Exhibit 10.79
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
 
 
LICENSE, DEVELOPMENT, COMMERCIALIZATION AND SUPPLY AGREEMENT
FOR LUBIPROSTONE

by and between

Takeda Pharmaceuticals International GmbH

and

SUCAMPO AG

 

 
Dated as of October 17, 2014
 
 
 

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LICENSE, DEVELOPMENT, COMMERCIALIZATION AND SUPPLY AGREEMENT
FOR LUBIPROSTONE

This LICENSE, DEVELOPMENT, COMMERCIALIZATION, AND SUPPLY AGREEMENT FOR
LUBIPROSTONE (“Agreement”) is entered into as of October 17, 2014, 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
Takeda Pharmaceuticals International GmbH, a corporation organized under the
laws of Switzerland with principal offices at Thurgauerstrasse 130, 8152
Glattpark-Opfikon, Zurich, Switzerland (“Takeda”).  Each of Takeda and Sucampo
is sometimes referred to individually herein as a “Party” and collectively as
the “Parties”.
 
BACKGROUND
 
WHEREAS, Sucampo has rights in the Sucampo Patent Rights and the Sucampo
Background Technology related to the Product in the Field in and outside the
Territory (as such terms are hereinafter defined);

WHEREAS, Takeda and its Affiliates form a pharmaceutical group of companies with
research, development and manufacturing activities worldwide; and

WHEREAS, Takeda desires to obtain, and Sucampo is willing to grant to Takeda, an
exclusive license (except as to Sucampo and its Affiliates) to Develop the
Licensed Product in the Field in the Territory and outside of the Territory for
the Territory, an exclusive license (including as to Sucampo and its Affiliates)
to Commercialize the Licensed Product in the Field in the Territory under an
exclusive license (including as to Sucampo and its Affiliates as further
described hereinafter) to the Product Trademark and a non-exclusive license to
undertake Secondary Packaging of the Product in and outside the Territory for
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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“Adverse Event/Reaction” 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 in the Field in the applicable country in the Territory, an
Adverse Event/Reaction 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/Reaction” includes all occurrences which
would be regarded as “adverse drug reactions” under Applicable Law in the
applicable country in the Territory.

“Affiliate” means, with respect to a Party, any Person that, directly or
indirectly, controls, or is controlled by, or is under common control with, such
Party.  For purposes of this definition, “control” means (a) ownership of fifty
percent (50%) or more of the shares of stock entitled to vote for the election
of directors, in the case of a corporation, or fifty percent (50%) or more of
the voting 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.

“Agreed Quality” has the meaning set forth in Section 9.1.3.

“Agreement” means this License, Development, Commercialization and Supply
Agreement for Lubiprostone, as identified in the preamble, including all
Exhibits hereto, as this Agreement (including such Exhibits) may be amended from
time to time in accordance with its terms.

“Alliance Manager” means the person appointed by each Party from within their
respective organization to coordinate and facilitate the communication,
interaction and cooperation of the Parties pursuant to this Agreement.  The
Alliance Managers shall be the primary contact between the Parties with respect
to the activities conducted pursuant to this Agreement.

“Ancillary Agreements” means the Quality Agreement, Pharmacovigilance Agreement
or any other agreements the Parties will confirm as Ancillary Agreements.

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

 
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“Applicable Law” means all federal, state, local, national and supra-national
laws, statutes, rules and regulations, including any rules, regulations or
orders 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 8.6.

“Auditing Party” has the meaning set forth in Section 8.6.

“Background Technology” means any Technology except for Developed Technology
that a Party (a) has developed or acquired prior to the Effective Date and/or
(b) can show it developed entirely independently of and without any reference to
any information, data or materials of the other Party or its Affiliates.  For
the avoidance of doubt, Background Technology of Sucampo shall be deemed to, and
shall, include the Sucampo Background Technology.

“Back-Up Supplier” means a Person selected by Sucampo to provide the Licensed
Product in the event the supplier initially selected by Sucampo fails to deliver
or is at risk to not be able to deliver the Compound or Licensed Product
according to terms hereunder.

“Business Day” means a day, other than a Saturday or Sunday, on which banking
institutions in the applicable country in the Territory are supposed to be open
for business.

“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, 2014, 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 applicable country 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 such country in the Territory, and/or any applicable foreign
equivalents thereof, and any updates to any of the foregoing.

“cGMP” means the quality systems and then-current good manufacturing practices
applicable to the manufacture, labeling, packaging, handling, storage, and
transport of the Compound and the Product, as set forth by the EMA, the FDA, and
equivalent foreign regulations or standards 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 applicable
country in the Territory, and/or any applicable foreign equivalents thereof, and
any updates to any of the foregoing.

 
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“CC Indication” means the prophylactic or therapeutic use in the prevention
and/or treatment of chronic constipation.

“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) in the applicable country in the Territory.  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.

“CMC Data” means the data contained in the chemistry, manufacturing and controls
section of an IND or MAA (or similar sections of their counterparts in the
applicable countries in the Territory) for Regulatory Approval of the Licensed
Product in the Field in the applicable country in the Territory.

“Commercialization” or “Commercialize” means any and all activities (whether
before or after Regulatory Approval) directed to the commercialization of the
Licensed Product in the Field in the applicable country in the Territory,
including pre-launch and post-launch marketing, Promoting, distributing
(including importing, exporting, transporting, customs clearance, warehousing,
invoicing, handling and delivering the Licensed Product to customers), offering
to sell and selling, sales force efforts, detailing, advertising, marketing,
sales and distribution, pricing, contracting managed markets and medical
affairs, including publications, medical education, medical information,
clinical science liaison activities, investigator initiated sponsored research
programs health economics and outcomes research, the preparation, filing, and
maintenance of Regulatory Approvals, including the filing of annual updates,
Phase IV Studies, Post Approval Marketing Studies and other activities similar
to any of the activities listed above that directly relate to the Licensed
Product in the Field in such country in the Territory.  For purposes of this
Agreement, “Commercialization” shall not include activities constituting
Manufacturing 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 for the
Commercialization of the Licensed Product in the Field in Key Markets in the
Territory as further described in Section 7.1.

 
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“Commercially Reasonable Efforts” means, with respect to the efforts to be
expended, or considerations to be undertaken, by a Party or its Affiliate with
respect to any objective, activity or decision to be undertaken hereunder,
reasonable, good faith efforts to accomplish such objective, activity or
decision as such Party would normally use to accomplish a similar objective,
activity or decision under similar circumstances, it being understood and agreed
that with respect to the Development or Commercialization of the Licensed
Product, such efforts and resources shall be consistent with those efforts and
resources commonly used by a Party under similar circumstances for similar
products owned by it or to which it has similar rights, which product, as
applicable, is at a similar stage in its development or product life and is of
similar market potential taking into account efficacy, safety, approved
labeling, the competitiveness of alternative products sold by third parties in
the marketplace, the patent and other proprietary position of the compound or
product, the likelihood of regulatory approval given the regulatory structure
involved, the profitability of the product taking into considerations, among
other factors, third party costs and expenses including among other things any
royalties, milestone and other payments required under this Agreement, and the
pricing and reimbursement relating to the product. Commercially Reasonable
Efforts shall be determined on a market-by-market and indication-by-indication
basis for the Licensed Product, as applicable, and it is anticipated that the
level of effort will change over time, reflecting changes in the status of the
Licensed Product, as applicable, and the market(s) involved.  Notwithstanding
the foregoing, neither Party shall be obligated to Develop, seek Regulatory
Approval or Commercialize a Licensed Product: (i) which, in its reasonable
opinion after discussion with the other Party, caused or is likely to cause a
fatal, life-threatening or other adverse safety event that is reasonably
expected, based upon then available data, to preclude obtaining Regulatory
Approval for such Licensed Product, or, if Regulatory Approval of such Licensed
Product has already been obtained, to preclude continued marketing of such
Licensed Product; or (ii) in a manner inconsistent with Applicable Laws.

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

“Competing Product” has the meaning set forth in Section 7.5.

“Compound” means lubiprostone as further described in EXHIBIT A, and its salts,
metabolites, as well as any active pro-drugs, isomers, tautomers, hydrates and
polymorphs.

 
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“Confidential Information” means any and all information or material, whether
oral, visual, in writing or in any other form,  that has been  disclosed 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 (“Sucampo Confidential
Information”) shall include the Sucampo Background Technology, Sucampo Developed
Technology, Sucampo Developed Patent Rights, Pre-Clinical Data, Clinical Data,
CMC Data, Manufacturing Data and other Data, content, Sucampo Know-how,
unpublished patent applications (including 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 or its Affiliates to
Takeda and/or its Affiliates that relate to Sucampo’s research, clinical
development, non-clinical development, marketing, sales and promotion
(including, 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.  For the avoidance of
doubt, “Confidential Information” of Takeda (“Takeda Confidential Information”)
shall include the Takeda Developed Technology and Takeda Developed Patent Rights
and other Data, content, know-how, unpublished patent applications (including
any patent applications included as part of the Takeda Developed Patent Rights)
and Technology and all other information and materials, disclosed or made
available by or for Takeda or its Affiliates to Sucampo and its Affiliates that
relate to Takeda’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 Takeda’s business.

“Confidentiality Agreement” means the Confidentiality Agreement by and between
Takeda Pharmaceuticals International GmbH and Sucampo Pharmaceuticals, Inc.,
effective as of April 1, 2013, as amended.

“Control” or “Controlled” means, with respect to any Confidential Information,
Technology, Patent Right, Other Intellectual Property Right, Data, Data
Exclusivity or Regulatory Filing, either (a) ownership of such item or (b)
possession of the right to grant a license or sublicense (but only to the extent
of such right).

“Core Data Sheet” means a document prepared by the Regulatory Approval holder
containing, in addition to the Company Core Safety Information (CCSI), material
relating to the CC Indication, IBS-C Indication OIC Indication, dosing,
pharmacokinetics, and other information on the Licensed Product for use in the
Field in the applicable country in the Territory based on scientific data that
are positioned on appropriate prescribing information for safe and effective use
of the Licensed Product in the Field in such country in the Territory.

 
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“Corporate Names” means (a) in the case of Takeda, the Trademark Takeda and the
Takeda corporate logo or such other names and Trademarks used generally by
Takeda and its Affiliates in their business (and not relating to a specific
product or Technology) as Takeda 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.

“Data” means the Pre-Clinical Data, Clinical Data, CMC Data and Manufacturing
Data and any other data and information generated by or on behalf of one or both
of the Parties during the Term in connection with the Compound and Licensed
Product.

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

“Development” or “Develop” means all development and research and all
pre-clinical and clinical activities conducted relating to the Licensed Product,
including test method development and stability testing, toxicology, animal
studies, formulation, process development, manufacturing scale-up, quality
assurance/quality control development for Clinical Studies in the Field,
statistical analysis and report writing, and Clinical Studies in the Field,
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, Licensed Product regulatory
documentation and other Technology with respect to the foregoing, in the
Field.  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 Licensed Product in the Field in the applicable country in
the Territory, as such plan may be amended or updated from time to time in
accordance with Section 4.1.1.

“Developed Patent Rights” has the meaning set forth in Section 2.1.4.

“Developed Technology” has the meaning set forth in Section 2.1.4.

“Developing Parties” has the meaning set forth in Section 2.1.4.

“Disclosing Party” means the Party disclosing Confidential Information; provided
that, with respect to each Party’s confidentiality obligations, 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.

 
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“Discretionary Changes” has the meaning set forth in Section 9.1.10.

“Dispute” has the meaning set forth in EXHIBIT G.

“Disputed Matter” has the meaning set forth in Section 3.1.5.

“Distributor” means any Third Party (other than any of Takeda’s Affiliates)
appointed by Takeda to Commercialize in the applicable country in the Territory
the Licensed  Product purchased from Takeda, its Affiliates or other
Sublicensees (regardless of whether such Third Party has the right or obligation
to provide Secondary Packaging services with respect to such Licensed Product).

“DMF” means drug master file or other comparable application or filing with the
applicable Regulatory Authority in the applicable country in the Territory.

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

“EMA” means the European Medicines Agency or any successor agency with a similar
scope of responsibility regarding the regulation of human pharmaceutical
products in the European Union.

“Emergency Arbitrator” has the meaning set forth in Section 6 in EXHIBIT G.

“European Paediatric Investigation Plan” shall have the meaning set forth in
Section 4.3.4/EXHIBIT M.

“Existing Regulatory Approvals” means those Regulatory Approvals listed in
EXHIBIT B hereof.

“FDA” means US Food and Drug Administration or any successor agency with
responsibility regarding the regulation of human pharmaceutical products in the
United States.

“Field” means all prophylactic and therapeutic uses in animals and humans for
all gastrointestinal indications related to the Compound.

“First Commercial Sale” means the first bona fide commercial sale of a Licensed
Product for use or consumption in the Field in any country in the Territory by
Takeda, its Affiliates or Sublicensees to a Third Party (other than any of
Takeda’s Affiliates) in such country in the Territory after all required
applicable Regulatory Approvals for such country have been granted.

 
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“Force Majeure” has the meaning set forth in Section 17.10.

“GAAP” means generally accepted accounting principles recognized in any
applicable country in the Territory, and being subject to International
Financial Reporting Standard (IFRS) as applicable.

“GSDB” has the meaning set forth in Section 6.3.

“IBS-C Indication” means the prophylactic or therapeutic use in the prevention
and/or treatment of constipation-predominant irritable bowel syndrome.

“IND” means an Investigational New Drug Application or other comparable
application or filing with the applicable Regulatory Authority in the applicable
country in the Territory, including but not limited to clinical trial
application, necessary to commence Clinical Studies in such country in the
Territory.

“Indemnification Claim Notice” has the meaning set forth in Section 16.3.1.

“Indemnitee” means any Sucampo Indemnitees or Takeda Indemnitees claiming
indemnification under Sections 16.1 or 16.2, 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.

“Inventory Sale Period” shall mean the period set forth in Section 12.3 (c).

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

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

“Key Markets” shall mean Brazil, Italy, Mexico, Russia, Saudi Arabia, South
Korea, Switzerland, UK.

“Latent Defect” means with respect to Licensed Product delivered to Takeda
according to Section 9.2, a Licensed Product non-conforming to Sucampo’s
warranty for the Licensed Product set forth in Section 9.1.2, such that (i) the
related non-conformance of such Licensed Product is not readily discoverable or
not reasonably expected to be readily discoverable based on Takeda’s, its
Affiliates’ or other Sublicensees’ normal, industry-standard and Commercially
Reasonable Efforts for incoming-goods inspections, as the case may be and (ii)
the non-conformance was not caused directly or indirectly by the Secondary
Packaging or any acts or omissions of Takeda, its Affiliates, Sublicensees,
Subcontractors or any other parties for whom Takeda is responsible hereunder.

