EXHIBIT 10.2


 





LICENSE, DEVELOPMENT, COMMERCIALIZATION
AND SUPPLY AGREEMENT

FOR LUBIPROSTONE FOR PEOPLE’S REPUBLIC OF CHINA


 


 


 


by and between:


 


 


Harbin Gloria Pharmaceuticals Co.,
Ltd.






 


 


and






 


 


SUCAMPO AG






 


 


 


 


 


 


 


 


 


 


 


Dated as of 5th May, 2015


 


 





	May 4, 2015	Confidential



 



    	 



    	 



    








LICENSE, DEVELOPMENT, COMMERCIALIZATION
AND SUPPLY AGREEMENT

FOR LUBIPROSTONE FOR PEOPLE’S REPUBLIC OF CHINA


 


 


This LICENSE, DEVELOPMENT,
COMMERCIALIZATION, AND SUPPLY AGREEMENT FOR LUBIPROSTONE FOR PEOPLE’S REPUBLIC OF CHINA (“Agreement”)
is entered into as of May 5, 2015, by and between Sucampo AG, a corporation organized under the laws of Switzerland with principal
offices at Baarerstrasse 22, CH-6300, Zug, Switzerland (“Sucampo”) and Harbin Gloria Pharmaceuticals Co., Ltd.
("Gloria"), a corporation organized under the laws of Peoples Republic of China with principal offices at #28 Ronghui
Garden, Yuhua Road, Konggang Airport Development Zone B, Shunyi District, Beijing 101318, People’s Republic of China (“Gloria”).
Each of Gloria and Sucampo is sometimes referred to individually herein as a “Party” and collectively as the
“Parties”.


 


BACKGROUND


 


WHEREAS, Sucampo has
rights in the Sucampo Patents Rights and the Sucampo Background Technology related to the Product and is in the process of Developing
the Product in the Field in the Territory (as such terms are hereinafter defined);


 


WHEREAS, Gloria is
a healthcare company with research, development and marketing activities in the People’s Republic of China; and


 


WHEREAS, Gloria desires
to obtain an exclusive (except to Sucampo and its Affiliates) license to Develop the Product in the Field in the Territory and
an exclusive license to Promote and Commercialize the Product in the Field in the Territory (as such terms are hereinafter defined).


 


NOW, THEREFORE, in
consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties hereto, intending to be legally bound, hereby agree as follows:


 


ARTICLE 1

DEFINITIONS


 


 


Whenever used in this
Agreement with an initial capital letter, the terms defined in this ARTICLE 1 shall have the meanings specified below:



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“Additional
Materials” means all raw materials, resins, chemical intermediates, components, excipients, and other ingredients and
packaging materials and supplies, including Product Labels and Inserts, needed to manufacture the Product for use in the Field
in the Territory, including costs for relevant in-bound freight.


 


“Adverse Event”
means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and
which does not necessarily have to have a causal relationship with treatment. An adverse event 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 medicinal product, whether or not considered related to the medicinal product. In addition to the foregoing, in the context
of Clinical Studies, an Adverse Event will also mean events associated with and/or possibly attributable to the Clinical Studies
or Clinical Study procedures. For the avoidance of doubt, an “Adverse Event” includes all occurrences which would be
regarded as “adverse drug reactions” under Applicable Law in the Territory.


 


“Affiliate”
means, with 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 (a) 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 interests in the case of any other type of legal entity, (b) status as a general partner
in any partnership, or (c) any other arrangement whereby a Person controls or has the right to control the Board of Directors or
equivalent governing body of a corporation or other entity.


 


“Agreement”
means this License, Development, Commercialization and Supply Agreement for Lubiprostone for People’s Republic of China,
including all Exhibits hereto, as may be amended from time to time in accordance with its terms.


 


“Applicable
Law” means all federal, state, local, national and supra-national laws, statutes, rules and regulations, including any
rules, regulations, or requirements of Regulatory Authorities, major national securities exchanges or major securities listing
organizations, that may be in effect from time to time during the Term and applicable to a particular activity or exercise of rights
hereunder.


 


“Audited Party”
has the meaning set forth in Section 8.7.


 


“Auditing
Party” has the meaning set forth in Section 8.7.


 


“Business
Day” means a day, other than a Saturday or Sunday, on which banking institutions in both the United States and China
are open for business.


 



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“Calendar
Year” means each successive period of twelve (12) consecutive calendar months commencing on January 1 and ending on December
31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31, 2015, and the
last Calendar Year of the Term shall commence on January 1 of the Calendar Year in which the Term ends and end on the last day
of the Term.


 


“cGCP”
means the then current Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording,
analysis, and reporting of clinical trials for pharmaceuticals as set forth in the International Conference on Harmonization (ICH)
guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” and equivalent regulations
or standards in the Territory and any update thereto and any other policies or guidelines applicable to the design, conduct, performance,
monitoring, auditing, recording, analysis, and reporting of clinical trials for pharmaceuticals in the Territory, and/or any applicable
foreign equivalents thereof, and any updates of any of the foregoing.


 


“cGMP”
means the quality systems and current good manufacturing practices applicable to the manufacture, labeling, packaging, handling,
storage, and transport of the Compound, the Additional Materials and the Product, as set forth in the Good Manufacturing Practices
for Pharmaceutical Products and any update thereto and any other policies or guidelines applicable to the manufacture, labeling,
packaging, handling, storage, and transport of pharmaceutical products in the Territory, and/or any applicable foreign equivalents
thereof, and any updates of any of the foregoing.


 


“CFDA”
means the China Food and Drug Administration and any successor thereto.


 


“CGAAP”
means the then-current Chinese accounting standards and generally accepted accounting principles in effect in the People's Republic
of China.


 


“Clinical
Data” means all data with respect to any product containing the Compound for use in the Field that is made, collected
or otherwise generated anywhere in the world under or in connection with the Clinical Studies for a product containing the Compound
for use in the Field (as opposed to Pre-Clinical Data or non-clinical data derived from laboratory studies, disease models and
animal studies). Clinical Data includes, but is not limited to, validated clinical databases.


 


“Clinical
Study(ies)” means Phase I Study, Phase II Study, Phase III Study, Phase IV Study conducted anywhere in the world, or
such other tests or studies in humans conducted anywhere in the world, that are required by Applicable Law, or otherwise recommended
by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for the Product in the Field in the Territory, but excluding
Post-Approval Marketing Studies.


 



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“CMC Data”
means the data contained in the chemistry, manufacturing and controls section of a submission for Regulatory Approval of the Product
in the Field in the Territory.


 


“Commercialization”
or “Commercialize” means any and all activities (whether before or after Regulatory Approval) directed to the
commercialization of the Product in the Field in the Territory, including pre-launch and post-launch marketing, Promoting, distributing,
offering to sell and selling the Product in the Field in the Territory. For purposes of this Agreement, “Commercialization”
shall not include activities constituting manufacturing and supply under this Agreement. When used as a verb, “Commercializing”
means to engage in Commercialization and “Commercialized” has a corresponding meaning.


 


“Commercialization
Plan” means a written one (1) year plan prepared by Gloria and approved by the JCC in accordance with Section 3.1.3 for
the Commercialization of the Product in the Field in the Territory, including, without limitation, a budget for such activities,
as such plan may be amended or updated from time to time in accordance with Section 7.1.


 


“Commercially
Reasonable Efforts” means, with respect to activities of each Party contemplated by this Agreement, the level of effort
commonly used in the pharmaceutical industry to conduct development, promotion or commercialization activities for a product that
is at a similar stage in its lifecycle and is of comparable market potential, profit potential and strategic value, taking into
account relevant considerations, including issues of safety (including Adverse Events) and efficacy, product profile, the proprietary
position, the then-current competitive environment for such product, the likely timing of the product’s entry into the market,
the then-current market penetration, the return on investment potential of such product, the regulatory environment and status
of the product, and other relevant scientific, technical and commercial factors, in each case in a manner consistent with the level
of effort and expenditure contemplated for such activities by the Development Plan or the Commercialization Plan, as the case may
be, and as measured by the facts and circumstances at the time such efforts are due. Without limiting the foregoing, Commercially
Reasonable Efforts requires that a Party: (i) timely assign responsibility for such Development, Promotion and Commercialization
activities to specific employees, contractors, agents, Affiliates or other Sublicensees, as applicable, who are held accountable
for progress with respect to such activities, (ii) monitor such progress on an on-going basis, (iii) set and seek to achieve objectives
and timelines for carrying out such Development, Promotion and Commercialization activities in accordance with the Development
Plan or the Commercialization Plan, as the case may be, and (iv) allocate resources designed to advance progress with respect to
such objectives and timelines.


 


“Committee(s)”
has the meaning set forth in Section 3.1.1. Each of the JDC, JCC and JSC is sometimes referred to individually herein as a “Committee”
and collectively as the “Committees.”


 



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“Competing
Product” has the meaning set forth in Section 7.8.





 


“Compound”
means lubiprostone (also known by the tradename AMITIZA®) as further described in Exhibit A, and its salts, metabolites, as
well as any active pro-drugs, isomers, tautomers, hydrates and polymorphs.


 


“Confidential
Information” means any and all confidential or proprietary information or material, whether oral, visual, in writing
or in any other form, that, at any time since January 1, 2014, has been or is provided, communicated or otherwise made known directly
or indirectly to the Receiving Party or any of its Affiliates by or on behalf of the Disclosing Party or any of its Affiliates
pursuant to this Agreement or in connection with the transactions contemplated hereby or any discussions or negotiations with respect
thereto, including pursuant to the Confidentiality Agreement and that may be reasonably understood from notices or legends, the
nature of such information itself or the circumstances of such information or materials’ disclosure to be confidential or
proprietary to the Disclosing Party. For the avoidance of doubt, “Confidential Information” of Sucampo shall include,
without limitation, the Sucampo Other Intellectual Property Rights, Sucampo Background Technology, any Pre-Clinical Data, Clinical
Data, CMC Data and other data, content, know-how, unpublished patent applications (including without limitation any patent applications
included as part of the Sucampo Patent Rights) and Technology and all other information and materials, disclosed or made available
by or for Sucampo to Gloria and its Affiliates that relate to Sucampo’s research, clinical development, non-clinical development,
marketing, sales and promotion (including, without limitation, financial information, procurement requirements, purchasing and
manufacturing information, customer lists and other customer-related information, business forecasts and sales, pricing information,
detailing-related information, and marketing and merchandising plans and information), or other aspects of Sucampo’s business.


 


“Confidentiality
Agreement” means the Confidentiality Agreement by and between Harbin Gloria Pharmaceutical Co., Ltd. and Sucampo, effective
as of February24, 2015, as amended.


 


“Control”
or “Controlled” means, with respect to any Technology, Patent Right, Other Intellectual Property Rights or Regulatory
Filing, possession of the unconditional right, through the ownership or the right to grant a license or sublicense, in each of
the foregoing cases, without giving rise to any obligation, including without limitation the obligation to pay any royalties or
other amounts to a Third Party, including but not limited to an employee or contractor of Sucampo or its Affiliates and without
violating the terms of any agreement or other arrangement with any Third Party.


 



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“Core Data
Sheets” means a document prepared by the Regulatory Approval holder containing, in addition to the Company Core Safety
Information (CCSI), material relating to the indications, dosing, pharmacokinetics, and other information on the Product for use
in the Field in the Territory based on scientific data that are positioned on appropriate prescribing information for safe and
effective use of the Product in the Field in the Territory.


 


“Corporate
Names” means (a) in the case of Gloria, the Trademark Gloria and the Gloria corporate logo or such other names and Trademarks
used generally by Gloria and its Affiliates in their business (and not relating to a specific product or Technology) as Gloria
may designate in writing from time to time, and (b) in the case of Sucampo, the Trademark Sucampo and the Sucampo corporate logo
or such other names and Trademarks used generally by Sucampo and its Affiliates in its business (and not relating to a specific
product or Technology), together with any variations and derivatives thereof.


 


“CTN”
means an application filed with a Regulatory Authority for authorization to commence human clinical trials of the Compound, including
(a) an application made to the CFDA, and (b) all supplements and amendments that may be filed with respect to the foregoing.


 


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


 


“Development”
or “Develop” means, with respect to the Product in the Field in the Territory, all research, all pre-clinical
and clinical activities conducted relating to the Product in the Field in the Territory, 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
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, Product regulatory documentation and other
Technology with respect to the foregoing, the preparation of Regulatory Filings, and obtaining and/ or maintaining Regulatory Approvals
for the Product in the Field in the Territory (including regulatory affairs activities and preparation of meetings with Regulatory
Authorities in the Territory). When used as a verb, “Developing” means to engage in Development and “Developed”
has a corresponding meaning.


 


“Development
Plan” means a written rolling three (3) year plan for the Development of the Product in the Field in the Territory, as
such plan may be amended or updated from time to time in accordance with Section 4.1.2.






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“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.


 


“Disputes”
means all disputes, differences, controversies or claims (whether based on contract, tort, statutory concepts, or any other legal
doctrine) arising out of, in connection with, or relating to this Agreement (including without limitation the existence, validity,
interpretation, performance, amendment, breach, default, or termination of this or the subject matter of this Agreement).


 


“Disputed
Matter” has the meaning set forth in Section 3.1.6.


 


“Distributor”
means any Third Party appointed by Gloria to distribute and sell in the Field in the Territory the Product purchased from Gloria,
its Affiliates or other Sublicensees (regardless of whether such Third Party has the right or obligation to provide packaging or
labeling services with respect to such Product) that: (i) is not required to make royalty or other similar payment to Gloria
with respect to any Sucampo Patent Rights, Sucampo Other Intellectual Property Rights, or Sucampo Background Technology related
to the Product in the Field in the Territory; and (ii) has no right to distribute and sell such Product under its own Trademark
and is only distributing and selling such Product for the benefit and account of Gloria.


 


“Drug Approval
Application” means an application submitted to a Regulatory Authority for Regulatory Approval for the Product in the
Field in the Territory, and all supplements and amendments that may be filed with respect to the foregoing.


 


“Effective
Date” means the date first set forth in the preamble to this Agreement.


 


“Field”
means the use of 8mcg and 24 mcg of the Product in soft gelatin capsule form for all prophylactic and therapeutic uses in animals
and humans.


 


“First Commercial
Sale” means the first bona fide commercial sale of the Product for use or consumption in the Field in the Territory by
Gloria, its Affiliates or Sublicensees to a Third Party in the Territory after all required applicable Regulatory Approvals have
been granted.


 


“Force Majeure”
has the meaning set forth in Section 15.10.


 


“Cumulative
Sales Volume Target” means [...***...] capsules of Product in the Field in the Territory within the first to
occur of (i) the first [...***...] months following the


 


*Confidential
Treatment Requested






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[...***...] of the [...***...] in the [...***...] in the [...***...]
and (ii) the first [...***...] months following the [...***...] the [...***...] is [...***...]
on the [...***...], in each case based on the assumptions listed in Exhibit J. The Cumulative Sales Volume Target shall
be adjusted upward or downward, as the case may be, by the Parties in the event any of the facts differ from the assumptions listed
in Exhibit J.


 


“Generic Product”
means, with respect to a Product, a pharmaceutical product in the Field in the Territory, other than a product that is developed,
marketed or sold by a Party or its Affiliates or other Sublicensees or a Third Party authorized or licensed by such Party to Develop
or Commercialize the Product in the Field in the Territory, that contains the Compound as its main or only active ingredient during
a period of time when the Product does not have, or loses its marketing exclusivity in the Field in the Territory (whether due
to failure to obtain patent protection or expiration, invalidity of enforceability of the Sucampo Patent Rights, loss or expiration
of any marketing exclusivity conferred by the Regulatory Authority in the Territory or other cause).


 


“Indemnification
Claim Notice” has the meaning set forth in Section14.2.3.


 


“Indemnitee”
means any Sucampo Indemnitees or Gloria Indemnitees claiming indemnification under Sections 14.1 or 14.2, as applicable.


 


“Infringement”
has the meaning set forth in Section 11.5.1.


 


“Infringement
Notice” has the meaning set forth in Section 11.5.1.


 


“Invoice Price”
means the Supply Price for Product in the Field in the Territory.


 


“JCC”
has the meaning set forth in Section 3.1.1(b).


 


“JDC”
has the meaning set forth in Section 3.1.1(c).


 


“Jointly Developed
Technology” shall mean any Sucampo Developed Technology that is conceived, created, developed or otherwise reduced to
practice jointly by Sucampo and Gloria.


 


“JSC”
has the meaning set forth in Section 3.1.1(a).


 


“Latent Defect”
means Product in the Field in the Territory not conforming to Sucampo’s warranty for such Product set forth in Section 9.1.2
such that (i) the related non-conformance of such Product is not readily discoverable or not reasonably expected to


 


*Confidential
Treatment Requested



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be readily discoverable based on Gloria’s, its Affiliates’ or other Sublicensees’
normal and commercially reasonable incoming-goods inspections, as the case may be and (ii) the related non-conformance was caused
by Sucampo.


 


“Losses”
has the meaning set forth in Section 14.1.


 


“Market Withdrawal”
means the removal or correction of a Product in the Field in the Territory which involves a minor violation that would not be subject
to legal action by the applicable Regulatory Authority or which involves no violation, including without limitation, normal stock
rotation practices, routine equipment adjustments and repairs.


 


“NDRC Price”
means the National Development and Reform Commission -approved price for the Product in the Field in the Territory.


 


“Other Formulation(s)
or Dosage(s)” means other formulations or dosage forms of the Product, including but not limited to liquid formulation
or pediatric dosage in the Territory.


 


“Other Intellectual
Property Rights” means (a) any copyrights, copyright registrations, copyright rights, moral rights and similar rights
(including, without limitation, the foregoing with respect to computer software, firmware, programming tools, drawings, specifications,
databases and documentation) and (b) any rights, title and interests in all trade secrets and trade secret rights arising under
national or local law, common law, state law, federal law or laws of foreign countries.


 


“Party”
means each of Gloria or Sucampo individually; Gloria and Sucampo are collectively referred to herein as “Parties”,
as identified in the preamble to this Agreement.


 


“Patent Defect”
means Product in the Field in the Territory not conforming to Sucampo’s warranty for such Product set forth in Section 9.1.2
such that the related non-conformance of such Product may be readily discovered or should be reasonably expected to be readily
discoverable based on Gloria’s, its Affiliates’ or other Sublicensees’ normal and commercially reasonable incoming-goods
inspections procedures, as the case may be.


 


“Patent Rights”
means the rights and interests in and to all patents and patent applications in the People’s Republic of China, including
provisional applications, divisional applications, continuation applications, continuation-in-part applications, continued prosecution
applications, certificate of inventions, extensions or restorations, including adjustments, revalidations, reissues, re-examinations,
patent term extensions, supplementary protection certificates and any similar rights, including so-called pipeline protection rights,
introduction patents, registration patents and patents of addition of any foregoing patents and patent applications.


 



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“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.


 


“Pharmacovigilance
Agreement” has the meaning set forth in Section 6.4.


 


“Phase I Study”
means a human clinical trial of a product containing the Compound, 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.


 


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


 


“Phase IIa
Study” means a human clinical trial of a product containing the Compound, 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.


 


“Phase IIb
Study” means a human clinical trial of a product containing the Compound, the principal purpose of which is to find the
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.


 


“Phase III
Study” means a human clinical trial of a product containing the Compound 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.


 


“Phase IV
Study” means a human clinical trial of a product containing the Compound that is not included in the original Drug Approval
Application submission for the Product for an indication, including studies conducted to fulfill commitments made as a condition
of the Regulatory Approval of the Drug Approval Application or any subsequent human clinical trials requested, required or recommended
by the Regulatory Authority(ies) in the Territory as a condition of maintaining such Regulatory Approval.


 


“Post-Approval
Marketing Studies” means a human clinical trial or other test or study with respect to the Product for use in the Field
in the Territory, which test or study is conducted on a voluntary basis by a Party (rather than under a mandate from a Regulatory
Authority in the Territory in order to obtain or maintain Regulatory Approval for the Product in the Field in the Territory) after
the Drug Approval Application for the Product in the Field in the Territory has been approved by the Regulatory Authority in the
Territory. Any human clinical study that is intended to expand the label for the Product for use in the Field in the Territory
shall be a Clinical Study. Subject to the foregoing, Post-Approval Marketing Studies may include clinical studies conducted in
support of pricing or reimbursement for the Product in the Field in the Territory, epidemiological studies, modeling and pharmacoeconomic
studies, post-marketing studies, investigator sponsored studies, and health economic studies.


 



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“Pre-Clinical
Data” means data derived from a study to test the Compound for use in the Field, including, but not limited to, laboratory
studies, toxicology, safety pharmacology, disease models and animal models.


 


“Pricing Approval”
means any and all pricing or reimbursement approvals, licenses, registrations, or authorizations of any Regulatory Authority necessary
to Promote and Commercialize the Product in the Field in the Territory.


 


“Product”
means any product (including any form or dosage form of a pharmaceutical composition or preparation) in finished form labeled and
packaged for (i) sale, (ii) distribution, or (iii) samples, comprising the Compound (whether as sole active ingredient or in combination
with one or more other active ingredients), including all future formulations, dosage forms and delivery modes. The term “Product”
or “the Product” as used herein may be used to reference one or more than one Product(s).


 


“Product Labels
and Inserts” means (a) any display of written, printed or graphic matter upon the immediate container, outside container,
wrapper or other packaging of the Product for use in the Field in the Territory or (b) any written, printed or graphic material
on or within the package from which the Product for use in the Field in the Territory is to be dispensed.


 


“Product Trademark”
means (i) the Trademark AMITIZA, (ii) the Trademarks listed on Exhibit C, (iii) in the event the Trademark AMITIZA or any
other trademarks listed in Exhibit C have not been registered to Sucampo at least one (1) year prior to the date of the estimated
launch of the Product in the Field in the Territory or the Regulatory Authorities in the Territory do not approve that the Product
uses the Trademark AMITIZA or any other Trademarks listed in Exhibit C, then any other Trademarks for Promoting or Commercializing
the Product in the Field in the Territory as designated by Sucampo in advance and in writing in its sole discretion and (iv) any
current or future modifications or variances of the foregoing Trademarks, but excluding the Corporate Names, that are designated
by Sucampo in advance and in writing to be used for Promoting or Commercializing the Product in the Field in the Territory.


 



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“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.


 


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


 


“Publication
Policies” has the meaning set forth in Section 10.3.2.


 


“Quality Agreement”
means the agreement to be entered into between Gloria and Sucampo, under which the Parties shall address Product quality issues,
including without limitation to assure the Product in the Field in the Territory is manufactured and packaged according to all
Applicable Laws in the Territory.


 


“Recall”
means a “recall” as such term is defined in the Administrative Measures for Drug Recalls (as amended from time to time,
or such successor Applicable Law as may take effect in the Territory) of the Product for use in the Field in the Territory, or
similar events.


 


“Receiving
Party” means the Party receiving Confidential Information; provided that 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.


 


“Regulatory
Approval” means any and all approvals, licenses (including product and establishment licenses), permits, certifications,
registrations, or authorizations of any Regulatory Authority necessary to Develop, manufacture, Promote, distribute, transport,
store, use, sell, import, export or otherwise Commercialize the Product for use in the Field in the Territory, including all CTNs,
Drug Approval Applications and the manufacturing license and marketing registration required under the Measures for the Administration
of Drug Registration in People’s Republic of China, or any update thereto, and Pricing Approvals, or pre- and Post-Approval
Marketing Studies, labeling approvals, technical, medical and scientific licenses.


