exv10w38



 





EXHIBIT 10.38



CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN

THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN

OMITTED AND FILED SEPARATELY WITH THE

SECURITIES AND EXCHANGE COMMISSION PURSUANT TO

RULE 24B-2 OF THE SECURITIES EXCHANGE

ACT OF 1934, AS AMENDED





License Agreement




on




Amrubicin Hydrochloride (SM-5887)




by and between




Sumitomo Pharmaceuticals Co., Ltd.




and




Conforma Therapeutics Corporation




Executed on June 23, 2005




 









 







TABLE OF CONTENTS




	 	 	 	 	 
	RECITALS
	 	 	1	 
	1. DEFINITIONS
	 	 	1	 
	2. GRANT OF RIGHTS
	 	 	6	 
	2.1. Exclusive Right
	 	 	6	 
	2.2. Sublicense
	 	 	6	 
	2.3. License Grant Back to SUMITOMO
	 	 	6	 
	3. CONSIDERATION
	 	 	6	 
	3.1. Up-front and Milestone Payments
	 	 	6	 
	3.2. Bonus Payments
	 	 	7	 
	3.3. Sublicensee Payments
	 	 	7	 
	3.4. Non-Refundability
	 	 	7	 
	4. DEVELOPMENT
	 	 	7	 
	4.1. Technology Transfer
	 	 	7	 
	4.2. Implementation of Development
	 	 	8	 
	4.2.1. Implementation of Development
	 	 	8	 
	4.2.2. Joint Steering Committee
	 	 	8	 
	4.2.3. Development Plan
	 	 	9	 
	4.3. Clinical Supplies for Development
	 	 	10	 
	4.3.1. Supply of Product
	 	 	10	 
	4.3.2. Specifications
	 	 	10	 
	4.3.3. Labeling and Packaging
	 	 	11	 
	5. MARKETING AND PROMOTION
	 	 	11	 
	5.1. Commercially Reasonable Efforts to Market
	 	 	11	 
	5.2. Commercialization Plan
	 	 	11	 
	5.3. Minimum Sales
	 	 	12	 
	5.4. Sales Outside the Territory
	 	 	12	 
	5.5. Labels and Packages
	 	 	12	 
	5.6. Competing Product
	 	 	13	 
	6. SUPPLY OF PRODUCT
	 	 	13	 
	6.1. Supply of Product
	 	 	13	 
	6.1.1. Supply Agreement
	 	 	13	 
	6.1.2. Requirements
	 	 	13	 
	6.1.3. Specifications
	 	 	14	 
	6.1.4. Delivery
	 	 	14	 
	6.2. Payment
	 	 	14	 
	6.2.1. Purchase Price during the Initial Period
	 	 	14	 
	6.2.2. Payments Procedure
	 	 	14	 
	6.2.3. Adjustments to Purchase Price After the Initial Period
	 	 	15	 
	6.2.4. Adjustment related to Combination Product
	 	 	16	 
	6.3. Forecast and Order
	 	 	16	 
	6.3.1. Supply Forecast
	 	 	16	 
	6.3.2. Firm Order
	 	 	17	 
	6.3.3. Quantity
	 	 	17	 
	6.3.4. Quality Assurance Tests
	 	 	17	 
	6.3.5. Retention of Samples
	 	 	17	 
	6.3.6. Labeling and Packaging
	 	 	18	 
	6.3.7. Backup/Complementary Source for the Manufacture of Compound or Product
	 	 	18	 
	6.4. Termination
	 	 	18	 
	7. TRADEMARK
	 	 	18	 
	7.1. Grant of Right
	 	 	18	 
	7.2. Ownership
	 	 	18	 
	7.3. Filing, Prosecution and Maintenance
	 	 	18	 
	7.4. Royalties for Trademark
	 	 	19	 






 









 






	 	 	 	 	 
	7.5. Infringement by Third Party
	 	 	19	 
	8. REGULATORY AFFAIRS AND INSPECTIONS
	 	 	20	 
	8.1. Acquisition and Maintenance of Authorization
	 	 	20	 
	8.2. Maintenance of Data
	 	 	20	 
	8.3. Inspections by Regulatory Authority
	 	 	21	 
	8.4. Inspections by Parties
	 	 	21	 
	8.5. Pharmacovigilance / Drug Safety Matters
	 	 	21	 
	9. PATENTS and Updated Technology
	 	 	22	 
	9.1. Updated Technology
	 	 	22	 
	9.2. Rights to Improvements
	 	 	22	 
	9.3. Application and Maintenance of Patents
	 	 	22	 
	9.4. No Warranty
	 	 	23	 
	9.5. Infringement by Third Party
	 	 	23	 
	9.6. Infringement Alleged by Third Party
	 	 	24	 
	10. RECORDS
	 	 	24	 
	10.1. Records
	 	 	24	 
	10.2. Examination by Certified Public Accountant
	 	 	24	 
	11. TAXATION
	 	 	25	 
	11.1. Responsibility for Tax
	 	 	25	 
	11.2. Withholding Tax
	 	 	25	 
	12. FINANCIAL MATTERS
	 	 	25	 
	12.1. Late Payments
	 	 	25	 
	12.2. Manner of Payment
	 	 	25	 
	13. CONFIDENTIALITY
	 	 	26	 
	13.1. Non-disclosure
	 	 	26	 
	13.2. Limited Purposes
	 	 	26	 
	13.3. Exceptions
	 	 	26	 
	13.3.1. Information Otherwise Available
	 	 	26	 
	13.3.2. Governmentally Required Disclosures
	 	 	26	 
	13.4. Publication Procedure
	 	 	27	 
	13.5. Return of Information
	 	 	27	 
	13.6. Additional Permitted Disclosures
	 	 	27	 
	13.7. Terms and Conditions of this Agreement
	 	 	27	 
	13.8. Previous Confidential Agreement
	 	 	27	 
	14. TERM AND TERMINATION
	 	 	28	 
	14.1. Expiration
	 	 	28	 
	14.2. Termination by CONFORMA
	 	 	28	 
	14.3. Termination for Breach
	 	 	28	 
	14.4. Termination for Bankruptcy
	 	 	28	 
	14.5. Termination for Patent Challenge
	 	 	28	 
	14.6. Termination for Change of Control
	 	 	28	 
	14.7. Consequences of Termination
	 	 	29	 
	14.7.1. Responsibilities of CONFORMA
	 	 	29	 
	14.7.2. Responsibilities of SUMITOMO
	 	 	29	 
	14.7.3. Regulatory Responsibilities of Both Parties
	 	 	29	 
	14.7.4. Ancillary Agreements
	 	 	29	 
	14.8. Outstanding Payments
	 	 	29	 
	14.9. Survival Clauses
	 	 	29	 
	15. INDEMNIFICATION
	 	 	30	 
	15.1. Indemnification by SUMITOMO
	 	 	30	 
	15.2. Indemnification by CONFORMA
	 	 	30	 
	15.3. Procedure
	 	 	31	 
	15.4. No Lost Profit
	 	 	31	 
	16. REPRESENTATIONS, WARRANTIES AND COVENANTS
	 	 	31	 
	16.1. Execution of Agreement
	 	 	31	 
	16.2. Additional SUMITOMO Representations
	 	 	32	 
	16.3. Material Facts
	 	 	32	 






 









 






	 	 	 	 	 
	16.4. Manufacture of Compound and Product
	 	 	32	 
	16.5. Express Warranties
	 	 	32	 
	17. MISCELLANEOUS PROVISIONS
	 	 	33	 
	17.1. Headings
	 	 	33	 
	17.2. Severability
	 	 	33	 
	17.3. Entire Agreement; Amendment
	 	 	33	 
	17.4. Assignability
	 	 	33	 
	17.5. Independent Party
	 	 	33	 
	17.6. Notice and Reports
	 	 	33	 
	17.7. Waiver
	 	 	34	 
	17.8. Force Majeure
	 	 	34	 
	17.9. Dispute Resolution and Arbitration
	 	 	34	 
	17.10. Applicable Law
	 	 	35	 
	17.11. Language
	 	 	35	 
	17.12. Counterparts
	 	 	35	 
	Annex 1.6
	 	 	37	 
	Annex 1.27
	 	 	38	 
	Annex 1.30
	 	 	39	 
	Annex 4.2.3
	 	 	40	 
	Annex 16.2
	 	 	41	 






 









 







License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation



This License Agreement is executed on this June 23, 2005, by and between




SUMITOMO PHARMACEUTICALS Co., Ltd.



a company duly established under the laws of Japan and having its principal place of business at
12-2, Kyobashi 1-chome, Chuo-ku, Tokyo, 104-8356, Japan (hereinafter “SUMITOMO”)




and



Conforma Therapeutics Corporation



a company duly established under the laws of Delaware, USA and having its principal place of
business at 9393 Towne Centre Drive, Suite 240, San Diego, CA, USA (hereinafter “CONFORMA “)




RECITALS



WHEREAS, SUMITOMO has developed and commercialized a certain anti-cancer drug (“Product” as defined
in Section 1) containing a compound known as Amrubicin Hydrochloride or SM-5887 (“Compound” as
defined in Section 1) in Japan;



WHEREAS, SUMITOMO desires to develop and commercialize the Product also in countries other than
Japan through licensing;



WHEREAS, CONFORMA has an interest in the development of the Product in North America and European
countries (“Territory” as defined in Section 1) and has an interest in obtaining rights to develop
and market the Product there;



WHEREAS, SUMITOMO and CONFORMA have exchanged certain information under the Confidential Disclosure
Agreement on Amrubicin dated August 12, 2004 in order to evaluate the possibility of business
collaboration on the Product;



WHEREAS, CONFORMA, as a result of above evaluation, desires to receive certain rights to develop
and commercialize the Product in the Territory and SUMITOMO desires to grant such rights to
CONFORMA;



NOW THEREFORE, in consideration hereof, the Parties hereby agree as follows:





	1. 	 	 DEFINITIONS
	 
	 	 	As used herein, the following terms shall have the respective meanings set forth below
unless the context clearly requires other meanings
	 
	1.1.	 	“Affiliate” or “Affiliates” shall mean any corporation or business entity controlling,
controlled by or under common control with a Party to this Agreement. For the purpose of the
foregoing, “control” shall mean the direct or indirect ownership of more than fifty percent
(50%) of the voting stock in such corporation or other entity, or the de facto decision-making
power in such corporation or entity
	 
	1.2.	 	“Annex” or “Annexes” shall mean any document attached to this Agreement with the title of
“Annex” which constitutes a part of this Agreement and is legally binding.
	 
	1.3.	 	“Authorization” shall mean an approval or a permit to market the Product, including




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




	 	 	pricing and reimbursement approval where required, in any of the countries within the
Territory which is granted by the Regulatory Authority.
	 
	1.4.	 	“Combination Product” shall mean a Finished Product sold by CONFORMA, its Affiliates or its
Sublicensees that contains a Compound together with at least one other active pharmaceutical
ingredient.
	 
	1.5.	 	“Commercially Reasonable Efforts” shall mean efforts consistent with those generally utilized
by companies of a similar size for their own internally developed pharmaceutical products of
similar market potential, at a similar stage of their product life taking into account the
existence of other competitive products in the market place or under development, the
proprietary position of the product, the regulatory structure involved, the anticipated
profitability of the product and other relevant factors. It is understood that such product
potential may change from time to time based upon changing scientific, business and marketing
and return on investment considerations.
	 
	1.6.	 	“Compound” shall mean the compound known as Amrubicin (international nonproprietary name)
hydrochloride which is generically known as (+)-(7S,
9S)-9-acetyl-9-amino-7-[(2-deoxy-b-D-erythro-pentopyranosyl)            

oxy]-7,8,9,
10-tetrahydro-6,11-dihydroxy-5,12-naphthacenedione hydrochloride as more fully
described in Annex 1.6 hereto.
	 
	1.7.	 	“Control” or “Controlled by” shall mean, with respect to any item of Information, Patent or
Know-how, possession of the right, whether directly or indirectly, and whether by ownership,
license or otherwise, to assign, or grant a license, sublicense or other right to or under,
such Information, Patent or Know-how as provided for herein without violating the terms of any
agreement or other arrangement with any Third Party.
	 
	1.8.	 	“Data Protection” shall mean certain data exclusivity and market exclusivity available to the
Product under a pharmaceutical law, regulation or any other governmental decree or order of a
certain country within the Territory.
	 
	1.9.	 	“Development” in the Territory shall mean all the activities necessary to obtain the
Authorization, including, but not limited to, pre-clinical studies, clinical studies, and
preparation of the documents for the submission to the Regulatory Authority.
	 
	1.10.	 	“Effective Date” shall mean the date on which this Agreement is executed.
	 
	1.11.	 	“EMEA” shall mean the European Medicines Agency, or any successor regulatory authority in
Europe.
	 
	1.12.	 	“Europe” shall mean the countries comprising the European Union on the date of the first
submission for the Authorization of the Product to EMEA or to the Regulatory Authorities of
one of the Major European Countries.
	 
	1.13.	 	“Finished Product” shall mean a packaged and labeled Product for commercial sale under
Authorization.
	 