 
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“Licensed Product” means any product comprising the Compound  (whether as sole
active ingredient or in combination with one or more other active ingredients),
including all dosage forms, dosage strengths and delivery modes. Examples of
package presentations of the Licensed Product are specified in EXHIBIT H . The
term “Licensed Product” as used herein may be used to reference one or more than
one Licensed Product.

“Losses” has the meaning set forth in Section 16.1.

“Manufacture” or “Manufacturing” means all activities related to the
manufacturing of a Compound or Licensed Product, including manufacturing of
Licensed Product for Development and Commercialization, primary packaging in
bottle and blister pack (consisting of labeling the bottle of the Licensed
Product with appropriate batch number and the blister foil of the Licensed
Product with the Product Trademark and lot number), in-process and Licensed
Product testing, validation, process improvement, and process development,
release of Licensed Product or any component or ingredient thereof, quality
assurance activities related to manufacturing and release of Licensed Product,
ongoing stability tests and regulatory activities related to any of the
foregoing. The Parties agree and acknowledge that Secondary Packaging shall be
excluded from the definition of “Manufacturing”.
 
“Manufacturing Data” means all information and data relating to or used in
connection with the manufacturing of the Compound and/or Licensed Product by
Sucampo or its Affiliates or other Third Parties working under authority of such
entities, including without limitation, such information and data as generated
or used during process development, stability studies, formulation development,
scale-up of manufacturing, production of preclinical and clinical product
batches, validation studies, development of quality assurance/quality control
testing, and related regulatory affairs; and all information and data contained
in the DMF or in the CMC section of an IND or MAA (or their counterparts in
other countries) with respect to the Compound and/or Licensed
Product.  Notwithstanding the foregoing, to the extent Sucampo and/or its
Affiliates do not have rights to such know-how, the term “Manufacturing Data”
shall exclude any proprietary manufacturing know-how described in a DMF that was
disclosed by a contract manufacturer of Sucampo or its Affiliates directly to
the Regulatory Authority (and not to Sucampo or its Affiliates), which know-how
had been entirely independently and separately developed by such contract
manufacturer prior to the first agreement between Sucampo and/or its Affiliates
and such contract manufacturer or which Sucampo and/or its Affiliates otherwise
do not Control or have the right to disclose.

“Market Withdrawal” means the removal or correction of a Licensed Product in the
Field in the applicable country 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.

 
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“Marketing Authorization Application” or “MAA” means, with respect to any
Licensed Product, an application or other comparable application or filing and
all amendments and supplements thereto filed with the applicable Regulatory
Authority requiring such filing, including all documents, Data, and other
information concerning such Licensed Product which are necessary for obtaining
Regulatory Approval to Manufacture and Commercialize such Licensed Product in
the applicable country in the Territory .

“Net Sales” means, for any period, the total amount billed or invoiced on sales
of Licensed Product in the Field in the applicable country in the Territory by
Takeda or its Affiliates less the following deductions (specifically excluding
any payments made by Takeda or its Affiliates to Sucampo pursuant to this
Agreement), in each case related specifically to the Licensed Product in such
country in the Territory and actually allowed and taken by such Third Parties
and, in the case of items (i), (ii) and (v) only, not otherwise recovered by or
reimbursed to Takeda or its Affiliates:

(i)           trade, cash and quantity discounts (other than price discounts
granted at the time of invoicing and already included in the gross amount
invoiced);

(ii)           price reductions or rebates, retroactive or otherwise, imposed
by, negotiated with or otherwise paid to Regulatory Authorities;

(iii)           taxes on sales (such as business tax, value added taxes, sales
or use taxes), but not including taxes assessed against the income derived from
such sales, and import and customs duties;

(iv)           freight, insurance and other transportation and handling charges
to the extent added to the sale price and set forth separately as such in the
total amount invoiced, as well as any out-of-pocket and arms-length fees for
services provided by wholesalers and warehousing chains related to the
distribution of the Licensed Product in the Field in such country in the
Territory that are treated as sales allowances under GAAP, provided that such
out-of-pocket fees are consistent with those charged across Takeda’s product
line; and

(v)           amounts repaid or credited by reason of rejections, defects,
[…***…] percent ([…***…]%)  return credits, recalls or returns or because of
retroactive price reductions (including rebates or wholesaler charge backs.

 
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Where any reduction in the amount of Net Sales is based on sales of a bundle of
products in which the Licensed Product for use in the Field in such country in
the Territory is included, the reduction in price or deduction therefrom would
be allocated as actually credited unless such Licensed Product receives a higher
than pro rata share of any reduction or deduction that the bundled set of
products receives.  In such case, the reduction or deduction therefrom shall be
allocated to such Licensed Product on a no greater than a pro rata basis based
on the sales value (i.e., the unit average selling price multiplied by the
number of units) of such Licensed Product relative to the sales value
contributed by the other products in the bundle with respect to such sale.

Subject to the above, Net Sales shall be calculated in accordance with Takeda’s
standard internal policies and procedures, which must be in accordance with
GAAP.   Net Sales shall not include (i) sales, transfers or dispositions between
or among Takeda or its Affiliates, unless such Affiliates are end-users, but
shall include the subsequent final sales to non-Affiliate Third Parties by any
such Affiliates, or (ii) sampling for preclinical, clinical, promotional or
educational purposes conducted by or on behalf of Takeda for the Licensed
Product in the Field in such country in the Territory in accordance with
Takeda’s usual and customary business practices.

All Net Sales will be calculated in United States Dollars.

If Takeda or its Affiliates appoint Distributors for the Licensed Product in the
Field in such country in the Territory, Net Sales will include the Net Sales
invoiced by Takeda or its Affiliates to such Distributors, but it will not
include any sales of the Licensed Product in the Field in such country in the
Territory made by any such Distributors.

“OIC Indication” means the prophylactic or therapeutic use in the prevention
and/or treatment of opioid induced constipation.

“Other Indication(s)” means any indication for use of the Compound other than
the Field.

“Other Intellectual Property Rights” means (a) any domains, designs, copyrights,
copyright registrations, copyright rights, moral rights and similar rights
throughout the world (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 common law, state law,
federal law or laws of foreign countries.

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

“Patent Defect” means with respect to Licensed Product delivered to Takeda
according to Section 9.2, a Licensed Product non-conforming to Sucampo’s
warranty for the Licensed Product, as set forth in Section 9.1.3, such that (i)
the related non-conformance of such Licensed Product may be readily discovered
or should be reasonably expected to be readily discoverable based on Takeda’s,
its Affiliates’ or other Sublicensees’ normal, industry-standard and
Commercially Reasonable Efforts for incoming-goods inspections procedures, as
the case may be and (ii) was not caused directly or indirectly by the Secondary
Packaging or any acts or omissions of Takeda, its Affiliates, Sublicensees,
Subcontractors or any other parties for whom Takeda is responsible hereunder.

 
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“Patent Rights” means the rights and interests in and to all patents and patent
applications throughout the world, 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 throughout the world. 

“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 6.3.

“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.

 
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“Phase IV Study” means a human clinical trial of a product containing the
Compound that is not included in the original MAA submission for the Product for
an indication, including studies conducted to fulfill commitments made as a
condition of the Regulatory Approval of the MAA 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 applicable country in the Territory
in order to obtain or maintain Regulatory Approval for the Licensed Product in
the Field in such country in the Territory) after the MAA for the Licensed
Product in the Field in such country in the Territory has been approved by the
Regulatory Authority in such country in the Territory.  Any human clinical study
that is intended to expand the label for the Licensed  Product for use in the
Field in such country 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 Licensed Product in the
Field in such country in the Territory, epidemiological studies, modeling and
pharmacoeconomic studies, post-marketing studies, investigator sponsored
studies, and health economic studies.

“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 applicable Regulatory
Authority necessary to Commercialize the Licensed Product in the Field in a
particular country in the Territory.

“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 Licensed Product or (b) any written, printed or graphic
material on or within the package from which the Licensed Product is to be
dispensed.

“Product Trademark” means (i) the Trademark AMITIZA, (ii) the Trademarks as and
in the exact form 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 Licensed
Product in the Field in the applicable country in the Territory or should any
registration of the Product Trademark in any country of the Territory be
withdrawn or be refused or should the Product Trademark be not acceptable to
Takeda due to linguistic reasons or the applicable Regulatory Authorities in
such country in the Territory do not approve that the Licensed Product uses the
Trademark AMITIZA or any other Trademarks listed in EXHIBIT C in such country,
then any other Trademarks for Commercializing the Licensed Product in the Field
in such country in the Territory as designated and agreed upon by both Parties
in advance 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 Commercializing the Licensed
Product in the Field in a particular country in the Territory.

 
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“Promote” or “Promotion” means those activities 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 Licensed Product for use in the Field in the applicable country in
the Territory, including visual aids, file cards, premium items, clinical study
reports, reprints, drug information updates, and any other promotional support
items.

“Proposed Disclosure” has the meaning set forth in Section 10.4.1.

“Provisional Relief” has the meaning set forth in Section 5 in EXHIBIT G.

“Publication Policies” has the meaning set forth in Section 10.4.2.

“Quality Agreement” means the agreement to be entered into between Takeda and
Sucampo, under which the Parties shall address Product quality issues to assure
the Licensed Product is Manufactured and packaged according to Applicable Law in
the applicable country in the Territory.

“Recall” means the removal or correction of a Licensed Product in the Field in a
particular country in the Territory.  Recall does not include a Market
Withdrawal.

“Receiving Party” means the Party receiving Confidential Information; provided
that, with respect to each Party’s confidentiality obligations, 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.

 
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“Regulatory Approval(s)” 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
distribute, dispose of and Commercialize the Licensed Product for use in the
Field in the applicable country in the Territory, including all INDs, MAAs and
the manufacturing license and marketing registration required under the
Applicable Law of such applicable country in the Territory, or any update
thereto, and Pricing Approvals, or pre- and Post-Approval Marketing Studies,
labeling approvals, technical, medical and scientific licenses.

“Regulatory Authority(ies)” 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 EMA and any governmental unit having jurisdiction over the Development,
Manufacture, Secondary Packaging and Commercialization of the Licensed Product
in the Field in the applicable country in the Territory).

“Regulatory Filings” means, with respect to the Licensed Product in the Field in
the applicable country 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 INDs, MAAs, Adverse
Event/Reaction files and complaint files.

“Required Change” has the meaning set forth in Section 9.1.10.

“Rolling Forecast” has the meaning set forth in Section 9.1.5(a).

“Secondary Packaging” means all the activities related to labeling of primary
packaged bulk bottles or bulk blister packs of Licensed Product including
packaging of labelled bottles or blister packs of the Licensed Product into a
carton with a leaflet, including sourcing of all packaging materials such as
labels, cartons and leaflets.

“Serious Adverse Event/Reaction” means an Adverse Event/Reaction 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 Licensed Product of an infectious agent
or (vii) may not be immediately life-threatening or result in death or
hospitalization and 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/Reaction” includes all occurrences
which would be regarded as “serious adverse drug reactions” under Applicable Law
of the applicable country in the Territory.

 
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“Service Process Agent” has the meaning set forth in Section 8 in EXHIBIT G.

“SKU(s)” means Stock Keeping Unit(s) and different pack formats used to identify
Manufacturing and distribution of the Licensed Product in the Field in the
applicable country 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 and packaging (including Secondary
Packaging) of the Licensed Product for the Field in the applicable country in
the Territory as reflected in the Quality Agreement and Regulatory Approvals.

“Specified Court” has the meaning set forth in Section 7 in EXHIBIT G.

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

“Subcontractor” means any Person to whom Takeda or Sucampo has subcontracted the
performance of its obligations or activities as provided hereunder.

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

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

“Sucampo Data Exclusivity” means all Data Exclusivity Controlled by Sucampo or
any of its Affiliates, as of the Effective Date or at any time during the
Term,  in relation to Developing or Commercializing the Licensed Product in the
Field in the applicable country in the Territory.

“Sucampo Developed Patent Rights” has the meaning set forth in Section 2.1.4.

“Sucampo Developed Technology” has the meaning set forth in Section 2.1.4.

“Sucampo Developing Parties” has the meaning set forth in Section 2.1.4.

“Sucampo Indemnitee(s)” has the meaning set forth in Section 16.1.

 
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“Sucampo Know-how” means all information owned or Controlled by Sucampo or any
of its Affiliates, as of the Effective Date or during the Term, that is related
to the Licensed Product in the Field that is necessary or useful for the
Development or Commercialization of such Licensed Product.  Know-How excludes
any Information contained within Sucampo’s published Patents Rights.

“Sucampo Other Intellectual Property Rights” means all Other Intellectual
Property Rights Controlled by Sucampo or any of its Affiliates, as of the
Effective Date or at any time during the Term, that is reasonably necessary or
beneficial for Developing or Commercializing the Licensed Product in the Field
in the applicable country in the Territory.

“Sucampo Patent Rights” means  all Patent Rights in the applicable country
during the Term, including patents applied for and issued in such country after
the Effective Date, and that would otherwise be infringed, absent a license, by
any of Takeda’s or its Sublicensees’ or Subcontractors’ activities authorized
under this Agreement, including but not limited to the Development or
Commercialization of the Licensed Product in the Field in such country.  Sucampo
Patent Rights include, but are not limited to, 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, solely to add additional
patents and patent applications.

“Supply Price” means the applicable supply price as set forth in EXHIBIT H.

“Takeda” means Takeda Pharmaceuticals International GmbH, as identified in the
preamble to this Agreement.

“Takeda Developed Patent Rights” has the meaning set forth in Section 2.1.4.

“Takeda Developed Technology” has the meaning set forth in Section 2.1.4.

“Takeda Developing Parties” has the meaning set forth in Section 2.1.4.

“Takeda Indemnitee(s)” has the meaning set forth in Section 16.2.

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

“Term” has the meaning set forth in Section 12.1.

“Terminated Country” has the meaning set forth in Section 12.2.5.

 
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“Terminated Licensed Product” has the meaning set forth in Section 12.2.5.

“Territory” means worldwide excluding the United States, Canada, Japan, and
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 16.1.

