Patent and Know-how Licensing, and Data Sharing Agreement

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

Table of Contents

[*] = 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

[*] = 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

[*] = 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.

[*] = 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.

[*] = 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:

[*] = 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.

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.

[*] = 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

[*] = 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

[*] = 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.

[*] = 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.

3.2 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

[*] = 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

[*] = 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:

[*] = 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.

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

[*] = 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.

Article 6. Development

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

[*] = 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.

6.5 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.

[*] = 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:

[*] = 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

[*] = 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