Exhibit 10.1
 [*] = 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.
    Unoprostone NDA Transfer, Data-Sharing and License Agreement
   Page 1 of 37




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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.
  Article 1.
    
    Definitions
    
    
    3Article 2.
    
    General Terms of Manufacturing and Supply
    
    
    9Article 3.
    
    Additional Services
    
    
    13Article 4.
    
    Pricing and Payment
    
    
    13Article 5.
    
    Confidentiality and Non-Disclosure
    
    
    16Article 6.
    
    Intellectual Property Rights.
    
    
    19Article 7.
    
    Regulatory and Legal.
    
    
    19Article 8.
    
    Representations and Warranties of SPA
    
    
    21Article 9.
    
    Representations and Warranties of RTU
    
    
    22Article 10.
    
    Indemnification; Insurance
    
    
    24Article 11.
    
    Term and Termination
    
    
    27Article 12.
    
    Dispute Resolution
    
    
    30Article 13.
    
    Miscellaneous
    
    
    31
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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.
    ®
  Unoprostone License Agreement
 Article 1. Definitions
 1.1 Additional Materials
 1.2 Adverse 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.
 Affiliate
 1.3 Annual Maintenance
 1.4 Applicable Law
 1.5 Business Day
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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.
 1.6 Certificate of Analysis
 1.7 cGLP
 1.8 cGMP
 1.9 Clinical Study(ies)
 1.10 Clinical Supply
 1.11 Commercial Commercialize
 1.12 Commercial Product
 1.13 Confidential Information
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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.
  1.14 Data Exclusivity
 1.15 Drug Approval Application
 1.16 DMF/CMC Package
 1.17 Drug Product
 1.18 Drug Substance
 1.19 IND
 1.20 Latent Defect
 1.21 Need to insert the definition of Licensed Product (from the IP 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.
 1.22 Licensed Patents Licensed Patents
 1.23 NDA
 1.24 Order
 1.25 Order Year
 1.26 Person
 1.27 Product Valid Claims
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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.
  1.28 Promote Promotion
 1.29 Promotional Sample
 1.30 Product Defect
 1.31 Regulatory Approval
 1.32 Regulatory Authority
 1.33 Regulatory Data and Information
 1.34 Regulatory Filings
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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.
  1.35 Specifications
 1.36 SPA Territory
 1.37 Term
 1.38 Third Party
 1.39 UNOPROSTONE
 Article 2. General Terms of Manufacturing and Supply
 2.1 Supply.
 a)
    
    be manufactured in accordance and in compliance with Applicable Law, including
cGMP;b)
    
    be manufactured in accordance with the applicable Regulatory Filings and
Regulatory Approvals;c)
    
    upon delivery, not be adulterated or misbranded as defined by Applicable Law;d)
    
    upon delivery, have a minimal [*] months shelf life;e)
    
    be free from defects in materials and workmanship; and
 Page 9 of 37




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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.
 f)
    
    be in compliance with all Specifications for the Drug Product ordered.
 2.2
    
    Cost to Produce.2.2.1
    
    General. RTU, at its sole liability and cost, will provide all labor, utilities,
equipment, personnel, facilities, raw materials, utilities, consumables, disposables and
components necessary for manufacturing, development and implementation of all appropriate
quality control measures, shipping, and storage of the Drug Substance and the Drug Product in
compliance with the Specifications and the warranties contained in Article 9 and the
Regulatory and Legal requirements of Article 7. RTU shall also be responsible for all process
development and scale up. SPA, at its sole expense, will provide all resources necessary to
ship, store, and otherwise handle the Drug Substance and Drug Product in a manner necessary to
meet applicable Regulatory and Legal requirements, after delivery of the Drug Substance and
Drug Product to SPA as described in Article 2.8.2.2.2
    
    Supply of Additional Materials. At RTUs own expense, RTU shall purchase all
Additional Materials (as referred to in the relevant Regulatory Approvals) which are needed
for the manufacture of Drug Substance and/or Drug Products as per the current regulatory
files, under its own liability and costs, from suppliers approved by SPA. If RTU wishes to
change suppliers, this must be approved in advance in writing by SPA, such approval not to be
unreasonably withheld. RTU is responsible for the testing and approval of the Additional
Materials.2.2.3
    
