Document:

exv10w2

Exhibit 10.2

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

Unoprostone

NDA Transfer,

Patent and Know-how Licensing,

and

Data Sharing

Agreement

Effective Date:

April 23, 2009

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Table of Contents

	 	 	 	 	 
	 
	Article 1. Definitions
	 	 	4	 
	 
	Article 2. NDA Transfer
	 	 	11	 
	 
	Article 3. Data Sharing
	 	 	12	 
	 
	Article 4. Patent License Grants and Know-How Access
	 	 	12	 
	 
	Article 5. Regulatory
	 	 	14	 
	 
	Article 6. Development
	 	 	16	 
	 
	Article 7. Promotion of Licensed Products
	 	 	17	 
	 
	Article 8. Consideration
	 	 	18	 
	 
	Article 9. Confidentiality and Non-Disclosure
	 	 	20	 
	 
	Article 10. Intellectual Property Rights
	 	 	23	 
	 
	Article 11. Term and Termination
	 	 	25	 
	 
	Article 12. Representations and Warranties
	 	 	28	 
	 
	Article 13. Indemnification; Insurance
	 	 	31	 
	 
	Article 14. Miscellaneous
	 	 	35	 
	 

 Page 2 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

Unoprostone NDA Transfer, Patent and Know-how Licensing and Data Sharing Agreement

THIS UNOPROSTONE NDA TRANSFER, PATENT AND KNOW-HOW LICENSING AND DATA SHARING AGREEMENT
(“Agreement”) is made this 23 day of April, 2009 (the “Effective Date”), by and among Sucampo
Pharma Americas, Inc. (“SPA”), a corporation organized and existing under the laws of the State of
Delaware, U.S.A., ( a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc., (“SPI”) a
corporation organized and existing under the laws of the state of Delaware, U.S.A.), and having its
principal office at 4520 East West Highway, Third Floor, Bethesda, Maryland 20814, and R Tech Ueno,
Ltd. (“RTU”), a corporation organized and existing under the laws of Japan and having its
registered office at 1-1-7 Uchisaiwai-cho, Chiyoda-ku, Tokyo, Japan ,100-0011 (SPA and RTU each
referred to herein as a “Party” and collectively as the “Parties”).

WHEREAS, SPA is a United States based pharmaceutical company that seeks the right to hold and
maintain the NDA (as defined below) for Unoprostone (as defined below and further described in
Exhibit A) within the SPA Territory (as defined below) in accordance with the requirements of the
Regulatory Authority (as defined below);

WHEREAS, SPA also seeks exclusive rights to license the existing Licensed Product (as defined
below) and Unoprostone patents and trademarks within the SPA Territory;

WHEREAS SPA also seeks the exclusive right to develop the Licensed Product and Unoprostone for
further patents and trademarks worldwide; and

WHEREAS, SPA also seeks to share in the further Clinical Development (defined below) and commercial
sale of Licensed Product and Unoprostone within the SPA Territory; and

WHEREAS, RTU has the right to transfer NDA control and maintenance responsibilities for Unoprostone
within the SPA Territory to SPA; RTU has the right to license existing Licensed Product and
Unoprostone patents and trademarks within the SPA Territory to SPA ; and RTU has the right to
license the Licensed Product and Unoprostone for further patents and trademarks worldwide to SPA;
and RTU has the right to license the further Clinical Development and commercial sale of Licensed
Product and Unoprostone within the SPA Territory to SPA;

WHEREAS, for this Agreement, SPA and RTU agreed upon a Draft Term Sheet dated December 15, 2008
(the “Term Sheet”), which sets forth the basic terms and conditions under which RTU shall license
and supply certain products to SPA consistent with the
terms of this Agreement, and the parties now wish to enter into this definitive agreement in
accordance with the Term Sheet.

NOW, THEREFORE, in consideration of the mutual promises exchanged herein, and in consideration of
the execution of the Unoprostone Exclusive Manufacturing and Supply Agreement (the “Unoprostone

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

Supply Agreement”) (Exhibit B) to be executed between the Parties contemporaneously with this
Agreement the receipt and sufficiency of such consideration is hereby acknowledged, the Parties
agree as follows:

Article 1. Definitions

1.1 “Adverse Event” means any untoward medical occurrence in any patient use of discontinuance of a
Licensed Product or clinical investigation subject administered a Licensed Product and which does
not necessarily have to have a causal relationship with this pharmaceutical treatment. An adverse
event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory
finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical
product, whether or not considered related to the pharmaceutical product, including but not limited
to those events that must or may be reported in accordance with the pre-clinical testing, clinical
trial testing or in market pharmaco-vigilance or other reporting requirements as may be required by
any Regulatory Agency incident to the prosecution or maintenance of an IND or an NDA or similar
regulatory filing with respect to the testing, registration, manufacture use or sale of a product
as a pharmaceutical for human use .

1.2 “Affiliate” means, with the respect to either Party, any Person that, directly or through one
or more Affiliates, controls, or is controlled by, or is under common control with, such Party.
For purposes of this definition, “control” means (i) ownership of more than fifty percent (50%) of
the shares of stock entitled to vote for the election of directors, in the case of a corporation,
or more than fifty percent (50%) of the equity or management voting interests in the case of any
other type of legal entity, (ii) status as a general partner in any partnership, or (iii) any other
arrangement whereby a Person controls or has the right to control, directly or indirectly, the
commercial operations, the Board of Directors or the equivalent governing body of a corporation or
other entity. Notwithstanding the foregoing, in no event at any time during the Term of this
Agreement shall SPA be considered Affiliate of RTU nor RTU be considered Affiliate of SPA for the
purpose of this Agreement.

1.3 “Annual Net Sales” means the cumulative Net Sales during any given Calendar Year.

1.4 “Applicable Law” means all federal, state, local, national and supra-national treaties,
conventions laws or statutes, and any implementing orders, rules and/or
regulations, including any rules, regulations, orders, judgments, determinations, guidance, or
requirements of Regulatory Authorities, the tax authorities, courts of competent jurisdiction and
any non-governmental agencies that control any aspect of the pharmaceutical, medical, commercial or
financial activities contemplated by the parties in utilizing the rights granted or received
incident to this Agreement, including but not limited to development of pharmaceutical products in
accordance with the International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (“ICH”) standards, listing of securities on stock
exchanges governed by major national securities exchanges or major securities listing
organizations or compliance with financial and accounting standards as promulgated by the Financial
Accounting Standards Board or its foreign equivalent for IFRF reporting

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

standards, that may be in
effect from time to time during the Term and applicable to a particular activity hereunder.

1.5 “Business Day” means a day, other than a Saturday or Sunday, on which banking institutions in
Washington, DC, USA, or Tokyo, Japan, are open for business, such that a bank holiday in the United
States which is not a banking holiday in Japan is nevertheless a Business Day under the terms of
this Agreement.

1.6 “Clinical Studies” means a human clinical study, or other test or study in humans, with respect
to a Unoprostone or a Licensed Product performed incident to an open IND, including, but not
limited to Phase I Study, Phase II Study, Phase III Study, Phase IV Study, early access programs,
compassionate use and single patient INDs, epidemiological studies, modeling and pharmacoeconomic
studies, post-marketing studies, investigator sponsored studies, and health economics studies.

1.7 “Commercialization” or “Commercialize” means any and all activities (whether before or after
Regulatory Approval) directed to the commercialization of the Licensed Product, including
pre-launch and post-launch marketing, Promoting, distributing, offering to sell and selling the
Licensed Product, and importing or exporting the Licensed Product for sale. When used as a verb,
“Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding
meaning.

1.8 “Commercial Product” means Drug Product specifically produced and packaged for Commercial use
and sale for indications with Regulatory Approval within the SPA Territory in final labeling and
packaging as approved incident to the NDA.

1.9 “Confidential Information” means all information that is not in the public domain and is
protectable by a Disclosing Party as a trade secret under Applicable Law (including, without
limitation, Regulatory Data and Information, as defined below) provided to a Party by another
Party, whether oral, in writing or otherwise, including, without limitation, any information on the
research, development, markets, customers,
suppliers, patent applications, inventions, products, procedures, designs, formulas, business
plans, financial projections, organizations, employees, consultants or any other similar aspects of
a Party’s present or future business.

1.10 “Corporate Names” means (i) in the case of SPA, the trademark SPA and the Sucampo corporate
logo or such other names and logos used generally by SPA and its Affiliates in their business (and
not relating to a specific product or technology) as SPA may designate in writing from time to
time, and (ii) in the case of RTU, the trademark RTU and the RTU corporate logo or such other names
and logos used generally by RTU in its business (and not relating to a specific product or
technology) as RTU may designate in writing from time to time, in each case ((i) and (ii)),
together with any variations and derivatives thereof.

1.11 “Data Exclusivity” means any data or market exclusivity granted to a Licensed Product in the
SPA Territory by any Regulatory Authority as of the Effective Date or at any time during the Term.

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

1.12 “Development” or “Develop” means, with respect to the Licensed Product, all research, all
pre-clinical and clinical activities conducted relating to the Licensed Product for any indication,
including without limitation, test method development and stability testing, toxicology, animal
studies, formulation, process development, manufacturing scale-up, quality assurance/quality
control development for clinical studies, statistical analysis and report writing, and Clinical
Studies, including without limitation clinical trial design, operations, data collection and
analysis and report writing, publication planning and support, risk assessment mitigation
strategies, health economics outcomes research planning and support, clinical laboratory work,
disposal of drugs and regulatory activities in connection therewith, the transfer of information,
materials, Licensed Product regulatory documentation and other technology with respect to the
foregoing, the preparation of Regulatory Filings, and obtaining and/ or maintaining Regulatory
Approvals (including regulatory affairs activities and preparation of meetings with Regulatory
Authorities). When used as a verb, “Developing” means to engage in Development and “Developed” has
a corresponding meaning.

1.13 “Disclosing Party” means the Party disclosing Confidential Information; provided a
Party owning certain property as provided hereunder shall be considered the Disclosing Party and
the other Party shall be considered the Receiving Party regardless of which Party discloses such
information.

1.14 “Drug Approval Application” means, on a Licensed Product-by-Licensed Product basis in SPA
Territory, an application submitted to a Regulatory Authority for Regulatory
Approval for the Licensed Product, and all supplements and amendments that may be filed with
respect to the foregoing.

1.15 “Glaucoma and Ocular Hypertension Indication” means the prophylactic or therapeutic use in the
prevention and/or treatment of glaucoma and Ocular Hypertension.

1.16 “Improvement Patent” shall mean any patent relating to any invention made by a Party that
improves the performance of the Licensed Product in terms of its safety, efficacy, patient
acceptance, cost, manufacture, formulation, dosing, use or sale, but shall not include inventions
that involve new compositions of matter used as active ingredients, or new formulation technology
otherwise patentable and applicable to other compositions of matter than the Licensed Product.

1.17 “IND” means an application filed with a Regulatory Authority for authorization to commence
human clinical trials or prosecute a Drug Approval Application of Unoprostone, including, but not
limited to, (i) an Investigational New Drug Application as defined in the Food, Drug and Cosmetic
Act (FDCA) or any update thereto or any successor application or procedure filed with the Food and
Drug Administration (FDA), (ii) any foreign equivalent of a United States IND, and (c) all
supplements and amendments that may be filed with respect to the foregoing.

1.18 “Licensed Know-How” means all Technology controlled by RTU or its Affiliates as of the
Effective Date or at any time during the Term that is useful or necessary for developing, using,
making, having made, offering for sale, registering, selling or importing the Licensed Product.

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

1.19 “Licensed Patents” means all patent and patent applications related to Unoprostone that are
hereunder licensed to SPA and/or enable SPA activities in SPA Territory (i) that are owned by or
licensed (with the right of sublicense) to RTU on before the Effective Date of this Agreement or
(ii) which derive from inventions that are acquired, made, created, developed, conceived or reduced
to practice by RTU during the Term of this Agreement, to the extent that such patents or patent
applications relate to Unoprostone (including, without limitation, its composition of matter, its
method of use, its formulation(s) (either alone or in combination with other active ingredients),
its dosing regimens, its manufacture, its synthesis, its metabolism, its safety and/or its utility
) or necessary, used, or useful for the development, manufacture or commercialization of
Unoprostone, or (iii) which derive from an invention that is made, created, developed, conceived or
reduced to practice jointly by RTU and SPA after the Effective Date of this Agreement the practice
of which would in the absence of a license, infringe on a claim of any unexpired patent described
in (i) or (ii). Licensed Patents include all reissues, continuations, continuations-in-part,
extensions,
reexaminations, and foreign counterparts of any of the foregoing. Licensed Patents include listing
set forth in Exhibit C (Licensed Patents), which may be amended from time-to-time to add additional
patents and patent applications.

1.20 “Licensed Product” means any human or veterinary pharmaceutical product (whether prescription
or over-the-counter and in any form or dosage form of a pharmaceutical composition or preparation),
comprising of Unoprostone (whether as a sole active ingredient or in combination with one or more
other active ingredients) for which the rights to manufacture, to use and to sell such product in
the SPA Territory as a pharmaceutical product are granted hereunder to SPA under the Licensed
Patents and the Licensed Know-How.

1.21 “Market Withdrawal” means a “market withdrawal” as such term is defined in Title 21, United
States Code of Federal Regulations, Part 7.3 (as amended from time to time, or such successor
Applicable Law as may take effect in the United States) or in equivalent Applicable Law outside the
United States, governing the possible withdrawal of the Licensed Product in the SPA Territory.

1.22 “NDA” means a New Drug Application, as defined by laws for such application within the SPA
Territories (as defined below) and applicable regulations promulgated in the countries or
territories there under, or other appropriate marketing authorization in Japan, or any counterpart
application or marketing authorization in any country of the SPA Territory. For the avoidance of
doubt, maintenance of the NDA with respect to compliance of the Drug Substance or the Drug Product
with the Drug Master File/Chemistry, Manufacturing and Controls (“DMF/CMC”) elements of the NDA
shall remain with and be maintained by RTU .

1.23 “Net Sales” means the total amount billed or invoiced on sales of Licensed Product by SPA or
its Affiliates in SPA Territory to independent, unrelated Third Parties such as wholesalers or
distributors and actually received in payment from such unrelated Third Parties in bona fide arm’s
length transactions, less the following deductions (specifically excluding any royalty payments
made by SPA or its Affiliates to RTU), in each case related specifically to Commercialization and
sale of the Licensed Product and actually allowed and taken by such Third Parties and not
otherwise recovered by or reimbursed to SPA or its Affiliates:

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	(i)	 	trade, cash and quantity discounts;
	 
	 	(ii)	 	price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or
otherwise paid to governmental authorities;
	 
	 	(iii)	 	taxes on sales (such as sales or use taxes) to the extent added to the sale price and
set forth separately as such in the total amount invoiced;
	 
	 	(iv)	 	freight, insurance and other transportation charges to the extent added to the sale price
and set forth separately as such in the total amount
invoiced, as well as any fees for services provided by wholesalers and warehousing chains related
to the distribution of the Licensed Product;
	 
	 	(v)	 	amounts repaid or credited by reason of rejections, defects, one percent (1%) return
credits, recalls or returns or because of retroactive price reductions, including, but not limited
to, rebates or wholesaler charge backs; and
	 
	 	(vi)	 	the portion of management, commercialization costs or fees paid during the relevant time
period to distributors, co-promotion partners, group purchasing organizations and/or pharmaceutical
benefit managers relating specifically to the finished Licensed Product.

Net Sales will include the amount or fair market value of all other consideration received by SPA
or its Affiliates in respect of the Licensed Product, whether such consideration is in cash,
payment in kind, exchange or other form.

Subject to the above, Net Sales will be calculated in accordance with SPA’s standard internal
policies and procedures, which must be in accordance with GAAP (Generally Accepted Accounting
Principles as regularly applied under the Financial Accounting Standards Board (“FASB”) as may be
promulgated from time to time).

Net sales will not include sales between or among SPA and its Affiliates.
For purposes of calculating Net Sales, all Net Sales will be converted into United States dollars
using SPA’s standard conversion methodology consistent with GAAP. The standard conversion
methodology is based on monthly averages (for example, the spot rate at the end of the month
immediately prior to the reporting month plus the spot rate at the end of the reporting month,
divided by two) using open market rates.

If SPA or its Affiliates appoint Third Party distributors for the Licensed Product or grant a
license or sublicense to any Third Party for manufacturing and selling the Licensed Product, Net
Sales will include the Net Sales invoiced and received by SPA or its Affiliates to such Third Party
distributors and the royalties or other compensation of any other kind whatsoever invoiced and
received by SPA or its Affiliates to any such Third Party manufacturer, but it will not include any
sales of the Licensed Product made by any such Third Party distributors or other Person.

1.24 “Order” means, in accordance with the Unoprostone Supply Agreement Sections 1.8 (Order), 2.4
(Clinical Supply; Order) and 2.5 (Commercial Supply; Exclusivity; Forecasting; Order), a written
communication from SPA to RTU of SPA’s order for purchase of a specified amount of Unoprostone or
Licensed Product at a delivery date, delivery price and delivery location set forth in such written
purchase order communication.

 Page 8 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

1.25 “Other Indications” means any indication for use of Unoprostone other than the Glaucoma
Indication and Ocular Hypertension Indication.

1.26 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited
liability partnership, corporation, limited liability company, business trust, joint stock company,
trust, incorporated association, joint venture, or other entity or organization, in any case
whether for-profit or not-for profit, and including, without limiting the generality of any of the
foregoing, a government or political subdivision, department or agency of a government or formal
non-governmental organization.

1.27 “Phase I Study” means a human clinical trial of a product, the principal purpose of which is a
preliminary determination of safety or pharmacokinetics in healthy individuals or patients or
similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to
Applicable Law or otherwise.

1.28 “Phase II Study” means, collectively, a Phase IIa Study and a Phase IIb Study.

1.29 “Phase IIa Study” means a human clinical trial of a product, the principal purpose of which is
a demonstration of proof of concept in the target patient population or a similar clinical study
prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or
otherwise.

1.30 “Phase IIb Study” means a human clinical trial of a product, the principal purpose of which is
to find the optimally safe and effective dose range in the target patient population or a similar
clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable
Law or otherwise.

1.31 “Phase III Study” means a human clinical trial of a product on a sufficient number of subjects
that is designated to establish that such product is safe and efficacious for its intended use, and
to determine warnings, precautions, and adverse reactions that are associated with such product in
the dosage range to be prescribed, which trial is intended to support marketing of such product,
including all tests, studies, or a similar clinical study prescribed by the Regulatory Authorities,
from time to time, pursuant to Applicable Law or otherwise.

1.32 “Product Label and Insert” means (i) any display of written, printed or graphic matter upon
the immediate container, outside container, wrapper or other packaging of the Licensed Product or
(ii) any written, printed or graphic material on or within the package from which the Licensed
Product is to be dispensed and is reviewed and approved from time to time by a Regulatory Authority
from time to time.

1.33 “Product Trademark” means (i) any trademark, trade dress, brand mark, service mark, brand
name, logo or business symbol, Internet domain name and e-mail address, whether or not registered
or any application, renewal, extension or modification thereto, that is applied to or used with the
Licensed Product by RTU, its Affiliates, or any other Party that is marketing, promoting, and/or
selling the Licensed Product and (ii) all
goodwill associated therewith; in each case ((i) and (ii)). Corporate Names are specifically
excluded, except where the name of the manufacturer is required to be mentioned on Licensed Product
labels or otherwise by a Regulatory Authority. Product Trademark shall include, but

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

not be limited
to, the mark “Rescula” as well as derivatives thereof. Product Trademarks existing as of the
Effective Date include, without limitation, those Product Trademarks set forth in Exhibit C
(Product Trademarks), which shall be updated from time to time.

1.34 “Product Valid Claims” means, with respect to the Licensed Product, a claim of any issued and
unexpired patent included within the Licensed Patents, the enforceability of which has not been
subject to one or more of any of the following: (i) irretrievable lapse, revocation or abandonment;
(ii) holding of unenforceability or invalidity by a decision of a court or other appropriate body
of competent jurisdiction, that is unappealable or unappealed within the time allowed for appeal;
and/or (iii) disclaimer or admission of invalidity or unenforceability through reissue or
re-examination or opposition, nullity action or invalidation suit response, terminal disclaimer or
otherwise. The foregoing notwithstanding, in the event a claim of a patent within the Licensed
Patent(s) has been held to be invalid or unenforceable, and an appeal is pending, such claim shall
not be considered a Product Valid Claim until reinstated by a final decision of a court or
governmental agency of competent jurisdiction.

1.35 “Promote” or “Promotion” means those activities normally undertaken by a pharmaceutical
company’s sales force and marketing team to implement marketing plans and strategies aimed at
encouraging the appropriate use of a particular prescription or other pharmaceutical product,
including detailing. When used as a verb, “Promote” means to engage in such activities.

1.36 “Promotional Material” means all written, printed or graphic material, other than Product
Labels and Inserts, intended for use by representatives in Promoting the Licensed Product,
including visual aids, file cards, premium items, clinical study reports, reprints, drug
information updates, and any other promotional support items.

