i) above,
including to develop and commercialize in the NK Territory any formulation





 




			
	[***]:	 	CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




8.









 









including Apaziquone that is not a Product.




          (c) Sublicenses.




               (i) NK shall have the right to grant sublicenses under the license in Section 2.1(a) to its
Affiliates or other Third Parties only with the prior written consent from Spectrum, such consent
not to be unreasonably withheld or delayed for the grant of sublicenses in countries and
territories in the NK Territory outside Japan. NK shall remain primarily responsible for the
performance of its Affiliates’ and sublicensees’ obligations set forth herein by each of its
Affiliates and sublicensees.



               (ii) NK shall, within thirty (30) days after granting any sublicense under Section 2.1(a)
above, notify Spectrum of the grant of such sublicense and provide Spectrum with a true and
complete copy of such sublicense agreement. Each sublicense agreement shall not conflict with the
terms and conditions under this Agreement. For clarity, NK may determine the terms and conditions
of such sublicense agreement at its sole discretion so long as they do not conflict with the terms
and conditions of this Agreement. NK shall, in each agreement under which it grants a sublicense
under the license set forth in Section 2.1(a) (each, a “Sublicense Agreement“), include the
following terms and conditions: (i) the sublicensee is required to carry out such tasks to ensure
that NK will comply with its obligations to Spectrum hereunder, to, among other things, allow
Spectrum to comply with its obligations to Allergan under the Allergan Agreement, including by
providing all Product-related Information to NK so that NK may comply with its obligations under
Section 5.5; (ii) the sublicensee is required to provide the following to NK if such Sublicense
Agreement terminates during the term of this Agreement: (A) the assignment and transfer of
ownership and possession of all Regulatory Filings and Regulatory Approvals held or possessed by
such sublicensee, and (B) the assignment of, or a freely sublicenseable exclusive license to, all
intellectual property Controlled by such sublicensee that covers or embodies a Product or its
respective use, manufacture, sale, or importation and was created by or on behalf of such
sublicensee during the exercise of its rights or fulfillment of its obligations pursuant to such
Sublicense Agreement; and (iii) if this Agreement terminates pursuant to Section 13.2 prior to the
expiration of the Term, then Spectrum may, at its sole discretion: (C) assume NK’s rights and
obligations under such Sublicense Agreement; or (D) terminate such Sublicense Agreement. Each
Sublicense Agreement shall include the sublicensees’ obligations set forth herein.



               (iii) NK shall pay to Spectrum [***] percent ([***]%) of all Sublicense Revenues within [***]
after the receipt of each payment of the Sublicense Revenue from each sublicensee. “Sublicense
Revenue” means all upfront payments and milestone payments made by any sublicensee to NK under any
Sublicense Agreement. For the avoidance of doubt, Sublicense Revenue shall not include: (A) any
sales-based royalty payment; (B) any payment in exchange for the fair market value for actual
services performed by or on behalf of NK to such sublicensee or the fair market value for the
supply of Products by NK to such sublicensee; and (C) any payment in exchange for the fair market
value of NK’s equity.



     2.2 License to Spectrum. NK hereby grants Spectrum: (a) a non-exclusive, fully-





 




			
	[***]:	 	CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




9.









 









paid, royalty free license, with the right to grant sublicenses, under the NK Technology to
perform Spectrum’s obligations under this Agreement; (b) an exclusive license, with the right to
grant sublicenses, under the NK Technology to research, Develop, make, have made, use, sell, offer
for sale and import products containing Apaziquone (including Products) for all fields of use in
the Retained Territory and outside the Field in the NK Territory; provided, however, that NK may
use or have used the NK Technology when NK has made the Product in the Retained Territory pursuant
to Section 2.1(a)(i)(B) and NK conducts the clinical Development in South Korea pursuant to Section
2.1(a)(ii); further provided that such license shall be royalty-free with respect to NK Know-How
and shall be royalty-bearing with respect to NK Patents (with reasonable royalty rates to be agreed
upon by the Parties through good faith negotiations upon Spectrum’s request prior to Spectrum’s
utilization of such NK Patents); and (c) an exclusive option to obtain an exclusive,
royalty-bearing license, (with reasonable royalty rates to be agreed upon by the Parties through
good faith negotiations upon Spectrum’s request prior to Spectrum’s utilization of the Joint
Patents), with the right to grant sublicenses, under NK’s interest in the Joint Patents to
research, Develop, make, have made, use, sell, offer for sale and import products containing
Apaziquone (including Products) for all fields of use in the Retained Territory and outside the
Field in the NK Territory; provided, however, that NK may use or have used such Joint Patents when
NK has made the Product in the Retained Territory pursuant to Section 2.1(a)(i)(B) and NK conducts
the clinical Development in South Korea pursuant to Section 2.1(a)(ii).




     2.3 Negative Covenant; No Implied License. NK covenants that it will not, and it will not
permit any of its Affiliates to, use or practice any Spectrum Technology outside the scope of the
license granted to it under Section 2.1 above. Spectrum covenants that it will not, and it will
not permit any of its Affiliates to, use or practice any NK Technology outside the scope of the
license granted to it under Section 2.2. Except as set forth herein, neither Party shall acquire
any license or other intellectual property interest, by implication or otherwise, under any
trademarks, patents or patent applications owned or Controlled by the other Party.



     2.4 Diversion.



          (a) NK hereby covenants and agrees that it will not, and will ensure that its Affiliates,
sublicensees and subcontractors will not, either directly or indirectly, promote, market,
distribute, import, sell or have sold Products, including via the Internet or mail order, to any
Third Party, address or Internet Protocol (“IP”) address in the Retained Territory. As to such
countries in the Retained Territory: (i) NK shall refrain from establishing or maintaining any
branch, warehouse or distribution facility for the Product in such countries; (ii) NK shall not
engage in any advertising or promotional activities relating to the Product directed primarily to
customers or other buyers or users of the Product located in such countries; and (iii) NK shall not
solicit orders from any prospective purchaser located in such countries. If NK receives any order
from a prospective purchaser located in a country in the Retained Territory, NK shall immediately
refer that order to Spectrum. NK shall not accept any such orders. NK may not deliver or tender
(or cause to be delivered or tendered) any Product outside of the NK Territory.




          (b) If any of NK’s Product is diverted for use in the Retained Territory, the following shall
apply: (i) if such Product were diverted by an identifiable customer, distributor, employee,
consultant or agent of NK then, upon the request of Spectrum, NK shall not sell such






10.









 







category of Product to, or allow the sale of such category of Product by, any such customer,
distributor, employee, consultant or agent for the remaining Term and shall use commercially
reasonable efforts to buy back all such Product from such customer, distributor, employee,
consultant or agent within seven (7) business days of receiving such request from Spectrum; or (ii)
NK shall use commercially reasonable efforts to investigate the location of such diverted Product
and buy it back; but, if and to the extent that, NK elects not to, or is unable to, buy back the
applicable diverted Product, then Spectrum may, in its sole discretion, buy back the applicable
diverted Product and NK shall reimburse Spectrum for all reasonable costs incurred by Spectrum in
connection with the buy-back of any such diverted Product.




          (c) If any formulation containing Apaziquone sold by NK, its Affiliates or sublicensees (the
“NK Product”) is used in the Retained Territory, NK shall pay to Spectrum an amount equal to the
amount Spectrum is obligated to pay to Allergan as a result of such sales.




     2.5 Exclusivity. For the period commencing on the Effective Date and ending ten (10) years
after the First Commercial Sale of a Product in the Field in the NK Territory: (a) neither Party or
its Affiliates will, either by itself or through the grant of licenses or sublicenses, without the
other Party’s written consent, commercialize any formulation that includes Apaziquone in the Field
in the NK Territory except under this Agreement; and (b) NK will not, and will ensure that its
Affiliates will not, either by itself or through the grant of licenses or sublicenses: (i)
commercialize any formulation that includes Apaziquone outside the Field in the NK Territory; (ii)
develop or commercialize any formulation that includes Apaziquone for any field of use in the
Retained Territory (except having made the Product in the Retained Territory pursuant to Section
2.1(a)(i)(B)), to the extent such obligation is not in conflict with applicable antitrust Laws in
Japan; or (iii) commercialize another low-molecular intravesical therapeutic agent for the
treatment of non-muscle invasive bladder cancer in the NK Territory, except: (A) those which have
already been commercialized by NK before the Effective Date; and (B) doxorubicin. This Section 2.5
shall not be construed as expanding the scope of license granted to either Party under this Article
2 in any manner.



     2.6 Registration of License. NK shall have the right to record or register the licenses
granted hereunder, and allow its sublicensees to record or register the sublicenses granted under
the Sublicense Agreement, at any patent office or other relevant authority in the NK Territory.
Spectrum shall execute all documents and give all declarations regarding the licenses or
sublicenses and reasonably cooperate with NK or its sublicensees at the costs of NK or its
sublicensees to the extent such documents, declarations and/or cooperation are required for such
record or registration of the licenses or sublicenses for the benefit of NK or its sublicensees.



     2.7 Disclosure of Spectrum Know-How. Spectrum shall, as soon as practicable after the
Effective Date but in no event later than six (6) months after the Effective Date, and from time to
time thereafter during the Term, disclose to NK all Spectrum Know-How material or necessary for the
Development and Commercialization of the Product that are set forth on Exhibit D attached hereto.



11.









 





ARTICLE 3




OVERVIEW; MANAGEMENT



     3.1 Alliance Managers. Within thirty (30) days following the Effective Date, each Party will
appoint (and notify the other Party of the identity of) a representative having the appropriate
qualifications including a general understanding of pharmaceutical Development and
Commercialization issues to act as its alliance manager under this Agreement (“Alliance Manager”).
The Alliance Managers will serve as the primary contact points between the Parties for the purpose
of providing each Party with information on the progress of the other Party’s Development and
Commercialization of the Product(s). The Alliance Managers will also be primarily responsible for
facilitating the flow of information and otherwise promoting communication, coordination and
collaboration between the Parties, providing single point communication for seeking consensus both
internally within each Party’s respective organization, including facilitating review of external
corporate communications, and raising cross-Party and/or cross-functional disputes in a timely
manner. Each Party may replace its Alliance Manager on written notice to the other Party.



     3.2 Joint Product Team.



          (a) Formation. Within thirty (30) days after the Effective Date, the Parties will establish a
joint product team (the “Joint Product Team” or “JPT”) to plan, administer, evaluate and carry out
all aspects of the Development, manufacture, regulatory and Commercialization activities by NK or
its Affiliates hereunder with respect to the Products.




          (b) Members. The JPT will primarily consist of the internal product team of NK for the
Products, include members from various NK functional groups (e.g., research, preclinical, safety,
clinical, regulatory, marketing, manufacturing, as appropriate) which are or which will be expected
to be involved in Developing, manufacturing and/or Commercialization of the Product and obtaining
Regulatory Approval for the Product. Spectrum shall have the right (but not the obligation) to
have its representatives on the JPT who will from time to time represent some or all of the
following functional groups of Spectrum: clinical development, regulatory, medical affairs,
pharmacovigilance, commercial and manufacturing. NK will appoint a chair of the JPT.




          (c) Meetings. NK shall schedule the half-yearly JPT meetings and shall inform Spectrum of
such schedule at least quarterly in advance. Spectrum shall inform NK as to whether it will
participate in each of such JPT meetings reasonably in advance. Either Party may call additional
ad hoc meetings of the JPT as the needs arise with reasonable advance notice to the other Party,
and such ad hoc meetings shall be conducted at times that are mutually agreed upon by the Parties,
if Spectrum chooses to participate in such meeting. No later than five (5) business days prior to
any regularly scheduled meeting of the JPT, the chairperson of the JPT shall prepare and circulate
an agenda for such meeting and, as soon as practicable, all materials, documents and information
for the meeting for distribution to both Parties (in the case of Spectrum, even in the event
Spectrum chooses not to participate in such meeting); provided, however, that either Party may
propose additional topics to be included on such agenda, either prior to or in the course of such
meeting. The JPT may meet in person, by videoconference or by






12.









 







teleconference. The chairperson of the JPT will be responsible for preparing reasonably
detailed written minutes of all JPT meetings that reflect, without limitation, material decisions
made at such meetings. The JPT chairperson shall send draft meeting minutes to the NK members and
the Spectrum members of the JPT (regardless of whether Spectrum chooses to participate in such
meeting) for review and approval within ten (10) business days after each JPT meeting. Such
minutes will be deemed approved unless one or more members of the JPT objects to the accuracy of
such minutes within ten (10) business days of receipt. Further, upon NK’s request, Spectrum will
use commercially reasonable efforts to coordinate any meeting among Spectrum, Allergan and NK for
the exchange of information helpful for the Development of the Product. In addition to the
regularly scheduled meetings, NK shall call additional ad hoc meetings of the JPT prior to making
any major decisions in the Development of the Product in the NK Territory, including without
limitation the decisions set forth in Sections 3.2(d)(A) through (F) below. The Parties shall also
maintain regular, frequent and informal communications for Spectrum to obtain updates from NK and
for the Parties to discuss the progress of the Development of the Product in the NK Territory.