    Novel Drug Product Formulations.The Parties acknowledge that SPA may from time to
time elect to register Unoprotone for additional indications in the SPA Territory that may
require development of a novel formulation as a new form of Drug Product form pursuant to
pre-clinical testing, novel CMC manufacturing and formulation process development, new product
specifications, IND enabled clinical testing and NDA approval and labeling. In the course of
the selection, research and development of new Drug Product formulations, the parties will
collaborate on the development of costs, processes, specifications and facilities that will
optimize the safety, efficacy, cost and utility of any anticipated novel formulation. The
parties shall also agree upon a process and cost improvements
to that process consistent with compliance obligations with Applicable Laws that enable the
most inexpensive, flexible, simplest, shortest and most reliable production process
practicable. In the course of such efforts, the Parties shall reasonably agree upon the
cost estimates for the production of such novel Drug Product dosage forms. Such novel Drug
Product formulation shall become a new supply obligation between the Parties with such
costs, timing and compliance obligations as will fairly compensate both of the Parties for
their respective rights, contributions and efforts and optimize the launch and promotion of
the novel Drug Product.2.2.4
    
    Sufficient Inventories. For the Term, at its own expense, RTU shall maintain
sufficient inventories of Additional Materials required to manufacture the Drug Substance and
such different Drug Product(s) as SPA may register and order from RTU in order to ensure
timely
 
 Page 10 of 37




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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.
 delivery of such amounts of a particular Drug Product in accordance with any issued
order or reasonably anticipated order.2.3
    
    Quality Assurance.2.3.1
    
    General. RTU, at its sole expense, will perform all testing for compliance with the
Specifications and the applicable cGMPs and will supply a chemical Certificate of Analysis
prepared in accordance with cGLP with each batch of Drug Substance and Drug Product and any
other documentation required by Applicable Law. Complete copies of all test results and/or
assays will be submitted to SPA promptly following any reasonable request therefore during the
Term of this Agreement. Should SPA further require a separate Quality Assurance Agreement at
any time during the Term of this Agreement, and give reasonable written notice of such
requirement to RTU, the Parties will negotiate such agreement in good time and in good faith.2.3.2
    
    Non-Conforming Product. SPA will have a period of ten (10) Business Days from the
date of its receipt of a shipment of Drug Substance and Drug Product to inspect and reject
such shipment for non-conformance with the obligations under this Section 2.3.2 and the
warranties of RTU pursuant to Section 9.7 including the Specifications based on SPAs (or SPA
designees) normal incoming-goods inspections procedures, by providing RTU with written notice
of rejection for any Product Defect within such period of ten (10) Business Days together with
samples of the non-conforming or Drug Substance and Drug Products in the relevant shipment for
testing. In the case of Product with Latent Defects, SPA will promptly, and in no event more
than ten (10) Business Days of SPA knowing of any such Latent Defect, notify RTU of such
Latent Defect; provided however, that any Latent Defect must be notified no later than one (1)
month following the expiry date of the applicable Drug Substance and Drug Product, together
with samples of the non-conforming Drug Substance and Drug Products in the relevant shipment
for testing. If RTU determines that such shipment did conform to the warranties of RTU for
product pursuant to Section 9.7, the Parties will submit samples of such shipment to a
mutually acceptable independent laboratory for testing. If such independent laboratory
determines that the shipment conformed to the warranties of RTU for Drug Substance and Drug
Product pursuant to Section 9.7 including the Specifications and was not affected by a
Product or Latent Defect, SPA will bear all expenses of shipping and testing by such
independent laboratory of such shipment samples. If RTU or such independent laboratory
confirms that such shipment did not meet the warranties of RTU for product pursuant to
Section 9.7 including the Specifications, RTU will, as soon as practicable, give SPA a
credit for any amount paid with respect to that portion of the Drug Substance or Drug
Product which does not conform and will bear all of SPAs expenses of returning such Drug
Substance or Drug Product to RTU or its nominee. RTU or SPA, as directed by RTU, will
dispose of any non-conforming portion of any shipment, at RTUs expense. The costs of the
activities of any such independent laboratory will be borne by the Party in error.
 Page 11 of 37