1.37 “Recall” means a “recall” as such term is defined in Title 21, United Stated Code of Federal
Regulations, Part 7.3 (as amended from time to time, or such successor Applicable Law as may take
effect in the United States) or equivalent Applicable Law outside the United States, of the
Licensed Product.

1.38 “Receiving Party” means the Party receiving Confidential Information; provided a Party
owning certain property as provided hereunder shall be considered the Disclosing Party and the
other Party shall be considered the Receiving Party regardless of which Party discloses such
information.

1.39 “Regulatory Approval” means, in the SPA Territory, any and all approvals, licenses (including
product and establishment licenses), registrations, or authorizations of any Regulatory Authority
necessary to Develop, manufacture, Commercialize, promote, distribute, transport, store, use, sell
or market the Licensed Product, including, where applicable, pricing or reimbursement approval, or
pre- and post-approval marketing authorizations, labeling approvals, import and export licenses,
technical, medical and scientific licenses.

1.40 “Regulatory Authority” means any national, supra-national, regional, federal, state,
provincial or local regulatory agency, department, bureau, commission, council or other
governmental entity

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

regulating or otherwise exercising authority over the distribution,
importation, exportation, manufacture, use, storage, transport, clinical testing,
Commercialization, or sale of the Licensed Product.

1.41 “Regulatory Data and Information” consists of data and information relating to a Licensed
Product that is derived from any or several of the following business activities undertaken by any
of the Parties at any time: (i) market and business research and intelligence; (ii) research and
development of pharmaceutical and medicinal products; (iii) obtaining Commercialization approval
for pharmaceutical products; and (iv) consultation with respect to any or several of the above
activities.

1.42 “Regulatory Filings” means, collectively, all INDs, Drug Approval Applications, diagnostic
product device approval applications, establishment license applications, drug master files, and
any product approvals under Section 505 (a) and (b) of the Food, Drug and Cosmetic Act (FDCA) (21
U.S.C. § 355(b)(4)(B)) or any update thereto or all other similar filings (including, without
limitation, any counterparts of any of the foregoing in SPA Territory) as may be required by any
Regulatory Authority for the Development, manufacture or Commercialization of Unoprostone or the
Licensed Product; and (b) all supplements and amendments to any of the foregoing.

1.43 “Technology” means, collectively, proprietary information, know-how and data, technical or
non-technical, trade secrets, materials (including tangible chemical, biological or other physical
materials) or inventions, discoveries, improvements, processes, methods of use, methods of
manufacturing and analysis, compositions of matter, or designs, whether or not patentable.

1.44 “Term” means the definition provided in Section 12.1.

1.45 “Territory” means (i) with respect to SPA, the United States of America and Canada, and all of
their territories and possessions and any other location where the FDA or its foreign counterparts
in the Territory has jurisdiction over pharmaceutical products intended for human use (“SPA
Territory”), and (ii) with respect to RTU, the remaining countries in the world (“RTU Territory”).

1.46 “Third Parties” means any Person other than RTU and SPA and their respective Affiliates.

1.47 “Unoprostone” (also known by the USAN name of Unoprostone isopropyl) is the composition of
matter defined chemically as isopropyl [*] as further described in Exhibit A, and its salts,
metabolites, as well as any active pro-drugs, isomers, tautomers, hydrates, chelates, complexes and
polymorphs and all other pharmaceutically acceptable modifications as may be projected in the
public domain as motivation to an medicinal chemistry expert in the drug development field.

Article 2. NDA Transfer

2.1 After the Effective Date, RTU shall cooperate with SPA for timely transfers to SPA of ownership
and control of all regulatory approvals and files, owned by RTU as of the Effective Date, for the
Licensed Product in the SPA Territory, at RTU’s expense, with the exception of the CMC matter to be
retained by RTU.

 Page 11 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

2.2 RTU shall provide SPA with transitional services relating to the regulatory approvals, which
shall consist of supporting SPA’s efforts to submit regulatory filings, reasonably requested by SPA
in writing for a period of up to six (6) months after Effective Date, at SPA ‘s expense.

2.3 Prior to the Effective Date, RTU shall maintain the NDA of the Licensed Product at RTU’s
expense and, as from the Effective Date, SPA shall maintain the NDA of the Licensed Product at
SPA’s expense within the SPA Territory.

Article 3. Data Sharing

3.1. Right to Use Regulatory Data and Information.

	3.1.1	 	Each Party (each, within this Article 3, a “Receiving Party”) shall have a right to use of
all Regulatory Data and Information developed by the other Party (each, within this Article 3,
a “Developing Party”) for the purpose specified in the Agreement in such Receiving Party’s
Territory. The Parties shall keep one another reasonably apprised of information pertaining
to Regulatory Data and Information and may request formal disclosure of Regulatory Data and
Information at any time, consent to such request shall not be unreasonably withheld.
	 
	3.1.2	 	The Parties anticipate that a Receiving Party may exercise its rights under this Section 3.1
at any time, and specifically at the start of Phase I Studies or at the end of Phase I
Studies, Phase II Studies, Phase III Studies or Regulatory Approval.
	 
	3.1.3	 	If a Receiving Party exercises its right to access and use a Developing Party’s Regulatory
Data and Information, such Receiving Party shall be entitled to use
such Regulatory Data and Information solely for the purpose of developing, obtaining
regulatory approval for, marketing and selling products in such Receiving Party’s Territory
pursuant to the terms and conditions of this Agreement. Such rights shall include the right
to refer, in any application for regulatory approvals for the Licensed Products and/or
Unoprostone in respect of any country in the Receiving Party’s Territory, to any and all
documentation filed by the Developing Party or its sublicenses with the regulatory
authorities in the Developing Party’s Territory, in support of any application for
regulatory approval of the Licensed Products and/or Unoprostone.

3.2 Data Sharing Intellectual Property Ownership. Subject to the rights obtained by a Party
pursuant to this Article 3, the Receiving Party shall retain all the rights in any invention,
technology, know-how or other intellectual property resulting from its use of the Regulatory Data
and Information in compliance herewith; provided, however, that such Receiving Party shall allow
the other Party to use non-exclusively in its Territory such Regulatory Data and Information
without consideration solely for the purpose of developing, obtaining regulatory approval for,
marketing and selling products in such Party’s Territory. The provisions set forth in Article 3
shall not be the basis of any joint development program, partnership or joint venture of any kind
unless separately agreed upon. Any joint development program, if any, shall be the subject of
separate definitive agreements.

Article 4. Patent License Grants and Know-How Access

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

4.1 Patent Licenses. Subject to the terms and conditions of this Agreement, and subject to no
further costs than those set forth in Article 9 below, RTU hereby grants to SPA a royalty-bearing
and exclusive license, with right of sublicense as provided in Section 4.3 (Sublicensing), under
the Licensed Patents to Develop, import, use, make, have made, export, register, Commercialize,
offer for sale and sell Licensed Products throughout the SPA Territory.

4.2 License to Know-How. Subject to the terms and conditions of this Agreement, and subject to no
further costs than those set forth in Article 9 below, RTU hereby grants to SPA a royalty-bearing
and exclusive license, with right of sublicense as provided in Section 4.3 (Sublicensing), under
the Licensed Know-How to Develop, import, use, make, have made, export, register, Commercialize
offer for sale and sell Licensed Products throughout the SPA Territory.

4.3 Sublicensing. SPA shall have the right to sublicense its rights under Sections 4.1 (Patent
Licenses) and 4.2 (License to Know-How) to Third Parties, provided that (i) the agreement in which
such sublicense is granted shall conform with the terms of this Agreement as may be necessary for
SPA to abide by all duties, obligations and restrictions provided under this Agreement, and (ii)
RTU shall provide written consent for
such sublicensing, which shall not be unreasonably withheld. In no event may SPA grant a
sublicense that diminishes the rights or increases the obligations of RTU under this Agreement
without the prior written consent of RTU. With reasonable promptness following execution, SPA
shall provide a copy of any sublicense to RTU provided that the financial terms of such sublicense
may be redacted. SPA shall be responsible hereunder for any failure of such Third Parties to
comply with the terms and conditions of this Agreement as if they are directly applicable to such
Third Parties.

4.4 Improvement Patents. As inventions are discovered by a Party that would be a basis for filing
for an Improvement Patent, that inventing Party shall inform the other Party and the Parties will
cooperate with each other before the filing, in the filing, and after filing such Improvement
Patent, to assure at lowest cost, and more reasonable level of effort the widest filing globally
of a patent filing most likely to be granted with the most comprehensive claims so as to best
extend and improve the commercial returns from the Licensed Product. Subject to the terms and
conditions of this Agreement, and subject to no further costs than those set forth in Article 9
below, RTU hereby grants to SPA a non-exclusive and royalty-free license, under any and all patents
to be owned by RTU with respect to any patentable inventions made, created, developed, conceived or
reduced to practice by RTU during the Term of this Agreement in relation to the Licensed Product
and/or Unoprostone, to Develop, make, register, Commercialize, use and sell the Licensed Products
within the SPA Territory hereunder. SPA hereby grants to RTU a non-exclusive and royalty-free
license, under any and all patents to be owned by SPA (including its Affiliates and sublicensees)
with respect to any patentable inventions made, created, developed, conceived or reduced to
practice by SPA during the Term of this Agreement in relation to the Licensed Products and/or
Unoprostone hereunder, to make, use and sell any product within the RTU Territory. SPA will notify
RTU and its Affiliates within thirty (30) days in the event that SPA decides not to prepare, file,
prosecute, maintain and/or defend the Improvement Patents outside of SPA Territory. RTU or its
Affiliates shall then have the right and option to do so at its own responsibilities and expense
and shall own any resulting patent applicable or patent. Such rights of RTU would be in addition
to, and

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

not replace, any other rights and remedies of RTU’s available by law and/or this Agreement.
RTU will notify SPA and its Affiliates within thirty (30) days in the event that RTU decides not
to prepare, file, prosecute, maintain and/or defend the Improvement Patents outside of SPA
Territory. SPA or its Affiliates shall then have the right and option to do so at its own
responsibilities and expense and shall own any resulting patent applicable or patent. Such rights
of SPA would be in addition to, and not replace, any other rights and remedies of SPA’s available
by law and/or this Agreement.

4.5 License to Product Trademarks. Subject to and in accordance with the terms and conditions of
this Agreement, and subject to no further costs than those set forth in Article 9 below, RTU hereby
grants to SPA an exclusive, even as to RTU and its Affiliates in the SPA Territory, royalty-free
license, with the right to sublicense to multiple tiers of Third Parties, to use all current and
future Product Trademarks in connection with the performance by SPA or its Affiliates of their
development and Commercialization obligations with respect to the Licensed Product, provided,
however RTU shall have the right to use these future trademarks without incurring any payment
obligations to SPA in RTU Territory. Notwithstanding the license to Product Trademarks granted by
RTU in this Section 4.5, SPA shall have the right not to use the Licensed Product Trademarks or to
use another trademark (each an “Alternative Trademark”) for the Licensed Product in SPA Territory,
and SPA shall own all rights to such Alternative Trademark and shall be free to use such
Alternative Trademark without regard to, or accounting to, RTU except as otherwise provided herein.
RTU shall have the right to use these Alternate trademarks without incurring any payment
obligations to SPA in RTU Territory.

Article 5. Regulatory

5.1 Regulatory Filings; Regulatory Approvals. Subject to Articles 2 (NDA Transfer) and 3 (Data
Sharing) the following provisions shall apply:

	5.1.1	 	Ownership. Ownership and control over all aspects of the NDA other than CMC
compliance for the Licensed Product and Unoprostone in the Territory shall be transferred to
SPA in accordance with the provisions of Article 2 and 3 above. Upon such transfer SPA shall
undertake it commercially reasonable efforts to prosecute and maintain the NDA for the
Licensed Products and/or Unoprostone [for all product indications] in the Territory.
	 
	5.1.2	 	Preparation of Regulatory Filings; Communications.

	 	a)	 	Preparation of Regulatory Filings; Review of Regulatory Filings. Subject to
all provisions above, the Parties shall reasonably cooperate and consult with each
other in good faith to develop strategies for all Regulatory Filings for Unoprostone
and the Licensed Product; provided that RTU shall be responsible for
determining for the CMC package and shall have a right of final approval for the
overall regulatory strategy. The Parties shall also be responsible within their
respective Territories for implementing the regulatory strategy for clinical studies
(including the interactions with Regulatory Authorities).

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	b)	 	Communications; Regulatory Meetings. The Parties shall cooperate with each
other’s reasonable requests and provide support in responding to Regulatory
Authorities, including providing comments on its submissions
and responses within ten (10) Business Days from the time of receipt or sooner if
required by Regulatory Authority.
	 
	 	c)	 	Occurrences or Information Arising out of RTU Manufacturing Activities. During
the Term, RTU will advise SPA without undue delay, however in any event within a period
not to exceed seven (7) Business Days of any occurrences or information arising out of
RTU’s manufacturing activities that have or could reasonably be expected to have
adverse regulatory compliance and/or reporting consequences concerning the Licensed
Product, including actual or threatened Regulatory Authorization withdrawals or
labeling changes in SPA Territory, and failure to do so shall constitute a material
breach of this Agreement by RTU.
	 
	 	d)	 	Regulatory Authority Inspections. During the Term, and subject to the
Unoprostone Supply Agreement, RTU will be responsible for handling and responding to
any Regulatory Authority inspections with respect to RTU’s manufacture of the Licensed
Product. RTU will provide to SPA any information reasonably requested by SPA and all
information requested by any Regulatory Authority concerning any governmental
inspection related to the Licensed Product and will allow Regulatory Authorities to
conduct reasonable inspections upon the request of such Regulatory Authority and
failure to do so shall constitute a material breach of this Agreement by RTU.
	 
	 	e)	 	Violations or Deficiencies Relating to the Licensed Product. SPA without undue
delay, but in any event within a period not to exceed five (5) Business Days, of any
written alleged violations or deficiencies relating to the Licensed Product and the
corrective action to be taken. RTU will as expeditiously as practicable take any such
corrective action required to comply with the provisions of this Agreement and with the
Unoprostone Supply Agreement, and failure to do so shall constitute a material breach
of this Agreement by RTU. Prior to submission of any written response submitted to any
applicable Regulatory Authority, SPA will have an opportunity to review any portion of
the response regarding written alleged violations or deficiencies relating to the
Licensed Product.

5.2 Product Labels and Inserts; Core Data Sheets. Each Party and its Affiliates shall own and be
responsible for all Product Labels and Inserts for all Licensed Products in its Territory. Each
Party and its Affiliates shall own and be responsible for all Core Data Sheets for all Licensed
Products in its Territory.

5.3 Adverse Event Reports. SPA and its Affiliates shall be responsible for investigating Adverse
Events and other required safety information associated with the use of the Licensed Product in SPA
Territory in accordance with the requirements of the relevant Regulatory Authority. SPA shall be
responsible for the collection, review, assessment, tracking and filing of information related to
Adverse

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

Events, and RTU will cooperate and provide or cause any Third Party to provide such
information to SPA and its Affiliates with respect thereto and failure to do so shall constitute a
material breach of this Agreement by RTU. Prior to any Commercialization of the Licensed Product
in the SPA Territory, the Parties shall enter into an agreement to initiate a process for the
exchange of Adverse Event safety data in a mutually agreed format, including, but not limited to,
post-marketing spontaneous reports received by a Party or its Affiliates in order to monitor the
safety of the Licensed Product and to meet reporting requirements with any applicable Regulatory
Authority (“Pharmacovigilance Agreement”).

5.4 Recalls and Market Withdrawals.

	5.4.1	 	Notification. Each Party shall make every reasonable effort to notify the other
Party promptly (but in no event later than forty-eight (48) hours) upon its determination that
any event, incident or circumstance has occurred that may result in the need for a Recall or
Market Withdrawal of the Licensed Product, in or outside of its Territory, and include in such
notice the reasoning behind such determination and any supporting facts.
	 
	5.4.2	 	Initiation. SPA shall determine whether to voluntarily implement any Recall and
upon what terms and conditions the Licensed Product shall be subject to a Recall in SPA
Territory. SPA shall determine whether to voluntarily implement a Market Withdrawal in SPA
Territory and upon what terms and conditions the Licensed Product shall be subject to a Market
Withdrawal or otherwise temporarily or on a limited basis withdrawn from sale in SPA
Territory. If a Recall is mandated by a Regulatory Authority, SPA shall initiate such a Recall
to be in compliance with Applicable Law.
	 
	5.4.3	 	Responsibility. For all Recalls or Market Withdrawals undertaken pursuant to this
Section 5.4, SPA and its Affiliates shall be solely responsible for the execution of such
Recall or Market Withdrawals, and RTU shall reasonably cooperate in all such Recall or Market
Withdrawal efforts. RTU shall be responsible for the costs associated with any Recall or
Market Withdrawal to the extent of its attribution to the cause of such Recall or Market
Withdrawal.
	 
	5.4.4	 	Complaints. In the case that the same lot of the Product is supplied for the SPA
Territory and RTU Territory, each Party shall refer any complaints that it receives concerning
the Licensed Product in the other Party’s Territory to the other Party
within forty-eight (48) hours of its
receipt of the same or earlier if
required by Applicable Law; provided
that all complaints concerning
suspected or actual Licensed Product
tampering, contamination or mix-up
(e.g. wrong ingredients) shall be
delivered within twenty-four (24)
hours of receipt of the same.
Unless otherwise required by any
Applicable Law, the Parties shall
not take any other action in respect
of any such complaint which it
receives concerning the Licensed
Product in the other Party’s
Territory without the prior written
consent of the other Party.

Article 6. Development

6.1 General. SPA, at its sole discretion, may engage in Development of Unoprostone and/or Licensed
Product in SPA Territory.

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

6.2 Additional Clinical Trials. SPA, at its sole discretion, may conduct clinical trials of
Unoprostone and/or Licensed Product in SPA Territory, at its sole expense.

6.3 Pharmacovigilance Administration. In SPA Territory, SPA shall be responsible for all costs of
pharmacovigilance administration in SPA Territory in accordance with the Pharmacovigilance
Agreement (as defined in Section 5.3 above, Adverse Events Reports). RTU shall ensure that it, its
Affiliates, or its licensees provide SPA with all information and data required to allow SPA to
comply with its regulatory obligations and RTU’s failure to do so shall constitute a material
breach of this Agreement by RTU.

6.4 Conduct of Development.

	6.4.1	 	Compliance. Within its Territory, each Party shall perform Development of
Unoprostone and/or Licensed Product in good scientific manner and in material compliance with
Applicable Law.
	 
	6.4.2	 	Cooperation. The Parties shall cooperate in good faith as needed in performance of
Development.

6.5 Records. Each Party shall maintain records of its Development activities in sufficient detail,
in good scientific manner and otherwise in a manner that reflects all work done and results
achieved in the performance of Development. Each Party shall retain such records for at least five
(5) years after the expiration or termination of this Agreement, or for such longer period as may
be required by Applicable Law or agreed to in writing by the Parties. Subject to Articles 10
(Confidentiality and Non-Disclosure) and 3 (Data Sharing), each Party shall provide the other
Party, upon reasonable request, a copy of such records to the extent reasonably required for the
performance of the requesting Party’s obligations and exercise of its rights under this Agreement.
Each Party agrees to maintain a policy that requires its employees and consultants to
record and maintain Technology developed during the development plans in accordance with generally
accepted practice in the industry.

6.6 Other Indications; Mutual Right of First Refusal. From time to time during the Term, each
Party may Develop products for Other Indication(s) within each Territory and grant the other Party
a non-exclusive license to Develop and Commercialize a product for such Other Indication(s) in its
Territory. Each Party shall provide the other with notice of any such Other Indication(s) in
writing. The Parties shall negotiate in good faith on basic terms and conditions of such license
agreement. Each party shall have the right to sublicense the right set out in this section 6.6
only upon prior written consent by the other party, which consent is within the other party’s full
and unfettered discretion.

Article 7. Promotion of Licensed Products

7.1 Efforts. Subject to the terms and conditions of this Agreement, SPA and its Affiliates shall
be solely responsible for all aspects of Commercializing the Licensed Product in SPA Territory,
including, but not limited to the utilization of Third Parties to Commercialize or detail the
Licensed Products. SPA shall have full discretion, without liability to RTU, in determining
whether or not to Commercialize the Licensed Product in SPA Territory.

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

7.2 Promotional Materials. SPA shall own all Promotional Materials for the Licensed Product in SPA
Territory. RTU shall provide SPA with copies of Promotional Materials, if prepared by RTU, for the
Licensed Product. SPA, its Affiliates and sublicensees may use such Promotional Materials, as
modified appropriately subject to the approval of RTU in writing, for use in SPA Territory for the
purpose of this Agreement. SPA shall permit RTU to use copies of the Promotional Materials,
including those so modified, within RTU Territory.

Article 8. Consideration

8.1 Upfront Payment. SPA or its Affiliates shall pay to RTU a non-refundable Three Million United
States Dollars (US$3,000,000) (payable in Japanese Yen, converted at the spot rate at the close of
the Business Day in which each such milestone payment becomes payable) within fifteen (15) days of
the Effective Date.