“Third Party Royalties” means all fees, milestones, royalties and other payments
payable to a Third Party (other than to any of Takeda’s Affiliates or other
Sublicensees) in consideration for intellectual property rights reasonably
necessary for Takeda to carry out the activities under this Agreement, including
the Development or Commercialization of a Licensed Product in the Field in the
applicable country 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.

“Transition Activities” has the meaning as set forth in Section 13.1.

“Transition Period” has the meaning as set forth in ARTICLE 13.

 
ARTICLE 2
LICENSE GRANTS; EXCLUSIVITY
 
2.1  License Grants
 
2.1.1  Sucampo Grants.  Subject to the terms and conditions of this Agreement,
during the Term, Sucampo hereby grants to Takeda, solely under the Sucampo
Patent Rights, Sucampo Know-how, Sucampo Confidential Information and Sucampo
Other Intellectual Property Rights, in and to the Sucampo Background Technology
and Sucampo Data Exclusivity Rights:
 
(a)  (i) an exclusive (except as to Sucampo and its Affiliates) and
non-transferable (except to the extent set forth in Section 17.8) right and
license, with the right to grant sublicenses solely in accordance with Section
2.1.2, to Develop the Licensed Product in the Field in the applicable country in
the Territory (ii) a non-exclusive and non-transferable (except to the extent
set forth in Section 17.8) right and license, with the right to grant
sublicenses solely in accordance with Section 2.1.2 to perform Development
outside the Territory of the Licensed Product in the Field for any country in
the Territory;
 
 
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(b)  an exclusive (including as to Sucampo and its Affiliates) and
non-transferable (except to the extent set forth in Section 17.8) right and
license, with the right to grant sublicenses solely in accordance with Section
2.1.2, to Commercialize the Licensed Product in the Field in the applicable
country in the Territory;
 
(c)  an exclusive (except as to Sucampo and its Affiliates) and non-transferable
(except to the extent set forth in Section 17.8) right and license, with the
right to grant sublicenses solely in accordance with Section 2.1.2, to use and
reference in Regulatory Filings for a particular country in the Territory (other
than any Regulatory Filings in connection with Manufacturing the Licensed
Product) any Data (other than Manufacturing Data) Controlled by Sucampo or its
Affiliates necessary to support such Regulatory Filings in such country in the
Territory; and
 
(d)  a non-exclusive and non-transferable (except to the extent set forth in
Section 17.8) right and license, with the right to grant sublicenses solely in
accordance with Section 2.1.2, to undertake Secondary Packaging of the Licensed
Product in the Territory and outside the Territory solely for the purpose of use
and importation into the Territory and to import and export the Licensed Product
outside of the Territory solely for the purpose of Commercialization of the
Licensed Product in the Territory.
 
2.1.2  Right to Sublicense and Subcontract.  Subject to the following, Takeda
may perform any activities in support of its Commercialization of the Licensed
Product in the Field in the applicable country in the Territory or of any
Development and Secondary Packaging of the Licensed Product in or outside of the
Territory for the Territory, through its Affiliates or contracting with a Third
Party. Such Subcontractors may include Distributors, wholesalers and any
services providers. Subject to and in accordance with the terms and conditions
of this Agreement, Takeda shall have the right to grant sublicenses under
Section 2.1.1 ((a) (b) (c) and (d)) and Section 2.1.3 to any of its Affiliates
and any Subcontractors, for such Subcontractors in the event the type of
activities to be performed or Applicable laws require a subcontractor to possess
a sublicense.
 
Takeda shall provide a list of the names of its Affiliates Developing and
Commercializing the Product on EXHIBIT J and update such list annually, and in
any event not more than once a year.
 
Takeda shall not be obliged to notify Sucampo of the appointment of any
Subcontractors in the Territory for Commercialization activities and in or
outside of the Territory for Development activities and Secondary Packaging for
the Territory.
 
Under its agreements with its Sublicensees and Subcontractors, Takeda shall
protect Sucampo’s interests and rights in its Confidential Information and
intellectual property rights to at least the same extent of this Agreement.
 
Any rights sublicensed by Takeda to any Affiliate or Subcontractor as hereunder
provided shall be of no greater scope than the license granted to Takeda under
Section 2.1.1 and Section 2.1.3 and such sublicense shall  terminate upon the
expiration or termination of this Agreement.
 
 
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Takeda shall not be relieved of its obligations pursuant to this Agreement as a
result of such sublicense or appointment of any Subcontractors and shall remain
fully responsible and liable for any action or omission of such Subcontractors
and Sublicensees which would constitute a breach of this Agreement if committed
by Takeda as if Takeda had committed such action or inaction itself.
 
Takeda shall, at its own expense, investigate each report and indication of
breach of any sublicense or appointment of any Subcontractor, and Takeda shall
promptly report to Sucampo any breach learned of or discovered by
Takeda.  Takeda shall diligently enforce the terms and conditions of each
sublicense, including without limitation, by pursuing all appropriate judicial
and administrative action and relief in the event of any material breach of the
Sublicense.
 
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 or appointment to Subcontractors either
extending beyond Sucampo’s obligations and liabilities under this Agreement or
otherwise.
 
2.1.3  License to Sucampo Corporate Names and Product Trademarks.  Subject to
the terms and conditions of this Agreement, during the Term, Sucampo hereby
grants to Takeda a non-exclusive right and license, with a right to sublicense
to Sublicensees, to use Sucampo Corporate Names in the Territory only to the
extent necessary to Commercialize the Licensed Product in the Field in the
applicable country in the Territory and an exclusive right and license, with a
right to sublicense to Sublicensees, to use the Product Trademarks solely to
perform the Secondary Packaging in or outside the Territory for the Territory
and Commercialize the Licensed Product in the Field in the applicable country in
the Territory.  Takeda shall not use the Product Trademarks other than for the
purpose expressly and specifically set forth in this Section 2.1.3 and shall use
Commercially Reasonable Efforts to comply with its then current trademark usage
guidelines and specifications, notice requirements, stylistic, quality and other
guidelines and specifications in connection with the use of the Product
Trademarks in the Field in the applicable country in the Territory.  All use of
the Product Trademarks by Takeda, and all goodwill associated with such use,
shall inure to the benefit of Sucampo. Notwithstanding the exclusive right and
license granted to Takeda under this Section 2.1.3 and for the sake of good
order, nothing in this Section shall prevent Sucampo from using the Product
Trademarks in any of its global promotion or information activities relating to
Sucampo its Affiliates and its product portfolio, including but not limited to
listing the Product Trademarks in its annual reports.
 
 
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2.1.4  Development of Developed Technology and Developed Patent Rights.  In the
event that Sucampo or any of its Affiliates (or any of their respective
employees, contractors, agents or subcontractors) (collectively, the “Sucampo
Developing Parties”) or Takeda or any of its Affiliates (or any of their
respective employees, contractors, agents or Subcontractors) (collectively, the
“Takeda Developing Parties”) (the Sucampo Developing Parties and Takeda
Developing Parties, together, the “Developing Parties” and individually, the
“Developing Party”) conceives, creates, develops or otherwise reduces 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 Developing Party or jointly by any
Developing Party with any other Developing Parties and/or any other Person: (a)
any Technology (which may or may not be patentable) (but expressly excluding
Background Technology of either Party or its Affiliates (“Developed Technology”)
and/or (b) any Patent Rights (but expressly excluding any Sucampo or Takeda
Patent Rights as of the Effective Date of this Agreement or any Product
Trademarks or Other Intellectual Property Rights as of the Effective Date of
this Agreement, Sucampo’s and Takeda’s Other Intellectual Property Rights and
other intellectual property rights in and to the Sucampo and Takeda Background
Technology and Sucampo’s intellectual property rights in and to the Data
Exclusivity, Product Trademarks and Sucampo and Takeda’s Corporate Names and any
other underlying intellectual property rights that are Controlled by Sucampo or
Takeda prior to the Effective Date or obtained or acquired independently of this
Agreement after the Effective Date) (“Developed Patent Rights”) then, each of
the Developing Parties agrees (for itself and its Affiliates), that it shall
promptly notify and disclose to the other Party such Developed Technology and
Developed Patent Rights after the conception, creation or discovery thereof and
the Parties hereby agree, to the fullest extent permitted by Applicable Law, as
and between the Parties and their respective Affiliates and other Developing
Parties the following ownership provisions:
 
(a)  Takeda shall be the sole and exclusive owner of all right, title and
interest in and to the Developed Technology conceived, created, developed or
reduced to practice solely by the Takeda Developing Parties (“Takeda Developed
Technology”) and all Developed Patent Rights conceived, created, developed or
reduced to practice solely by the Takeda Developing Parties (“Takeda Developed
Patent Rights”) in each case, throughout the world but only with respect to
Takeda Developed Technology not related to the Compound or Licensed Product.
Takeda Developed Technology related to the Compound or Licensed Product shall be
assigned to Sucampo on request and shall on assignment be treated as “Sucampo
Developed Technology” .  Any exercise by Takeda, the Takeda Developing Parties
and any of their Sublicensees or Subcontractors in and to their rights to the
Takeda Developed Technology (and any intellectual property rights therein or
thereto) and Takeda Developed Patent Rights shall be subject to the terms and
conditions of this Agreement, including, without limitation, Section 2.1.2 and
ARTICLE 10 and ARTICLE 11. Takeda hereby agrees to grant to Sucampo on written
request an unrestricted, perpetual, irrevocable, fully paid-up, royalty-free,
transferable, sublicenseable (through multiple levels of sublicensees) worldwide
exclusive (except as to Takeda, the Takeda Developing Parties and any of their
Sublicensees) right and license, free from any liens or encumbrances, to use
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 Takeda Developed Technology (and any Patent rights therein or
thereto) and Takeda Developed Patent Rights, in any form or media (now known or
later developed) .
 
 
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(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 the Developed Technology other than the Takeda Developed
Technology not related to the Compound or the Licensed Product (“Sucampo
Developed Technology”) and all Developed Patent Rights relating to the Sucampo
Developed Technology  (“Sucampo Developed Patent Rights”) in each case,
throughout the world.  For clarification, any Developed Technology that relates
to the Compound or the Licensed Product will be owned by Sucampo, and if a
patent application is filed for the said Developed Technology relating to the
Compound or the Licensed Product, said patent will be a “Sucampo Patent
Right”.  Sucampo Developed Technology shall, in each of the foregoing cases, be
licensed to Takeda under Section 2.1.1 for the purpose of and in accordance with
all of the terms and conditions of this Agreement. In exchange for the foregoing
licenses granted by Sucampo to Takeda pursuant to Section 2.1.1 and for other
good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, to the maximum extent permitted by Applicable Law, Takeda shall
cause the Takeda Developing Parties to, irrevocably grant, convey, transfer,
assign and deliver to Sucampo all ownership, right, title and interest in and to
such Sucampo Developed Technology (and all intellectual property rights therein
or thereto) and Sucampo Developed Patent Property Rights, in perpetuity and
throughout the world, effective immediately upon the inception, conception,
creation or development thereof.  Sucampo shall pay  for or reimburse Takeda for
all inventor’s remuneration required to be paid under Applicable Law. To the
extent that any Sucampo Developed Technology (or any intellectual property
rights therein or thereto) or Sucampo Developed Patent Rights are not assignable
as provided in this Section 2.1.4 or that Takeda or any of the Takeda Developing
Parties retain any ownership, rights, title or interest in or to any Sucampo
Developed Technology (or any intellectual property rights therein or thereto) or
Sucampo Developed Patent Rights in any jurisdictions in the world then, in
exchange for the licenses granted by Sucampo to Takeda pursuant to Section 2.1.1
and for other good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, to the maximum extent permitted by Applicable
Law, Takeda hereby agrees, at Sucampo’s request and expense, to consent to and
join in any action to enforce such rights, and hereby agrees to grant to Sucampo
an unrestricted, perpetual, irrevocable, fully paid-up, royalty-free, fully
transferable, sublicensable (through multiple levels of sublicensees), exclusive
(except as to Takeda and other Takeda Developing Parties) right and license,
throughout the world, free from any liens or encumbrances, to use, 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 Sucampo Developed Technology (or any intellectual property rights therein
or thereto) and Sucampo Developed Patent Rights, in any form or media (now known
or later developed).
 
 
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(c)  Each Party agrees to (and will cause its Developing Parties to), at the
Patent owner’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 the other Party any assistance
required in order to perfect the rights set forth in this Section 2.1.4,
including without limitation, obtaining patents registrations, and to apply for,
obtain, perfect, evidence, sustain and enforce Takeda’s and Sucampo’s Patent
Rights in connection with their respective Developed Technology and Developed
Patent Rights for Takeda and in any jurisdictions throughout the world for
Sucampo.
 
2.1.5  Publication.  Publication or presentation of a manuscript related to any
Developed Technology or Developed Patent Rights under this ARTICLE 2 shall be
governed by Section 3.1.3(b)(viii) and Section 10.4.2.
 
2.1.6  Product Diversion.  To the extent permitted by Applicable Law, Sucampo
shall not, and shall cause its Affiliates and sublicensees not to, knowingly or
intentionally Commercialize the Licensed Product in the Field in any country in
the Territory. Should Sucampo become aware of any unauthorized Commercialization
of Licensed Product in the Field in any country in the Territory, it shall use
Commercially Reasonable Efforts to stop such unauthorized Commercialization.
 
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.
 
2.3  Retained Rights.  All rights not expressly and specifically granted under
this ARTICLE 2 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, for purposes of this Agreement (and without affecting any other
agreements between the parties which may exist), Sucampo retains any and all
other rights under the Sucampo Patent Rights and Sucampo Background Technology
to develop, make, have made, modify, use, market, promote, sell, have sold,
export, import, distribute, commercialize or otherwise exploit the Compound and
the Licensed Product in the Field outside of the Territory and, (b) subject to
Section 5.2 below, for Other Indications anywhere in the world.
 
 
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ARTICLE 3
ADMINISTRATION OF THE COLLABORATION
 
3.1  Committees
 
3.1.1  Committees’ Establishment.  Within thirty (30) days of the Effective
Date, Sucampo and Takeda shall establish the following committees (the
“Committees”):
 
(a)  a Joint Steering Committee (“JSC”) with responsibility for managing the
collaboration and resolving any conflicts, overseeing Commercialization-related
activities with respect to the Licensed Product in the Field in the Territory
and overseeing the JWG (as defined hereinafter); and
 
(b)  a Joint Working Group (“JWG”) with responsibility for overseeing
Development-related activities with respect to the Licensed Product in the Field
in the applicable country in the Territory, including the regulatory approach
and filing strategy designed to generate the successful submission and approval
of the Licensed Product in the Field in such applicable country in the
Territory.
 