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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.
 2.4 Clinical Order; Supply.
 2.5 Promotional Sample Supply.
 2.6 Commercial Supply; Exclusivity; Forecasting; Order.
 2.7 Placement and Acceptance of an Order.
 2.7.1
    
    Placement. All purchases of Drug Product shall be pursuant to Order(s) placed by
SPA and/or its Affiliates, sublicensees or distributors at least ninety (90) days prior to the
date of which Drug Products shall be delivered to SPA or the applicable Affiliate, sublicensee
or distributor. Each Order hereunder shall specify the desired quantities and formulation of
each of the Drug Product ordered, and the delivery dates therefore.2.7.2
    
    Acceptance. RTU shall have ten (10) Business Days from receipt of an Order from SPA
to reject or propose to modify an Order. If an Order is not rejected or modified it shall be
deemed accepted and RTU shall, subject to the terms and conditions of this Agreement, be
obligated to supply such order in accordance with its terms.
 2.8 Delivery and Acceptance; Risk of Loss.
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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.
  2.9 Inventory.
 2.10. Non-Exclusivity.
 2.11. Performance Issue; Safety Reporting.
 2.12. Product Liability.
 Article 3. Additional Services
 3.1 Laboratory and Regulatory Consulting Services.
 Article 4. Pricing and Payment
 4.1 Clinical Supply Price. Clinical Order; Supply)
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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.
 4.2 Promotional Sample Price. Promotional Sample Supply).
 4.3 Commercial Product Price; Cost of Goods; Royalty; Annual Maintenance.
 4.3.1
    
    Commercial Product shall be supplied pursuant to an Order issued in accordance with Section
2.6 (Commercial Supply; Exclusivity; Forecasting; Order), and shall be priced per Order Year
as follows:
  For bottles [*] ordered by SPA in an 
Order Year
    
    US$[*] per bottle of 5 mL of 0.15%
formulation of Drug Product
(payable in Japanese Yen, converted
at the spot rate at the close of
Business Day in which Order invoice
is paid)For bottles [*] ordered by SPA in an 
Order Year
    
    US$[*] per bottle of 5 mL of 0.15%
formulation of Drug Product
(payable in Japanese Yen, converted
at the spot rate at the close of
Business Day in which Order invoice
is paid)For bottles [*] and over ordered by
SPA in an Order Year
    
    US$[*] per bottle of 5 mL of 0.15%
formulation of Drug Product
(payable in Japanese Yen, converted
at the spot rate at the close of
Business Day in which Order invoice
is paid)
  For bottles [*] ordered by SPA in an 
Order Year
    
    US$[*] per bottle of 5 mL of 0.15%
formulation of Drug Product (payable
in Japanese Yen, converted at the
spot rate at the close of Business
Day in which Order invoice is paid)For bottles [*] and over ordered by
SPA in an Order Year
    
    US$[*] per bottle of 5 mL of 0.15%
formulation of Drug Product (payable
in Japanese Yen, converted at the
spot rate at the close of Business
Day in which Order invoice is paid)
 Payment issued under this Section 4.3.1 shall be considered payment-in-full of all
cost-of-goods plus royalties.4.3.2
    
    SPA shall pay to RTU an Annual Maintenance service fee based on Drug Product Specifications
and Commercial Product Orders as follows:
 Page 14 of 37




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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.
 For bottles [*] ordered by SPA in an 
Order Year
    
    US$[*] (payable in Japanese Yen,
converted at the spot rate at the
close of Business Day in which Order
invoice is paid)For bottles [*] ordered by SPA in an 
Order Year
    
    US$[*] (payable in Japanese Yen,
converted at the spot rate at the
close of Business Day in which Order
invoice is paid)For bottles [*] and over ordered by
SPA in an Order Year
    
    US$[*] (payable in Japanese Yen,
converted at the spot rate at the
close of Business Day in which Order
invoice is paid)
 4.3.3
    
    Notwithstanding the prices in Section 2.5 and herein Section 4.3, in the event of
significant economic changes, including those with regards to the price of Rescula®, the
Parties shall meet and discuss in good faith modifications to the pricing detailed herein in
accordance with Section 13.1 below.
 4.4 Withholding Taxes.
 4.5 Terms of Payment.
 4.6 No Other Compensation.
 Page 15 of 37