	1.14.	 	“Generic Product(s)” shall mean any pharmaceutical products having the same active
pharmaceutical ingredient and sold for the same indication and in same dosage form as the
Compound.
	 
	1.15.	 	“Generic Product Entry” shall mean, for a given country of the Territory, the first day of
the first calendar quarter for which publicly reported quantity of sales in units of Generic
Product(s) during such quarter exceed twenty percent (20%) of the aggregate quantity of all
units of Generic Product(s) and Product sold in the relevant country during the same
calendar quarter.




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




	1.16.	 	“Improvements” shall mean, whether patentable or not, new compositions and processes
pertaining directly to the Compound and/or the Product, or new techniques of using, applying,
administering, or manufacturing the Compound and/or the Product which are owned or Controlled
by CONFORMA or its Affiliates during the term of this Agreement.
	 
	1.17.	 	“IND” shall mean an investigational new drug application filed with the FDA for
authorizations to commence human clinical trials, or its equivalent in other countries within
the Territory, as applicable.
	 
	1.18.	 	“Initial Period” shall mean, on a country-by-country basis and on a Product-by-Product
basis, the period from the Effective Date through the later of:






	 	(a)	 	the end of the calendar month following the tenth (10th) anniversary of the
Launch; or
	 
	 	(b)	 	the Generic Product Entry.






	1.19.	 	“Know-how” shall mean, whether patentable or not, all the proprietary information or data
related to the research and development of the Compound and/or the Product, or those related
to the marketing, using, sale or distribution of the Finished Product which is owned or
Controlled by SUMITOMO or its Affiliates as of the Effective Date or during the term of this
Agreement, including without limitation all the data, documentation and other information
contained in or making up the regulatory filings made by SUMITOMO or its Affiliates for the
Product outside the Territory.
	 
	1.20.	 	“Launch” shall mean, on a county-by-country basis, the date of the first commercial sale of
the Finished Product by CONFORMA, its Affiliate or its Sublicensee in a given country after
Authorization in such country. For the avoidance of doubt, the first commercial sale of the
Finished Product shall mean the date on which CONFORMA, its Affiliates, and/or the Sublicensee
ship the first Finished Product in such given country to distributors, wholesalers or other
end users.
	 
	1.21.	 	“Licensee” shall mean any company or legal entity other than SUMITOMO’s Affiliates which is
granted by SUMITOMO a right to import, use, develop, register, market, promote, distribute
and/or sell the Compound and/or the Product outside the Territory.
	 
	1.22.	 	“Major European Countries” shall mean any or all of the United Kingdom, Germany, France,
Spain and Italy.
	 
	1.23.	 	“Manufacturing Technology” shall mean all methods, processes, technology, information, data,
results of tests, studies, and analyses, whether patentable or not which are specifically
related to the manufacturing process of the Compound and/or Product, owned or Controlled by
SUMITOMO or its Affiliates as of the Effective Date or during the term of this Agreement.
	 
	1.24.	 	“NDA” shall mean a new drug application filed with the FDA for authorization to market a
pharmaceutical product or its equivalent in other countries within the Territory, as
applicable.
	 
	1.25.	 	“Net Sales” shall be defined as the gross amount invoiced by CONFORMA, its Affiliates,
and/or its Sublicensees upon sales of the Finished Product to unaffiliated Third Parties, less
the following items pertaining to such Finished Product, consistent with U.S. GAAP:






	 	(a)	 	trade quantity and cash discounts actually allowed;




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




	 	(b)	 	commissions, discount, refunds, rebates, charge backs, retroactive price
adjustment, and any other allowance paid to Third Parties that effectively reduce net
selling price;
	 
	 	(c)	 	actual Finished Product returns and allowances;
	 
	 	(d)	 	freight, shipping, packing, and insurance charges;
	 
	 	(e)	 	use, sales or other taxes, duties or tariffs applicable to the import, export
or sale of Finished Products (excluding taxes based on the selling party’s income);
and
	 
	 	(f)	 	any other similar or customary deductions, as consistent with U.S. GAAP.






	1.26.	 	“Party” shall mean SUMITOMO or CONFORMA and “Parties” shall mean SUMITOMO and CONFORMA.
	 
	1.27.	 	“Patent” or “Patents” shall mean any or all patents and patent applications filed or owned
or Controlled by SUMITOMO or its Affiliates as of the Effective Date or during the term of
this Agreement in any country within the Territory which cover the Compound, the Product, the
Finished Product and/or its use, including any continuation, continuation in part, divisional
or reissue patent application(s), re-examinations, renewals, substitutions, provisionals,
inventor’s certificates or patent addition(s), or patent(s) filed thereon and any extension(s)
thereof (by way of example, an extension by supplementary protection certificate) and any
patents issuing therefrom; provided, however, that in the event any claimed invention
theretofore covered by the Patents shall no Ionger be covered thereby for any reason
whatsoever, including expiration, renunciation, abandonment, disclaimer, withdrawal, failure
to maintain, or an adjudication of invalidity by a court of competent jurisdiction from the
judgment of which no further appeal can be taken, such invention shall be deemed automatically
excluded from the term “Patents” to such extent. Annex 1.27 is the list of the Patents as of
the Effective Date which is to be updated from time to time by mutual agreement.
	 
	1.28.	 	“Product” shall mean pharmaceutical products for human use containing the Compound as a
pharmaceutically active ingredient in unlabeled vial.
	 
	1.29.	 	“Regulatory Authority” shall mean the governmental organization or the
administrative body subject to state supervision which has authority to regulate
pharmaceutical affairs in a country within the Territory, and more specifically, which has
authority to grant marketing authorizations for pharmaceutical products and/or authority to
decide prices of pharmaceutical products in such country.
	 
	1.30.	 	“Specifications” shall mean, after the NDA filing in the USA, those specifications for the
Product mutually agreed upon by the Parties and set forth in the NDA filed in the USA. Prior
to such application, Specifications shall refer to the specifications for the Product as
tested mutually agreed upon by the Parties and pursuant to the IND opened in the USA. Prior
to the IND, Specifications shall refer to the specifications for the Product described in
Annex 1.30, which may be changed or modified with the prior written agreement of the Parties.
	 
	1.31.	 	“Sublicensee” shall mean any company or legal entity other than CONFORMA’s Affiliates which
is sublicensed by CONFORMA all or a part of CONFORMA’s rights granted hereof.
	 
	1.32.	 	“Supply Agreement” shall have the meaning ascribed to it in Section 6.
	 
	1.33.	 	“Territory” shall mean North America and Europe.
	 
	1.34.	 	“Third Party” or “Third Parties” shall mean any or all persons or entities other than (a)




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation





	 	 	SUMITOMO, any of its Affiliates or Licensees or (b) CONFORMA, any of its Affiliates or
Sublicensees.
	 
	1.35.	 	“Trademark” or “Trademarks” shall mean any or all trademarks or tradenames to be selected by
CONFORMA pursuant to Section 7.1. for use on and in connection with the Finished Product in
the Territory.




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




	2. 	 	 GRANT OF RIGHTS 
	 
	2.1.	 	Exclusive Right
	 
	 	 	Subject to the terms and conditions of this Agreement, SUMITOMO (on behalf of itself and its
Affiliates) hereby grants to CONFORMA and CONFORMA hereby accepts an exclusive right and
license (even as to SUMITOMO and its Affiliates), with a right to sublicense as set forth in
Section 2.2, under the Patents and the Know-how (a) to import and use the Compound and the
Product, (b) to develop, register, import, use, market, promote, distribute and sell the
Product or Finished Product, and (c) to use the Trademark, each of (a), (b) and (c) within
the Territory. The right and license granted to CONFORMA under this Section 2.1. excludes
the right to manufacture the Compound and the Product in Initial Period.
	 
	2.2.	 	Sublicense
	 
	 	 	CONFORMA may sublicense its rights hereof to its Affiliates and/or a Third Party, provided
that in case of sublicense to a Third Party, CONFORMA shall obtain SUMITOMO’s prior written
consent which shall not be unreasonably withheld, conditioned or delayed. CONFORMA shall
ensure that any such Sublicensee complies with at least the same obligations as CONFORMA
assumes under this Agreement and the Supply Agreement, and CONFORMA shall make to SUMITOMO
the same milestone payments, bonus payments, payment for the Product, royalties for the
Manufacturing Technology and the Trademark license, as those which CONFORMA should pay if it
developed or marketed the Product by itself.
	 
	2.3.	 	License Grant Back to SUMITOMO
	 
	 	 	CONFORMA grants to SUMITOMO a non-exclusive, perpetual, royalty-free license, with a right
to sublicense, of the Improvements to develop, register, manufacture, import, use, market,
promote, distribute and sell the Compound and/or Product outside the Territory.
	 
	 	 	During the term of this Agreement, CONFORMA shall advise SUMITOMO as soon as
commercially reasonable of any Improvements necessary or useful for the development or
commercialization of the Product outside the Territory.
	 
	3.	 	 CONSIDERATION
	 
	 	 	In partial consideration of the rights and licenses granted to CONFORMA hereof, CONFORMA
shall pay SUMITOMO according to the schedule set forth in Section 3.1 and 3.2. The
remaining consideration shall be paid as a part of the Purchase Price and as a royalty for
the Trademark according to the Supply Agreement and Section 7.4. of this Agreement,
respectively.
	 
	3.1.	 	Up-front and Milestone Payments




CONFORMA shall pay to SUMITOMO, up to a total amount of [***] US Dollars
(US$ [***]) within thirty (30) days after the first occurrence of the following events:




	 	 	 
	          [Events]            	 	[Payments]
	(i) On signing:

	 	USD [***] million
	(ii) Upon first-patient-in of the first clinical trial
of the Product sponsored by CONFORMA:

	 	USD [***] million
	(iii) On receipt of Authorization in the USA:

	 	USD [***] million
	(iv) On receipt of first Authorization in Europe:

	 	USD [***] million





 




			
	***	 	Confidential Treatment Requested




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




	3.2.	 	Bonus Payments
	 
	 	 	CONFORMA shall pay to SUMITOMO the following one-time bonus payments within ninety (90)
days from the end of the first calendar year in which total annual Net Sales in the
Territory exceeds:





	 	 	 
	         [Events]            	 	[Payments]
	(i) USD 25 million:

	 	USD [***] million
	(ii) USD 50 million

	 	USD [***] million
	(iii) USD 100 million

	 	USD [***] million







	 	 	In case foregoing two events occur in the same calendar year, CONFORMA shall pay both
bonus payments to SUMITOMO at the same time.
	 
	3.3.	 	Sublicensee Payments
	 
	 	 	In the event that CONFORMA receives any up-front or milestone payments, excluding equity
investment or reimbursement of expenses, from its Sublicensee as a consideration of the
sublicense of CONFORMA’s rights granted hereof, (a) if received by CONFORMA during the
period from the Effective Date through the Launch (the “Development Period”), CONFORMA shall
pay to SUMITOMO [***] percent ([***]%) of any such amounts received
during the Development Period within thirty (30) days of receipt; and (b) if received by
CONFORMA after the last day of the Development Period, the amount of such payments shall be
deemed to be Net Sales.
	 
	3.4.	 	Non-Refundability
	 
	 	 	Unless otherwise agreed in this Agreement, all the payments set forth in this Section 3 are
non-refundable once they have been paid, and are not creditable to other payment obligations
of CONFORMA.
	 
	4. 	 	 DEVELOPMENT
	 
	4.1.	 	Technology Transfer






	 	(i)	 	As soon as commercially reasonable after the Effective Date of this Agreement,
SUMITOMO shall disclose and make available to CONFORMA, free of charge, all the
Know-how to the extent necessary or useful to the Development.
	 
	 	(ii)	 	CONFORMA shall provide SUMITOMO, free of charge, with the following information
which CONFORMA, its Affiliates, and its Sublicensees obtain from the Development or
marketing activities in the Territory, as soon as commercially reasonable after
CONFORMA acquires such information, or if specifically so designated below, at
SUMITOMO’s request:






	 	a)	 	abstracts and summaries of the Development data, and at SUMITOMO’s
request, copies thereof,
	 
	 	b)	 	copies of documents submitted to or filed with the Regulatory Authority,
	 
	 	c)	 	safety and efficacy data,
	 
	 	d)	 	new indication or new formulation which may be applied to the Product.







 




			
	***	 	Confidential Treatment Requested




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation









	 	 	 	Subject to Section 13 of this Agreement, SUMITOMO, its Affiliates and its Licensees
shall be free to use the foregoing information provided by CONFORMA for the purposes of
developing or marketing the Product outside the Territory, pursuant to Section 2.3.
	 
	 	(iii)	 	SUMITOMO shall provide CONFORMA, free of charge, with the following
information which SUMITOMO, its Affiliates and its Licensees obtain from the
development or marketing activities outside the Territory, as soon as commercially
reasonable after SUMITOMO acquires such information, or if specifically so designated
below, at CONFORMA’s request:






	 	a)	 	abstracts and summaries of the development data, at CONFORMA’s request,
copies thereof,
	 
	 	b)	 	copies of documents submitted to or filed with regulatory authorities
outside the Territory, at CONFORMA’s request,
	 
	 	c)	 	safety and efficacy data,

	 
	 	d)	 	new indication or new formulation which may be applied to the Product.