 



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“Regulatory
Authority” means any national, supra-national, regional, federal, state, provincial or local regulatory agency, department,
bureau, commission, council or other governmental entity (including, without limitation, the CFDA, the Ministry of Human Resources
and Social Security, and any governmental unit having jurisdiction over the Development, Commercialization, manufacture, importation
of the Product in the Field in the Territory).


 


“Regulatory
Filings” means, with respect to the Product in the Field in the Territory, all applications, registrations, submissions,
dossiers, notifications, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted
to or received from the Regulatory Authorities (including minutes and official contract reports relating to any communications
with any Regulatory Authority) and all supporting documents and all Pre-Clinical Data, Clinical Data and CMC Data (including all
Clinical Studies and Post-Approval Marketing Studies), and all data contained in any of the foregoing, including all CTNs, Drug
Approval Applications, Adverse Event files and complaint files.


 


“Rolling Forecast”
has the meaning set forth in Section 9.1.6(a).


 


“Serious Adverse
Event” means an Adverse Event that (i) results in death; (ii) is life-threatening; that is, an event where the patient
and/or clinical investigation subject was at risk of death at the time of the event and not an event that, hypothetically, might
have caused death if it had been more severe; (iii) requires hospitalization or prolongation of existing hospitalization; (iv)
results in persistent or significant disability or incapacity; (v) is a congenital anomaly or birth defect in the fetus/child,
fetal death, spontaneous abortion and serious adverse reactions in the neonate; (vi) involves suspected infection via a Product
of an infectious agent or (vii) may not be immediately life-threatening or result in death or hospitalization but may jeopardize
the subject or require medical or surgical intervention to prevent one of the outcomes listed in (i) - (vi). For the avoidance
of doubt, a “Serious Adverse Event” includes all occurrences which would be regarded as “serious adverse drug
reactions” under Applicable Law in the Territory.


 


“SKU(s)”
means Stock Keeping Unit(s) and are the smallest unit of measure to identify manufacturing and distribution of the Product in the
Field in the Territory.


 


“Specifications”
means the processes, methods, formulae, analyses, instructions, standards, know-how, testing and control procedures, information
and specifications relating to the manufacture of the Product in the Field in the Territory as reflected in the relevant formulae
edition and Regulatory Approvals.


 


“Sublicensee”
means any Person (including a Gloria Affiliate) to whom Gloria sublicenses any rights as permitted by Section 2.1.2.


 


“Sucampo”
means Sucampo AG, as identified in the preamble to this Agreement.


 


“Sucampo Background
Technology” means any Technology Controlled by Sucampo as of the Effective Date or at any time during the Term, that
is reasonably necessary for Developing, Promoting or Commercializing the Product in the Field in the Territory.


 



    	13



    	 



    




“Sucampo Indemnitee(s)”
has the meaning set forth in Section 14.1.


 


“Sucampo Other
Intellectual Property Rights” means any Other Intellectual Property Rights Controlled by Sucampo as of the Effective
Date or at any time during the Term, that are reasonably necessary for Developing, Promoting or Commercializing the Product in
the Field in the Territory.


 


“Sucampo Patent
Rights” means any Patent Rights that are Controlled by Sucampo as of the Effective Date or at any time during the Term,
including patents applied for and issued after the Effective Date, and that would otherwise be infringed, absent a license, by
the Development, Promotion or Commercialization of the Product in the Field in the Territory. Sucampo Patent Rights include the
patents and patent applications set forth in Exhibit D, which may be amended from time-to-time by Sucampo at its option and
in its sole discretion to add additional patents and patent applications.


 


“Supply Price”
means the price of [...***...] per capsule for Product in the Field. In the event Sucampo intends to supply [...***...]
to Gloria, the Parties shall negotiate in good faith a supply price for [...***...]. In the event a Generic Product enters
the Field in the Territory, Gloria and Sucampo will work together to re-evaluate the supply price in order to maintain market competitiveness.


 


“Technology”
means, collectively, proprietary information, ideas, concepts, know-how and data (including any clinical or Post-Approval Marketing
Studies 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.


 


“Term”
has the meaning set forth in ARTICLE 12.


 


“Territory”
means the People’s Republic of China.


 


“Third Party”
means any Person that is not a Party.


 


“Third Party
Claim(s)” has the meaning set forth in Section 14.1.


 


“Third Party
Royalties” means all fees, milestones, royalties and other payments payable to a Third Party (other than to any of Gloria’s
Affiliates or other Sublicensees) in consideration for intellectual property rights reasonably necessary for the Development,


 


*Confidential
Treatment Requested






    	14



    	 



    

manufacturing, Commercialization or Promotion of the Product in the Field in the Territory.


 


“Trademark”
means (a) 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, and (b) all goodwill associated
therewith.


 


“Gloria”
means Harbin Gloria Pharmaceuticals Co., Ltd., as identified in the preamble to this Agreement.


 


“Gloria Indemnitee(s)”
has the meaning set forth in Section 14.2.


  


ARTICLE 2

LICENSE GRANTS; EXCLUSIVITY


 





2.1             
Development and Commercialization Licenses


 


2.1.1       
Sucampo Grants. Subject to the terms and conditions of this Agreement, during the Term, Sucampo hereby grants to
Gloria solely under the Sucampo Patent Rights, and Sucampo Other Intellectual Property Rights, in and to the Sucampo Background
Technology, and any Jointly Developed Technology and Sucampo’s rights in Data Exclusivity:


 


(a)                  
an exclusive, except to Sucampo and its Affiliates, royalty-bearing and non-transferable (except to the extent set forth
in Section 15.8) right and license, with the right to grant sublicenses solely in accordance with Section 2.1.2, to Develop, to
the extent expressly agreed to by the Parties in the JDC, the Product in the Territory in support of obtaining Regulatory Approval
for the Product in the Field in the Territory;


 


(b)                 
an exclusive, royalty-bearing and non-transferable (except to the extent set forth in Section 15.8) right and license, with
the right to grant sublicenses solely in accordance with Section 2.1.2, to Promote and Commercialize the Product in the Field in
the Territory; and


 


(c)                  
an exclusive, except as to Sucampo and its Affiliates, royalty-bearing and non-transferable (except to the extent set forth
in Section 15.8) license under the Regulatory Filings, with the right to grant sublicenses solely in accordance with Section 2.1.2,
to use and reference in Regulatory Filings in the Territory any data Controlled by Sucampo reasonably necessary to support Regulatory
Filings.


 



    	15



    	 



    




2.1.2       
Right to Sublicense. Subject to and in accordance with the terms and conditions of this Agreement, Gloria shall have
the right to grant sublicenses and rights of reference granted by Sucampo under Section 2.1.1 to (a) its Affiliates without prior
approval of Sucampo as long as such Affiliate remains an Affiliate of Gloria and is listed as an Affiliate in Exhibit L as such
Exhibit may be updated at least annually, and (b) any other Person, only if approved by Sucampo in advance and in writing, which
approval may be granted in Sucampo’s sole discretion after having the opportunity, but not the obligation, to conduct its
own due diligence with respect to the proposed sublicensee (each of the foregoing, a “Sublicensee”) provided
that (i) in connection with a sublicense to any Person which is not an Affiliate of Gloria, Gloria shall enter into a binding and
written sublicense agreement with each such Sublicensee (“Sublicense Agreement”) that is consistent in all respects
with this Agreement and protects Sucampo’s interests and rights in its confidential and proprietary information and intellectual
property rights to at least the same extent of this Agreement, including without limitation containing provisions for the benefit
of Sucampo substantially similar in language and scope to Sections 2.1.4 and 11.1 and ARTICLE 10 of this Agreement; and provided
that any such sublicense shall be of no greater scope than the license granted to Gloria under Section 2.1.1, (ii) in connection
with a sublicense to any Person which is an Affiliate of Gloria, Gloria shall ensure that such Affiliate complies all respects
with this Agreement as such terms apply to Gloria and protects Sucampo’s interests and rights in its confidential and proprietary
information and intellectual property rights to the same extent of this Agreement, including without limitation Sections 2.1.4
and 11.1 and ARTICLE 10 of this Agreement; and provided that any such sublicense shall be of no greater scope than the license
granted to Gloria under Section 2.1.1 (iii) Sucampo shall be an intended third party beneficiary of each Sublicense Agreement and
to the extent permitted by the law, shall have the right, but not the obligation, to enforce any and all obligations of Gloria
under a Sublicense Agreement, (iv) Gloria shall not be relieved of its obligations pursuant to this Agreement as a result of such
sublicense and shall remain fully responsible and liable for any action or omission of each Sublicensee which would constitute
a breach of this Agreement if committed by Gloria as if Gloria had committed such action or inaction itself and (v) the Sublicensee
shall expressly agree in writing to be bound by and subject to the terms and conditions of this Agreement in the same manner and
to the same extent as Gloria. Gloria shall, at its own expense, investigate each report and indication of breach of this Agreement
by any Affiliate Sublicensee or any Sublicense Agreement, and Gloria shall promptly report to Sucampo any breach learned of or
discovered by Gloria. Gloria shall diligently enforce the terms and conditions of this Agreement against each Affiliate Sublicensee
and the terms and conditions of each Sublicense Agreement against each applicable Sublicensee, including without limitation, by
(x) pursuing all appropriate judicial and administrative action and relief in the event of any breach of this Agreement by any
Affiliate Sublicensee or breach of the Sublicense Agreement and (y) upon Sucampo’s request, terminating the Sublicense Agreement
upon a breach thereof or the sublicense granted to the Affiliate Sublicensee upon a breach of the terms of this Agreement. Upon
any expiration or termination of this Agreement for any reason, all Sublicense Agreements and all sublicenses granted to Affiliate
Sublicensees under this Agreement shall automatically terminate. In no event shall Sucampo or any of its Affiliates have any obligation
to assume any obligations or liabilities, or be under any obligation or requirement of performance, under any such Sublicense Agreement
or to any Affiliate Sublicensee either extending beyond Sucampo’s obligations and liabilities under this Agreement or otherwise.


 



    	16



    	 



    




2.1.3       
License to Product Trademarks. The Parties shall enter into a separate trademark license agreement within [...***...]
days of the execution of this Agreement, which form shall be attached to this Agreement as Exhibit E and incorporated by reference(the
“Trademark License Agreement”), which shall provide that subject to and in accordance with the terms and conditions
of this Agreement and the Trademark License Agreement, during the Term, Sucampo shall grant to Gloria an exclusive, except as to
Sucampo and its Affiliates, royalty-bearing, non-sublicensable and non-transferable (except to the extent set forth in Section
15.8) license, to use the Product Trademarks solely to Promote and Commercialize the Product in the Field in the Territory. For
the avoidance of doubt, Gloria is not obligated to make any additional royalty payment for its use of the Product Trademark other
than the payments as set forth in Section 8.3 of this Agreement. Gloria shall not use the Product Trademarks other than for the
purpose expressly and specifically set forth in this Section 2.1.3 and shall comply with Sucampo’s then-current trademark
usage guidelines or other trademark guidelines expressly approved in writing by Sucampo (“Trademark Guidelines”),
which Trademark Guidelines may be updated by Sucampo from time to time upon written notice to Gloria and shall set forth notice
requirements, stylistic, quality and other guidelines in connection with the use of the Product Trademarks in the Field in the
Territory. All use of the Product Trademarks by Gloria, and all goodwill associated with such use, shall inure to the benefit of
Sucampo.


 


2.1.4       
Development of Developed Technology and Developed Intellectual Property Rights. The Parties agree that there is no
intent to develop any Technology or intellectual property rights under this Agreement and this Agreement is entered into by the
Parties for the purpose of Gloria: (a) performing clinical trials and any Post-Approval Marketing Studies on behalf of and for
the benefit and account of Sucampo in the Territory, (b) preparing and maintaining Regulatory Filings in the name of Sucampo for
the Product in the Field and the Territory and (c) Commercializing the Product in the Field and the Territory. In the event that
Sucampo, Gloria or any of their respective Affiliates (or any employees, contractors, agents and subcontractors of any of the foregoing)
conceive, create, develop or otherwise reduce to practice in connection with their activities under this Agreement, regardless
of whether such conception, creation, development or reduction to practice is done independently by or on behalf of one Party or
jointly by any Party with any of the foregoing Parties and/or any other Third Parties: (a) any Technology and any improvements,
derivatives or other modifications to such Technology (but expressly excluding any underlying Sucampo Background Technology and
any other Technology provided or made accessible by or for Sucampo in connection with this Agreement in any medium and in any stage
of development or completion)(“Developed Technology”) and/or (b) any intellectual property rights (including
any patents or patent applications) and any improvements, derivatives or other modifications of any of the foregoing (but expressly


*Confidential Treatment Requested



    	17



    	 



    




excluding any underlying
Sucampo Patent Rights, any of Sucampo’s Other Intellectual Property Rights and other intellectual property rights in and
to the Sucampo Background Technology and Sucampo’s rights in the Data Exclusivity and Product Trademarks) (“Developed
Intellectual Property Rights”) then, Gloria for itself and its Affiliates, shall promptly notify and disclose to Sucampo
such Developed Technology and Developed Intellectual Property after the conception, creation or discovery thereof and the Parties
hereby agree as follows:


 





(a)               
To the extent that any Developed Technology (but excluding any improvements, derivatives or other modifications of any Sucampo
Background Technology or any other Technology provided or made accessible by or for Sucampo in connection with this Agreement in
any medium and in any stage of development or completion) is conceived, created, developed or otherwise reduced to practice solely
by Gloria in the Territory (“Gloria Developed Technology”) and/or to the extent any Developed Intellectual Property
Rights (but excluding any improvements, derivatives or other modifications of any Sucampo Patent Rights, any of Sucampo’s
Other Intellectual Property Rights and other intellectual property rights in and to the Sucampo Background Technology, any improvements,
derivatives or other modifications of any Sucampo Background Technology and Sucampo’s rights in the Data Exclusivity and
Product Trademarks) are conceived, created, developed or otherwise reduced to practice solely by Gloria in the Territory (“Gloria
Developed Intellectual Property Rights”), during the Term, Gloria shall be the sole and exclusive owner of all right,
title and interest in and to the Gloria Developed Technology and all intellectual property rights therein or thereto and the Gloria
Developed Intellectual Property Rights, in each case, solely in the Territory. Gloria hereby grants to Sucampo an unrestricted,
perpetual, irrevocable, fully paid-up, royalty-free, sublicensable (through multiple levels of sublicensees), exclusive (during
the Term, except as to Gloria in the Territory, and after the Term, even as to Gloria and its Affiliates) worldwide right and license,
free from any liens or encumbrances, to use, reproduce, distribute, display and perform (whether publicly or otherwise), prepare
derivative works of, and otherwise enhance, modify, make, have made, sell, offer to sell, and otherwise dispose of, commercialize
and exploit (and have others exercise such rights on behalf of Sucampo) all or any portion of the Gloria Developed Technology (or
any intellectual property rights therein or thereto) and Gloria Developed Intellectual Property Rights, in any form or media (now
known or later developed).Any exercise by Gloria of its rights in respect of the Gloria Developed Technology or Gloria Intellectual
Property Rights shall be subject to the terms and conditions of the Agreement (including, without limitation, Section 2.1.2
and ARTICLE 10).


 


(b)              
To the fullest extent permitted by Applicable Law, as and between the Parties, Sucampo shall be the sole and exclusive owner
of all right, title and interest in and to (i) the Developed Technology other than the Gloria Developed Technology (“Sucampo
Developed Technology”) and all intellectual property rights therein or thereto and the Developed Intellectual Property
Rights other than the Gloria Intellectual Property Rights (“Sucampo Intellectual Property Rights”), in each
case, throughout the world.



    	18



    	 



    




 


To the maximum extent
permitted by Applicable Law, (i) Gloria shall and hereby does, and shall cause its Affiliates to, irrevocably grant, convey, transfer,
assign and deliver to Sucampo all right, title and interest in and to such Sucampo Developed Technology (and all intellectual property
rights therein or thereto) and Sucampo Intellectual Property Rights, in perpetuity and throughout the world, effective immediately
upon the inception, conception, creation or development thereof, and (ii) upon the expiration or termination of this Agreement,
Gloria shall, and shall cause its Affiliates to, irrevocably grant, convey, transfer, assign and deliver to Sucampo all right,
title and interest in and to the Gloria Developed Technology (and all intellectual property rights therein or thereto) and Gloria
Developed Intellectual Property Rights, in perpetuity and throughout the world.


 


To the extent that
any Sucampo Developed Technology (or any intellectual property rights therein or thereto), Sucampo Intellectual Property Rights,
Gloria Developed Technology (or any intellectual property rights therein or thereto), or Gloria Developed Intellectual Property
Rights (collectively, “Project Developed Technology and Rights”) are not assignable as provided in this Section
2.1.4(b) or that Gloria or its Affiliates retain any right, title or interest in or to any Project Developed Technology and Rights
(or any intellectual property rights therein or thereto) in any jurisdictions in the world then, to the maximum extent permitted
by Applicable Law, Gloria hereby unconditionally and irrevocably waives and quitclaims (and will cause to be unconditionally and
irrevocably waived and quitclaimed) to Sucampo any and all claims and causes of action of any kind against Sucampo, its Affiliates
and licensees (through multiple tiers) with respect to such rights, and agrees, at Sucampo’s request and expense, to consent
to and join in any action to enforce such rights, and hereby grants to Sucampo an unrestricted, perpetual, irrevocable, fully paid-up,
royalty-free, fully transferable, sublicensable (through multiple levels of sublicensees), exclusive (even as to Gloria and its
Affiliates) right and license, throughout the world, free from any liens or encumbrances, to use, reproduce, distribute, display
and perform (whether publicly or otherwise), prepare derivative works of, and otherwise enhance, modify, make, have made, sell,
offer to sell, and otherwise dispose of, commercialize and exploit (and have others exercise such rights on behalf of Sucampo)
all or any portion of the Project Developed Technology and Rights (or any intellectual property rights therein or thereto) in any
form or media (now known or later developed). Gloria agrees to (and will cause any Affiliates to), at Sucampo’s expense,
take all reasonable additional actions and execute such agreements, instruments and documents as may be required, both during and
after the Term, and agrees otherwise to give to Sucampo and any Person designated by Sucampo any assistance required in order to
perfect the rights set forth in this Section 2.1.4, including without limitation, obtaining patents and copyright registrations,
and to apply for, obtain, perfect, evidence, sustain and enforce Sucampo’s intellectual property rights in connection with
the Project Developed Technology and Rights in any jurisdictions throughout the world and Gloria hereby irrevocably appoints, and
will cause its Affiliates to irrevocably appoint, Sucampo and any Person designated by Sucampo as its attorney in fact to act for
and on behalf of, and instead of, Gloria and its Affiliates, for the purposes of accomplishing any of the foregoing, with the same
legal force and effect as if executed by Gloria and its Affiliates. Gloria further waives, and shall cause its Affiliates to waive,
any “moral” rights, or other rights with respect to attribution of authorship or integrity relating to the Project
Developed Technology and Rights as Gloria or any of its Affiliates may have under any applicable law and regulations under any
legal theory.



    	19



    	 



    




(c)               
The Parties hereby acknowledge and agree that the Parties’ entering into this Agreement, Sucampo’s disclosure
of Sucampo Patent Rights, Sucampo Other Intellectual Property Rights and Sucampo Background Technology as and to the extent set
forth under Section 4.7 and Sucampo’s provision of assistance and support to Gloria as expressly set forth under this Agreement
are good, valuable and sufficient consideration for the foregoing assignments and license grants by Gloria to Sucampo. If and to
the extent that, notwithstanding the foregoing agreement of the Parties, local law of the Territory requires that additional consideration
or payment needs to be made by Sucampo to Gloria in respect of the assignments or license grants under this Agreement, then the
Parties may agree upon a reasonable minimum amount required to comply with such local law to be paid to Gloria for such foregoing
assignments and license grants. The Parties hereby further acknowledge and agree that neither the foregoing nor any failure by
the Parties to agree upon any reasonable minimum amount that may be required under such local law or otherwise shall waive, limit,
restrict, condition, modify or otherwise affect the effectiveness of the foregoing assignments and license grants or Sucampo’s
exercise of its rights hereunder.


 


2.1.5       
Publication. Publication or presentation of a manuscript related to any Developed Technology or Developed Intellectual
Property Rights under this ARTICLE 2 shall be governed by Section 3.1.4(b)(viii) and Section 10.3.2.


 


2.1.6       
Product Diversion. To the extent permitted by Applicable Law, Sucampo shall not, and shall cause its Affiliates and
sublicensees not to distribute, offer to sell, sell or otherwise Promote or Commercialize the Product in the Field into the Territory
and should Sucampo become aware of any such Product diversion, it shall, in addition to and not in lieu or limitation of any other
rights or remedies available to Gloria under this Agreement or at law or in equity, use Commercially Reasonable Efforts to stop
the diversion at its sole cost and expense. To the extent permitted by Applicable Law, Gloria shall not, and shall include in its
Sublicense Agreements with Sublicensees and its written agreements with Subcontractors that sell Product in the Field in the Territory
covenants from such Sublicensees and Subcontractors to not, and shall cause its Affiliate Sublicensees to not, distribute, offer
to sell, sell or otherwise Promote or Commercialize the Product outside of the Territory or outside the Field. Should Gloria become
aware of any such Product diversion, it shall, in addition to and not in lieu or limitation of any other rights or remedies available
to Sucampo under this Agreement or at law or in equity, use Commercially Reasonable Efforts to stop the diversion at its sole cost
and expense.


 


2.2             
No Implied Licenses. No license or other right is or shall be created or granted hereunder by implication, estoppel
or otherwise for any purpose. All such licenses and rights are or shall be granted only as expressly and specifically provided
in this Agreement.


 



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2.3             
Retained Rights. All rights not expressly and specifically granted under thisARTICLE 2 or such other terms and conditions
of this Agreement are reserved by Sucampo and may be exercised or practiced by Sucampo for any purpose. In addition to and without
limiting the generality of the foregoing, Sucampo retains any and all rights under the Sucampo Patent Rights, Sucampo Other Intellectual
Property Rights and Sucampo Background Technology to make, have made, use, sell, have sold, export, import, distribute, commercialize
or otherwise exploit the Compounds and the Product in the Field outside of the Territory and, subject to Section 5.2 below, for
Other Formulation(s) or Dosage(s) and Other Indications anywhere in the world.


 


ARTICLE 3

ADMINISTRATION OF THE COLLABORATION


3.1             
Committees


 


Committees’
Establishment. Within thirty (30) days of the Effective Date, Sucampo and Gloria shall establish the following committees (the
“Committees”):


 


(a)               
a Joint Steering Committee (“JSC”) with responsibility for and managing the collaboration and resolving any
conflicts and overseeing the JCC and JDC,


 


(b)              
a Joint Commercialization Committee (“JCC”) with responsibility for overseeing Commercialization-related
activities with respect to the Product in the Field in the Territory, and


 


(c)               
a Joint Development Committee (“JDC”) with responsibility for overseeing Development-related activities
with respect to the Product in the Field in the Territory, including, without limitation, the regulatory approach and filing strategy
designed to generate the successful submission and approval of the Product in the Field in the Territory.


 


Within sixty (60) days of the establishment
of the foregoing Committees, the Committees shall meet to prepare such procedures and mechanisms as may be reasonably necessary
for their operation to assure the most efficient conduct of each Party’s obligations under this Agreement.