8.2 Milestone Payments. SPA shall make each of the following non-refundable, payments to RTU, in
United States dollars, but paid in Japanese Yen, converted at the spot rate at the close of the
Business Day in which each such milestone payment becomes payable and each on a one (1) time basis
at the end of the month following which the milestone event is achieved:

	 	 	 
	Milestone Event	 	Milestone Payment
	Re-launch of Rescula® for Glaucoma
Indication in SPA Territory

	 	SPA to pay RTU US$500,000 in
accordance with 9.2 after the
occurrence of the Milestone Event
	 
	 	 
	Other Indication Regulatory Approval
in SPA Territory for efficacy

	 	SPA to pay RTU US$1,000,000 in
accordance with 9.2 after the
occurrence of the Milestone Event
	 
	 	 
	1st occurrence of Annual
Net Sales in total of all
indications of US$[*] or more in SPA
Territory

	 	SPA to pay RTU US$500,000 in
accordance with 9.2 after the
occurrence of the Milestone Event
	 
	 	 
	1st occurrence of Annual
Net Sales in total of all
indications of US$[*] or more in SPA
Territory

	 	SPA to pay RTU US$1,000,000 in
accordance with 9.2 after the
occurrence of the Milestone Event
	 
	 	 
	1st occurrence of Annual
Net Sales in total of all
indications US$[*] or more in SPA
Territory

	 	SPA to pay RTU US$2,500,000 in
accordance with 9.2 after the
occurrence of the Milestone Event

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

8.3 Third Party Royalties and Milestones. Within SPA Territory, SPA shall be solely responsible
for the payment of any Third Party Royalties, milestone payments and any other payments arising
from Third Party intellectual property rights claims related to the Licensed Product.

8.4 Payment Dates and Reports. Upon making the payments under Sections 9.2 (Milestone Payments)
and 9.3 (Third Party Royalties and Milestones), SPA and its Affiliates shall also provide a report
showing: (i) a statement identifying the Annual Net Sales of the Licensed Product in the Territory;
(ii) the withholding taxes, if any, required by Applicable Law to be deducted with respect to such
Net Sales; and (iii) the exchange rates, if any, used in determining the amount of United States
dollars.

8.5 Audit Rights. Each Party shall keep and maintain for at least three (3) years complete and
accurate records in accordance with GAAP or IFRF as the case may be in sufficient detail to allow
confirmation of any payment calculations or components thereof and made hereunder. Upon the
written request of a Party (herein, the “Auditing Party”) and not more than once in each Calendar
Year, the other Party
(herein, the “Audited Party”) shall permit an independent certified public accounting firm of
internationally-recognized standing, selected by the Auditing Party (provided that the Auditing
Party shall not without the Audited Party’s prior written consent select the same public accounting
firm that conducts the Auditing Party’s annual financial statement audit) and reasonably acceptable
to the Audited Party, at the Auditing Party’s expense, to have access, with not less than thirty
(30) days notice, during normal business hours, to the records of the Audited Party and its
Affiliates as may be reasonably necessary to verify the accuracy of the payments hereunder for any
year ending not more than thirty-six (36) months prior to the date of such request. The accounting
firm will be instructed to provide its audit report first to the Audited Party, and will be further
instructed to redact any proprietary information of the Audited Party not relevant to verifying the
accuracy of payments prior to providing that audit report to the Auditing Party. The accounting
firm’s audit report shall state whether the applicable report(s) is/are correct or not, and, if
applicable, the specific details concerning any discrepancies. No other information shall be
shared. If such accounting firm concludes that additional monies were owed by the Audited Party to
the other, the Audited Party shall have the option to invoke the arbitration proceedings of
Sub-Section 14.1.2 or pay the additional monies within thirty (30) days of the date the Audited
Party receives such accounting firm’s written report so concluding. The fees charged by such
accounting firm shall be paid by the Auditing Party; provided if an error in favor of the
Auditing Party of more than ten percent (10%) is discovered, then the Audited Party shall pay the
reasonable fees and expenses charged by such accounting firm. Any audit reports provided hereunder
shall be the Confidential Information of the Audited Party.

8.6 Withholding Taxes. All payments made under this Agreement shall be free and clear of any and
all taxes, duties, levies, fees or other charges, except for withholding taxes. Where any sum due
to be paid to a Party hereunder is subject to any withholding tax, the Parties shall use
commercially reasonable efforts to do all such acts and things and to sign all such documents as
will enable them to take advantage of any applicable double taxation agreement or treaty. In the
event there is no applicable double taxation agreement or treaty, or if an applicable double
taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, the
paying Party shall deduct any

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

withholding taxes from payment and pay such withholding or similar
tax to the appropriate government authority, deduct the amount paid from the amount due to the
receiving Party and secure and send to the receiving Party the best available evidence of such
payment.

8.7 Payments. All payments due under this Agreement shall be payable in Japanese Yen, converted at
the spot rate at the close of the Business Day in which each such milestone payment becomes
payable. Unless specified otherwise herein or in the Unoprostone Supply Agreement, RTU will
invoice SPA for Licensed Product upon RTU’s delivery thereof to SPA’s carrier and payments shall be
due within thirty (30) days from date of receipt of invoice. All payments under this Agreement
shall be by appropriate electronic funds transfer in immediately available funds to such bank
account as RTU shall designate. Each payment shall reference this Agreement and identify the
obligation specific as to time and Net Sales or other condition incurring the payment obligation
under this Agreement that the payment satisfies. If at any time legal restrictions prevent the
remittance of part or all of payments owed by a Party hereunder, the Parties shall promptly
negotiate in good faith the terms for repayment under lawful means or methods.

8.8 No Other Compensation. Unless otherwise agreed to by the Parties and set forth in writing, RTU
and SPA hereby agree that the terms of this Agreement and all ancillary agreements hereto
(including, without limitation, the Unoprostone Supply Agreement attached hereto) shall fully
define any and all consideration, compensation and benefits, monetary or otherwise, to be paid,
granted or delivered by each Party to the other in connection with the transactions contemplated
herein. Neither Party has previously paid or entered into any other commitment to pay, whether
orally or in writing, any employee of the other Party, directly or indirectly, any consideration,
compensation or benefits, monetary or otherwise, in connection with the transactions contemplated
herein.

Article 9. Confidentiality and Non-Disclosure

9.1 Confidentiality.

	9.1.1	 	Nondisclosure Obligations. Except to the extent expressly permitted by this
Agreement, at all times during the Term and for a period of ten (10) years
following the expiration or termination hereof, the Receiving Party shall keep confidential
and shall not publish or otherwise disclose or use for any purpose other than the purpose of
this Agreement, any Confidential Information of the Disclosing Party. The Receiving Party
shall treat and protect the trade secret status of Confidential Information as it would its
own proprietary information which in no event shall be with less than a reasonable standard
of care, and take reasonable precautions to prevent the publication or unauthorized use or
disclosure of Confidential Information to a Third Party, except as explicitly set forth
herein, without prior, explicit, written consent of the other Party.
	 
	9.1.2	 	Exceptions to Confidentiality. The Receiving Party’s obligations set forth in this
Agreement shall not extend to any information of a Disclosing Party or information developed
in the performance of this Agreement that:

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	a)	 	is or hereafter becomes part of the public domain in accordance with Article 4,
by public use, publication, general knowledge or the like or is made generally
available in the public domain by a Third Party with right to make such publication; in
each case, other than through a breach of this Agreement;
	 
	 	b)	 	is received from a Third Party without restriction and with the right to
disclose such information or information developed in the performance of this
Agreement;
	 
	 	c)	 	the Receiving Party can demonstrate by competent pre-existing written evidence
properly maintained as a formal business record was already in its possession without
any limitation on its use or disclosure prior to its receipt from the Disclosing Party;
	 
	 	d)	 	the Receiving Party can demonstrate by competent written evidence properly
maintained as a formal business record was independently developed by or for the
Receiving Party without reference to, use of or disclosure of the Disclosing Party’s
Confidential Information or information developed in confidence in the performance of
this Agreement; or
	 
	 	e)	 	is released from the restrictions set forth in this Agreement by the express
prior written consent of the Disclosing Party, or in the case of information developed
in confidence in the performance of this Agreement, the other Party.

	 	 	Notwithstanding the foregoing, specific aspects or details of Confidential Information shall
not be deemed to be within the public domain or in the possession of the Receiving Party
merely because the Confidential Information is embraced by more general information in the
public domain or in the possession
of the Receiving Party. Further, any combination of Confidential Information shall not be
considered in the public domain or in the possession of the Receiving Party merely because
individual elements of such Confidential Information are in the public domain or in the
possession of the Receiving Party unless the combination and its principles are in the
public domain or in the possession of the Receiving Party.
	 
	9.1.3	 	Authorized Disclosures. Each Party may disclose Confidential Information and/or
Information developed in confidence in the performance of this Agreement to the extent that
such disclosure is:

	 	a)	 	made in response to a valid relevant unappealed or unappealable order of a
court of competent jurisdiction or other Regulatory Authority or any political
subdivision or regulatory body thereof of competent jurisdiction; provided that the
Receiving Party shall first have, if reasonably possible, given notice to the
Disclosing Party and given the Disclosing Party, at such Disclosing Party’s own
expense, a reasonable opportunity to quash such order or to obtain a protective order
requiring that the Confidential Information and/or Information developed in confidence
in the performance of this Agreement or documents that are the subject of such order be
held in confidence by

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	 	 	such court or Regulatory Authority or, if disclosed, be used only
for the purposes for which the order was issued; and provided, further, that if a
disclosure order is not quashed or a protective order is not obtained, the Confidential
Information disclosed in response to such order shall be limited only to that
information which is legally required, in the opinion of legal counsel to the Receiving
Party, to be disclosed in such response to such court or governmental order;
	 
	 	b)	 	otherwise required by Applicable Law or the requirements of a major national
securities exchange, in the opinion of legal counsel to the Receiving Party, provided
that the Party disclosing such Confidential Information shall exercise its commercially
reasonable efforts to obtain a protective order or other reliable assurance that
confidential treatment will be accorded and if possible give the other Party a
reasonable opportunity to review and comment on any such disclosure in advance thereof
(but not less than five (5) Business Days, if possible, prior to the date of such
disclosure);
	 
	 	c)	 	made to an applicable Regulatory Authority as useful or required in connection
with any filing, application or request for Regulatory Approval; provided that
reasonable measures shall be taken to assure confidential treatment and narrowest
possible use and disclosure of such information;
	 
	 	d)	 	(i) reasonably necessary in filing or prosecution of patents or other
intellectual and/or industrial property rights covering the manufacture, use or sale
of Unoprostone or the Licensed Product(s) or (ii) reasonably necessary in defending
litigation related to Licensed Patents if such litigation relates to this Agreement,
and in each case of (i) and (ii), provided that the Receiving Party or Party disclosing
information developed in confidence in the performance of this Agreement, if such
disclosure is non-confidential, gives reasonable advance notice to the Disclosing
Party, or other Party in the case of information developed in confidence in the
performance of this Agreement, of such disclosure; and
	 
	 	e)	 	to the extent necessary, and subject to subcontracting provisions set forth in
this Agreement, to its Affiliates, directors, officers, employees, consultants,
sublicensees of SPA or RTU (or bona fide potential sublicensees of SPA or RTU), vendors
and clinicians, under written agreements of confidentiality substantially similar or at
least as restrictive as those set forth in this Agreement, who have a need to know such
information in connection with a Party performing its obligations or exercising its
rights under this Agreement; provided, that either Party may enter into such written
agreements that provide for shorter timeframes for maintaining confidentiality than
those set forth in this Agreement with the written consent of the other Party.

9.2 Patient Information. The Parties shall abide (and cause their respective Affiliates to abide),
and take (and cause their respective Affiliates to take) all reasonable and appropriate actions to
ensure that

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

all Third Parties conducting or assisting with any clinical development activities
hereunder in accordance with, and subject to the terms of, this Agreement, shall abide, to the
extent applicable, by all Applicable Law concerning the confidentiality or protection of patient
identifiable information and other patient protected health information, the confidentiality of
Confidential Information and the patentability of any concepts, ideas, or inventions developed
incident to the performance of this Agreement.

9.3 Use of Name and Disclosure of Terms. Each Party shall keep the existence of, the terms of and
the transactions and the subject matter covered by this Agreement confidential and shall not
disclose such information to any Third Party through a press release, publication, promotional
material, other form of publicity or otherwise, or, except as expressly permitted in this
Agreement, mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype
of the other Party or its Affiliates in any manner without the prior written consent of the other
Party in each instance. The restrictions imposed by this Section shall not prohibit either Party
from making any disclosure identifying the other Party that, in the opinion of the disclosing
Party’s
counsel, is required by Applicable Law, rule or regulation or the requirements of a major national
securities exchange or another similar regulatory body, provided that any such disclosure
shall be governed by this Article and that the other Party is given a reasonable opportunity to
review and comment on any such press release or public communication in advance thereof (but not
less than five (5) Business Days prior to the date of disclosure). Further, the restrictions
imposed on each Party under this Section are not intended, and shall not be construed, to prohibit
a Party from identifying the other Party in its internal business communications, provided
that any Confidential Information in such communications remains subject to this Article. Each
Party agrees that it shall obtain its own legal advice with regard to its compliance with
securities laws, rules and regulations, and will not rely on any statements made by the other Party
relating to such securities laws, rules and regulations.

Article 10. Intellectual Property Rights

10.1 RTU Intellectual Property Rights. As between the Parties, RTU and its Affiliates shall have
sole and exclusive ownership of all right, title and interest (subject to the licenses granted in
this Agreement) in and to any and all Licensed Patents (in case of joint patent with SPA, those
rights shall include only the RTU portion of the joint rights), Licensed Know-How and Product
Trademarks in the SPA Territory.

10.2 Patent Filing Prosecution and Maintenance. Subject to Article 2 (NDA Transfer) RTU, acting
through patent counsel of its choice, and at its own sole discretion, as to which claims, shall be
responsible for the preparation, filing, prosecution, maintenance and/or defense of the Licensed
Patents in SPA Territory. RTU will notify SPA and its Affiliates within thirty (30) days in the
event that RTU decides not to prepare, file, prosecute, maintain and/or defend the Licensed Patents
in SPA Territory. SPA or its Affiliates shall then have the right and option to do so at its own
expense and shall own any resulting patent applicable or patent. Such rights of SPA would be in
addition to, and not replace, any other rights and remedies of SPA’s available by law and/or this
Agreement.

10.3 Information and Cooperation. RTU shall (i) provide SPA with copies of all patent applications
filed with respect to the Licensed Product and other material submissions and correspondence with
the

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

U.S. Patent and Trademark Office and other patent offices, in sufficient time to allow for
review and comment by SPA, (ii) provide SPA and its patent counsel with an opportunity to consult
with RTU and its patent counsel regarding the filing and contents of any such application,
amendment, submission or response and (iii) provide notice of filing of new Licensed Patents to SPA
within ten (10) Business Days of such filing. RTU hereby agrees that the advice and suggestions of
SPA and its patent counsel shall be taken into reasonable consideration by RTU and its patent
counsel in connection with each filing.

10.4 Product Trademarks. RTU shall be responsible for the filing, prosecution, defense and
maintenance before all trademark offices of all Product Trademarks and using commercially
reasonable efforts to ensure Product Trademarks exist in SPA Territory, and are kept in good
standing for an initial period of ten (10) years with three (3) ten (10) year automatic renewals.
If, at the end of the Term, SPA wishes to continue to sell the Licensed Product under the Product
Trademark, RTU shall grant SPA an exclusive license in SPA Territory to continue to use the Product
Trademark for an additional ten (10) years with the option to renew for two (2) additional terms of
ten (10) years each. If RTU chooses not to prepare, file, prosecute, maintain or defend Product
Trademarks in SPA Territory, then SPA or its Affiliates shall have the right and option to do so at
its own expense. At SPA’s request, RTU shall register domain names containing the Rescula
trademark. SPA shall be responsible for the filing, prosecution, defense and maintenance before
all trademark offices of all Alternative Trademarks.

10.5 Intellectual Property Legal Actions.

	10.5.1	 	Notice of Third Party Infringement, Opposition or Interference. In the event (ia)
either Party becomes aware of any possible infringement, opposition of or interference with
any Licensed Patent Rights or Licensed Know-How relating to the Licensed Product or any
Product Trademark in the SPA Territory, (ii) either Party becomes aware of the submission by
any Third Party of regulatory filing in SPA Territory for a product that includes the
manufacture, use or sale of Unoprostone, or (iii) either Party becomes aware of any
infringement, interference, opposition, or a nullity action being filed against any Licensed
Patent by a Third Party (each, an “Infringement”), that Party shall promptly notify the other
Party and provide it with all details of such Infringement of which it is aware (each, an
“Infringement Notice”).
	 
	10.5.2	 	SPA’s Right to Enforce. In the event of an Infringement, RTU shall have the first
right and option to initiate legal proceedings or take other commercially reasonable steps
regarding such Infringement. If RTU does not take or initiate commercially reasonable steps
to initiate legal proceedings or take other actions regarding the Infringement within ten (10)
days from any Infringement Notice, then SPA or its Affiliates shall have the right and option
to do so at its own expense.
	 
	10.5.3	 	No Settlement and Allocation of Damages. Neither Party shall settle any
Infringement claim or proceeding under this Article that would limit the rights of a Party
hereunder without the prior written consent of the other Party, which consent shall not be
unreasonably withheld, conditioned or delayed. If either SPA and/or RTU collects any
settlement or judgment from any

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	 	Third Party Infringers, the Parties shall first allocate any
such amounts to each Party equal to
their respective attorneys’ fees and litigation costs. Any additional amounts collected
shall be payable to SPA.
	 
	10.5.4	 	Right to Represent. RTU and its Affiliates shall have the right, at their own
expense, to participate and be represented by counsel that it selects, in any legal
proceedings or other action instituted under this Article by SPA.
	 
	10.5.5	 	Cooperation. In any action, suit or proceeding instituted under this Article, the
Parties shall cooperate with and assist each other in all reasonable respects. Upon the
reasonable request of the Party instituting such action, suit or proceeding, the other Party
shall join therein and shall be represented using counsel of its own choice, at the requesting
Party’s expense.

Article 11. Term and Termination

11.1 Term

	11.1.1	 	If no Order is submitted from SPA to RTU, or no Clinical Trials are initiated from two (2)
years of the Effective Date, then this Agreement shall terminate without further consideration
or notice; OR
	 
	11.1.2	 	With respect to each Licensed Product, the term of this Agreement shall commence on the
Effective Date and, unless earlier terminated as provided in this Agreement, shall expire upon
the later of (i) a period of ten (10) years, or (ii) the expiry of all Product Valid Claims in
SPA Territory with respect to such Licensed Product, or (iii) the loss of Data Exclusivity
with respect to such Licensed Product. If this Agreement expires (i.e., not terminated
pursuant to Section 11.2, Termination for Material Breach), then, at RTU’s request, the
Parties shall negotiate in good faith the terms by which SPA could continue to promote or
co-promote and distribute the Licensed Product or SPA will sell back to RTU, and RTU will
repurchase from SPA, at SPA’s actual cost, remaining inventory with greater than twelve (12)
months remaining shelf life.

11.2 Termination.

	11.2.1	 	Termination for Material Breach. In the event of an alleged material breach of this
Agreement by a Party, the other Party must give the Party that is allegedly in default notice
thereof if such non-breaching party intends to terminate the Agreement pursuant to this
Section 11.2.1. Any dispute regarding an alleged material breach of this Agreement shall be
resolved in accordance with this Article. It is the Parties’ express intent that consideration
shall first and foremost be given to remedying any breach of this Agreement through the
payment of monetary damages or such other legal or equitable remedies as shall be
appropriate under the circumstances, as decided, in each case, according to the provisions
of Section 14.1.2 (Dispute Resolution), and that there shall only be a limited right to
terminate this Agreement as a matter of last resort. If,

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with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	 	however, a Party receives a notice
of material breach that relates solely to the payment of amounts due hereunder, and (i)
there is no dispute as to the amounts owed and (ii) such breach for non-payment is not cured
within ninety (90) days after receipt of such notice, the notifying Party shall be entitled
to immediately terminate this Agreement by giving written notice to the defaulting Party. In
the event that the neutral (as defined in Section 14.1.2 (Dispute Resolution)), in
accordance with the procedures set forth in Section 14.1.2, has rendered a ruling that a
Party has materially breached this Agreement, which ruling specified the remedies imposed on
such breaching Party for such breach, and the breaching Party has failed to comply with the
terms of such adverse ruling within the time period specified therein for compliance, or if
such compliance cannot be fully achieved by such date, the breaching Party has failed to
commence compliance and/or has failed to use diligent efforts to achieve full compliance as
soon thereafter as is reasonably possible, or in the event the material breach cannot be
remedied, then in each case the non-breaching Party shall then in each case the
non-breaching Party shall have the following rights:

	 	a)	 	if SPA is the breaching Party that failed to cure such breach or, if applicable
comply with an adverse ruling and if the basis for such breach is SPA’s failure to
abide by a material obligation under this Agreement, RTU may terminate this Agreement
with respect only to such specific Licensed Product(s) to which such breach relates to
by delivering written notice to SPA after the expiration of the period during which SPA
was to comply as set forth in the adverse ruling (if applicable) or may at its option
continue this Agreement in effect and seek monetary or relief against SPA in an amount
commensurate with the damages suffered; and
	 
	 	b)	 	if RTU is the breaching Party that failed to cure such breach or, if
applicable, comply with an adverse ruling and if the basis for such breach is RTU’s
failure to abide by a material obligation under this Agreement, SPA may terminate this
Agreement with respect only to such specific Licensed Product(s) to which such breach
relates to by delivering written notice to RTU after the expiration of the period
during which RTU was to comply as set forth in the adverse ruling (if applicable) or
may at its option continue this Agreement in effect and seek monetary or relief against
RTU in an amount commensurate with the damages suffered.