	 	 	 	Subject to Section 13 of this Agreement, CONFORMA, its Affiliates and its
Sublicensees shall be free to use the foregoing information provided by SUMITOMO for the
purposes of developing or marketing the Product in the Territory, pursuant to Sections
2.1 and 2.2.
	 
	 	(iv)	 	SUMITOMO shall disclose the Manufacturing Technology only to the extent
necessary for CONFORMA to obtain Authorization in the Territory. In connection with
the foregoing, if SUMITOMO establishes and maintains a Drug Master File (“DMF”) with
the Regulatory Authority, SUMITOMO grants CONFORMA, its Affiliates and its Sublicensees
a right to reference to the data included in the DMF for incorporation into the NDA and
agrees to provide such further written authorizations as may be required to effectuate
this right of reference.






	4.2.	 	Implementation of Development






	 	4.2.1.	 	Implementation of Development






	 	 	CONFORMA shall have the sole responsibility for conducting the clinical Development in the
Territory. The cost of clinical Development in the Territory shall be borne by CONFORMA.
The cost of non-clinical Development activities in the Territory initiated by CONFORMA after
the Effective Date shall be borne by CONFORMA.
	 
	 	 	CONFORMA undertakes to give SUMITOMO progress reports of the Development on a semi annual
basis covering items such as the status of recruitment and registration of the patients, the
result of each trial and the status of preparation of the regulatory documents for IND or
NDA.
	 
	 	 	It is understood and agreed that SUMITOMO has a right to participate in the investigators
meetings held in the Territory and in the meetings with Regulatory Authorities in the
Territory, provided that SUMITOMO’s participation shall be passive and without a right to
comment.






	 	4.2.2.	 	Joint Steering Committee






	 	 	In order to facilitate the development of the Product and share the information and
coordinate each Party’s development activities in and outside the Territory, CONFORMA
and




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation





	 	 	SUMITOMO shall organize and hold a Joint Steering Committee meeting at least twice in each
calendar year but no more than four times a year, unless required by exceptional
circumstances. The meetings will be held in the form of face-to-face meeting,
teleconference or videoconference. The Joint Steering Committee shall consist of two (2)
representatives of each Party. The Parties shall hold the first Joint Steering Committee
meeting within sixty (60) days of the Effective Date.
	 
	 	 	The Joint Steering Committee shall have responsibility to:






	 	(i)	 	discuss the development plan (including any revisions thereof) for the Product
in the Territory, with the general time schedule (“Development Plan” as more fully
described in Section 4.2.3.);
	 
	 	(ii)	 	discuss protocols of clinical studies for the Development;
	 
	 	(iii)	 	ensure the appropriate sharing of data and information relating to the
Development of the Product in the Territory and the development of the Product outside
the Territory;
	 
	 	(iv)	 	review and evaluate CONFORMA’s Development activities and the Development
efforts, including but not limited to the Development strategy and study protocols;
	 
	 	(v)	 	discuss the coordination of each Party’s respective Development activities
relating to the Product;
	 
	 	(vi)	 	discuss a coordinated publication strategy for the Product;
	 
	 	(vii)	 	review the requirements of the Compound and the Product for the Development by
CONFORMA, including forecasts thereof; and
	 
	 	(viii)	 	discuss the expansion of indications, Improvements and life cycle management.
	 
	 	4.2.3.	 	Development Plan






	 	 	CONFORMA shall have the sole responsibility for designing and implementing the Development
Plan in the Territory provided that such design and implementation is done using
Commercially Reasonable Efforts. CONFORMA shall have the final decision making right with
respect to the Development Plan, provided that such decisions are made in a commercially
reasonable manner and that CONFORMA presents the draft of the Development Plan to SUMITOMO
at least thirty (30) days prior to the Joint Steering Committee meetings, explains the draft
to SUMITOMO and refers to SUMITOMO’s comments and opinions in the Joint Steering Committee
meetings before finalizing the Development Plan, and provided further that in the event of a
material delay in the Development, SUMITOMO has the rights described below.
	 
	 	 	The Development Plan shall contain an estimated timeline for clinical studies and the filing
of NDA or its equivalent documents in the Territory [***].
	 
	 	 	The draft for the Development Plan as of the Effective Date is attached hereto as Annex
4.2.3.
	 
	 	 	CONFORMA shall use Commercially Reasonable Efforts to implement the Development Plan,
contingent on SUMITOMO fulfilling its obligations under Sections 4.1(i), 4.1(iii) and 4.3.1
of this Agreement. Any revision of the Development Plan requires the discussions in the
Joint Steering Committee meetings as described above.







 




			
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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




	 	 	If CONFORMA foresees or becomes aware of any material delay in the Development Plan that
would delay the planned NDA filing date, CONFORMA shall provide SUMITOMO with a description
of the nature of the delay and a revised Development Plan within thirty (30) days after
becoming aware of such delay and CONFORMA and SUMITOMO shall hold a Joint Steering Committee
meeting within thirty (30) days thereafter.
	 
	 	 	If there is a material delay in the implementation of the Development Plan and CONFORMA is
not able to demonstrate to SUMITOMO’s reasonable satisfaction that it used Commercially
Reasonable Efforts in carrying out the Development Plan under this Section 4.2.3., SUMITOMO
may terminate the rights granted to CONFORMA under thisAgreement pursuant to Section 14.3.
However, in case such material delay would occur only in Europe, SUMITOMO may terminate this
Agreement only with respect to Europe, and upon such termination, all the member states of
the Europe shall be excluded from the Territory.
	 
	 	 	If the delay is attributable to CONFORMA’s negligence or willful misconduct with respect to
Section 4.2.3, SUMITOMO may, at its discretion, terminate this Agreement in its entirety
pursuant to Section 14.3., but upon shorter notice period of thirty (30) days.
	 
	 	 	In addition to the draft of the Development Plan, CONFORMA shall send to SUMITOMO all the
draft of the study protocols before finalization and refer to SUMITOMO’s comment.
	 
	4.3.	 	Clinical Supplies for Development






	 	4.3.1.	 	Supply of Product






	 	 	SUMITOMO shall supply CONFORMA, its Affiliates’ and/or Sublicensees’ with their requirements
for Product for use in Development. Product supplied by SUMITOMO for Development purposes
shall be provided free of charge in quantities not to exceed eight thousand (8000) 50mg
vials. If CONFORMA requires supplies of the Product in excess of this amount, SUMITOMO
shall supply such excess amounts of Product to CONFORMA at the Minimum Price as defined in
Section 6.2.1 or the Supply Agreement.
	 
	 	 	CONFORMA shall place its first order for clinical supplies no later than thirty (30) days
following the Effective Date, to be delivered no later than January 15, 2006. CONFORMA
shall place subsequent orders for clinical supplies at least six (6) months prior to the
desired delivery date. SUMITOMO will use commercially reasonable efforts to meet CONFORMA’s
requested quantities and delivery dates. SUMITOMO shall notify CONFORMA of the specific
delivery date and quantity for each subsequent order no later than (2) months following
CONFORMA’s order.
	 
	 	 	Additionally, SUMITOMO shall use commercially reasonable efforts to deliver one hundred
(100) 50mg vials of Product no later than September 30, 2005 which CONFORMA will use for the
purposes of certifying Third Parties who will conduct release testing, labeling and
packaging.
	 
	 	 	The trade term which applies to the transaction of the Compound and the Product under this
Section 4.3 shall be FCA (INCOTERMS 2000) Kansai International Airport, Japan.






	 	4.3.2.	 	Specifications






	 	 	All the Product for clinical trials supplied by SUMITOMO shall conform to the Specifications
and cGMP of the USA.




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation











	 	4.3.3.	 	Labeling and Packaging






	 	 	CONFORMA shall label and package the Product for Development.
	 
	5.	 	MARKETING AND PROMOTION
	 
	5.1.	 	Commercially Reasonable Efforts to Market
	 
	 	 	CONFORMA shall use Commercially Reasonable Efforts to commercialize the Finished
Product in the Territory as soon as reasonably practicable given applicable business and
market conditions and the regulatory environment and contingent on SUMITOMO fulfilling its
obligations under Sections 4.1.(i) and 4.1.(iii) of this Agreement and to supply the
Product under Section 6 or the Supply Agreement.
	 
	5.2.	 	Commercialization Plan
	 
	 	 	Within sixty (60) days after completion of the last clinical trial for the NDA for the first
country in which an NDA is to be made, CONFORMA shall provide SUMITOMO with a three (3) year
commercialization plan (“Commercialization Plan”) which will be updated by the end of third
quarter every year. The Commercialization Plan shall include CONFORMA’s launch plans, such
as publication planning, opinion development, positioning and pricing strategies, campaign
development and annual marketing strategy for the Product as well as annual sales forecast
of the Product in value separately for North America and Europe. CONFORMA’s
commercialization plans shall set forth that CONFORMA will launch the Finished Product in
the USA within three (3) months from the date on which the Authorization is granted in the
USA and launch the Finished Product at least in three of five Major European Countries
within one (1) year after receipt of Authorization in each such country.
	 
	 	 	If CONFORMA foresees or becomes aware of any material delay in the commercialization plan
that would delay the actual Launch date of the Finished Product more than ninety (90) days,
CONFORMA will provide SUMITOMO with a description of the nature of the delay and a revised
Annual Commercialization Plan for the impacted countries within sixty (60) days after
becoming aware of such delay.
	 
	 	 	If CONFORMA is not able to demonstrate to SUMITOMO’s reasonable satisfaction that there are
reasonable commercial reasons for the material delay of the Launch date such as reasons
related to pricing and reimbursement, SUMITOMO may terminate the rights granted to CONFORMA
under this Agreement pursuant to Section 14.3. However, in case such material delay would
occur only in Europe, SUMITOMO may terminate this Agreement only with respect to Europe, and
upon such termination, all the member states of the Europe shall be excluded from the
Territory
	 
	 	 	
If the delay is attributable to CONFORMA’s negligence or willful misconduct with respect to
this Section 5.2., SUMITOMO may, at its discretion, terminate this Agreement in its entirety
pursuant to Section 14.3., but upon shorter notice period of thirty (30) days.




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation










	5.3.	 	Minimum Sales
	 
	 	 	CONFORMA shall achieve the minimum sales which is seventy percent (70%) of the annual sales
forecast as specified in the Commercialization Plan (“Minimum Sales”). For the purpose of
defining CONFORMA’s Minimum Sales requirement, only the sales forecast specified in the
latest Commercialization Plan prior to the start of the relevant calendar year shall be
binding, and with respect to the Minimum Sales requirement for the period covering the first
Launch in the Territory to December 31st of such year, CONFORMA may update the
sales forecast by the time of the expected Authorization date in the USA. If CONFORMA fails
to achieve the Minimum Sales for any consecutive two (2) calendar years in North America or
Europe, SUMITOMO may, at its discretion, terminate this Agreement pursuant to Section 14.3.
or convert CONFORMA’s exclusive license to non-exclusive upon thirty (30) days’ written
notice with respect to the area where CONFORMA cannot achieve the Minimum Sales (i.e., North
America or Europe); provided, however, that CONFORMA may, in lieu of such termination or
conversion, agree prior to the expiration of such thirty (30) day period to pay to SUMITOMO
an amount equal to the Minimum Sales minus the actual sales during the relevant period
multiplied by 1/2 of the Calculated Price (e.g., 1/2 of [***]% or 1/2 of
[***]%, as the case may be). For the avoidance of doubt, if the Minimum Sales
were $10 million and the actual sales for the applicable period were $7 million and the
Calculated Price is [***]%, the payment would be equal to $[***].
	 
	 	 	In the event that SUMITOMO elects to convert the exclusive license to
non-exclusive, CONFORMA will provide commercially reasonable support to SUMITOMO or its
designee in their efforts to obtain additional Authorizations in the relevant
geographic area. CONFORMA is not entitled to receive any compensation in relation to
such support.
	 
	5.4.	 	Sales Outside the Territory
	 
	 	 	CONFORMA and its Affiliates shall not market the Finished Product outside the Territory or
export the Product or the Finished Product to countries outside the Territory and shall
terminate any agreements with any Sublicenses who market the Finished Product outside the
Territory or export the Product or the Finished Product to countries outside the Territory.
	 
	 	 	SUMITOMO and its Affiliates shall not market the Finished Product in the Territory or export
the Product or the Finished Product to countries within the Territory and shall terminate
any agreements with any Licensees who market the Finished Product within the Territory or
export the Product or the Finished Product to countries within the Territory.
	 
	5.5.	 	Labels and Packages
	 
	 	 	The package and label of the Product, and advertising and promotional materials for the
Product shall appropriately include relevant Patent information in accordance with the laws
in each country within the Territory and such other information as required by the laws in
each country within the Territory, and shall also indicate for the USA and the Major
European Countries, at SUMITOMO’s request and to the extent the laws and regulations of the
Territory permit, that the Product is manufactured and marketed under a license from
SUMITOMO. Upon the reasonable request of SUMITOMO, CONFORMA shall provide SUMITOMO, free of
charge, with samples of labels, packages, advertising and promotional materials used in the
designated countries in the Territory for information purposes.