 


		3.1.2	JSC



 


(a)               
Membership. Sucampo and Gloria shall each designate two (2) of its employees or consultants or its Affiliates’
employees or consultants to serve as members of the JSC (or such other equal number of representatives as the Parties may agree).
The initial members of the JSC are set forth on Exhibit F. Each representative of the JSC shall have the requisite experience
and seniority to make decisions on behalf of the Parties with respect to issues falling within the jurisdiction of the JSC. The
chairperson shall serve for a term of one (1) year, beginning on the Effective Date or an anniversary thereof, as the case may
be. The right to name the chairperson of the JSC shall alternate between the Parties. The initial chairperson shall be selected
by Sucampo and is set forth on Exhibit F. Each Party shall have the right at any time to substitute individuals, on a permanent
or temporary basis, for any of its previously designated representatives to the JSC by giving written notice to the other Party;
provided such substitute meets the criteria defined herein. Neither Party shall have the right to remove a sitting member of the
other Party. The JSC shall meet quarterly unless otherwise agreed by the JSC.



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(b)              
Responsibilities. The JSC shall have the responsibilities set forth in Section 3.1.1(a), including to:


 


(i)                
Discuss strategies for Commercialization of the Product in the Field in the Territory;


 


(ii)              
Review the activities and monitor the progress of the JCC and JDC;


 


(iii)            
Resolve any Disputed Matters referred to the JSC by the JDC or JCC; and


 


(iv)            
Perform such other functions as the Parties may mutually agree in writing, except where in conflict with any provision of
this Agreement.


 


		3.1.3	JCC.



 


(a)               
Membership. Sucampo and Gloria shall each designate three (3) of its employees or consultants or its Affiliates’
employees or consultants to serve as members of the JCC (or such other equal number of representatives as the Parties may agree).
The initial members of the JCC are set forth on Exhibit F. Each representative of the JCC shall have the requisite experience
and seniority to make decisions on behalf of the Parties with respect to issues falling within the jurisdiction of the JCC. The
chairperson shall serve for a term of one (1) year, beginning on the Effective Date or an anniversary thereof, as the case may
be. The right to name the chairperson of the JCC shall alternate between the Parties. The initial chairperson shall be selected
by Gloria and is set forth on Exhibit F. Each Party shall have the right at any time to substitute individuals, on a permanent
or temporary basis, for any of its previously designated representatives to the JCC by giving written notice to the other Party;
provided such substitute meets the criteria defined herein. Neither Party shall have the right to remove a sitting member of the
other Party. The JCC shall meet quarterly unless otherwise agreed by the JCC.


 


 


(b)              
Responsibilities. The JCC shall have the responsibilities set forth in Section 3.1.1(b), including to:


 


(i)                
Review and approve the Commercialization Plan, including any material updates, amendments, modifications, and waivers of
provisions thereof by consensus of all of its members in accordance with Section 3.1.6 below;


 


(ii)              
Review and evaluate progress under the Commercialization Plan;


 


(iii)            
Review and approve the Promotional Materials; and






    	22



    	 



    

(iv)            
Perform such other functions as the Parties may mutually agree in writing, except where in conflict with any provision of
this Agreement.


 


3.1.4       
JDC


 


(a)               
Membership. Sucampo and Gloria shall each designate three (3) of its employees or consultants or its Affiliates’
employees or consultants to serve as members of the JDC (or such other equal number of representatives as the Parties may agree).
Each Party shall designate to be members of the JDC at least one (1) representative from its regulatory department and one (1)
representative from its clinical development department. The initial members of the JDC are set forth on Exhibit F. Each representative
of the JDC shall have the requisite experience and seniority to make decisions on behalf of the Parties with respect to issues
falling within the jurisdiction of the JDC. The chairperson shall serve for a term of one (1) year beginning on the Effective Date
or an anniversary thereof, as the case may be. The right to name the chairperson of the JDC shall alternate between the Parties.
The initial chairperson shall be selected by Gloria and is set forth in Exhibit F. Each Party shall have the right at any time
to substitute individuals, on a permanent or temporary basis, for any of its previously designated representatives to the JDC by
giving written notice to the other Party; provided such substitute meets the criteria defined herein. Neither Party shall have
the right to remove a sitting member of the other Party. The JDC shall meet quarterly unless otherwise agreed by the JDC.


 


(b)              
Responsibilities. The JDC shall have the responsibilities set forth in Section 3.1.1(c), including to:


 


(i)                
Review and approve the Development Plan, including all material updates, amendments, modifications, and waivers of provisions
thereof by consensus of all of its members in accordance with Section 3.1.6 below;


 


(ii)              
Review and evaluate progress under the Development Plan, including without limitation all health, safety and quality concerns;


 


(iii)            
Review the statistical analysis plans and protocols for all pre-clinical and Clinical Studies in the Territory prepared
in support of obtaining or maintaining Regulatory Approvals for the Product in the Field in the Territory;


 


(iv)            
Unless otherwise agreed by the Parties, review all proposed initial submissions for the Product in the Field to Regulatory
Authorities anywhere in the world;


 


(v)              
Unless otherwise agreed by the Parties, review the submission of all draft and final Product Labels and Inserts for the
Product in the Field in the Territory and any material changes thereto;


 


(vi)            
Monitor the progress of all Clinical Studies and other development activities for the Product in the Field anywhere in the
world;


 


(vii)          
Assess the potential impact of Clinical Studies conducted anywhere in the world on Product Labels and Inserts for the Product
in the Field in the Territory;



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(viii)        
Review all proposed publications or presentations for the Territory related to the Product in the Field pursuant to Clinical
Studies that is based on data developed by or for Sucampo and its Affiliates; and


 


(ix)            
Perform such other Development functions as the Parties may mutually agree in writing, except where in conflict with any
provision of this Agreement.


 


3.1.5       
Committee Meetings. Each Committee shall establish a schedule of times for regular meetings. The JSC, JCC and JDC
shall meet quarterly unless the Committees otherwise agree. Meetings may be held in person, by telephone or videoconference, provided
that at least one meeting per Calendar Year shall be held in person. Such in-person meeting shall alternate between the respective
offices of Gloria and Sucampo or such other locations mutually agreed upon by the Committees. The chairperson of each Committee
shall prepare and circulate to each Committee member an agenda for each Committee meeting reasonably in advance of each meeting.
At each Committee meeting, the presence of at least one (1) member designated by each Party shall constitute a quorum. The Committees
shall keep minutes of their meetings that record all decisions and all actions recommended or taken in reasonable detail. The chairperson
of each Committee shall circulate a draft of the minutes no later than five (5) Business Days after each meeting and each member
of the Committee shall have the opportunity to comment on the draft minutes. The minutes shall be approved, disapproved or revised
as necessary within thirty (30) days of each meeting; provided, however, that if the Parties cannot agree as to the content of
the minutes, such minutes will be finalized to reflect such disagreement. The chairperson of each Committee shall circulate final
minutes of each meeting to each Committee member.


 


3.1.6       
Decision-Making. Except as otherwise provided herein, decisions of each Committee shall be made by consensus. Each
Committee shall use reasonable efforts to reach agreement on any and all matters for which it is responsible. In the event that,
despite such reasonable efforts, agreement on a particular matter cannot be reached by a Committee within fifteen (15) Business
Days after the Committee first meets to consider such matter (each such matter, a “Disputed Matter”), then the
following procedure shall apply:


 


(a)               
JDC Disputed Matters. Disputed Matters arising from the JDC shall be referred for resolution to the JSC. The JSC
shall initiate discussions in good faith to resolve each Disputed Matter within [...***...] of receipt of the notice
of such Disputed Matter. In the event that the JSC does not reach agreement on such Disputed Matter within [...***...]
from the date of initiation of such discussions, such Disputed Matter shall be referred to senior management for resolution in
accordance with Section 3.1.6(d).


 


(b)              
JCC Disputed Matters. Disputed Matters arising from the JCC shall be referred for resolution to the JSC. The JSC
shall initiate discussions in good


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faith to resolve each
Disputed Matter within [...***...] of receipt of the notice of such Disputed Matter. In the event that the JSC does not
reach agreement on such Disputed Matter within [...***...] from the date of initiation of such discussions, such Disputed
Matter shall be referred to senior management for resolution in accordance with Section 3.1.6(d).


 


(c)               
JSC Disputed Matters. Disputed Matters first arising in the JSC or not resolved by the JSC which had first arose
in the JDC or JCC shall be referred to senior management for resolution in accordance with Section 3.1.6(d).


 


(d)              
Management Negotiations. In the event that the JSC cannot resolve a Disputed Matter, either Party may, by written
notice to the other, refer such Disputed Matter to the Parties’ respective senior management for good faith negotiations.
In the event that, despite good faith efforts, resolution of such Disputed Matter cannot be reached by senior management of the
Parties within [...***...] of its referral:


 


(i)                
with respect to any Disputed Matter that relates to (1) pharmacovigilance, including monitoring and reporting of Adverse
Events and Serious Adverse Events; (2) monitoring and evaluation of the manufacturing process, quality, stability, efficacy and
adverse drug reactions of the Product in the Field in the Territory; (3) Product quality control and cGMP compliance; (4) Product
recalls in the Field in the Territory; (5) renewal of the marketing authorization on expiry, amendment of the marketing authorization
to reflect changes in the Product permit and other regulatory matters; (6) conduct of Phase IV Clinical Trials, which shall be
performed by Gloria on behalf of Sucampo; (7) legal matters, including the potential infringement of the Product on any intellectual
property or proprietary rights of any Third Party in the Territory; and (8) any other matters agreed upon by the Parties in writing,
if such Disputed Matter occurred before the commencement of Commercialization and does not directly or materially affect Gloria’s
compliance with PRC laws in connection with this Agreement, Sucampo shall have the final decision-making authority; if such Disputed
Matter occurred prior to the commencement of Commercialization of the Product and directly and materially affects Gloria's compliance
with PRC laws in connection with this Agreement, Gloria shall have the final decision-making authority; and if such Dispute Matter
occurred after the commencement of Commercialization of the Product, Gloria shall have the final decision-making authority, provided
however that, notwithstanding the foregoing, Sucampo shall have final decision-making authority over any of the foregoing Disputed
Matters to the extent they relate to, are in connection with or implicated by the manufacture of the Product;


 


(ii)              
with respect to any Disputed Matter that relates to the Commercialization of the Product in the Field in the Territory other
than the matters set forth in Section 3.1.6(d)(i) above, Gloria shall have final decision-making authority; and


 


(iii)            
with respect to any Disputed Matter that relates to Development of the Product in the Field in the Territory, the final
decision-making authority shall rest with Sucampo, unless (A) the Disputed Matter relates to the conduct of Post-Approval Marketing
Studies by Gloria under Section 4.3.1 other than the matters set 


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forth in Section 3.1.6(d)(i)
above, in which case Gloria shall have final decision-making authority; and (B) to the extent the Disputed Matter will result in
a material deviation from the budget of Gloria for the Development of the Product for use in the Field in the Territory and such
material deviation has not been approved by the JDC or agreed upon by Gloria and Sucampo, in which case Gloria shall have final
decision-making authority.


 





3.2             
Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement,
and no such rights, powers, or discretion shall be delegated to or vested in a Committee unless such delegation or vesting of rights
is expressly and specifically provided for in this Agreement, or the Parties expressly so agree in writing. In addition to and
without limiting the generality of the foregoing, (a) no Committee shall substitute for either Party’s ability to exercise
any rights set forth under this Agreement nor excuse the performance of any obligation set forth under this Agreement, (b) no Committee
shall have the authority to make any determination that a Party is in breach of this Agreement, or that a Party has engaged or
not engaged in acts related to breach and (c) no Committee shall have the power to amend, modify or waive compliance with this
Agreement, which may only be amended or modified, or compliance with which may only be waived, solely as and to the extent provided
in Section 15.5.


 


3.3             
Interactions Between a Committee and Internal Teams. The Parties recognize that each Party possesses an internal
structure (including various committees, teams and review boards) that will be involved in administering such Party’s activities
under this Agreement. Nothing contained in this Article shall prevent a Party from making routine day-to-day decisions relating
to the conduct of those activities for which it has a performance or other obligation hereunder, provided that such decisions are
consistent with the then-current Commercialization Plan or Development Plan, as applicable, and the terms and conditions of this
Agreement and all Applicable Law.


 


3.4             
Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other
representatives to attend meetings of, and otherwise participate on, a Committee.


 


3.5             
Purpose of the Committees. The Parties acknowledge and agree that the Committees are strictly for the purposes of
decision-making and governance of the Agreement.


 


3.6             
Communication. With regard to the Parties’ entire relationship, the Parties shall cooperate and provide support
in connection with each other’s reasonable requests and shall promptly respond to each other’s communications.



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ARTICLE 4

DEVELOPMENT


 


4.1             
Development Plan


 


4.1.1       
Initial Plan. The Development of the Product for use in the Field in the Territory shall be governed by a comprehensive,
multi-year plan containing (a) the Development program (including pharmacokinetics studies) to be conducted by Gloria on an activity-by-activity
basis and the study protocol, and (b) the regulatory strategy for obtaining Regulatory Approval for the Product in the Field in
the Territory, which Development program is designed to generate all the Clinical Data and regulatory information required to obtain
the Regulatory Approval required for Gloria to be able to Promote and Commercialize the Product in the Field in the Territory (the
“Development Plan”). Within [...***...] following the Effective Date, Gloria shall prepare and provide
to the JDC a proposed Development Plan for its review and approval in accordance with the provisions of ARTICLE 3. The Development
Plan shall not negatively impact Sucampo or its licensees’ marketing of the Product outside of the Territory.


 


4.1.2       
Amendments. Commencing in the first full Calendar Year after the Effective Date and continuing during the Term, Gloria
shall prepare and submit no later than January 31st of each Calendar Year for review and approval by the JDC appropriate
amendments and updates to the Development Plan. Such amendments and updates of the Development Plan shall not negatively impact
Sucampo or its licensees’ marketing of the Product outside of the Territory.


 


4.2             
Responsibilities. Gloria shall be solely responsible for conducting all Development activities set forth in the Development
Plan unless otherwise agreed by the JDC.


 


4.3             
Development Activities


 


4.3.1       
Responsibilities. Gloria shall use Commercially Reasonable Efforts to Develop the Product in the Field in the Territory,
including the activities in the Development Plan and in this Section 4.3.1, in accordance with the Development Plan, the terms
and conditions of this Agreement, all Applicable Laws and cGCP. Gloria shall be solely responsible for funding and completing all
Clinical Studies required to obtain and maintain Regulatory Approval for the benefit and account of Sucampo for the Product in
the Territory in the Field. Gloria shall be responsible for all the other Development activities contemplated by the Development
Plan and shall bear all Development costs required for registration for the Product in the Field in the Territory and approved
by JDC for the benefit and account of Sucampo. If the CFDA or any other Regulatory Authority in 


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the Territory requires
or recommends any Phase IV Clinical Studies as a condition to obtaining the Regulatory Approval for the Product in the Field in
the Territory or maintaining such Regulatory Approval, Gloria shall fund, conduct and direct all such Phase IV Clinical Studies
based on a plan approved by the JDC. For the avoidance of doubt, if Sucampo or its Affiliates conduct any Development activity
by itself in the Territory, Sucampo shall be solely responsible for funding those Development activities.


 


4.3.2       
Other Post-Approval Marketing Studies. Gloria shall fund, conduct and direct any Post-Approval Marketing Studies
determined by the JCC provided that such Post-Approval Marketing Studies shall not negatively impact: (a) Sucampo’s marketing
of the Product outside of the Territory or (b) Sucampo’s marketing of the Product for Other Indications in the Territory.


 


4.3.3       
Other Development Activities. In the event the JDC identifies an opportunity to expand and optimize the Compound
in the Field in the Territory such as expanding the label for the Product for use in the Field in the Territory, Gloria shall submit
a Development Plan and be responsible for the related Development costs (including any Clinical Studies required to expand the
label of the Product for use in the Field in the Territory) of pursing any such opportunities subject to the approval of the JDC.
The Development Plan shall not negatively impact Sucampo or its licensees’ marketing of the Product outside of the Territory.


 


4.4             
Conduct of Development


 


4.4.1       
Compliance. The Parties shall perform their obligations under the Development Plan and all other Development activities
required for registration for the Product in the Field in the Territory in good scientific manner and in compliance with the Development
Plan, the terms and conditions of this Agreement, cGCP and all Applicable Law.


 


4.4.2       
Cooperation. The Parties shall reasonably cooperate through the JDC in the performance of the Development Plan.


 


4.4.3       
Segregation. Gloria shall, and shall cause each of its Sublicensees to, establish, internal procedures consistent
with industry best practices (including, without limitation, the procedures set forth below) to keep and maintain all Sucampo Background
Technology, Sucampo’s Confidential Information, Pre-Clinical Data, Clinical Data, CMC Data and any other data, information
and materials provided by or for Sucampo in a secure environment and prevent the contamination of any of the foregoing that is
received in accordance with the terms under this Agreement. Gloria shall, and shall cause each of its Sublicensees to: (a)cause
all such Sucampo Background Technology, Sucampo’s Confidential Information, Pre-Clinical Data, Clinical Data, CMC Data and
any other data, information and materials to be promptly logged and stored pursuant to this Section 4.4.3, (b)store all electronic
versions of such Sucampo Background Technology, Sucampo’s Confidential Information, Pre-Clinical Data, Clinical Data, CMC
Data and any other data, information and materials on dedicated electronic storage media and ensure that such dedicated electronic
storage media is accessible only through a separate and unique login account, (c)ensure that the only persons with access to such
Sucampo Background Technology, Sucampo’s Confidential Information, Pre-Clinical Data, Clinical Data, CMC Data and any other
data, information and materials are its employees who have a need to access such Sucampo Background Technology, Sucampo’s
Confidential Information, Pre-Clinical Data, Clinical Data, CMC Data and any other data, information and materials pursuant to
this Agreement and who are subject to confidentiality obligations which are substantially the same as and no less restrictive than
those set forth in ARTICLE 10(such persons, “Access Individuals”), (d)keep complete, detailed and accurate records
of all Access Individuals and such Sucampo Background Technology, Sucampo’s Confidential Information, Pre-Clinical Data,
Clinical Data, CMC Data and any other data, information and materials (or any portion thereof) accessed by such Access Individuals,
and (e)comply with any other measures reasonably requested by Sucampo. In addition to and without limiting the generality of the
foregoing, Gloria shall use best efforts to ensure that any Regulatory Authorities and other Third Parties to whom any Pre-Clinical
Data, Clinical Data, CMC Data and any other data in connection with the Product in the Field in the Territory are disclosed under
and subject to the express terms and conditions of this Agreement shall, in each case, keep all such data segregated and confidential.


 



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4.5             
Records. The Parties shall maintain records of its Development activities under the Development Plan in sufficient
detail, in good scientific manner appropriate for patent application and regulatory purposes and in accordance with all Applicable
Law and otherwise in a manner that reflects all work done and results achieved in the performance of the Development Plan. The
Parties 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 ARTICLE 10, a 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. Although the Parties agree that there
is no intent to develop any Technology under the Development Plan or otherwise, each Party agrees to maintain a policy that requires
its employees and consultants to record and maintain any Technology developed during the Development Plan in accordance with generally
accepted practice in the industry.


 


4.6             
Right to Inspect. Subject to ARTICLE 10, upon reasonable advance notice to Gloria and the Sublicensee (if applicable),
Sucampo shall have the right, but not the obligation to (a) have access to Gloria’s or any Sublicensee’s facilities
in which Development activities are performed, the investigators, project managers, other employees, contractors and other personnel
performing the Development activities; (b) have access to and the right to examine all information, books and records in accordance
with Section 4.5 above; (c) visit, examine and inspect Gloria’s and any Sublicensee’s facilities in which the Development
activities are performed and any containers or other equipment used in the work conducted for the Development activities, including
any areas where the Compound is stored or handled; (d) inspect the work conducted and Development activities; and (e) inspect and
obtain copies of licenses, authorizations, approvals or written communications from any Regulatory Authority in connection with
such Development activities, in each of the foregoing cases, during normal business hours and subject to Gloria’s customary
rules and restrictions with respect to site visits by non-Gloria personnel, in order that Sucampo may be assured as to whether
the Development activities are being performed in conformance with the Development Plan and otherwise in accordance with this Agreement.


 



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4.7             
Technology or Manufacturing Transfer. As soon as reasonably practicable after the Effective Date and from time to
time during the Term, Sucampo shall disclose to Gloria such of the Sucampo Patent Rights, Sucampo Other Intellectual Property Rights,
and Sucampo Background Technology necessary for Gloria to exercise its rights and perform its obligations to Develop, Promote and
Commercialize the Product in the Field in the Territory. During the Term, Sucampo will provide Gloria with reasonable technical
assistance relating to the use of Sucampo Patent Rights, Sucampo Other Intellectual Property Rights and Sucampo Background Technology,
provided that Gloria provides Sucampo with sufficient prior notice of, and discusses with Sucampo, the type and scope of assistance
needed. Gloria may include in such notice the feasibility assessment of such technology or manufacturing transfer and a preliminary
implementation plan. Sucampo shall have [...***...] from the date of the notice to provide a written response as to whether
it wishes to participate in negotiations with Gloria with respect to such technology or manufacturing transfer opportunity in the
Territory; provided, that Sucampo agrees that, if it determines not to participate in such negotiations prior to the end of such
period, it shall in good faith provide written notice to Gloria promptly upon such determination and propose a new timeline for
the negotiation (as applicable).If Sucampo’s response indicating whether or not it wishes to participate in negotiations
with respect to such technology or manufacturing transfer opportunity in the Territory is not delivered to Gloria within the [...***...]
response period, Sucampo shall not be free to discuss such technology or manufacturing transfer opportunity with any Third Party
in the Territory until Sucampo has provided Gloria with a response. If Sucampo indicates in its response delivered within such
[...***...] period that it wishes to participate in negotiations with Gloria with respect to such technology or manufacturing
transfer opportunity in the Territory, Gloria has the right to carry out exclusive negotiations with Sucampo in good faith for
a period [...***...] after Sucampo’s receipt of such notice to include such technology or manufacturing transfer
under a license agreement. For the avoidance of doubt, Sucampo shall not negotiate or enter into discussion with any Third Party
in the Territory in respect of such technology or manufacturing transfer opportunity prior to the expiry of the [...***...]
period. If the terms and conditions for such license agreement have not been agreed upon by the Parties upon the expiry of the
foregoing period, Sucampo shall be entitled to negotiate with Third Parties for such technology or manufacturing transfer without
further obligation or liability to Gloria.