	11.2.2	 	Termination for Insolvency. In the event a Party files for protection under the
bankruptcy laws, makes an assignment for the benefit of creditors, appoints or
suffers appointment of a receiver or trustee over its property, files a petition under any
bankruptcy or insolvency act or has any such petition filed against it which is not
discharged within sixty (60) days of the filing thereof, then the other Party may terminate
this Agreement effective immediately upon written notice to such Party.
	 
	11.2.3	 	Termination for Licensed Product Withdrawal or Material Adverse Event. In the event
the Licensed Product is withdrawn from the market by a Regulatory Authority in any country in
the

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with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	 	world or a material Adverse Event occurs, then SPA may terminate this Agreement effective
immediately upon written notice to RTU.

11.3 Consequences of Termination of Agreement in its Entirety. Upon any termination of this
Agreement by a Party pursuant to Sub-Sections 11.2.1 or 11.2.2:

	11.3.1	 	the licenses granted by RTU to SPA under this Agreement shall terminate and any and all
rights and properties (including Regulatory Filings) provided to SPA hereunder shall revert to
RTU;
	 
	11.3.2	 	with respect to all Clinical Studies or post approval studies for any Licensed Product(s)
being conducted as of the effective date of termination, the applicable Party shall end such
Clinical Studies or post approval studies with respect to enrolled subjects in an orderly and
prompt manner in accordance with Applicable Law, including any required follow up treatment
with previously enrolled subjects, and all other Development, Commercialization and Promotion
activities under this Agreement shall promptly cease.
	 
	11.3.3	 	each Party shall return, or if allowed by the other Party destroy (and soon thereafter
provide to the other Party written certification evidencing such destruction), all data,
files, records and other materials in its possession or control relating to the other Party’s
Technology, or containing or comprising the other Party’s Confidential Information.

11.4 Consequences of Termination of Agreement with respect to a Licensed Product. Upon any
termination of this Agreement with respect to a Licensed Product by a Party pursuant to
Sub-Sections

	11.4.1	 	the licenses granted by RTU to SPA under this Agreement shall terminate with respect to such
terminated Licensed Product(s);
	 
	11.4.2	 	with respect to all Clinical Studies or post approval studies for such terminated Licensed
Product being conducted as of the effective date of termination, the applicable Party shall
end such Clinical Studies or post approval studies with respect to enrolled subjects in an
orderly and prompt manner in accordance
with Applicable Law, including any required follow up treatment with previously enrolled
subjects, and all other Development, Commercialization and Promotion activities under this
Agreement shall promptly cease.

11.5 Surviving Provisions. The rights and obligations set forth in this Agreement shall extend
beyond the Term or termination of this Agreement only to the extent expressly provided for in this
Agreement. Without limiting the generality of the foregoing, it is agreed that the provisions of
Articles 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, and 14 and all defined terms referenced in such
Articles as will provide agreed meanings used in such Articles shall survive and govern any after
termination claims, liabilities, disputes and rights and, to the extent applicable, all other
Articles referenced in any such Article shall survive such termination. Without limiting the
generality of the foregoing, the obligations of confidentiality non-disclosure and non use set
forth in Article 9 of this Agreement and Intellectual Property set forth in Article 10 and
Indemnification set forth in Article 13 shall survive for not less than ten (10) years past
effective termination of this Agreement.

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[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

11.6 Continued Obligations. Upon expiration or termination of this Agreement, in whole or in part,
for any reason, nothing herein shall be construed to release either Party from any accrued rights
or obligations that matured prior to the effective date of such expiration or termination, nor
preclude either Party from pursuing any right or remedy it may have hereunder or at law or in
equity with respect to any breach of this Agreement.

Article 12. Representations and Warranties

12.1 Mutual Representations and Warranties. SPA and RTU each represents and warrants to the other,
as of the Effective Date, as follows:

	12.1.1	 	Corporate Power. Such Party is duly organized, validly existing and in good
standing under the laws of its jurisdiction of incorporation or formation, and has full
corporate or other power and authority to enter into this Agreement and to carry out the
provisions hereof.
	 
	12.1.2	 	Due Authorization. Such Party (i) has the power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder and (ii) has taken all
necessary action on its part required to authorize the execution and delivery of this
Agreement and the performance of its obligations hereunder.
	 
	12.1.3	 	Binding Agreement. This Agreement has been duly executed and delivered on behalf of
such Party and constitutes a legal, valid and binding obligation of such Party and is
enforceable against it in accordance with the terms hereof subject to the effects of
bankruptcy, insolvency or other laws of general application affecting the enforcement of
creditor rights and judicial principles affecting the
availability of specific performance and general principles of equity, whether
enforceability is considered a proceeding at law or equity.
	 
	12.1.4	 	Conflicts. The execution and delivery of this Agreement and the performance of such
Party’s obligations hereunder (i) does not conflict with or violate any provision of the
articles of incorporation, bylaws or any similar instrument of such Party, as applicable, in
any material way and (ii) does not conflict with, violate or breach, or constitute a default
or require any consent under, any contractual obligation or court or administrative order by
which such Party is bound.

12.2 Compliance with Applicable Law. SPA and RTU each represents and warrants to the other that it
shall comply, in all material respects, with Applicable Law relating to such Party’s rights,
duties, responsibilities and obligations set forth in this Agreement.

12.3 Intellectual Property – RTU Representations and Warranties.

	12.3.1	 	Right to Grant Licenses. RTU represents and warrants to SPA that it has the right
to grant to SPA rights and licenses within the scope set forth in this Agreement that is free
and clear of any licenses, sublicenses and all encumbrances and RTU will not enter into an
agreement that is inconsistent with the rights and licenses granted to SPA in this Agreement.
RTU represents and

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with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	 	warrants that no agreements exist with Third Parties that limits or
restricts use of the Licensed Patents.
	 
	12.3.2	 	No Existing Claims or Infringement. RTU represents and warrants that, to the best
of its knowledge, with respect to all relevant patents and patent applications, trademarks and
trademark applications in relation to the Licensed Patents and Product Trademarks, that all
patents are valid and in good standing, all assignments for patents and patent applications
have been appropriately obtained and recorded, all inventors have been correctly and
appropriately listed, no inventorship disputes exist, and there is no claim or demand of any
Person pertaining to, or any proceeding which is pending or to the best of its knowledge
threatened, that challenges RTU’s interest in or the validity of, scope of , infringement of
or enforceability of the Licensed Patents or Product Trademarks or makes any adverse claim of
inventorship or ownership thereof. None of the relevant patents and patent applications,
trademarks and trademark applications in the Licensed Patents and Product Trademarks are the
subject of any ongoing infringement by any Third Party or any pending or, to RTU’s knowledge,
threatened adverse claim, judgment, injunction, order, decree or agreement restricting its use
in connection with the Licensed Product.
	 
	12.3.3	 	Disclosure and Delivery. RTU represents and warrants that at the time of disclosure
and delivery of the Licensed Patents and Product Trademarks to SPA, RTU shall, to the best of
its knowledge, have the full right and legal capacity to
disclose and license the Licensed Patents and Trademark Applications without violating the
rights of Third Parties.
	 
	12.3.4	 	Maintaining Existing Licenses and Rights. RTU represents and warrants that RTU
shall maintain all rights and licenses executed by RTU as of the Effective Date that
materially affect SPA’s rights set forth in this Agreement. All such licenses are listed in
Exhibit B (Licensed Patents) to this Agreement. In the event RTU receives notice that it is
in breach of any such rights or license, RTU represents and warrants that it shall give prompt
written notice to SPA and take all actions to cure such breach, including at SPA’s option,
allowing SPA to cure such breach if possible without impairing SPA’s legal rights and remedies
set forth in this Agreement. RTU represents and warrants that RTU shall use commercially
reasonable efforts to ensure Product Trademarks exist in each country in SPA Territory and are
kept in good standing for an initial period of ten (10) years with ten (10) year automatic
renewals, as listed in Exhibit D (Product Trademarks) to this Agreement, which shall be
updated from time to time.
	 
	12.3.5	 	Future Authorizations. RTU shall obtain and maintain during the Term all
authorizations, consents and approvals, governmental or otherwise, necessary for RTU to grant
the rights and licenses granted by RTU under this Agreement.

12.4 No Debarment. Each Party certifies that as of the Effective Date, neither it, nor any of its
employees or agents that will be performing hereunder have ever been or are currently, or are the
subject of a proceeding that could lead to it or such employees or agents becoming, as applicable,
a

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with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or
Individual. Each Party further agrees that if, during the Term, it, or any of its employees or
agents, become, or are the subject of a proceeding that could lead to it or such employees or
agents becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual
or a Convicted Entity or Individual, such Party shall notify the other and shall prohibit such
employee or agent from performing on its behalf under this Agreement. This provision shall survive
termination or expiration of this Agreement for a period of ten (10) years. For purposes of this
provision, the following definitions shall apply:

	12.4.1	 	“Debarred Individual” means an individual who has been debarred by the Food and Drug
Administration (FDA) pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any
capacity to a Person that has an approved or pending drug product application or is similarly
debarred under corresponding Applicable Law outside of the United States but in the SPA
Territory.
	 
	12.4.2	 	“Debarred Entity” means a corporation, partnership or association that has been debarred by
the Food and Drug Administration (FDA) pursuant to 21 U.S.C. §335a(a) or (b) from submitting
or assisting in the submission of any abbreviated
drug application, or a subsidiary or affiliate of a Debarred Entity or is similarly debarred
under corresponding Applicable Law outside of the United States but in the SPA Territory..
	 
	12.4.3	 	“Excluded Individual” or “Excluded Entity” means (i) an individual or entity, as applicable,
who has been excluded, debarred, suspended or is otherwise ineligible to participate in
federal health care programs such as Medicare or Medicaid by the Office of the Inspector
General (OIG/HHS) of the U.S. Department of Health and Human Services, or (ii) is an
individual or entity, as applicable, who has been excluded, debarred, suspended or is
otherwise ineligible to participate in federal procurement and non-procurement programs,
including those produced by the U.S. General Services Administration (GSA) or is similarly
debarred under corresponding Applicable Law outside of the United States but in the SPA
Territory..
	 
	12.4.4	 	“Convicted Individual” or “Convicted Entity” means an individual or entity, as applicable,
who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. §335a(a)
or 42 U.S.C. §1320a — 7(a), but has not yet been excluded, debarred, suspended or otherwise
declared ineligible or is similarly debarred under corresponding Applicable Law outside of the
United States but in the SPA Territory..

12.5 No Litigation. RTU represents and warrants that there is no threatened, pending or settled
litigation with respect to the Unoprostone or the Licensed Product or that may affect in any way
RTU’s ability to grant the rights and licenses granted by RTU under this Agreement.

12.6 No Additional Material Information. RTU represents and warrants that, to the best of its
knowledge, there is no material information that has not been provided to SPA that may be relevant
to the transaction contemplated by this Agreement.

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with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

12.7 Warranty Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY
MAKES ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE MANUFACTURE OF LICENSED PRODUCT, ANY
TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND EACH PARTY HEREBY
SPECIFICALLY DISCLAIMS ALL WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, EITHER IN FACT
OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.

12.8 Limited Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, EXCEPT IN
CIRCUMSTANCES OF INTENTIONAL MISCONDUCT BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO (I)
INDEMNIFICATION OBLIGATIONS FOR THIRD PARTY CLAIMS SET FORTH IN ARTICLE 13 (INDEMNIFICATION;
INSURANCE), NEITHER PARTY SHALL
BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR ANY SPECIAL, PUNITIVE, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST PROFITS OR LOST REVENUES,
OR COST/EXPENSE OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES, WHETHER UNDER ANY
CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY.

Article 13. Indemnification; Insurance

13.1 Indemnification by SPA. SPA agrees to indemnify, defend and hold harmless RTU and its
Affiliates and their respective employees, agents, officers, directors and permitted assigns (“RTU
Indemnitees”) from and against any Third Party claims, judgments, expenses (including reasonable
attorneys’ fees), damages and awards (collectively a “Third Party Claim”) arising out of or
resulting from the following events:

	13.1.1	 	improper storage or handling of the Unoprostone or the Licensed Product by SPA or its
Affiliates or sublicensees including but not limited to failure to comply with CMC
specifications, practices or procedures filed in support of the NDA for the Licensed Products;
	 
	13.1.2	 	SPA’s negligence or willful misconduct in regard to its performance, or non-performance,
under this Agreement including but not limited to its compliance with cGMP law and regulations
and filed CMC requirements of the NDA for the Licensed Products; or
	 
	13.1.3	 	a breach of any of SPA’s representations or warranties hereunder;

except, in the respective events, to the extent that such Third Party Claim arises out of or
results from the gross negligence or willful misconduct of any RTU Indemnitee;

13.1.4 any personal injury and /or product liability of arising from the inherent safety of the
Drug Substance, Drug Product or Commercial Product.

13.2 Indemnification by RTU. RTU agrees to indemnify, defend and hold harmless SPA and its
Affiliates and their respective employees, agents, officers, directors and permitted assigns (“SPA

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with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

Indemnitees”) from and against any Third Party Claim arising out of or resulting from the following
events:

	13.2.1	 	improper storage, handling, manufacturing, formulation or contamination of the Unoprostone
or the Licensed Product by RTU or its Affiliates Agreement including but not limited to its
compliance with cGMP law and regulations and filed CMC requirements of the NDA for the
Licensed Products;
	 
	13.2.2	 	Infringement of Third Party intellectual property rights by the manufacture, use or sale of
Licensed Products pursuant to the terms and conditions of this Agreement
or the filing and prosecution of any Licensed Patents or Licensed Know-How or any Product
Trademark;
	 
	13.2.3	 	failure by RTU or any Affiliate or subcontractor of RTU to supply Licensed Product in
accordance with the Specifications and Applicable Law including but not limited to its
compliance with cGMP law and regulations and filed CMC requirements of the NDA for the
Licensed Products;
	 
	13.2.4	 	any product liability claims arising from quality defect of the Product;
	 
	13.2.5	 	Non-Conforming Product as set forth in Unoprostone Supply Agreement, Section 2.3.2;
	 
	13.2.6	 	RTU’s and/or its subcontractors’ negligence or willful misconduct in regard to its
performance, or non-performance, under this Agreement; or
	 
	13.2.7	 	a breach of any of RTU’s representations or warranties hereunder;

except, in the respective events, to the extent that such Third Party Claim arises out of or
results from the gross negligence or willful misconduct of any SPA Indemnitee.

13.3 Procedures for Indemnification. The obligations of an indemnifying Party under Section 13.1
and Section 13.2 shall be governed by and contingent upon the following:

	13.3.1	 	Notice of Claim. Each Party shall give the other Party prompt written notice of any
Third Party Claim (an “Indemnification Claim Notice”). Each Indemnification Claim Notice
shall contain a description of the claim and the nature and amount of the loss claimed (to the
extent that the nature and amount of such loss is known at such time). The indemnified Party
shall furnish promptly to the indemnifying Party copies of all papers and official documents
received in respect of any such Third Party Claim. The indemnifying Party shall not be
required to provide indemnification notice with respect to a Third Party Claim to the extent
that the defense of such Third Party Claim is materially prejudiced by the failure to give
timely notice by the indemnified Party or the intentional misconduct of the indemnified Party.

	13.3.2	 	Assumption of Defense. At its option, the indemnifying Party may assume the defense
of any Third Party Claim by giving written notice to the indemnified Party within fourteen
(14) days after the indemnifying Party’s receipt of an Indemnification Claim Notice or sooner
if necessary. The assumption of the defense of a Third Party Claim by the indemnifying Party
shall not be

Page 32 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	 	construed as an acknowledgement that the indemnifying Party is liable to
indemnify any SPA Indemnitees or RTU Indemnitees (as applicable) in respect of the Third Party
Claim, nor shall it constitute a waiver by the indemnifying Party of any defenses it may
assert against any indemnified Party’s claim for indemnification.
	 
	13.3.3	 	Control of the Defense. Upon the assumption of the defense of a Third Party Claim
by the indemnifying Party:

	 	a)	 	the indemnifying Party may appoint as lead counsel in the defense of the Third
Party Claim any legal counsel selected by the indemnifying Party, which shall be
reasonably acceptable to the indemnified Party;
	 
	 	b)	 	the indemnified Party shall promptly deliver to the indemnifying Party all
original notices and documents (including court papers) received by the indemnified
Party in connection with the Third Party Claim; and
	 
	 	c)	 	except as expressly provided in Section 13.3.4, the indemnifying Party shall
not be liable to the indemnified Party for any legal expenses subsequently incurred by
such indemnified Party or any SPA Indemnitee or RTU Indemnitee (as applicable) in
connection with the analysis, defense or settlement of the Third Party Claim. To the
extent that it is ultimately determined that the indemnifying Party is not obligated to
indemnify, defend or hold harmless an Indemnitee from and against the Third Party
Claim, the indemnified Party shall reimburse the indemnifying Party for any and all
costs and expenses (including reasonable attorneys’ fees and costs of suit) and any
loss incurred by the indemnifying Party in its defense of the Third Party Claim with
respect to such indemnified Party or Indemnitee.

	13.3.4	 	Right to Participate in the Defense. Without limiting Section 13.3.2 or Section
13.3.3, any SPA Indemnitee or RTU Indemnitee (as applicable) shall be entitled to participate
in, but not control, the defense of a Third Party Claim and to retain counsel of its choice
for such purpose; provided that such retention shall be at its own expense unless, (i) the
indemnifying Party has failed to assume the defense and retain counsel in accordance with
Section 13.3.2 (in which case the indemnified Party shall control the defense), or (ii) the
interests of the Indemnitee and the indemnifying Party with respect to such Third Party Claim
are sufficiently adverse to prohibit the representation by the same counsel of both parties
under Applicable Law, ethical rules or equitable principles.
	 
	13.3.5	 	Settlement. The indemnifying Party shall have the sole right to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of any Third Party
Claim, on such terms as the indemnifying Party, in its reasonable discretion, shall deem
appropriate; provided that:

	 	a)	 	the sole relief provided is the payment of money damages;

Page 33 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	b)	 	the consent, settlement or other disposition does not, and will not, result in
a finding or admission of any negligence, intentional malfeasance, violation of any
Applicable Law or any violation of the rights of any person and does not effect on any
other claims that may be made against the indemnified Party;
	 
	 	c)	 	the consent, settlement or other disposition does not, and will not, result in
the indemnified Party’s rights under this Agreement being adversely affected; and
	 
	 	d)	 	the consent, settlement or other disposition does not, and will not, result in
the indemnified Party becoming subject to injunctive or other relief or otherwise will
adversely affect the business of the indemnified Party in any manner.

	 	 	With respect to all other Third Party Claims, where the indemnifying Party has assumed the
defense of the Third Party Claim in accordance with Section 13.3.2, the indemnifying Party
shall have authority to consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Third Party Claim with the prior written consent of the
indemnified Party (which consent shall not be unreasonably withheld, conditioned or
delayed). The indemnifying Party shall not be liable for any settlement or other
disposition of a Third Party Claim by an indemnified Party that is reached without the prior
written consent of the indemnifying Party. Regardless of whether the indemnifying Party
chooses to defend or prosecute any Third Party Claim, no indemnified Party shall admit any
liability with respect to, or settle, compromise or discharge, any Third Party Claim without
the prior written consent of the indemnifying Party, such consent not to be unreasonably
withheld, conditioned or delayed.
	 
	13.3.6	 	Cooperation. Regardless of whether the indemnifying Party chooses to defend or
prosecute any Third Party Claim, the indemnified Party shall, and shall cause each Indemnitee
to, cooperate in the defense or prosecution thereof and shall furnish such records,
information and testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals as may be reasonably requested in connection
therewith. Such cooperation shall include access during normal business hours afforded to
indemnifying Party to, and reasonable retention by the indemnified Party of, records and
information that are reasonably relevant to such Third Party Claim, and making indemnified
Parties and other employees and agents available on a mutually convenient basis to provide
additional information and explanation of any material provided hereunder, and the
indemnifying Party shall reimburse the indemnified Party for any out-of-pocket expenses in
connection therewith.