 




			
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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




	5.6.	 	Competing Product
	 
	 	 	During the Initial Period, CONFORMA shall not market, promote or sell any pharmaceutical
product which contains an anthracycline anti-cancer agent as an active ingredient which is
directly competitive in the market (“Competing Product”) in any country within the
Territory.
	 
	 	 	Notwithstanding the above, in case CONFORMA acquires any Competing Product marketed,
promoted and/or sold in any country within the Territory as a result of merger, acquisition
or transfer of business, then CONFORMA shall divest or license out the right to such
Competing Product to a Third Party within one hundred and eighty (180) days of the
acquisition of such Competing Product.
	 
	 	 	The failure to comply with the provision in this Section 5.6. will give SUMITOMO:






	 	(i)	 	the right to immediately terminate this Agreement without cure period with
respect to the affected country pursuant to Section 14.3, upon notice; or
	 
	 	(ii)	 	the right to convert the exclusive license hereof to non-exclusive with respect
to the affected country on prior written notice to CONFORMA.






	 	 	In the event that SUMITOMO elects to exercise the right of the foregoing clause (ii),
CONFORMA will provide reasonable support to SUMITOMO or its designee in their efforts to
obtain additional Authorizations in such country. CONFORMA is not entitled to receive any
compensation in relation to such support.
	 
	6. 	 	 SUPPLY OF PRODUCT
	 
	6.1.	 	Supply of Product






	 	6.1.1.	 	Supply Agreement






	 	 	Within six (6) months of the Effective Date the Parties shall enter into a separate document
(“Supply Agreement”) which, unless otherwise agreed by both Parties, restates the terms and
conditions set forth in this Section 6. and is supplemented by such other terms and
conditions as are customary in the supply of pharmaceutical products. In the event the
Parties fail to agree on the terms and conditions of the Supply Agreement within such six
(6) month period, the provisions of Section 6. shall control.






	 	6.1.2.	 	Requirements






	 	 	SUMITOMO will supply CONFORMA with the Product to be sold by CONFORMA, its Affiliates and
Sublicensees. CONFORMA shall purchase from SUMITOMO all the Product to be sold by
CONFORMA, its Affiliates and Sublicensees in the countries during the Initial Period.
	 
	 	 	In the event that CONFORMA desires to purchase the Product from Third Parties or to
manufacture the Product itself for use by CONFORMA, its Affiliates or Sublicensees in
countries where the Initial Period has expired, CONFORMA shall provide SUMITOMO with two (2)
years’ prior notice thereof.




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation










	 	6.1.3.	 	Specifications






	 	 	All of the Product supplied by SUMITOMO shall conform to the Specifications and cGMP of the
USA. With respect to the GMP of other relevant countries, CONFORMA shall inform SUMITOMO of
the specific requirements thereof in writing in a timely manner if such requirements are
different from cGMP of the USA. SUMITOMO shall use its Commercially Reasonable Efforts to
satisfy such special requirements.






	 	6.1.4.	 	Delivery






	 	 	All the Product shall be delivered to CONFORMA FCA (Incoterms 2000) at Kansai International
Airport, Japan.
	 
	6.2.	 	Payment






	 	6.2.1.	 	Purchase Price during the Initial Period






	 	 	The price for the Product shall be calculated semiannually based on Net Sales of the Product
for each of the first six months and second six months of each calendar year (the
“Semiannual Periods”) with respect to the Product to be sold in the countries during the
Initial Period in the following manner:
	 
	 	 	The price at which the Product should be sold by SUMITOMO to CONFORMA, its Affiliates or
Sublicensees (the “Purchase Price”) shall be the higher of the following:
	 
		 	(i) The amount resulting from the application of the following formula (the “Calculated
Price”):






	 	 	 	(A × B) ÷ C
	 
	 	 	 	Where:
	 
	 	A =  	 	 Net Sales during the relevant Semiannual Period;
	 
	 		 	B =   [***] ([***]%) until the end of the month
of the second (2nd) anniversary of the first Launch in the Territory, and
thereafter, [***] ([***]%);
	 
	 		 	C =   the number of fifty (50) mg vials of the Product actually
sold by CONFORMA, its Affiliates or Sublicensees during the relevant Semiannual
Period;
	 
	 	or	 	 
	 
	 	(ii)	 	[***] per fifty (50) mg unlabeled vial (the “Minimum Price”).
	 
	 	 	 	The Purchase Price will include the manufacturing cost of the Product and running royalties
for the licenses for Patents, Know-how and Trademarks granted with respect thereto under
this Agreement.
	 
	 	6.2.2.	 	Payments Procedure






(i) SUMITOMO shall invoice CONFORMA in US Dollars (“USD”) only after a shipment of the
Product is available under FCA as set forth in Section 6.1.4 above. Payment for each
shipment shall be made within two (2) months from the date of invoice and as directed by
SUMITOMO.





 




			
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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




(ii) At each shipment, SUMITOMO shall issue the invoice based on the Minimum Price
calculated in USD at the average of Telegraphic Transfer Middle (TTM) rate published by the
Bank of Tokyo Mitsubishi on the last banking day of the month proceeding the month of
shipment.




(iii) Within two (2) months of the end of each Semiannual Period CONFORMA shall calculate
the Net Sales and the Calculated Price of the said Semiannual Period in USD. With respect
to sales of any Finished Products invoiced in a currency other than USD, the Net Sales
hereunder shall be converted from local currency to USD by CONFORMA and such exchange shall
be determined based on the USD equivalent exchange rate as reported in the Unites States
Federal Reserve Statistical Release: Foreign Exchange Rates (Annual), available on-line at
http://www.federalreserve.gov/releases/ for said calendar year.




(iv) CONFORMA shall provide SUMITOMO with a financial report showing the Net Sales and
Calculated Price within two (2) months of the end of each Semiannual Period.




(v) If the Calculated Price in the relevant Semiannual Period calculated in accordance with
the foregoing is higher than the Minimum Price by CONFORMA, CONFORMA shall pay the
difference as running royalties for the rights granted hereunder by the end of third month
following the end of said Semiannual Period with the financial report for such Semiannual
Period including the information of annual sales volume, Net Sales, Calculated Price and
amount of running royalties with the exchange rate applied.




(vi) The Parties shall treat such financial reports and information as confidential under
Section 13 of this Agreement and shall cause their respective accounting firms to retain all
such financial reports and information in confidence.




6.2.3. Adjustments to Purchase Price After the Initial Period




With respect to the Product to be sold in the countries where the Initial Period has
expired, SUMITOMO will continue the supply of the Product to CONFORMA under the conditions
of clause (i) below unless CONFORMA elects to pursue the option under clause (ii) below.




(i) If CONFORMA, its Affiliates or Sublicensees wish to continue to purchase the Product
from SUMITOMO, the Purchase Price shall be adjusted to the higher of (a) the price defined
as [***] percent ( [***] %) of the Net Sales divided by the number of
fifty (50) mg vials of the Product actually sold by CONFORMA, its Affiliates or Sublicensees
or (b) the new Minimum Price that the Parties will discuss in good faith and agree to. In
the event the Parties fail to agree upon the new Minimum Price, the Minimum Price shall
remain [***] per fifty (50) mg unlabeled vial.




(ii) If CONFORMA, its Affiliates or Sublicensees decide to purchase the Product from a Third
Party or manufacture the Product by itself, upon the request of CONFORMA and the provision
to SUMITOMO of two (2) years’ notice pursuant to Section 6.1.2, SUMITOMO will license to
CONFORMA, its Affiliates or its Sublicensees the Know-how and Manufacturing Technology which
is necessary or useful for manufacturing the Compound and Product. In such event, as
consideration of such license, CONFORMA shall pay to SUMITOMO [***] percent
( [***] %) of the Net Sales of the Finished Product manufactured by CONFORMA, its
Affiliates or its Sublicensees until the twenty fifth (25th) anniversary of the date of the
first Launch.


 
 




			
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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




(iii) SUMITOMO may decide after ten (10) years from the first Launch of CONFORMA to
discontinue manufacturing the Product with two (2) years prior notice to CONFORMA. In such
event, SUMITOMO shall (A) grant to CONFORMA, its Affiliate or its Sublicensee a royalty-free
license for the Know-how and Manufacturing Technology which is necessary or useful for
manufacturing the Compound and Product; (B) provide CONFORMA, its Affiliate or its
Sublicensee with any technical data incorporated in the Know-How, and SUMITOMO shall
promptly provide related documentation; and (C) assist CONFORMA, its Affiliate or its
Sublicensee with the working up and use of the Know-How and Manufacturing Technology and
with the training of personnel to the extent which may reasonably be necessary in relation
to the manufacture of the Product by CONFORMA, its Affiliate or its Sublicensee.




6.2.4. Adjustment related to Combination Product




Notwithstanding the other provisions of this Section 6.2.4, with respect to any Combination
Product, the Parties shall meet approximately one (1) year prior to the anticipated first
Launch of such Combination Product to negotiate in good faith and agree to the Minimum Price
applied to such Combination Product, as well as an appropriate adjustment to Net Sales which
will be calculated as a fraction determined as follows:



	 	 	 	 	 
	Net Sales of the Combination Product  x

	 	A
	 	 
	 	 	 	 
	 	A+B	 	 







Where “A” above represents the standard sales price of the Finished Product, containing the
same amount of the Compound as the sole active ingredient as the Combination Product in
question, in the given country and “B” above represents the standard sales price of the
ready-for-sale form of a product containing the same amount of the other active
pharmaceutical ingredient(s) that is contained in the Combination Product in question in the
given country. If such products are not sold separately, the Parties shall use good faith
efforts to agree on an appropriate mechanism for adjustment of the Net Sales for such
Combination Product. In the event the parties fail to agree on the Minimum Price to be
applied to such Combination Product or the mechanism for adjustment of such Net Sales, the
Minimum Price shall remain [***] per fifty (50) mg unlabeled vial.




	6.3.	 	Forecast and Order






	 	6.3.1.	 	Supply Forecast






(i) Eighteen (18) months prior to the expected first delivery date of Product for the first
Launch in the Territory, the Parties shall discuss the projected quantity requirements for
the Product for the first three (3) years following the first Launch in the Territory.



 
 




			
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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




(ii) Twelve (12) months prior to the beginning of the calendar quarter which contains the
expected date of the first Launch in the Territory, CONFORMA shall provide SUMITOMO with a
good faith forecast of projected quantity requirements for the Product for the forthcoming
three (3) years beginning with the calendar quarter six (6) months after the delivery of
such forecast, including the quarterly quantities of the Product for the first year and the
yearly quantities of the Product for the subsequent two years. The first quarter of the
forecast shall be deemed as a firm order. CONFORMA shall designate a delivery date within
the applicable calendar quarter at the time the forecast becomes a firm order. CONFORMA
shall update such forecast for the three (3) year period on a rolling basis by the end of
every calendar quarter thereafter during the term of this Agreement and the forecast for
each first calendar quarter shall become a firm order on a rolling basis.




6.3.2. Firm Order




The quantity of the Product in the firm order shall not be less than seventy five percent
(75%) nor more than one hundred and twenty five percent (125%) of the quantity specified in
the latest forecast for the same quarter. In case the quantity in the firm order exceeds
one hundred and twenty five percent (125%) of that in the latest forecast, SUMITOMO’s
failure to supply the quantities exceeding one hundred and twenty five percent (125%) of
that in the latest forecast shall not constitute a breach of this Agreement.




6.3.3. Quantity




The minimum order quantity (lot) per shipment shall not be less than the actual batch size
of 8000 vials.




6.3.4. Quality Assurance Tests




CONFORMA shall be responsible for (i) performing quality assurance testing of all Products
in accordance with the Specifications and (ii) notifying SUMITOMO of the result, within
forty (40) days after receipt at CONFORMA’s facilities of each shipment of the Product. On
CONFORMA’s failure to reject any Product within forty five (45) days of receipt, CONFORMA
shall be deemed to have accepted such Product. In the event that the tests performed by
CONFORMA indicate that a shipment of Product does not meet the Specifications, SUMITOMO
shall as soon as is commercially reasonable replace the quantity of the Product affected.
In such event, SUMITOMO shall be offered an opportunity to re-test such Product and if tests
performed by CONFORMA and SUMITOMO reach inconsistent results, the Parties agree to have the
Product tested by a reputable Third Party testing organization selected jointly by the
Parties and to cooperate in the furnishing of necessary analytical methodology, subject to
appropriate safeguards of confidentiality, to such testing organization. The decision of
such Third Party organization shall be binding upon both Parties and the Party whose test
results led to the false conclusion with respect to the Product meeting, or failing to meet,
Specifications shall bear the costs of such analysis and of the replacement shipment of
Product, if any; provided that if CONFORMA’s test results led to a false conclusion, the
initial shipment of Product shall be sent to CONFORMA.




6.3.5. Retention of Samples




SUMITOMO shall retain samples from each lot of the Product in quantities sufficient for
complete analysis and manufacturing batch records of each lot of the Product, until the
first (1st) anniversary of the expiration of the shelf life of such lot.



page 17









 





License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




6.3.6. Labeling and Packaging




CONFORMA shall label and package the Product for the Territory at a facility to be
determined by CONFORMA, in its sole discretion in conformity with all the laws and
regulations including GMP of the relevant countries in the Territory.