          (d) JPT Actions. The JPT shall strive to seek consensus in its actions and decision making
process. In the event of a disagreement between the Spectrum members and NK members of the JPT,
either Party may refer the matter to one senior executive of each Party (i.e., the Chief Executive
Officer or Managing Director of such Party or an executive of such Party who reports directly to
the Chief Executive Officer or Managing Director) for resolution. If such senior executives cannot
resolve the matter within ten (10) business days, then such senior executive of NK shall have the
final decision making authority on such matter, provided that any final determination made by such
senior executive of NK shall be consistent with the terms of this Agreement, further provided that
NK shall not make any decision with respect to the following critical issues without the consent of
Spectrum, such consent not to be unreasonably withheld or delayed: (A) discontinue the Development
of any Product; (B) initiate or discontinue any clinical trial; (C) modify the TPP of the Product
under Development; (D) unreasonably delay the process of or cease to seek Regulatory
Approval for any Product; (E) unreasonably delay or cancel the commercial launch of any Product;
and (F) remove any Product from the market, other than for safety reasons.




     3.3 Costs of Governance. The Parties agree that the costs incurred by each Party in
connection with its participation at any meetings under this Article 3 shall be borne solely by
such Party.



     3.4 Discontinuation of Participation in the JPT. Spectrum shall have the right, at any time
during the Term and in its sole discretion, to provide NK with written notice of its intention to
no longer participate in the JPT. Once Spectrum has provided such written notice to NK, NK shall
continue with the JPT structure with NK members only, and all decisions formerly made within or by
the JPT shall be determined by NK, consistent with the principles set forth in Sections 3.2(d). NK
will continue to provide Spectrum with Information provided to its members at such JPT meetings.



13.









 





ARTICLE 4




PRODUCT DEVELOPMENT



     4.1 Overview of Product Development. The Parties desire and intend to collaborate with
respect to the clinical development of the Product by or for NK or its Affiliates or sublicensees
in the NK Territory in the Field (including the clinical Development pursuant to Section
2.1(a)(ii)), with the oversight by the JPT, as and to the extent set forth in this Agreement. As
described in more detail in this Article 4, NK shall be solely responsible for the conduct of NK
Development Plan of the Product by or for NK or its Affiliates and for the overseeing of the
conduct of the Sublicensee Development Plan by its sublicensees, in order to obtain Regulatory
Approval for the Product in the NK Territory (including the clinical Development pursuant to
Section 2.1(a)(ii)). Spectrum will provide assistance to NK in an advisory role through the JPT.
The Parties agree that NK will seek the approval from the Regulatory Authority in Japan for the
final form of a Product to be used in clinical trials to be conducted to support Regulatory Filings
in Japan, and NK agrees to use the Product in such final form in connection with NK’s Development
activities in clinical trials conducted by or on behalf of NK to support Regulatory Filing
throughout the NK Territory. The Parties anticipate that NK will initially seek Regulatory
Approval for the Product in Closed-System Packaging.



     4.2 Development Plan.



          (a) General. As of the Effective Date, the Parties have agreed upon a development plan for
the Development of the Product in Japan, and such development plan is attached to this Agreement as
Exhibit E (the “NK Development Plan”). The NK Development Plan includes all clinical studies to be
performed for the Immediate Instillation Indication(s) and Multiple Instillation Indication(s),
including those that are required for Regulatory Approval for such indications for the Product(s)
in Japan. The development plan for the Development of the Product in the NK Territory other than
Japan will be, in accordance with Section 4.2(b): (i) prepared by NK to the extent such Development
activities are to be conducted by NK or its Affiliates, and such development plan shall be
incorporated into the NK Development Plan; and (ii) prepared with the input of sublicensees of NK
or its Affiliates to the extent such Development activities are to be conducted by such
sublicensees, and such development plan shall be deemed the “Sublicensee Development Plan”. The NK
Development Plan and the Sublicensee Development Plan are referred to collectively as the
“Development Plan” hereunder. The NK Development Plan and the Sublicensee Development Plan will
also set forth timelines regarding the activities set forth thereunder, respectively. The NK
Development Plan and Sublicensee Development Plan shall also each specify the plans and timeline
for preparing the necessary Regulatory Filings and for obtaining Regulatory Approval for such
Immediate Instillation Indication and such Multiple Instillation Indication in the respective
territories. NK shall conduct the Development activities in accordance with the then-current NK
Development Plan (including the timelines set forth therein) and under the direction of the JPT,
and NK shall oversee the Development activities in accordance with the then-current Sublicensee
Development Plan (including the timelines set forth therein) and under the oversight of the JPT.




          (b) Updates to Development Plan. From time to time during the Term, the JPT shall update and
amend (with input from the applicable sublicensees with respect to any






14.









 







Sublicensee Development Plan), as appropriate, the then-current Development Plan and submit
such updated or amended Development Plan for the Parties’ approval, such approval not to be
unreasonably withheld or delayed. Once approved by the Parties, each updated or amended
Development Plan shall become effective and supersede the previous Development Plan as of the date
of such approval.




4.3 NK Development Activities




          (a) NK shall Develop the Product and seek Regulatory Approval in each of the Immediate
Instillation Indication and the Multiple Instillation Indication in Japan, by timely and diligently
conducting all Development activities under the NK Development Plan (the “NK Development
Activities”). With respect to each of the Major Markets other than Japan, NK shall (i) Develop the
Product and seek Regulatory Approval in each of the Immediate Instillation Indication and the
Multiple Instillation Indication, or (ii) grant sublicenses to do so under Section 2.1(c), in
accordance with Section 4.3(c).




          (b) The status, progress and results of the Development activities in the NK Territory shall
be discussed at meetings of the JPT, and NK shall provide the JPT with a written report on the
status and progress of such Development activities on a half-yearly basis at least five (5)
business days prior to each scheduled JPT meeting. In addition, NK shall make available to
Spectrum such information about such Development activities as may be reasonably requested by
Spectrum from time to time.




          (c) NK shall: (i) in Japan, carry out the NK Development Activities in accordance with the NK
Development Plan; (ii) in mainland China, (A) grant a sublicense in accordance with Section 2.1(c)
to a sublicensee who will undertake to initiate activities under the applicable Sublicensee
Development Plan within [***] after the Effective Date or (B) initiate activities under the NK
Development Plan within [***] after the Effective Date; and (iii) in every country that is a Major
Market other than Japan and mainland China, initiate activities under the applicable Development
Plan within [***] after the first Regulatory Approval for the Product in the U.S., provided that,
NK may fulfill such obligation under this subsection (iii) within such timeframe in each such
country through a sublicensee pursuant to Section 2.1(c) if such sublicensee agrees to carry out
development activities pursuant to the applicable Sublicensee Development Plan. In the event NK
does not fulfill the foregoing obligation as set forth above within a particular country in the NK
Territory other than Japan, Spectrum may remove such country from the NK Territory by giving NK a
written notice to that effect. Notwithstanding anything to the contrary in this Agreement, in all
countries in the NK Territory other than Japan, Spectrum shall have no other remedy in respect of
the NK’s failure to fulfill the foregoing obligation, and for such NK’s failure NK’s sole liability
and the sole remedy of Spectrum shall be such removal of such country from the NK Territory.




     4.4 Compliance.



          (a) NK agrees that in performing its obligations under this Agreement: (i) it shall comply
with all applicable Laws; and (ii) it will not employ or engage any person who has






 




			
	[***]:	 	CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




15.









 









been debarred by any Regulatory Authority, or, to such Party’s knowledge, is the subject of
debarment proceedings by a Regulatory Authority. NK shall have the right to engage subcontractors
for the performance of its obligations under the Development Plan. NK remains responsible for the
performance of such subcontractor(s) and the engagement of such subcontractors shall not relieve NK
from its obligations to comply with the terms and conditions of this Agreement.




          (b) NK shall maintain complete, current and accurate records of all work conducted by it under
the NK Development Plan, and all data and other Information resulting from such work. NK shall
cause the sublicensees to maintain complete, current and accurate records of all work conducted by
such sublicensees under the applicable Sublicensee Development Plan, and all data and other
Information resulting from such work. Such records shall fully and properly reflect all work done
and results achieved in the performance of the Development activities in good scientific manner
appropriate for regulatory purposes. Spectrum shall have the right to review all records
maintained by NK or such sublicensees at reasonable times, upon Spectrum’s written request.




          (c) NK shall document all preclinical studies and clinical trials conducted by or for it in
written study reports and shall provide Spectrum with a summary of each such report in English
promptly after its completion.




     4.5 Development Costs. As between the Parties, NK shall bear all Development Costs for the
Development: (a) conducted by or for NK and incurred by NK; or (b) conducted by Spectrum for NK at
the written request of or with the written consent of NK and incurred by Spectrum, in each case
after the Effective Date in connection with the research, manufacture and Development (including
development of manufacturing processes for the Products and other matters relating to the
chemistry, manufacture and controls of the Products) of the Products in accordance with the
Development Plan or the other provisions of this Agreement, as well as any other research,
manufacture and development of the Products by NK.



ARTICLE 5




REGULATORY MATTERS



     5.1 NK Regulatory Responsibilities.



          (a) NK shall own all Regulatory Filings and Regulatory Approvals for the Products in Japan,
and shall be solely responsible for preparing any and all Regulatory Filings for the Product in
Japan at its sole expense in accordance with the NK Development Plan, with the direction of the JPT
and subject to the terms of this Article 5. With respect to the countries in the NK Territory other
than Japan, the relevant Regulatory Filings and Regulatory Approvals for the Products shall be
owned by NK or NK’s sublicensees, and NK may delegate to its sublicensees the responsibility for
preparing any and all Regulatory Filings for the Product subject to the terms of this Article 5,
subject to Section 2.1(c), at the expense of NK or such sublicensees in accordance with the
Sublicensee Development Plan. Spectrum shall assist NK or






16.









 







its sublicensees as they may reasonably request in connection with the preparation and filing
of such Regulatory Filings, at NK’s or its sublicensees’ reasonable request and expense;




          (b) NK shall keep Spectrum informed of regulatory developments specific to Products throughout
the NK Territory, and Spectrum shall have the right to contribute to the regulatory plans and
strategies for the Products in the NK Territory;




          (c) NK shall, and shall ensure that its sublicensees will, lead discussions with any
Regulatory Authority related to any Development of any Products. NK will, and will cause its
sublicensees to, inform Spectrum of any such discussions in advance to the extent practicable, and
NK will, and will ensure that its sublicensees will, reasonably consider any input from Spectrum in
preparation for such discussions;




          (d) NK shall, and shall ensure that its sublicensees will, be responsible to ensure, at its
sole expense, that the Development, manufacture and Commercialization of the Products in the NK
Territory are in compliance with all applicable Laws, including without limitation all rules and
regulations promulgated by any of the Regulatory Authorities in the NK Territory. Specifically and
without limiting the foregoing, NK shall, and shall ensure that its sublicensees will, file all
compliance filings, certificates and safety reporting (subject to Section 5.2(a)) in the NK
Territory at its sole expense;




          (e) to the extent permitted by the applicable Regulatory Authority and as requested by
Spectrum, NK shall, and shall ensure that its sublicensees will, allow representatives of Spectrum
to participate in any scheduled conference calls and meetings between NK or its sublicensees and
the Regulatory Authority in the Major Markets at Spectrum’s expense. If Spectrum elects not to
participate in such calls or meetings, NK shall, and shall ensure that its sublicensees will,
provide Spectrum with written summaries of such calls and meetings in English as soon as
practicable after the conclusion thereof; and




          (f) with respect to all Regulatory Filings, NK shall, and shall ensure that its Affiliates and
sublicensees will: (i) submit only data and information that are free from fraud or material
falsity; (ii) not use bribery or the payment of illegal gratuities in connection with its
Regulatory Filings for the Product; and (iii) submit only data and information that are accurate
and reliable in all material respects for purposes of supporting Regulatory Approval.




     5.2 Adverse Events.



          (a) Within one (1) year prior to the planned first Regulatory Approval of the Product in the
NK Territory, the Parties shall discuss in good faith and enter into a pharmacovigilance and
adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the
Parties with respect to the Product, such as safety data sharing, adverse events reporting and
prescription events monitoring (the “Pharmacovigilance Agreement”). Such Pharmacovigilance
Agreement shall govern the global pharmacovigilance procedures to be agreed upon by NK, Spectrum
and the commercial partners of each Party (including without limitation Allergan and the Korean
Partner).