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4.8             
Supply of Compound. Sucampo shall use Commercially Reasonable Efforts to supply, at its cost, the Compound to Gloria
as reasonably required by Gloria for the completion of the Development of the Product in the Field in the Territory. Gloria shall
be fully responsible for its and its employees’, agents’ and contractors’ (including without limitation its Affiliates’
and other Sublicensees’) use, storage, handling and disposition of the Compound. Unless otherwise directed by Sucampo, upon
suspension, discontinuation or completion of the Development of the Product in the Field in the Territory, Gloria shall: (a) promptly
provide to Sucampo an accounting of the receipt and disposition of the Compound, (b) at Sucampo’s sole option, return to
Sucampo or its designee properly all unused supplies of the Compounds as well as any empty containers in accordance with all Applicable
Laws and any requirements of or instructions by Sucampo, and (c) promptly provide to Sucampo a written certification by a duly
authorized representative of Gloria of such return of the Compound. Gloria shall not, and shall ensure that its employees, agents
and contractors, including the investigators, its Affiliates and other Sublicensees shall not: (a) use the Compound except as expressly
and specifically provided in this Agreement and the Development Plan, (b) distribute, transfer or release the Compound to any other
Person for any purpose or use, except as expressly and specifically described in this Agreement and the Development Plan; and (c)
chemically, physically or otherwise modify the Compound, except the extent expressly and specifically required by the Development
Plan. In addition to and not in lieu or limitation of the foregoing, Gloria shall (i) limit access to the Compound to only the
participants of any Clinical Studies who have provided their informed consent and who are under the principal investigator’s
supervision, as expressly and specifically described in the Development Plan; and (ii) hold, store and transport the Compound in
compliance with all Applicable Laws and any other requirements or instructions of Sucampo. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE
LAW, THE COMPOUND IS BEING SUPPLIED TO GLORIA WITH NO, AND SUCAMPO HEREBY EXPRESSLY DISCLAIMS, ANY REPRESENTATIONS OR WARRANTIES
OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY REPRESENTATION OR WARRANTY OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE OR THAT THEY ARE FREE FROM THE RIGHTFUL CLAIM OF ANY THIRD PARTY, BY WAY OF INFRINGEMENT OR THE LIKE. SUCAMPO
MAKES NO AND HEREBY DISCLAIMS ANY, REPRESENTATIONS THAT THE USE OF THE COMPOUND WILL NOT INFRINGE ANY PATENT OR OTHER INTELLECTUAL
PROPERTY OR PROPRIETARY RIGHTS OF ANY THIRD PARTIES.


 



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ARTICLE 5

DEVELOPMENT AND COMMERCIALIZATION OF Other Formulation(s) or Dosage(s)


 


5.1             
Reporting. From time to time during the Term, Sucampo and its Affiliates may seek to develop or commercialize Other
Formulation(s) or Dosage(s) or Other Indication(s). Sucampo shall provide Gloria with notice of such Other Formulation(s) or Dosage(s)
within [...***...] after the Phase IIa Study reports or other advanced Clinical Study reports are available for such
Other Formulation(s) or Dosage(s). The notice shall include such information with regard to such Other Formulation(s) or Dosage(s)
as Gloria reasonably determines is necessary to permit Gloria and its Affiliates to evaluate such Other Formulation(s) or Dosage(s)
and its/their potential marketability in the Territory for purposes of determining whether to exercise the option described in
Section 5.2.


 


5.2             
Gloria Right of First Refusal for Other Formulation(s) or Dosage(s).Subject to Gloria’s compliance with all
terms and conditions of this Agreement, Gloria shall have [...***...] from the date of the notice referred to in Section
5.1 to provide a written response as to whether it wishes to participate in negotiations with Sucampo with respect to such Other
Formulation(s) or Dosage(s) opportunity in the Territory, provided that Gloria agrees that, if it determines not to participate
in such negotiations prior to the end of such period, it shall in good faith provide written notice to Sucampo promptly upon such
determination. If Gloria’s response indicating whether or not it wishes to participate in negotiations with respect to such
Other Formulation(s) or Dosage(s) opportunity in the Territory is not delivered to Sucampo within the [...***...] response
period, Gloria shall no longer have the right to exercise such Other Formulation(s) or Dosage(s) opportunity, as applicable, and
Sucampo shall be free to discuss such Other Formulation(s) or Dosage(s) opportunity, as applicable, with any Third Party without
further obligation or liability to Gloria. If Gloria indicates in its response delivered within such [...***...] period
that it wishes to participate in negotiations with Sucampo with respect to such Other Formulation(s) or Dosage(s) opportunity in
the Territory, Gloria has the right to carry out exclusive negotiation with Sucampo in good faith for a period of [...***...]
after Gloria’s receipt of such notice to include such Other Formulation(s) or Dosage(s), as applicable, under a license agreement
with the terms and conditions no less favorable to Gloria than those of this Agreement. For the avoidance of doubt, Sucampo shall
not negotiate or enter into discussion with any Third Party in the Territory in respect of such Other Formulation(s) or Dosage(s)opportunity
prior to the expiry of the [...***...]. If the terms and conditions for such license agreement have not been agreed upon
by the Parties upon the expiry of the foregoing period, Sucampo shall be entitled to negotiate with Third Parties for the development
and commercialization of such Other Formulation(s) or Dosage(s) without further obligation or liability to Gloria.


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ARTICLE 6

REGULATORY


 


6.1             
Regulatory Filings; Regulatory Approvals


 


6.1.1       
Ownership. To the maximum extent permitted by Applicable Law, Sucampo shall own, and Gloria shall provide Sucampo
with original copies of, all Regulatory Filings (including all Regulatory Approvals) upon the expiration or earlier termination
of this Agreement or at any time upon Sucampo’s reasonable request and Gloria shall register and maintain all Regulatory
Approvals, including obtaining any variations or renewals thereof, solely for the benefit and account of Sucampo, at Gloria’s
sole cost and expense, provided however that Gloria shall have the right to keep in custody of all original copies of the Regulatory
Approvals throughout the Term of this Agreement to the extent required by Applicable Law provided that Gloria provides Sucampo
with legible copies of all such Regulatory Approvals promptly upon receipt thereof and that Gloria promptly returns all original
copies of the Regulatory Approvals to Sucampo upon the termination or expiration of this Agreement. Each Party agrees that neither
it nor its Affiliates will do anything to adversely affect any of the Regulatory Approvals or other Regulatory Filings.


 


6.1.2       
Regulatory Strategy; Preparation of Regulatory Filings; Communications.


 


(a)               
Development of Regulatory Strategy. The Parties shall reasonably cooperate and consult with each other, through the
JDC, in good faith, to develop strategies for all Regulatory Filings in the Field in the Territory for the Compounds and the Product,
and from time to time update the Development Plan as appropriate to reflect such developed strategies.


 


(b)              
Preparation of Regulatory Filings; Review of Regulatory Filings. Gloria shall be responsible for: (i) implementing
the regulatory strategy for Clinical Studies (other than Post-Approval Marketing Studies) (including interactions with Regulatory
Authorities) in the Territory; (ii) preparing and submitting, solely for the benefit and account of Sucampo, all Regulatory Filings
in the Territory in the Field in Sucampo’s name (provided that the Parties shall reasonably cooperate with each other regarding
such preparation and submission); and (iii) other public disclosure and confidentiality provisions in this Agreement notwithstanding,
obtaining, referencing and using all Regulatory Filings, Pre-clinical Data, Clinical Data and CMC Data for the Product in the Field
(including but not limited to countries outside the Territory) solely for use in the Territory in connection with the Regulatory
Filings, without any additional compensation from Sucampo. For the avoidance of doubt, Sucampo shall not carry out any of the activities
indicated in (i) - (iii) of this Section in the Territory without the prior approval of Gloria in writing, which approval shall
not be unreasonably withheld, conditioned or delayed. Such approval by Gloria should also be subject to any regulations by Regulatory
Authority and Applicable Law in the Territory. At Sucampo’s request, Gloria shall provide Sucampo with (a) copies of such
Regulatory Filings in the Territory in the Field, Pre-clinical Data, Clinical Data, CMC Data and all other data generated by or
for Gloria in connection with the Product in the Field in the Territory and this Agreement within thirty (30) days, and (b) with
other related information as soon as practicable and otherwise keep Sucampo informed of any developments from time to time.


 



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(c)               
Communications; Regulatory Meetings. After the Regulatory Authorities in the Territory have approved the Drug Approval
Application, Sucampo shall cooperate with Gloria’s reasonable requests relating to, and provide support in responding to,
communications from Regulatory Authorities in the Territory related to the Product in the Field, including using Commercially Reasonable
Efforts to provide comments on Gloria’s submissions’ and responses within ten (10) Business Days from the time of receipt
or sooner if required by such Regulatory Authorities.


 


(d)              
Occurrences or Information Arising out of Sucampo Manufacturing Activities. During the Term, Sucampo will advise
Gloria, without undue delay following, and in any event within a period not to exceed [...***...] of, any occurrences
or information arising out of Sucampo’s manufacturing activities that Sucampo is aware have or could reasonably be expected
to have adverse regulatory compliance and/or reporting consequences concerning the Product in the Field in the Territory, including
actual or threatened Regulatory Filing withdrawals or labeling changes to the Product in the Field in the Territory.


 


(e)               
Regulatory Authority Inspections. During the Term, each Party will be responsible for handling and responding to
any Regulatory Authority inspections with respect to the Party’s role in the Development, manufacture, Promotion and Commercialization
of the Product in the Field in the Territory. Each Party will provide to the other Party any information reasonably requested by
the other Party and all significant information requested by any Regulatory Authority in the Territory concerning any governmental
inspection related to the Product, and will allow Regulatory Authorities in the Territory to conduct reasonable inspections upon
the request of such Regulatory Authority. In the event such Regulatory Authorities conduct an inspection, the Party under inspection
will inform the other Party of the occurrence of such inspection, and invite the other Party to participate in the inspection process.


 


(f)               
Violations or Deficiencies Relating to the Product. In the event a Party is inspected by any Regulatory Authority
in the Territory, the inspected Party will notify the other Party without undue delay, and in any event within a period not to
exceed [...***...], of any written alleged violations or deficiencies relating to the Product, and any proposed corrective
actions to be taken. The inspected Party shall as expeditiously as practicable take any such corrective action required to comply
with the provisions of this


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Agreement and Applicable
Law. Prior to submission of any written response submitted to any applicable Regulatory Authority in the Territory, to the extent
reasonably practicable, the other Party may review and comment on any portion of the response regarding written alleged violations
or deficiencies relating to the Product; provided that the inspected Party shall have final say regarding the content of any submission
to such Regulatory Authority.


 


6.2             
Product Labels and Inserts; Core Data Sheets. Sucampo shall own and be responsible for the manufacturing of all Product
Labels and Inserts and Core Data Sheets for the Product in the Field in the Territory. Gloria shall provide the artwork for the
Product Labels and Inserts, subject to Sucampo’s prior written consent, which shall not be unreasonably withheld, conditioned
or denied. Gloria shall not alter, change or in any way modify the artwork that has previously been approved, for any reason, without
Sucampo’s prior written consent, which shall not be unreasonably withheld, conditioned or delayed, and provided that such
approved artwork shall conform to all applicable Laws and Regulatory Approval.


 


6.3             
Pharmacovigilance Administration. Sucampo delegates to Gloria the responsibility, and Gloria shall bear all costs,
of pharmacovigilance administration of the Compound and Product in the Field in the Territory in accordance with the Development
Plan, the Pharmacovigilance Agreement and all Applicable Law, including without limitation, any post-marketing Clinical Studies
obligations (PMS) and any obligations to submit periodic safety updated reports (PSUR) to the Regulatory Authorities in the Territory.
Sucampo shall ensure that it and its Affiliates provide Gloria with all information and data reasonably required to allow Gloria
to comply with its regulatory obligations.


 


6.4             
Adverse Event Reports. Sucampo delegates to Gloria the responsibility for investigating Adverse Events, Serious Adverse
Events and other required safety information associated with the Clinical Studies and any Post-Approval Marketing Studies of the
Compound and the use of the Product in the Field in the Territory according to the requirements of PRC law. Gloria shall be responsible
for the collection, review, assessment, tracking and filing of information related to Adverse Events and Serious Adverse Events.
Gloria shall set up special bodies and arrange for full-time personnel with professional knowledge about medicine, pharmacy, epidemiology
and statistics and the ability to scientifically analyze and assess Adverse Events and Serious Adverse Events to undertake the
reporting and monitoring of Adverse Events and Serious Adverse Events. Each Party shall ensure that it and its Affiliates promptly
provide the other Party with all necessary information and data to allow the other Party to comply with its regulatory obligations.
Within [...***...] from the Effective Date, the Parties shall enter into an agreement to initiate a process for the exchange
of Adverse Event and Serious 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, sublicensees, Distributors or other 


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Subcontractors in order
to monitor the safety of the Product in the Field and the Territory, and to: (a) establish and keep detailed files for the reporting
and monitoring of Adverse Events and Serious Adverse Events, (b) investigate any Adverse Events and Serious Adverse Events,(c)
meet notification and reporting requirements with any applicable Regulatory Authority and (d) implement effective measures to reduce
and prevent the repeated occurrence of Adverse Events or Serious Adverse Events, all of the foregoing, in accordance with all Applicable
Law (“Pharmacovigilance Agreement”).


 


6.5             
Recalls and Market Withdrawals


 


6.5.1       
Notification. Each Party shall make every reasonable effort to notify the other Party promptly (but in no event later
than [...***...] upon its determination that any event, incident or circumstance has occurred that may result in the
need for a Recall or Market Withdrawal of the Product in the Field in the Territory, and include in such notice the reasoning behind
such determination and any supporting facts.


 


6.5.2       
Initiation. Both Parties shall jointly determine whether to voluntarily implement any Recall and upon what terms
and conditions the Product in the Field shall be subject to a Recall in the Territory. Both Parties shall jointly determine whether
to voluntarily implement a Market Withdrawal in the Territory and upon what terms and conditions the Product in the Field shall
be subject to a Market Withdrawal or otherwise temporarily or on a limited basis withdrawn from sale in the Territory; provided
that notwithstanding the foregoing or anything to the contrary in this Agreement, Sucampo may, in accordance with its internal
regulations with respect to compliance and Adverse Events and Serious Adverse Events, cause Gloria and its Sublicensees and Subcontractors
to cease or suspend the Development, Promotion and Commercialization of the Compound and Product, as applicable, upon reasonable
written notice to Gloria. In addition to and not in lieu or limitation of the foregoing, in the event that Sucampo and Gloria are
unable to agree whether or not to implement a voluntary Recall or Market Withdrawal of the Product in the Territory, notwithstanding
anything herein to the contrary, Sucampo shall make the final determination but Gloria shall have the right to immediately terminate
this Agreement if it disagrees with Sucampo’s determination. If a Recall is mandated by a Regulatory Authority, Gloria shall
initiate such a Recall to be in compliance with Applicable Law. In the event of any voluntary Recall, Market Withdrawal or other
withdrawal of the Product in the Field in the Territory, Gloria shall Recall or Withdraw the Product in the Field in the Territory.
Each Party shall ensure that it and its Affiliates provide the other Party with all necessary information and data and any necessary
assistance and support required by Applicable Law to support the Recall or Withdrawal of the Product in the Field in the Territory.


 


6.5.3       
Responsibility. In the event of a Recall or Market Withdrawal of the Product in the Field in the Territory or any
lot(s) thereof, Gloria shall bear all costs and 


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expenses of such Recall
or Market Withdrawal, including expenses and other costs or obligations of Third Parties, the cost and expense of notifying customers
and the costs and expenses associated with the Market Withdrawal or Recall of the Product in the Field in the Territory and the
cost and expenses of destroying the Product in the Field in the Territory recalled from the market, if necessary, unless such Recall
or Market Withdrawal was caused by: (a) the manufacturing and supply of the Product by Sucampo for commercial distribution and
use in the Field and Territory; provided that the defect of the Product in the Field in the Territory that resulted in the Market
Withdrawal or Recall is a Patent Defect or Latent Defect that existed prior to delivery of the Product to Gloria, or (b) Sucampo’s
final determination to implement a voluntary Recall or Market Withdrawal of the Product in the Field in the Territory after the
Parties are unable to agree with respect to the same and it is later determined that such Recall or Market Withdrawal was not necessary,
or (c) other causes solely attributable to Sucampo, in which case, Sucampo shall pay for all costs and expenses of such Recall
or Market Withdrawal to the extent such Recall or Market Withdrawal was directly caused by Sucampo.


 


6.6             
Complaints. Each Party shall maintain a record of all complaints it receives from a Third Party with respect to any
Product in the Field in the Territory and shall refer to the other Party complaints that it receives concerning the Product in
the Field in the Territory within [...***...] of its receipt of the same; provided that all complaints concerning suspected
or actual Product tampering, contamination or mix-up (e.g. wrong ingredients) shall be delivered within [...***...] of
receipt of the same. Each Party shall be responsible for investigating complaints and taking corrective action as necessary and,
in addition to the foregoing, Gloria shall provide all reasonable efforts and collaboration with Sucampo in the resolution of complaints,
and shall train its employees on the proper handling and resolution of complaints concerning the Product in the Field in the Territory.


 


ARTICLE 7

PROMOTION AND COMMERCIALIZATION OF PRODUCTS


 


 


7.1             
Commercialization Plan


 


7.1.1       
Initial Plan and Updates. Approximately [...***...] prior to the estimated date for the filing of the Drug
Approval Application, Gloria shall prepare and submit to the JCC for approval the initial Commercialization Plan by market in the
Territory. The Commercialization Plan shall be revised annually by Gloria and submitted to the JCC for written approval on or before
November 30 of each year. The initial Commercialization Plan for the Territory shall include:


 


(a)               
The pre-launch plans with milestones to be achieved in the launch period and through year three, five, seven, and ten;



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(b)              
the number of full-time representative equivalents to be deployed during the launch and during the Term;


 


(c)               
a detailed P&L for the Product in the Field in the Territory, the detailed budget for each year of the Term, and revenue
and sales forecasts for year of the Term; and


 


(d)              
marketing plans to achieve revenue and sales forecasts.


 


7.1.2       
Contents of Plan. Gloria shall, among other things, update the initial Commercialization Plan annually, identify
specific Gloria responsibilities for Promotion and Commercialization of the Product in the Field in the Territory, including the
estimated number of FTEs to be used to Promote the Product in the Field in the Territory, the key annual internal goals of the
Gloria’s commercial team for the Product in the Field in the Territory by market and the annual forecasts for sales volume
in the Territory by market. For the purposes of this Section 7.1.2, “FTE” means the equivalent of the work of
one (1) employee full time for one (1) year for work directly related to the Promotion and/or Commercialization of the Product
in the Field in the Territory or any other activities specifically permitted under this Agreement.


 


7.2             
Responsibility. Subject to the terms and conditions of this Agreement, Gloria shall be responsible for all aspects
of Commercializing the Product in the Field in the Territory in accordance with the Commercialization Plan and all Applicable Law,
including, but not limited to, the utilization of Third Parties (including Distributors) to Commercialize the Production the Field
in the Territory solely as and to the extent permitted pursuant to Section 7.3 below.


 


7.3             
Subcontracting. Subject to Section 2.1.2, Gloria may at its discretion, perform any activities in support if its
Commercialization of the Product in the Field in the Territory through contracting to a Distributor or other Third Party (“Subcontractor”)
without prior consent of Sucampo; provided that: (a)  prior to Gloria subcontracting any Commercialization activities it shall
notify Sucampo of the identity of any such Subcontractor and ensure that such Subcontractor meets any minimum standards as may
be required by Sucampo to perform the activities as a Subcontractor; (b) Gloria shall enter into an appropriate written agreement
with any such Subcontractor such that the Subcontractor shall be bound by all applicable provisions of this Agreement to the same
extent as Gloria and such that Sucampo’ rights under this Agreement are not adversely effected, including without limitation
Sucampo’s rights under Section 2.1.4; (c) any such Subcontractor to whom Gloria discloses Confidential Information of
Sucampo shall enter into an appropriate written agreement obligating such Subcontractor to be bound by obligations of confidentiality
and restrictions on use of such Sucampo Confidential Information that are no less restrictive than the obligations in this Agreement;
and (d) Gloria shall at all times be fully responsible and liable for any action or omission of such Subcontractor which would
constitute a breach of this Agreement if committed by Gloria as if Gloria had committed such action or inaction itself. Upon any
expiration or termination of this Agreement for any reason, all agreements with Subcontractors shall automatically terminate.


 



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7.4             
Sales Efforts by Gloria. Gloria shall use Commercially Reasonable Efforts in accordance with the terms and conditions
of this Agreement and all Applicable Law (a) to Commercialize the Product in the Field in the Territory throughout the Term, and
(b) to accomplish the objectives set forth in the Commercialization Plan. In the event the Gloria fails to Commercialize the Product
in the Field in the Territory within [...***...] of the [...***...], Sucampo has the right to terminate this
Agreement under Section 12.2.1.


 


7.5             
Sales Volume Target. In the event Gloria fails to achieve, in the aggregate, the Cumulative Sales Volume Target during
the first to occur of (i) the [...***...] after the [...***...] of the [...***...] in the [...***...]
in the [...***...] and (ii) the [...***...] after the [...***...] the [...***...] is [...***...]
on the [...***...], Sucampo may terminate upon [...***...] prior written notice to Gloria In no event shall
Sucampo’s termination of the Agreement under this Section 7.5 prevent Sucampo from pursuing any other rights or remedies
under this Agreement or at law or in equity for breach of any other provision of this Agreement, including Section 7.3.


 


7.6             
Costs. Gloria will be responsible for all costs of Commercialization in the Territory, including the costs of developing
all Promotional Materials, scientific meetings, CME-related educational symposia, promotional marketing programs, sales training,
distribution, salaries and similar expenses, as appropriate.


 


7.7             
Promotional Materials


 


7.7.1       
Materials. During the Term, Gloria shall be solely responsible for creating and developing all Promotional Materials
to be used in connection with the Promotion of the Product in the Field in the Territory. All Promotional Material are subject
to the prior review, comment and approval of the JCC. Unless and until Promotional Materials are approved by JCC for publication
or other general dissemination, such Promotional Materials shall be maintained in strict confidence. Gloria shall ensure that all
Promotional Materials comply with all Applicable Laws in the Territory and do not infringe or otherwise violate the intellectual
property or other rights of any Third Party. To the extent that any Promotional Materials are required by Applicable Law to be
submitted to the Regulatory Authority in the Territory, Gloria shall make such submissions, and Gloria shall be the Regulatory
Authority liaison on all marketing, advertising and Promotional matters for the Product in the Field in the Territory. Sucampo,
if and to the extent permitted under any agreement with other parties, shall provide Gloria with copies of Promotional Materials
used by Sucampo, its Affiliates, its licensees and distributors. During the Term, Gloria shall own all rights to the Promotional
Materials in the Territory but shall only use such Promotional Materials for the Promotion of the Product in the Field in the Territory
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compliance in all respects
with this Agreement and all Applicable Laws. To the maximum extent permitted by Applicable Law, Gloria agrees that it shall and
hereby does, and shall cause its Affiliates to, irrevocably grant, convey, transfer, assign and deliver to Sucampo all right, title
and interest in and to such Promotional Materials (and all intellectual property rights therein or thereto), in perpetuity and
throughout the world upon the expiration or termination of this Agreement. Notwithstanding the foregoing, Sucampo agrees not to
exercise its ownership rights with respect to the Promotional Materials until the expiration or termination of this Agreement.
Upon termination or expiration of this Agreement, Gloria shall, at Sucampo's discretion, destroy all such Promotional Materials
or, at Sucampo's cost, return all such Promotional Materials to Sucampo.


 





7.7.2       
Presentation and Promotion of the Product. The Commercialization Plan shall describe the manner in which the Product
in the Field in the Territory will be presented and described to the medical community in any Promotional Materials or other materials
and the placement of the Corporate Names of the Parties, in each case as permitted by Applicable Law in the Territory and with
the Product Labels and Inserts for the Product approved by the applicable Regulatory Authority in the Territory. Gloria shall have
the right to display its Corporate Name and logo on the packaging of the Product in the Field in the Territory subject to Applicable
Law in the Territory and Sucampo’s Trademark Guidelines.


 


7.8             
Non Compete. During the Term, Gloria and Sucampo shall refrain, and shall cause their respective Affiliates, to refrain
from developing, promoting, marketing, selling, offering to sell, distributing, commercializing or otherwise exploiting any pharmaceutical
product of the same active ingredient in the Territory other than the Product in the Field in the Territory (a “Competing
Product”), without the prior written approval of the other Party, which approval shall not be unreasonably withheld, conditioned
or delayed. Such approval shall be notified no later than [...***...] following the date of the other Party’s receipt
of request from such Party.