6.3.7. Backup/Complementary Source for the Manufacture of Compound or Product




SUMITOMO shall maintain a reasonable amount of safety stock for the Product and the Compound
and/or the main stable intermediate in a quantity to be agreed to by CONFORMA and SUMITOMO
no later than eighteen (18) months prior to the expected first delivery date of Product for
the first Launch in the Territory. In case of necessity, SUMITOMO and CONFORMA will discuss
the backup /complementary source.




	6.4.	 	Termination
	 
	 	 	In the event the Supply Agreement is executed, the Supply Agreement shall automatically
terminate in the event of the early termination of this Agreement for any reason. Upon the
expiration of this Agreement, the Supply Agreement will continue in effect, but each Party
may terminate the Supply Agreement upon two (2) years’ notice, which notice may be delivered
up to two (2) years prior to the expiration date of this Agreement.
	 
	7. 	 	 TRADEMARK
	 
	7.1.	 	Grant of Right
	 
	 	 	“Calsed” is the first candidate of the Trademark in the Territory but Parties shall discuss
and agree on the selection of the Trademark if Calsed is not available or not suitable as a
Trademark in the Territory. However, in the event of disagreement between Parties, CONFORMA
has the final decision-making right. Then, SUMITOMO shall file, prosecute and maintain the
Trademark at its own cost in each country within the Territory in which CONFORMA shall
market the Finished Product.
	 
	7.2.	 	Ownership
	 
	 	 	SUMITOMO shall own the Trademark.
	 
	7.3.	 	Filing, Prosecution and Maintenance
	 
	 	 	SUMITOMO shall diligently prosecute and maintain the Trademark at its sole cost and expense
and shall keep CONFORMA reasonably advised as to the status of the maintenance of the
Trademark and any clearance, applications and registrations for any substitute Trademarks.
SUMITOMO will consult with CONFORMA in a timely manner, as it relates to the Territory,
concerning:






	 	(i)	 	scope and content of any application or amendment in connection with the
Trademark prior to filing such application or amendment
	 
	 	(ii)	 	content of any proposed responses to official actions in connection with the
Trademark.




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License Agreement Amrubicin Hydrochloride (SM-5887)

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	 	 	If SUMITOMO fails to timely file for or to maintain a registration for the Trademark
following a request by CONFORMA, or to pay any fee required to maintain the Trademark,
CONFORMA shall have the right, at its expense, to clear, file, prosecute and maintain the
applications and registrations for the Trademark in SUMITOMO’s name and on SUMITOMO’s
behalf.
	 
	7.4.	 	Royalties for Trademark







	 	(i)  Even after the expiration of this Agreement, as far as CONFORMA purchases the Product
from SUMITOMO, the license set forth in Section 2.1(c) shall remain in full force and effect
and the royalties for such license are included in the Purchase Price as defined in Section
6 or the Supply Agreement.
	 
	 	(ii)  In case CONFORMA purchases the Product from a supplier other than SUMITOMO, or CONFORMA
manufactures the Product by itself, and CONFORMA wishes to continue to use the Trademark in
the Territory, the license set forth in Section 2.1(c) shall remain in full force and effect
and CONFORMA shall pay to SUMITOMO royalties for such license at a rate of [***] percent
([***]%) of Net Sales in relevant countries, on a country-per-country basis until the twenty
fifth (25th) anniversary of the date of the first Launch of the Finished Product.
Payment for above royalties shall be made within ninety (90) days from the date from the
end of calendar year and be accompanied by the financial report as described in Section 6 or
the Supply Agreement.






	7.5.	 	Infringement by Third Party
	 
	 	 	Each Party shall notify the other promptly upon learning of any actual, alleged, or
threatened infringement of the Trademark applicable to a Product or of any unfair trade
practices, trade dress imitation, passing off of counterfeit goods, or like offenses. Upon
learning of such offense, CONFORMA shall have the first right to respond to and defend any
such infringement or offense. In the event CONFORMA elects to do so, SUMITOMO will
cooperate with and provide assistance and authority to CONFORMA, provided that such
assistance is economically reasonable. In the event that CONFORMA elects, within ninety (90)
days of notification thereof, not to respond to or defend any such infringement or offense
or abandons such defense, then, in such event, SUMITOMO shall have the option to do so,
provided that CONFORMA will cooperate with and provide assistance to SUMITOMO, and provided
that such assistance is economically reasonable.
	 
	 	 	The Party bringing the foregoing action shall do so at its own cost and expense. The Party
not bringing such action agrees to join in such action as a plaintiff if necessary to
prosecute the action. Any damages or other monetary awards recovered from settlement or
judgment from such an action shall be allocated first to reimburse the costs and expenses of
the Party bringing the action, then to reimburse the costs and expenses, if any, of the
other Party (except for costs associated with the other Party being represented by counsel
of its own choice). Any amounts remaining shall be deemed as the Net Sales and the Parties
shall agree on an appropriate royalty rate to adequately share such incremental Net Sales
reflecting the principles set forth in Section 7.4.





 




			
	***	 	Confidential Treatment Requested



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	8. 	 	 REGULATORY AFFAIRS AND INSPECTIONS
	 
	8.1.	 	Acquisition and Maintenance of Authorization
	 
	 	 	CONFORMA shall have the sole responsibility for preparing and filing the INDs and the NDA
for the Product with the Regulatory Authority in the countries where CONFORMA has an
intention to market the Finished Product. CONFORMA shall immediately notify SUMITOMO of the
submission of any IND and NDA for the Product and of the grant of any Authorization.
CONFORMA shall be responsible for applying for and obtaining any extensions of the Data
Protection period in countries where CONFORMA markets the Product.
	 
	 	 	CONFORMA shall use Commercially Reasonable Efforts to make regulatory filings in the
countries where CONFORMA has an intention to market the Finished Product, contingent on
SUMITOMO fulfilling its obligations under Sections 4.1(i) and 4.1(iii) of this Agreement and
supply obligations under Section 6 or the Supply Agreement.
	 
	 	 	CONFORMA shall be solely responsible for any actions, including but not limited to clinical
trials after obtaining the Authorization, at its expense to maintain each
Authorization in the countries where CONFORMA markets the Product.
	 
	 	 	CONFORMA shall be responsible for all interactions with Regulatory Authorities in the
Territory. Authorization shall be held by CONFORMA in CONFORMA’s name in the Territory.
CONFORMA will have the sole responsibility for applying for, obtaining and maintaining
Authorization in the Territory. All expenses necessary for applying for, obtaining and
maintaining Authorization in the Territory shall be borne by CONFORMA. At CONFORMA’s
request, SUMITOMO shall cooperate in the preparation and maintenance of all regulatory
filings for the Finished Product filed by CONFORMA, including, without limitation, preparing
sections of regulatory filings that are applicable to the manufacturing activities of
SUMITOMO or to preclinical, clinical and commercial data generated by SUMITOMO.
	 
	8.2.	 	Maintenance of Data
	 
	 	 	SUMITOMO shall keep and maintain all the reports, data and raw data which SUMITOMO provides
to CONFORMA and which constitute parts of or basis of the NDA for the Product submitted by
CONFORMA for the period which the laws and regulations of the countries where CONFORMA
markets or intends to market the Product require. In order to ensure the foregoing,
CONFORMA shall inform SUMITOMO of such period. If there are any Affiliates or Third Party
which produced all or parts of the foregoing reports, data, and raw data for SUMITOMO,
SUMITOMO shall have such Affiliate or seek to have such Third Party comply with the
foregoing obligation of maintenance.
	 
	 	 	In the event that SUMITOMO notifies CONFORMA of its intent to use the reports, data and raw
data obtained by CONFORMA for the purpose of the NDA for the Product outside the Territory,
CONFORMA shall keep and maintain all such reports, data and raw data for the period which
the laws and regulations of the each country outside the Territory requires. In order to
ensure the foregoing, SUMITOMO shall inform CONFORMA of such period of each county outside
the Territory. If there is any Affiliate or Third Party which produces all or parts of the
foregoing reports, data, and raw data for CONFORMA, CONFORMA shall have such Affiliate or
seek to have such Third Parties comply with the foregoing obligation of maintenance.




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	8.3.	 	Inspections by Regulatory Authority
	 
	 	 	SUMITOMO shall accept, have its Affiliate accept, and seek to have the Third Parties who
cooperate with or assist SUMITOMO regarding the development or manufacture of the Product
outside the Territory, if any, to accept, the inspection by the Regulatory Authority if it
is required for CONFORMA to obtain or maintain the Authorization. CONFORMA will use
Commercially Reasonable Efforts to obtain the information of such inspection in advance and
forward it to SUMITOMO. SUMITOMO shall permit CONFORMA or its Affiliates to be present at
any inspection by Regulatory Authorities and shall provide advance notice of any such
inspection.
	 
	 	 	In the event that SUMITOMO uses the reports, data and raw data obtained by CONFORMA for the
purpose of the NDA for the Product outside the Territory, CONFORMA shall accept, have its
Affiliate accept, and seek to have the Third Parties who cooperate with or assist CONFORMA
regarding the Development, if any, to accept, the inspection by the regulatory authorities
of the countries outside the Territory if it is required to obtain or maintain the marketing
authorization for the Product in such country. SUMITOMO shall use Commercially Reasonable
Efforts to obtain the information of such inspection in advance and forward it to CONFORMA.
	 
	 	 	In case of requests from Regulatory Authorities regarding specific historical reports, the
Parties agree to reasonably collaborate to meet those requests.
	 
	8.4.	 	Inspections by Parties
	 
	 	 	CONFORMA may inspect SUMITOMO’s or its Affiliate’s facilities during each entity’s normal
business hours upon reasonable prior notice and SUMITOMO shall accept or shall have its
Affiliate accept such inspection to the extent such facilities relate to the manufacture of
the Compound or the Product or the maintenance of the reports, data and raw data referred to
in Section 8.2.
	 
	 	 	SUMITOMO may inspect CONFORMA’s or its Affiliate’s facilities during each entity’s normal
business hours upon reasonable prior notice and CONFORMA shall accept or shall have its
Affiliate accept such inspection to the extent such facilities relate to the Development,
manufacture, or distribution of the Product in the Territory.
	 
	 	 	Each Party shall use Commercially Reasonable Efforts to have the Third Parties who are
entrusted or contracted out to a part of each Party’s responsibility under this Agreement,
if any, to accept the foregoing inspections by the other Party.
	 
	8.5.	 	Pharmacovigilance / Drug Safety Matters
	 
	 	 	The Parties agree to inform each other about adverse events occurring or having occurred in
connection with the use of the Compound or the Product which comes into its knowledge. The
Parties agree to handle data and information about adverse events occurring or having
occurred in connection with the use of the Compound or the Product according to the
respective ICH-Guidelines, FDA requirements, requirements of the relevant European
registration authorities, requirements of the Regulatory Authority and/or requirements of
any other relevant regulatory authority.
	 
	 	 	The Parties shall execute a separate agreement specifying the procedure for the information
exchange of the adverse drug reactions which may occur during the Development no later than
the Initiation by CONFORMA of the first clinical trial of the Product in the Territory
(“Clinical Pharmacovigilance Agreement”).




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	 	 	After completion of the last clinical trial for the NDA for the first country in which an
NDA is to be made but no later than the expected date when CONFORMA obtains the first
Authorization in the Territory, the Parties shall execute another agreement which includes
handling of post marketing studies and spontaneous or literature reports, surveillance, etc.
in relation to Compound, Product, and Finished Product in the Territory by CONFORMA, its
Affiliates or its Sublicensees, and outside Territory by SUMITOMO, its Affiliates or its
Licensees, specifying the procedure for the information exchange of the adverse events which
may occur after the Launch (“Post Marketing Pharmacovigilance Agreement”).
	 
	 	 	SUMITOMO shall be solely responsible for reporting adverse events to the regulatory
authorities outside the Territory. CONFORMA, as the Party owning the IND, NDA or
Authorization, shall be solely responsible for reporting adverse drug experiences to the
Regulatory Authorities in the respective territories.
	 
	 	 	The Parties will maintain a safety database for the Product, that allows them to manage
safety data collected and fulfill their regulatory requirements in their respective
Territory.
	 
	9. 	 	 PATENTS and Updated Technology
	 
	9.1.	 	Updated Technology
	 
	 	 	During the term of this Agreement, SUMITOMO shall advise CONFORMA as soon as commercially
reasonable of any improvements or inventions concerning the Compound and/or the Product or
its use made by either SUMITOMO or any of its Affiliates, Licensees or Third Parties
contracted by SUMITOMO, as well as status of each Patent and acquisition of new Patent. The
foregoing improvements or inventions constitute parts of the rights granted to CONFORMA
under Section 2.1, except for those rights which SUMITOMO has acquired or obtained pursuant
to a license from a Third Party which is subject to the payment of consideration by
SUMITOMO, in which case SUMITOMO shall only be obliged to grant a license to such
improvements or inventions to CONFORMA to the extent permitted by the arrangement with such
Third Party and the grant of such license to CONFORMA shall be subject to the payment of
reasonable additional compensation by CONFORMA, provided that SUMITOMO shall use its
Commercially Reasonable Efforts to obtain from such Third Party the right to license such
improvements or inventions to CONFORMA, and use its Commercially Reasonable Efforts to
mitigate the consideration thereof. With respect to an additional compensation for such
improvements or inventions, the Parties shall negotiate in good faith a reasonable
compensation for license grant to CONFORMA.
	 