          (b) Prior to the execution of such Pharmacovigilance Agreement, the Parties agree to
coordinate the pharmacovigilance procedures in connection with the Development of the






17.









 







Products, and NK shall submit to Spectrum all safety information and reporting in a manner
that meets the reporting requirements in the Retained Territory, as outlined in Exhibit F attached.
Each Party shall notify the other Party within twenty-four (24) hours of such Party’s learning of
any Serious Adverse Events (as defined below) that is attributed to or potentially attributable to
the use of the Products. Each Party shall also provide the other Party, on an annual basis and
more frequently as reasonably requested by the other Party, a summary report of Adverse Events (as
defined below), as well as those Serious Adverse Events that are not attributable to the use of the
Products. As used herein, unless defined differently by the FDA, “Adverse Events” means any side
effect, injury, toxicity or sensitivity reaction, or any unexpected incident, and the severity
thereof, whether or not determined to be attributable to any Product, and “Serious Adverse Events”
means an Adverse Event which results in death, is immediately life-threatening, results in
persistent and significant disability/incapacity or requires in-patient hospitalization or
prolongation of existing hospitalization.




          (c) After the execution of the Pharmacovigilance Agreement, the Parties shall comply with the
such Pharmacovigilance Agreement with respect to all aspects of pharmacovigilance activities with
respect to the Products, and Section 5.2(b) above shall be of no further effect.




     5.3 No Harmful Actions. If either Party believes that the other Party, as the case may be, is
taking or intends to take any action with respect to the Product that could reasonably be expected
to have a material adverse impact upon the regulatory status of the Product in the Retained
Territory or the NK Territory, such Party shall have the right to bring the matter to the attention
of the JPT. Without limiting the foregoing, unless the Parties otherwise agree: (a) except as
necessary for the clinical Development in South Korea pursuant to Section 2.1(a)(ii), NK shall not
communicate with any Regulatory Authority having jurisdiction in the Retained Territory, unless so
ordered by such Regulatory Authority, in which case NK shall provide immediately to Spectrum notice
of such order; and (b) NK shall not submit any Regulatory Filings (except as necessary for the
clinical Development in South Korea pursuant to Section 2.1(a)(ii)) or seek Regulatory Approvals
for the Product in the Retained Territory.



     5.4 Notification of Threatened Action. Each Party shall immediately notify the other Party of
any information it receives regarding any threatened or pending action, inspection or communication
by or from any party, including, without limitation, a Regulatory Authority, which may affect the
safety or efficacy claims of the Product or the continued marketing of the Product. Upon receipt
of such information, the Parties shall consult with each other in an effort to arrive at a mutually
acceptable procedure for taking appropriate action.



     5.5 Data Exchange and Use. This Section 5.5 shall not apply to any pharmacovigilance data
(which is addressed in Section 5.2). NK shall, and shall ensure that its sublicensees will,
provide Spectrum with copies of all final submissions and correspondence to and from all Regulatory
Authorities relating to the Product in the Field within seven (7) days of submission or receipt, as
applicable, and shall, and shall ensure that its sublicensees will, provide Spectrum a summary of
each significant submission (such as application for approval for clinical trials, Regulatory
Approval and fast track or orphan drug designation, the protocol for clinical trials and any
modifications thereof) in English as soon as practicable but in any event within ten (10) business
days after such submission. Each Party shall permit the other Party to access, and



18.









 




shall provide the other Party with rights to reference and use in association with the Product
in the Field, all of its, its Affiliates’, and its or their licensees’ and sublicensees’
regulatory, preclinical and clinical data documentation, Regulatory Filings, and Regulatory
Approvals with respect to the Product in the Field.




     5.6 Remedial Actions. Each Party will, and will ensure that its Affiliates and sublicensees
will, notify the other Party immediately, and promptly confirm such notice in writing, if it
obtains information indicating that the Product may be subject to any recall, corrective action or
other regulatory action with respect to a Product taken by virtue of applicable Law in the NK
Territory (a “Remedial Action”). The Parties (or NK’s sublicensees and Spectrum), as the case may
be, will assist each other in gathering and evaluating such information as is necessary to
determine the necessity of conducting a Remedial Action. NK shall, and shall ensure that its
Affiliates and sublicensees will, maintain or have maintained adequate records to permit the
Parties to trace the manufacture of the Product and the distribution and, to the extent feasible,
the use of the Product. In the event NK or its any sublicensee determines that any Remedial Action
with respect to the Product in the Field in the NK Territory should be commenced or Remedial Action
is required by any Regulatory Authority having jurisdiction over the matter, NK will, and will
ensure that its sublicensees will, as the case may be, control and coordinate all efforts necessary
to conduct such Remedial Action. In the event Spectrum determines that any Remedial Action with
respect to the Product outside the Field in the NK Territory should be commenced or Remedial Action
is required by any Regulatory Authority having jurisdiction over the matter, Spectrum will control
and coordinate all efforts necessary to conduct such Remedial Action. For clarity, as between the
Parties, Spectrum shall have sole discretion with respect to any matters relating to any Remedial
Action in the Retained Territory, except the Remedial Action relating to the manufacture of the
Product for NK in the Retained Territory pursuant to Section 2.1(a)(i)(B) or the clinical
Development by NK in South Korea pursuant to Section 2.1(a)(ii). The cost and expense of a
Remedial Action arising from the development, manufacture or commercialization of the Product in
the Field in the NK Territory shall be borne solely by NK or its sublicensees, unless, to the
extent the Product subject to such Remedial Action is supplied by Spectrum to NK, such Remedial
Action is caused by (i) such Product’s non-conformity to specifications at the time such Product is
delivered by Spectrum to NK or any of its Affiliates or sublicensees or (ii) such Product’s
manufacture not in compliance with applicable Laws including applicable Good Manufacturing
Practice.



ARTICLE 6




COMMERCIALIZATION



     6.1 Overview of Commercialization in the NK Territory. NK or its sublicensees will be solely
responsible for all aspects of the Commercialization of the Product in the Field in the NK
Territory, in compliance with all applicable Laws and, in case of Commercialization of the Product
in Japan, in accordance with a commercialization plan to be prepared by NK and approved by both
Parties (such approval not to be unreasonably withheld or delayed) prior to the First Commercial
Sale of the Product in Japan (the “Japan Commercialization Plan”), and in the case of each country
in the NK Territory outside of Japan where NK or any of its Affiliates or sublicensees has received
Regulatory Approval for the Product, in accordance with a commercialization plan to be prepared by
NK and/or such Affiliate or sublicensee, as applicable,



19.









 




and approved by the Parties and any applicable sublicensee (such approval not to be
unreasonably withheld or delayed) prior to the First Commercial Sale of the Product in such country
(such commercialization plans collectively, the “Outside Japan Commercialization Plan”, and
together with the Japan Commercialization Plan, the “Commercialization Plan”). Such
Commercialization Plan shall include the activities and timelines in preparation for the launch of
the Product and after such Product launch in the respective countries, and shall be updated on an
annual basis by NK or its sublicensees subject to the approval of the Parties, such approval not to
be unreasonably withheld or delayed. NK or its sublicensees shall book sales for the Products in
the NK Territory.




     6.2 NK Performance.



          (a) Commercial Diligence. NK shall Commercialize the Product in Japan in accordance with the
Japan Commercialization Plan. NK shall, by itself or through an Affiliate or sublicensee,
Commercialize the Product in other countries and territories in the NK Territory, in accordance
with the applicable Outside Japan Commercialization Plan. Without limiting the foregoing, NK shall
launch the first Product in at least one of the Major Markets (including Japan) within [***] after
obtaining relevant Regulatory Approval to do so, and, with respect to Commercialization in Japan,
after such launch, shall commit at least the same number of sales representatives, the same level
of resources and infrastructure in connection with the Commercialization of such Product as that
are expended by NK and comparable pharmaceutical companies having operations in Japan in connection
with the commercialization of products with similar market potential.




          (b) Reports. NK shall update Spectrum periodically regarding NK’s Commercialization
activities with respect to the Product in the NK Territory. In addition, NK shall present a
written report to Spectrum summarizing NK’s Commercialization activities with respect to the
Product in the NK Territory pursuant to this Agreement to the extent practicable, covering subject
matter at a level of detail reasonably requested by Spectrum and sufficient to enable Spectrum to
determine NK’s compliance with its diligence obligations pursuant to this Section 6.2. NK shall
provide such written reports on a quarterly basis for the Commercialization activities in Japan and
on an annual basis for the Commercialization activities in the other countries and territories in
the NK Territory.




     6.3 Trademark. NK shall have the right to brand the Products using NK related trademarks and
any other trademarks and trade names it determines appropriate for the Products in consultation
with Spectrum, which may vary by country or within a country (“Product Marks”). NK shall own all
rights in the Product Marks and register and maintain the Product Marks in the countries and
regions it determines reasonably necessary. NK shall not, and shall ensure that its Affiliates and
sublicensees will not, make any use of the trademarks assigned by Spectrum to Allergan under the
Allergan Agreement, or any trademark that includes any such trademark or is confusingly similar
thereto, on or in connection with the Commercialization of the Product in the NK Territory.





 




			
	[***]:	 	CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.






20.











 





ARTICLE 7




MANUFACTURING



     7.1 Overview. The Parties recognize that Spectrum manufactures the Products for the Retained
Territory through certain Third Party contract manufacturer(s) as of the Effective Date and may
engage other Third Party contract manufacturers after the Effective Date (collectively, the
“Manufacturers”). The Parties agree that Spectrum assists NK with the manufacture and supply of the
Product for use or sale by NK or its sublicensees in the NK Territory as follows:



          (a) Spectrum shall: (i) procure from Manufacturers and supply to NK all requirements (in
accordance with standard forecast terms) of the Product, in the form used by Spectrum and its
licensees in the Retained Territory at the time of such supply, for use by NK or its sublicensees
in conducting its or their Development activities under the Development Plan in the NK Territory
(including South Korea in case NK needs the Product for clinical Development pursuant to Section
2.1(a)(ii)); and (ii) procure from Manufacturers and supply to NK all requirements (in accordance
with standard forecast terms) of either the Brite Stock or Kitted Product (each as defined below),
pursuant to the Parties’ agreement as set forth below, for commercial sale by NK and its
sublicensees for a period of [***] after the First Commercial Sale (the “Initial Supply Period”) in
the NK Territory, and, subject to Section 7.1(c), for an additional [***] period after the Initial
Supply Period. “Brite Stock” means all components of the Kitted Product, including the drug vials
containing Apaziquone and the diluent vials, for incorporation into the final Kitted Product.
“Kitted Product” means the Brite Stock that has been labeled and packaged in final form ready for
sale. As soon as practicable after the Effective Date but in any event prior to the third
(3rd) anniversary of the Effective Date, the Parties shall discuss in good faith and
agree as to whether Spectrum will supply the Brite Stock or Kitted Product to NK under Section
7.1(a)(ii). If the Parties agree that Spectrum will supply NK with the Brite Stock, then NK or its
sublicensees will be responsible for the labeling and packaging of the Brite Stock into Kitted
Product for Development and commercial sale in the NK Territory, using such Brite Stock supplied by
Spectrum. Spectrum shall supply Brite Stock or Kitted Product to NK under Section 7.1(a) above at
[***] percent ([***]%) of Spectrum’s Cost of Goods Sold for such Products (i.e., if the Cost of
Goods Sold is $100, NK shall pay Spectrum $[***]).




          (b) Notwithstanding Section 7.1(a) above, in the event the form or packaging of the Product
used in the Development of the Product in the NK Territory or commercialized in the NK Territory is
different from the form or packaging of the product used by Spectrum or its commercial partners in
the Retained Territory, then Spectrum’s obligation to supply as set forth above shall apply only
with respect to Apaziquone and the Parties shall discuss in good faith to allocate the
responsibilities for the fill and finish of the Product in such alternative form or packaging.
Spectrum will consult with NK as to the selection of packaging materials for the Product or
materials used in the components of the Product and will take into consideration NK’s comments in
such consultation. For clarity, for the purpose of this Section 7.1(b), so long as the






 




			
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21.









 









components of the Product are same, Brite Stock shall not be deemed to be different from
Kitted Product and vice versa.