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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.
  4.7 Shipping Terms.
 Article 5. Confidentiality and Non-Disclosure
 5.1 Confidentiality.
 5.1.1
    
    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 unauthorized
disclosure of Confidential Information to a Third Party, except as explicitly set forth
herein, without prior, explicit, written consent of the other Party.5.1.2
    
    Exceptions to Confidentiality. The Receiving Partys obligations set forth in this
Agreement shall not extend to any l Information of the Disclosing Party or information
developed in the performance of this Agreement that:
 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 iInformation 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 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
 Page 16 of 37




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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.
 Confidential Information or information
developed in confidence in the performance of this Agreement; ore)
    
    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.5.1.3
    
    Authorized Disclosures. Each Party may disclose Confidential Information and/or
Program Confidential Information 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 Agreementor documents that are the subject of such order be
held in confidence by 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 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 pre-existing requirements of a
major national securities exchange (e.g., U.S. Securities and Exchange Commission), in
the opinion of legal counsel to the Receiving Party,
provided that the Party disclosing such Confidential Information and/or information
developed in confidence in the performance of this Agreement 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
 Page 17 of 37




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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.
 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)
    
    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.
 5.2 Patient Information.
 5.3 Use of Name and Disclosure of Terms. provided provided
 Page 18 of 37




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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.
  Article 6. Intellectual Property Rights
 6.1 Ownership.
 6.1.1
    
    Prior to each transaction hereunder, each Party shall retain all right, title and interest
in its intellectual property, including information, improvements, developments, inventions,
patents, trade secrets and know-how, and Confidential Information.6.1.2
    
    RTU shall retain all rights to and ownership of any data processes, software (including
codes) technology, means and know how developed by RTU.6.1.2
    
    SPA shall retain all rights to and ownership of any data processes, software (including
codes) technology, means and know how developed by SPA
 6.2 Grant of Limited License.
 Article 7. Regulatory and Legal
 7.1 Compliance.
 7.1.1
    
    RTU shall manufacture and package the Drug Substance and Drug Product in compliance with (i)
the Specifications, (ii) cGMP, and (iii) any other requirements set forth in the Regulatory
Approval for the relevant Drug Substance or Drug Product including but not limited to DMF/CMC
package requirements.7.1.2
    
    RTU shall not make any modifications to the manufacturing process, Specifications, suppliers
of Additional Materials specified in the relevant Drug Substance or Drug Product dossier,
testing and control methods, or sampling procedures for the Drug Substance or Drug Products,
without obtaining SPAs prior written consent, then, where relevant, the authorization of the
Regulatory Authorityand other competent government agencies, based on a dossier to be
submitted by SPA and prepared with the assistance of RTU. SPA may make any modifications to
the Specifications upon prior written notification and in accordance with the relevant
Regulatory Approvals subject that RTU may request SPA to compensate in cash for any additional
works and services to be done by RTU to accommodate such modifications.7.1.3
    
    RTU assumes any and all responsibility to make changes required by any Regulatory Authority
following Effective Date to the manufacturing processes, test methods, etc. that would be
 Page 19 of 37




---



##### 



[*] = 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.
 required for the manufacture of products at that location, not specific to the Drug Substance
or Drug Product, and will solely bear all expenses related thereto (Required Manufacturing
Changes). For changes to the Specifications that are not Required Manufacturing Changes,
including but not limited to reformulations of the Drug Substance or Drug Product, addition of
new strengths to the Drug Substance or Drug Product, new formulations, presentations and
formats of the Product and changes to labeling and packaging (collectively Discretionary
Manufacturing Changes), RTU and SPA must each agree to any Discretionary Manufacturing Change
and will, to the extent commercially reasonable under the circumstances, cooperate in making
such changes, and each agrees that it will not unreasonably withhold or delay its consent to
such Discretionary Manufacturing Changes proposed by the other Party. SPA or RTU, as the case
may be, shall be deemed to have reasonably withheld consent to a proposed change if such
change will result in a material disruption of the supply of the Drug Substance or Drug
Product or have a material adverse impact on pending, existing or reasonably anticipated
Regulatory Filings or Regulatory Approvals of the Drug Substance or Drug Product. RTU, or SPA
as the case may be, shall use commercially reasonable efforts to ensure that any regulatory or
manufacturing change will not result in a material disruption of the supply of the Drug
Substance or Drug Product. Notwithstanding the foregoing, RTUs standard change control
procedures will
be utilized in reviewing such changes. Notwithstanding the foregoing, all reasonable
internal and external costs, associated with the Required Manufacturing Changes will be
borne by RTU and all reasonable internal and external costs associated with Discretionary
Manufacturing Changes will be borne by the Party requesting the change.
 7.2 Records.
 7.3 Authorization of the Manufacturing Facility by FDA.
 Page 20 of 37