	9.2.	 	Rights to Improvements
	 
	 	 	As between SUMITOMO and CONFORMA, CONFORMA or its Affiliates own all right, title and
interest in and to all the Improvements, subject to the SUMITOMO’s right to the Improvements
as set forth in Section 2.3. CONFORMA or its Affiliates have the right to file a patent in
the Territory and outside the Territory related to such Improvements.
	 
	 	 	During the term of this Agreement, CONFORMA shall inform SUMITOMO as soon as commercially
reasonable of any patent applications covering an Improvement.
	 
	9.3.	 	Application and Maintenance of Patents
	 
	 	 	SUMITOMO shall, subject to the provisions of Section 9.4, at its cost, be responsible for
diligently preparing, filing, maintaining, and renewing the Patents in the Territory.




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	 	 	SUMITOMO shall be responsible for applying for and obtaining any patent term extensions,
including supplementary protection certificate; provided, however, that should SUMITOMO
decide not apply for, continue to prosecute or maintain a Patent in the Territory because
SUMITOMO reasonably believes that such Patent can no longer provide exclusivity protection
for the Compound or Product in the Territory, SUMITOMO shall so notify CONFORMA and then
CONFORMA may take over the prosecution and/or maintenance of the Patent from SUMITOMO at its
own cost.
	 
	9.4.	 	No Warranty
	 
	 	 	SUMITOMO will use Commercially Reasonable Efforts to obtain the grant of the Patents by the
governmental patent office in each country in the Territory where SUMITOMO elects to apply
for Patents, but gives no warranty that Patents will be granted or upheld in such country or
in any other country within the Territory. CONFORMA acknowledges that the rights granted
hereunder may not provide market exclusivity in the Territory and that SUMITOMO makes no
representations or warranties regarding the existence of market exclusivity. Even if no
patent protection is obtained in the Territory, it shall not provide a basis for
termination, rescission or cancellation of this Agreement, nor shall it entitle any Party to
demand a revision or renegotiation of this Agreement or any of its provisions.
	 
	9.5.	 	Infringement by Third Party
	 
	 	 	Each Party shall promptly notify the other of any infringement of the Patents or threat of
such infringement by a Third Party in the Territory which the Party comes to know. In the
event of the foregoing infringement or threat, SUMITOMO will, at SUMITOMO’s option and at
its sole cost and expense, commence appropriate legal action to stop or prevent such
infringement. Only SUMITOMO has the right to engage in any legal action and, once engaged,
has the sole right to pursue such action, in its complete and sole discretion, provided that
SUMITOMO shall refer to the suggestions or opinions of CONFORMA. CONFORMA shall provide
SUMITOMO, upon the request of SUMITOMO and at the cost of SUMITOMO, with support which is
necessary for SUMITOMO to show the infringement or the damage in the action, provided that
such support is economically reasonable.
	 
	 	 	Within sixty (60) days after receiving or giving above notice, SUMITOMO shall notify
CONFORMA of whether SUMITOMO commence legal action to stop or prevent the infringement. If
SUMITOMO decides not to commence legal action or fails to initiate such action within thirty
(30) days after giving a notice to CONFORMA of its decision of commencement of legal action,
CONFORMA has the right, but not the obligation to begin action at CONFORMA’s option and at
CONFORMA’s sole cost and expense. In such event, SUMITOMO shall provide CONFORMA, at the
cost of CONFORMA, with support which is necessary for CONFORMA to initiate and maintain the
action, provided that such support is economically reasonable.
	 
	 	 	Notwithstanding the foregoing paragraph, in the event that the Third Party asserts, as a
defense or as a counterclaim that the Patent is invalid or unenforceable, then each Party
shall promptly notify the other Party. SUMITOMO shall have the first right, but not the
obligation, to respond to such defense or defend against such counterclaim, provided that no
settlement or consent judgment or other voluntary final disposition may be entered into
without the consent of CONFORMA if such settlement would effect CONFORMA’s rights under this
Agreement.





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	 	 	Neither Party shall settle such action without the consent of the other Party, such consent
not to be unreasonably withheld, conditioned or delayed. Any resulting award, judgment or
settlement amount in favor of SUMITOMO or CONFORMA in the action under this Section 9.5.
shall be first allocated to cover the cost and expenses, including reasonable attorney’s
fees, which each Party has spent for the action, and shall be split [***] percent
( [***] %) to CONFORMA and [***] 
percent ( [***] %) to SUMITOMO.
	 
	9.6.	 	Infringement Alleged by Third Party
	 
	 	 	If any Third Party claims or alleges that CONFORMA, its Affiliates, or Sublicensee infringes
such Third Party’s patent or other intellectual property by manufacturing, importing, using,
marketing, promoting, distributing or selling the Product in the Territory, CONFORMA has the
right, but not the obligation to defend against such Third Party at its sole cost and
expense. However, if CONFORMA needs the technical information of SUMITOMO to defend against
such Third Party which CONFORMA does not have, SUMITOMO shall provide it to CONFORMA.
CONFORMA agrees to use the technical information provided by SUMITOMO under this Section
9.6. only for the purpose of defending against the Third Party alleging the infringement.
	 
	 	 	Notwithstanding the foregoing paragraph, in the event that the Third Party asserts in a
claim that the Patent is invalid or unenforceable, then CONFORMA shall promptly notify
SUMITOMO. SUMITOMO shall have the first right, but not the obligation, to respond to such
claim provided that no settlement or consent judgment or other voluntary final disposition
may be entered into without the consent of CONFORMA if such settlement would effect
CONFORMA’s rights under this Agreement, provided however, that CONFORMA shall not withhold
such consent unreasonably.
	 
	10. 	 	 RECORDS
	 
	10.1.	 	Records
	 
	 	 	CONFORMA shall maintain and retain all records relating to sales, sales contracts, invoices,
accounts, medical enquiries and other transactions directly related to the Product that may
be necessary for the purpose of calculating, Net Sales under this Agreement for a period of
not less than five (5) years from the date on which such records arose.
	 
	10.2.	 	Examination by Certified Public Accountant
	 
	 	 	SUMITOMO has the right to have independent certified public accountant selected by and
retained at the expense of SUMITOMO with approval of CONFORMA, which shall not be
unreasonably withheld, examine during normal working hours of CONFORMA and at a date
previously agreed upon with CONFORMA the books and records kept by CONFORMA and its
Affiliate to the extent necessary to verify the accuracy of the Finished Product sales or
payments made in this Agreement, if any, reports presented and payments made to SUMITOMO
hereunder. Such examination shall not be more often than once per calendar year and for not
more than two (2) previous years. Any deviations shall either be credited or paid by the
other Party, as the case may be. CONFORMA shall ensure that corresponding provisions are
contained in the sublicense agreements with Third Parties. SUMITOMO agrees that the report
of above examination by certified public accountant to SUMITOMO shall be limited to the
information relevant to verification of the accuracy of Product sales or payments in this
Agreement, if any, reports presented and payments made to SUMITOMO hereunder.






 




			
	***	 	Confidential Treatment Requested



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Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation





	11. 	 	 TAXATION
	 
	11.1.	 	Responsibility for Tax
	 
	 	 	Subject to Section 11.2 below, CONFORMA is solely responsible for the payment of any and all
taxes arising from the existence or operation of its business or from the performance of its
obligations hereunder including, without limitation, income taxes, withholding taxes,
employee payroll and social security and welfare taxes which may be imposed upon CONFORMA in
accordance with applicable laws. Likewise, subject to Section 11.2 below, SUMITOMO is
solely responsible for the payment of any taxes arising from the existence or operation of
its business, the income and profits resulting therefrom or from the performance of its
obligations hereunder and for any and all obligations which may arise from its employment of
any persons including, without limitation, any personnel of SUMITOMO dedicated to the
manufacturing of the Compound.
	 
	11.2.	 	Withholding Tax
	 
	 	 	If a withholding tax is imposed on any event payment, payment for the Product, or royalty
hereof is enacted, CONFORMA shall deduct the amount of any such applicable withholding tax
from the amount due to SUMITOMO and pay over such withholding tax deducted to the relevant
taxing authorities. CONFORMA shall not provide any gross-up amount with respect to any
applicable withholding tax. CONFORMA shall provide SUMITOMO with the official receipts and
such other evidence of payment of any such applicable withholding tax as SUMITOMO may
request in writing promptly following such request. SUMITOMO shall provide documentation to
CONFORMA as reasonably requested to minimize withholdings otherwise required by the taxing
authorities. CONFORMA shall render SUMITOMO reasonable assistance in order to allow
SUMITOMO to obtain the benefit of any present and future treaty for the avoidance of double
taxation in force between Japan and the respective countries in the Territory.
	 
	12. 	 	 FINANCIAL MATTERS
	 
	12.1.	 	Late Payments
	 
	 	 	In case CONFORMA fails to make each payment required hereof by the due date, SUMITOMO will
charge CONFORMA a penalty at the lower of (i) interest accruing on any such unpaid balance
at the average year-to-date rate London Inter-Bank Offering Rate (LIBOR) in effect from time
to time plus two percent (2 %) per annum or (ii) the highest rate allowable under applicable
law.
	 
	12.2.	 	Manner of Payment
	 
	 	 	All amounts due to either CONFORMA or SUMITOMO under this Agreement shall be paid by wire
transfer to such bank account as CONFORMA or SUMITOMO, as the case may be, may direct from
time to time. All bank expenses incurred by CONFORMA or SUMITOMO in making such wire
transfer shall be on its own account.
	 
	 	 	All payments required under this Agreement shall be made in USD.




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	13. 	 	 CONFIDENTIALITY
	 
	13.1.	 	Non-disclosure
	 
	 	 	SUMITOMO and CONFORMA agree to hold in strict confidence any and all information disclosed
by the other and identified in writing as confidential whether disclosed prior to the
Effective Date or thereafter (“Confidential Information”), in accordance with these efforts
taken by each Party to protect its own information, data or other tangible or intangible
property that it regards as proprietary or confidential but using not less than reasonable
diligent efforts.
	 
	13.2.	 	Limited Purposes
	 
	 	 	The receiving Party shall not use the Confidential Information for any purpose other than in
connection with exercising its rights and fulfilling its obligations hereof. The receiving
Party will not disclose any such Confidential Information to any person other than to its
officers, employees, legal counsel or technical advisors, or to officers, employees, legal
counsel or technical advisors of any of its Affiliates, provided that they have a clear need
to know such Confidential Information in connection with the performance of their
professional responsibilities under this Agreement, and provided further that they are bound
by the confidentiality and non-use obligations substantially similar to those in this
Section 13. The receiving Party shall further take all reasonable steps to prevent its
officers, employees, legal counsel or technical advisors, or any others having access to the
Confidential lnformation, from disclosing to any Third Party or making unauthorized use of
any Confidential Information, or from committing any acts or making any omissions that may
result in a violation of this Section 13.
	 
	13.3.	 	Exceptions






	 	13.3.1.	 	Information Otherwise Available






	 	 	Neither Party shall have any obligation of confidentiality or non-use with respect to any
portion of the Confidential lnformation which:






	 	(i)	 	at the time of disclosure by the other Party, is in the public domain;
	 
	 	(ii)	 	after disclosure by the other Party, enters the public domain by means other
than a breach of this Agreement by the receiving Party;
	 
	 	(iii)	 	the receiving Party can establish by competent proof is in its possession at
the time of disclosure by the other Party or thereafter is independently developed by
persons in its employment who had no contact with and were not aware of the content of
the Confidential lnformation; or
	 
	 	(iv)	 	the receiving Party obtains from a Third Party not bound by a duty of
confidentiality.






	 	13.3.2.	 	Governmentally Required Disclosures






	 	 	Each Party may disclose Confidential Information disclosed to it by the other Party to the
extent that such disclosure is reasonably necessary for the following reasons:






	 	(i)	 	for regulatory filings, including without limitation filings with the U.S.
Securities and Exchange Commission, and filings with regulatory authorities permitted
hereunder;
	 
	 	(ii)	 	to comply with a subpoena or an order issued by a court or other tribunal of
competent jurisdiction, provided however, that the receiving Party shall immediately
provide a notice to the disclosing Party so that the disclosing Party may seek a




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License Agreement Amrubicin Hydrochloride (SM-5887)

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	 	 	 	protective order or other remedy from relevant court or tribunal.






	13.4.	 	Publication Procedure
	 
	 	 	When a Party plans to publish the results of the studies conducted in the course of the
development in and outside Territory, such Party shall submit the draft of the publication,
translated into English, to the other Party at least six (6) weeks prior to the planned
submission for publication for approval. Any such publication shall need the other Party’s
prior written consent, which shall not be unreasonably withheld. Any comment, reasonable
request for modification, or reasonable rejection must be made within four (4) weeks from
receipt of the draft. Thereafter, the draft is deemed to be approved. However, for the
elimination of any doubt, CONFORMA will have the sole right to decide upon its own
publication strategy in the Territory.
	 