          (c) Notwithstanding the provisions of 7.1(a)(ii), in the event, at Spectrum’s reasonable
determination, it is no longer practicable for Spectrum to continue to supply NK with commercial
supply under Section 7.1(a)(ii) after the Initial Supply Period, (for reasons including, but not
limited to, the termination of Spectrum’s agreement with a Manufacturer or Allergan’s assumption of
manufacturing obligations outside of Asia), Spectrum shall inform NK in writing of its desire to
cease such supply at the end of the Initial Supply Period (or anytime thereafter) at least eighteen
(18) months prior to the end of the Initial Supply Period (or at least eighteen (18) months prior
to such later time) and may cease the supply of the Product (Brite Stock or Kitted Product) at the
end of the Initial Supply Period (or such later time). In such event, (1) Spectrum shall ensure
that NK enters into direct supply agreement(s) with Spectrum’s then-current Manufacturer(s) for the
supply of the same Brite Stock or Kitted Product for at least an additional [***] period after the
Initial Supply Period on the terms and conditions similar to those which Spectrum used to be
provided with during the Initial Supply Period, (2) Spectrum shall arrange the supply of such
Product (Brite Stock or Kitted Product) from the then-current Manufacturer(s) to NK until such time
NK has entered into such direct supply agreement(s) with such Manufacturers, so that NK and its
sublicensees are able to continue to sell such Product in the NK Territory without interruption and
(3) NK shall cooperate with Spectrum in such arrangements.




     7.2 Manufacturing Technology Disclosure. As soon as practicable after the Effective Date but
no later than sixty (60) days after the Effective Date in any event, Spectrum shall make available
and transfer copies to NK of the Spectrum Technology that are necessary or reasonably useful in the
manufacture of Product and as of the Effective Date are being used by Spectrum or its Manufacturers
to manufacture Product, as set forth in Exhibit G, including without limitation Drug Master File of
the Product if applicable (the “Spectrum Manufacturing Know-How”). During the Term, Spectrum shall
continue to provide information relating to the chemistry, manufacture and control of the Product,
and NK shall promptly provide Spectrum with its feedback and/or comments to such information
relating to the supply of Product for the NK Territory. During the Initial Supply Period, if NK
desires to assume the responsibility to procure the Product for the NK Territory by itself, NK
shall notify Spectrum in writing, and, upon Spectrum’s agreement, the Parties shall discuss in good
faith with respect to an orderly transfer of such responsibility from Spectrum to NK.



     7.3 Manufacture of Product by Spectrum or its Manufacturer. Spectrum shall manufacture or
procure the manufacture of the Product to be supplied to NK hereunder in accordance with applicable
Good Manufacturing Practice, other applicable Laws and specifications of the Product agreed by the
Parties. If Spectrum or its Manufacturers intend to make a change to (a) manufacturing site of the
Product, (b) manufacturing process of the Product or (c) such specification, Spectrum shall
promptly notify NK of such change and shall provide NK with all information and data obtained by
any tests conducted by or on behalf of Spectrum in respect of any such proposed change for the
purpose of NK or its sublicensees applying for an amendment to any Regulatory Approval of the
Product in the NK Territory which is required





 




			
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22.









 









with respect to such change. Further, Spectrum shall provide NK with test samples manufactured
at the proposed manufacturing site or in accordance with such proposed new process or proposed new
specification for the purpose of NK or its sublicensees applying for such amendment. NK shall use
commercially reasonable best efforts to complete the amendment process with the relevant Regulatory
Authority as quickly as possible, and shall notify Spectrum immediately on receipt by NK of
notification from the relevant Regulatory Authority that such amendment has been completed.
Spectrum shall not supply any Product manufactured with such change until such time as NK or its
sublicensees are notified by the Regulatory Authority that such amendment has been completed. Until
such time as NK or its sublicensees are notified by the Regulatory Authority that such amendment
has been completed, Spectrum shall use commercially reasonable best efforts to continue to supply
NK with the Product manufactured at the current manufacturing site in accordance with the current
process and specifications. Spectrum shall be responsible for and shall bear the costs for (as
part of the Costs of Goods Sold) the delivery of the Product to airport(s) from where such Product
will be exported to NK, where the title to such Product and the risk of loss and damage shall
transfer to NK and NK shall bear the costs of the shipment of such Product thereafter (including
the cost for air transportation).




     7.4 Regulatory Inspections. Each Party shall use good faith efforts to obtain and reveal to
the other Party, all inspection reports for itself, its Affiliates, or for any of its vendors,
suppliers or other Third Parties by any Regulatory Authority arising from an inspection of the
facilities where a Product is manufactured, packaged or stored (a “Facility Inspection”), and the
progress and outcome of any Facility Inspection as it may relate to the Product. Upon receipt of
notice of any Facility Inspection, the receiving Party will promptly notify the other Party thereof
and the receiving Party will provide the other Party with the inspection report and any other
relevant information available about the progress and outcome of such inspection available to the
receiving Party.



     7.5 Audits. Each Party and its duly authorized representatives shall have the right to
inspect all facilities utilized by the other Party or any of its subcontractors (either directly or
with the contracting Party, as permitted in the agreement governing the engagement of such
subcontractor) in connection with the development, manufacture, sale, storage or distribution of
the Product in the NK Territory, upon reasonable prior written notice during normal business hours
to ensure compliance with the terms and conditions of this Agreement, and compliance with industry
standard and applicable Law. For clarity, NK shall have the right to inspect facilities of
Spectrum or its subcontractors where the Product is manufactured or stored for supply to NK and
facilities of the manufacture and storage of Apaziquone which is used for the manufacture of the
Product for NK Territory. All audits shall be without any undue disruption to the business and
operations of the audited Party, and in the case of an inspection involving facilities of a
subcontractor of Spectrum, consistent with the terms under the applicable agreement between
Spectrum and such subcontractor, and the Allergan Agreement to the extent applicable. Any Third
Parties conducting such audits shall enter into confidentiality agreements with the audited Party
in a form suitable to the audited Party, and all information or reports gained by the auditing
Party as a result of such audit shall be deemed Confidential Information of the audited Party. In
the event of a disagreement between the Parties as to the outcome of a particular audit, an
independent, mutually agreed upon arbiter shall be selected by the Parties to resolve the dispute.
The cost of such arbiter shall be borne by the Party whose position is overruled by such arbiter.
Spectrum shall have the right to appoint Allergan as its authorized



23.









 




representative for the purpose of this Section 7.5.




ARTICLE 8




FINANCIAL PROVISIONS



     8.1 Upfront Fee. After the sixtieth (60th) day after the Effective Date and before
the seventy-fifth (75th) day after the Effective Date, NK shall pay to Spectrum a
one-time, non-refundable and non-creditable upfront fee of fifteen million Dollars ($15,000,000).



     8.2 Milestone Payments. NK shall make the following non-refundable and non-creditable
milestone payments to Spectrum within [***] after the first achievement of each milestone event for
a Product as set forth in this Section 8.2 by NK, its Affiliates or sublicensees. Each milestone
payment by NK to Spectrum hereunder shall be payable only once, regardless of the number of times
achieved by the Products, provided that, if more than one sales milestones that are triggered by
annual aggregate Net Sales that have not been previously paid are triggered at the end of any
particular calendar year, then each and every of such sales milestones shall be deemed to have been
achieved upon the end of such calendar year and the corresponding milestone payments triggered by
each and every of such sales milestones shall become due at the end of such calendar year.



	 	 	 
	Milestone Event	 	Milestone Payment
	Regulatory Milestones

	Regulatory Approval of a Product in the United States
for the Immediate Instillation Indication

	 	$[***]
	Regulatory Approval of a Product in the United States
for a Multiple Instillation Indication

	 	$[***]
	First NDA Filing for a Product in Japan

	 	$[***]
	First Regulatory Approval for a Product in Japan

	 	$[***]
	First Regulatory Approval for a Product in the NK 

Territory excluding Japan

	 	$[***]
	Sales Milestones

	The aggregate Net Sales of all Products in Japan during
the Term equal or exceed $[***]

	 	$[***]
	The aggregate Net Sales of all Products in Japan during
the Term equal or exceed $[***]

	 	$[***]
	The aggregate Net Sales of all Products in Japan during
any calendar year equal or exceed $[***]

	 	$[***]






 




			
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24.









 






	 	 	 
	Milestone Event	 	Milestone Payment
	The aggregate Net Sales of all Products in Japan during
any calendar year equal or exceed $[***]

	 	$[***]
	The aggregate Net Sales of all Products in Japan during
any calendar year equal or exceed $[***]

	 	$[***]
	The aggregate Net Sales of all Products in the NK
Territory (excluding Japan) during the Term equal or
exceed $[***]

	 	$[***]
	The aggregate Net Sales of all Products in the NK
Territory (excluding Japan) during the Term equal or
exceed $[***]

	 	$[***]
	The aggregate Net Sales of all Products in the NK
Territory (excluding Japan) during any calendar year
equal or exceed $[***]

	 	$[***]
	The aggregate Net Sales of all Products in the NK
Territory (excluding Japan) during any calendar year
equal or exceed $[***]

	 	$[***]
	The aggregate Net Sales of all Products in the NK
Territory (excluding Japan) during any calendar year
equal or exceed $[***]

	 	$[***]






     8.3 Royalties.



          (a) Royalty Rates. NK shall pay to Spectrum a running royalty at the following royalty rates,
on Net Sales of the Products in all countries of the NK Territory during the Royalty Term.




	 	 	 
	Aggregate Annual Net Sales of all Products in the	 	Royalty Rate Applicable to All
	NK Territory for a Particular Calendar Year	 	Net Sales in such Calendar Year
	For a calendar year in which the
aggregate annual Net Sales
throughout the NK Territory are less
than $[***]

	 	[***]%
	For a calendar year in which the
aggregate annual Net Sales
throughout the NK Territory equal to
or greater than $[***]

	 	[***]%








 




			
	[***]:	 	CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




25.









 










     For clarity, for each calendar year, NK shall initially calculate its royalty payments to
Spectrum and submit such royalty payments at the royalty rate of [***]% until the aggregate annual
Net Sales for all Products throughout the NK Territory reaches $[***]. Thereafter, NK shall
calculate royalty payments to Spectrum and submit such royalty payments at the royalty rate of
[***]%. In addition, NK shall submit to Spectrum a true-up payment at the end of the calendar
quarter during which such aggregate annual Net Sales reaches $[***], in the amount of $[***].



          (b) Royalty Term. The royalty payment obligation under Section 8.3 shall be due, on a
country-by-country basis, during the period of time beginning upon the First Commercial Sale of the
Product in such country, and ending upon the later of (i) the expiration of the last-to-expire
Valid Claim covering the Product sold in such country; (ii) the expiration of Regulatory
Exclusivity covering the Product sold in such country; and (iii) the tenth (10th)
anniversary after the First Commercial Sale of the Product in such country (the “Royalty Term”).




          (c) Royalty Payments and Reports. NK shall deliver to Spectrum a report containing the
following information for the prior calendar quarter: (i) the gross sales associated with each
Product sold by NK, its Affiliates and sublicensees; (ii) a calculation of Net Sales of each
Products that are sold by NK, its Affiliates and (if applicable) sublicensees; and (iii) a
calculation of payments due to Spectrum with respect to the foregoing. NK shall use commercially
reasonable efforts to deliver the foregoing report to Spectrum within thirty-five (35) days after
the end of such calendar quarter, but in any event NK shall provide to Spectrum such report within
forty-five (45) days after the end of such calendar quarter. If, despite commercially reasonable
efforts, NK is unable to provide Spectrum with such report within the foregoing thirty-five (35)
day period, NK shall provide Spectrum with a report containing reasonable estimates of the amounts
described in subsections (i) through (iii) above by the end of such thirty-five (35) day period for
Spectrum to comply with its quarterly reporting obligations. Within sixty (60) days after the end
of each calendar quarter, NK shall remit to Spectrum any payment due for the applicable calendar
quarter. If no royalties are due to Spectrum for such reporting period, the report shall so state.
The method of payment shall be wire transfer to an account specified in writing by Spectrum.




     8.4 Foreign Exchange. The rate of exchange to be used in computing the amount of currency
equivalent in Dollars of Net Sales invoiced in other currencies shall be made at the average of the
closing exchange rates reported in The Wall Street Journal (U.S., Western Edition) over the
applicable reporting period for the payment due.



     8.5 Payment Method; Late Payments. All payments due to Spectrum hereunder shall be made by
wire transfer of immediately available funds into an account designated by Spectrum. If Spectrum
does not receive payment of any sum due to it on or before the due date, simple interest shall
thereafter accrue on the sum due to Spectrum until the date of payment at the per annum rate of
[***] percent ([***]%) over the then-current prime rate reported in The





 




			
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26.









 









Wall Street Journal (U.S., Western Edition) or the maximum rate allowable by applicable Law,
whichever is lower.