13.4 Insurance. Each Party shall obtain and carry in full force and effect the minimum insurance
requirements set forth herein, which shall protect Indemnitees with respect to events covered by
Section 13.1 and Section 13.2. Such insurance (i) shall be primary insurance with respect to each
Party’s own participation under this Agreement, (ii) shall be issued by a recognized insurer rated
by A.M. Best “A-VII” (or its equivalent) or better, or an insurer pre-approved in writing by the
other Party, (c) shall list the other Party as an additional named insured thereunder, and (d)
shall require thirty (30) days written

Page 34 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

notice to be given to the other Party prior to any
cancellation, non-renewal or material change thereof. The types of insurance, and minimum limits
shall be General liability insurance with a minimum limit of [*] per occurrence and [*] in
aggregate. General liability insurance shall include, at a minimum, Professional Liability,
Clinical Trial Insurance and, beginning at least thirty (30) days prior to First Commercial Sale of
the Licensed Product, product liability insurance. Upon request by a Party, the other Party shall
provide Certificates of Insurance evidencing compliance with this Section. The insurance policies
shall be under an occurrence form, but if only a claims-made form is available to a Party, then
such Party shall continue to maintain such insurance after the expiration or termination of this
Agreement during any period in which such Party continues to make, to have made, to use, to offer
for sale, to sell or to import a product that was the Licensed Product under this Agreement, and
thereafter for a period of five (5) years. Notwithstanding the foregoing, either Party may
self-insure in whole or in part the insurance requirements described above, provided such Party
continues to be investment grade determined by reputable and accepted financial rating agencies.

Article 14. Miscellaneous

	14.1	 	Governing Law; Dispute Resolution.
	 
	14.1.1	 	Governing Law. This Agreement and all disputes arising out of or related to this
Agreement, or the performance, enforcement, breach or termination hereof, and any remedies
relating thereto, shall be construed, governed, interpreted and applied in accordance with the
substantive laws of New York, United States of America, without regard to conflict of laws
principles, except that questions affecting the construction and effect of any patent shall be
determined by the law of the country in which the patent shall have been granted. The Parties
hereby exclude the application of or reference to the United Nations Convention on Contracts
for the International Sale of Goods from this Agreement.
	 
	14.1.2	 	Dispute Resolution.

	 	a)	 	Negotiation. The parties agree to consult and negotiate in good faith to try to
resolve any dispute, controversy or claim, of any nature or kind, whether in contract,
tort or otherwise, that arises out of or relates to this
Agreement. No formal dispute resolution shall be used by either party unless and
until the chief executive officers of each party shall have attempted to meet in
person to achieve such an amicable resolution.
	 
	 	b)	 	Arbitration. Any dispute, controversy or claim that arises out of or relates
to this Agreement that is not resolved under Section 14.1.2(a) shall be settled by
final and binding arbitration in accordance with the Rules of Arbitration of the
International Chamber of Commerce (“ICC”) in effect on the Effective Date, as modified
by Section 14.1.2(c) below. Judgment upon the award rendered by the arbitrators may be
entered in any court of competent jurisdiction. The place of arbitration shall be
Paris, France unless another location is agreed upon between the parties and
arbitrators. The arbitration shall be conducted in the English language by three (3)
neutral arbitrators

Page 35 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	 	 	selected by mutual agreement of the parties or, if that is not
possible within thirty (30) days of the initial demand for such arbitration, by the
ICC. At least one (1) arbitrator shall have professional knowledge of and experience
in the regulation of and terms of trade of the ethical pharmaceutical industry.
	 
	 	c)	 	Special Rules. Notwithstanding any provision to the contrary in the ICC’s
Rules of Arbitration, the parties hereby stipulate that any arbitration hereunder shall
be subject to the following special rules:

	 	(i)	 	The arbitrators may not award or assess punitive damages
against either party; and
	 
	 	(ii)	 	Each party shall bear its own costs and expenses of the
arbitration and shall share equally the fees and costs of the arbitrators,
subject to the power of the arbitrators, in their sole discretion, to award all
such reasonable costs, expenses and fees to the prevailing party.

	14.2	 	Notices.
	 
	14.2.1	 	Notice Requirements. Any notice, request, demand, waiver, consent, approval or
other communication permitted or required under this Agreement shall be in writing and in
English, shall refer specifically to this Agreement and shall be deemed given only if
delivered by hand with written confirmation of receipt, by telefax with written confirmation
of receipt issued by other means than by automated telefax response or by internationally
recognized overnight delivery service that maintains records of delivery, addressed to the
Parties at their respective addresses specified in Sub-Section 14.2.2 or to such other address
as the Party to whom notice is to be given may have provided to the other Party in accordance
with this Section. Such notice shall be deemed to have been given
as of the date delivered by hand or transmitted by facsimile (with transmission
confirmed by other means than automated telefax response) or upon receipt (at the
place of delivery) if sent by an internationally recognized overnight delivery
service. Any notice delivered by facsimile shall be confirmed by a hard copy
delivered by internationally recognized overnight delivery service that maintains
records of delivery as soon as practicable thereafter. This Section is not intended
to govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.
	 
	14.2.2	 	Addresses for Notice.

	 	 	 
	For SPA:
	 	Sucampo Pharma Americas Inc.
	 
	 	4520 East West Highway
	 
	 	3rd Floor
	 
	 	Bethesda, MD 20814
	 
	 	USA

Page 36 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

	 	 	 
	 
	 	Attention: Legal Department
	 
	 	Fax: 301 961 3440
	 
	 	 
	For RTU:
	 	R-Tech Ueno, Ltd.
	 
	 	4-1, Techno-Park
	 
	 	Sanda, Hyogo, 669-1339
	 
	 	Japan
	 
	 	Attention: Mr. Ryu Hirata
	 
	 	Facsimile Number: 81-795-60-7180

14.3 Equitable Relief. The Parties acknowledge and agree that the restrictions set forth in
Article 10 (Confidentiality and Non-Disclosure) are reasonable and necessary to protect the
legitimate interests of the Parties and that neither Party would have entered into this Agreement
in the absence of such restrictions, and that any breach or threatened breach of any provision of
Article 10 (Confidentiality and Non-Disclosure) may result in irreparable injury to the other Party
for which there will be no adequate remedy at law. In the event of a breach or threatened breach
of any provision of Article 10 (Confidentiality and Non-Disclosure) by a Party, the other Party may
be authorized and entitled to obtain from any court of competent jurisdiction injunctive relief,
whether preliminary or permanent, specific performance and an equitable accounting of all earnings,
profits and other benefits arising from such breach, which rights shall be cumulative and in
addition to any other rights or remedies to which such Party may be entitled in law or equity.
Nothing in this Section is intended, or shall be
construed, to limit the Parties’ rights to equitable relief or any other remedy for a breach of any
provision of this Agreement.

14.4 Amendment; Waiver. This Agreement may be amended, modified, superseded or canceled, and any
of the terms of this Agreement may be waived, only by a written instrument signed by duly
authorized representatives of each Party or, in the case of waiver, signed by duly authorized
representatives of the Party or Parties waiving compliance. The delay or failure of any Party at
any time or times to require performance of any provisions shall in no manner affect the rights at
a later time to enforce the same. No waiver by any Party of any condition or of the breach of any
term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances,
shall be deemed to be, or considered as, a further or continuing waiver of any such condition or of
the breach of such term or any other term of this Agreement.

14.5 No Third Party Beneficiaries. Except as set forth in Section 13.1 (Indemnification by SPA)
and Sub-Section 13.2.2, the provisions of this Agreement are for the sole benefit of the Parties
and their permitted successors and permitted assigns and none of the provisions of this Agreement
shall be for the benefit of or enforceable by any Third Party, including, without limitation, any
employee or creditor of either Party hereto. No such Third Party shall obtain any right under any
provision of this Agreement

Page 37 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

or shall by reasons of any such provision make any claim in respect of
any debt, liability or obligation (or otherwise) against either Party.

14.6 Relationship of the Parties. Nothing in this Agreement shall be construed (i) to create or
imply a partnership, association, joint venture or fiduciary duty between the Parties, (ii) to make
either Party the agent of the other for any purpose, (iii) to alter, amend, supersede or vitiate
any other arrangements between the Parties with respect to any subject matters not covered
hereunder, or (d) to give either Party the right to bind the other or to create any duties or
obligations between the Parties, except as expressly set forth herein. All Persons employed by a
Party shall be employees of such Party and not of the other Party and all costs/expenses and
obligations incurred by reason of such employment shall be for the account and expense of such
Party. The Parties agree that the rights and obligations under this Agreement are not intended to
constitute a partnership or similar arrangement that will require separate reporting for tax
purposes in SPA Territory.

14.7 Assignment and Successors. This Agreement is personal to both Parties and neither Party shall
sell, transfer, assign, delegate, pledge or otherwise dispose – other than SPA’s right to
sublicense under Article 4 (Patent License Grants and Know-How Access) of its rights or delegate
its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part
without the prior written consent of the
other Party, which shall not be unreasonably withheld, excepting always that each Party may, on
providing written notice to the other Party, assign this Agreement and the rights, obligations and
interests of such Party, in whole or in part, without the written consent of the other Party to any
of its Affiliates, or to any purchaser of all or substantially all of its assets and/or all or
substantially all of its assets to which this Agreement relates or to any successor corporation
resulting from any merger or consolidation of such Party with or into such corporation. Any
permitted assignee of all of a Party’s rights under this Agreement shall be deemed to be a party to
this Agreement as though named herein; provided with respect to an assignment to an Affiliate, such
assigning Party shall remain responsible for the performance by such Affiliate of the rights and
obligations hereunder. Any attempted assignment or delegation in violation of this Section shall
be void.

14.8 Binding Effect. All validly assigned rights of a Party shall inure to the benefit of and be
enforceable by, and all validly delegated obligations of such Party shall be binding on and be
enforceable against, the permitted successors and assigns of such Party, provided that such Party,
if it survives, shall remain jointly and severally liable for the performance of such delegated
obligations under this Agreement.

14.9 Force Majeure. The occurrence of an event which materially interferes with the ability of a
Party to perform its obligations or duties under this Agreement which is not within the reasonable
control of the Party affected, not due to malfeasance, and which, with the exercise of due
diligence could not have been avoided (“Force Majeure”), including, without limitation, fire,
explosion, flood, earthquake, war, accident, strike, riot, terrorist attacks, civil commotion, acts
of God, or the like, will not excuse such Party from the performance of its obligations or duties
under this Agreement, but will suspend such performance during the continuation of Force Majeure.
The Party prevented from

Page 38 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

performing its obligations or duties because of Force Majeure shall be
required to, as soon as reasonably possible, notify the other Party hereto of the occurrence and
particulars of such Force Majeure and shall be required to provide the other Party, from time to
time, with its best estimate of the duration of such Force Majeure and with notice of the
termination thereof. The Party so affected shall use reasonable efforts to avoid or remove such
causes of nonperformance. Upon termination of Force Majeure, the obligation to perform any
previously suspended obligation or duty shall promptly recommence.

14.10 Headings; References. Article, Section and Subsection headings are inserted for convenience
of reference only and do not form a part of this Agreement. Unless otherwise specified, (i)
references in this Agreement to any Article, Section or Exhibit shall mean references to such
Article, Section or Exhibit of this Agreement, (ii) references in any section to any clause are
references to such clause of such section, and (iii) references to any agreement, instrument or
other document in this Agreement
refer to such agreement, instrument or other document as originally executed or as amended if
expressly stated in this Agreement.

14.11 Interpretation. Except where the context otherwise requires, wherever used, the singular
shall include the plural, the plural the singular, the use of any gender shall be applicable to all
genders. The term “including” as used herein shall mean including, without limiting the generality
of any description preceding such term. The language of this Agreement shall be deemed to be the
language mutually chosen by the Parties. The Parties acknowledge and agree that: (i) the rule of
construction to the effect that any ambiguities are resolved against the drafting Party shall not
be employed in the interpretation of this Agreement; and (ii) the terms and provisions of this
Agreement shall be construed fairly as to all Parties and not in favor of or against any Party,
regardless of which Party was generally responsible for the preparation of this Agreement.

14.12 Severability. If and to the extent that any court or tribunal of competent jurisdiction holds
any of the terms, provisions or conditions or parts thereof of this Agreement, or the application
hereof to any circumstances, to be illegal, invalid or to be unenforceable in a final
non-appealable order, (i) such provision shall be fully severable, (ii) this Agreement shall be
construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a
part hereof, and (iii) the remaining provisions of this Agreement shall remain in full force and
effect and shall not be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom, in each case provided that the basic purpose and structure of this Agreement is
not altered.

14.13 Entire Agreement. This Agreement and the Unoprostone Supply Agreement, and all subsequent
related agreements, constitute the entire agreement between the Parties with respect to the subject
matter of the Agreement. This Agreement supersedes all prior agreements and understandings,
whether written or oral, with respect to the subject matter of the Agreement, including all
confidentiality agreements entered in to between the Parties with respect to the subject matters
hereof. Each Party confirms that it is not relying on any representations, warranties or covenants
of the other Party except as specifically set out in this Agreement. All Exhibits referred to in
this Agreement are intended to be and are hereby specifically incorporated into and made a part of
this Agreement. In

Page 39 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

the event of any inconsistency between any such Exhibits and this Agreement,
the terms of this Agreement shall govern.

14.14 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which
shall be deemed an original and both of which, taken together shall constitute one and the same
instrument. Signatures to this Agreement transmitted by
facsimile transmission, by electronic mail in “portable document format” (“.pdf”) form, or by any
other electronic means intended to preserve the original graphic and pictorial appearance of a
document, will have the same effect as physical delivery of the paper document bearing the original
signature.

14.15 Expenses. Except as otherwise expressly provided in this Agreement, each Party shall pay the
fees and expenses of its respective attorneys and all other expenses and costs incurred by such
Party incidental to the negotiation, preparation, execution and delivery of this Agreement.

14.16 Further Assurance. Each Party shall perform all further acts and things and execute and
deliver such further documents as may be reasonable and necessary or as the other Party may
reasonably require to give effect to this Agreement.

14.17 License Survival During Bankruptcy. All rights and licenses granted under or pursuant to any
Section of this Agreement are and shall otherwise be deemed to be “intellectual property” as that
term is defined in Section 101(56) of Title 11, United States Code (the “Bankruptcy Code”) or in
other corresponding definitions under corresponding foreign bankruptcy codes under other
Applicable Law in other country(ies) in the SPA Territory. Upon and after any Insolvency Event
involving any Party, the other Party shall retain and may fully exercise all of its respective
rights and elections under the applicable insolvency law, including, without limitation, rights and
elections under Section 365(n) of the Bankruptcy Code or in other corresponding sections under
corresponding foreign bankruptcy codes under other Applicable Law in other country(ies) in the SPA
Territory to the extent applicable. Furthermore, upon and after any Insolvency Event involving any
Party, the other Party shall be entitled to (i) a complete duplicate of, or complete access to, any
such intellectual property, and such intellectual property, if not already in its possession, shall
be promptly delivered to the non-insolvent Party, unless the insolvent Party elects to continue,
and continues, to perform all of its obligations under this Agreement, and (ii) elect to refrain
from treating this Agreement as terminated with respect to the intellectual property rights granted
to it under this Agreement and instead retain its rights to such intellectual property, as such
rights existed immediately before the Insolvency Event and without interference, for the duration
of the term of this Agreement.

14.18 Press Release. Subject to Section 10.3 (Use of Name and Disclosure of Terms), the Parties
shall issue the Press Release attached hereto as Exhibit E(Press Release) on the Execution Date of
this Agreement.

Page 40 of 41

 

[*] = Certain confidential information contained in this document, marked by brackets, is filed

with the Securities and Exchange Commission pursuant to Rule 24b-2 of

The Securities Exchange Act of 1934, as amended.

IN WITNESS WHEREOF, each of the Parties to this Agreement has caused one of its duly authorized
representatives to execute this Agreement where provided below effective this 23 day of April 2009,
on its behalf and in evidence of its intention to be bound to the terms, obligations,
representations and warranties of this Agreement as set forth above.

	 	 	 	 	 	 	 	 	 	 	 
	For and on behalf of	 	 	 	For and On Behalf of	 	 
	Sucampo Pharma Americas, Inc.	 	 	 	R Tech Ueno, Ltd.	 	 
	By Its Duly Authorized Representative	 	 	 	By Its Duly Authorized Representative	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Signature

	 	 /s/ Gayle Dolecek
	 	 	 	Signature
	 	/s/ Yukiko Hashitera	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	Name

	 	Gayle Dolecek, PD, MPH
	 	 	 	Name
	 	Yukiko Hashitera	 	 
	Title

	 	SVP, Research and Development
	 	 	 	Title
	 	President	 	 
	Date

	 	April 23, 2009
	 	 	 	Date
	 	April 23, 2009	 	 

Page 41 of 41

 

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

Exhibit A

					
	 	 	 	 	 
	CONFIDENTIAL
	 	Unoprostone NDA Transfer/IP and Data Sharing Agreement
	 	 

Exhibit A

Description of Unoprostone Isopropyl

	 	 	 
	Generic name:
	 	Unoprostone Isopropyl (USAN)
	 
	 	 
	Chemical names:
	 	[*]
	 
	 	 
	CAS No.:
	 	120373-24-2
	 
	 	 
	Structural Formula:
	 	[*]

1/1

 

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

Exhibit B

					
	 	 	 	 	 
	CONFIDENTIAL
	 	Unoprostone NDA Transfer/IP and Data Sharing Agreement
	 	 

Exhibit B

[Separately filed with the Securities and Exchange Commission]

1/1

 

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

	 	 	 
	Confidential

	 	Exhibit C Licensed Patents

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title	 	Country	 	Application No	 	Filling Date	 	Patent No	 	Issue Date	 	Expiration date
	 
	Prostaglandins of the F series
	 	USA	 	07/945594	 	 	9/16/1992	 	 	5221763	 	6/22/1993	 	7/15/2012
	 
	 
	 	Canada	 	565406	 	 	4/28/1988	 	 	1324129	 	11/9/1993	 	11/9/2010
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Treatment of Ocular Hypertension with a
Synergistic Combination for Ocular
Administration
	 	USA	 	07/703660	 	 	5/21/1991	 	 	5208256	 	5/4/1993	 	5/21/2011
	 
	 	Canada	 	2042972-1	 	 	5/22/1991	 	 	2042972	 	10/15/1996	 	5/21/2011
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TREATMENT OF OCULAR HYPERTENSION WITH A
SYNERGISTIC COMBINATION
	 	USA	 	07/704570	 	 	5/21/1991	 	 	5166175	 	11/24/1992	 	5/21/2011
	 
	 	Canada	 	2042937-2	 	 	5/21/1991	 	 	2042937	 	4/30/2002	 	5/21/2011
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TREATMENT OF OCULAR HYPERTENSION WITH A
SYNERGISTIC COMBINATION FOR OPHTHALMIC USE
	 	USA	 	07/899170	 	 	6/15/1992	 	 	5175189	 	12/29/1992	 	5/21/2011
	 
	 	Canada	 	2042936-4	 	 	5/21/1991	 	 	2042936	 	4/30/2002	 	5/21/2011
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TREATMENT OF OCULAR HYPERTENSION WITH A
SYNERGISTIC COMBINATION
	 	USA	 	08/031875	 	 	3/16/1993	 	 	5397797	 	3/14/1995	 	3/14/2012
	 
	 	Canada	 	2042934-8	 	 	5/21/1991	 	 	2042934	 	4/23/2002	 	5/21/2011
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TREATMENT OF OCULAR HYPERTENSION WITH A
SYNERGISTIC COMBINATION
	 	USA	 	08/487637	 	 	6/7/1995	 	 	5547968	 	8/20/1996	 	8/20/2013
	 
	 	Canada	 	2061907-4	 	 	2/26/1992	 	 	2061907	 	4/8/2003	 	2/26/2012
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	INCREASING THE CHOROIDAL BLOOD FLOW
	 	USA	 	07/867359	 	 	4/13/1992	 	 	5221690	 	6/22/1993	 	4/13/2012
	 
	 	Canada	 	2065889-4	 	 	4/13/1992	 	 	2065889	 	8/27/2002	 	4/13/2012
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TREATMENT OF OCULAR HYPERTENSION
	 	USA	 	08/162386	 	 	12/7/1993	 	 	5432174	 	7/11/1995	 	8/24/2012
	 
	PROCESS FOR PRODUCTION OF PROSTAGLANDIN
INTERMEDIATES
	 	USA	 	07/937949	 	 	9/1/1992	 	 	5274130	 	12/28/1993	 	9/1/2012

1/2

 

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

	 	 	 
	Confidential

	 	Exhibit C Licensed Patents

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Title	 	Country	 	Application No	 	Filling Date	 	Patent No	 	Issue Date	 	Expiration date
	 
	STABILIZATION OF A PROSTANOIC ACID COMPOUND
	 	USA	 	08/202132	 	 	2/25/1994	 	 	5523461	 	6/4/1996	 	2/25/2014
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Treatment of Optic Nerve Disorder with
Prostanoic Acid Compounds
	 	USA	 	08/613048	 	 	3/8/1996	 	 	5773471	 	6/30/1998	 	3/8/2016
	 
	 	Canada	 	[*]	 	 	[*]	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TREATMENT OF OCULAR HYPERTENSION WITH A
SYNERGISTIC COMBINATION
	 	USA	 	09/220847	 	 	12/28/1998	 	 	6329426	 	12/1/2001	 	9/30/2018
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	PHARMACEUTICAL COMPOSITION FOR THE TREATMENT
OF HYPERTENSION AND GLAUCOMA
	 	Canada	 	2356912	 	 	12/25/1998	 	 	23536912	 	2/24/2009	 	12/25/2018
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Apotosis Inhibitor
	 	USA	 	09/816655	 	 	3/26/2001	 	 	7129272	 	10/31/2006	 	3/26/2021
	 
	 
	 	Canada	 	[*]	 	 	[*]	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Treatment of Ocular Hypertension and Glaucoma
	 	USA	 	09/900021	 	 	7/9/2001	 	 	6458836	 	10/1/2002	 	7/9/2021
	 
	Treatment of Ocular Hypertension and Glaucoma
	 	Canada	 	[*]	 	 	[*]	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	CONTROL OF INTRAOCULAR PRESSURE DURING
SURGERY
	 	USA	 	09/645361	 	 	8/25/2000	 	 	6414021	 	7/2/2002	 	8/25/2020
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	USA	 	[*]	 	 	[*]	 	 	 	 	 	 	 
	 
	 
	 	Canada	 	[*]	 	 	[*]	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	USA	 	[*]	 	 	[*]	 	 	 	 	 	 	 
	 
	 
	 	Canada	 	[*]	 	 	[*]	 	 	 	 	 	 	 
	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[*]
	 	USA(pro)	 	[*]	 	 	[*]	 	 	 	 	 	 	 

2/2

 

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

Exhibit D

	 	 	 	 	 
	CONFIDENTIAL
	 	Unoprostone NDA Transfer/IP and Data Sharing Agreement
	 	 

Exhibit D

List of Trademarks RESCULA

	 	 	 	 	 	 	 	 	 
	Country	 	Application No.	 	Category	 	Application Date	 	Registration No.
	 