---



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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.
 7.4 Testing and Release.
 7.5 Audits.
 7.5.1
    
    Regulatory Audit. RTU shall make its facilities, records and personnel available to
any other Regulatory Authority as may be needed for compliance with the Applicable Laws
enforced by such authority. RTU shall advise SPA in writing immediately if:
 a)
    
    an agent of any Regulatory Authority having jurisdiction over the manufacture
or distribution of the Drug Substance or Drug Product in the SPA Territory (i) makes an
inquiry about the Drug Substance or Drug Product or (ii) visits RTUs manufacturing
facility for the manufacture,
storage or distribution of Drug Substance or Drug Product, and shall specify what,
if any, inquiry was made; orb)
    
    any Regulatory Authority takes action against RTU on any issue related directly
or indirectly to the manufacturing or distribution of the Drug Substance or Drug
Product.
 7.5.2
    
    SPA Audit. At no additional charge by RTU to SPA or any other charges by RTU
outside of the Annual Maintenance fee, SPA may conduct audits or inspections of the Drug
Substance and Drug Product production, storage and distribution sites. SPA and its designated
representatives shall have the right to inspect the Drug Substance and Drug Product, work in
process, Additional Materials, inventories, premises, documentation, manufacturing methods,
testing and packaging procedures associated with the manufacture of the Drug Substance and
Drug Products at all reasonable intervals not more than once each calendar year during RTUs
normal business hours, but provided that follow up inspections will be permitted to assure .
 7.6 DMF/CMC Package.
 7.7 Import/Export.
 Article 8. Representations and Warranties of SPA
 Page 21 of 37




---



##### 



[*] = 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.
 8.1 Organization.
 8.2. Authority.
 8.3. No Conflicts.
 8.4. Insurance.
 8.5. Obligations of Confidentiality.
 Article 9. Representations and Warranties of RTU
 9.1 Organization.
 9.2. Authority.
 9.3. No Conflicts.
 9.4 Qualified Personnel.
 Page 22 of 37




---



##### 



[*] = 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.
 9.5 Regulatory and Legal Compliance.
 9.6 Obligations of Confidentiality.
 9.7 Process and Product Warranties.
 a)
    
    Drug Substance or Drug Product sold by RTU to SPA hereunder shall (i)
materially comply with the Specifications for Drug Substance or Drug Product, and (ii)
materially conform with the information shown on the Certificate of Analysis provided
for the particular shipment;b)
    
    no Drug Substance or Drug Product sold by RTU to SPA hereunder shall be
adulterated or misbranded within the meaning of the United States Food, Drug, and
Cosmetic Act and implementing regulations, as amended and in effect at the time of
shipment and foreign equivalents of such law in the SPA Territory (the Act), or
within the meaning of any state or municipal laws in the United States applicable to
the Drug Product and containing terms with substantially similar meanings as the
meaning of adulteration or misbranding under the Act and foreign equivalents of such
law in the SPA Territory; provided, however, that this paragraph shall not apply to,
and RTU shall have no responsibility for, misbranding caused directly by SPA as a
result of labels or package texts specified or provided by SPA for the Drug Product;
and RTU shall have no responsibility for issues of regulatory and legal compliance that
are the responsibility of SPA, including but not limited to (1) maintaining a complete
and valid NDA for the product, (2) ensuring that the product specifications are
consistent with the NDA, and (3) ensuring that the product is stored and distributed in
the SPA Territory in a manner that does not result in its becoming adulterated,
misbranded, or otherwise in violation of Applicable Law.
 9.8 Continuity of Supply.
 Page 23 of 37