     8.6 Records; Audits. NK will, and will assure that its sublicensees will, maintain complete
and accurate records in sufficient detail to permit Spectrum to confirm the accuracy of the
calculation of royalty payments under this Agreement. Upon reasonable prior notice, such records
shall be available during regular business hours for a period of three (3) years from the end of
the calendar year to which they pertain for examination at the expense of Spectrum, and not more
often than once each calendar year, by an independent certified public accountant selected by
Spectrum and reasonably acceptable to NK or its sublicensees, for the sole purpose of verifying the
accuracy of the financial reports furnished by NK pursuant to this Agreement. Any such auditor
shall not disclose to Spectrum NK’s Confidential Information or sublicensees’ confidential
information, except to the extent such disclosure is necessary to verify the accuracy of the
financial reports furnished by NK or the amount of payments due by NK under this Agreement. Any
amounts shown to be owed but unpaid shall be paid within [***] from the receipt by NK of the
accountant’s report, plus interest (as set forth in Section 8.5) from the original due date. If
such audit discloses an underpayment by NK of more than [***] percent ([***]%), then NK shall also
pay to Spectrum a premium equal to [***] percent ([***]%) of such underpayment. Spectrum shall
bear the full cost of such audit unless such audit discloses an underpayment by NK of more than
[***] percent ([***]%) of the amount due, in which case NK shall bear the full cost of such audit.



     8.7 Taxes.



          (a) Taxes on Income. Each Party shall be solely responsible for the payment of all taxes
imposed on its share of income arising under this Agreement or directly or indirectly from the
efforts of the Parties under this Agreement.




          (b) Tax Responsibility. The Parties understand that, in accordance with the applicable Laws
existing as of the Effective Date, none of the payments to be submitted by NK to Spectrum under
Sections 8.1, 8.2 and/or 8.3 shall be subject to any deduction of tax or withholding tax.
Consequently, NK shall submit to Spectrum the upfront fee under Section 8.1 above without any
deduction or withholding. If, after the Effective Date, as a result of any modification to the
applicable Laws, any payment required to be made by NK to Spectrum (other than the upfront fee
under Section 8.1) is subject to a deduction of tax or withholding tax, NK may deduct such tax or
withholding tax.




          (c) Tax Cooperation. The Parties agree to cooperate with one another and use reasonable
efforts to reduce or eliminate tax withholding or similar obligations in respect of royalties,
milestone payments, and other payments made by NK to Spectrum under this Agreement. To the extent
NK is required to deduct and withhold taxes on any payment to Spectrum, NK shall pay the amounts of
such taxes to the proper Governmental Authority in a timely manner and promptly transmit to
Spectrum an official tax certificate or other evidence of such withholding sufficient to enable
Spectrum to claim such payment of taxes. Spectrum shall provide NK any tax forms that may be
reasonably necessary in order for NK to not withhold tax






 




			
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27.









 









or to withhold tax at a reduced rate under an applicable bilateral income tax treaty.
Spectrum shall use reasonable efforts to provide any such tax forms to NK at least thirty (30) days
prior to the due date for any payment for which Spectrum desires that NK applies a reduced
withholding rate. Each Party shall provide the other with reasonable assistance to enable the
recovery, as permitted by applicable law, of withholding taxes, value added taxes, or similar
obligations resulting from payments made under this Agreement, such recovery to be for the benefit
of the Party bearing such withholding tax or value added tax. NK shall require its sublicensees in
the NK Territory to cooperate with Spectrum in a manner consistent with this Section 8.7(c).




ARTICLE 9




INTELLECTUAL PROPERTY



     9.1 Ownership of Inventions. Each Party shall own any inventions made solely by its own
employees, agents, or independent contractors in the course of conducting its activities under this
Agreement, together with all intellectual property rights therein (“Sole Inventions”). The Parties
shall jointly own any inventions that are made jointly by employees, agents, or independent
contractors of each Party in the course of performing activities under this Agreement, together
with all intellectual property rights therein (“Joint Inventions”). Inventorship shall be
determined in accordance with U.S. patent laws. All Patents claiming patentable, jointly owned
Joint Inventions shall be referred to herein as “Joint Patents.” Except to the extent otherwise
set forth in this Agreement, each Party shall be entitled to practice and exploit (including
through the grant of licenses) the Joint Inventions without the duty of accounting or seeking
consent from the other Party.



     9.2 Disclosure of Inventions. Each Party shall promptly disclose to the other Party any
invention disclosures, or other similar documents, submitted to it by its employees, agents or
independent contractors describing inventions that are either Sole Inventions or Joint Inventions.
Further, each Party shall promptly disclose to the other Party all Information relating to Joint
Inventions to the extent necessary for the preparation, filing and maintenance of any Joint Patent
with respect to such Joint Invention.



     9.3 Prosecution of Patents.



          (a) Spectrum Patents.




               (i) Subject to Sections 9.3(a)(ii). 9.3(a)(iii) and 9.3(a)(iv) below, Spectrum shall have the
sole right to prepare, file, prosecute and maintain Spectrum Patents and Joint Patents
(collectively, the “Spectrum Prosecuted Patents”). Spectrum shall provide NK reasonable
opportunity to review and comment on such prosecution efforts regarding such Spectrum Prosecuted
Patents in the NK Territory. Spectrum shall provide NK with a copy of material communications from
any patent authority in the NK Territory regarding such Spectrum Prosecuted Patents, and shall
provide drafts of any material filings or responses to be made to such patent authorities a
reasonable amount of time in advance of submitting such filings or responses for NK’s review and
comment. Spectrum shall reasonably consider such comments by



28.









 




NK in connection with the prosecution of Spectrum Prosecuted Patents.




               (ii) The costs and expenses incurred after the Effective Date by Spectrum in connection with
the preparation, filing, prosecution and maintenance of Spectrum Patents and Joint Patents under
Section 9.3(a)(i) above shall be allocated between the Parties as follows: (A) NK shall reimburse
Spectrum for all out-of-pocket costs incurred by Spectrum in connection with the preparation,
filing, prosecution and maintenance of: (1) the [***] in the [***]; (2) the [***] in [***]; and (3)
the [***], and Spectrum shall bear its internal costs incurred in connection with the activities
set forth in [***]; (B) Spectrum shall bear its own internal and out-of-pocket costs incurred: (1)
in connection with the preparation, filing, prosecution and maintenance of [***] in [***]; and (2)
in connection with the preparation, filing, prosecution and maintenance of [***] in the [***]; and
(C) [***], NK may request that Spectrum prepare, file, prosecute and maintain [***] in such country
provided that NK reimburses Spectrum for all out-of-pocket costs incurred by Spectrum in connection
with such activities. Notwithstanding the foregoing, NK shall have the right to opt out of its
payment obligations for the [***] under [***] by providing Spectrum with written notification
thereof, and NK hereby assigns to Spectrum all of its rights and interests in such [***], effective
upon Spectrum’s receipt of such notification.



               (iii) If Spectrum wishes to cease the prosecution or maintenance of any Spectrum Prosecuted
Patents in the NK Territory, it shall notify NK to that effect in writing, and NK may, at its
discretion, assume the rights to the prosecution or maintenance of such Spectrum Prosecuted
Patents, at NK’s sole expense, by informing Spectrum in writing within sixty (60) days after
receiving such notification from Spectrum. If NK notifies Spectrum of its intention to assume such
rights, Spectrum shall assign to NK all rights and interests in and to such Spectrum Prosecuted
Patents, and NK hereby grants to Spectrum a royalty-free, fully-paid, worldwide, perpetual,
irrevocable, non-exclusive license, with the right to grant sublicenses, under such Spectrum
Prosecuted Patents so assigned to NK for all purposes other than to develop, make, have made, use,
sell, offer for sale or import the Product in the Field in the NK Territory.



               (iv) Spectrum shall not assign or transfer Spectrum’s rights and interests in and to the
Spectrum Technology to any Third Party in conflict with the terms of this Agreement; provided,
however, that Spectrum shall assign and transfer Spectrum’s all rights and interests in and to the
Spectrum Technology to the Third Party when Spectrum assigns or transfers this Agreement to such
Third Party pursuant to Section 15.5.



          (b) NK Patents.




               (i) NK shall have the sole right to prepare, file, prosecute and maintain NK Patents at NK’s
costs and expense.



               (ii) If NK decides to cease the prosecution or maintenance of any NK Patents, it shall notify
Spectrum in writing sufficiently in advance. Spectrum may, at its discretion, assume the rights to
the prosecution or maintenance of such NK Patents, at Spectrum’s sole expense by informing NK in
writing within sixty (60) days after receiving such





 




			
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29.









 









notification from NK, in which event NK shall assign to Spectrum all rights and interests in
and to such NK Patents.




          (c) Cooperation in Prosecution. Each Party shall provide the other Party all reasonable
assistance and cooperation with respect to the assignment of Spectrum Prosecuted Patents by
Spectrum to NK or the assignment of NK Patents by NK to Spectrum pursuant to Sections 9.3(a) or
9.3(b), as the case may be, including providing any documents necessary to complete such
assignments.




     9.4 Infringement of Patents by Third Parties.



          (a) Notification. Each Party shall promptly notify the other Party in writing of any existing
or threatened infringement of the Spectrum Patents through the Development or Commercialization of
a Product in the Field in the NK Territory by a Third Party, of which such Party becomes aware,
including any certification or the like in the NK Territory similar to “patent certification” of 21
U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) and of any declaratory judgment, opposition, or similar
action alleging the invalidity, unenforceability or non-infringement of any of the Spectrum Patents
(collectively “Product Infringement”).




          (b) Product Infringement.




               (i) For any Product Infringement in the Field in the NK Territory, each Party shall share with
the other Party all Information available to it regarding such existing or threatened infringement.
NK shall have the first right, but not the obligation, to bring an appropriate suit or other action
against any person or entity engaged in such Product Infringement, subject to Section 9.4(b)(ii)
through 9.4(b)(iv), below. If NK fails to institute and prosecute an action or proceeding to abate
such Product Infringement within a period of ninety (90) days after the first notice under Section
9.4(a) to elect to enforce such Spectrum Patent or otherwise having knowledge of such Product
Infringement, then Spectrum shall have the right, but not the obligation to, commence a suit or
take action to enforce the applicable Spectrum Patent against such Third Party perpetrating such
Product Infringement in the NK Territory at its own cost and expense. In this case, NK shall take
appropriate actions, if any, in order to enable Spectrum to commence a suit or take the actions set
forth in the preceding sentence.



               (ii) Each Party shall provide to the Party enforcing the Spectrum Patent under this Section
9.4(b) reasonable assistance in such enforcement, at such enforcing Party’s request and expense,
including joining such action as a party plaintiff if required by applicable Law to pursue such
action. The enforcing Party shall keep the other Party regularly informed of the status and
progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any
such efforts, and shall seek consent of the other Party in any important aspects of such
enforcement including, without limitation, determination of litigation strategy, filing of
important papers to the competent court, which shall not be unreasonably withheld or delayed.



               (iii) Each Party shall bear all of its own internal costs incurred in connection with its
activities under this Section 9.4(b). In the event NK commences a Product Infringement action, it
shall bear all external costs and expenses for such action. In the event



30.









 




that Spectrum commences a Product Infringement action, it shall bear all external costs and
expenses for such action.




               (iv) The Party not bringing an action with respect to Product Infringement under this Section
9.4(b) shall be entitled to separate representation in such matter by counsel of its own choice and
at its own expense, but such Party shall at all times cooperate fully with the Party bringing such
action.



          (c) Infringement Other Than a Product Infringement. For any and all infringement of any
Spectrum Patent other than a Product Infringement in the Field in the NK Territory, as between the
Parties, Spectrum shall have the sole and exclusive right to bring an appropriate suit or other
action against any person or entity engaged in such other infringement, in its sole discretion, and
as between the Parties shall bear all related expenses and retain all related recoveries.




          (d) Settlement. NK shall not settle any claim, suit or action that it brought under this
Section 9.4 involving Spectrum Patents in any manner that would negatively impact such Spectrum
Patents or that would limit or restrict the ability of Spectrum to Develop, make, import, use,
offer for sale, sell or otherwise Commercialize Products anywhere in the Retained Territory or to
make or have made Product anywhere in the world for such Development, use, sale or import anywhere
in the Retained Territory, without the prior written consent of Spectrum, which consent shall not
be unreasonably withheld or delayed. Nothing in this Article 9 shall require Spectrum to consent
to any settlement that is reasonably anticipated by Spectrum to have a substantially adverse impact
upon any Spectrum Patent in the Retained Territory, or to the commercialization, manufacture, use,
importation, offer for sale or sale of the Product in the Retained Territory.




          (e) Allocation of Recoveries. [***].




     9.5 Infringement of Third Party Rights in the NK Territory. If any Product used or sold by
NK, its Affiliates or sublicensees becomes the subject of a Third Party’s claim or assertion of
infringement of a Patent granted by a jurisdiction within the NK Territory, NK shall promptly
notify Spectrum thereof and [***].





 




			
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31.