	13.5.	 	Return of Information
	 
	 	 	Unless otherwise set forth in this Agreement, title and all rights to, and emanating from,
the ownership of all Confidential Information disclosed under this Agreement shall remain
vested in the disclosing Party. Upon written request of the disclosing Party, the receiving
Party shall return to the disclosing Party all written materials and documents within sixty
(60) days, as well as any computer software or other media, in their possession, made
available or supplied by the disclosing Party to the receiving Party that contains
Confidential Information, together with any copies thereof, except for one copy which may be
retained by the receiving Party only for the purpose of determining the receiving Party’s
continuing obligations or exercising its rights hereunder.
	 
	13.6.	 	Additional Permitted Disclosures
	 
	 	 	Each Party may provide the Confidential Information to a Third Party which is interested in
obtaining the license or sublicense of the Product in its Territory, provided that such
Third Party has signed a confidentiality agreement containing essentially similar provisions
of confidentiality as contemplated hereof. In addition, CONFORMA may disclose the terms and
conditions of this Agreement to potential investors or financial advisors for purposes of
due diligence in connection with a financing or other financial transaction involving
CONFORMA.
	 
	13.7.	 	Terms and Conditions of this Agreement
	 
	 	 	The Parties agree to keep the terms and conditions of this Agreement confidential and
neither Party shall disclose any such terms and conditions to the public or to Third
Parties, except as set forth in Sections 13.2, 13.3 and 13.6, without the prior written
consent of the other Party.
	 
	13.8.	 	Previous Confidential Agreement
	 
	 	 	Upon the execution of this Agreement, information which has been protected by the provisions
of the Secrecy Agreement on “SM-5887“ executed between the Parties on August 12, 2004, shall
be covered by this Section 13 and the provisions of the above Secrecy Agreement shall no
longer be effective.
	 
	 	 	The provisions of this Section 13 shall survive the termination or expiration of this
Agreement for ten (10) years.




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License Agreement Amrubicin Hydrochloride (SM-5887)

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	14. 	 	 TERM AND TERMINATION
	 
	14.1.	 	Expiration
	 
	 	 	Unless sooner terminated pursuant to the provisions hereof, this Agreement shall expire on
the date when the Initial Period has expired in all the countries in the Territory.
	 
	14.2.	 	Termination by CONFORMA
	 
	 	 	In the occurrence of safety or toxicology issues CONFORMA may terminate this Agreement at
any time by providing SUMITOMO with thirty (30) days’ prior written notice.
	 
	14.3.	 	Termination for Breach
	 
	 	 	Upon a material breach of any term of this Agreement or the Supply Agreement by one Party,
the other Party may give written notice of such breach to the breaching Party. Should the
breaching Party fail to cure such breach within sixty (60) days of such notice, the other
Party may terminate this Agreement with further sixty (60) days’ notice. In addition to
this right to terminate this Agreement in its entirety, SUMITOMO shall have the right to
terminate the rights granted to CONFORMA under this Agreement on a country-by-country basis
as set forth in Sections 4.2.3, 5.2 and 5.6.
	 
	14.4.	 	Termination for Bankruptcy
	 
	 	 	This Agreement may be terminated by SUMITOMO within thirty (30) days upon written notice in
case CONFORMA becomes insolvent or makes an assignment for the benefit of creditors or
become involved in receivership, bankruptcy or other insolvency or debtor relief
proceedings, or any similar proceedings, or in proceedings, voluntary or forced, whereby
CONFORMA is limited in the free and unrestrained exercise of its own judgment as to the
carrying out of the terms of this Agreement.
	 
	14.5.	 	Termination for Patent Challenge
	 
	 	 	Until the expiry of all Patents in all countries in the Territory, SUMITOMO shall have the
right to terminate this Agreement if CONFORMA or its Affiliate takes, or actively assists a
Third Party in taking, any action to challenge or contest the title or validity of any of
the Patents.
	 
	14.6.	 	Termination for Change of Control
	 
	 	 	In addition to the rights under Section 5.6 in case a Change in Control occurs for CONFORMA
and the Third Party in such Change of Control transaction has a Competing Product in the
Territory (“Competing Party”), CONFORMA shall notify SUMITOMO of this event and the Parties
shall discuss in good faith how to ensure that sale of the Product is not adversely affected
by the Change of Control, and modify this Agreement as necessary. If the Parties are unable
to reach an agreement after ninety (90) days, SUMITOMO shall have thirty (30) days to
terminate this Agreement with sixty (60) days’ written notice to CONFORMA. For purposes of
this Section 14.6, a “Change of Control” shall mean a transaction in which a single Third
Party becomes the beneficial owner of fifty percent (50%) or more of the combined voting
power of the outstanding securities of CONFORMA or a sale or other disposition to a Third
Party of all or substantially all of the assets or business of CONFORMA, by means of a
merger, reorganization or similar corporate transaction.




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License Agreement Amrubicin Hydrochloride (SM-5887)

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	14.7.	 	Consequences of Termination






	 	14.7.1.	 	Responsibilities of CONFORMA






	 	 	Upon the termination by CONFORMA pursuant to Section 14.2. or the termination by
SUMITOMO pursuant to Section 14.3., 14.4., and 14.5., CONFORMA shall:






	 	(i)	 	transfer and assign to SUMITOMO or its designee CONFORMA’s right and title to
all INDs and NDAs relating to the Product and all other applications, clinical trial
agreements (to the extent assignable and non-cancelable) and data obtained in the
course of the Development;
	 
	 	(ii)	 	provide to SUMITOMO or its designee all existing and reasonably available
marketing information; and
	 
	 	(iii)	 	grant to SUMITOMO a non-exclusive, perpetual, royalty-free license, with a
right to sublicense, of the Improvements to develop, register, manufacture, import,
use, market, promote, distribute and sell the Compound and/or Product in the Territory.






In addition to the foregoing, in the event that the termination notice under
Section 14.5. is issued by SUMITOMO after the initiation of any clinical trials for the
Product by CONFORMA in the USA, CONFORMA shall, at its cost and expenses, complete any
ongoing trial to which the patients have already been enrolled before the issuance of
the termination notice. However, from the issuance of the termination notice until the
effective date of the termination notice, CONFORMA is not required to initiate any new
studies.




14.7.2. Responsibilities of SUMITOMO




Upon termination by CONFORMA pursuant to Section 14.3, SUMITOMO shall grant to CONFORMA
for the Territory an exclusive, perpetual paid-up license, including a right to sublicense,
to all the Patents and Know-how, which SUMITOMO has a right as of the termination date, to
the extent necessary for CONFORMA or its Sublicensees to continue all pending Development
activities or marketing and sales activities relating to the Product in the Territory.




14.7.3. Regulatory Responsibilities of Both Parties




Even after the termination for any ground, each Party shall comply with the regulatory
requirements which the Regulatory Authority of the relevant countries imposes on the
Parties, if any.




14.7.4. Ancillary Agreements




Unless otherwise agreed in the Supply Agreement or otherwise by the Parties, the
termination of this Agreement with respect to all countries in the Territory in entirety
shall cause the automatic termination of all ancillary agreements related hereto, including
but not limited to Supply Agreement.




	14.8.	 	Outstanding Payments
	 
	 	 	Termination of this Agreement by a Party, for any reason, will not release CONFORMA from any
obligation to make any payments to SUMITOMO which were due and payable prior to the
effective date of termination.
	 
	14.9.	 	Survival Clauses
	 
	 	 	Even after this Agreement is terminated or has expired in all countries within the
Territory, the following Sections shall survive in addition to any Sections which by their
terms survive




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License Agreement Amrubicin Hydrochloride (SM-5887)

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	 	 	termination or expiration of this Agreement: Sections 1, the first paragraph of Section 2.3,
Section 6, 7.1, 7.2, 7.4, 7.5, 8.2, 8.5, 9.5, 9.6, 10, 11, 12, 13, 14.7, 14.8, 14.9, 15,
16.5 and 17.
	 
	15. 	 	 INDEMNIFICATION
	 
	15.1.	 	Indemnification by SUMITOMO
	 
	 	 	Subject only to the provisions of this Agreement and the Supply Agreement (if executed),
SUMITOMO hereby agrees to indemnify and hold harmless CONFORMA, its Affiliates and
Sublicensees, and the officers, directors, agents, representatives and employees of each of
them, upon demand, against all losses, costs, claims, proceedings, actions, damages,
liabilities, penalties and expenses, including reasonable legal fees and expenses
(“Losses”), suffered or incurred by any of them, arising out of, resulting from or in
connection with claims brought by a Third Party that are based upon:






	 	(i)	 	the performance or breach of this Agreement and the Supply Agreement (if
executed) by SUMITOMO; or
	 
	 	(ii)	 	non-compliance of the Compound or the Product to the Specifications, provided
that the Compound or Product is supplied by SUMITOMO or its Affiliate; or
	 
	 	(iii)	 	the development activities, regulatory approval, distribution, sale,
marketing and promotion of the Product outside the Territory by SUMITOMO, its
Affiliates or its Licensees; or
	 
	 	(iv)	 	except as expressly set forth in Section 15.2, any damage or injury to a
Third Party arising from any use or misuse of the Product sold by SUMITOMO, its
Affiliates or its Licensees except for those sold to CONFORMA, its Affiliates, or the
Sublicensees, including any adverse effects caused by or arising from the Product;
	 
	 	 except to the extent such Losses are due to the gross negligence or willful misconduct, or
failure to act of CONFORMA.







	15.2.	 	Indemnification by CONFORMA
	 
	 	 	Subject only to the provisions of this Agreement and the Supply Agreement (if executed),
CONFORMA hereby agrees to indemnify and hold harmless SUMITOMO, its Affiliates, and
Licensees, and the officers, directors, agents, representatives and employees of each of
them, upon demand, against all Losses suffered or incurred by any of them, arising out of,
resulting from or in connection with claims brought by a Third Party that are based upon:






	 	(i)	 	the performance or breach of this Agreement and the Supply
Agreement (if executed) by CONFORMA;
	 
	 	(ii)	 	the Development, registration of the Authorization, distribution, sale,
marketing and promotion of the Product in the Territory by CONFORMA, its Affiliates or
the Sublicensees;
	 
	 	(iii)	 	the packaging or labeling of the Product by CONFORMA or its Affiliates or a
Third Party on behalf of CONFORMA; or
	 
	 	(iv)	 	except as expressly set forth in Section 15.1., any damage or injury to a
Third Party arising from any use or misuse or mishandling of the Product sold by
CONFORMA, its Affiliates or its Sublicensees, including any adverse effects caused by
or arising




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License Agreement Amrubicin Hydrochloride (SM-5887)

Sumitomo Pharmaceuticals Co., Ltd. — Conforma Therapeutics Corporation




	 	 	 	from the Product;






	 	 	except to the extent such Losses are due to the gross negligence or willful misconduct, or
failure to act of SUMITOMO.
	 
	15.3.	 	Procedure
	 
	 	 	If any Third Party notifies any party hereto (the ”Indemnified Party“) with respect to any
matter that may give rise to a claim for indemnification against the other Party hereto (the
”Indemnifying Party“) under this Section 15, then the Indemnified Party will notify the
Indemnifying Party thereof promptly and in any event within thirty (30) days after receiving
any written notice from a Third Party; provided that no delay on the part of the Indemnified
Party in notifying the Indemnifying Party will relieve the Indemnifying Party from any
obligation hereunder unless, and then solely to the extent that, the Indemnifying Party is
prejudiced thereby. Once the Indemnified Party has given notice of the matter to the
Indemnifying Party, the Indemnified Party may defend against the matter in any manner it
reasonably may deem appropriate. If the Indemnifying Party notifies the Indemnified Party
within thirty (30) days after the date the Indemnified Party has given notice of the matter
that the Indemnifying Party is assuming the defense of such matter, then (i) the
Indemnifying Party will defend the Indemnified Party against the matter with counsel of its
choice reasonably satisfactory to the Indemnified Party, (ii) the Indemnified Party may
retain separate counsel at its sole cost and expense, except that the Indemnifying Party
will be responsible for the fees and expenses of such separate co-counsel to the extent the
Indemnified Party concludes in good faith that the Indemnifying Party and the Indemnified
Party have a potential or actual conflict of interest which necessitates separate counsel,
(iii) the Indemnified Party will not consent to the entry of a judgment or enter into any
settlement with respect to the matter without the written consent of the Indemnifying Party,
which shall not be withheld or delayed unreasonably, and (iv) the Indemnifying Party will
not consent to the entry of a judgment with respect to the matter or enter into any
settlement that does not include a provision whereby the plaintiff or claimant in the matter
releases the Indemnified Party from all liability with respect thereto, without the written
consent of the Indemnified Party, which shall not be withheld or delayed unreasonably.
	 
	15.4.	 	No Lost Profit
	 
	 	 	Except as expressly set forth in this Agreement, the indemnification provisions set forth in
this Section 15 shall be the exclusive remedy of the Parties for monetary damages under this
Agreement and the Supply Agreement (if executed). IN NO EVENT SHALL EITHER PARTY BE LIABLE
TO THE OTHER PARTY, ITS AFFILIATES, ITS LICENSEES, ITS SUBLICENSEES, AND ITS DEVELOPMENT
PARTNERS, OFFICERS, DIRECTORS, AGENTS, REPRESENTATIVES OR EMPLOYEES FOR ANY LOST PROFITS,
LOSS OF BUSINESS, LOSS OF CONTRACTS, DIMINISHED GOODWILL, DIMINISHED REPUTATION, OR
CONSEQUENTIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR SPECIAL DAMAGES ARISING FROM OR
IN CONNECTION WITH THIS AGREEMENT.
	 