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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.
 Article 10. Indemnification; Insurance
 10.1 Indemnification by SPA. RTU
Indemnitees Third Party Claim
 10.1.1
    
    improper storage or handling of the Unoprostone or the Drug Substance or Drug Product by SPA
or its Affiliates or sublicensees;10.1.2
    
    any personal injury and/or product liability arising from SPAs failure to warn of aspects
of the lack of inherent safety of the Licensed Products.10.1.3
    
    SPAs negligence or willful misconduct in regard to its performance, or non-performance,
under this Agreement; or10.1.4
    
    a breach of any of SPAs representations or warranties hereunder;except, in each case, to the extent that such Third Party Claim arises out of or results
from the gross negligence or willful misconduct of any RTU Indemnitee.
 10.2 Indemnification by RTU. SPA
Indemnitees"
 10.2.1
    
    improper storage, handling, manufacturing, formulation or contamination of the Unoprostone
or the Drug Substance or Drug Product by RTU or its Affiliates;10.2.2
    
    Infringement of Third Party intellectual property rights by the Drug Substance or Drug
Products or any Licensed Patents;10.2.3
    
    failure by RTU or any Affiliate or subcontractor of RTU to supply Drug Substance or Drug
Product in accordance with the Specifications and Applicable Law;10.2.4
    
    any product liability claims arising from quality defect of the Product or failure to warn
of an inherent lack of safety of the Drug Substance or Drug Product;10.2.5
    
    non-conforming product per Section 2.3.2;10.2.6
    
    RTUs and/or its subcontractors negligence or willful misconduct in regard to its
performance, or non-performance, under this Agreement; or10.2.7
    
    a breach of any of RTUs representations or warranties hereunder;
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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.
 
 except, in each case, to the extent that such Third Party Claim arises out of or results
from the gross negligence or willful misconduct of any SPA Indemnitee.
 10.3 Procedures for Indemnification.
 10.3.1
    
    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.10.3.2
    
    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 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.10.3.3
    
    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; andc)
    
    except as expressly provided in Section 14.3.4, 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
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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.
 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.
 10.3.4
    
    Right to Participate in the Defense. Without limiting Section 14.3.2 or Section
14.3.3, 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 14.3.2 (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.10.3.5
    
    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;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; andd)
    
    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 10.3.2, 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
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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.
 
 discharge, any Third Party Claim without the prior written consent of the indemnifying
Party, such consent not to be unreasonably withheld, conditioned or delayed.10.3.6
    
    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.
 10.4 Insurance.
 Article 11. Term and Termination
 11.1
    
    Term.The Term for this Agreement shall be as follows: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 consideration; OR
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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.
 
 11.1.2
    
    With respect to each Drug Substance or Drug 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 Drug Substance or Drug Product, or
(iii) the loss of Data Exclusivity with respect to such Drug Substance or Drug Product. If
this Agreement expires (i.e., not terminated pursuant to Section 11.2.1, 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 Drug 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 Article 12
(Dispute Resolution), and that there shall only be a limited right to terminate this Agreement
as a matter of last resort. If, 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 Article 12 (Dispute Resolution), in accordance with the procedures set forth in
Article 12, 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 Drug Substance or Drug Product(s) to which such
breach relates to 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.
 
 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;; andb)
    
    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 Drug Substance or Drug 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
relief against SPA 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 Drug Substance or Drug Product Withdrawal or Material Adverse Event.
In the event the Drug Substance or Drug Product is withdrawn from the market by a Regulatory
Authority in any country in the 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.
 11.3.1
    
    the licenses granted by RTU to SPA under this Agreement shall terminate;11.3.2
    
    with respect to all Clinical Studies or post approval studies for any Drug Substance or Drug
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 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
Confidential Information.
 
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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.
 