 










ARTICLE 10




REPRESENTATIONS AND WARRANTIES



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



          (a) Corporate Existence and Power. It is a company or corporation duly organized, validly
existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and
has full corporate power and authority and the legal right to own and operate its property and
assets and to carry on its business as it is now being conducted and as contemplated in this
Agreement, including, without limitation, the right to grant the licenses granted by it hereunder.




          (b) Authority and Binding Agreement. As of the Effective Date, (i) it has the corporate power
and authority and the legal right to enter into this Agreement and perform its obligations
hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the
execution and delivery of this Agreement and the performance of its obligations hereunder; and
(iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes
a legal, valid, and binding obligation of such Party that is enforceable against it in accordance
with its terms.




          (c) No Conflict; Covenant. It is not a party to any agreement that would materially prevent
it from granting the rights granted to the other Party under this Agreement or performing its
obligations under this Agreement.




          (d) No Debarment. In the course of the development of Products, each Party shall not use,
during the Term, any employee or consultant who has been debarred by any Regulatory Authority, or,
to the best of such Party’s knowledge, is the subject of debarment proceedings by a Regulatory
Authority.




     10.2 Additional Representations and Warranties of Spectrum. Spectrum represents and warrants
to NK that, as of the Effective Date:



          (a) it has the right under the Spectrum Technology to grant the licenses to NK as purported to
be granted pursuant to this Agreement;




          (b) as of the Effective Date, Spectrum or its licensee has not received any written notice
from any Third Party asserting or alleging that any research or development of any Product by
Spectrum or its licensee prior to the Effective Date infringed or misappropriated the intellectual
property rights of such Third Party; and




          (c) there are no actual, pending, alleged or threatened adverse actions, suits, claims,
interferences or formal governmental investigations involving the Product and/or the Spectrum
Technology relating to the Product by or against Spectrum or any of its Affiliates or licensees in
or before any court, governmental or regulatory authority.







32.









 








     10.3 Disclaimer. NK understands that the Products are the subject of ongoing clinical
research and development and that Spectrum cannot assure the safety or efficacy of the Products.
In addition, Spectrum makes no warranties except as set forth in this Article 10 concerning the
Spectrum Technology.



     10.4 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS
AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, IS MADE OR
GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES OTHER THAN THOSE EXPRESSLY
STATED IN THIS AGREEMENT, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY
EXCLUDED.



ARTICLE 11




INDEMNIFICATION



     11.1 Indemnification by Spectrum. Spectrum hereby agrees to defend, hold harmless and
indemnify (collectively “Indemnify”) NK and its Affiliates, sublicensees, agents, directors,
officers and employees (the “NK Indemnitees”) from and against any and all liabilities, expenses
and/or losses, including without limitation reasonable legal expenses and attorneys’ fees
(collectively “Losses”) in each case resulting from Third Party suits, claims, actions and demands
(each, a “Third Party Claim”) arising directly or indirectly out of (a) a breach of any of
Spectrum’s obligations under this Agreement, including without limitation Spectrum’s
representations and warranties or covenants set forth in Article 10, or (b) the negligence or
willful misconduct of any Spectrum Indemnitee. Spectrum’s obligation to Indemnify the NK
Indemnitees pursuant to this Section 11.1 shall not apply to the extent that any such Losses arise
from: (A) the negligence or willful misconduct of any NK Indemnitees; (B) the research, Development
or Commercialization of Products by NK or its Affiliates, or sublicensees in the NK Territory
without negligence or willful misconduct of any Spectrum Indemnitee and Spectrum’s breach of this
Agreement; or (C) NK’s breach of this Agreement.



     11.2 Indemnification by NK. NK hereby agrees to Indemnify Spectrum and its Affiliates,
licensees, agents, directors, officers and employees (the “Spectrum Indemnitees”) from and against
any and all Losses resulting from Third Party Claims arising directly or indirectly out of (a) a
breach of any obligations of NK under this Agreement, including without limitation NK’s
representations and warranties or covenants set forth in Article 10; (b) the research, Development,
manufacture or Commercialization of Products by NK or its Affiliates or sublicensees in the NK
Territory (including any activities undertaken by Spectrum under this Agreement at the direction of
or on behalf of NK); or (c) the negligence or willful misconduct of NK Indemnitees. NK’s
obligation to Indemnify the Spectrum Indemnitees pursuant to the foregoing sentence shall not apply
to the extent that any such Losses arise from: (A) the negligence or willful misconduct of any
Spectrum Indemnitees; or (B) Spectrum’s breach of this Agreement.




33.











 





     11.3 Procedure. The indemnified Party shall provide the indemnifying Party with prompt
notice of the claim giving rise to the indemnification obligation pursuant to this Article 11 and
the exclusive ability to defend (with the reasonable cooperation of the indemnified Party) or
settle any such claim; provided, however, that the indemnifying Party shall not enter into any
settlement for damages other than monetary damages without the indemnified Party’s written consent,
such consent not to be unreasonably withheld. The indemnified Party shall have the right to
participate, at its own expense and with counsel of its choice, in the defense of any claim or suit
that has been assumed by the indemnifying Party. If the Parties cannot agree as to the application
of Sections 11.1 and 11.2 to any particular Third Party Claim, the Parties may conduct separate
defenses of such Third Party Claim. Each Party reserves the right to claim indemnity from the
other in accordance with Sections 11.1 and 11.2 above upon resolution of the underlying claim,
notwithstanding the provisions of this Section 11.3 requiring the indemnified Party to tender to
the indemnifying Party the exclusive ability to defend such claim or suit.



     11.4 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL,
INCIDENTAL, PUNITIVE, INDIRECT, OR CONSEQUENTIAL DAMAGES OR LOSS OF PROFITS ARISING FROM OR
RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH
DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR SHALL LIMIT
OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 OR 11.2, OR
DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 12, PROVIDED THAT
A PARTY’S LIABILITY TO THE OTHER PARTY UNDER THIS SENTENCE SHALL NOT EXCEED $10,000,000, EXCEPT
WHEN SUCH LIABILITY ARISES FROM SUCH PARTY’S INTENTIONAL BREACH OF, OR WILLFUL MISCONDUCT
REGARDING, ITS OBLIGATIONS UNDER ARTICLE 12, IN WHICH CASE THERE SHALL BE NO LIMIT TO SUCH
LIABILITY.



     11.5 Insurance. Each Party shall procure and maintain insurance, including product liability
insurance, adequate to cover its obligations hereunder and which are consistent with normal
business practices of prudent companies similarly situated at all times during which any Product is
being clinically tested in human subjects or commercially distributed or sold by such Party. It is
understood that such insurance shall not be construed to create a limit of either Party’s liability
with respect to its indemnification obligations under this Article 11. Each Party shall provide
the other Party with written evidence of such insurance upon request, if insurance company so
agrees. Each Party shall provide the other Party with written notice at least thirty (30) days
prior to the cancellation, non-renewal or material change in such insurance or self-insurance which
materially adversely affects the rights of the other Party hereunder.



ARTICLE 12




CONFIDENTIALITY



     12.1 Confidentiality. Except to the extent expressly authorized by this Agreement or
otherwise agreed in writing by the Parties, each Party agrees that it shall keep confidential and
shall not publish or otherwise disclose and shall not use for any purpose other than as provided



34.









 







for in this Agreement (which includes the exercise of any rights or the performance of any
obligations hereunder) any Confidential Information of the other Party pursuant to this Agreement.
The foregoing confidentiality and non-use obligations shall not apply to any portion of the
Confidential Information that the receiving Party can demonstrate by competent written proof:



          (a) was already known to the receiving Party or its Affiliate, other than under an obligation
of confidentiality, at the time of disclosure by the other Party;




          (b) was generally available to the public or otherwise part of the public domain at the time
of its disclosure to the receiving Party;




          (c) became generally available to the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the receiving Party in breach of this
Agreement;




          (d) is subsequently disclosed to the receiving Party or its Affiliate by a Third Party who has
a legal right to make such disclosure; or




          (e) is subsequently independently discovered or developed by the receiving Party or its
Affiliate without the aid, application, or use of the disclosing Party’s Confidential Information,
as evidenced by a contemporaneous writing.




     12.2 Authorized Disclosure. Notwithstanding the obligations set forth in Section 12.1, a
Party may disclose the other Party’s Confidential Information and the terms of this Agreement to
the extent:



          (a) such disclosure: (i) is reasonably necessary for the filing or prosecuting patent rights
as contemplated by this Agreement; or (ii) is reasonably necessary for the prosecuting or defending
litigation as contemplated by this Agreement; or




          (b) such disclosure is reasonably necessary: (i) to such Party’s directors, attorneys,
independent accountants or financial advisors for the sole purpose of enabling such directors,
attorneys, independent accountants or financial advisors to provide advice to the receiving Party,
provided that in each such case on the condition that such directors, attorneys, independent
accountants and financial advisors are bound by confidentiality and non-use obligations consistent
with those contained in this Agreement; or (ii) to actual or potential investors and/or acquirors
solely for the purpose of evaluating an actual or potential investment or acquisition; provided
that in each such case on the condition that such actual or potential investors and/or acquirers
are bound by confidentiality and non-use obligations consistent with those contained in this
Agreement;




          (c) such disclosure is required by judicial or administrative process, provided that in such
event such Party shall promptly inform the other Party such required disclosure and provide the
other Party an opportunity to challenge or limit the disclosure obligations.
Confidential Information that is disclosed by judicial or administrative process shall remain
otherwise subject to the confidentiality and non-use provisions of this Article 12, and the Party
disclosing Confidential Information pursuant to law or court order shall take all steps reasonably



35.









 






necessary, including seeking of confidential treatment or a protective order to ensure the
continued confidential treatment of such Confidential Information; and




          (d) such disclosure is reasonably necessary to its collaborators in its respective territory
(including CROs, hospitals, doctors, consultants, subcontractors and Affiliates) for the purpose of
the development, manufacture and/or commercialization of the Products, solely for the purpose of
carrying out such collaboration, on the condition that such collaborators are bound by
confidentiality and non-use obligations consistent with those contained in this Agreement. For
clarity, Spectrum shall have the right to disclose to its commercial partners in the Retained
Territory (including without limitation Allergan and the Korean Partner), and such commercial
partners shall have the right to use, the Confidential Information of NK, in each case in
connection with the research, development, manufacture and commercialization of products in the
Retained Territory on condition that such partners are bound by confidentiality and non-use
obligations consistent with those contained in this Agreement. For further clarity, NK shall have
the right to disclose to its sublicensees in the NK Territory, and such sublicensees shall have the
right to use, the Confidential Information of Spectrum in accordance with the right granted under
the sublicense under Section 2.1(a) on condition that such sublicensees are bound by
confidentiality and non-use obligations consistent with those contained in this Agreement.




          (e) such disclosure is reasonably necessary to its potential sublicensees to have such
potential sublicensees to evaluate the possibility of sublicenses under Section 2.1(a) on condition
that such potential sublicensees are bound by confidentiality and non-use obligations consistent
with those contained in this Agreement.




     12.3 Publication. NK shall deliver to Spectrum a copy of any proposed publication or
presentation for Spectrum’s review and approval. Spectrum shall have the right to require
modifications of the proposed publication or presentation for reasons such as: (a) to protect
Spectrum’s Confidential Information; (b) for trade secret reasons or business reasons; and/or (c)
to delay such submission for an additional ninety (90) days as may be reasonably necessary to seek
patent protection for the Sole Inventions owned by Spectrum or the Joint Invention disclosed in
such proposed submission.



     12.4 Publicity; Use of Names. Subject to Section 12.2 and the rest of this Section 12.4, no
disclosure of the terms of this Agreement may be made by either Party or its Affiliates, and no
Party shall use the name, trademark, trade name or logo of the other Party, its Affiliates or their
respective employee(s) in any publicity, promotion, news release or other public disclosure
relating to this Agreement or its subject matter, without the prior express written permission of
the other Party, except as may be required by law.



          (a) A Party may disclose this Agreement and its terms in securities filings with the
Securities Exchange Commission or other regulatory agency (“SEC”) (or equivalent foreign agency) to
the extent required by law after complying with the procedure set forth in this Section 12.4. In
such event, the Party seeking such disclosure will prepare a draft confidential treatment request
and a proposed redacted version of this Agreement to request confidential
treatment for this Agreement, and the other Party agrees to promptly (and in any event, no
less than seven (7) days after receipt of such confidential treatment request and proposed
redactions) give its input in a reasonable manner in order to allow the Party seeking disclosure to
file its



36.









 






request within the time lines proscribed by applicable SEC regulations or equivalent
foreign agency regulations. The Party seeking such disclosure shall exercise Commercially
Reasonable Efforts to obtain confidential treatment of this Agreement from the SEC or equivalent
foreign agency as represented by the redacted version reviewed by the other Party.