 


ARTICLE 8

CONSIDERATION


 


8.1             
Upfront Payment. Gloria shall make a nonrefundable[...***...] payment to Sucampo in the amount of USD One
Million (US$1,000,000), within [...***...] of the Effective Date and USD Five Hundred Thousand ($500,000) within [...***...]
of the first IND approval.


 


8.2             
Milestone Payments. Gloria shall make the following non-refundable 


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payment to Sucampo, in
the amounts set forth below, on a one (1) time basis and meet the milestone event within the time period specified below:


 





	Milestone Event	Milestone Payment
	1.	Upon the first to occur (i) the [...***...]  the [...***...] is [...***...] on the [...***...] in the Territory and (ii) the date the [...***...] of the Product [...***...] in the Territory.	USD One Million Five Hundred Thousand (US$1,500,000), within [...***...] ([...***...]) Business Days after the occurrence of the milestone event



 


8.3             
Invoice Price. When supplying the Product in the Field to Gloria under ARTICLE 9, promptly after shipment of such
Product to Gloria, Sucampo shall invoice Gloria the Invoice Price and costs of Additional Materials for such Product shipped to
Gloria. Gloria shall pay for such Product and Additional Materials within [...***...] after such shipment is [...***...]
by Gloria in the [...***...] by Gloria, provided that if Gloria rejects such Product pursuant to Section 9.7 due to a
Patent Defect, a Latent Defect or because the delivery of such Product is not in compliance with the quantities set forth on the
relevant purchase order, then, in the case the Product in the Field is not in compliance with the quantities set forth in the purchase
order, payment shall still be due for the quantities actually shipped to Gloria pursuant to Section 9.7 within [...***...]
after such invoice is received by Gloria or, in the case of a Patent Defect or Latent Defect, payment shall be due within [...***...]
after receipt by Gloria of notice from the laboratory or other expert that the invoiced Product in the Field does not contain a
Patent Defect or Latent Defect. In the event that Product delivery is delayed by the Regulatory Authority at the port designated
by Gloria, Gloria shall by written notification to Sucampo request that the time periods set forth above in this Section 8.4 be
extended for a period of time that Gloria and Sucampo negotiate in good faith.


 


8.4             
Third Party Royalties. If the Development, Promotion or Commercialization of the Product by Gloria in the Field in
the Territory infringes or misappropriates any intellectual property rights of a Third Party (other than Gloria’s Affiliate)
or Sucampo Affiliate in the Field in the Territory such that Gloria cannot Develop, Promote or Commercialize the Product in the
Field in the Territory as provided for herein without infringing such intellectual property rights of such Third Party (other than
Gloria’s Affiliate) and/or Sucampo Affiliate, then each Party shall promptly notify the other Party upon becoming aware of
the same and Sucampo may, along with indemnification as and to the extent set forth below and to the maximum extent permitted by
Applicable Law, as Gloria’s sole and exclusive remedy and at Sucampo's sole option and discretion, and to the reasonable
satisfaction of Gloria: (a) obtain such licenses and rights as are necessary for 


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Gloria to Develop, Promote
or Commercialize the Product in the Field in the Territory as expressly provided for herein within [...***...] after
Sucampo becomes aware of such infringement or misappropriation with respect to such Product in the Field in the Territory as set
forth in this Section 8.5 above and Sucampo shall be solely responsible for the payment of all such Third Party Royalties; or (b)
replace or modify any affected Sucampo Background Technology within [...***...] after Sucampo becomes aware of such infringement
or misappropriation with respect to such Product in the Field in the Territory as set forth in this Section 8.4 above, so that
it does not infringe such intellectual property rights of such Third Party (other than Gloria’s Affiliates) at Sucampo’s
sole cost and expense, provided however that with respect to (i) any such infringement or misappropriation before Sucampo implements
a remedy in accordance with this Section 8.4 and (ii) any such infringement or misappropriation which is not remedied in accordance
with this Section 8.4, Sucampo shall indemnify, defend, and hold harmless Gloria against any Losses resulting from a Third Party
Claim to the extent that such Third Party Claim results from such infringement or misappropriation pursuant to Section 14.2, including
paying the costs of such defense and any judgments finally awarded to such Third Party (other than Gloria’s Affiliates) by
a court of competent jurisdiction or settlements entered with such Third Party (other than Gloria’s Affiliates) and Gloria’s
reasonable attorneys’ fees to the extent that such Third Party Claim results from such infringement or misappropriation.
For the avoidance of doubt, Gloria shall not be entitled to indemnification with respect to such infringement or misappropriation
under this Agreement, including Section 8.4 and Section 14.2, if Sucampo has implemented a remedy in accordance with Section 8.4(a)
or Section 8.4(b).


 


8.5             
Audit Rights. Each Party shall keep and maintain for at least [...***...] complete and accurate records
in sufficient detail to allow confirmation of any payment calculations made hereunder. Upon the written request of a Party (“Auditing
Party”) and not more than once in each Calendar Year, the other Party (“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 acceptable to the Audited Party, at the Auditing
Party’s expense, to have access, with not less than [...***...] 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 [...***...] 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 Confidential 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 


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owed by the Audited Party
to the other, the Audited Party shall pay the additional monies within [...***...] 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 [...***...] 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. Gloria shall either: (a) require each of its Affiliates and other Sublicensees to maintain similar
books and records and to open such records for inspection to the accounting firm in the manner paralleling that set forth in this
Section 8.5, or (b) obtain such audit rights from its Affiliates and other Sublicensee for itself and exercise such audit
rights on behalf of Sucampo upon Sucampo’s request and disclose the results thereof to Sucampo. In either case Sucampo shall
be deemed the Auditing Party, and such Sublicensee the Audited Party for purposes of this Section 8.5.


 


8.6             
Withholding Taxes. All payments made under this Agreement shall be free and clear (exclusive of) of any and all taxes,
duties, levies, fees or other charges required by Applicable Law, except that such payments may be subject to any withholding taxes.
Where any sum due to be paid to a Party hereunder is subject to any withholding tax under Applicable Law, 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 under Applicable
Law, the paying Party shall deduct any 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 obligation together with proof of payment.


 


8.7             
Payments. All payments due under this Agreement shall be payable in USD. Unless expressly specified otherwise herein,
all payments under this Agreement shall be by appropriate electronic funds transfer in immediately available funds to the following
bank account of Sucampo:


 


Bank information






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For USD






	
        Bank: 

         
	[...***...]
	
        Address: 

         
	[...***...]
	
        Swift Code:

         
	[...***...]
	
        Account:

         
	[...***...]
	
        Contact Person:

         
	[...***...]
	
        Telephone:

         
	[...***...]


 


Each payment shall
reference this Agreement and identify the obligation under this Agreement that the payment satisfies. If at any time legal restrictions
prevent the remittance of part or all of payments owed by a Party hereunder in the Territory, payments due hereunder shall continue
to accrue until such time payment shall be made through any lawful means or methods that may be available as the Parties shall
reasonably determine.


 


8.8             
No Other Compensation. Unless otherwise agreed to by the Parties and set forth in writing, Sucampo and Gloria hereby
agree that the terms of this Agreement and all ancillary agreements hereto fully define all consideration, compensation and benefits,
monetary or otherwise, to be paid, granted or delivered by each Party to the other in connection with the transactions contemplated
herein. Neither Party has previously paid or entered into any other commitment to pay, whether orally or in writing, any employee
of the other Party, directly or indirectly, any consideration, compensation or benefits, monetary or otherwise, in connection with
the transactions contemplated herein.


 


ARTICLE 9

SUPPLY


 


9.1             
General


 


9.1.1       
Strategy. The JCC shall determine the supply strategy for the Compound and the Product in the Field in the Territory.
The Parties, through the JCC, shall provide regular updates on the supply of Product in the Field in the Territory, and issues
related thereto. The Parties will review the supply strategy on an ongoing basis to ensure adequate risk mitigation for supply
of the Compound and the Product for the Field in the Territory. Sucampo shall keep Gloria reasonably informed of inventory or production



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issues that
it is aware may affect the availability of Product for the Field in the Territory. Gloria hereby acknowledges and agrees that it
shall, and shall cause each of its Affiliates and other Sublicensees to, exclusively purchase the Product in the Field from Sucampo
during the Term.


 


9.1.2       
Manufacturing by Sucampo. Subject to the terms and conditions of this Agreement, Sucampo shall manufacture (or have
manufactured by a Third Party), in compliance with the Specifications and test and supply to Gloria and/or its Affiliates or Sublicensees
Product in the Field, in the quantities and at times as provided herein, for the Commercialization thereof. All such Product in
the Field manufactured and supplied by or on behalf of Sucampo shall:


 


(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 [...***...]of [...***...] months;


(e)               
be free from material defects in materials and workmanship; and


(f)               
be in material compliance with all Specifications for the Product in the Field.


 


9.1.3       
Supply of Additional Materials. Sucampo shall purchase or have purchased all Additional Materials (as referred to
in the relevant Regulatory Approvals) which are needed for the manufacture of the Product in the Field as per the current regulatory
files, at Gloria’s sole cost and expense. Gloria shall pay for the cost of the Additional Materials in accordance with Section
8.4.


 


 


9.1.1       
Samples Supply for Clinical Trials. Sucampo or its designated CMO shall manufacture and supply the Product and placebos
[...***...] (Incoterms 2010) and Gloria shall pay [...***...] for the Product and the placebos for the clinical
trials as per the regulatory requirements in the Territory.


 


9.1.5                   
Sufficient Inventories. For the Term, and subject to the timely supply of the Rolling Forecast pursuant to Section
9.1.6, Sucampo shall use Commercially Reasonable Efforts to cause its supplier to maintain sufficient inventories of Additional
Materials required to manufacture the Product in the Field in order to ensure timely delivery of the Product in the Field. If only
one site is used for manufacturing the Compound, Sucampo shall use Commercially Reasonable Efforts to cause its supplier to maintain
a safety stock of active Compound equal to [...***...] of forecast demand based on Gloria’s 


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most recent Rolling Forecast.
Sucampo shall use Commercially Reasonable Efforts to cause its supplier to maintain a safety stock of Additional Materials to support
the Product manufacture and packaging equal to [...***...] of forecast demand based on Gloria’s most recent Rolling
Forecast.


 


9.1.6       
Supply Price. In the event a Generic Product enters the Field in the Territory, the Parties will work together in
good faith to re-evaluate the Supply Price in order to maintain market competitiveness.


 


9.1.7       
Forecasts and Orders.


 


(a)               
No later than the [...***...] of each [...***...] during the Term, Gloria will provide Sucampo with
an updated [...***...] rolling forecast of the Product in the Field to be manufactured and supplied by or on behalf of
Sucampo (each a “Rolling Forecast”) for the [...***...] period commencing at the beginning of the
following month with the first [...***...] considered a purchase order period. Each Rolling Forecast will be broken down
for each [...***...] of such period into the quantity (by SKU, packaging and size of Product) and shipping dates. The
first [...***...] of each new Rolling Forecast will restate the balance of the purchase order period of the prior Rolling
Forecast, and the [...***...] of the Rolling Forecast will constitute the new purchase order for which Gloria will be
obligated to purchase and take delivery of the Product.


 


(b)              
Except as set forth herein, all months of the Rolling Forecast other than the first [...***...] will set forth
Gloria’s best estimate of its requirements for the supply of Product in the Field in the Territory, and the Rolling Forecast
for the [...***...] through [...***...] of each Rolling Forecast will not be binding.


 


9.1.8       
Purchase Order. All purchases of Product shall be pursuant to written purchase orders consistent with Section 9.1.6(a),
which shall be placed by Gloria at least [...***...] prior to the date of which such Product shall be delivered to Gloria
or the applicable Affiliate or Sublicensee. Each such purchase order will be consistent with the purchase order period of the most
recent Rolling Forecast. If a purchase order for any month is not submitted by the above deadline, Gloria will be deemed to have
submitted a purchase order in that month for the amount of Product set forth in the most recent Rolling Forecast for such month.
Each purchase order hereunder shall specify the desired quantities of each of the Product, in finished forms and samples, and the
delivery dates therefor.


 


9.1.9       
Acceptance of Orders. Orders and delivery dates will be deemed accepted unless Gloria and/or its Affiliate or Sublicensee
receives written notice of rejection within [...***...]. Sucampo may only reject an order (a) that lists products that
are not covered by this Agreement, (b) that is inconsistent with the amounts permitted by 


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Section 9.1.5 and
Section 9.1.7 or (c) during a supply constraint situation in accordance with Section 9.2.1below.


 


9.1.10   
Subcontracting. Gloria hereby authorizes that Sucampo may subcontract the manufacturing of the Compound, the Product
and Additional Materials without the prior written consent of Gloria.


 


9.2             
Delivery. The Products including the Additional Materials hereunder shall be delivered [...***...] to the
[...***...] in the Territory ([...***...] will [...***...] for the [...***...] for delivering
the Products to the [...***...] in the Territory) (Incoterms 2010) for the relevant Product on or up to [...***...]
before the delivery date specified in the order accepted by Sucampo, subject to the release of such Products as per Section 9.3.
Gloria shall designate to Sucampo the [...***...] which will [...***...] of the Product. Sucampo shall contact
such [...***...] when the Product is [...***...] for [...***...] and shall [...***...]
for [...***...], and [...***...] of such Product. Sucampo shall inform Gloria [...***...] prior to
[...***...] by the [...***...] . [...***...] shall [...***...] the [...***...]
and will be [...***...] by the[...***...] for [...***...] of the Product from the [...***...]
of [...***...] to [...***...] of [...***...]. Gloria will notify Sucampo in writing the delivery
documents including PO number, quantity, copy of the certificate of analysis, items codes and description, lot number, expiry date
of Product, number of shippers, weight, number of pallets and other documents required by the Regulatory Authorities in the Territory
for Gloria to import the Product and conduct customs clearance.


 


9.2.1       
Limited Supply. In the event that Product is in short supply, Sucampo shall notify Gloria of such shortage as soon
as possible upon becoming aware of the same. In the event there is a short supply of Product and Sucampo cannot supply such Product
to Gloria in an amount equal to Gloria’s firm order, then Sucampo shall use Commercially Reasonable Efforts to allocate such
available Product and cause its Third Party manufacturer to allocate manufacturing capacity to provide to Gloria in each month
that such a shortfall exists (and in each month thereafter until the shortfall to Gloria is remedied) the Product in an amount
equal to (a) the amount of available [...***...] and/or [...***...], multiplied by (b) a [...***...]
of which is (i) the [...***...] Gloria over the subsequent [...***...] period including the shortfall month
and the [...***...] of which is (ii) the [...***...] of (x) the [...***...] of [...***...]
made by Gloria over the subsequent [...***...] period including the shortfall months and (y) the [...***...]
of Compound or Product over the same [...***...] period required by other licensees outside the Territory by reference
to firm orders placed with Sucampo for such licensees’ requirements outside the Territory.


 


9.2.2       
Specifications. Sucampo shall manufacture and package the Product in material compliance with (a) the Specifications,
(b) cGMP, and (c) any other requirements set forth in the Regulatory Approval for the relevant Product in the Field in 


*Confidential
Treatment Requested



    	47



    	 



    




the Territory and other
applicable laws in the PRC as such requirements are identified and provided to Sucampo in writing and in the English language.
Unless agreed otherwise by Gloria in writing, all Products supplied by Sucampo shall have a minimal shelf life of [...***...].


 


9.3             
Testing and Release. Testing and release of the Product shall be made in accordance with Quality Agreement and any
amendments thereto and/or any changes to the People’s Republic of China pharmacopoeia. During the Term, Sucampo will conduct
the commercial stability program with respect to the Product pursuant to Applicable Law, at its own expense.


 


9.4             
Records. At its own cost, Sucampo shall keep and maintain documentation and records with respect to manufacturing,
testing and delivery of Product in accordance with Applicable Law.


 


9.5             
Manufacturing Changes. Sucampo assumes any and all responsibility for any changes that it makes to the manufacturing
processes and test methods for the Product, and for any other changes that it makes relating to the manufacture of such Product
at the manufacturing location, that are not specific to such Product, and will solely bear all expenses related thereto.


 


9.6             
Quality Agreement. A Quality Agreement shall be executed between Sucampo and Gloria within [...***...]
of the expected launch date.


 


9.7             
Non-Conforming Shipment. Gloria will have a period of [...***...] from the date of its receipt of a shipment
of Product to: (a) inspect and reject such shipment for Patent Defects and (b) report any discrepancy in the quantity of the SKUs
of such Product for such shipment, in each case, based on Gloria’s normal incoming commercially reasonable -goods inspections
procedures. If Gloria provides Sucampo with a notice of non-conformity in respect of any discrepancy in the quantity of the SKUs
of the Product for any shipment within such [...***...] period then, as Gloria’s sole and exclusive remedy, Gloria
shall have the option of: (i) in the event of a shortfall in the quantity of such delivered Product, (x) requiring Sucampo
to, and Sucampo shall, promptly supply Gloria with such additional Product as is necessary to meet the amount ordered at Sucampo’s
sole cost and expense for shipping, through the carrier used to deliver such Product to Gloria (or such other carrier as Sucampo
may direct in writing), or (y) paying for the quantity actually received in accordance with the provisions of ARTICLE 8 without
requiring Sucampo to supply any additional Product as is necessary to meet the amount ordered or (ii) in the event of an excess
in the quantity of the delivered Product, (x) returning the excess units to Sucampo, at Sucampo’s sole cost and expense
for shipping, through the carrier used to deliver such Product to Gloria (or such other carrier as Sucampo may direct in writing),
or (y) accepting any such excess Product as against future orders of Product. In each case,


*Confidential
Treatment Requested



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Gloria shall pay for
the quantity actually received and accepted unless otherwise agreed in writing by the Parties. In the event Gloria wishes to reject
any such shipment for a Patent Defect, Gloria shall provide Sucampo with written notice of such rejection for any Patent Defect
within such period of [...***...] together with samples of the non-conforming Product in the relevant shipment for testing.
In the case of Product with Latent Defects, Gloria will promptly, and in no event more than [...***...] of Gloria knowing
of any such Latent Defect, notify Sucampo in writing of such Latent Defect; provided however, that any Latent Defect must be notified
no later than [...***...] following the date of Gloria’s receipt of a shipment of the applicable Product, together
with samples of such non-conforming Product in the relevant shipment for testing. If Sucampo disagrees with Gloria regarding Gloria’s
rejection of a shipment or portion thereof based on a Patent Defect or a Latent Defect , the Parties will submit samples of such
shipment to a mutually acceptable independent laboratory for testing. If such independent laboratory determines that the shipment
did not contain a Patent Defect or a Latent Defect, Gloria will bear all reasonable and recorded expenses of shipping Product to
and from and the testing by such independent laboratory for such shipment. If Sucampo or such independent laboratory confirms that
such shipment did contain a Patent Defect or a Latent Defect, Sucampo will (i) as soon as practicable, give Gloria a credit for
any amount paid with respect to that portion of the Product which had a Patent Defect or Latent Defect, (ii) bear all of Gloria’s
reasonable direct and documented out-of-pocket expenses of returning such Product to Sucampo or its designee, and (iii)all reasonable
direct and documented out-of-pocket expenses of shipping Product to and from and the testing by such independent laboratory for
such shipment. Sucampo or Gloria, as directed by Sucampo, will dispose of any non-conforming portion of any shipment in accordance
with all Applicable Law, at Sucampo’s expense for any reasonable direct and documented out-of-pocket costs actually incurred
for such disposal.


 


9.8             
Audits & Inspections. Sucampo shall use Commercially Reasonable Efforts to make available facilities being used
to manufacture Products and relevant manufacturing records for inspection by Gloria for regulatory or quality assurance purposes
upon reasonable notice and at reasonable times during normal business hours and subject to Sucampo’s customary rules and
restrictions with respect to site visits by non-Sucampo personnel; provided, however, that the inspection by Gloria hereunder shall
be within the scope of inspection that is allowed under the relevant statutes and regulations and shall be no more than once per
year.


*Confidential Treatment
Requested


 


 


 



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ARTICLE 10

CONFIDENTIALITY AND NON-DISCLOSURE


 


10.1         
Confidentiality


 


10.1.1   
Nondisclosure Obligations. The Receiving Party shall keep confidential and shall not publish or otherwise disclose
or use for any purpose other than the purpose of the Parties to perform their respective obligations and exercise their respective
rights under this Agreement, any Confidential Information of the Disclosing Party. The Receiving Party shall treat 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 disclosure of Confidential Information to a Third Party, except as explicitly set
forth herein, without written consent of the Disclosing Party.


 


10.1.2   
Exceptions to Confidentiality. The Receiving Party’s obligations set forth in this Agreement shall not extend
to any Confidential Information of the Disclosing Party to the extent that such Confidential Information:


 


(a)               
is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like or is made generally
available by a Third Party, in each case, other than through a wrongful act, fault or negligence on the part of the Receiving Party
or a breach of this Agreement;


 


(b)              
is received from a Third Party without restriction and with the right to disclose such Confidential Information;


 


(c)               
the Receiving Party can demonstrate by competent evidence 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 evidence was independently developed by or for the Receiving Party without
reference to, use of or disclosure of the Disclosing Party’s Confidential Information; or


 


(e)               
is released from the restrictions set forth in this Agreement by the express prior written consent of the Disclosing 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.


 



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10.1.3   
Authorized Disclosures. The Receiving Party may disclose Confidential Information to the extent that such disclosure
is:


 


(a)               
made in response to an 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 or 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 reasonable opinion of legal counsel to the Receiving Party, to be disclosed in such response to such court or governmental
order;


 


(b)              
otherwise required by Applicable Law or the requirements of a major national securities exchange (e.g., U.S. Securities
and Exchange Commission), in the reasonable opinion of legal counsel to the Receiving Party, provided that the Party disclosing
such Confidential Information shall exercise its commercially reasonable efforts to obtain a protective order or other reliable
assurance that confidential treatment will be accorded and if possible give the other Party a reasonable opportunity to review
and comment on any such disclosure in advance thereof (but not less than [...***...], 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 of such information;


 


(d)              
 (i) reasonably necessary in filing or prosecuting of Sucampo Patent Rights directed to the Compound or the Product in the
Field in the Territory or (ii) reasonably necessary in defending litigation related to Sucampo Patent Rights in the Territory if
such litigation relates to this Agreement; and


 


(e)               
to the extent necessary, and subject to sublicensing and subcontracting provisions set forth in this Agreement, to its Affiliates,
directors, officers, employees, consultants, advisors, sublicensees or subcontractors of Gloria or Sucampo,


*Confidential
Treatment Requested


 



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under written agreements
of confidentiality substantially similar to and 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.


 


10.2         
Patient Information. The Parties shall abide (and cause their respective Affiliates and sublicensees to abide), and
take (and cause their respective Affiliates and sublicensees to take) all reasonable and appropriate actions to ensure that all
Third Parties conducting or assisting with any clinical development activities hereunder in accordance with, and subject to the
terms of, this Agreement, shall abide, to the extent applicable, by all Applicable Law concerning the confidentiality or protection
of patient identifiable information and other patient protected health information.


 


10.2.1   
Ownership of Confidential Information. The Receiving Party agrees that it shall not receive any right, title or interest
in, or any license or right to use, the Disclosing Party’s Confidential Information (including, without limitation, all copies,
extracts and portions thereof) or any intellectual property rights therein, by implication or otherwise, except as expressly and
specifically permitted herein. All rights relating to the Disclosing Party’s Confidential Information that are not expressly
granted hereunder to the Receiving Party are reserved and retained by the Disclosing Party.