	16. 	 	 REPRESENTATIONS, WARRANTIES AND COVENANTS
	 
	16.1.	 	Execution of Agreement
	 
	 	 	Each Party represents and warrants to the other Party at the time of the execution of this
Agreement that:




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License Agreement Amrubicin Hydrochloride (SM-5887)

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	 	(i)	 	it has the cooperate power and authority to execute and deliver this
Agreement, and to perform its obligations hereunder;
	 
	 	(ii)	 	the execution, delivery and performance of this Agreement by each Party have
been duly and validly authorized and approved by proper corporate action on the part
of such Party; and
	 
	 	(iii)	 	it has no legal obligations or commitments to Third Parties inconsistent
with this Agreement.






	16.2.	 	Additional SUMITOMO Representations
	 
	 	 	SUMITOMO represents and warrants to CONFORMA that:






	 	(i)	 	it has not (in any manner that is inconsistent with or would interfere with
the rights granted to CONFORMA in this Agreement) previously assigned, transferred,
conveyed or otherwise encumbered any right, title or interest in or to the Patents or
Know-how in the Territory, granted to any Third Party any license to use the Patents
or Know-how in the Territory, or granted any covenant not to sue for any use of the
Patents or Know-how in the Territory ; and
	 
	 	(ii)	 	to the best of its knowledge, as of the Effective Date no claim of ownership,
invalidity or patent infringement has been asserted by any Third Party against
SUMITOMO with respect of the Patents or the Manufacturing Technology; provided,
however, that SUMITOMO is aware of the patent described in Annex 16.2.






	16.3.	 	Material Facts
	 
	 	 	Each Party represents and warrants that it has disclosed all information in its possession
or control which is material to the other Party entering into this Agreement, and such
information does not contain any untrue statement of material fact or omit to state a
material fact.
	 
	16.4.	 	Manufacture of Compound and Product
	 
	 	 	SUMITOMO warrants that the manufacturing processes of the Compound and Product are to
continue to be consistent with the Specifications, including conformity with GMP of Japan
and will, at all times that Product is supplied to CONFORMA, its Affiliates or its
Sublicensees, be consistent with the Specifications, including conformity with cGMP of the
USA.
	 
	16.5.	 	Express Warranties
	 
	 	 	The Parties intend and agree that this Agreement is not subject to the Uniform Commercial
Code in force in any state of the USA, and that no warranties exist beyond these stated in
this Agreement. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS SECTION 16, NEITHER
PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY
OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES,
WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE
VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES.




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License Agreement Amrubicin Hydrochloride (SM-5887)

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	17. 	 	 MISCELLANEOUS PROVISIONS
	 
	17.1.	 	Headings
	 
	 	 	The headings and captions used in this Agreement are for the convenience of the Parties only
and are not to be construed to define, limit or affect the construction or interpretation
hereof.
	 
	17.2.	 	Severability
	 
	 	 	In the event that any provision of this Agreement is found to be invalid or unenforceable,
then such provision shall not render any other provision of this Agreement invalid or
unenforceable, and all other provisions shall remain in full force and effect and shall be
enforceable, unless the provisions which have been found to be invalid or unenforceable
shall substantially affect the remaining rights or obligations granted or undertaken by
either Party. The Parties agree to attempt to substitute for any invalid or unenforceable
provision which achieves to the greatest extent possible the economic objectives of the
invalid or unenforceable provision.
	 
	17.3.	 	Entire Agreement; Amendment
	 
	 	 	This Agreement, including Annexes attached hereto, contains the entire agreement of the
Parties regarding the subject matter hereof and supersedes all prior agreements,
understandings or conditions, whether oral or written, regarding the same.
	 
	 	 	This Agreement may not be changed, modified, amended or supplemented except by a written
agreement signed by both Parties. The Parties acknowledge and agree that they intend to
enter into a Supply Agreement which shall provide for additional rights and obligations on
each of their parts as set forth in each of those agreements.
	 
	17.4.	 	Assignability
	 
	 	 	This Agreement and the rights and obligations established hereunder may not be assigned or
transferred by either Party without the prior written consent of the other Party, such
consent of which shall not to be unreasonably withheld, conditioned or delayed; provided,
however, that either Party may, without such consent, assign this Agreement and its rights
and obligations hereunder to an Affiliate, to the purchaser of all or substantially all of
its assets related to the Product or the Party’s business, or to its successor entity or
acquirer in the event of a merger, consolidation or change in control of the Party. In
addition, CONFORMA acknowledges and agrees that SUMITOMO plans to merge with DAINIPPON
PHARMACEUTICAL CO., LTD. as of October 1, 2005, and SUMITOMO’s rights and obligations hereof
will be assigned to the surviving company, Dainippon Sumitomo Pharma Co., Ltd. upon such
merger. Notwithstanding the foregoing, in the event of a Change of Control in CONFORMA,
Section 14.6 of this Agreement shall govern.
	 
	17.5.	 	Independent Party
	 
	 	 	This Agreement does not constitute either Party as being the agent or legal representative
of the other for any purpose whatsoever. Neither Party is granted any right or authority to
assume or to create any obligation or responsibility, express or implied, on behalf of, or
in the name of the other, with regard to any manner or thing whatsoever, unless otherwise
specifically and express agreed upon in writing.
	 
	17.6.	 	Notice and Reports
	 
	 	 	All notices, consents or approvals required by this Agreement shall be in writing and




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	 	 	personally delivered, or sent by internationally recognized overnight courier service or by
facsimile (confirmed by such international courier service) to the Parties at the following
addresses or such other addresses as may be designated in writing by the respective Party.
Notices shall be deemed effective on the seventh (7th) day of sending, provided
that the receipt by the Party is confirmed by the record.





	 	 	 
	            If to CONFORMA:

	 	If to SUMITOMO:
	            Attn.: Vice President,

	 	     Attn.: General Manager,
	                      Corporate Development

	 	               Corporate Licensing
	            9393 Towne Centre Drive, Suite 240

	 	     12-2, Kyobashi 1-chome,
	            San Diego, California 92121

	 	     Chuo-ku, Tokyo, 104-8356, Japan
	 
	            Tel-No: (858) 657-0300

	 	     Tel-No: +81-3-5159-2511
	 
	            Fax-No: (858) 657-0343

	 	     Fax-No: +81-3-5159-1981







	 	 	Any change in an address or fax number shall be the subject of a required notice under this
Agreement.
	 
	17.7.	 	Waiver
	 
	 	 	The failure of any Party to enforce at any time any provision of this Agreement, or any
right with respect thereto, or to exercise any election herein provided, shall in no way be
considered to be a waiver of such provision, right or election, or in any way affect the
validity of this Agreement. The exercise by any Party of any right or election under the
terms or covenants herein shall not preclude or prejudice any Party from exercising the same
or any other right it may have under this Agreement, irrespective of any previous action or
proceeding taken by the Parties hereunder.
	 
	17.8.	 	Force Majeure
	 
	 	 	A Party shall not be liable for non-performance or delay in performance caused by any event
reasonably beyond the control of such Party including, without limitation, wars (declared or
undeclared), hostilities, revolutions, riots, civil disturbances, national emergencies,
strikes, lockouts, shortage of energy, computer viruses, epidemics, fires, floods,
earthquakes, other forces of nature, explosions, embargoes, or any other acts of God, or any
laws, proclamations, regulations, ordinances, or other acts or orders of any court,
government or governmental agency. Any occurrence of Force Majeure shall be reported
promptly to the other Party.
	 
	17.9.	 	Dispute Resolution and Arbitration
	 
	 	 	In the event that any dispute arising between the Parties relating to this Agreement cannot
be resolved by their respective staffs, said dispute shall be referred promptly to the
Managing Director of SUMITOMO and the Chief Executive Officer of CONFORMA, who shall make a
good faith effort to resolve the matter within ninety (90) days from the date of any such
referral. If the matter has not been resolved utilizing the process set forth above, either
or both Parties may elect to pursue definitive resolution through binding arbitration, which
the Parties agree to accept in lieu of litigation or other legally available remedies,
except for injunctive relief where such relief is necessary to protect a Party from
irreparable harm pending the outcome of arbitration. Any such arbitration shall be settled
in




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License Agreement Amrubicin Hydrochloride (SM-5887)

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	 	 	accordance with the Rules of Arbitration of the International Chamber of Commerce by three
arbitrators chosen in accordance with said Rules.
	 
	 	 	The arbitration will be conducted in English and will be held in the city of Honolulu,
Hawaii. Judgment upon the award rendered may be entered in any court having jurisdiction
thereof.
	 
	 	 	Nothing in this Section 17.9 will preclude any Party from seeking interim or provisional
relief from a court of competent jurisdiction, including a temporary restraining order,
preliminary injunction or other interim equitable relief, concerning a dispute either prior
to or during any arbitration if necessary to protect the interests of such Party or to
preserve the status quo pending the arbitration proceeding.
	 
	17.10.	 	Applicable Law
	 
	 	 	This Agreement shall be governed by and construed in accordance with the laws of the State
of New York, without reference to the principles of conflict of laws that would result in
the application of any law other than the State of New York.
	 
	17.11.	 	Language
	 
	 	 	The language of this Agreement and of any communication between the Parties shall be in
English unless otherwise mutually agreed.
	 
	17.12.	 	Counterparts
	 
	 	 	This Agreement shall be executed in two counterparts, each of which shall be considered and
shall have the force and effect of an original.




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License Agreement Amrubicin Hydrochloride (SM-5887)

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IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly authorized
representatives, as of the day and year first written above.




	 	 	 
	Conforma Therapeutics Corporation

	 	Sumitomo Pharmaceuticals Co., Ltd.
	 
	 	 
	June 23, 2005

	 	June 23, 2005
	 
	 	 
	/s/ Lawrence C. Fritz, Ph.D.

	 	/s/ Yasuo Okamoto
	 

	 	 
	Lawrence C. Fritz, Ph.D.

	 	Yasuo Okamoto
	President and Chief Executive Officer

	 	President






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 License Agreement Amrubicin Hydrochloride (SM-5887)

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Annex 1.6




Compound



Amrubicin Hydrochloride (SM-5887) is anthracycline anti-cancer agent.




	 	 	 
	Chemical name:

	 	(+)-(7 S,9
S)-9-acetyl-9-amino-7-[(2-deoxy-b-D-erythro-pentopyranosyl)oxy ] - 7,8,9, 
10-tetrahydro-6,11-dihydroxy-5,12-naphthacenedione
hydrochloride
	 
	 	 
	Nonproprietry name:

	 	Amrubicin (INN) Hydrochloride
	 
	 	 
	Additional name:

	 	SM-5887
	 
	 	 
	Structural formula:
	 	 
	 

	 	






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License Agreement Amrubicin Hydrochloride (SM-5887)

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Annex 1.27




Patents




1. Formulation



Title: STABILIZED ANTHRACYCLINE PREPARATION CONTAINING L-CYSTEINE



Japan: 2603480 (registered)




	 	 	 	 	 	 	 	 	 
	 	 	Date of	 	 	 	 
	Countries	 	Application	 	Patent Number	 	Status
	United States

	 	1988/8/2
	 	 	4952566	 	 	registered
	Canada

	 	1988/8/5
	 	 	1324959	 	 	registered
	Austria

	 	1988/8/4
	 	EP 302729
	 	registered
	Belgium

	 	1988/8/4
	 	EP 302729
	 	registered
	Swizerland

	 	1988/8/4
	 	EP 302729
	 	registered
	Germany

	 	1988/8/4
	 	EP 302729
	 	registered
	Spain

	 	1988/8/4
	 	EP 302729
	 	registered
	France

	 	1988/8/4
	 	EP 302729
	 	registered
	United Kingdom

	 	1988/8/4
	 	EP 302729
	 	registered
	Greece

	 	1988/8/4
	 	EP 302729
	 	registered
	Italy

	 	1988/8/4
	 	EP 302729
	 	registered
	Netherland

	 	1988/8/4
	 	EP 302729
	 	registered
	Sweden

	 	1988/8/4
	 	EP 302729
	 	registered
	Denmark

	 	1988/8/4
	 	 	173317	 	 	registered
	Finland

	 	1988/8/1
	 	 	91483	 	 	registered
	Norway

	 	1988/8/3
	 	 	175134	 	 	registered






2. [***]




3. [***]




4. [***]




5. [***]




6. [***]




7. [***]





 




			
	***	 	Confidential Treatment Requested



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License Agreement Amrubicin Hydrochloride (SM-5887)

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Annex 1.30




Specifications




[***]





 




			
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License Agreement Amrubicin Hydrochloride (SM-5887)

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Annex 4.2.3




Development Plan




[***]





 




			
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Annex 16.2




[***]




 




			
	***	 	Confidential Treatment Requested




page 41