          (b) Further, each Party acknowledges that the other Party may be legally required to make
public disclosures (including in filings with the SEC or other agency) of certain material
developments or material information generated under this Agreement and agrees that each Party may
make such disclosures as required by law, provided that the Party seeking such disclosure first
provides the other Party a copy of the proposed disclosure, and provided further that (except to
the extent that the Party seeking disclosure is required to disclose such information to comply
with applicable laws or regulations) if the other Party demonstrates to the reasonable satisfaction
of the Party seeking disclosure, within three (3) business days of such Party’s providing the copy,
that the public disclosure of previously undisclosed information will materially adversely affect
the development and/or commercialization of a Product being developed and/or commercialized, the
Party seeking disclosure will remove from the disclosure such specific previously undisclosed
information as the other Party shall reasonably request to be removed.




          (c) Notwithstanding the foregoing, the Parties have agreed on language of a press release
announcing the collaboration, attached hereto as Exhibit H, to be issued promptly after the
execution of this Agreement by both Parties.




          (d) During the Term, each Party shall have the right to issue press release or make a public
announcement concerning the material terms of this Agreement or the Development or
Commercialization of the Product under this Agreement, such as announcing the commencement and
completion of clinical studies for the Products in countries of the NK Territory, the filing and
obtaining of Regulatory Approvals for the Products in countries of the NK Territory, the First
Commercial Sale of the Products in countries of the NK Territory, and the publication of data and
results in accordance with Section 12.3, by providing the other Party with reasonable advance
notice of the content thereof. Such other Party shall have the right to review and comment on such
proposed press release or announcement and the Party seeking such disclosure shall take into
consideration and incorporate when appropriate the comment from the other Party.




          (e) The Parties agree that after a disclosure pursuant to Sections 12.4(a) or (b) has been
reviewed and approved by the other Party, the disclosing Party may make subsequent public
disclosures or issue a press release disclosing the same content without having to obtain the other
Party’s prior consent and approval.




          (f) The Parties agree that NK may publish or disclose any data, results and other
information generated from or obtained by the Development hereunder to the extent reasonably
necessary or helpful for the Development or Commercialization of the Product under this Agreement,
subject to Section 12.3.




     12.5 Equitable Relief. Each Party and its Affiliates acknowledge that a breach of this
Article 12 cannot reasonably or adequately be compensated in damages in an action at law and



37.









 




that
such a breach shall cause the other Party irreparable injury and damage. By reason thereof, each
Party and its Affiliates agree that the other Party shall be entitled, in addition to any other
remedies it may have under this Agreement or otherwise, to preliminary and permanent injunctive and
other equitable relief to prevent or curtail any breach of the obligations relating to Confidential
Information set forth herein by the other Party.




     12.6 Obligation Period. The obligations of the Parties under this Article 12 shall continue
for a period of [***] ([***]) years after the expiration or termination of this Agreement.



ARTICLE 13




TERM AND TERMINATION



     13.1 Term. This Agreement shall become effective on the Effective Date and, unless earlier
terminated pursuant to this Article 13, shall remain in effect, on a country-by-country basis,
until the expiration of the Royalty Term of the Product in such country (“Term”). Upon the
expiration of the Term in a particular country, the license granted to NK under the Spectrum
Technology in such country shall become fully-paid, royalty-free and non-exclusive.



     13.2 Termination for Breach or for Other Reasons.



          (a) Notice. If either Party believes that the other Party is in material breach of this
Agreement, then the Party holding such belief (the “Non-breaching Party”) may deliver notice of
such breach to the other Party (the “Notified Party”). The Notified Party shall have [***] to cure
such breach to the extent involving non-payment of amounts due hereunder, and [***] to either cure
such breach for all other material breaches, or, if cure of such breach other than non-payment
cannot reasonably be effected within such [***] period, to deliver to the Non-breaching Party a
plan reasonably calculated to cure such breach within a timeframe that is reasonably prompt in
light of the circumstances then prevailing but in no event longer than an additional [***].
Following delivery of such a plan, the Notified Party shall carry out the plan and cure the breach
within the timeframe set forth in the plan and the failure of the Notified Party to cure the breach
within such timeframe shall be result in the immediate and automatic termination of this Agreement
upon the expiration of such timeframe.




          (b) Failure to Cure. If the Notified Party fails to cure a material breach of this Agreement
as provided for in Section 13.2(a), then the Non-Breaching Party may terminate this Agreement upon
written notice to the Notified Party.




          (c) Termination by NK. In the event NK determines at its sole discretion that further
Development or Commercialization of the Product is commercially, financially or otherwise not
advisable or reasonable due to the reasons of (i) efficacy, (ii) safety, (iii) infringement of
Third Party’s patent or other intellectual property or (iv) marketability, NK may terminate this
Agreement by giving to Spectrum nine (9)-month written notice to that effect.






 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




38.









 










          (d) Disputes. If a Party gives notice of termination under this Section 13.2 and the
other Party disputes whether such termination is proper under this Section 13.2, then the issue of
whether this Agreement may properly be terminated upon expiration of the notice period (unless such
breach is cured as provided in Section 13.2(a)) shall be resolved in accordance with Article 14.
If as a result of such dispute resolution process it is determined that the notice of termination
was proper, then such termination shall be deemed to have been effective ninety (90) days following
the date of the notice of termination (or such other time period applicable pursuant to Section
13.2(a) or Section 13.2(c)). If as a result of such dispute resolution process it is determined
that the notice of termination was improper, then no termination shall have occurred and this
Agreement shall remain in effect.




     13.3 Spectrum Rights upon Termination of this Agreement. In the event this Agreement is
terminated, upon the early termination of this Agreement, the following shall apply (in addition to
any other rights and obligations otherwise under this Agreement with respect to such termination),
subject to Section 13.4 below:



          (a) Regulatory Filings; Data. To the extent permitted by applicable Laws, NK shall transfer
and assign to Spectrum all Regulatory Filings, Regulatory Approvals, and related preclinical,
analytical, and clinical data for the Products throughout the NK Territory.




          (b) NK License and Assignment. NK hereby grants to Spectrum, effective only in event of such
termination, an exclusive, royalty-free license, with the right to grant multiple tiers of
sublicenses if applicable, under NK Technology to Develop, make, have made, use, sell, offer for
sale, have sold, import and otherwise Commercialize the Products in the NK Territory, which license
shall be effective as of the date of such termination. NK hereby assigns to Spectrum, effective
only in the event of such termination, all of its rights and interests in and to the Product Marks
(other than the corporate names of NK) and NK shall provide such further assistance to Spectrum
promptly after the effective date of such termination to effect such assignment.




          (c) Revocation of Registration of License. NK shall, and shall cause its sublicensees to,
execute all documents and give all declarations regarding the licenses or sublicenses and
reasonably cooperate with Spectrum to the extent such documents, declarations and/or cooperation
are required for the revocation of record or registration of the licenses or sublicenses for the
benefit of NK or its sublicensees in the NK Territory made pursuant to Section 2.6.




          (d) Transition Assistance. NK shall provide such assistance, at no cost to Spectrum, as may
be reasonably necessary or useful for Spectrum to commence or continue, at Spectrums cost,
Developing or Commercializing Products in the NK Territory, to the extent NK is then performing or
having performed such activities, including without limitation transferring or amending as
appropriate, upon request of Spectrum, any agreements or arrangements with Third Party vendors to
sell Products in the NK Territory. To the extent that any such contract between NK and a Third
Party is not assignable to Spectrum, then NK shall reasonably cooperate with Spectrum to arrange to
continue to provide and provide such services from such entity.







39.









 








     13.4 Payment by Spectrum. In the event this Agreement is terminated by NK pursuant to Section
13.2 for Spectrum’s material breach of its material obligations under this Agreement, in order for
Sections 13.3(a) through (d) to take effect, Spectrum shall first agree in writing to reimburse NK,
in [***] equal monthly installments, for all reasonable and documented out-of-pocket and internal
costs (including labor costs) incurred by NK (or its sublicensees, to the extent NK’s assignment
and assistance obligations in Sections 13.3(a) through (d) above in the NK Territory outside of
Japan are fulfilled through such sublicensees) after the Effective Date and prior to the effective
date of such termination that are directly attributable to: (a) the conduct of preclinical,
analytical and clinical studies (including clinical studies in South Korea) using the Product for
the purpose of generating data to support Regulatory Approval for the Product in the Field in the
NK Territory; and (b) the preparation and filing for Regulatory Approval for the Product in the
Field in the NK Territory, including any filing fees associated therewith.



     13.5 Survival. The following provisions shall survive any expiration or termination of this
Agreement: Articles 1, 8 (solely with respect to payments that are due prior to or as of the
effective date of such expiration or termination), 11 (excluding Section 11.5), 12, 14, and 15, and
Sections 2.2 (other than subclause (a)), 9.1, 9.2, 9.3, 10.3, 10.4, 13.1, 13.3, 13.4 and 13.5.



ARTICLE 14




DISPUTE RESOLUTION



     14.1 Disputes. The Parties recognize that disputes as to certain matters may from time to
time arise during the Term which relate to either Party’s rights and/or obligations hereunder. It
is the objective of the Parties to establish procedures to facilitate the resolution of disputes
arising under this Agreement in an expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in
this Article 14 to resolve any controversy or claim arising out of, relating to or in connection
with any provision of this Agreement, if and when a dispute arises under this Agreement.



     14.2 Internal Resolution. With respect to all disputes arising between the Parties under this
Agreement, including, without limitation, any alleged breach under this Agreement or any issue
relating to the interpretation or application of this Agreement, if the Parties are unable to
resolve such dispute within thirty (30) days after such dispute is first identified by either Party
in writing to the other, the Parties shall refer such dispute to the Chief Executive Officers or
the Managing Director of the Parties (or any senior executive reporting directly to either Party’s
Chief Executive Officer or Managing Director) for attempted resolution by good faith negotiations
within thirty (30) days after such notice is received.



     14.3 Binding Arbitration. If the Chief Executive Officers or the Managing Director or such
senior executive of the Parties are not able to resolve such disputed matter within thirty (30)
days and either Party wishes to pursue the matter, each such dispute, controversy or claim





 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




40.









 









that is not an Excluded Claim (defined in Section 14.4 below) shall be finally resolved by
binding arbitration administered by JAMS pursuant to JAMS’ Streamlined Arbitration Rules and
Procedures then in effect (the “JAMS Rules”), and judgment on the arbitration award may be entered
in any court having jurisdiction thereof. The Parties agree that:




          (a) The arbitration shall be conducted by a panel of three persons experienced in the
pharmaceutical business: within thirty (30) days after initiation of arbitration, each Party shall
select one person to act as arbitrator and the two Party-selected arbitrators shall select a third
arbitrator within thirty (30) days of their appointment. If the arbitrators selected by the
Parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be
appointed by JAMS. The place of arbitration shall be Los Angeles, California, and all proceedings
and communications shall be in English.




          (b) Either Party may apply to the arbitrators for interim injunctive relief until the
arbitration award is rendered or the controversy is otherwise resolved. Either Party also may,
without waiving any remedy under this Agreement, seek from any court having jurisdiction any
injunctive or provisional relief necessary to protect the rights or property of that Party pending
the arbitration award. The arbitrators shall have no authority to award punitive or any other type
of damages not measured by a Party’s compensatory damage. Each Party shall bear its own costs and
expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative
fees of arbitration regardless of the outcome of such arbitration.




          (c) Except to the extent necessary to confirm an award or as may be required by law, neither a
Party nor an arbitrator may disclose the existence, content, or results of an arbitration without
the prior written consent of both Parties. In no event shall an arbitration be initiated after the
date when commencement of a legal or equitable proceeding based on the dispute, controversy or
claim would be barred by the applicable California statute of limitations.




     14.4 Excluded Claim. As used in Section 14.3, the term “Excluded Claim” shall mean a dispute,
controversy or claim that concerns (a) the scope, validity, enforceability, inventorship or
infringement of a patent, patent application, trademark or copyright; or (b) any antitrust,
anti-monopoly or competition law or regulation, whether or not statutory.



ARTICLE 15




MISCELLANEOUS



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



41.









 





     15.2 Force Majeure. Each Party shall be excused from the performance of its obligations under
this Agreement to the extent that such performance is prevented by force majeure and the
nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse
shall be continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition. For purposes of this
Agreement, force majeure shall include conditions beyond the reasonable control of the
nonperforming Party, including without limitation, an act of God or terrorism, involuntary
compliance with any regulation, law or order of any government, war, civil commotion, epidemic,
failure or default of public utilities or common carriers, destruction of production facilities or
materials by fire, earthquake, storm or like catastrophe. Notwithstanding the foregoing, a Party
shall not be excused from making payments owed hereunder because of a force majeure affecting such
Party. If a force majeure persists for more than ninety (90) days, then the Parties will discuss
in good faith the modification of the Parties’ obligations under this Agreement in order to
mitigate the delays caused by such force majeure.