 


10.2.2   
Confidentiality Agreement. If any terms or conditions set forth in this ARTICLE 10 conflict with or are inconsistent
with the terms and conditions of the Confidentiality Agreement, this ARTICLE 10 will govern over the Confidentiality Agreement
to the extent of such conflict or inconsistency.


 


10.3         
Press Releases; Publications; Use of Name and Disclosure of Terms.


 


10.3.1   
Press Release. The Parties have agreed upon the content of a press release which shall be issued substantially in
the form attached hereto as Exhibit I as soon as practicable after the execution and delivery of this Agreement. Except for
the press release set forth on Exhibit I, each Party shall maintain the confidentiality of all provisions of this Agreement and
this Agreement itself and, without the prior written consent of both Parties, no Party shall make any press release or other public
announcement of or otherwise disclose to any Third Party this Agreement or any of its provisions, except for: (a) disclosure to
those of its directors, officers, employees, accountants, attorneys, advisers and agents whose duties reasonably require them to
have access to the Agreement, provided that such directors, officers, employees, accountants, attorneys, advisers, and agents are
required to maintain the confidentiality of the Agreement to the same extent as if they were Parties hereto under written agreements
of confidentiality substantially similar and at least as restrictive as those set forth in this Agreement, (b) such disclosures
as may be required by Applicable Law pursuant to Section 10.1.3, and (c) either Party may disclose the terms of this Agreement
to its existing or potential investors, lenders, collaborative partners or, in the case of a change of control, acquirers as part
of their due diligence investigations, provided, however, that such existing investors, lenders, collaborative partners or acquirers
have agreed to maintain the confidentiality of the terms of this Agreement and to use such information solely for the purpose of
such due diligence investigation under written agreements of confidentiality substantially similar to and at least as restrictive
as those set forth in this Agreement.


 



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10.3.2   
Publications. The Parties, through the JDC, shall develop policies and procedures (the “Publication Policies”)
for any publication with respect to the results of Clinical Studies and Post-Approval Marketing Studies for a Product in the Field
in the Territory, including disclosure applicable to clinical trial registries, which policies and procedures shall be consistent
with the Parties’ respective policies and procedures for publication and disclosure of the results of human clinical trials
consistently applied. All abstracts, manuscripts and presentations (including information to be presented verbally) that disclose
results of Clinical Studies or Post-Approval Marketing Studies for a Product in the Field in the Territory shall be reviewed and
approved by the JDC in accordance with the Publication Policies. Notwithstanding the foregoing, each Party shall provide to the
other Party (through the JDC) the opportunity to review each of the submitting Party’s proposed abstracts, manuscripts or
presentations (including information to be presented verbally) in the Territory that relate to any Development activities or otherwise
with respect to the Product for use in the Field in the Territory, at least [...***...] prior to its intended presentation
or submission for publication, and such submitting Party agrees, upon written request from the other Party given within such [...***...]
period, not to submit such abstract or manuscript for publication or to make such presentation until the other Party is given up
to [...***...] from the date of such written request to seek appropriate patent protection for any material in such publication
or presentation that it reasonably believes may be patentable. Once an abstract, manuscript or presentation has been reviewed and
approved by the JDC, the exact same abstract, manuscript or presentation does not have to be provided again to the other Party
for review for a later submission for publication; provided that once the abstract or manuscript is accepted for publication or
the presentation is finalized, the submitting Party shall provide the other Party with a copy of the final version of such abstract,
manuscript or presentation. Each Party also shall have the right to require that any of its Confidential Information (but not the
results of the Clinical Studies or Post-Approval Marketing Studies for a Product in the Field in the Territory that have been approved
for disclosure pursuant to the Publication Policies) that is disclosed in any such proposed publication or presentation be deleted
prior to such publication or presentation. In any permitted publication or presentation by a Party, the other Party’s contribution
shall be duly recognized, and co-authorship shall be determined in accordance with customary standards. For the avoidance of doubt
and notwithstanding the foregoing, this Section10.3.2 shall not limit or restrict Sucampo’s ability to publish or present
publicly available information for the Product outside of the Territory or, for Other Formulation(s) or Dosage(s) or Other Indications
within the Territory (except to the extent that Gloria has exercised its right of refusal for a particular Other Formulation or
Dosage or Other 


*Confidential Treatment Requested



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Indication and the Parties
have reached written agreement with respect to the same under Section 5.2) or otherwise, provided that in each case such publication
or presentation does not contain Gloria’s Confidential Information.


 


ARTICLE 11

INTELLECTUAL PROPERTY RIGHTS


 


11.1         
Sucampo Intellectual Property Rights. As between the Parties, Sucampo and its Affiliates shall have sole and exclusive
ownership of all right, title and interest (subject to the licenses granted in this Agreement) in and to any and all Sucampo Patent
Rights, Sucampo Other Intellectual Property Rights, Sucampo Background Technology and Product Trademarks and, subject solely to
Section 2.1.4(a), all Technology and intellectual property rights in connection with the Product anywhere in the world, including
without limitation all Pre-Clinical Data, Clinical Data, CMC Data and other data in connection with the Product.


 


11.2         
Patent Filing, Prosecution and Maintenance. Sucampo and its Affiliates, acting through patent counsel of its choice,
and in reasonable consultation with Gloria solely during the Term, shall be responsible for the preparation, filing, prosecution
and maintenance of the Sucampo Patent Rights in the Field in the Territory. During the Term, Sucampo will notify Gloria within
[...***...] in the event that Sucampo or its Affiliates decide not to prepare, file, prosecute and/or maintain any of
the Sucampo Patent Rights in the Field in the Territory and, upon the receipt of such notice, Gloria shall then have the right
and option to do so at its own expense. For the avoidance of doubt, any Sucampo Patent Right for which Gloria assumes the responsibility
to prepare, file, prosecute and/or maintain pursuant to this Section11.2 shall remain part of the Sucampo Patent Rights and shall
be solely and exclusively owned by Sucampo.


 


11.3         
Information and Cooperation. During the Term, Sucampo shall (a) provide Gloria with copies of all patent applications
filed with respect to the Sucampo Patent Rights and other material submissions and correspondence with the People’s Republic
of China Patent Office relating thereto, in sufficient time to allow for reasonable review and comment by Gloria, (b) provide Gloria
and its patent counsel with an opportunity to consult with Sucampo and its patent counsel regarding the filing and contents of
any such application, amendment, submission or response with respect to the Sucampo Patent Rights and (c) provide notice of filing
of new Sucampo Patent Rights to Gloria within [...***...] of such filing. Sucampo hereby agrees that the advice and suggestions
of Gloria and its patent counsel shall be taken into reasonable consideration by Sucampo and its patent counsel in connection with
each filing; provided that Sucampo and its patent counsel shall make the final determination in connection with each filing.


 


*Confidential Treatment
Requested


 



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11.4         
Product Trademarks. As between the Parties, Sucampo and its Affiliates shall own all Product Trademarks and all goodwill
associated therewith. Sucampo shall be responsible for the filing, prosecution, defense and maintenance before all Trademark offices
of all Product Trademarks and using Commercially Reasonable Efforts to ensure Product Trademarks exist in the Territory, and that
any registered Product Trademarks are maintained during the Term. At Gloria’s request, Sucampo shall register domain names
containing all or any of the Product Trademarks, including without limitation, the AMITIZA Trademark in the Territory. All such
domain and account names and all goodwill associated with such use shall inure to the benefit of Sucampo.


 


11.5         
Intellectual Property Legal Actions


 


11.5.1   
Notice of Third Party Infringement and Third Party Litigation. In the event (a) either Party becomes aware of any
possible infringement, violation or misappropriation of any Sucampo Patent Rights, Sucampo Other Intellectual Property Rights or
Sucampo Background Technology relating to the Product or any Product Trademark in the Field in the Territory, (b) either Party
becomes aware of the submission by any Third Party of regulatory filing in the Territory for a product that seeks approval to sell
the Compound in Field, or the regulatory approval is granted upon such regulatory filing,(c) either Party becomes aware of any
interference, opposition, or a nullity action being filed in the Territory against any Sucampo Patent Right that relates to the
development, manufacture, use, sale, offer to sell, export, import, distribution, commercialization or other exploitation by a
Third Party of a Product in the Field, or (d) either Party becomes aware of the institution or threatened institution of any suit
by a Third Party against such Party for patent infringement involving the development, manufacture, use, sale, offer to sell, export,
import, distribution, commercialization and other exploitation of any Product in the Field in the Territory (each, an “Infringement”),
that Party shall promptly notify the other Party and provide it with all details of such Infringement of which it is aware (each,
an “Infringement Notice”).


 


11.5.2   
Sucampo’s Right to Enforce and Defend. In the event of an Infringement, Sucampo and its Affiliates shall have
the right and option to initiate legal proceedings, through counsel of its choosing, or take other commercially reasonable steps
regarding such Infringement. If Sucampo and its Affiliates do not take or initiate commercially reasonable steps to initiate legal
proceedings or take other actions regarding the Infringement within [...***...] from any Infringement Notice, then Gloria
and its Affiliates shall have the right and option to do so at its own expense and Sucampo and its Affiliates shall have the right,
at their own expense, to join such legal proceedings.


 


11.5.3   
No Settlement and Allocation of Damages. Neither Party shall settle any Infringement claim or proceeding under this
Section 11.5 without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned



*Confidential Treatment Requested


 



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or delayed. If either
Gloria and/or Sucampo collects any settlement or judgment from any Third Party infringers, the Parties shall first allocate any
such amounts to each Party equal to their respective attorneys’ fees, litigation costs and expenses in making such recovery
(which amounts shall be allocated pro rata if insufficient to cover the totality of the attorneys’ fees, litigation costs
and expenses of both Parties). To the extent that any such award of damages represents lost net sales, any additional amounts collected
shall be payable to Gloria. To the extent that any such award of damages does not represent lost net sales, Sucampo shall retain
all of any additional amounts collected after the allocation for costs described above.


 


11.5.4   
Right to Representation. Gloria and its Affiliates shall have the right, at their own expense, to participate and
be represented by counsel that it selects, in any legal proceedings or other action instituted under this Section 11.5 by Sucampo.


 


11.5.5   
Cooperation. In any action, suit or proceeding instituted under this Section 11.5, the Parties shall cooperate with
and assist each other in all reasonable respects. Upon the reasonable request of the Party instituting such action, suit or proceeding,
the other Party shall join therein and shall be represented using counsel of its own choice, at the requesting Party’s expense.


 


ARTICLE 12

TERM AND TERMINATION


 


12.1         
Term. The term of this Agreement shall commence on the Effective Date and, unless earlier terminated as provided
in this Agreement, shall expire on the thirteenth anniversary of the Effective Date (the “Term”).The Term shall
renew for successive three (3) year periods unless terminated by one (1) year prior written notice by one of the Parties; provided
that (a) the Cumulative Sales Volume Target and any other sales target have been met or exceeded by Gloria, (b) the Parties are
in compliance with the terms and conditions of this Agreement and (c) there are no unresolved disputes in which Sucampo is alleging
in good faith a breach by Gloria of its obligations under this Agreement. If the Term of this Agreement expires or this Agreement
is terminated earlier by Gloria pursuant to Sections 12.2.1or12.2.3, then, at Gloria’s request, the Parties shall negotiate
in good faith the period of time in which Gloria could continue to promote and distribute its existing inventories of the Product
in the Field in the Territory that are on hand or actually and already manufactured as of the expiration or termination date of
this Agreement in the Field in the Territory subject to all of the terms and conditions of this Agreement, including without limitation
the running royalties and other payments set forth in ARTICLE 8 or, subject to the agreement between the Parties, Gloria will sell
back to Sucampo, and Sucampo will repurchase from Gloria, at Gloria’s actual reasonable direct and documented out-of-pocket
cost, any remaining inventory of Product in the Field in the Territory with greater than [...***...] remaining shelf
life.


 



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12.2         
Termination


 


12.2.1   
Termination for Material Breach. If either Party materially breaches this Agreement, the non-breaching Party shall
have the right to terminate this Agreement by written notice unless the breaching Party remedies the default within ninety (90)
calendar days after receipt of written notice of such default.


 


12.2.2   
Termination for Failure to Comply with Applicable Law. Notwithstanding the provisions of Section 12.2.1 above, in
the event that either Party fails to comply with Applicable Law (including in accordance with Section 13.2 below) then, the other
Party may terminate this Agreement if such Party fails to cure such non-compliance with Applicable Law within sixty (60) days of
the other Party’s written notice thereof, except with respect to any breach of the anti-bribery and anti-corruption laws
in which case either Party may terminate this Agreement effective immediately and upon such termination no payments of any kind
will be payable by the other Party under this Agreement, whether accrued or otherwise.


 


12.2.3   
Termination for Insolvency. Notwithstanding the provisions of Section 12.2.1 above, 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.


 


12.2.4   
Termination for Product Withdrawal or Material Adverse Event. In the event the Product or another product containing
the Compound for use in the Field is withdrawn from the market by a Regulatory Authority in the Territory, in the United States,
Europe, Japan or other major market in the world or either Party has a reasonable health and safety concern, including due to any
Adverse Event or Serious Adverse Event, with respect to the Compound or Product, then either Party may terminate this Agreement
effective immediately upon written notice to the other Party.


 


12.3         
Consequences of Expiration or Termination of Agreement. Upon any expiration or termination of this Agreement:


 


(a)               
all rights and licenses granted by Sucampo to Gloria under this Agreement shall terminate;


 


(b)              
the license granted by Gloria to Sucampo with respect to the Gloria Developed Technology and Gloria Intellectual Property
Rights under Section 2.1.4(a) shall be exclusive even as to Gloria in the Territory;


*Confidential Treatment
Requested


 



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(c)               
all Development, Commercialization and Promotion activities under this Agreement shall promptly cease;


 


(d)              
Gloria shall cease all use of, and shall cause its Affiliate and other Sublicensees to cease all use of, the Sucampo Background
Technology, Sucampo Patent Rights, Sucampo Other Intellectual Property Rights, Promotional Materials, Product Trademarks, Sucampo’s
Confidential Information, Pre-Clinical Data, Clinical Data and CMC Data and any other data, information, materials and Technology
provided by or for Sucampo; each Party, at the request of the other Party, shall return or destroy, and thereafter provide to the
other Party written certification evidencing such destruction, all data, files, records and other materials in its possession or
control relating to the other Party’s Technology, or containing or comprising the other Party’s Confidential Information;


 


(e)               
Gloria shall provide to Sucampo: (i) one (1) copy (and all originals, if applicable) of all Regulatory Filings (including,
without limitation, all Regulatory Approvals and other documents necessary to Develop, Promote and Commercialize the Product in
the Field in the Territory, as they exist as of the date of such expiration or termination) and (ii) all documents and filings
contained in or referenced in any of the foregoing, together with the raw and summarized data for any Clinical Studies and Post-Approval
Marketing Studies (and where reasonably available, electronic copies thereof). To the maximum extent permitted by Applicable Law,
Gloria shall also assign all of its right, title and interest to any of the foregoing to Sucampo. Sucampo shall have the right
to obtain specific performance of Gloria’s obligations referenced in this Section and/or, in the event of failure to obtain
an assignment, Gloria hereby consents and grants to Sucampo the right to access and reference (without any further action required
on the part of Gloria, whose authorization to file this consent with any Regulatory Authority is hereby granted) any and all such
Regulatory Filings for any regulatory or other use or purpose, provided that, if Sucampo reasonably deems it necessary,
Gloria will provide written confirmation to the Regulatory Authority for such grant or assignment; and


 


(f)               
If the Term of this Agreement expires or this Agreement is terminated earlier by Gloria under Section 12.2.1 for Sucampo's
material breach or Section 12.2.3, then without limitation to the provisions of Section 12.1, subject to the agreement between
the Parties, Gloria will sell back to Sucampo, and Sucampo will repurchase from Gloria at Gloria’s actual reasonable direct
and documented out-of-pocket cost, any remaining inventory of Product in the Field in the Territory with greater than [...***...]
remaining shelf life.


 


12.4         
Surviving Provisions. The rights and obligations set forth in this Agreement shall extend beyond the Term or termination
of this Agreement only to the extent expressly and specifically provided for in this Agreement. Without limiting the generality
of the foregoing, it is agreed that the provisions of ARTICLE 1, Sections 2.1.2 (but only Section 2.1.2(iv) and the last 2 sentences),
2.1.3 (last sentence only), 2.1.4, 2.2, 2.3, 4.5, 4.6, 4.8


*Confidential Treatment Requested



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(last 2 sentences only),
6.5.3, 6.6, 7.3(d), 7.5 (last sentence only), 7.7.1 (last 3 sentences only), Article 8, Section 9.7, Article 10, Sections 11.1,
11.4 (first sentence and last sentence only), 12.1 (last sentence only), 12.3, 12.4, 12.5, 13.6, 13.8, Article 14 and Article 15
and, to the extent applicable, all other Sections or Articles referenced in any such Section or Article, shall survive such expiration
or termination.


 


12.5         
Continued Obligations. Upon expiration or termination of this Agreement, in whole or in part, for any reason, nothing
herein shall be construed to release either Party from any accrued rights or obligations that matured prior to the effective date
of such expiration or termination, nor preclude either Party from pursuing any right or remedy it may have hereunder or at law
or in equity with respect to any breach of this Agreement.


 


ARTICLE 13

REPRESENTATIONS AND WARRANTIES


 


13.1         
Mutual Representations and Warranties. Sucampo and Gloria each represents and warrants to the other, as of the Effective
Date, as follows:


 


13.1.1   
Corporate Power. Such Party is duly organized, validly existing and in good standing under the laws of its jurisdiction
of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement and to perform
its obligations hereunder.


 


13.1.2   
Due Authorization. Such Party has taken all necessary corporate action required to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder.


 


13.1.3   
Binding Agreement. This Agreement has been duly executed and delivered on behalf of such Party and constitutes a
legal, valid and binding obligation of such Party and is enforceable against it in accordance with the terms hereof subject to
the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial
principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered
a proceeding at law or equity.


 


13.1.4   
Conflicts. The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder
(a) does not conflict with or violate any provision of the articles of incorporation, bylaws or any similar instrument of such
Party, as applicable, in any material way and (b) does not conflict with, violate or breach, or constitute a default or require
any consent under, any contractual obligation or court or administrative order by which such Party is bound.


 


13.2         
Compliance with Applicable Law.


 



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13.2.1   
Sucampo and Gloria each represents, warrants and covenants to the other that it shall comply, in all material respects,
with Applicable Law relating to such Party’s rights, duties, responsibilities and obligations set forth in this Agreement.


 


13.2.2   
Gloria hereby makes each of the representations and warranties set forth in Exhibit K as if such representations and warranties
were set forth in this Section 13.2, and such representations and warranties are incorporated by reference into this Agreement
and made a part hereof. Gloria shall comply with each of the covenants set forth in Exhibit K as if each such covenant were set
forth in this Section 13.2, and such covenants are incorporated by reference into this Agreement and made a part hereof. Sucampo
may update any provision of Exhibit K at any time, and from time to time, upon written notice to Gloria to the extent reasonably
necessary to implement changes in Applicable Law and Regulations defined in Exhibit K, changes in interpretations of such Applicable
Law and Regulations or changes in policies of enforcement.


 


13.2.3   
Sucampo and Gloria acknowledge and agree that there are anti-bribery and anti-corruption laws to which Sucampo and Gloria
are subject, that prohibit the payment, or offering, or receiving, as the case may be, of anything of value to, or from, a government
employee, or official, or private individual, for the purpose of (a) inducing or influencing any governmental act, or decision
affecting Sucampo or Gloria, (b) to help Sucampo or Gloria obtain or retain any business, or (c) to otherwise improperly benefit
Sucampo’s or Gloria’s business activities, and such laws prohibit Sucampo and Gloria from being involved with clients,
contractors, agents, advisors or other Third Parties involved in such activity. Each Party agrees to refrain from any activity
in connection with this Agreement that would constitute a contravention by that Party of such laws. Notwithstanding Section 12.2.1
above, breach of this Section by either Party shall entitle the other Party to terminate this Agreement with immediate effect to
the extent legally and clinically possible.


 


13.2.4   
The Parties acknowledge and agree that the payments provided under this Agreement constitutes fair market value for the
performance of each Party’s obligations and exercise of its rights under this Agreement and shall not be used in a manner
that violates applicable anti-bribery and anti-corruption laws.


 


13.3         
Intellectual Property


 


13.3.1   
Right to Grant Licenses and Assignments. Each Party represents and warrants to the other Party that it has the right
to grant to such other Party the rights, licenses and assignments granted under this Agreement, free and clear of any and all encumbrances
and without the need for any assignments, releases, consents, approvals, immunities or other rights not yet obtained. Sucampo represents
and warrants that no agreements or arrangements of any kind exist between Sucampo and Third Parties that limit or restrict use
of the Sucampo Patent Rights or Sucampo Background Technology for the Product in the Field in the Territory. Each Party represents,
warrants and covenants that it will not enter into an agreement that is inconsistent with the rights, licenses and assignments
granted to the other Party in this Agreement.


 



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13.3.2   
No Existing Claims. Except as set forth on Exhibit M, (i)there is, to Sucampo’s knowledge, as of the Effective
Date, no claim or demand of any Person pertaining to, or any proceeding whichis pending or threatened that challenges Sucampo’s
right or interest in the Sucampo Patent Rights or Product Trademarks in the Territory or makes any adverse claim of ownership thereof,
and (ii) to Sucampo’s knowledge, as of the Effective Date, none of the relevant Patent Rights and Trademarks in the Sucampo
Patent Rights and Product Trademarks are the subject of any pending or threatened, adverse claim, judgment, injunction, order,
decree or agreement restricting its use for the Product in the Field in the Territory.


 


13.3.3   
Disclosure and Delivery. Sucampo represents, warrants and covenants that Sucampo shall, to its knowledge, have the
full right and legal capacity to disclose and deliver the Sucampo Patent Rights, Sucampo Background Technology and Product Trademark
to Gloria to exercise such rights with respect to the Sucampo Patent Rights, Sucampo Background Technology and Product Trademark
solely as and to the extent expressly permitted under this Agreement without violating the rights of Third Parties.


 


13.3.4   
Maintaining Existing Licenses and Rights. Subject to Section 11.2 above, Sucampo represents, warrants and covenants
that Sucampo shall maintain all rights and licenses executed by Sucampo that materially affect Gloria’s rights with respect
to the Product in the Field in the Territory as and to the extent set forth in this Agreement. Sucampo represents, warrants and
covenants that Sucampo shall use Commercially Reasonable Efforts to ensure the Product Trademarks are registered and maintained
in the Territory for the Product in the Field during the Term.


 


13.3.5   
Exercise of Rights and Licenses. Gloria represents, warrants and covenants that it shall not engage in any activities
that (a) is outside the scope of the license rights granted to it under this Agreement or (b) infringe the intellectual property
rights of any Third Party (excluding the infringement solely caused by Gloria’s exercise of its rights in and to the Sucampo
Patent Rights or Sucampo Background Technology solely as and to the extent permitted under this Agreement). Prior to any employees,
agents and representatives of Gloria or Gloria’s Affiliates or other Sublicensees or Subcontractors being granted access
by Gloria to any Compounds, Sucampo Other Intellectual Property Rights, Sucampo Background Technology, Sucampo’s Confidential
Information or Pre-Clinical Data, Clinical Data, CMC Data or other data, information, materials and Technology provided by or for
Sucampo, Gloria shall have executed agreements with such Persons providing for intellectual property rights protection consistent
in all respects with the terms of this Agreement and for protection of Confidential Information of Sucampo, and Gloria covenants
to take all reasonable actions to enforce the terms of such agreements against such Persons.