 11.4 Consequences of Termination of Agreement with respect to a Drug Substance or Drug Product.
  11.4.1
    
    the licenses granted by RTU to SPA under this Agreement shall terminate with respect to such
terminated Drug Substance or Drug Product(s);11.4.2
    
    with respect to all Clinical Studies or post approval studies for such terminated Drug
Substance or Drug 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.
 11.6 Continued Obligations.
 Article 12. Dispute Resolution
 12.1
    
    Negotiation and Arbitration.
 12.1.1
    
    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.
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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.
 
 12.1.2
    
    Arbitration. Any dispute, controversy or claim that arises out of or relates to
this Agreement that is not resolved under Section 12.1.1 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 12.1.3 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 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.12.1.3
    
    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:
 a)
    
    The arbitrators may not award or assess punitive damages against either Party; andb)
    
    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.
 Article 13. Miscellaneous
 13.1
    
    Changed Circumstances; Equitable Relief.13.1.1
    
    The Parties recognize that the obligations of this Agreement may run for many years in the
future. In the event of any material change in circumstances, the parties shall meet and
confer in good faith in order to try and find a solution that equitably accommodates the
interests of both parties. RTU acknowledges that SPA will enter into one or more agreements
with Third Parties for the purpose of commercial sale of UNOPROSTONE in the SPA Territory, and
in the event that such Third Parties raise concerns or place demands on SPA concerning matters
pertaining to this Agreement, RTU shall work with SPA to resolve such concerns or demands,
including amending this Agreement, as may be commercially appropriate or necessary. SPA
acknowledges that RTU will enter into agreements with Third Parties for the purpose of
procuring various materials necessary for RTU to manufacture and supply UNOPROSTONE hereunder,
and in the event that such Third Parties raise concerns or place demands on RTU that will
result in increase of manufacturing costs, SPA shall work with RTU to resolve such concerns or
demands, including amending this Agreement, as may be commercially appropriate or necessary.
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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.
 13.1.2
    
    The Parties acknowledge and agree that the restrictions set forth in Article 5
(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 5 (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 5 (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.
 13.2. Subcontracting.
 13.3. Entire Agreement; Binding Effect.
 13.3.1
    
    This Agreement and the Unoprostone License 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 the event of any inconsistency between any such Exhibits and this
Agreement, the terms of this Agreement shall govern.13.3.2
    
    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.
 13.4. Relationship of Parties.
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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.
  13.5. Assignment and Successors.
 13.6. Governing Law.
 13.7.
    
    Notices.13.7.1
    
    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 15.2.2 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
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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.
 
 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.13.7.2
    
    Addresses for Notice.
 For SPA:
    
    Sucampo Pharma Americas Inc.4520 East West Highway3rd FloorBethesda, MD 20814USAAttention: Legal DepartmentFax: 301 961 3440For RTU:
    
    R-Tech Ueno, Ltd.4-1, Techno-ParkSanda, Hyogo, 669-1339JapanAttention: Mr. Ryu HirataFacsimile Number: 81-795-60-7180
 13.8. Severability.
 13.9. Amendment; Waiver.
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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.
  13.10.
    
    Headings; References; Interpretation.13.10.1
    
    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.13.10.2
    
    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.
 13.11 No Third Party Beneficiaries. Indemnification by SPA)
 13.12 Counterparts.
 13.13 Force Majeure. Force Majeure"
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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.
  13.14 Expenses.
 13.15 Further Assurances.
 IN WITNESS WHEREOF
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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.
   Signature:
    
    /s/ Gayle Dolecek
      Signature:
    
    /s/ Yukiko Hashitera
    Page 37 of 37




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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.
  CONFIDENTIAL
    
    Unoprostone Manuf. & Supply Agreement
 Exhibit A
 Specifications   Specification of Unoprostone Isopropyl Drug Substance
 Test Items
    
    Acceptance Criteria[*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*]
 1/2




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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.
  CONFIDENTIAL
    
    Unoprostone Manuf. & Supply Agreement
 Specifications for Unoprostone isopropyl ophthalmic solution 0.15%
 Test Items
    
    Acceptance Criteria[*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*]
 Quantitative Composition of Unoprostone Isopropyl Ophthalmic Solution 0.15%
 RAW MATERIAL
    
    FORMULA (mg/mL)[*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*][*]
    
    [*]
 2/2