Within thirty (30) 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 Takeda shall each designate two (2) of its
employees or its Affiliates’ employees 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 will be determined by each Party within thirty (30) days from
the Effective Date of this Agreement.  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.  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.
 
 
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(b)  Responsibilities.  The JSC shall have the responsibilities set forth in
Section 3.1.1(b), including to:
 
(i)  Oversee and discuss strategies for Commercialization of the Licensed
Product in the Field in the applicable country in the Territory and review and
comment on the Commercialization Plan and any material updates, amendments,
modifications to the Commercialization Plan;
 
(ii)  Oversee and coordinate the overall development strategy including Phase IV
Studies;
 
(iii)  Review and coordinate the activities and monitor the progress of the JWG;
 
(iv)  Review and approve material updates, amendments, modifications of the
Development Plan;
 
(v)  Review any budget related to activities under the Development Plan versus
actual expenses;
 
(vi)  Review and approve any material changes in Manufacturing of the Licensed
Product for the Territory and strategy to qualify a Back-up Supplier for the
Territory;
 
(vii)  Review progress under the Commercialization Plan;
 
(viii)  Review the initial Promotional Materials for Key Markets;
 
(ix)  Review the product lifecycle plans for the Product including indication
and label extension, new dosage forms and new formulations or delivery systems;
 
(x)  Resolve any Disputed Matters referred to the JSC by the JWG; and
 
(xi)  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  JWG
 
 
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(a)  Membership.  Sucampo and Takeda shall each designate an appropriate equal
number of its employees or its Affiliates’ employees to serve as members of the
JWG, such appropriate equal number to be mutually agreed upon by the
Parties.  Each Party shall designate to be a member of the JWG at least one (1)
representative from its regulatory department, one (1) representative from its
clinical development department, one (1) representative from their CMC
department and one (1) representative from their supply chain department.  Each
representative of the JWG 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 JWG.  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 JWG shall alternate between the
Parties.  The initial chairperson shall be selected by Takeda.  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 JWG
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.  
 
(b)  Responsibilities.  The JWG shall coordinate operational activities of the
Parties in the performance of the Development Plan and conduct those activities
as directed by the JSC and shall have the responsibilities set forth in Section
3.1.3(b), including to:
 
(i)  Review and  discuss  the Development Plan and any material updates,
amendments, and modifications to the Development Plan;
 
(ii)  Review and compile the applicable budgets with a presentation of the
budget by items versus actual expenses for the JSC;
 
(iii)  Review and evaluate progress under the Development Plan, including
without limitation all health, safety and quality concerns;
 
(iv)  Discuss plans and protocols for all pre-clinical, CMC and Clinical Studies
in the Field in the Territory prepared in support of obtaining or maintaining
Regulatory Approvals for the Licensed Product in the Field in the applicable
country in the Territory;
 
(v)  Unless otherwise agreed by the Parties, review a high level regulatory plan
for all proposed initial submissions for the Licensed Product in the Field to
Regulatory Authorities in the applicable country in the Territory;
 
(vi)  Discuss the plans and protocols for and monitor the progress of all
Clinical Studies and other development activities for the Licensed 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 Licensed Product in the Field in the
applicable country in the Territory;
 
 
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(viii)  Discuss publication or presentations strategies for the applicable
country in the Territory related to the Licensed Product in the Field pursuant
to Clinical Studies in the Field in the applicable country in the Territory that
is based on Data developed by or for either Party and its Affiliates; and
 
(ix)  Review Manufacturing related matters including the forecasts for the
supply of the Licensed Product, production planning for the Licensed Product,
Back-up Supplier qualification, Secondary Packaging; and
 
(x)  Perform such other Development functions as the Parties may mutually agree
in writing, except where in conflict with any provision of this Agreement.
 
3.1.4  Committee Meetings.  Each Committee shall establish a schedule of times
for regular meetings.  The JSC shall meet semi-annually and the JWG shall meet
at least quarterly until Regulatory Approval has been obtained from the
Regulatory Authority in the Key Markets and thereafter on an as needed basis to
carry out the responsibilities of the JWG unless the applicable Committee
otherwise agrees, or unless otherwise required by this Agreement.  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 Takeda and Sucampo or such other
locations mutually agreed upon by the applicable Committee.  The chairperson of
each Committee (or its designee) 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.  Each Party may invite
non-voting employees to attend any meeting of the JSC and shall notify the other
Party reasonably in advance, but no later than ten (10) Business Days prior to
the meeting date. The Committees shall keep minutes of their meetings that
record all decisions and all actions recommended or taken in reasonable
detail.  The chairperson (or its designee) of each Committee shall circulate a
draft of the minutes no later than ten (10) 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 or its designee
shall circulate final minutes of each meeting to each Committee member.
 
3.1.5  Decision-Making.  Except as otherwise provided herein, decisions of each
Committee shall be made by consensus with each Party having one (1) single
vote.  Each Committee shall use Commercially Reasonable Efforts to reach
agreement on any and all matters for which it is responsible.  In the event
that, despite such Commercially 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:
 
 
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(a)  JWG Disputed Matters.  Disputed Matters arising from the JWG shall be
referred for resolution to the JSC.  The JSC shall initiate discussions in good
faith to resolve each Disputed Matter within ten (10) Business Days of receipt
of the notice of such Disputed Matter.  In the event that the JSC does not reach
agreement on such Disputed Matter within fifteen (15) Business Days from the
date of initiation of such discussions, such Disputed Matter shall be referred
to senior management for resolution in accordance with Section 3.1.5(c).
 
(b)  JSC Disputed Matters.  Disputed Matters first arising in the JSC or not
resolved by the JSC which had first arisen in the JWG shall be referred to
senior management for resolution in accordance with Section 3.1.5(c).
 
(c)  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
thirty (30) Business Days of its referral then:
 
(i)  with respect to any Disputed Matter that relates to the Commercialization
of the Licensed Product in the Territory under this Agreement, Takeda shall have
final decision-making authority; and
 
(ii)  with respect to any Disputed Matter that relates to Development of the
Licensed Product in order to Commercialize the Licensed Product in the Field in
the Territory, the final decision-making authority shall rest with Takeda;
 
(iii)  with respect to any Disputed Matter that relates to Manufacturing of the
Licensed Product, the final decision-making authority shall rest with Sucampo;
provided, however, that in the event the Disputed Matter relating to
Manufacturing of the Licensed Product will have a direct impact or effect on the
Commercialization of the Licensed Product, the final decision-making authority
shall rest with Takeda.
 
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 17.5.
 
 
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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. Each of the Parties shall
appoint one representative who possesses a general understanding of development,
regulatory and commercialization issues to act as its Alliance Manager.  The
role of the Alliance Manager is to act as a first point of contact between the
Parties.  The Alliance Managers shall have the right to attend all meetings of
any committees that the Parties may decide to form hereunder and may act as
designees of the co-chair of the JSC to organize and facilitate JSC meetings.
The Alliance Managers shall also work together to facilitate the communication
and coordination between the Parties solely related to matters that the JSC has
the authority to oversee under Section 3.1.2(b), and in the event the Alliance
Managers fail to resolve any deadlock in good faith between the Parties within
fifteen (15) days, the Alliance Managers shall immediately refer such deadlock
to the JSC for resolution.  Each Party may change its designated Alliance
Manager from time to time upon written notice to the other Party. Any Alliance
Manager may designate a substitute to temporarily perform the functions of that
Alliance Manager upon written notice to the other Party’s Alliance Manager.
 
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 Licensed Product for use in the
Field in the applicable country in the Territory shall be governed by the
Development Plan attached to this Agreement as EXHIBIT L, which includes (a) the
Development program  to be conducted by Takeda on an activity-by-activity,
Licensed Product-by-Licensed Product and country-by-country basis in the
Territory and the study design and (b) the budget for the Development program on
an activity-by-activity, Licensed Product-by-Licensed Product and
country-by-country basis, which Development program is designed to generate all
the Clinical Data and regulatory information required to obtain or maintain the
Regulatory Approval required for Takeda to be able to Commercialize the Licensed
Product in the Field in such applicable country in the Territory.  For the
avoidance of doubt, any Clinical Studies other than Post-Approval Marketing
Studies and Phase IV Studies performed by Takeda shall be included in the
Development Plan. For the avoidance of doubt, the Development Plan, including
any updates and amendments to the Development Plan in accordance with Section
4.1.2, must be reviewed and approved by the JSC before it becomes effective.
 
4.1.2  Amendments.  Commencing in the first full Calendar Year after the
Effective Date and continuing during the Term, Takeda shall prepare and submit
no later than January 31 of each Calendar Year for review and approval by the
JSC appropriate amendments and updates to the Development Plan to the extent
necessary, as determined by Takeda in its reasonable discretion.  Takeda shall
use Commercially Reasonable Efforts to take into consideration Sucampo’s
comments on the amendments and updates to the Development Plan, including but
not limited to any comments relating to a potential impact on activities
relating to the Licensed Product in a country or jurisdiction outside of the
Territory.
 
4.2  Responsibilities.  Takeda shall be solely responsible for conducting all
Development activities set forth in the Development Plan provided, however, that
Sucampo shall conduct any stability activities, including stability testing,
required to obtain and maintain the Regulatory Approvals  in the applicable
country in the Territory, unless otherwise agreed by the JSC; provided, however,
that any protocol for stability testing shall be approved by JSC.
 
4.3  Development Activities
 
 
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4.3.1  Takeda shall use Commercially Reasonable Efforts to Develop the Licensed
Product in the Field in the applicable country in the Territory in accordance
with the Development Plan, the terms and conditions of this Agreement, all
Applicable Law and cGCP. Notwithstanding the foregoing or any other provision of
this Agreement to the contrary, Takeda shall use Commercially Reasonable Efforts
to conduct any and all Clinical Studies set forth in the Development Plan.  If
in addition to the Clinical Studies described in the Development Plan, as
amended or updated, the EMA or any other Regulatory Authority in the applicable
country in the Territory requires or recommends any Phase IV Studies or any
other Clinical Studies in the Field in the applicable country in the Territory
as a condition to obtaining Regulatory Approval for the Licensed Product in the
Field in such applicable country in the Territory or maintaining such Regulatory
Approval, Takeda shall use Commercially Reasonable Efforts to decide whether or
not to conduct such studies.
 
4.3.2  Other Post-Approval Marketing Studies.  Takeda shall use Commercially
Reasonable Efforts to conduct and direct any Post-Approval Marketing Studies
that Takeda, in its sole discretion, decides to conduct. Takeda shall use
Commercially Reasonable Efforts to take into consideration Sucampo’s comments on
the protocol of any Post-Approval Marketing Studies, including but not limited
to any comments relating to a potential impact on activities relating to the
Product in a country or jurisdiction outside of the Territory. For the avoidance
of doubt, any Post-Approval Marketing Studies and Phase IV Studies shall be
included in the Commercialization Plan.
 
4.3.3  European Paediatric Investigation Plan. Sucampo shall use Commercially
Reasonable Efforts to conduct and direct the European Paediatric Investigation
Plan at its own costs and shall bear all responsibilities related to the
performance of the European Paediatric Investigation Plan. Sucampo shall use its
Commercially Reasonable Efforts to keep the JWG informed of the progress of the
European Paediatric Investigation Plan. For the avoidance of doubt, Sucampo will
not be required to perform any additional studies other than those studies set
for the European Paediatric Investigation Plan attached as EXHIBIT M.
 
4.3.4  Post Allocation.  Sucampo shall be exclusively responsible for any
Development costs (including for clarification, the Supply Price for any
Licensed Product that are supplied by Sucampo to Takeda for Development
purposes) set forth in the budgetary portion of the Development Plan attached to
this Agreement and as may be amended for up to an aggregate total of […***…]
United States Dollars (USD […***…]) for Developing the Licensed Product in the
Field in all countries in the Territory.  Takeda shall be responsible for all
Development costs (including for clarification, the Supply Price for any
Licensed Product that are supplied by Sucampo to Takeda for Development
purposes) above […***…] United States Dollars (USD […***…]). For the avoidance
of doubt, any and all costs or fees related to the European Paediatric
Investigation Plan are not included in the […***…] United States Dollars (USD
[…***…]) of Development costs which are stated in this Section 4.3.4 and will be
the sole responsibility of Sucampo as provided in Section 4.3.3.
 
 
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4.3.5  Other Development Activities.  In the event the JWG or the JSC identifies
an opportunity to expand and optimize the Licensed Product in the applicable
country in the Territory such as expanding the label for the Licensed Product
for use in the
 
Field in such applicable country in the Territory, the Parties shall discuss the
possibility of Takeda amending the Development Plan (including any Clinical
Studies in the Field in the applicable country in the Territory required to
expand the label of the Licensed Product for use in the Field in the applicable
country in the Territory) to pursue any such opportunities at Takeda’s sole cost
and expense, subject to the review of the JSC.
 
4.4  Conduct of Development
 
4.4.1  Compliance.  The Parties shall use Commercially Reasonable Efforts to
perform their obligations under the Development Plan in a 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 JWG in
the performance of the Development Plan.
 
4.4.3  Segregation.  Takeda 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 provided by or for
Sucampo in a secure environment and prevent the contamination of any of the
foregoing that is received or made accessible in accordance with the terms and
conditions under this Agreement.
 
4.5  Records.  The Parties shall maintain records of their 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.  In
addition to and not in lieu or limitation of the foregoing, each Party shall
calculate and maintain detailed records of its Development costs.  To the extent
that, consistent with a Development Plan, a Party incurs Development costs, such
Party shall provide the other Party with a reasonably detailed written invoice
for such Development costs, and such Development costs shall be accounted for in
the calendar quarter in which such invoice is received by the other Party.  A
Party shall provide to the other Party, within thirty (30) days after the end of
each calendar quarter, a reasonably detailed written invoice showing an itemized
statement of the Development costs together with adequate documentation for all
expenses submitted hereunder.  Such invoices shall set forth, among other
things, a comparison of actual Development costs to expense budgets included in
the applicable Development Plan and the cash settlement required between the
Parties.  Each Party agrees to make any required cash settlements of any
undisputed amounts with the other Party within thirty (30) days following
receipt of the applicable quarterly invoice issued by the other Party and
provide a written notice of the basis of any disputed amounts to the other Party
within fifteen (15) business days after receipt of the applicable quarterly
invoice.  Each Party shall notify the other Party in writing as soon as possible
upon becoming aware that it may or will exceed the annual budget for the
Development of any Licensed Product approved in the applicable Development
Plan.  The Parties will promptly meet to discuss the nature and extent by which
the Party may exceed the annual budget and various ways to prevent, avoid or
mitigate future expenses.  Neither Party shall exceed the annual budget for the
Development of a Licensed Product without the prior written consent of the other
Party.  The Parties shall retain such records for at least ten (10) 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.
 