 



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13.3.6   
Future Authorizations. Each Party shall obtain and maintain during the Term all authorizations, consents and approvals,
governmental or otherwise, necessary for such Party to grant the rights and licenses granted by such Party under this Agreement
and to perform its obligations under this Agreement.


 


13.3.7   
Non-Infringement. As of the Effective Date, each Party is not aware of any intellectual property rights owned or
controlled by a Third Party that would be infringed or misappropriated by the Development, Promotion and Commercialization of the
Product in the Field in the Territory, and such Party has received no written claims relating to any such infringement or misappropriation.


 


13.4         
No Debarment. Each Party certifies as of the Effective Date that neither Party has been debarred by any Regulatory
Authority, or, to such Party’s knowledge, is the subject of debarment proceedings by any Regulatory Authority. Each Party
further certifies as of the Effective Date that it has not used prior to the Effective Date and shall not use during the Term,
any employee, agent or independent contractor who has been debarred by any Regulatory Authority or, to such Party’s knowledge,
is the subject of debarment proceedings by any Regulatory Authority. Each Party further represents, warrants and covenants that
it has not been sanctioned, suspended, excluded or otherwise declared ineligible from any Regulatory Authority healthcare program,
including, but not limited to any United States healthcare program, such as Medicare or Medicaid or comparable foreign healthcare
program. In the event that during the Term, such Party (i) becomes debarred, suspended, excluded, sanctioned, or otherwise declared
ineligible; (ii) received notice of an action or threat of an action with respect to any such debarment, suspension, exclusion,
sanction or ineligibility, such Party shall immediately notify the other Party. In the event a Party becomes debarred by a Regulatory
Authority during the Term, the other Party shall have a right to terminate this Agreement upon thirty (30) days written notice
to the debarred Party.


 


13.5         
No Litigation. Except as set forth on Exhibit M, as of the Effective Date, each of Sucampo and Gloria represents
and warrants that there is no pending, settled or, to its knowledge, threatened litigation with respect to the Compound or the
Product in the Territory or against that Party that may affect such Party’s ability to perform its obligations or exercise
its rights under this Agreement.


 


13.6         
Legal Authority. Gloria represents and warrants to Sucampo that it has the corporate authority and power to, and
it shall in accordance with the terms and conditions of this Agreement, legally bind its Affiliates listed in Exhibit L to the
terms and conditions of this Agreement, including without limitation under and as required by Section 2.1.2.


 



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13.7         
Warranty Disclaimer. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN
THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE MANUFACTURE OF PRODUCT, ANY TECHNOLOGY,
GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND EACH PARTY HEREBY EXPRESSLY AND SPECIFICALLY DISCLAIMS ALL
WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.


 


13.8         
Limited Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, EXCEPT IN CIRCUMSTANCES OF INTENTIONAL
MISCONDUCT OR GROSS NEGLIGENCE BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO EACH PARTY’S INDEMNIFICATION OBLIGATIONS
SET FORTH IN ARTICLE 14 AND ANY OTHER INDEMNIFICATION OBLIGATIONS OF SUCH PARTY UNDER THIS AGREEMENT, TO THE MAXIMUM EXTENT PERMITTED
BY APPLICABLE LAW, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR ANY SPECIAL, PUNITIVE, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST PROFITS OR LOST REVENUES, OR COST/EXPENSE OF PROCUREMENT
OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES, WHETHER UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL
OR EQUITABLE THEORY. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT, EXCEPT FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS SET
FORTH IN ARTICLE 14 AND ANY OTHER INDEMNIFICATION OBLIGATIONS OF SUCH PARTY UNDER THIS AGREEMENT, TO THE MAXIMUM EXTENT PERMITTED
BY APPLICABLE LAW, EACH PARTY’S ENTIRE AGGREGATE LIABILITY UNDER THIS AGREEMENT SHALL NOT EXCEED THE GREATER OF [...***...]
AND THE [...***...] AND [...***...] OR [...***...] UNDER OR IN CONNECTION WITH THIS AGREEMENT.


 


ARTICLE 14

INDEMNIFICATION; INSURANCE


 


14.1         
Indemnification by Gloria. Gloria agrees to indemnify, defend and hold harmless Sucampo and its Affiliates and their
respective employees, agents, officers, directors and permitted assigns (“Sucampo Indemnitees”) from and against
any and all liabilities, damages, losses, costs or expenses (including reasonable attorneys' fees and 


*Confidential
Treatment Requested



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other expenses of litigation
and/or arbitration) (collectively, “Losses”) resulting from a claim, suit or proceeding made or brought by a
Third Party (collectively, a “Third Party Claim”) arising out of or resulting from the following:


 


(a)               
The Development, improper use, storage, handling or other disposition of the Compound or Product by Gloria or its Affiliates,
Sublicensees, Distributors or other Subcontractors or other parties for whom Gloria is responsible;


 


(b)              
The exercise or practice by Gloria or its Sublicensees of the license granted under this Agreement other than as expressly
and specifically provided in this Agreement;


 


(c)               
product liability, bodily injury, risk of bodily injury, death or other torts or property damage arising out of the Compounds
or Products to the extent due to the negligence of Gloria, its Affiliates or other Sublicensees, Distributors or other Subcontractors
or other parties for whom Gloria is responsible;


 


(d)              
Negligence, recklessness or willful misconduct by in regard to its performance, or non-performance, under this Agreement;


 


(e)               
Gloria’s breach of or failure to perform under this Agreement, including a breach of any of Gloria’s representations
or warranties hereunder;


 


(f)               
Any Third Party Claim or threat thereof that the Developed Technology and/or Developed Intellectual Property Rights to the
extent conceived, created, developed or reduced to practice by or for Gloria or its Affiliates (and the exercise of rights granted
herein with respect thereto) infringe, misappropriate or violate any patent, copyright, trademark, trade secret, publicity, privacy
or other intellectual property or other proprietary rights of any Third Party;


 


(g)              
Violation of Applicable Law by Gloria or its Affiliates, Sublicensees, Distributors or other Subcontractors or other parties
for whom Gloria is responsible; or


 


(h)              
Promotion or Commercialization of the Product other than as set forth in this Agreement, including without limitation any
Promotion of the Product that is not consistent with the Product Labels and Inserts or Promotional Materials.


 





14.2         
Indemnification by Sucampo.


 


14.2.1   
General Indemnity. Sucampo agrees to indemnify, defend and hold harmless Gloria and its Affiliates and their respective
employees, agents, officers, directors and permitted assigns (“GloriaIndemnitees”) from and against any and
all Losses resulting from a Third Party Claim arising out of or resulting from the following:


 



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(a)               
improper storage, handling, manufacturing, formulation or contamination of the Compound or the Product by Sucampo or its
Affiliates or Third Party subcontractors prior to delivery of the Compound or Product to Gloria;


 


(b)              
subject to Section 8.5 above, any Third Party Claim of infringement of Sucampo Background Technology or any Product Trademark,
any Jointly Developed Technology (but excluding any Third Party Claim based in whole or in part on any portion of such Jointly
Developed Technology to the extent conceived, created, developed or otherwise reduced to practice by or for Gloria or its Affiliates),
in each of the foregoing cases, solely in the Field in the Territory;


 


(c)               
failure by Sucampo or any Affiliate or subcontractor of Sucampo to manufacture and supply Product in accordance with the
Specifications and Applicable Law;


 


(d)              
any product liability, bodily injury, risk of bodily injury, death or other torts or property damage arising out of the
Compounds or Products in the Territory to the extent due to the negligence of Sucampo or its Affiliate or a Third Party manufacturer
subcontracted by Sucampo, or any Latent Defect or Patent Defect of the Product that existed prior to delivery of such Product to
Gloria; or


 


(e)               
Sucampo’s and/or its subcontractors’ negligence, recklessness or willful misconduct in regard to its performance,
or non-performance, under this Agreement;


 


(f)               
Sucampo’s breach of or failure to perform under this Agreement, including a breach of any of Sucampo’s representations
or warranties hereunder;


 


(g)              
subject to Section 8.5 above, any Third Party Claim or threat thereof that the Sucampo Background Technology or Product
Trademarks, any Jointly Developed Technology (but excluding any Third Party Claim based in whole or in part on any portion of such
Jointly Developed Technology to the extent conceived, created, developed or reduced to practice by or for Gloria or its Affiliates)(and
the exercise of rights granted herein with respect thereto) infringe, misappropriate or violate any patent, copyright, trademark,
trade secret, publicity, privacy or other intellectual property or other proprietary rights of any Third Party in the Territory;
and


 


(h)              
violation of Applicable Law by Sucampo or its Affiliates, or its subcontractors or other parties for whom Sucampo is responsible.


 


In all cases (a) through
(h), except for Losses for which each Party has an obligation to indemnify the other Party pursuant to Section 14.1 or Section
14.2, as applicable, as to which Losses each Party shall indemnify the other to the extent of their respective liability for such
Losses. THE FOREGOING CONSTITUTES THE SOLE INDEMNIFICATION OBLIGATIONS OF SUCAMPO IN CONNECTION WITH THIS AGREEMENT.



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14.2.2   
Procedures for Indemnification. The obligations of an indemnifying Party under Section 14.1 and Section 14.2 shall
be governed by and contingent upon the following:


 


14.2.3   
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. Notwithstanding the foregoing, the Parties hereby acknowledge and agree that the failure to give an Indemnification Claim
Notice shall not relief the indemnifying Party of its indemnification obligations under this Agreement except and only to the extent
that the indemnifying Party is actually and materially prejudiced with respect to a Third Party Claim by the failure to give timely
notice by the indemnified Party.


 


14.2.4   
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 under Applicable Law. 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 Gloria Indemnitees or
Sucampo 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.


 


14.2.5   
Control of the Defense. Upon the assumption of the defense of a Third Party Claim by the indemnifying Party:


 


(a)               
the indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by
the indemnifying Party, which shall be reasonably acceptable to the indemnified Party;


 


(b)              
the indemnified Party shall promptly deliver to the indemnifying Party all original notices and documents (including court
papers) received by the indemnified Party in connection with the Third Party Claim; and


 


(c)               
the indemnifying Party shall not be liable to the indemnified Party for any legal expenses subsequently incurred by such
indemnified Party or any Gloria Indemnitee or Sucampo 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 reasonable and documented out-of-pocket costs and expenses (including reasonable attorneys’ fees and costs
of suit) and any Loss actually incurred by the indemnifying Party in its defense of the Third Party Claim with respect to such
indemnified Party or Indemnitee.



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14.2.6   
Right to Participate in the Defense. Without limiting Section 14.2.4 or Section 14.2.5, any Gloria Indemnitee or
Sucampo 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, (a) the
indemnifying Party has failed to assume the defense and retain counsel in accordance with Section 14.2.4 (in which case the indemnified
Party shall control the defense), or (b) 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.


 


14.2.7   
Settlement. The indemnified Party shall not have the right to consent to the entry of any judgment or enter into
any settlement or otherwise dispose of any Third Party Claim without the prior written consent of the indemnifying Party (which
consent shall not be unreasonably withheld, conditioned or delayed). The indemnifying Party shall not be liable for any settlement
or other disposition of a Third Party Claim by an indemnified Party that is reached without the prior written consent of the indemnifying
Party. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, no indemnified Party
shall admit any liability with respect to, or settle, compromise or discharge, any Third Party Claim without the prior written
consent of the indemnifying Party, such consent not to be unreasonably withheld, conditioned or delayed.


 


14.2.8   
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.


 


14.3         
Insurance. Each Party shall obtain and carry in full force and effect the minimum insurance requirements set forth
herein, which shall protect Indemnitees with respect to events covered by Section 14.1 and Section 14.2. Such insurance (a) shall
be primary insurance with respect to each Party’s own participation under this Agreement, (b) shall be issued by a recognized
insurer rated by A.M. Best "A-VII" (or its equivalent) or better, or an insurer pre-approved in writing by the other
Party, (c) shall list the other Party as an additional named insured thereunder, and (d) shall require thirty (30) days written
notice to be given to the other Party prior to any cancellation, non-renewal or material change thereof. The types of insurance,
and minimum limits shall be General liability insurance with a minimum limit of USD [...***...] per occurrence and USD
[...***...] in aggregate. General liability insurance shall include, at a minimum, Professional Liability, Clinical Trial
Insurance and, beginning at least thirty (30) days prior to First Commercial Sale of the Product in the Field in the Territory,
product liability insurance. Upon request by a Party, the other Party shall provide Certificates of Insurance evidencing compliance
with this Section. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party,
then such Party shall continue to maintain such insurance after the expiration or termination of this Agreement during any period
in which such Party continues to make, to have made, to use, to offer for sale or to sell a product that was the Product in the
Field in the Territory under this Agreement solely as and to the extent expressly and specifically provided under this Agreement,
and thereafter for a period of [...***...]. Notwithstanding the foregoing, either Party may self-insure in whole or in
part the insurance requirements described above, provided such Party continues to be investment grade determined by reputable and
accepted financial rating agencies.



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ARTICLE 15

MISCELLANEOUS


 


15.1         
Governing Law. This Agreement and all disputes arising out of or related to this Agreement, or the performance, enforcement,
breach or termination hereof, and any remedies relating thereto, shall be construed, governed, interpreted and applied in accordance
with the substantive laws of Hong Kong, Special Administrative Region of the People’s Republic of China without regard to
conflict of laws principles, except that (a) questions affecting the construction and effect of any patent shall be determined
by the law of the country in which the patent has been granted, (b) matters related to Regulatory Filings and Regulatory Approval
in the Territory, shall be governed by Applicable Law in the Territory and (c) any matters to be exclusively resolved pursuant
to the Applicable Laws in the Territory as provided under this Agreement, shall be resolved by the Applicable Laws in the Territory.
For the avoidance of doubt, except to the extent applicable and expressly set forth in subsections (a), (b) and (c) of this Section
15.1, Disputes shall not be construed, governed and applied in accordance with PRC law. The Parties hereby exclude the United Nations
Convention on Contracts for the International Sale of Goods from this Agreement.


 


15.2         
Arbitration. In the event of any Disputes other than any Disputed Matter that is submitted for resolution as provided
in Section 3.1.6 and non-conformity of Product in


*Confidential Treatment Requested


 



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the Field in the Territory
under Section 9.7, either Party shall initiate an arbitration proceeding that shall be conducted in accordance with the procedures
set forth in Exhibit G.


 


15.3         
Notices


 


15.3.1   
Notice Requirements. Any notice, request, demand, waiver, consent, approval or other communication permitted or required
under this Agreement shall be in writing and in both Chinese and English, shall refer specifically to this Agreement and shall
be deemed given only if delivered by hand or by internationally recognized overnight delivery service that maintains records of
delivery, or transmitted by facsimile (with transmission confirmed), addressed to the Parties at their respective addresses specified
in Section 15.3.2, or to such other address as the Party to whom notice is to be given may have provided in writing to the other
Party, in accordance with this Section 15.3. Such notice shall be deemed to have been given as of the date delivered by hand or
transmitted by facsimile (with transmission confirmed) or upon receipt (at the place of delivery) if sent by an internationally
recognized overnight delivery service. Any notice delivered by facsimile shall be confirmed by a hard copy delivered 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.


 


15.3.2   
Addresses for Notice (Mail preferred as primary notice method)


 


 


	For Gloria:
	For Sucampo:

	 	 
	
        Harbin Gloria Pharmaceuticals Co.,
Ltd.
	
        Sucampo AG

	 	 
	#28 Ronghui Garden, Yuhua
Road, Konggang Airport Development Zone B, Shunyi District

                                                          Beijing 101318, China

                                                          P.R.China
	Baarerstrasse 22

                                                          CH-3600

                                                          Zug

                                                          Switzerland

	 	 
	Fax: [...***...]	Fax: [...***...]
	 	 
	Attention: Business Development	Attention: Secretary & Director
	 	 
	*Confidential Treatment Requested	 



 



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	With a copy to:	With a copy to:
	 	 
	 	Sucampo Pharmaceuticals, Inc.

        

	Fax: [...***...]	4520 East West Highway

        Bethesda, MD 20814

	 	 
	Attention: Legal Department	 
	 	 
	 	Fax: [...***...]
	 	 
	 	Attention: Commercial Officer
	 	 
	 	 
	 	With a copy to: Executive Vice President,
        Chief Legal Officer & Corporate Secretary



 


 


 


 


 


15.4         
Equitable Relief. The Parties acknowledge and agree that the restrictions set forth in Sections 2.1.4 and 7.8, ARTICLE
10 and ARTICLE 11 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 Sections 2.1.4 and 7.8, ARTICLE 10 and/or ARTICLE 11 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 Sections 2.1.4 and 7.8, ARTICLE
10 and/or ARTICLE 11 by a Party, the other Party shall be entitled to obtain from any court of competent jurisdiction injunctive
relief, whether preliminary or permanent, 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 15.4 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.


 


15.5         
Amendment; Waiver. This Agreement may be amended, modified, superseded or canceled, and any of the terms of this
Agreement may be waived, only by a 


*Confidential Treatment Requested


 



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written instrument signed
by duly authorized representatives of both Parties or, in the case of waiver, signed by duly authorized representatives of the
Party waiving compliance. The delay or failure of a Party at any time or times to require performance of any provisions shall in
no manner affect the rights at a later time to enforce the same. No waiver by a Party of any condition or of the breach of any
term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances, shall be deemed to be, or considered
as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement.


 


15.6         
No Third Party Beneficiaries. Except as set forth in Section 14.1 and Section 14.2, the provisions of this Agreement
are for the sole benefit of the Parties and their permitted successors and permitted assigns and none of the provisions of this
Agreement shall be for the benefit of or enforceable by any Third Party, including, without limitation, any employee or creditor
of either Party hereto. No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of
any such provision make any claim in respect of any debt, liability or obligation (or otherwise) against either Party.


 


15.7         
Relationship of the Parties. Nothing in this Agreement shall be construed (a) to create or imply a partnership, association,
joint venture or fiduciary duty between the Parties, (b) to make either Party the agent of the other for any purpose, (c) to alter,
amend, supersede or vitiate any other arrangements between the Parties with respect to any subject matters not covered hereunder,
or (d) to give either Party the right to bind the other or to create any duties or obligations between the Parties, except as expressly
set forth herein. All Persons employed by a Party shall be employees of such Party and not of the other Party and all costs/expenses
and obligations incurred by reason of such employment shall be for the account and expense of such Party. The Parties agree that
the rights and obligations under this Agreement are not intended to constitute a partnership or similar arrangement that will require
separate reporting for tax purposes in the Territory.


 


15.8         
Assignment and Successors. This Agreement is personal to both Parties and neither Party shall sell, transfer, assign,
delegate, pledge or otherwise dispose other than Gloria’s right to sublicense under its rights as and to the extent expressly
and specifically permitted under Sections 2.1.2or subcontract its Commercialization obligations as and to the extent expressly
and specifically permitted under Section 7.3 of this Agreement and Sucampo’s right to subcontract its manufacturing obligations
under Section 9.1.9 of this Agreement, whether by operation of law or otherwise, in whole or in part without the prior written
consent of the other Party, except that Sucampo may, on providing written notice to Gloria, assign this Agreement and the rights,
obligations and interests of Sucampo, in whole or in part, without the written consent of Gloria to any of its Affiliates or to
any purchaser of all or substantially all of its assets and/or all or substantially all of its assets to which this Agreement relates
or to any successor corporation resulting from any merger or consolidation of Sucampo with or into such corporation. Any permitted
assignee of all of a Party’s rights under this Agreement shall be deemed to be a party to this Agreement as though named
herein. Any attempted assignment or delegation in violation of this Section shall be void. Without limiting the foregoing, in the
event that Gloria transfers any rights to the Sucampo Patent Right, Sucampo Other Intellectual Property Rights and Sucampo’s
intellectual property rights in and to the Sucampo Background Technology upon Sucampo’s prior written consent, such transfer
shall be made expressly subject to the rights and licenses granted to and restrictions imposed on Gloria under this Agreement.


 



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15.9         
Binding Effect. All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all
validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns
of such Party, provided that such Party, if it survives, shall remain jointly and severally liable for the performance of such
delegated obligations under this Agreement.


 


15.10     
Force Majeure. The occurrence of an event which materially interferes with the ability of a Party to perform its
obligations or duties under this Agreement which is not within the reasonable control of the Party affected, not due to malfeasance,
and which, with the exercise of due diligence could not have been avoided (“Force Majeure”), including, without limitation,
fire, explosion, flood, earthquake, war, accident, strike, riot, terrorist attacks, civil commotion, acts of God, or the like,
will not excuse such Party from the performance of its obligations or duties under this Agreement (other than payment obligations),
but will suspend such performance during the continuation of Force Majeure; provided that(a)the Party prevented from performing
its obligations or duties because of Force Majeure shall be required to, as soon as reasonably possible, notify the other Party
hereto of the occurrence and particulars of such Force Majeure and shall be required to provide the other Party, from time to time,
with its best estimate of the duration of such Force Majeure and with notice of the termination thereof and (b) the Party so affected
shall use commercially reasonable efforts to avoid or remove such causes of nonperformance. Upon termination of Force Majeure,
the obligation to perform any previously suspended obligation or duty shall promptly recommence. If performance is prevented for
more than ninety (90) days, the unaffected Party may terminate this Agreement upon written notice to the affected Party.


 


15.11     
Headings; References. Article, Section and subsection headings are inserted for convenience of reference only and
do not form a part of this Agreement. Unless otherwise specified, (a) references in this Agreement to any Article, Section or Exhibit
shall mean references to such Article, Section or Exhibit of this Agreement, (b) references in any section to any clause are references
to such clause of such section, and (c) 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.


 


15.12     
Interpretation. Except where the context otherwise requires, wherever used, the singular shall include the plural,
the plural the singular, the use of any gender shall be applicable to all genders. The term “including” as used herein
shall mean including, without limiting the generality of any description preceding such term. The language of this Agreement shall
be deemed to be the language mutually chosen by the Parties. The Parties acknowledge and agree that: (a) 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 (b) 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.


 



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15.13     
Severability. If and to the extent that any court or tribunal of competent jurisdiction holds any of the terms, provisions
or conditions or parts thereof of this Agreement, or the application hereof to any circumstances, to be illegal, invalid or to
be unenforceable in a final non-appealable order, (a) such provision shall be fully severable, (b) this Agreement shall be construed
and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, and (c) the remaining provisions
of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision
or by its severance herefrom, in each case provided that the basic purpose and structure of this Agreement is not altered.


 


15.14     
Entire Agreement. This Agreement and the Quality Agreement, Trademark License Agreement and Pharmacovigilance Agreement
constitute the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement and the
Quality Agreement, Trademark License Agreement and Pharmacovigilance Agreement supersedes all prior agreements and understandings,
whether written or oral, with respect to the subject matter of the Agreement, including the Confidentiality Agreement and all other
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. To the extent of any conflict or inconsistency among this Agreement, the Quality Agreement, Trademark License Agreement
or Pharmacovigilance Agreement, the terms and conditions of this Agreement shall govern.


 


15.15     
Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original
and both of which, taken together shall constitute one and the same instrument.


 


15.16     
Expenses. Except as otherwise expressly provided in this Agreement, each Party shall pay the fees and expenses of
its respective attorneys and all other expenses and costs incurred by such Party incidental to the negotiation, preparation, execution
and delivery of this Agreement.