     15.3 Notices. Any notice required or permitted to be given under this Agreement shall be in
writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate
Party at the address specified below or such other address as may be specified by such Party in
writing in accordance with this Section 15.3, and shall be deemed to have been given for all
purposes (a) when received, if hand-delivered or sent by confirmed facsimile or a reputable courier
service, or (b) five (5) business days after mailing, if mailed by first class certified or
registered airmail, postage prepaid, return receipt requested.




	 	 	 
	If to Spectrum:

	 	Spectrum Pharmaceuticals, Inc.
	 

	 	701 N. Green Valley Parkway Suite 265
	 

	 	Henderson, NV 89074
	 

	 	Attention: Legal Counsel
	 

	 	Fax: (702) 990-3001
	 
	 	 
	With copies to:

	 	Spectrum Pharmaceuticals, Inc.
	 

	 	157 Technology Drive
	 

	 	Irvine, CA 92618
	 

	 	Attention: Legal Counsel
	 

	 	Fax: (949) 788-6706
	 
	 	 
	and

	 	Cooley Godward Kronish LLP
	 

	 	5 Palo Alto Square
	 

	 	3000 El Camino Real
	 

	 	Palo Alto, CA 94306
	 

	 	Attention: Robert L. Jones, Esq.
	 

	 	Facsimile: (650) 849-7400






42.









 






	 	 	 
	If to NK:

	 	Nippon Kayaku Co., Ltd.
	 

	 	Tokyo Fujimi Bldg., 11-2,
	 

	 	Fujimi 1-chome, Chiyoda-ku
	 

	 	Tokyo 102-8172, Japan
	 

	 	Attention: General Manager of Licensing Division
	 

	 	Fax: +81-3-(3237)5920






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



     15.5 Assignment. Neither Party may assign or transfer this Agreement or any rights or
obligations hereunder without the prior written consent of the other, except that a Party may make
such an assignment without the other Party’s consent to Affiliates or to a successor to
substantially all of the business of such Party to which this Agreement relates (whether by merger,
sale of stock, sale of assets or other transaction) (the “Acquisition”). Any permitted successor
or assignee of rights and/or obligations hereunder shall, in writing to the other Party, expressly
assume performance of such rights and/or obligations. Any permitted assignment shall be binding on
the successors of the assigning Party. Any assignment or attempted assignment by either Party in
violation of the terms of this Section 15.5 shall be null, void and of no legal effect.



     15.6 Performance by Affiliates. Each Party may discharge any obligations and exercise any
right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its
Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to
comply with the provisions of this Agreement in connection with such performance. Any breach by a
Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach
by such Party, and the other Party may proceed directly against such Party without any obligation
to first proceed against such Party’s Affiliate.



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



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



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



43.









 





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



     15.11 English Language. This Agreement was prepared in the English language, which language
shall govern the interpretation of, and any dispute regarding, the terms of this Agreement. To the
extent this Agreement requires a Party to provide to the other Party Information, correspondence,
notice and/or other documentation, such Party shall provide such Information, correspondence,
notice and/or other documentation in the English language.



     15.12 Governing Law. This Agreement and all disputes arising out of or related to this
Agreement or any breach hereof shall be governed by and construed under the laws of the State of
California, without giving effect to any choice of law principles that would require the
application of the laws of a different state.



     15.13 Counterparts. This Agreement may be executed in one (1) or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument.



44.









 







Exhibit 10.36




EXECUTION COPY




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



	 	 	 	 	 	 	 	 	 	 	 
	Spectrum Pharmaceuticals, Inc.	 	Nippon Kayaku Co., Ltd.
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Rajesh C. Shrotriya, M.D.	 	By:	 	/s/ Akira Mandai
	 	 	 	 	 	 	 
	 

	 	Name:
	 	Rajesh C. Shrotriya, M.D.	 	 	 	Name:	 	Akira Mandai
	 

	 	 	 	 
	 	 	 	 	 	 
	 

	 	Title:	 	Chairman & Chief Executive Officer	 	 	 	Title:	 	Managing Director
	 

	 	 	 	 
	 	 	 	 	 	 





45.









 






Exhibit A




Apaziquone



[***]






 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




46.









 










Exhibit B




Spectrum Patents Existing as of the Effective Date



[***]






 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




47.









 










Exhibit C




Target Product Profile (TPP)



[***]






 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




48.









 










Exhibit D




Certain Spectrum Know-How



[***]






 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




49.









 










Exhibit E




NK Development Plan



[***]






 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




50.









 










Exhibit F



Outline of Adverse 

Reporting Requirements




[***]






 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.




51.









 










Exhibit G




Spectrum Manufacturing Know-How



[***]






 




			
	[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.






52.











 





Exhibit H




Joint Press Release


[On 6 am of November 10 (PST) from Spectrum]









COMPANY CONTACTS

Paul Arndt

Senior Manager, Investor Relations

949-788-6700x216




SPECTRUM PHARMACEUTICALS AND NIPPON KAYAKU ENTER COLLABORATION

AGREEMENT FOR APAZIQUONE IN ASIAN TERRITORIES





	 	•	 	Total Potential Value Of Collaboration Exceeds $151 Million
	 
	 	•	 	Spectrum to Receive an Upfront Payment of $15 Million, up to $136 Million in Milestones,
and Royalties
	 
	 	•	 	Nippon Kayaku Responsible for 100% of Development and Commercial Expenses
	 
	 	•	 	Spectrum Retains Commercial Rights to South Korea




IRVINE, California — November 10, 2009 —Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a
commercial stage biotechnology company with a primary focus in oncology, and Nippon Kayaku today
announced an exclusive collaboration for the development and commercialization of apaziquone in
Asia. Apaziquone is an antineoplastic agent currently being investigated for the treatment of
non-muscle invasive bladder cancer by intravesical instillation. Spectrum Pharmaceuticals has
previously entered into a strategic collaboration with Allergan, Inc. (NYSE: AGN) for North
America, Europe, and other key markets. These two collaborations are representative of the
Company’s stated objective of achieving solid strategic partnerships that are aimed at fully
exploiting developmental goals for apaziquone on a worldwide basis.



“We are excited to partner apaziquone with a strong Japanese oncology company such as Nippon
Kayaku,” said Rajesh C. Shrotriya, Chairman of the Board and Chief Executive Officer of Spectrum
Pharmaceuticals, Inc. “Nippon Kayaku is one of the most established and reputable pharmaceutical
companies in Japan and has unparalleled experience in Asia in the field of non-muscle invasive
bladder cancer and prostate cancer. We believe that Nippon Kayaku is a terrific strategic partner
for apaziquone and for Spectrum.”



“Apaziquone is an ideal candidate to complement our portfolio of 24 anti-cancer products,”
said Akira Mandai, Head of Pharmaceuticals Group of Nippon Kayaku. “We look forward to working
with Spectrum in developing apaziquone for non-muscle invasive bladder cancer.”



Under the terms of the agreement, Nippon Kayaku will pay Spectrum an upfront payment of $15 million
and will make additional payments of up to $136 million based on the achievement of certain
regulatory and commercialization milestones. Nippon Kayaku received exclusive rights to apaziquone
for the treatment of non-muscle invasive bladder cancer in Asia, including Japan and China but
excluding South Korea. Nippon Kayaku will conduct the apaziquone clinical trials


53.









 






pursuant to a
development plan. Nippon Kayaku will be responsible for all expenses relating to the development
and commercialization of apaziquone in the Nippon Kayaku territory.




Spectrum is currently conducting two Phase 3 clinical trials to investigate apaziquone’s safety and
efficacy in non-muscle invasive bladder cancer. Spectrum’s goal is to complete enrollment in both
Phase 3 studies by year-end 2009.




About Non-Muscle Invasive Bladder Cancer



Non-muscle invasive bladder cancer is a form of bladder cancer localized in the surface layers of
the bladder and is commonly treated with intravesical therapies. Approximately 70% of all patients
newly diagnosed with bladder cancer have non-muscle invasive bladder cancer.1 More than
one million patients in the United States, Europe and Japan are estimated to be affected by the
disease, which is treated predominantly by urologists.2




About Apaziquone



Apaziquone is a drug currently being investigated for the treatment of non-muscle invasive bladder
cancer. Apaziquone, an anti-cancer agent that becomes activated by reductase enzymes found in
cancer cells, is formulated for administration directly into the urinary bladder. Phase 2 data has
confirmed anti-tumor activity in patients with multiple, recurrent non-muscle invasive bladder
cancer, as evidenced by 31 of 46 patients (67%) showing a complete response after receiving six
weekly treatments with 4 mg of apaziquone instilled into the urinary bladder in a marker lesion
study. In another Phase 2 study, apaziquone instilled into the bladder following surgery was well
tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream
and therefore, is expected to carry a low risk of systemic toxicity, if any.



The apaziquone registration plan, which the U.S. Food and Drug Administration (FDA) concurred with
under a Special Protocol Assessment, calls for two double blind, placebo-controlled, randomized
Phase 3 clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder
cancer. Patients are randomized in a one-to-one ratio to apaziquone or placebo. Under the
protocol, the patients are given a single 4 mg dose following surgical removal of the tumors.
The primary endpoint is a statistically significant difference (p<0.05) in the rate of
tumor recurrence between the two treatment groups by year two. The FDA has granted Fast Track
Designation for the investigation of apaziquone for the treatment of non-muscle invasive bladder
cancer. Spectrum also received scientific advice from the European Medicines Agency
(EMEA) whereby the EMEA agreed that the two Phase 3 studies as designed should be sufficient for a
regulatory decision regarding European registration.




About Nippon Kayaku



Nippon Kayaku is a general chemical company focused on IT, health care and safety systems. The
Company’s Pharmaceuticals Group maintains extensive original expertise related to research and
development, production, sales, and aftermarket investigations of anti-cancer drugs. The Company’s
lineup of cancer-fighting drugs and cancer supportive products has reached 28 products. Nippon
Kayaku is also strengthening its licensing activities, and is






 




			
	1	 	Kirkali Z, et al. Bladder Cancer:
Epidemiology, Staging and Grading, and Diagnosis. Urology 66 (Suppl 6A): 4-34,
2005.
	 
	2	 	For U.S. see National Cancer Institute.
Bethesda, MD, http://seer.cancer.gov/statfacts/html/urinb.html accessed
10-23-2008; For Europe see Globocan 2002 database, http://www-dep.iarc.fr/
accessed 10-23-2008.




54.









 







introducing generic products in order
to expand its cancer-related business. For more information, please visit the Company’s website at
www.nipponkayaku.co.jp/english/.



About Spectrum Pharmaceuticals



Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a primary focus in
oncology. The Company’s strategy is comprised of acquiring and developing a broad and diverse
pipeline of late-stage clinical and commercial products; establishing a commercial organization for
its approved drugs; continuing to build a team with people who have demonstrated skills, passion,
commitment and have a track record of success in its areas of focus; and, leveraging the expertise
of partners around the world to assist it in the execution of its strategy. For more information,
please visit the Company’s website at www.sppirx.com.



Forward Looking Statements — This press release may also contain forward-looking statements
regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks
and uncertainties that could cause actual results to differ materially. These statements include
but are not limited to statements that relate to Spectrum’s business and its future, Spectrum’s
ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage
clinical and commercial products, establishing a commercial organization for Spectrum’s approved
drugs, continuing to build Spectrum’s team, leveraging the expertise of partners around the world
to assist Spectrum in the execution of its strategy, that apaziquone is expected to carry a low
risk of systemic toxicity, if any, the safety and efficacy of apaziquone and that enrollment in the
Phase 3 clinical trials will be completed by year-end 2009, and any statements that relate to the
intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of
historical fact. Risks that could cause actual results to differ include the possibility that
Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that
Spectrum’s existing and new drug candidates may not receive approval from the FDA, and other
regulatory agencies in a timely manner or at all, the possibility that Spectrum’s existing and new
drug candidates, if approved, may not be more effective, safer or more cost efficient than
competing drugs, the possibility that Spectrum’s efforts to acquire or in-license and develop
additional drug candidates may fail, Spectrum’s lack of revenues, limited marketing experience,
dependence on third parties for clinical trials, manufacturing, distribution and quality control
and other risks that are described in further detail in Spectrum’s reports filed with the
Securities and Exchange Commission. Spectrum does not plan to update any such forward-looking
statements and expressly disclaim any duty to update the information contained in this press
release except as required by law.



SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum, TURNING INSIGHTS
INTO HOPETM and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals,
Inc.




Information
regarding Nippon Kayaku has been obtained from Nippon Kayaku and not independently verified by Spectrum.




© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.






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56.









 














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