 
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4.6  Right to audit.  Upon reasonable advance notice to the other Party and
subject to the other Party’s customary rules and restrictions with respect to
site visits by non-Party personnel, a Party shall have the right, but not the
obligation, to not more than once per year, except where there exists a
reasonable cause to perform one (1) or more audits, (a) have access to the other
Party’s or any of its Sublicensee’s and Subcontractors’ 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 reasonable information,
books and records; (c) visit, examine and audit the other Party’s and any
Sublicensee’s and Subcontractors’ 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)
audit 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 in
order that the Auditing Party may be assured as to whether the Development
activities are being performed in conformance with the Development Plan and
Applicable Law and otherwise in accordance with this Agreement.
 
4.7  Technology Transfer.  As soon as reasonably practicable after the Effective
Date and from time to time during the Term, Sucampo shall disclose to Takeda
such of the Sucampo Patent Rights and Sucampo Background Technology that are
necessary for Takeda to exercise its rights and perform its obligations to
Develop and Commercialize the Licensed Product in the Field in any country in
the Territory.  During the Term, Sucampo will provide Takeda with reasonable
technical assistance relating to the use of the Sucampo Patent Rights and
Sucampo Background Technology, solely to the extent expressly permitted under
this Agreement and the license granted to Takeda herein.
 
 
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4.8  Supply of Licensed Product.  Sucampo shall use Commercially Reasonable
Efforts to supply the Licensed Product to Takeda as reasonably required for the
completion of the Development of the Licensed Product in the Field in the
applicable country in the Territory.  Takeda shall be responsible for its and
its employees’, agents’, Sublicensees’, Affiliates’, and Subcontractors’ use,
storage, handling and disposition of such Licensed Product.  Unless otherwise
directed by Sucampo, upon suspension, discontinuation or completion of the
Development of the Licensed Product in the Field in any country in the
Territory, Takeda shall: (a) promptly provide to Sucampo an accounting of the
receipt and disposition of such Licensed Product, (b) at Sucampo’s sole option
and cost and expense, and to the extent reasonably possible, return to Sucampo
or its designee properly all unused supplies of such Licensed Product in
accordance with all Applicable Law and any requirements of or instructions by
Sucampo, and (c) promptly provide to Sucampo a written notice by a duly
authorized representative of Takeda of such return of such Licensed
Product.  Takeda shall not, and shall ensure that its employees, agents and
contractors, including the investigators, its Affiliates and other Sublicensees
shall not: (a) use such Licensed Product except as expressly and specifically
provided in this Agreement and the Development Plan, (b) distribute, transfer or
release such Licensed Product to any other Person for any purpose or use, except
as expressly and specifically described in this Agreement and the Development
Plan; or (c) chemically, physically or otherwise modify such Licensed Product,
except the extent expressly and specifically required by the Development
Plan.  In addition to and not in lieu or limitation of the foregoing, Takeda
shall (i) limit access to such Licensed Product to only the participants of any
Clinical Studies in the Field in the applicable country in the Territory 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 such Licensed Product  in
compliance with all Applicable Law and any other requirements or instructions of
Sucampo.
 
 
ARTICLE 5
DEVELOPMENT AND COMMERCIALIZATION OF OTHER INDICATIONS
 
5.1  Reporting.  From time to time during the Term, Sucampo and its Affiliates
may seek to develop or commercialize Other Indication(s) in the
Territory.  Sucampo shall provide Takeda with written notice of such Other
Indication(s) within thirty (30) Business Days after the Phase IIa Study reports
or other similarly advanced Clinical Study reports are available for such Other
Indication(s).  The notice shall include such information with regard to such
Other Indication(s) as Sucampo and its Affiliates reasonably determines is
necessary to permit Takeda and its Affiliates to evaluate such Other
Indication(s) and its/their potential marketability in the Territory for
purposes of determining whether to exercise the option described in Section 5.2.
 
 
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5.2  Takeda Right of First Option to Negotiate for Other Indications.  Takeda
shall have […***…] ([…***…]) days 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 Indication(s)
opportunity in the Territory, provided that Takeda 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 Takeda’s response indicating whether or not it wishes to
participate in negotiations with respect to such Other Indication(s) opportunity
in the Territory is not delivered to Sucampo within the […***…] ([…***…]) day
response period, Takeda shall no longer have the right to exercise such Other
Indication(s) opportunity, as applicable, and Sucampo shall be free to discuss
such Other Indication(s) opportunity, as applicable, with any Third Party
without further obligation to Takeda.  If Takeda indicates in its response
delivered within such […***…] ([…***…]) day period that it wishes to participate
in negotiations with Sucampo with respect to such Other Indication(s)
opportunity in the Territory, the Parties shall then negotiate in good faith for
a period of […***…] ([…***…]) days after Takeda’s notice to Sucampo to include
such Other Indication(s), as applicable, under a license agreement with the same
legal terms and conditions as this Agreement. During the first period of […***…]
([…***…]) days and the second period of […***…] ([…***…]) days, Sucampo shall
discuss exclusively with Takeda such Other Indication(s) opportunity in the
Territory. If terms and conditions other than the legal terms and conditions of
such license agreement have not been agreed upon by the Parties within the
foregoing period, Sucampo shall be entitled to negotiate with Third Parties for
the development and commercialization of such Other Indication(s) without
further obligation or liability to Takeda.
 
ARTICLE 6
REGULATORY
 
6.1  Regulatory Filings; Regulatory Approvals
 
6.1.1  Ownership.  To the maximum extent permitted by Applicable Law, Takeda or
its Affiliates shall own all Regulatory Filings in the Territory, including all
Regulatory Approvals (excluding all Regulatory Filings and Regulatory Approvals
in connection with the Manufacturing of the Licensed Product) and Takeda, its
Affiliates or Distributors shall file the Marketing Authorization Applications
(where no Existing Regulatory Approvals exist), register (where no Existing
Regulatory Approvals exist) and maintain (including submitting variations of)
all such Regulatory Approvals, including obtaining any variations or renewals
thereof at Takeda’s sole cost and expense for the Licensed Product in the Field
in the applicable country in the Territory.  To the maximum extent permitted by
Applicable Law, Sucampo shall own all Regulatory Filings and Regulatory
Approvals in connection with the Manufacturing of the Licensed Product and
Sucampo shall register and maintain all such Regulatory Approvals in the
Territory, including obtaining any variations or renewals thereof at Sucampo’s
sole cost and expense.  Each Party agrees that neither it nor its Affiliates
will do anything to adversely affect any of the Regulatory Approvals or other
Regulatory Filings.  Notwithstanding the foregoing and for the avoidance of
doubt, to the maximum extent permitted by Applicable Law, Sucampo shall own all
Data in accordance with Section 11.1 below.
 
 
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6.1.2  Regulatory Strategy; Preparation and Maintenance of Regulatory Filings;
Communications.
 
(a)  Development of Regulatory Strategy.  Takeda shall be responsible for the
regulatory strategy (other than for Manufacturing) and will be part of the
Development and Commercialization Plans as applicable. The Parties shall use
Commercially Reasonable Efforts to cooperate and consult with each other,
through the JWG, in good faith, to support the strategies for all Regulatory
Filings in the Field in the applicable country in the Territory for the Licensed
Product including the impact on the Regulatory Approvals outside the Territory,
and Takeda shall update the Development and Commercialization Plans in
accordance with Section 4.1.2.
 
(b)  Preparation of Regulatory Filings; Review of Regulatory Filings;
Maintenance of Regulatory Approvals.
 
(i)  Sucampo shall provide all Data, documents and support reasonably required
for the successful transfer to Takeda of all Existing Regulatory Approvals for
the Licensed Product (other than Existing Regulatory Approvals for
Manufacturing) in all countries of the Territory as well as all Data, documents
and support for applying, and obtaining Regulatory Approval where no Existing
Regulatory Approvals exist in any applicable country in the Territory and for
maintaining such Regulatory Approvals. Sucampo shall bear all costs for such
Data, documents and support to the extent under Sucampo’s Control and Takeda
shall bear the cost for the Data, documents and support which is not under the
Control of Sucampo.  Subject to the terms of this Agreement, Takeda shall: (i)
use Commercially Reasonable Efforts to implement the regulatory strategy for
Clinical Studies in the Development Plan (other than Post-Approval Marketing
Studies) including interactions with Regulatory Authorities; (ii) use
Commercially Reasonable Efforts to prepare and submit Regulatory Filings in the
applicable country in the Territory, where no Existing Regulatory Approvals
exists for the Licensed Product other than Regulatory Filings for Manufacturing
the Licensed Product (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, use
Commercially Reasonable Efforts in obtaining, referencing and using all
Regulatory Filings, Pre-clinical Data, Clinical Data and CMC Data for the
Licensed Product (including but not limited to countries outside of the
Territory) solely for use in the applicable country in the Territory in
connection with the Regulatory Filings, without any additional compensation from
Sucampo.  At Sucampo’s reasonable request, and subject to Applicable Law, Takeda
shall use Commercially Reasonable Efforts to provide Sucampo with (a) copies of
such Regulatory Filings in the applicable country in the Territory in the Field,
material Pre-clinical Data, material Clinical Data, material CMC Data and other
material Data generated by or for Takeda in connection with the Licensed Product
and this Agreement within ninety (90) days of the Regulatory Filings, and (b)
other material information as soon as practicable and otherwise keep Sucampo
informed of any material developments from time to time.
 
 
 
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(ii)  Sucampo shall also provide Takeda in a timely manner with samples,
standards and disposable items as the transfer of analytical methods, necessary
for local laboratory control, required by Regulatory Authorities for obtaining,
maintaining (including amending) Regulatory Approvals and/or for product
certification and customs clearance for the Licensed Product in the Field in the
applicable country in the Territory. As necessary, the Parties shall sign
specific agreements to govern the matters relating to the supply of such
samples, standards and disposable items and the transfer of analytical methods
to Takeda at the latest before the first items are sent to Takeda. Each Party
shall furthermore give prompt notice to the other Party in the event it becomes
aware of any upcoming changes in Applicable Law to maintain the Existing
Regulatory Approvals in the Territory. It is agreed by the Parties that the Data
shall remain the property of Sucampo.
 
(iii)  Promptly after the Effective Date, Sucampo shall use Commercially
Reasonable Efforts to assign and transfer and/or cause its Affiliates to assign
and transfer the Existing Regulatory Approvals for the Licensed Product in the
Field in all countries in the Territory to Takeda or an Affiliate of Takeda in
the Territory (excluding all Regulatory Approvals in connection with the
Manufacturing of the Licensed Product). Takeda or an Affiliate of Takeda shall
use Commercially Reasonable Efforts to become the holder of the Existing
Regulatory Approvals for the Licensed Product in the Field in each country in
the Territory (excluding all Regulatory Approvals in connection with the
Manufacturing of the Licensed Product) and take appropriate steps for the
transfers to occur as soon as possible. If required by Applicable Law or if
requested by Takeda, Sucampo shall execute power of attorney in favor of Takeda
and/or its Affiliates, and shall execute all documents as may reasonably be
required by the Regulatory Authorities in the applicable country in the
Territory to enable Takeda and/or its Affiliates to apply for, obtain and
maintain the Regulatory Approvals for the Licensed Product in the Field in such
country and become the holder thereof (other than any Regulatory Approval in
connection with the Manufacturing of the Licensed Product). Sucampo shall
furthermore provide all reasonable support necessary (at Takeda’s own cost) to
enable the successful transfer and assignment of the Existing Regulatory
Approvals to Takeda (excluding all Regulatory Approvals in connection with the
Manufacturing of the Licensed Product), including providing (i) necessary
documents or other materials required by Applicable Law in such country in the
Territory, (ii) access and reference to any relevant Regulatory Filings outside
the Territory, and (iii) Regulatory Filings with the FDA, in a format and
standard reasonably requested by Takeda, in each case at Takeda’s sole cost and
expense. Until such Regulatory Approvals are fully transferred to Takeda or its
Affiliate, Sucampo or its Affiliate shall perform, at Sucampo’s expense,
reasonable activities with respect to such Existing Registration Approval and
shall continue to maintain the Existing Regulatory Approvals, in each of the
foregoing cases, at Takeda’s sole cost and expense.
 
 
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(c)  Communications; Regulatory Meetings.  After the Regulatory Authorities in
the applicable country in the Territory have approved the MAA, Sucampo shall, at
Takeda’s sole cost and expense, cooperate with Takeda’s reasonable requests
relating to, and provide support in responding to, communications from
Regulatory Authorities in such applicable country in the Territory related to
the Licensed Product in the Field, including using Commercially Reasonable
Efforts to provide comments on Takeda’s submissions and responses within ten
(10) Business Days from the time of receipt by Sucampo or sooner if required by
such Regulatory Authorities.
 
(d)  Occurrences or Information Arising out of Sucampo Manufacturing
Activities.  During the Term, Sucampo will discuss in good faith at the JWG any
planned Manufacturing activity in the Territory and, only to the extent that any
Licensed Product that is supplied by Sucampo to Takeda under this Agreement is
Manufactured outside of the Territory and any planned Manufacturing activity
outside of the Territory, that Sucampo is aware could potentially affect a
Regulatory Filing or Regulatory Approval that is owned by Takeda or its
Affiliates for the Licensed Product in the Field in the applicable country in
the Territory under Section 6.1.1, and such activities shall always follow the
change request procedure in this Agreement and the Quality Agreement.  Sucampo
shall also inform Takeda, without undue delay following, and in any event within
a period not to exceed seven (7) Business Days, 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 Licensed Product in the Field in
the applicable country in the Territory, including actual or threatened
Regulatory Filing withdrawals or labeling changes to the Licensed Product in the
Field in such applicable country 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 such Party’s role in the Development, Manufacture and
Commercialization of the Licensed Product.  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 applicable
country in the Territory concerning any governmental inspection related to the
Licensed Product, and will allow Regulatory Authorities in such applicable
country in the Territory to conduct 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 Licensed Product.  In the event
a Party is inspected by any Regulatory Authority in the applicable country in
the Territory relating to the Licensed Product, the inspected Party will notify
the other Party without undue delay, and in any event within a period not to
exceed seven (7) Business Days, of any written alleged violations or
deficiencies relating to the Licensed 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
Agreement and Applicable Law of such country.  Prior to submission of any
written response submitted to any applicable Regulatory Authority in the
applicable country 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.
 