	 
	 	 	 	 	 	 	 	 
	USA
	 	77/470526	 	Class 5	 	2008.5.9	 	 
	 
	 	 	 	 	 	 	 	 
	Canada
	 	806022	 	Class 5	 	1996.3.4	 	806022

 

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

Exhibit E

Contact:

Kate de Santis

Sucampo Pharmaceuticals, Inc.

240-223-3834

kdesantis@sucampo.com

and

John Woolford

Westwicke Partners

410-213-0506

john.woolford@westwicke.com

Sucampo Acquires Rights to Rescula® for U.S. and Canada

Strengthens Sucampo’s Prostone Product Portfolio

Potential for Label Expansion in Dry AMD

Bethesda, Maryland, and Tokyo, Japan — April 23, 2009 — Sucampo Pharmaceuticals, Inc., (NASDAQ:
SCMP) and R-Tech Ueno, Ltd. (RTU) (Osaka Exchange Hercules code: 4573), today announced that
Sucampo Pharma Americas, Inc. (SPA), a wholly owned subsidiary of Sucampo Pharmaceuticals Inc.,
licensed from RTU the commercialization rights to Rescula® (unoprostone isopropyl) in
the United States and Canada, including all associated patents and other intellectual property. In
addition, RTU will be the exclusive supplier of finished product to Sucampo.

Rescula was approved by the U.S. Food and Drug Administration (FDA) for the treatment of open-angle
glaucoma and ocular hypertension in 2000. In addition to these approved indications, Sucampo
management believes that Rescula has the potential to be a treatment for dry age-related macular
degeneration (dry AMD). As a result, Sucampo plans to initiate a phase 2 clinical trial with
Rescula for dry AMD in 2010.

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals,
said, “We are very pleased to add Rescula to Sucampo’s product portfolio, alongside
Amitiza®. We look forward to re-launching Rescula for its currently approved
indications and to developing it as a potential treatment for dry AMD. We believe Rescula will be
an important and integral part of our product portfolio. Both Rescula and Amitiza are created from
the prostone technology whose therapeutic potential I discovered in the 1980s and is also the basis
for Sucampo’s clinical and preclinical pipeline compounds. Rescula targets disorders caused by the
aging process, which is consistent with the commercial focus of Sucampo and one of my abiding
passions.”

Ms. Yukiko Miyake-Hashitera, President and Chief Executive Officer of R-Tech Ueno Ltd., said, “I am
very pleased with this agreement as it provides an opportunity for Rescula to significantly impact
the quality of vision and quality of life of patients both in the U.S. and Canada. I have the
utmost confidence that the potential of Rescula will be fully maximized.”

1

 

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

Gayle Dolecek, P.D., M.P.H., Senior Vice President of Research & Development, Sucampo
Pharmaceuticals, said, “Rescula’s safety profile and novel mechanism of action are two of its
product attributes that provide a rationale for new indications. Its existing FDA approval status
and safety profile should facilitate entry into clinical trials for dry AMD patients. If those
trials are successful, Rescula will provide us the opportunity to meet the unmet medical needs of a
substantial patient population.”

Stanley G. Miele, Senior Vice President of Sales & Marketing, Sucampo Pharmaceuticals, said, “This
agreement provides Sucampo’s sales team with a second prostone product. As part of our future
re-launch of Rescula, we will continue focusing on the Amitiza market segments we now serve, while
establishing relationships and a collaborative approach with specialists who treat ocular
disorders. This is a very nice fit for our commercial team.”

Terms of the Agreement

Under the terms of the agreement, Sucampo will hold the exclusive rights to commercialize Rescula
in the U.S. and Canada for the treatment of glaucoma and ocular hypertension. Sucampo also will
have the right to develop Rescula for additional indications. Sucampo also will have the right of
first refusal to commercialize in the U.S. and Canada any additional indications for which Rescula
is developed by RTU. RTU will be exclusively responsible for supply of Rescula to Sucampo for the
U.S. and Canada.

Sucampo will make an upfront payment to RTU of $3.0 million and will be responsible for additional
milestone payments based on the achievement of specified development and commercialization goals.
Sucampo will be responsible for the development, regulatory, and commercialization activities and
expenses for Rescula in the U.S. and Canada.

As of April 1, 2009, RTU held six percent of the outstanding common stock of Sucampo
Pharmaceuticals’ outstanding shares. Dr. Ueno, Chairman and Chief Executive Officer of Sucampo
Pharmaceuticals, Inc., and his wife, Dr. Sachiko Kuno directly and indirectly own a majority of the
capital stock of RTU. Dr. Ueno and Dr. Kuno do not hold any management or board positions with
RTU. Dr. Ueno and Dr. Kuno are both members of the board of directors of Sucampo Pharmaceuticals
and together directly or indirectly hold a substantial majority of the common stock of Sucampo
Pharmaceuticals.

About Rescula (unoprostone isopropyl)

Rescula (unoprostone isopropyl) is a synthetic docosanoid that is administered topically as a
liquid eye drop that activates the BK channels in cells within the retina. Sucampo management
believes that this activation of BK channels lowers intraocular pressure (IOP) by increasing the
outflow of aqueous humor. Clinical studies have shown that in patients with a mean baseline IOP of
23 mm Hg, unoprostone isopropyl lowers IOP by approximately 3 to 4 mm Hg throughout the day.

In clinical and preclinical studies Rescula has: increased ocular blood flow to the optic nerve and
in the choroid; maintained visual field; delayed retinal degeneration induced by rhodoposin by
inhibiting apoptosis; inhibited topographic and blood changes in an ischemic optic nerve head; and
lowered intraocular pressure. SPA believes that these clinical effects suggest that Rescula could
potentially be effective in the treatment of other ocular diseases.

Rescula received its first marketing approval in Japan in 1994 for the treatment of glaucoma and
ocular hypertension.

2

 

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

Rescula is a registered trademark of RTU and has been licensed to Sucampo for use in the U.S. and
Canada.

Amitiza is a registered trademark of Sucampo Pharmaceuticals, Inc.

About dry age-related macular degeneration (dry AMD)

More than 8 million people in the U.S. currently have age-related macular degeneration (AMD), a
disease which causes damage to the retina resulting in loss of vision. AMD is the leading cause of
irreversible blindness in adults, worldwide. The prevalence of AMD in the U.S. is expected to
increase by more than 50 percent, to approximately 12 million by 2020. More than 85 percent of all
people with intermediate and advanced AMD have the dry form, [1]

AMD is a disease associated with aging that gradually destroys sharp, central vision. Central
vision is needed for seeing objects clearly and for common daily tasks such as reading and driving.
AMD affects the macula, the part of the eye that allows the seeing of fine detail. The macula is
located in the center of the retina, the light-sensitive tissue at the back of the eye. The retina
instantly converts light, or an image, into electrical impulses or nerve signals, which are sent to
the brain. Dry AMD occurs when the light-sensitive cells in the macula slowly break down,
gradually blurring central vision in the affected eye. As dry AMD progresses, patients may see a
blurred spot in the center of their vision. Over time, as less of the macula functions, central
vision is gradually lost in the affected eye. The most common symptom of dry AMD is slightly
blurred vision and a need for more light to read and do other tasks. Dry AMD generally affects
both eyes, but vision can be lost in one eye while the other eye seems unaffected. [2] Currently,
no drugs have been approved by regulatory authorities for the treatment of dry AMD.

About glaucoma

Glaucoma is a group of diseases that can damage the eye’s optic nerve, or retina, resulting in
vision loss and blindness. Glaucoma occurs when the normal fluid pressure inside the eyes slowly
rises. However, with early treatment, one can often protect one’s eyes against serious vision
loss.

It is estimated that over 4 million Americans have glaucoma and that it accounts for 9 to 12
percent of all cases of blindness in the U.S. [3]

For more information visit: http://nei.nih.gov/health and http://www.glaucoma.org

Sources:

	 	1.	 	Retina Today, January/February 2007
	 
	 	2.	 	National Eye Institute, Facts about Age-Related Macular Degeneration [NEI Health
Information]
	 
	 	3	 	Glaucoma Research Foundation, Glaucoma Facts and Stats

About Sucampo Pharmaceuticals

Sucampo Pharmaceuticals, Inc., a biopharmaceutical company based in Bethesda, Maryland, focuses on
the development and commercialization of medicines based on prostones. The therapeutic potential
of prostones, which are bio-lipids that occur naturally in the human body, was first identified by
Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ Chairman and Chief Executive Officer. Dr.
Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive
Officer and currently Advisor, International Business Development and a Director.

3

 

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

Sucampo markets Amitiza® (lubiprostone) 24 mcg in the U.S. for chronic idiopathic constipation in
adults and Amitiza 8 mcg in the U.S. to treat irritable bowel syndrome with constipation in adult
women. Sucampo also is developing the drug for additional gastrointestinal disorders with large
potential markets. In addition, Sucampo has a robust pipeline of compounds with the potential to
target underserved diseases, inclusive of age-related diseases, affecting millions of patients
worldwide. Sucampo Pharmaceuticals, Inc. has three wholly owned subsidiaries: Sucampo Pharma
Europe, Ltd., located in the UK; Sucampo Pharma, Ltd., located in Japan; and, Sucampo Pharma
Americas, Inc., located in Maryland. To learn more about Sucampo Pharmaceuticals and its products,
visit www.sucampo.com.

About R-Tech Ueno

R-Tech Ueno was founded in 1989 by Ryuji Ueno, M.D. Ph.D., Ph.D., and has been a pharmaceutical
venture corporation focusing on research, development, manufacturing and sales promotion of
prescription drugs mainly in the area of ophthalmic diseases. Products which we manufacture are
Rescula eye drops, glaucoma and ocular hypertension drug and Amitiza capsules, Chronic Idiopathic
Constipation and Irritable Bowel Syndrome drug. Utilizing the highest level of expertise in the
field of ophthalmology, our “physicians oriented new drug innovation” is making advances into the
development of new drugs that target ophthalmic diseases with no currently effective medications.
We also offer comprehensive support services to venture companies which seek new drug development.
R-Tech Ueno was listed on the Hercules, Osaka Stock Exchange on April 9, 2008. R-Tech Ueno
contributes to the society and progress by developing effective pharmaceutical products which are
derived from our own innovative ideas.

To learn more about R-Tech Ueno Ltd. and its products, visit http://www.rtechueno.com/en/index.php

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Sucampo
Pharmaceuticals are forward-looking statements made under the provisions of The Private Securities
Litigation Reform Act of 1995. Forward-looking statements may be identified by the words
“project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,”
“could,” “will,” “may” or other similar expressions. Forward-looking statements include statements
about potential growth in the prevalence of particular diseases or conditions, including dry AMD,
the commercial relaunch of Rescula and the ability of Sucampo to commercialize and market it, the
potential utility of Rescula to treat additional indications and future clinical trials. Actual
results may differ materially from those indicated by such forward-looking statements as a result
of various important factors, including those described in Sucampo Pharmaceuticals’ filings with
the Securities and Exchange Commission (SEC), including the annual report on Form 10-K for the year
ended December 31, 2008 and other periodic reports filed with the SEC. Any forward-looking
statements in this press release represent Sucampo Pharmaceuticals’ views only as of the date of
this release and should not be relied upon as representing its views as of any subsequent date.
Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to
change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements
publicly at some point in the future, Sucampo Pharmaceuticals specifically disclaims any obligation
to do so, whether as a result of new information, future events or otherwise.

# # #

4exv10w1

Exhibit 10.1

STOCK PURCHASE AGREEMENT

     This Stock Purchase Agreement (this “Agreement”) is dated March 31, 2009, by and
between Satellite Overseas (Holdings) Limited (the “Investor”) and Novavax, Inc., a
Delaware corporation (the “Company”), whereby the parties agree as set forth herein.
Certain terms are defined in Section 10 of this Agreement.

     WHEREAS, the Company and the Investor have entered into an agreement (the “JV Agreement”) to
form a joint venture to develop and commercialize vaccines, including vaccines that leverage the
Company’s VLP technology and vaccines based on Investor’s technology, for sale within the Indian
market and to establish local manufacturing capability in India based on the Company’s novel
disposable vaccine production system under licensing rights to be obtained from the Company;

     WHEREAS, the Company and the Investor have entered into a Master Services Agreement under
which Investor and/or its affiliates will perform certain services for the Company; and

     WHEREAS, in connection with the anticipated joint venture, Investor has agreed to make an
equity investment in the Company, in accordance with the terms and conditions set forth in this
Agreement.

     NOW, THEREFORE, in consideration of the premises and the mutual promises herein made, and in
consideration of the representations, warranties, and covenants herein contained, the Parties agree
as follows.

          1. Subscription.

               (a) Investor agrees to buy and the Company agrees to sell and issue to Investor 12,500,000
shares (the “Shares”) of the Company’s common stock, $0.01 par value per share (the
“Common Stock”), for an aggregate purchase price of $11,000,000, at a per share purchase
price of $0.88 (the “Purchase Price”).

               (b) The Shares have been registered on a Registration Statement on Form S-3, Registration
No. 333-138893 (the “Registration Statement”), which registration statement has been
declared effective by the Securities and Exchange Commission and is effective on the date hereof
(together with any registration statement filed by the Company pursuant to Rule 462(b) under the
Securities Act of 1933, as amended (the “Securities Act”)). A final prospectus supplement
will be delivered to the Investor as required by law.

               (c) On the closing date, which, in accordance with Rule 15c6-1 promulgated under the
Securities Exchange Act of 1934, as amended, is expected to occur on or about March 31, 2009 (the
“Closing Date”), upon satisfaction or waiver of all the conditions to closing set forth in
this Agreement, (i) the Purchase Price for the Shares purchased by the Investor will be delivered
by or on behalf of the Investor to the Company against delivery of the Shares, and (ii) the Company
shall cause its transfer agent to release to the Investor the number of Shares being purchased by
the Investor (such release shall be made through the facilities of The Depository Trust Company’s
DWAC system). The provisions set forth in Exhibit B hereto shall be incorporated herein by
reference as if set forth fully herein.

 

 

          2. Representations, Warranties and Agreements of the Company. The Company represents
and warrants to and agrees with Investor as of the date hereof and as of the Closing Date and any
other date specified below, that:

               (a) The Company has been duly incorporated and has a valid existence and the authorization to
transact business as a corporation under the laws of the State of Delaware, with corporate power
and authority to own its properties and conduct its business as described in the Prospectus, and
has been duly qualified as a foreign corporation for the transaction of business and is in good
standing under the laws of each other jurisdiction in which it owns or leases properties or
conducts any business so as to require such qualification, except for such jurisdictions wherein
the failure to be so qualified and in good standing would not individually or in the aggregate have
a Material Adverse Effect.

               (b) Each subsidiary of the Company has been duly incorporated and is validly existing as a
corporation in good standing under the laws of its jurisdiction of incorporation, with corporate
power and authority to own its properties and conduct its business as described in the Prospectus,
and has been duly qualified as a foreign corporation for the transaction of business and is in good
standing under the laws of each other jurisdiction in which it owns or leases properties or
conducts any business so as to require such qualification, except for such jurisdictions wherein
the failure to be so qualified and in good standing would not individually or in the aggregate have
a Material Adverse Effect. All subsidiaries and their respective jurisdictions of incorporation
are identified on Schedule I hereto. Except as disclosed in Schedule I, all of the
outstanding capital stock or other voting securities of each subsidiary is owned by the Company,
directly or indirectly, free and clear of any lien and free of any other limitation or restriction
(including any restriction on the right to vote, sell or otherwise dispose of such capital stock or
other voting securities). Other than the Company’s 4.75% senior convertible notes (the
“Convertible Notes”) and warrants to purchase 3,343,325 of Company Common Stock (the
“2008 Warrants”), there are no outstanding (i) securities of the Company or any subsidiary
of the Company which are convertible into or exchangeable for shares of capital stock or voting
securities of any subsidiary of the Company or (ii) options or other rights to acquire from the
Company or any subsidiary of the Company, or other obligation of the Company or any subsidiary of
the Company to issue, any capital stock, voting securities or securities convertible into or
exchangeable for capital stock or voting securities of any subsidiary of the Company (collectively,
the “Subsidiary Securities”). There are no outstanding obligations of the Company or any
subsidiary of the Company to repurchase, redeem or otherwise acquire any outstanding Subsidiary
Securities.

               (c) The execution, delivery and performance of this Agreement by the Company and the
consummation of the transactions contemplated hereby are within the corporate powers of the Company
and have been duly authorized by all necessary corporate action on the part of the Company, and the
Agreement, when duly executed and delivered by the Company, will constitute a valid and legally
binding instrument of the Company enforceable in accordance with its terms, except as enforcement
hereof may be limited by the effect of any applicable bankruptcy, insolvency, reorganization or
similar laws or court decisions affecting enforcement of creditors’ rights generally and except as
enforcement hereof is subject to general principles of equity (regardless of whether enforcement is
considered in a proceeding in equity or at law).

               (d) The Shares have been duly authorized by the Company, and when issued and delivered by the
Company against payment therefor as contemplated by this Agreement, the Shares will (i) be validly
issued, fully paid and nonassessable, (ii) not be subject

Stock Purchase Agreement

2

 

to any statutory or contractual preemptive rights or other rights to subscribe for or purchase
or acquire any shares of Common Stock, which have not been waived or complied with, and (iii)
conform to the description of the Common Stock contained in the Prospectus. The capital stock of
the Company, including the Common Stock, conforms as to the legal matters to the description
thereof, if any, contained in the Registration Statement and the Prospectus, and as of the date
thereof, the Company had authorized capital stock as set forth therein. The Shares are in due and
proper form and the holders of Shares will not be subject to personal liability by reason of being
such holders.

               (e) The execution and delivery of the Agreement does not, and the compliance by the Company
with the terms hereof will not, (i) violate the Certificate of Incorporation (as amended to date)
of the Company or the By-Laws (as amended to date) of the Company, (ii) result in a breach or
violation of any of the terms or provisions of, or constitute a default under, any indenture,
mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company or
its subsidiary is bound, or (iii) result in a violation of, or failure to be in compliance with,
any applicable statute or any order, judgment, decree, rule or regulation of any court or
governmental, regulatory or self-regulatory agency or body having jurisdiction over the Company or
its subsidiary, except in the case of (ii) and (iii) where such breach, violation, default or the
failure to be in compliance would not have a Material Adverse Effect; and no consent, approval,
authorization, order, registration, filing or qualification of or with any such court or
governmental, regulatory or self-regulatory agency or body is required for the valid authorization,
execution, delivery and performance by the Company of the Agreement or the issuance of the Shares,
except for such consents, approvals, authorizations, registrations, filings or qualifications as
may be required under the Securities Act or state securities or “blue sky” laws and have been or
will be obtained and which have been or will be made in connection with the listing of the Shares
on the Nasdaq Global Market.