 



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15.17     
Further Assurance. Each Party shall perform all further acts and things and execute and deliver such further documents
as may be necessary or as the other Party may reasonably require to give effect to this Agreement.


 


15.18     
Language. This Agreement contains a Chinese translation of the English text for the convenience of the Parties only.
In the event of any ambiguity or discrepancy between the English and Chinese provisions of this Agreement, the English language
provisions shall govern.


[Remainder of page intentionally
left blank.]



 


 


 


 


 


 


 


 


 


 


 






    	74



    	 



    

 




IN WITNESS WHEREOF, the
Parties have caused this Agreement to be executed by their duly authorized representatives.


 





	SUCAMPO AG	 	Harbin Gloria Pharmaceuticals Co., Ltd.
	 	 	 
	By: /s/ Peter Greenleaf	 	By: /s/ YanPing Zhao [SEAL]
	(Signature)	 	(Signature)
	 	 	 
	 	 	 
	(Printed Name)Peter
        Greenleaf	 	(Printed Name)
        YanPing Zhao
	 	 	 
	 	 	 
	(Title)
        President & Director.	 	(Title) Executive
        President



 


 


 



 


 



    	 



    	 



    




EXHIBIT A






COMPOUND, ISOMERS AND TAUTOMERS






 


Chemical Name:


			[...***...]







 


Code Name:[...***...]






CAS Number:[...***...]






[...***...]






CAS Number: [...***...]


 


CAS[...***...]


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


*Confidential Treatment Requested



    	 



    	 



    




EXHIBIT B






 


 


None






 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 



    	 



    	 



    




EXHIBIT C






PRODUCT TRADEMARKS






 


 


 


 



    	 



    	 



    




EXHIBIT C






PRODUCT TRADEMARKS


 


	Trade Mark	Country	Class	Appl. No.	Appl. Date	Pub. No.	Pub. Date	Regist. No.	Regist. [...***...]Date	Status
	AMITIZA	China	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	Registered
	阿密提薩*	China	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	Registered


*阿密提薩
is a Chinese equivalent of “AMITIZA”.


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


*Confidential Treatment Requested


 


 


 


 



    	 



    	 



    




EXHIBIT D






SUCAMPO PATENT RIGHTS






 


 


 


 



    	 



    	 



    




EXHIBIT D






SUCAMPO PATENT RIGHTS 


	
         

        Title
	
         

        Country
	
         

        Application No.
	Filing Date	Publication No.	Publication Date	
         

        Patent No.
	Issue Date
	[...***...]	
         

        China
	
        [...***...]

         
	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	[...***...]	China	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	[...***...]	
         

        China
	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	[...***...]	China	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	[...***...]	China	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	[...***...]	
         

        China
	[...***...]	[...***...]	[...***...]	[...***...]	 	 
	[...***...]	China	[...***...]	[...***...]	[...***...]	[...***...]	 	 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


*Confidential Treatment Requested



    	 



    	 



    




EXHIBIT E






Form
of Trademark License Agreement 






 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 



    	 



    	 



    




EXHIBIT F






JSC, JCC AND JDC INITIAL MEMBERS






 


 


GLORIA






 


JSC Initial members: [...***...]






JCC Initial members: [...***...]


 


JDC Initial members:[...***...]


 


SUCAMPO






 


JSC Initial members: [...***...]






JCC Initial members: [...***...]






JDC Initial members: [...***...]


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


*Confidential Treatment Requested


 






    	 



    	 



    

EXHIBIT G

DISPUTE RESOLUTION






 


 


Before commencing any arbitration, a Party
first must send written notice of the Dispute to the other Party for attempted resolution by good faith negotiations between their
respective presidents (or their designees) of the affected subsidiaries, divisions, or business units within [...***...]
after such notice is received (all references to “[...***...]” in this provision are to [...***...]).
If the matter has not been resolved within [...***...] of the notice of Dispute, or if the Parties fail to meet within
such [...***...], either Party may initiate an arbitration as provided in Section 15.2 of the Agreement and in accordance
with this Exhibit G. The Parties shall have the right to be represented by counsel in such a proceeding.






 


1.                 
All Disputes shall be finally resolved by three arbitrators in accordance with the Hong Kong International Arbitration Centre
(“HKIAC”) Administered Arbitration Rules. Sucampo and Gloria shall each appoint one arbitrator, and the two arbitrators
so appointed shall nominate the third, who shall act as the chair of the tribunal.


 


2.                 
The seat of the arbitration shall be Hong Kong.


 


3.                 
The language of the arbitration shall be Chinese and English.


 


4.                 
All awards and procedural orders from the arbitral tribunal shall be final and binding. Judgment on any award may be entered
in any court of competent jurisdiction.


 


5.                 
The arbitral tribunal shall have the authority to award interim, injunctive, conservatory, or provisional measures of protection
(“Provisional Relief”), declaratory relief, monetary compensation, equitable relief, and specific performance.


 


6.                 
In addition to any remedy available pursuant to Article 23.1 and Schedule 4 of the HKIAC Administered Arbitration Rules
(“Emergency Arbitrator”), prior to the time the arbitral tribunal is constituted, Sucampo and Gloria may apply
to the Specified Court for Provisional Relief. In the event that Sucampo or Gloria applies to the Specified Court for Provisional
Relief, the decision of the Specified Court, and not the Emergency Arbitrator, shall prevail. If Sucampo or Gloria seeks Provisional
Relief in such circumstances, such Party will not be deemed to have breached its agreement to arbitrate or to have affected the
powers reserved to the arbitral tribunal.


 


7.                 
The Parties each acknowledge and agree that, for the purposes of an application for Provisional Relief, damages would not
be an adequate remedy in respect of


*Confidential Treatment Requested


 



    	 



    	 



    




any breach or failure fully to perform
the terms of this Agreement. Each of Sucampo and Gloria further agrees not to raise the adequacy of legal remedies as a defense
against any action by a Party seeking Provisional Relief and agrees to waive any requirement for posting a bond or security to
obtain equitable relief (or other interim or conservatory measures).


 


8.                 
The Parties unconditionally and irrevocably consent to the exclusive jurisdiction of the courts of Hong Kong (the “Specified
Court”) in any action, suit or proceeding with respect to the enforcement of the arbitration agreement or Provisional
Relief, and the non-exclusive jurisdiction of the Specified Court with respect to the enforcement of any award. The Parties expressly
waive any objection, and they agree not to plead or claim, that (i) the Specified Court does not possess personal jurisdiction
over the Parties, (ii) any such action or proceeding has been brought in an inconvenient forum, or (iii) an injunction or other
judicial order (interlocutory or final) should be issued that would have the effect (directly or indirectly) of restraining or
impeding the maintenance or prosecution by either Sucampo or Gloria of the arbitration. The Parties further agree that any award
may be enforced by Sucampo or Gloria against the assets of the other Party wherever those assets are located (including but not
limited to Hong Kong), and that any award may be entered into and enforced by any court or tribunal of competent jurisdiction,
and that no claim of immunity from such proceedings will be claimed on behalf of such Party or its assets.


 


9.                 
Sucampo, on the one hand, and the Gloria, on the other hand, each hereby irrevocably appoints the designated person set
forth below (the “Service Process Agent”) as its agent for service of process in Hong Kong in any Dispute, provided
that the agent named by such Party set forth below may be replaced by another agent in Hong Kong upon thirty (30) days’ written
notice. Service of process on the designated agent at the designated address shall be deemed, for all purposes, to be due and effective
service, and service shall be deemed completed whether or not forwarded to or received by the respective Parties. Any correspondence
sent to a Party’s agent for service of process shall also be copied to that Party directly as set forth below, provided,
however that the failure to copy any Party directly shall not affect the effectiveness of any service of process.



    	 



    	 



    




 


	Service Process Agent For Gloria:	Service Process Agent For Sucampo:
	 	 
	
         

        Harbin Gloria Pharmaceuticals Co., Ltd.

        

        

        #28 Ronghui Garden, Yuhua Road, Konggang Airport
        Development Zone B, Shunyi

        District

        Beijing 101318, China

        P.R.China

         

        Fax: [...***...]

        

        

        Attention: Business Development

        

        

         
	
         

        Sucampo AG

        Baarerstrasse 22

        CH-3600

        Zug

        Switzerland

         

         

         

        Fax: [...***...]

        Attention: Secretary & Director

        

        

	 	 
	
        With a copy to:

         
	
        With a copy to:

         

	
         

        Fax: [...***...]

        

        

        Attention:Legal Department

        

        
	
        Sucampo Pharmaceuticals, Inc.

         

        4520 East West Highway

        Bethesda, MD 20814

        4520 East West Highway

        Bethesda, MD 20814

         

         

         

        Fax: [...***...]

        Attention: Commercial Officer

         

	 	 
	
         

         

         

         

         
	
        With a copy to: Executive Vice President,
        Chief Legal Officer & Corporate Secretary

         

         

	
        *Confidential Treatment Requested

         

         

         

         

         
	 






    	 



    	 



    

10.             
The prevailing Party in any arbitration shall be entitled to recover its fees, costs and expenses, including administrative
fees, arbitrators’ fees and expenses, and attorneys’ fees and expenses.


 


11.             
Except as required by Applicable Law, the existence of the Dispute, any settlement negotiations, the arbitration hearing,
any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be kept confidential by the
Parties. The arbitral tribunal shall have the authority to impose sanctions for unauthorized disclosure of any of the foregoing.


 


 


 


 


 


 


 


 






    	 



    	 



    

 


EXHIBIT H










 


[Reserved]


 


 


 


 


 


 


 


 


 






    	 



    	 



    








EXHIBIT I

PRESS RELEASE






 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 



    	 



    	 



    




EXHIBIT J



CUMULATIVE SALES VOLUME TARGET ASSUMPTIONS






 


	 	 	 	 	 	 	 
	[...***...]	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


*Confidential
Treatment Requested






    	 



    	 



    

 



EXHIBIT K






ANTI-CORRUPTION AND ANTI-BRIBERY PROVISIONS






 


Gloria’s Representations and Warranties


 


Gloria hereby represents and warrants that:


 


1.                 
it has adopted the third party code of conduct provided by Sucampo (“Code of Conduct”);


 


2.                 
it does not have any direct or indirect owner (in the case of a publicly traded company, an owner of 5% or more of the outstanding
shares), director, officer, supervisor or employee who is a Government Official, or a Family Member or Close Business Associate
of a Government Official;


 


3.                 
it (a) has not, either directly or indirectly, made, promised, authorized or attempted to make or authorize, any Prohibited
Payment to a Government Official with respect to the work performed for, or products or services provided to or on behalf of, Sucampo,
and (b) does not have any knowledge or evidence that its direct or beneficial owners (in the case of a publicly traded company,
an owner of 5% or more of the outstanding shares), directors, officers or employees, or its partners, contractors, subcontractors,
agents or representatives, or their respective Affiliates (collectively the “Related Parties” or “Related
Party”), who perform work for, or provide products or services to or on behalf of Sucampo, either directly or
indirectly, have made, promised or authorized the making of a Prohibited Payment;


 


4.                 
it (a) has not engaged in any Prohibited Transaction with respect to the work performed for, or products or services provided
to or on behalf of, Sucampo, and (b) does not have any knowledge or evidence that any Related Party has engaged in a Prohibited
Transaction; and


 


5.                 
it acknowledges and agrees that Sucampo has the right to terminate this Agreement and any other agreement between Sucampo
and Gloria in the event that Gloria has committed a Substantive Violation. In the event of such termination, Gloria will not be
entitled to any further payment, regardless of the work performed prior to termination, and will be liable for damages or remedies
as provided by law. Gloria shall fully indemnify and hold harmless Sucampo from any claims, costs, liabilities, obligations and
damages that Sucampo may incur as a result of a Substantive Violation.


 


The representations and warranties set
forth in this Exhibit K shall be made on the date hereof and shall be repeated on each day throughout the continuance of this Agreement,
with reference to the facts and circumstances then existing.


 



    	 



    	 



    




Gloria’s Covenants


From the date hereof and throughout the
continuance of this Agreement, Gloria hereby covenants and agrees with Sucampo that Gloria shall:


 


1.                 
not make or attempt to make, directly or indirectly, in connection with any work performed for, or products or services
provided to or on behalf of, Sucampo, any payments, including Facilitation Payments to a Government Official for the purpose of
securing government services including without limitation permission to unload cargo, obtain work permits, secure electricity or
telephone service, or police protection;


 


2.                 
not provide or attempt to provide, directly or indirectly, any gifts, meals, or entertainment to any Government Official
in connection with any work performed for, or products or services provided to or on behalf of, Sucampo;


 


3.                 
not assign its rights and/or responsibilities under any agreement with Sucampo to a third party without the express prior
written authorization of Sucampo, which authorization may be withheld in Sucampo’s sole discretion;


 


4.                 
take all reasonable steps to ensure that the Related Parties do not, either directly or indirectly, make, promise, authorize
or attempt to make or authorize any Prohibited Payment to a Government Official, or engage in a Prohibited Transaction, with respect
to the work performed for, or products or services provided to or on behalf of, Sucampo;


 


5.                 
promptly notify Sucampo in writing if any representation set forth in this Exhibit K shall no longer be accurate in any
respect;


 


6.                 
promptly notify Sucampo in writing of any Prohibited Payment, Prohibited Transaction or any violation of, or conspiracy
or attempt to violate, any of the Applicable Laws and Regulations, or any allegations of such conduct, related to work performed
for, or products or services provided to or on behalf of, Sucampo, of which it obtains knowledge or has any reason to believe has
occurred, and it shall cooperate fully and in good faith with any inquiry by Sucampo if Sucampo, in its sole discretion, believes
that a violation of, or conspiracy or attempt to violate, any of the Applicable Laws and Regulations or the compliance provisions
of the contract with Sucampo has occurred;


 


7.                 
advise Sucampo prior to retaining any third party contractors to perform services that may be compensated under this Agreement
with Sucampo, conduct such due diligence on these parties to the satisfaction of Sucampo prior to their retention and otherwise
comply with Sections 2.1.2 and 7.3 of the Agreement. Such third party contractors shall not be engaged without the express prior
written authorization of Sucampo;


 



    	 



    	 



    




 


8.                 
annually certify compliance with the Applicable Laws and Regulations in form and substance acceptable to Sucampo and provide
periodic certifications when and if any change in the personnel performing work for, or providing products or services to or on
behalf of, Sucampo under this Agreement occurs to ensure new personnel are aware of permissible and prohibited activity under this
Agreement;


 


9.                 
certify to Sucampo the results of any periodic internal and independent audits that it conducts with respect to (a) work
performed for, or products or services provided to or on behalf of, Sucampo, and (b) Gloria’s compliance with all Applicable
Laws and Regulations; and


 


10.             
upon the request of Sucampo, at Sucampo’s sole discretion and expense, and upon at least thirty (30) days advance
notice, permit and procure audits by independent auditors acceptable to Sucampo, and provide such auditors with full and unrestricted
access to, and to conduct reviews of, all records related to the work performed for, or products or services provided to or on
behalf of, Sucampo, and immediately notify Sucampo of any violation of any of the Applicable Laws and Regulations, or of the compliance
provisions of its contract with Sucampo, to Sucampo with respect to: (a) the effectiveness of existing compliance programs and
codes of conduct; (b) the origin and legitimacy of any funds paid to Sucampo; (c) its books, records and accounts, or those of
any of its subsidiaries, joint ventures or Affiliates, related to work performed for, or products or services provided to or on
behalf of, Sucampo; (d) all disbursements made for or on behalf of Sucampo; and (e) all funds received from Sucampo in connection
with work performed for, or products or services provided to or on behalf of, Sucampo.


 


Definitions






 


For the purposes of this Exhibit K,
the following additional definitions apply:






 


1.                 
“Applicable Laws and Regulations “means the substantive anti-bribery and books and records provisions
of the U.S. Foreign Corrupt Practices Act and its equivalent in China and all other commercial bribery, anti-money laundering and
anti-terrorism laws of the United States and China, as further set out herein in the definitions of Commercial Bribery, Government
Official, Prohibited Payment, Prohibited Transactions, as well as all other relevant substantive laws of the United States and
China and all other countries in which Sucampo conducts business, except to the extent inconsistent with, or penalized under, the
laws of the United States.


 


2.                 
 “Close Business Associate “means a current or former partner, joint owner, joint venturer, co-investor,
consultant or advisor.


 



    	 



    	 



    




 


3.                 
 “Commercial Bribery “means offering, paying, promising or giving, directly or indirectly, anything of
value to the agent, representative, intermediary or employee of any company, including Sucampo, without the knowledge and consent
of that company, with the intent to improperly influence the recipient’s action in relation to that company’s affairs
or business for the benefit of Sucampo or Gloria.


 


4.                 
 “Sucampo” means: (a) Sucampo; (b) all of its parents, subsidiaries and Affiliates; and (c) any of its
or their officers, directors, partners, shareholders, employees, agents and representatives.


 


5.                 
 “Designated Party “means any person, entity or country that is: (a) identified in publicly available
records or published lists as a party with respect to whom the U.S. or Chinese government has prohibited financial transactions
involving that party’s assets; (b) designated in published lists issued by the U.S. or Chinese governments or the United
Nations as a foreign terrorist organization or an organization that assists or provides support to a foreign terrorist organization;
or (c) identified in publicly available records as having been convicted, found guilty or against whom a judgment or order was
entered in any proceedings for violating anti-money laundering, anti-corruption or bribery, or international economic or anti-terrorism
sanction laws, or whose assets were seized, blocked, frozen or ordered forfeited for violation of money laundering or international
anti-terrorism laws.


 


6.                 
 “Facilitation Payments “means any payment intended to secure the performance of a Routine Governmental
Action to which the payor is unquestionably entitled, made to a low level Government Official whose duties are ministerial or clerical,
that is modest in amount and not intended to influence the exercise of discretion by the Government Official. A payment to a Government
Official who is involved in the decision making process with regard to Sucampo’s business dealings with the government can
never be considered a Facilitation Payment and is prohibited by this Agreement.


 


7.                 
 “Family Member “means a parent or parent-in-law, spouse, child, sibling, uncle, aunt, grandparent, or
cousin to the first degree.


 


8.                 
 “Government Official “means (a) any officer or employee of a government, department (whether executive,
legislative, judicial or administrative), agency or instrumentality of such government, including a regional governmental body
or a government-owned or government-controlled business, or a public international organization; (b) any person acting in an official
capacity for or on behalf of such government, department, agency, instrumentality or public international organization; (c) any
person holding a legislative, administrative or judicial office, whether appointed or elected; (d) any person exercising a public
function, including for a public agency or public enterprise; (e) an agent, advisor or consultant to such person; (f) an officer
of a Political Party or a candidate for public office (other than in the U.S.); or (g) a member of the royal family or officer
of the military.



    	 



    	 



    




9.                 
 “Improper Advantage” means a benefit or an advantage (a) to which a company, including Sucampo, is or
was not clearly entitled; and/or (b) which is not readily available to other competitors; and/or (c) which if secured, retained
or obtained, constitutes a violation of the Applicable Laws and Regulations and/or the Code of Conduct of Sucampo.


 


10.             
 “Political Party” means any political organization which seeks to attain and maintain political power
within a government and seeks to realize these goals by participating in activities related to the nomination, election and/or
appointment of Government Officials.


 


 


11.             
 “Prohibited Payment “means any offer, gift, payment, promise to pay, or authorization of the payment
of any money or anything of value, including charitable contributions, directly or indirectly, to a Government Official or a Political
Party, or to a third party, if one knows or has reasonable grounds for believing that all or a portion of the money or thing of
value which was given or is to be given to the third party will be paid, offered, promised, given or authorized to be paid, directly
or indirectly, to a Government Official, for the purpose of: (a) influencing any act or decision of the Government Official in
his/her official capacity; (b) inducing the Government Official to do or omit doing any act in violation of his/her lawful duty;
(c) securing any Improper Advantage; or (d) inducing the Government Official to use his/her influence with a non-U.S. government
or instrumentality thereof to affect or influence any act or decision of such government or instrumentality, in order to assist
in improperly obtaining or retaining business or in directing business to any party.


 


12.             
 “Prohibited Transaction “means any transaction (including any act of omission, commission, assistance
to another, or aiding and abetting in furtherance of the transaction) that involves: (a) the receipt, transfer, transportation,
retention, use, structuring, diverting, or hiding of the proceeds of any criminal activity whatsoever, including fraud and bribery
of a Government Official; (b) engaging or becoming involved in, financing or supporting financially, or otherwise sponsoring, facilitating,
or giving aid or comfort to any terrorist person, activity or organization; or (c) a Designated Party.


 


13.             
 “Routine Governmental Action” means only an action that is ordinarily and commonly performed by a Government
Official, such as: (a) obtaining permits, licenses or other official documents to qualify a person to do business in a country
other than the United States; (b) processing governmental papers, such as visas and work orders; (c) providing police protection,
mail pick-up and delivery or scheduling inspections associated with contract performance or inspections related to transit of goods
across country; (d) providing phone service, power and water supply, loading and unloading cargo, or protecting perishable products
or commodities from deterioration; or (e) actions of a similar nature. “Routine Governmental Action” does not include
any decision by a Government Official whether, or on what terms, to award new business to or to continue business with a particular
party, or any action taken by a Government Official involved in the decision-making process to encourage a decision to award new
business to or continue business with a particular party.


 



    	 



    	 



    




14.             
 “Substantive Violation” means one or more of the following on the part of Gloria: (a) a violation or
aiding and abetting a violation of, or a conspiracy to violate, Applicable Laws and Regulations; (b) a breach of any of Gloria’s
representations, warranties or covenants to Sucampo set forth in this Exhibit K; (c) a refusal, where required by this Agreement,
to submit to an audit by independent accountants; or (d) a refusal to provide a certification required by Sucampo and this Agreement.


 


 


 


 


 


 


 


 


 


 


 






    	 



    	 



    

 


EXHIBIT L


AFFILIATES OF GLORIA


 


1、Harbin Gloria Jingwei
Pharmaceutical Development Company


2、Beijing
Medconxin Pharm Technology Company


3、Harbin
Jier Biotechnology Company


4、Jilin
Targeted Biotechnology Pharmaceutical Company


5、Gloria
(Shandong) Pharmaceuticals Company


6、Gloria
Jia Yun Medical Investment Company


7、Tibet
Gloria Sunshine Pharmaceutical Company


8、Aonuo
(China) Pharmaceutical Company


9、Harbin
Gloria Anbo Pharmaceutical Company


10、GuangZhou
NHC Biotechnology Company


11、Harbin
PuGongYing Pharmaceutical Company


12、Shanghai
Hotmed Sciences Co., Ltd.


13、Shanxi
Powerdone Pharmaceutics Co., Ltd.


14、Nanjing
Varsal Medicine Company


15、Shanghai
Hechen Pharmaceutical Engineering Company


16、Harbin
Laiboten Pharmaceutical Co., Ltd. 


17、Qidong
Hotmed Pharmaceutical Company


18、Hainan
Hotmed Nuokang Pharmaceutical Company


19、Hainan
Hotmed Tianya Pharmaceutical Company


20、Shanxi
Powerdone Food Company


21、Tibet
Powerdone Pharmaceutical Company






    	 



    	 



    

EXHIBIT M


EXCEPTIONS TO REPRESENTATIONS


 


Section [...***...]; Section [...***...]:
There is an [...***...] regarding the [...***...] against the [...***...].


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


*Confidential Treatment Requested