 
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6.2  Product Labels and Inserts.  Takeda shall own and be responsible for the
manufacturing of all Product Labels (for Secondary Packaging) and Inserts for
the Licensed Product in the Field in the applicable country in the
Territory.  Takeda shall provide to Sucampo the initial artwork and the amended
versions for such Product Labels and Inserts, for Sucampo’s consent within five
(5) Business Days, which shall not be unreasonably withheld or conditioned,
provided that the absence of answer from Sucampo during this five (5) Business
Days period shall be considered as consent to the artwork provided by
Takeda.  The Product Labels and Inserts for each country in the Territory shall
comply with Applicable Law and Regulatory Approval in such country in the
Territory.
 
6.3  Pharmacovigilance Administration.  The Parties shall enter into a
Pharmacovigilance Agreement detailing the procedures of the pharmacovigilance
system administration including but not limited to the exchange of safety
related information and safety reporting procedures, which shall be separately
agreed within ninety (90) days of the Effective Date of this Agreement (the
“Pharmacovigilance Agreement”).  Such procedures shall at all times include any
measures necessary for each Party to fully comply with Applicable Law and such
procedures may be amended with the Parties’ mutual agreement from time to time.
Sucampo has the responsibility of maintaining the Global Safety Database
(“GSDB”) for the Licensed Product and generating and compiling periodic safety
update reports (“PSUR”/”PBERER”) and development safety update reports (“DSUR”).
Takeda, including any Affiliate and Distributor, has the responsibility for the
pharmacovigilance system administration of the Compound and Licensed Product in
the Field in the applicable country in the Territory including but not limited
to operating any call centers, conducting any reporting obligations of Adverse
Events/Reactions, literature monitoring, submitting safety related information
to Sucampo required to be included in the GSDB, submitting any PSUR/PBERER and
DSUR, any other applicable pharmacovigilance report (including but not limited
to risk management plan (“RMP”) or any periodic safety report). Takeda shall pay
for all costs of the local pharmacovigilance system administration. Takeda shall
pay Sucampo for all costs for the maintenance of the GSDB and the generation and
compiling PSUR/PBERER and DSUR on a prorata basis of the number of cases
reported by Takeda for the Territory over the total number of cases reported
worldwide but in no event shall Takeda, including its Affiliates, […***…] and
under the Collaboration and Licence Agreement between Takeda Pharmaceutical
Company Limited and Sucampo Pharmaceuticals, Inc. made on October 29, 2004. For
instance, if Takeda reports ten (10) cases a year for the Territory and the
total amount of cases reported worldwide is one hundred (100), then Takeda shall
pay only ten percent (10%) of the costs for the maintenance of the GSDB. The
current estimated cost for processing a case is […***…] United States Dollars
(USD […***…]). Takeda shall be responsible and bear all costs associated with
the management and the reporting of the local safety databases. Sucampo and
Takeda shall ensure that they and their Affiliates provide each other with all
information and data reasonably required to allow Sucampo and Takeda to each
comply with its regulatory obligations in or outside of the Territory.  For
clarification, the Pharmacovigilance Agreement shall govern with respect to
matters in connection with the pharmacovigilance administration for the Compound
and Licensed Product; provided that the cost allocation of such
pharmacovigilance system administration and GSDB shall be governed by this
Section 6.3.
 
 
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6.4  Recalls and Market Withdrawals
 
6.4.1  Notification.  Each Party shall make every reasonable effort to notify
the other Party promptly upon its determination that any event, incident or
circumstance has occurred that may result in the need for a Recall or Market
Withdrawal of the Licensed Product in the applicable country in the Territory,
and include in such notice the reasoning behind such determination and any
supporting facts. The timelines for such notification will be mutually agreed by
the Parties in the Quality Agreement.
 
6.4.2  Initiation.  Both Parties shall jointly discuss whether to voluntarily
implement any Recall and upon what terms and conditions the Licensed Product
shall be subject to a Recall in the applicable country in the Territory.  If
time allows, both Parties shall jointly discuss and the JSC shall determine
whether to voluntarily implement a Market Withdrawal in the applicable country
in the Territory and upon what terms and conditions the Licensed Product shall
be subject to a Market Withdrawal or otherwise temporarily or on a limited basis
withdrawn from sale in such applicable country in the Territory; provided that
notwithstanding the foregoing or anything to the contrary in this Agreement,
Takeda may, in accordance with its Commercially Reasonable Efforts and generally
applied internal regulations with respect to compliance and Adverse
Events/Reactions and Serious Adverse Events/Reactions and the terms and
conditions of the Pharmacovigilance Agreement or the Quality Agreement as
applicable, cause Takeda and its Sublicensees and Subcontractors to, cease or
suspend (on a country-by-country and Licensed Product-by-Licensed Product basis)
the Development and Commercialization of the Licensed Product in the Field in
the applicable country in the Territory, as applicable, upon reasonable written
notice to, and good faith consultations with, Sucampo prior to any such
cessation or suspension in the event that (a) such cessation or suspension is
required by the applicable Regulatory Authority in the applicable country in the
Territory or (b) Takeda reasonably and in good faith believes that such
cessation or suspension is needed in order to limit any potential material
liability of the Parties due to any health and safety issues reported in
connection with such Development and
 
 
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Commercialization, including any reported Adverse Events/Reactions or Serious
Adverse Events/Reactions.  In addition to and not in lieu or limitation of the
foregoing, in the event that Sucampo and Takeda are unable to agree within
appropriate timelines whether or not to voluntary implement a Recall or Market
Withdrawal of the Licensed Product in the applicable country in the Territory,
notwithstanding anything herein to the contrary, Takeda shall make the final
determination.  If a Recall is mandated by a Regulatory Authority in a
particular country in the Territory, Takeda shall initiate such a Recall to be
in compliance with Applicable Law in such country.  In the event of any Recall,
Market Withdrawal or other withdrawal of the Licensed Product in the applicable
country in the Territory, each Party shall provide, and cause its Affiliates and
other Sublicensees to provide, any and all assistance and support required by
Applicable Law in such country, or reasonably requested by the other Party;
provided that for clarification, Takeda shall be responsible for initiating such
Recall, Market Withdrawal or other withdrawal of such Licensed Product.  For the
avoidance of doubt, (a) the Recall or Market Withdrawal of a Licensed Product
under this Section 6.4.2 shall be determined on a Licensed Product-by-Licensed
Product basis and on a country-by-country basis in the Territory, and (b) the
Recall or Market Withdrawal of a Licensed Product in a particular country in the
Territory may, but shall not automatically, affect the Development or
Commercialization of any other Licensed Product or any other country in the
Territory.
 
6.4.3  Responsibility.  In the event of a Recall or Market Withdrawal of the
Licensed Product or any lot(s) thereof in any country in the Territory, Takeda
shall bear all costs and 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 Licensed Product in such country and the cost and
expenses of destroying the Licensed Product recalled from such country, if
necessary, unless such Recall or Market Withdrawal was solely caused by: (a) the
Manufacturing (other than Secondary Packaging) and supply of the Licensed
Product solely as and in the form supplied by Sucampo to Takeda for commercial
distribution and use in the Field in the applicable country in the Territory;
provided that the defect of the Licensed Product that resulted in the Market
Withdrawal or Recall is a Patent Defect or Latent Defect, or (b) Sucampo’s final
determination to implement a voluntary Recall or Market Withdrawal of the
Licensed Product in such country 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, in which case Sucampo shall pay for all
reasonable costs and expenses of such Recall or Market Withdrawal to the extent
such Recall or Market Withdrawal was caused by Sucampo.
 
 
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6.5  Complaints.  Each Party shall maintain a record of all complaints it
receives from a Third Party with respect to any Licensed Product in the Field in
any country in the Territory and shall refer to the other Party complaints that
it receives concerning the Licensed Product in the Field in any country in the
Territory within forty-eight (48) hours of its receipt of the same as provided
for in the Quality Agreement; provided that all complaints concerning suspected
or actual Licensed Product occurrence of any of the following: mixed strengths
in same bottle, foreign product in container/package, foreign matter in vial,
general package contamination, label mix, missing label, missing or incorrect
lot/expiration on primary or secondary (if secondary packaging has
tamper-evident tape) package, missing package insert (if design includes a PI),
and missing tamper evident tape shall be delivered within twenty-four (24) hours
of  receipt of the same as provided for in the Quality Agreement.  Each Party
shall be responsible for investigating complaints and taking corrective action
as necessary at its own  cost and expense and, shall use Commercially Reasonable
Efforts in providing all reasonable efforts and collaboration with the other
Party in the resolution of complaints, and shall train its employees on the
proper handling and resolution of complaints concerning the Licensed Product as
provided for in the Quality Agreement; provided that the costs and expenses
therefor shall be borne by the Party solely liable for the complaints, or by
both Parties based on the allocation of liability, if they are jointly and
severally liable for the complaints; provided that for clarification, the
foregoing shall not waive, modify, limit, restrict, condition or otherwise
affect the cost allocation between the Parties in the event of a Recall or
Market Withdrawal pursuant to Section 6.4 above.
 
 
ARTICLE 7
COMMERCIALIZATION OF LICENSED PRODUCT
 
7.1  Commercialization Plan
 
7.1.1  Initial Commercialization Plan.  Approximately six (6) months prior to
the estimated date for the filing of the first MAA Takeda shall prepare and
submit to the JSC for review and comments the initial Commercialization Plan by
Key Markets.  For countries of the Territory where there is an Existing
Regulatory Approval upon the Effective Date of this Agreement, the initial
Commercialization Plan shall be prepared by Takeda within sixty (60) days of the
Effective Date. The initial Commercialization Plan for the Key Markets in the
Territory shall include:
 
(a)  the pre-launch plan with key regulatory milestones to be achieved in the
launch period and through years three (3) and five (5);
 
(b)  the number of full-time representative equivalents to be deployed during
the launch and during the first five (5) years of the Term;
 
(c)  volume and sales forecasts for the five (5) next years;
 
(d)  marketing plans to achieve revenue and sales forecasts; and
 
(e)  budget allocation in percentages of the total budget with regard to
activities specified in the Commercialization Plan.
 
 
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7.1.2  Update of the Commercialization Plan.  The Commercialization Plan shall
be revised annually by Takeda and submitted to the JSC for review and comments
on or before November 30 of each year.
 
7.2  Responsibility.  Subject to the terms and conditions of this Agreement,
Takeda shall be responsible for all aspects of Commercializing the Licensed
Product in the Field in the applicable country in the Territory in accordance
with the Commercialization Plan and all Applicable Law.
 
7.3  Costs. Takeda will be responsible for the costs of Commercialization in the
Territory, including the costs of developing Promotional Materials, scientific
meetings, CME-related educational symposia, promotional marketing programs,
sales training, distribution, salaries and similar expenses, as appropriate.
 
7.4  Promotional Materials.  During the Term, Takeda shall be solely responsible
for creating and developing Promotional Materials to be used in connection with
the Promotion of the Licensed Product in the Field in the applicable country in
the Territory. First version of Promotional Material for the Key Markets are
subject to the prior review and comment by the JSC on a Licensed
Product-by-Licensed Product basis and on a country-by-country basis in the
Territory. Takeda shall ensure that all Promotional Materials comply with all
Applicable Law in the applicable country 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 applicable country in the
Territory, Takeda shall make such submissions, and Takeda shall be the
Regulatory Authority liaison on all marketing, advertising and Promotional
matters. Sucampo shall use Commercially Reasonable Efforts to provide Takeda
with copies of Promotional Materials used by Sucampo, its Affiliates, its
licensees and distributors.  During the Term, Takeda shall only use such
Promotional Materials for the Promotion of the Licensed Product in the Field in
such applicable country in the Territory in compliance in all respects with this
Agreement and all Applicable Law and after the Term, Sucampo shall own all
rights in the Promotional Materials provided by Sucampo to Takeda during the
Term anywhere in the world. For the avoidance of doubt, any Promotional Material
created and developed by or on behalf of Takeda or its Affiliates will be owned
by Takeda after the Term. As part of the foregoing, to the maximum extent
permitted by Applicable Law, Takeda 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 provided by Sucampo to Takeda during the Term (and all intellectual
property rights therein or thereto), throughout the world.  Notwithstanding the
foregoing, Sucampo agrees not to exercise its ownership or license rights with
respect to the Promotional Materials with respect to a Licensed Product in any
particular country in the Territory until the earlier of (a) the termination of
Takeda’s right to Promote or Commercialize such Licensed Product in such country
pursuant to Section 12.2.2 below, and (b) the expiration or termination of this
Agreement.
 
 
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7.4.1  Presentation and Promotion of the Licensed Product.  The
Commercialization Plan shall describe, with respect to Key Markets, the manner
in which the Licensed Product in the Field in the applicable country in the
Territory will be presented and described to the medical community in any
Promotional Materials or other materials and any placement of the Corporate
Names of the Parties, in each case as and to the extent expressly and
specifically permitted according to Section 11.4 and by Applicable Law in the
applicable country in the Territory and with the Product Labels and Inserts for
the Licensed Product approved by the applicable Regulatory Authority in such
applicable country in the Territory.
 
7.5  Non-Compete.  For a period of […***…] ([…***…]) years from the First
Commercial Sale, on a country by country basis, to the extent permitted by
Applicable Law, Takeda and Sucampo shall refrain, and shall cause their
respective Affiliates to refrain from, promoting, marketing, selling, offering
for sale, distributing, commercializing or otherwise exploiting in any country
of the Territory in the Field any small molecule oral pharmaceutical product
that have the same mode of action as the Licensed Product (i.e. chloride channel
activator), for Takeda other than the Licensed Product and other than Takeda’s
pharmaceutical products in the Field as of the Effective Date (a “Competing
Product”), without the prior written approval of the other Party, which approval
shall not be unreasonably withheld, conditioned or delayed. The Parties
acknowledge and agree that the following specific pharmaceutical products shall
be considered as Competing Products: Linaclotide, Prucalopride Methylnaltrexone
and Naloxegol.
 
 
ARTICLE 8
CONSIDERATION
 
8.1  Upfront Payment.  In consideration of the rights and licenses granted under
this Agreement, Takeda shall make a nonrefundable payment to Sucampo in the
amount of […***…] United States Dollars (USD […***…]), against proper invoice
within thirty (30) days of the Effective Date.
 