               (f) The Company meets the requirements for the use of Form S-3 under the Securities Act for
the primary issuance of securities. The Registration Statement has been declared effective by the
Commission and at the time it became effective, and as of the date hereof, the Registration
Statement complied and complies with Rule 415 under the Securities Act. No stop order suspending
the effectiveness of the Registration Statement has been issued and no proceeding for that purpose
has been initiated or, to the Company’s knowledge, threatened by the Commission. On the effective
date of the Registration Statement, the Registration Statement complied, on the date of the
Prospectus, the Prospectus will comply, and at the date of the Closing, the Registration Statement
and the Prospectus will comply, in all material respects with the applicable provisions of the
Securities Act and the applicable rules and regulations of the Commission thereunder; on the
effective date of the Registration Statement, the Registration Statement and the additional
information disclosed by the Company to the Investor in a document titled “Investor Information”
(the “Investor Information”) did not, on the date of the Prospectus, the Prospectus did not, and at
the date of the Closing, the Registration Statement and the Prospectus and the Investor
Information, will not, contain an untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary in order to make the statements therein, in light
of the circumstances under which they were made (with respect to the Prospectus), not misleading;
and when filed with the Commission, the documents incorporated by reference in the Registration
Statement and the Prospectus, complied or will comply in all material respects with the applicable
provisions of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the
applicable rules and regulations of the Commission thereunder. There is no material document of a
character required to be described in the Registration Statement or the Prospectus or to be filed
as an exhibit to the Registration Statement

Stock Purchase Agreement

3

 

that is not described or filed as required. The Company’s form 10-K for year ended 2008 will
not contain any material information that is not included in the Investor Information.

               (g) The consolidated financial statements of the Company included or incorporated by reference
in the Registration Statement, the Prospectus and the Investor Information comply as to form with
the applicable accounting requirements of the Securities Act and have been prepared in conformity
with generally accepted accounting principles (except, with respect to the unaudited consolidated
financial statements and the accompanying footnotes which are subject to customary audit
adjustments) applied on a consistent basis, are consistent in all material respects with the books
and records of the Company, and accurately present in all material respects the consolidated
financial position, results of operations and cash flow of the Company and its subsidiary as of and
for the periods covered thereby. There are no other financial statements (historical or pro forma)
that are required to be included in the Registration Statement and the Prospectus.

               (h) There are no material liabilities of the Company or any subsidiary of the Company of any
kind whatsoever, whether accrued, contingent, absolute, determined, determinable or otherwise, and
there is no existing condition, situation or set of circumstances which could reasonably be
expected to result in such a liability, other than liabilities disclosed in the consolidated
financial statements and financial schedules of the Company included or incorporated by reference
in the Registration Statement and the Prospectus, and other undisclosed liabilities which,
individually or in the aggregate, are not material to the Company and its subsidiary, taken as a
whole.

               (i) Neither the Company nor its subsidiary has sustained, since the respective dates of the
latest audited financial statements included or incorporated by reference in the Registration
Statement and Prospectus, any material loss or interference with its business from fire, explosion,
flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or
governmental action, order or decree, otherwise than as disclosed in or contemplated by the
Registration Statement and Prospectus; and, since the respective dates as of which information is
given in the Registration Statement and Prospectus, there has not been any material change in the
capital stock or long-term debt of the Company or its subsidiary, the Company and its subsidiary
have not incurred any material liabilities or obligations, direct or contingent, nor entered into
any material transactions, except for entering into purchase orders in the ordinary course of
business, and there has not been any material adverse change in or affecting the general affairs,
assets, business, management, financial position or condition, stockholders’ equity or results of
operations of the Company and its subsidiary considered as a whole, otherwise than as disclosed in
the Registration Statement and Prospectus.

               (j) Other than as disclosed in the Prospectus, there are no legal, governmental or regulatory
proceedings pending to which the Company or its subsidiary is a party or of which any material
property of the Company or its subsidiary is the subject which, taking into account the likelihood
of the outcome, the damages or other relief sought and other relevant factors, would individually
or in the aggregate reasonably be expected to have a Material Adverse Effect or adversely affect
the ability of the Company to issue and sell the Shares; to the best of the Company’s knowledge, no
such proceedings are threatened or contemplated by governmental or regulatory authorities or
threatened by others.

               (k) The Company and its subsidiary have good and marketable title to all the real property and
owns all other properties and assets, reflected as owned in the financial statements included or
incorporated by reference in the Registration Statement, the Prospectus

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and the Investor Information, subject to no lien, mortgage, pledge, charge or encumbrance of
any kind except those, if any, reflected in such financial statements or which are not material to
the Company and its subsidiary taken as a whole. The Company and its subsidiary hold their
respective leased real and personal properties under valid and binding leases, except where the
failure to do so would not reasonably be expected to individually or in the aggregate have a
Material Adverse Effect.

               (l) The Company has filed all necessary federal and state income and franchise tax returns and
has paid all taxes shown as due thereon or has filed all necessary extensions, and there is no tax
deficiency that has been, or to the knowledge of the Company might be, asserted against the Company
or any of its properties or assets that would in the aggregate or individually reasonably be
expected to have a Material Adverse Affect.

               (m) There are no authorized options, warrants, preemptive rights, rights of first refusal or
other rights to purchase, or equity or debt securities convertible into or exchangeable or
exercisable for, any capital stock of the Company or its subsidiary other than the 2008 Warrants
and those accurately described in the Registration Statement and the Prospectus. There are no
holders or beneficial owners of securities of the Company having rights to registration thereof
whose securities have not been previously registered or who have not waived such rights with
respect to the registration of the Company’s securities on the Registration Statement, except where
the failure to obtain such waiver would not individually or in the aggregate reasonably be expected
to have a Material Adverse Effect.

               (n) Other than as disclosed in the Prospectus, the Company together with its subsidiary owns
and possesses all right, title and interest in and to, or, to the Company’s knowledge, has duly
licensed from third parties, all patents, patent rights, trade secrets, inventions, know-how,
trademarks, trade names, copyrights, service marks and other proprietary rights (“Intellectual
Property”) material to the business of the Company and its subsidiary taken as a whole as
currently conducted and as described in the Prospectus. To the Company’s knowledge and except as
would not individually or in the aggregate have a Material Adverse Effect, there is no infringement
or other violation by third parties of any of the Intellectual Property of the Company. Neither
the Company nor its subsidiary has received any notice of infringement or misappropriation from any
third party that has not been resolved or disposed of. Further, there is no pending or, to the
Company’s knowledge and except as would not individually or in the aggregate have a Material
Adverse Effect, threatened action, suit, proceeding or claim by governmental authorities or others
that the Company is infringing a patent, and there is no pending or, to the Company’s knowledge and
except as would not individually or in the aggregate have a Material Adverse Effect, threatened
legal or administrative proceeding relating to patents and patent applications of the Company,
other than proceedings initiated by the Company before the United States Patent and Trademark
Office and the patent offices of certain foreign jurisdictions which are in the ordinary course of
patent prosecution. To the Company’s knowledge, the patent applications of the Company presently
on file disclose patentable subject matter, and the Company is not aware of any inventorship
challenges, any interference which has been declared or provoked, or any other material fact that
(i) would preclude the issuance of patents with respect to such applications, or (ii) would lead
outside patent counsel for the Company to reasonably conclude that such patents, when issued, would
not be valid and enforceable in accordance with applicable regulations.

               (o) The Company conducts its business in compliance in all respects with applicable laws,
rules and regulations of governmental and regulatory bodies to which it is subject, except where
the failure to be in compliance would not have a Material Adverse Effect.

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               (p) All offers and sales of the Company’s capital stock prior to the date hereof were at all
relevant times registered pursuant to the Securities Act or exempt from the registration
requirements of the Securities Act and were issued in compliance in all material respects with
applicable state securities or blue sky laws.

               (q) The Company has filed with the Nasdaq Global Market a Notification of Listing of
Additional Shares with respect to the Shares required by the rules of the Nasdaq Global Market and
has not received a notice from the Nasdaq Global Market that such notification is insufficient.
The offer and sale of the Shares does not require stockholder approval under Rule 4350 of the
Nasdaq Stock Market Rules.

               (r) Neither the Company nor its subsidiary nor, to the best of the Company’s knowledge, any
employee or agent of the Company or its subsidiary, has (i) used any corporate funds for unlawful
contributions, gifts, entertainment or other unlawful expenses relating to political activity, (ii)
made any unlawful payment to foreign or domestic government officials or employees or to foreign or
domestic political parties or campaigns from corporate funds, (iii) violated any provision of the
Foreign Corrupt Practices Act of 1977, as amended, or (iv) made any other unlawful payment.

               (s) There is no broker, finder or other party that is entitled to receive from the Company any
brokerage or finder’s fee or other fee or commission as a result of any transactions contemplated
by this Agreement.

               (t) The Company maintains a system of internal accounting controls sufficient to provide
reasonable assurances that (i) transactions are executed in accordance with management’s general or
specific authorization; (ii) transactions are recorded as necessary to permit preparation of
consolidated financial statements in conformity with generally accepted accounting principles and
to maintain accountability for assets; (iii) access to assets is permitted only in accordance with
management’s general or specific authorization; and (iv) the recorded accountability for assets is
compared with existing assets at reasonable intervals and appropriate action is taken with respect
to any differences. Except as described in the Registration Statement and the Prospectus, since
the most recent audit of the effectiveness of the Company’s internal control over financial
reporting, there has been (i) no material weakness in the Company’s internal control over financial
reporting (whether or not remediated) and (ii) no change in the Company’s internal control over
financial reporting that has materially affected, or is reasonably likely to materially affect, the
Company’s internal control over financial reporting.

               (u) The Company has established, maintains and evaluates “disclosure controls and procedures”
(as such term is defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act), which (i) are
designed to ensure that material information relating to the Company is made known to the Company’s
principal executive officer and its principal financial officer by others within those entities,
particularly during the periods in which the periodic reports required under the Exchange Act are
being prepared, (ii) have been evaluated for effectiveness as of the end of the last fiscal period
covered by the Registration Statement; and (iii) such disclosure controls and procedures are
effective to perform the functions for which they were established. There are no significant
deficiencies and material weaknesses in the design or operation of internal controls which could
adversely affect the Company’s ability to record, process, summarize, and report financial data to
management and the board of directors of the Company. The Company is not aware of any fraud,
whether or not material, that involves management or other employees who have a role in the
Company’s internal controls; and since the date of the most recent evaluation of such disclosure
controls and procedures, there have been

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no significant changes in internal controls or in other factors that could significantly
affect internal controls, including any corrective actions with regard to significant deficiencies
and material weaknesses.

               (v) The Company and, to its knowledge, all of the Company’s directors or officers, in their
capacities as such, is in compliance in all material respects with all applicable effective
provisions of the Sarbanes-Oxley Act and any related rules and regulations promulgated by the
Commission.

               (w) The Company is not, nor after giving effect to the offering and sale of the Securities and
the application of the proceeds thereof as described in the Prospectus, will be, (i) required to
register as an “investment company” as defined in the Investment Company Act of 1940, as amended
(the “Investment Company Act”), and the rules and regulations of the Commission thereunder
or (ii) a “business development company” (as defined in Section 2(a)(48) of the Investment Company
Act).

               (x) The Company maintains insurance in such amounts and covering such risks as it reasonably
considers to be adequate for the conduct of its business and the value of its properties and as is
customary for companies engaged in similar businesses in similar industries. All such insurance is
fully in force on the date hereof and will be fully in force as of the Closing Date. The Company
has no reason to believe that it will not be able to renew its existing insurance coverage as and
when such coverage expires or to obtain similar coverage from similar insurers as may be necessary
to continue its business at a cost that would not have a Material Adverse Effect.

               (y) The Company has not sold or issued any securities that would be integrated with the
offering of the Securities contemplated by this Agreement pursuant to the Securities Act, the
published rules and regulations thereunder, or the interpretations thereof by the Commission.

               (z) The section entitled “Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Critical Accounting Policies and Estimates” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and
Estimates for Discontinued Operations” in the Company’s most recent Annual Report on Form 10-K,
Quarterly Report on Form 10-Q and in the Investor Information accurately and fully describes (A)
the accounting policies that the Company believes are the most important in the portrayal of the
Company’s financial condition and results of operations and that require management’s most
difficult, subjective or complex judgments (“Critical Accounting Policies”); and (B) the
judgments and uncertainties affecting the application of Critical Accounting Policies.

               (aa) Neither the Company nor, to the Company’s knowledge, any of its officers, directors,
affiliates or controlling persons has taken or will take, directly or indirectly, any action
designed to cause or result in, or which has constituted or which might reasonably be expected to
constitute the stabilization or manipulation of the price of any security of the Company to
facilitate the sale or resale of the Shares.

               (bb) No relationship, direct or indirect, exists between or among the Company on the one hand
and the directors, officers, stockholders, customers or suppliers of the Company on the other hand
which is required to be described in the Registration Statement and the Prospectus which has not
been so described. There are no outstanding loans, advances (except

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normal advances for business expenses in the ordinary course of business) or guarantees or
indebtedness by the Company to, or for the benefit of, any of the current officers or directors of
the Company.

               (cc) The Company has filed in a timely manner all reports required to be filed pursuant to
Sections 13(a), 13(e), 14 and 15(d) of the Exchange Act during the preceding 12 months (except to
the extent that Section 15(d) requires reports to be filed pursuant to Sections 13(d) and 13(g) of
the Exchange Act, which shall be governed by the next clause of this sentence); and the Company has
filed in a timely manner all reports required to be filed pursuant to Sections 13(d) and 13(g) of
the Exchange Act during the preceding 12 months, except where the failure to timely file could not
reasonably be expected individually or in the aggregate to have a Material Adverse Effect.

               (dd) The Company and its subsidiary (a) are in compliance with any and all applicable foreign,
federal, state and local laws, orders, rules, regulations, directives, decrees and judgments
relating to the protection of human health and safety, the environment or hazardous or toxic
substances or wastes, pollutants or contaminants (“Environmental Laws”), (b) have received
all permits, licenses or other approvals required of them under applicable Environmental Laws to
conduct their business and the same are effective and in use on the date of this Agreement and (c)
are in compliance with all terms and conditions of any such permit, license or approval, except
where such noncompliance with Environmental Laws, failure to receive required permits, licenses or
other approvals or failure to comply with the terms and conditions of such permits, licenses or
approvals would not, individually or in the aggregate, result in a Material Adverse Effect. There
are no costs or liabilities associated with Environmental Laws (including, without limitation, any
capital or operating expenditures required for clean-up, closure of properties or compliance with
Environmental Laws or any permit, license or approval, any related constraints on operating
activities and any potential liabilities to third parties) which would, individually or in the
aggregate, result in a Material Adverse Effect.

               Neither the Company nor its subsidiary is engaged in any unfair labor practice; except for
matters that would not, individually or in the aggregate, result in a Material Adverse Effect and
(i) there is (A) no unfair labor practice complaint pending or, to the Company’s knowledge after
due inquiry, threatened against the Company or its subsidiary before the National Labor Relations
Board, and no grievance or arbitration proceeding arising out of or under collective bargaining
agreements is pending or threatened, (B) no strike, labor dispute, slowdown or stoppage pending or,
to the Company’s knowledge after due inquiry, threatened against the Company or its subsidiary and
(C) no union representation dispute currently existing concerning the employees of the Company or
its subsidiary, and (ii) to the Company’s knowledge (A) no union organizing activities are
currently taking place concerning the employees of the Company or its subsidiary and (B) there has
been no violation of any federal, state, local or foreign law relating to discrimination in the
hiring, promotion or pay of employees or any applicable wage or hour laws concerning the employees
of the Company or its subsidiary.

               (ff) The Company and its subsidiary are in compliance in all material respects with all
applicable provisions of the Employee Retirement Income Security Act of 1974, as amended, including
the regulations thereunder (“ERISA”); no “reportable event” (as defined in ERISA) has
occurred with respect to any “pension plan” (as defined in ERISA) for which the Company or its
subsidiary would have any liability; neither the Company nor its subsidiary has incurred and does
not expect to incur liability under (i) Title IV of ERISA with respect to termination of, or
withdrawal from, any “pension plan” or (ii) Sections 412 or 4971 of the

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Internal Revenue Code of 1986, as amended, including the regulations thereunder (the
“Code”); and each “pension plan” for which the Company would have any liability that is
intended to be qualified under Section 401(a) of the Code is the subject of a favorable opinion or
determination letter issued by the Internal Revenue Service and nothing has occurred, whether by
action or by failure to act, which is reasonably expected to result in the revocation of such
determination letter.

               (gg) Any statistical, industry-related and market-related data included or incorporated by
reference in the Registration Statement, the Prospectus and the Investor Information, are based on
or derived from sources that the Company reasonably and in good faith believes to be reliable and
accurate, and such data agree with the sources from which they are derived.

               (hh) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or
sponsored by the Company or its subsidiary or in which the Company or its subsidiary or products or
product candidates have participated that are described in the Registration Statement and the
Prospectus were and, if still pending, are being conducted in accordance in all material respects
with all statutes, laws, rules and regulations administered by the Food and Drug Association
(“FDA”) and with standard medical and scientific research procedures. The descriptions in
the Registration Statement, the Prospectus and the Investor Information of the results of such
studies and tests are accurate and complete in all material respects and fairly present the
published data derived from such studies and tests. Neither the Company nor its subsidiary has
received any notices or other correspondence from the FDA with respect to any ongoing clinical or
pre-clinical studies or tests requiring the termination, suspension or material modification of
such studies or tests, which such termination, suspension or material modification would reasonably
be expected to result in a Material Adverse Effect. The Company and its subsidiary is in
compliance with all applicable laws, regulations, orders and decrees governing its business as
prescribed by the FDA except where noncompliance would not, singly or in the aggregate, result in a
Material Adverse Effect.

               (ii) Other than as set forth on Schedule II attached hereto, as of the date of this Agreement,
the only outstanding indebtedness of the Company consists of (i) the Convertible Notes, which,
unless converted into Common Stock or amended, will be paid on or before July 19, 2009 with funds
then held by the Company, and (ii) ordinary course trade payables.

               (jj) The board of directors of the Company has taken all actions necessary to be taken to
pre-approve the transactions contemplated by this Agreement such that (i) the restrictions
contained in Section 203 of the Delaware General Corporation Law (“DGCL”) applicable to a “business
combination” (as defined therein), and (ii) the applicable anti-takeover provisions contained in
the Company’s Shareholder Rights Plan adopted on August 7, 2002 (the “Shareholder Rights Plan”)
will not apply to the execution, delivery or performance of this Agreement or the consummation of
the transactions contemplated by this Agreement.

          3. Investor Representations, Warranties and Acknowledgments.

               (a) The Investor represents and warrants that: (i) it has full right, power and authority to
enter into this Agreement and to perform all of its obligations hereunder; (ii) this Agreement has
been duly authorized and executed by the Investor and, when delivered in accordance with the terms
hereof, will constitute a valid and binding agreement of the Investor enforceable against the
Investor in accordance with its terms, except as such enforceability may

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be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the
rights and remedies of creditors generally or subject to general principles of equity; (iii) the
execution and delivery of this Agreement and the consummation of the transactions contemplated
hereby do not result in a breach of (A) the Investor’s certificate of incorporation or by-laws (or
other governing documents), or (B) any material agreement or any law or regulation to which the
Investor is a party or by which any of its property or assets is bound; (iv) it has had full access
to the base prospectus included in the Registration Statement, the Prospectus and the Company’s
periodic reports and other information incorporated by reference therein, and was able to read,
review, download and print such materials; (v) in making its investment decision in this offering,
the Investor and its advisors, if any, have relied solely on the Company’s public filings with the
Securities and Exchange Commission and the Investor Information; (vi) it is knowledgeable,
sophisticated and experienced in making, and is qualified to make, decisions with respect to
investments in securities representing an investment decision like that involved in the purchase of
the Shares; (vii) except as set forth below, the Investor has had no position, office or other
material relationship within the past three years with the Company or persons known to it to be
affiliates of the Company and (viii), except as set forth below, the Investor is not a, and it has
no direct or indirect affiliation or association with any, National Association of Securities
Dealers, Inc. member as of the date hereof.

 

(If no exceptions, write “none.” If left blank, response will be deemed to be “none.”)

               (b) The Investor also represents and warrants that, other than the transactions contemplated
hereunder, the Investor has not directly or indirectly, nor has any person acting on behalf of or
pursuant to any understanding with the Investor, executed any disposition, including “short sales”
as defined in Rule 200 of Regulation SHO under the Securities Exchange Act of 1934 (the “Short
Sales”), in the securities of the Company during the period commencing from the time that the
Investor first became aware of the proposed transactions contemplated hereunder until the date
hereof (“Discussion Time”). The Investor has maintained the confidentiality of all
disclosures made to it in connection with this transaction (including the existence and terms of
this transaction).

          4. Investor Covenant Regarding Short Sales and Confidentiality. The Investor covenants
that neither it nor any affiliates acting on its behalf or pursuant to any understanding with it
will execute any Short Sales during the period after the Discussion Time and ending on the date the
transactions contemplated by this Agreement are publicly disclosed. The Investor covenants that
until such time as the transactions contemplated by this Agreement are publicly disclosed by the
Company through a press release, the Investor will maintain the confidentiality of all disclosures
made to it in connection with this transaction (including the existence and terms of this
transaction).

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          5. Pre-emptive Right.

               (a) Except with respect to Exempt Issuances, for so long as Investor “beneficially owns” (as
determined under Rule 13d-3 of the Securities and Exchange Act of 1934, as amended) an aggregate
number of shares of Common Stock equal to or greater than five percent (5%) of the then issued and
outstanding shares of Common Stock (the “Threshold Amount”), the Company hereby grants
Investor the right to purchase its Pro-Rata Portion of any new Equity Securities that the Company
may from time to time propose to issue or sell to any party.