8.2  Payments on Annual Net Sales.  Takeda shall make each of the following
non-refundable and non-creditable payments to Sucampo against proper invoice, in
the amounts set forth below, each on a one (1) time basis as specified below:
 
 
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Annual Net Sales Milestones and Due Date
Payment
Aggregate Annual Net Sales for the Licensed Product in all countries in the
Territory first exceed […***…] United States Dollars (USD […***…]) in a calendar
year
[…***…] United States Dollars (USD […***…]) within thirty (30) Business Days
after the occurrence of the submission of the report demonstrating the event
Aggregate Annual Net Sales for the Licensed Product in all countries in the
Territory first exceed […***…] Million United States Dollars (USD […***…]) in a
calendar year
[…***…] United States Dollars (USD […***…]) within thirty (30) Business Days
after the occurrence of the submission of the report demonstrating the event
Aggregate Annual Net Sales for the Licensed Product in all countries in the
Territory first exceed […***…] United States Dollars (USD […***…]) in a calendar
year
[…***…] United States Dollars (USD […***…]) within thirty (30) Business Days
after the occurrence of the submission of the report demonstrating the event

8.3  Supply Price.  Promptly after shipment of Licensed Product to Takeda,
Sucampo shall, subject to Section 4.4.3, invoice Takeda the Supply Price for
such Licensed Product shipped to Takeda.  Takeda shall pay the Supply Price for
such Licensed Product within sixty (60) days after such invoice is received by
Takeda, provided that if Takeda rejects such Licensed Product pursuant to
Section 9.7 due to a Patent Defect, a Latent Defect or because the delivery of
such Licensed Product is not in compliance with the quantities set forth on the
relevant purchase order, then, in the case the Licensed Product is not in
compliance with the quantities set forth in the purchase order, payment shall
still be due for the quantities actually shipped to and received and accepted by
Takeda pursuant to Section 9.7 below within sixty (60) days after such invoice
is received by Takeda or, in the case of an allegation of a Patent Defect or
Latent Defect, payment shall then be due within sixty (60) days after receipt by
Takeda of notice from the independent laboratory pursuant to Section 9.7 below
that such allegation is not the case. In the event that during the term of this
Agreement the Supply Price does not allow for commercially viable margins for
Takeda, as decided by Takeda using Commercially Reasonable Efforts, or otherwise
has an impact on the Commercialisation of the Product in the Territory, then the
Parties will enter good faith negotiations to discuss and agree to a potential
reduction of the Supply Price. Specifically in the event Takeda attains the
Annual Net Sales Milestones described in Section 8.2, the Parties shall discuss
and shall agree in good faith to an adjustment in the Supply Price for the
Licensed Product within three (3) months following the attained Annual Net Sales
Milestones, which such reduction being […***…] percent ([…***…]%).
 
 
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8.4  Third Party Royalties.  If any of Takeda’s activities under this Agreement,
including the Development or Commercialization of the Licensed Product by Takeda
in a particular country in the Territory or outside the Territory infringes or
misappropriates or otherwise makes unauthorized use of any intellectual property
rights of a Third Party (other than Takeda’s Affiliates or other Sublicensees)
in such country such that Takeda cannot carry out the activities under this
Agreement (such as but not limited to use, Develop or Commercialize the Licensed
Product) in such country as provided for herein without infringing,
misappropriating or making unauthorized use of the intellectual property rights
of such Third Party (other than Takeda’s Affiliates or other Sublicensees), then
each Party shall promptly notify the other Party upon becoming aware of the same
and, Sucampo shall, use Commercially Reasonable Efforts to, within three (3)
months: (a) obtain such licenses and rights as are necessary for Takeda to
Develop or Commercialize the Licensed Product in the Field in such country as
expressly provided for herein 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 so that it does not infringe or misappropriate at
Sucampo’s sole cost and expense. Notwithstanding the above, after expiration of
the before mentioned three (3) month period, Takeda may at its sole discretion
decide to negotiate with such Third Party to obtain such licenses and rights as
are necessary for Takeda to Develop or Commercialize the Licensed Product in the
Field in such country. The payments due to Sucampo according to this Agreement
shall be reduced to the extent Takeda pays Patents or Trademarks royalties to
any Third Parties in connection with Takeda’s activities under this Agreement,
such as Development, Secondary Packaging, or Commercialization of the Licensed
Product in the Field in the applicable country of the Territory.
 
8.5  Payment Dates and Reports.  Starting with the month following the calendar
quarter in which the First Commercial Sale occurs in any country in the
Territory and continuing thereafter during each calendar quarter of the Term
within fifteen (15) days following the end of each calendar quarter, Takeda
shall provide one consolidated report based on GAAP showing on a Licensed
Product-by-Licensed Product basis and on a country-by-country basis a statement
identifying the amount of Net Sales during the relevant calendar quarter.
 
8.6  Financial Audit Rights.  Each Party shall keep and maintain for at least
ten (10) years complete and accurate records in sufficient detail to allow
confirmation of any payment and Development cost calculations made hereunder,
unless under local Applicable Law a longer timeframe is required.  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 reasonably acceptable to the Audited Party, at the Auditing Party’s
expense, to have access, with not less than thirty (30) days’ notice, during
normal business hours, to the records of the Audited Party and its Affiliates as
may be reasonably necessary to verify the accuracy of the payments hereunder for
any Calendar Year ending not more than thirty-six (36) months prior to the date
of such request.  The accounting firm will be instructed to provide its audit
report first to the Audited Party, and will be further instructed to redact
 
 
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any Confidential Information of the Audited Party not relevant to verifying the
accuracy of payments or Development costs prior to providing that audit report
to the Auditing Party.  The accounting firm’s audit report shall state whether
the applicable report(s) is/are correct or not, and, if applicable, the specific
details concerning any discrepancies.  No other information shall be shared.  If
such accounting firm concludes that additional monies were owed by the Audited
Party to the other, the Audited Party shall pay the additional monies against
invoice within thirty (30) days of the date the Audited Party receives such
accounting firm’s written report so concluding.  The fees charged by such
accounting firm shall be paid by the Auditing Party; provided if an error in
favor of the Auditing Party of more than ten percent (10%) is discovered, then
the Audited Party shall pay the reasonable fees and expenses charged by such
accounting firm.  Any audit reports provided hereunder shall be the Confidential
Information of the Audited Party.  Takeda shall either: (a) require each of its
Affiliates 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 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 Affiliates and other Sublicensees of Takeda the
Audited Party for purposes of this Section 8.6.
 
8.7  Withholding Taxes.  All payments made under this Agreement shall be free
and clear (exclusive of) of any withholding taxes required by Applicable
Law.  Where any sum due to be paid to a Party hereunder is subject to any
withholding tax under Applicable Law of a particular country in the Territory,
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 in such country, or not all documents required
to claim benefits of any applicable double taxation agreement or treaty are made
available to the paying Party at least five (5) Business Days prior to the
payment, the paying Party shall deduct any withholding taxes from payment and
pay such withholding or similar tax to the appropriate Regulatory Authority in
such country, deduct the amount paid from the amount due to the receiving Party
and secure and send to the receiving Party to its reasonable satisfaction an
available evidence of such obligation together with proof of payment.
 
8.8  Payments.  All payments due under this Agreement shall be payable in United
States Dollars (USD) other than the Supply Price, which shall be payable in JPY
unless Sucampo has notified Takeda in writing that Sucampo will change the
Manufacturing site and will Manufacture the Licensed Product through its Back-Up
Supplier; in which case, Sucampo will advise Takeda of the applicable currency
to be applied to the Supply Price at the agreed exchange rate.  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 the applicable Party:
 
 
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Bank information

For Sucampo:

For USD
Bank: […***…]
Address: […***…]
Swift Code: […***…]
Account: […***…]
IBAN Number : […***…]
Contact Person:   […***…]

For JPY
Bank: […***…]
Address: […***…]
Swift Code: […***…]
Account: […***…]
IBAN Number : […***…]
Contact Person:   […***…]

For Takeda:

Bank: […***…]
Address: […***…]
Swift Code: […***…]
Account: […***…]
IBAN Number : […***…]
Contact Person:  […***…]

Each payment shall reference this Agreement and identify the obligation under
this Agreement that the payment satisfies.
 
8.9  Supply Price Adjustment. On a yearly basis the Parties will adjust for any
changes in the exchange rate between: (a) the currency in which Sucampo pays for
its labor and, overhead and JPY solely to the extent any changes in the exchange
rate exceeds […***…] % from the Contract Rates (defined below) and (b) the
currency in which revenues from Net Sales are received and USD based on the
weighted average exchange rate over the prior consecutive twelve (12) month
period from the date that the consolidated report is being prepared by Takeda
pursuant to Section 8.5.   On the first business day of the third month of any
calendar quarter prior to the quarter of application, the Parties shall
establish the exchange rates (“Contract Rates”) to be applied to the following
quarter’s costs (for those costs denominated in currencies different from the
currency in which the costs of labor and overhead are denominated) by
calculating the average exchange rate over the prior consecutive twelve (12)
month period.  The source of the Contract Rates and the exchange rates will be
the European Central Bank.  
 
 
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8.10  No Other Compensation.  Unless otherwise agreed to by the Parties and set
forth in writing, Sucampo and Takeda hereby agree that the terms of this
Agreement 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, agent or contractor of the other Party, directly or
indirectly, or any consideration, compensation or benefits, monetary or
otherwise, in connection with the transactions contemplated herein other than as
expressly and specifically set forth in this Agreement.
 
 
ARTICLE 9
SUPPLY
 
9.1  General
 
9.1.1  Strategy.  The Parties, through the JWG, shall provide regular updates on
the supply of Licensed Product in the applicable country 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 by Sucampo of the
Licensed Product. Sucampo shall keep Takeda reasonably informed of inventory or
production issues that it is aware may affect the availability of Licensed
Product.  Takeda hereby acknowledges and agrees that it shall, and shall cause
each of its Affiliates and other Sublicensees to, exclusively purchase the
Licensed Product from Sucampo during the Term, subject to Applicable
Law.  Sucampo agrees and acknowledges that it shall supply to Takeda the
quantities specified in the forecast attached in EXHIBIT O and that Takeda has
no commitment to order further quantities of Licensed Product. Under no
circumstances shall Sucampo withhold supply from Takeda, including, but not
limited to, during a dispute between the Parties. The Parties acknowledge and
agree that Sucampo is not obligated to provide copies of or access to the
Manufacturing Data to Takeda except to the extent required for Takeda to comply
with its obligations under this Agreement, including without limitation its
Adverse Event/Reaction reporting obligations and the filing and maintenance of
Regulatory Filings.
 
9.1.2  Manufacturing by Sucampo.  In accordance with the applicable terms and
conditions of this Agreement, Sucampo shall use Commercially Reasonable Efforts
to Manufacture (excluding Secondary Packaging) or have Manufactured by an
Affiliate or a Subcontractor on the conditions as stated on Section 9.1.3 in
compliance with the Specifications and test and deliver to Takeda and/or its
Affiliates or Sublicensees its entire requirement of Licensed Product, for the
Commercialization.
 
 
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9.1.3 Sucampo represents and warrants that all such Licensed Product
Manufactured (other than Secondary Packaging) and supplied by or on behalf of
Sucampo has been and shall:
 
(a)  be Manufactured in accordance and in compliance with Applicable Law in the
countries in the Territory where such Licensed Product is to be distributed for
sale in the Field, including cGMP;
 
(b)  be Manufactured in accordance with the applicable Regulatory Filings and
Regulatory Approvals in the countries in the Territory where such Licensed
Product is to be distributed for sale in the Field;
 
(c)  upon delivery, not be adulterated or misbranded as defined by Applicable
Law in the countries in the Territory where such Licensed Product is to be
distributed for sale in the Field;
 
(d)  upon delivery, not have reached the term of […***…] ([…***…]) months on a
total shelf life which shall not be in any event less than of […***…]([…***…])
months;
 
(e)  be free from material defects in materials and workmanship; and
 
(f)  be in compliance with all Specifications for such Licensed Product
 
(hereinafter collectively “Agreed Quality”).
 
9.1.4  Sufficient Inventories.  For the Term, and subject to the timely supply
of the Rolling Forecast pursuant to Section 9.1.5, Sucampo shall use
Commercially Reasonable Efforts to cause its supplier to maintain sufficient
inventories of Compound required to Manufacture the Licensed Product (other than
Secondary Packaging) in order to ensure timely delivery of the Licensed
Product.  Sucampo shall cause its supplier to maintain a safety stock of
Compound equal to […***…] ([…***…]) months of forecast demand based on Takeda’s
most recent Rolling Forecast.
 
9.1.5  Forecasts and Orders
 
(a)  No later than […***…] during the Term, Takeda will provide Sucampo with an
updated […***…] ([…***…]) month rolling forecast of the Licensed Product to be
Manufactured and supplied by or on behalf of Sucampo (each a “Rolling Forecast”)
for the […***…] ([…***…]) month period commencing at the beginning of the
following month with the first […***…] ([…***…]) months considered a purchase
order period.  Each Rolling Forecast will be broken down for each month of such
period by: (i) the Licensed Product, (ii) the quantity (by SKU of Licensed
Product).  The first […***…] ([…***…]) months of each new Rolling Forecast will
constitute the new purchase order for which Takeda will be obligated to purchase
and take delivery of the Licensed Product.
 
 
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(b)  Except as set forth herein, all months of the Rolling Forecast other than
the first […***…] ([…***…]) months will set forth Takeda’s estimate of its
requirements for the supply of Licensed Product on a Licensed
Product-by-Licensed Product basis and on a country-by-country basis in the
Territory, and the Rolling Forecast for the months […***…] ([…***…]) through
[…***…] ([…***…]) of each Rolling Forecast will not be binding.
 
(c)  In the event that the Rolling Forecast sets forth more than […***…]
([…***…]) capsules as samples of Licensed Product, the Parties will in good
faith renegotiate the Supply Price for samples.
 
9.1.6  Purchase Order.  All purchases of Licensed Product shall be pursuant to
written purchase orders consistent with Section 9.1.5(a), which shall be placed
by Takeda at least sixty (60) days prior to the date of which such Licensed
Product shall be delivered to Takeda 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 which is binding pursuant to Section 9.1.5(a) and 9.1.5(b) above is not
submitted by the above deadline, then the quantity of the Licensed Product that
Takeda is committed to purchase for such binding month shall carry forward and
be added to the next calendar month until fulfilled; provided that
notwithstanding the foregoing, Takeda must issue a purchase order therefor prior
to the end of the then-current calendar year. Each purchase order hereunder
shall specify the desired quantities of each Licensed Product and the delivery
dates therefor.
 