               (b) Additional Issuance Notices. The Company shall give written notice (an
“Issuance Notice”) of any proposed issuance or sale described in subsection (a) above to
the Investor. The Issuance Notice shall, if applicable, be accompanied by a written offer from any
prospective purchaser seeking to purchase Equity Securities, to the extent known to the Company at
the time, and shall set forth the material terms and conditions of the proposed issuance,
including, without limitation:

                    (i) the number and description of the new Equity Securities proposed to be issued and the
percentage of the Company’s outstanding equity interests such issuance would represent;

                    (ii) the proposed issuance date; and

                    (iii) the proposed purchase price per share.

The Company shall provide written notice to Investor if the terms set forth in the Issuance Notice
are updated or changed in any material respect (a “Material Update”) as the details listed
in Sections 5(b)(i), (ii) and (iii) are known.

               (c) Exercise of Pre-emptive Rights. Investor shall, for a period of fifteen (15)
business days following the initial receipt of an Issuance Notice (the “Exercise Period”),
have the right to elect irrevocably to purchase up to its Pro Rata Portion of the new Equity
Securities at the purchase price and on the other terms set forth in the Issuance Notice by
delivering a written notice to the Company. If the Company provides a Material Update, the
Exercise Period shall be extended by five calendar days from the date of receipt of the Material
Update, if such extension is longer than the expiration of the Exercise Period. The closing of any
purchase by Investor shall be consummated concurrently with the consummation of the issuance or
sale described in the Issuance Notice; provided, however that, the closing of any purchase by
Investor may be extended beyond the closing of the transaction described in the Issuance Notice to
the extent necessary to obtain required government approvals and other required third party
approvals or consents (and the Company shall use its reasonable best efforts to obtain such
approvals and consents).

               (d) Sales to the Prospective Buyer. If Investor fails to elect to purchase all or part
of its Pro Rata Portion allotment of the new Equity Securities described in the Issuance Notice
within the time period described in subsection (c), the Company shall be free to complete the
proposed issuance or sale of new Equity Securities described in the Issuance Notice at a price and
on other terms no less favorable to the Company than those set forth in the Issuance Notice. If the
Company does not enter into an agreement for the sale of such new Equity Securities within twenty
(20) business days after the expiration of the time period described in subsection (c), or if such
agreement is not consummated within sixty (60) days after the execution thereof, the pre-emptive
right provided hereunder shall be deemed to be revived and such new

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Equity Securities shall not be issued or sold unless first reoffered to the Investor in
accordance with this Section 5.

          6. Board Seat. During the period of time (the “Investor Board Representation
Period”) beginning on the date the Investor “beneficially owns” (as determined under Rule 13d-3
of the Securities Exchange Act of 1934, as amended) the Threshold Amount, and ending on the date
the Investor owns less than the Threshold Amount, the Investor may designate one member of the
Board (the “Investor Director”), who shall also serve on such committees of the Board as
designated by the Board. In connection therewith, the Company hereby agrees to create a vacancy
and appoint Dr. Rajiv I. Modi (the “Representative”) as a Class I director of the Company.
As a Class I director, the Representative will be subject to stockholder vote at the Annual Meeting
of Stockholders to be held in June 2011. The Company agrees to cause the Representative to be
nominated and recommended for reelection for so long as the Investor beneficially owns Common Stock
in excess of the Threshold Amount, and to promptly take any action as may be necessary after any
stockholder meeting to effect the first sentence of this Section 6. The Investor will cause the
Representative to supply any customary or required information and consents reasonably required by
the Company to be included in the Company’s Proxy Statements and filings with the Commission under
the Securities Act and the Exchange Act of 1934. The Company agrees that in the event it receives
a request by the Investor to replace the Representative, the Company will reasonably cooperate with
Investor to effect such replacement provided that the replacement individual is reasonably
acceptable to the Board of Directors.

          7. Public Disclosure. The Company shall (i) before the opening of trading on the
Nasdaq Global Market on the next trading day after the date hereof, issue a press release,
disclosing all material aspects of the transactions contemplated hereby, to the extent permitted by
applicable law, and (ii) make such other filings and notices in the manner and time required by the
Securities and Exchange Commission with respect to the transactions contemplated hereby. The
Company shall not identify the Investor by name in any press release or public filing, or otherwise
publicly disclose the Investor’s name, without the Investor’s prior written consent, unless
required by law or the rules and regulations of any self-regulatory organization or exchange to
which the Company or its securities are subject.

          8. Conditions. The obligation of the Investor to purchase and acquire the Shares
hereunder shall be subject to the condition that all representations and warranties and other
statements of the Company shall be true and correct as of and on each of the date of this Agreement
and the date of the Closing, the condition that the Company shall have performed all of its
obligations hereunder theretofore to be performed, and the following additional conditions:

               (a) The Prospectus shall have been filed with the Commission pursuant to Rule 424(b) under the
Securities Act within the applicable time period prescribed for such filing, no stop order
suspending the effectiveness of the Registration Statement or any part thereof shall have been
issued and no proceeding for that purpose shall have been initiated or threatened by the
Commission, and the Investor shall have received the Prospectus in accordance with the federal
securities laws.

               (b) Prior to the Closing Date, there shall not have occurred any change, or any development
involving a prospective change, which would constitute a Material Adverse Effect, and that makes it
impracticable to market the Shares on the terms and in the manner contemplated in the Prospectus.

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               (c) No action shall have been taken and no statute, rule, regulation or order shall have been
enacted, adopted or issued by any governmental agency or body which would, as of the Closing Date,
prevent the issuance or sale of the Shares or materially and adversely affect or reasonably be
believed to materially and adversely affect the business or operations of the Company; and no
injunction, restraining order or order of any other nature by any federal or state court of
competent jurisdiction shall have been issued as of the Closing Date which would prevent the
issuance or sale of the Shares or materially and adversely affect or reasonably be believed to
materially and adversely affect the business or operations of the Company.

               (d) The Investor shall have received from Ballard Spahr Andrews & Ingersoll, LLP, counsel to
the Company, such counsel’s written opinion and written statement, addressed to the Investor and
dated the Closing Date, in form and substance as set forth in Exhibit B.

               (e) The Shares shall have been authorized for quotation on the Nasdaq Global Market, Inc.

               (f) The JV Agreement and the agreements contemplated thereby, and the Services Agreement shall
have been executed and delivered by the parties thereto.

               (g) The actions taken by the Company’s board of directors to pre-approve the transactions
contemplated by this Agreement for purposes of Section 203 of the DGCL and the Company’s
Shareholder Rights Agreement shall not have been amended or modified in any respect and remain in
full force and effect.

          9. Indemnification.

               (a) Indemnification of the Investor. The Company agrees to indemnify and hold harmless each
of the Investors and its owners, officers, directors, managers, members, agents, advisors,
successors and assigns (each, an “Indemnified Party”), against any losses, claims, damages
or liabilities, joint or several, to which such Indemnified Party may become subject, under the
Securities Act or otherwise (including in settlement of any litigation if such settlement is
effected with the written consent of the Company, insofar as such losses, claims, damages or
liabilities (or actions in respect thereof) arise out of or are based upon (i) an untrue statement
or alleged untrue statement of a material fact contained in the Registration Statement, including
the information deemed to be a part of the Registration Statement at the time of effectiveness and
at any subsequent time pursuant to Rules 430A and 430B of the Rules and Regulations promulgated
under the Securities Act, if applicable, any Preliminary Prospectus, the Prospectus, or any
amendment or supplement thereto (including any documents filed under the Exchange Act and deemed to
be incorporated by reference into the Prospectus), any Issuer Free Writing Prospectus or in any
materials or information provided to investors by, or with the approval of, the Company in
connection with the marketing of the offering of the Common Stock (“Marketing Materials”),
including any roadshow or investor presentations made to investors by the Company (whether in
person or electronically) or arise out of or are based upon the omission or alleged omission to
state therein a material fact required to be stated therein or necessary to make the statements
therein not misleading, and will reimburse each Indemnified Party for any legal or other expenses
reasonably incurred by it in connection with investigating or defending against such loss, claim,
damage, liability or action; or (ii) in whole or in part upon any inaccuracy in the representations
and warranties of the Company contained herein; or (iii) in whole or in part upon any failure of
the Company to perform their respective obligations hereunder or under law; provided, however, that
the

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Company shall not be liable in any such case to the extent that any such loss, claim, damage,
liability or action arises out of or is based upon an untrue statement or alleged untrue statement
or omission or alleged omission made in the Prospectus Supplement in reliance upon and in
conformity with written information furnished to the Company by the Indemnified Party, specifically
for use in the preparation thereof.

          In addition to their other obligations under this Section 9(a), the Company agrees
that, as an interim measure during the pendency of any claim, action, investigation, inquiry or
other proceeding brought or threatened against the Indemnified Party and which arises out of or
based upon any statement or omission, or any alleged statement or omission, described in this
Section 9(a), they will reimburse each Indemnified Party on a monthly basis for all
reasonable legal fees or other expenses incurred in connection with investigating or defending any
such claim, action, investigation, inquiry or other proceeding, notwithstanding the absence of a
judicial determination as to the propriety and enforceability of the Company’s obligation to
reimburse such Indemnified Party for such expenses and the possibility that such payments might
later be held to have been improper by a court of competent jurisdiction. To the extent that any
such interim reimbursement payment is so held to have been improper, each Indemnified Party that
received such payment shall promptly return it to the party or parties that made such payment,
together with interest, determined on the basis of the prime rate (or other commercial lending rate
for borrowers of the highest credit standing) announced from time to time by The Wall Street
Journal (the “Prime Rate”). Any such interim reimbursement payments which are not made to
an Indemnified Party within 30 days of a request for reimbursement shall bear interest at the Prime
Rate from the date of such request. This indemnity agreement shall be in addition to any
liabilities which the Company may otherwise have.

               (b) Notice and Procedures. Promptly after receipt by an Indemnified Party under subsection (a)
above of notice of the commencement of any action, such Indemnified Party shall, if a claim in
respect thereof is to be made against the Company under such subsection, notify the Company in
writing of the commencement thereof; but the omission so to notify the Company shall not relieve
the Company from any liability that it may have to any Indemnified Party except to the extent the
Company has been materially prejudiced by such failure. In case any such action shall be brought
against any Indemnified Party, and it shall notify the Company of the commencement thereof, the
Company shall be entitled to participate in, and, to assume the defense thereof, with counsel
satisfactory to such Indemnified Party, and after notice from the Company to such Indemnified Party
of the Company’s election so to assume the defense thereof, the Company shall not be liable to such
Indemnified Party under such subsection for any legal or other expenses subsequently incurred by
such Indemnified Party in connection with the defense thereof other than reasonable costs of
investigation; provided, however, that if, in the sole judgment of the Indemnified Party, it is
advisable for the Indemnified Party to be represented by separate counsel, the Indemnified Party
shall have the right to employ a single counsel to represent such Indemnified Party, in which event
the reasonable fees and expenses of such separate counsel shall be borne by the Company and
reimbursed to the Indemnified Party as incurred (in accordance with the provisions of the second
paragraph in subsection (a) above).

          The Company under this Section 9 shall not be liable for any settlement of any
proceeding effected without its written consent, but if settled with such consent or if there be a
final judgment for the plaintiff, the Company agrees to indemnify each Indemnified Party against
any loss, claim, damage, liability or expense by reason of such settlement or judgment.
Notwithstanding the foregoing sentence, if at any time an Indemnified Party shall have requested
the Company to reimburse such Indemnified Party for fees and expenses of counsel as contemplated by
this Section 8, the Company agrees that it shall be liable for any settlement of any
proceeding effected without its written consent if (i) such settlement is entered into more than

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30 days after receipt by the Company of the aforesaid request and (ii) the Company shall not have
reimbursed the Indemnified Party in accordance with such request prior to the date of such
settlement. The Company shall not, without the prior written consent of the Indemnified Party,
effect any settlement, compromise or consent to the entry of judgment in any pending or threatened
action, suit or proceeding in respect of which any Indemnified Party is or could have been a party
and indemnity was or could have been sought hereunder by such Indemnified Party, unless such
settlement, compromise or consent (a) includes an unconditional release of such Indemnified Party
from all liability on claims that are the subject matter of such action, suit or proceeding and (b)
does not include a statement as to or an admission of fault, culpability or a failure to act by or
on behalf of any Indemnified Party.

               (c) Contribution; Limitation on Liability. If the indemnification provided for in this
Section 9 is unavailable or insufficient to hold harmless an Indemnified Party under
subsection (a) above, then the Company shall contribute to the amount paid or payable by such
Indemnified Party as a result of the losses, claims, damages or liabilities referred to in
subsection (a) above, (i) in such proportion as is appropriate to reflect the relative benefits
received by the Company on the one hand and the Indemnified Party on the other from the offering of
the Shares or (ii) if the allocation provided by clause (i) above is not permitted by applicable
law, in such proportion as is appropriate to reflect not only the relative benefits referred to in
clause (i) above but also the relative fault of the Company on the one hand and the Indemnified
Party on the other in connection with the statements or omissions that resulted in such losses,
claims, damages or liabilities, as well as any other relevant equitable considerations. The
relative fault shall be determined by reference to, among other things, whether the untrue or
alleged untrue statement of a material fact or the omission or alleged omission to state a material
fact relates to information supplied by the Company or the Indemnified Party and the parties’
relevant intent, knowledge, access to information and opportunity to correct or prevent such untrue
statement or omission. The Company and the Indemnified Party agree that it would not be just and
equitable if contributions pursuant to this Section 9(c) were to be determined by pro rata
allocation or by any other method of allocation which does not take account of the equitable
considerations referred to in the first sentence of this Section 9(c). The amount paid by
an Indemnified Party as a result of the losses, claims, damages or liabilities referred to in the
first sentence of this Section 9(c) shall be deemed to include any legal or other expenses
reasonably incurred by such Indemnified Party in connection with investigating or defending against
any action or claim which is the subject of this Section 9(c). Notwithstanding the
provisions of this Section 9(c), no Indemnified Party shall be required to contribute any
amount in excess of the amount received by it (net of expenses) from the public sale of Shares
purchased by it pursuant to this Agreement. No person guilty of fraudulent misrepresentation
(within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from
any person who was not guilty of such fraudulent misrepresentation.

               (d) Non-Exclusive Remedies. The obligations of the Company under this Section 9 shall
be in addition to any liability which the Company may otherwise have and shall extend, upon the
same terms and conditions, to each person, if any, who controls any Indemnified Party within the
meaning of the Securities Act. Each Indemnified Party shall also have all rights and remedies
available to it under the law and in equity, in addition to the rights and benefits of this
Section 9.

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15

 

               (e) Survival. Except in the case of fraud, gross negligence or willful misconduct, the
provisions of this Section 9 shall survive until the first anniversary of the Closing.

          10. Miscellaneous.

               (a) Definitions. As used herein, the following terms have the meanings indicated:

                    (i) “Commission” means the Securities and Exchange Commission.

                    (ii) “Exempt Issuances” means issuances in which Equity Securities are issued (i) as a
dividend, stock split or other distribution payable pro rata to all holders of Common Stock,
(ii) to employees, officers, directors or consultants of the Company pursuant to any employee
benefit plans or programs approved by the Board or any committee thereof, to the extent that the
total number of Equity Securities issuable pursuant to such plans or programs does not exceed 15%
of the shares of Common Stock outstanding on the date hereof, (iii) upon the conversion or exercise
of any options, warrants or other rights to purchase Common Stock (A) outstanding on the date
hereof or (B) issued in accordance with the foregoing clause (ii), (iv) as consideration for a
merger, consolidation or purchase of assets; and (v) in connection with any strategic partnership
or joint venture (the primary purpose of which is not to raise equity capital), provided that (A)
any transaction described in this clause (v) has been approved by a majority of the full Board of
Directors of the Company and (B) in any twelve (12)-month period, (I) the aggregate number of
Equity Securities issued in any transaction or series of related transactions described in this
clause (v) at a price per share of less than $0.88 (appropriately adjusted for any stock splits,
reverse stock splits, stock dividends, combinations, recapitalizations or the like, the “Per Share
Purchase Price”) shall not exceed 5% of the number of issued and outstanding shares of Common Stock
at the beginning of such period (the “Initial Capitalization”), and (II) the aggregate number of
Equity Securities issued in all transactions described in this clause (v) at a price per share less
than the Per Share Purchase Price shall not exceed 10% of the Initial Capitalization.

                    (iii) “Equity Securities” means any and all shares of Common Stock of the Company and
any securities of the Company convertible into, or exchangeable or exercisable for, such shares,
and options, warrants or other rights to acquire such shares or such convertible, exchangeable or
exercisable securities.

                    (iv) “Material Adverse Effect” means a material adverse effect on the results of
operations, assets, business, or financial condition of the Company and the its subsidiary, taken
as a whole, or a material adverse effect on the Company’s ability to perform in any material
respect on a timely basis its obligations under the Transaction Documents or to consummate any
transactions contemplated by the Transaction Documents or the Prospectus.

                    (v) “Pro Rata Portion” means that portion of Equity Securities that equals the
proportion that the number of shares of Common Stock issued and held, or issuable upon the
conversion, exchange or exercise of any convertible, exchangeable or exercisable securities then
held, by the Investor bears to the total number of shares of Common Stock of the Company then
outstanding (assuming full conversion, exchange and exercise of all outstanding convertible,
exchangeable and exercisable securities).

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16

 

                    (vi) “Prospectus” means the prospectus forming a part of the Registration Statement
and the prospectus supplement relating to the Offered Shares in the form first filed pursuant to
Rule 424(b) under the Securities Act, as amended (the “Securities Act”), as further amended
or supplemented prior to the execution of this Agreement, and shall include all information and
documents incorporated by reference in such prospectus.

               (b) This Agreement constitutes the entire understanding and agreement between the parties with
respect to the subject matter hereof, and there are no agreements or understandings with respect to
the subject matter hereof which are not contained in this Agreement. Notwithstanding any
investigation made by any party to this Agreement, all covenants, agreements, representations and
warranties made by the Company and the Investor herein will survive the execution of this
Agreement, the delivery to the Investor of the Shares being purchased and the payment therefor
until the first anniversary of the Closing. This Agreement may be modified only in writing signed
by the parties hereto.

               (c) This Agreement may be executed in any number of counterparts, all of which taken together
shall constitute one and the same instrument and shall become effective when counterparts have been
signed by each party and delivered to the other parties hereto, it being understood that all
parties need not sign the same counterpart. Execution may be made by delivery by facsimile, PDF or
other electronically transmitted means.

               (d) The provisions of this Agreement are severable and, in the event that any court or
officials of any regulatory agency of competent jurisdiction shall determine that any one or more
of the provisions or part of the provisions contained in this Agreement shall, for any reason, be
held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other provision or part of a provision of this Agreement and
this Agreement shall be reformed and construed as if such invalid or illegal or unenforceable
provision, or part of such provision, had never been contained herein, so that such provisions
would be valid, legal and enforceable to the maximum extent possible, so long as such construction
does not materially adversely effect the economic rights of either party hereto.

               (e) All communications hereunder, except as may be otherwise specifically provided herein,
shall be in writing and shall be mailed, hand delivered, sent by a recognized overnight courier
service such as Federal Express, or sent via facsimile and confirmed by letter, to the party to
whom it is addressed at the following addresses or such other address as such party may advise the
other in writing:

     To the Seller: as set forth on the signature page hereto.

     To the Investor: as set forth on the signature page hereto.

     All notices hereunder shall be effective upon receipt by the party to which it is addressed.

               (f) This Agreement shall be governed by and interpreted in accordance with the laws of the
State of Delaware for contracts to be wholly performed in such state and without giving effect to
the principles thereof regarding the conflict of laws. To the extent determined by such court, the
prevailing party shall reimburse the other party for any reasonable legal fees and disbursements
incurred in enforcement of, or protection of any of its rights under this Agreement.

Stock Purchase Agreement

17

 

     If the foregoing correctly sets forth our agreement, please confirm this by signing and
returning to us the duplicate copy of this Agreement.

	 	 	 	 	 	 	 
	 	 	NOVAVAX, INC.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Rahul Singhvi
 

Rahul Singhvi
	 	 
	 

	 	 	 	President and Chief Executive Officer	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	Address for Notice:	 	 
	 

	 	 	 	Novavax, Inc.	 	 
	 

	 	 	 	9920 Belward Campus Drive	 	 
	 

	 	 	 	Rockville, MD 20850	 	 
	 

	 	 	 	Facsimile: 240-268-2128	 	 
	 

	 	 	 	Email: rsinghvi@novavax.com	 	 
	 

	 	 	 	Attention: Chief Executive Officer	 	 

	 	 	 	 	 
	SATELLITE OVERSEAS (HOLDINGS) LIMITED
	 
	 	 	 	 
	By:

	 	/s/ Rajiv I. Modi
 

Rajiv I. Modi
	 	 
	 

	 	Director	 	 

Address for Notice:

c/o Barleigh Wells Limited

7 Hill Street

Douglas, Isle of Man

Facsimile: +44 20 74905102

Email: PankajShah@LubbockFine.co.uk

Attention: Pankaj Shah

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