9.1.7  Acceptance of Orders.  Orders and delivery dates will be deemed accepted
unless Takeda and/or its Affiliate or Sublicensee receives written notice of
rejection within ten (10) Business Days.  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 Section 9.1.5 and Section 9.1.6 or
(c) during a supply constraint situation in accordance with Section 9.3 below.
 
9.1.8  Secondary Packaging by Takeda.  Subject to the terms and conditions of
this Agreement, Takeda has the responsibility to perform the Secondary Packaging
of the Licensed Product supplied by Sucampo for the Development and
Commercialization of the Licensed Product in accordance and in compliance with
any applicable Specifications for the Secondary Packaging and Applicable Law in
the countries in the Territory where such Licensed Product is to be
Commercialized, including cGMP.  All costs in connection with the Secondary
Packaging of the Licensed Product, including any and all additional incremental
costs resulting from changes to the Specifications for Secondary Packaging that
are required to export the Licensed Product to countries in the Territory on a
country-by-country basis under Applicable Law shall be borne by Takeda.
 
 
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9.1.9  Subcontracting.  Takeda hereby authorizes that Sucampo may subcontract
the Manufacturing of the Compound and the Licensed Product. The Parties
acknowledge and agree that Takeda may subcontract the Secondary Packaging of the
Licensed Product in accordance with Section 2.1.2 above. Sucampo shall not be
relieved of its obligations pursuant to this Agreement as a result of such
appointment of any Subcontractors and shall remain fully responsible and liable
for any action or omission of such Subcontractors which would constitute a
breach of this Agreement if committed by Sucampo as if Sucampo had committed
such action or inaction itself.
 
9.1.10  Changes Control.  Sucampo shall, and shall cause its appointed Third
Parties to,  promptly implement any changes to the Licensed and/or its
Specifications that are required by Applicable Law or by Regulatory Authorities
(collectively, “Required Changes”) in accordance with the change control
procedure set forth in the Quality Agreement.  For changes to the Licensed
Product and/or its Specifications that are not Required Changes, including but
not limited to sub-contracting of Manufacturing or Secondary Packaging
(collectively, “Discretionary Changes”), the requesting Party shall notify the
other Party in advance of such Discretionary Changes in order to obtain such
Party’s prior written approval, such approval not to be unreasonably withheld or
delayed, in accordance with the change control process to be established under
the Quality Agreement.  Sucampo shall implement any such changes only upon prior
approval of Takeda. The Parties shall, to the extent commercially reasonable
under the circumstances, cooperate in making such changes.
 
9.1.11  Costs of Changes.  All costs and expenses associated with Required
Changes shall be shared equally between the Parties. All costs and expenses
associated with Discretionary Changes shall be borne by the Party requesting
such change, provided, however, that if a Discretionary Change is supported by
both Parties and is foreseen to improve the commercial viability or the health
and safety of a Licensed Product in the Territory, the costs of such
Discretionary Change shall be shared equally between the Parties. Costs
associated with changes requested by Sucampo solely in order to optimize the
Manufacturing process (other than Secondary Packaging) of the Licensed Product
(but which do not otherwise improve the commercial viability or health and
safety of a Licensed Product), shall be borne by Sucampo.  All changes required
for Secondary Packaging shall be covered by Takeda.
 
 
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9.1.12  Back-Up Supplier. Sucampo shall use Commercially Reasonable Efforts to
provide Takeda, within ninety (90) days after the Effective Date, with a written
list of Third Party contract manufacturer(s) (other than for Secondary
Packaging) identified by Sucampo to act as potential Back-Up Suppliers. The
Parties will discuss the strategy to qualify the Back-Up Supplier in the
meetings of the JSC and JWG. Not later than […***…], Sucampo shall identify one
or more Third Party contract manufacturers  reasonably acceptable to Takeda to
act as a secondary source for the Manufacture and supply of the Licensed
Product. Not later than twelve (12) months after […***…], Sucampo shall use
Commercially Reasonable Efforts to obtain all Regulatory Approvals required for
the Back-Up Supplier to Manufacture and supply the License Product for use in
Development and Commercialization of such Licensed Product as provided under
this Agreement. Sucampo will be responsible for all costs associated with
qualifying the Back-Up Suppliers, including costs for materials, start up,
validation and test batches, stability testing and equipment. Upon written
request by Takeda from time to time, Sucampo shall provide a reasonably detailed
written report of Sucampo's efforts and progress to qualify the Back-Up
Suppliers as required hereunder. Sucampo shall ensure that the Back-Up Supplier
has the capacity to Manufacture and supply the Licensed Product in sufficient
quantities to meet Takeda's binding forecast in any given quarter in the event
of an interruption to the primary source of supply. Sucampo, at their cost,
shall prepare and submit to the applicable Regulatory Authorities all
information and filings, and take such other actions reasonably required, to
obtain and maintain the Regulatory Approvals required for the Back-Up Supplier
to Manufacture and supply the Licensed Product for Development and
Commercialization activities under and during the Term of this Agreement. For
the avoidance of doubt, Takeda shall continue to purchase the Licensed Product
directly from Sucampo in the event that it is necessary for Sucampo to use the
Back-Up Supplier to Manufacture, and supply to Takeda, the Licensed Product.
Under no circumstances shall Sucampo willfully withhold supply of the Compound
or the Licensed Product from Takeda during the Term of this Agreement,
including, but not limited to, during a dispute with Takeda.
 
9.2  Delivery.  Sucampo shall deliver the Licensed Product CIP at the packaging
site of Sucampo (Incoterms 2010) for Licensed Product primary packaged in
blisters PCI located in Philadelphia, USA and for the Licensed Product primary
packaged in bottles Aphena Pharma Solutions, located in Whippany, NJ USA,
subject to the release of the relevant Licensed Product as per Section
9.4.  Takeda shall designate to Sucampo the carrier which will take delivery of
the Licensed Product.  Sucampo shall contact such carrier when the Licensed
Product is ready for shipping and shall arrange for collection, and
transportation of the Licensed Product.  Sucampo shall inform Takeda two (2)
Business Days prior to pick-up by the carrier.  Takeda shall bear the costs for
transport of the Licensed Product and will be invoiced directly by the
carrier.  Delivery documents shall include purchase order number, quantity, copy
of the certificate of analysis, items codes and description, lot number,
manufacturing date of the Licensed Product, number of shippers, weight, number
of pallets, and any other documents in accordance with the terms of the Quality
Agreement.
 
 
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9.3  Limited Supply.  In the event that the Licensed Product in the Field in the
Territory is not meeting Takeda’s requirements for the Licensed Product in
excess of […***…] ([…***…]%) of the Binding Forecast in a given quarter, Sucampo
shall notify Takeda of such shortage as soon as possible upon becoming aware of
the same.  In the event there is a short supply of the Licensed Product in the
Territory and Sucampo cannot supply the Licensed Product to Takeda in an amount
equal to Takeda’s firm order, then Sucampo shall use Commercially Reasonable
Efforts to allocate available Licensed Product and cause its Third Party
manufacturer to allocate Manufacturing capacity to provide to Takeda in each
month that such a shortfall exists (and in each month thereafter until the
shortfall to Takeda is remedied) the  Licensed Product in an amount equal to (a)
the amount of available Compound or Licensed Product and/or related
manufacturing capacity, multiplied by (b) a fraction the numerator of which is
(i) the aggregate of firm orders made by Takeda over the subsequent twelve (12)
month period including the shortfall month and the denominator of which is (ii)
the sum of (x) the aggregate quantity of firm orders made by Takeda over the
subsequent twelve (12) month period including the shortfall months and (y) the
aggregate quantity of Compound or Licensed Product over the same twelve (12)
month period required by other licensees in a country outside of the Territory
by reference to firm orders placed with Sucampo for such licensees’ requirements
outside of the Territory.  In the event Takeda terminates this Agreement
according to Section 12.2.2(a), Sucampo shall assist Takeda with initiating,
implementing and finishing the qualification of an alternative supplier of
Licensed Product capable of supplying Takeda and its Affiliates and Sublicenses
with its requirements of Licensed Product. Any Third Party direct and documented
out-of-pocket costs actually incurred by Takeda that are reasonably required and
necessary and directly attributable to the qualification of an alternative
supplier and for which Takeda is able to provide supporting documentation
therefor shall be borne by Sucampo; provided that: (a) Takeda will promptly
provide Sucampo with an itemized list of all such documented actual third party
direct out-of-pocket costs and the Parties shall negotiate in good faith to
mutually agreed upon any such third party direct and documented out-of-pocket
costs prior to Takeda incurring such costs, and (b) the Parties will use
Commercially Reasonable Efforts and cooperate to minimize any such costs.
 
9.4  Testing and Release.  Testing and release of the Licensed Product for the
applicable country in the Territory shall be made at the cost and expense of
Sucampo, in accordance with Quality Agreement and Applicable law.  During the
Term, Sucampo will conduct the commercial stability program with respect to the
Licensed Product pursuant to Applicable Law, at its own expense.
 
9.5  Records.  At its own cost, Sucampo shall keep and maintain documentation
and records with respect to Manufacturing (other than Secondary Packaging),
testing and delivery of Licensed Product in accordance with Applicable Law.  At
its own cost, Takeda shall keep and maintain documentation and records with
respect to Secondary Packaging, testing and delivery of Licensed Product to end
users in accordance with Applicable Law.
 
9.6  Quality Agreement.  A Quality Agreement shall be executed between Sucampo
and Takeda within ninety (90) days of the Effective Date and in any event no
later than the first order of Licensed Product.
 
 
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9.7  Non-Conforming Shipment.  Takeda will have a period of ninety (90) Business
Days from the date of its or its Affiliates, Subcontractor or Sub-licensees (as
applicable)  receipt of a shipment of the Licensed Product to: (a) inspect and
reject such shipment for Patent Defects and (b) report any discrepancy in the
quantity of the SKUs of the Licensed Product for such shipment.  If Takeda
provides Sucampo with a notice of non-conformity in respect of any discrepancy
in the quantity of the SKUs of the Licensed Product for any shipment within such
ninety (90) Business Day period then, as Takeda’s sole and exclusive remedy
under this Agreement, Takeda shall have the option of: (i) in the event of a
shortfall in the quantity of the delivered Licensed Product, (x) requiring
Sucampo to, and Sucampo shall, promptly supply Takeda with such additional
Licensed Product as is necessary to meet the amount ordered or (y) paying for
the quantity actually received in accordance with the provisions of ARTICLE 8
without requiring Sucampo to supply any additional Licensed Product as is
necessary to meet the amount ordered or (ii) in the event of an excess in the
quantity of the delivered Licensed Product, (x) returning the excess units to
Sucampo, at Sucampo’s sole cost and expense, through the carrier used to deliver
the Licensed Product to Takeda (or such other carrier as Sucampo may direct in
writing), or (y) accepting any such excess Licensed Product as against future
orders of such Licensed Product.  In each case, Takeda shall pay for the
quantity actually received and accepted unless otherwise agreed in writing by
the Parties.  In the event that Takeda has the right to and elects to reject any
such shipment for a Patent Defect, Takeda shall provide Sucampo with written
notice of such rejection for any Patent Defect within such period of ninety (90)
Business Days together with samples of the non-conforming Licensed Product in
the relevant shipment for testing.  In the case of Licensed Product with Latent
Defects, Takeda will promptly, and in no event more than ninety (90) Business
Days of Takeda knowing of any such Latent Defect, notify Sucampo in writing of
such Latent Defect and provide Sucampo with samples of the non-conforming
Licensed Product in the relevant shipment for testing. If Sucampo disagrees with
Takeda regarding Takeda’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, Takeda will bear all expenses of shipping the
Licensed 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 Takeda a credit for any amount paid with respect to
that portion of the Licensed Product which had a Patent Defect or Latent Defect,
(ii) bear all of Takeda’s reasonable direct and documented out-of-pocket
expenses of returning such Licensed Product to Sucampo or its designee, and
(iii) all reasonable direct and documented out-of-pocket expenses of shipping
Licensed Product to and from and the testing by such independent
laboratory.  Sucampo or Takeda, 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 by Takeda for such disposal.
 
9.8  Quality Audits
 
9.8.1  Sucampo shall use Commercially Reasonable Efforts to make available
facilities being used to Manufacture the Licensed Product (other than Secondary
Packaging) and relevant manufacturing records for audit by Takeda or its
designee 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 audit by Takeda hereunder shall be no
more than once per year, except where there exists a reasonable cause to perform
one (1) or more audits. This shall include reasonable access for Takeda and its
representatives to the facility and all records and personnel required for the
sole purpose of conducting such quality assurance audits of Sucampo. In the
event of: (a) any investigations or requests from the applicable Regulatory
Authorities regarding the Manufacturing process, Product quality control and
cGMP compliance and stability of the Licensed Product (other than Secondary
Packaging), or (b) any occurrence of Market Withdrawals Recalls, Adverse
Events/Reactions or Serious Adverse Events/Reactions caused by or alleged to be
caused by defects in the Manufacturing process of the Licensed Product (other
than Secondary Packaging), in each of the foregoing cases, such access shall be
provided as promptly as possible to Takeda or its designee, subject to Sucampo’s
customary rules and restrictions with respect to site visits by non-Sucampo
personnel.  Sucampo will co-operate with Takeda representatives for all of these
purposes, and shall use Commercially Reasonable Efforts to promptly correct any
reasonable deficiencies noted during the audits.  All information from the audit
will be considered the Confidential Information of Sucampo.
 
9.8.2  Takeda shall use Commercially Reasonable Efforts to make available
facilities being used for Secondary Packaging of the Licensed Product and
relevant packaging records for audit by Sucampo for regulatory or quality
assurance purposes upon reasonable notice and at reasonable times during normal
business hours and subject to Takeda’s customary rules and restrictions with
respect to site visits by non-Takeda personnel; provided, however, that the
audit by Sucampo hereunder shall be no more than once per year, except where
there exists a reasonable cause to perform one (1) or more audits.  This shall
include reasonable access for Sucampo and its representatives to the facility
and all records and personnel required for the sole purpose of conducting such
quality assurance audits of Takeda. In the event of: (a) any investigations or
requests from the applicable Regulatory Authorities regarding the Development,
Commercialization or Secondary Packaging of the Licensed Product, or (b) any
occurrence of Market Withdrawals, Recalls, Adverse Events/Reactions or Serious
Adverse Events/Reactions (except if the foregoing is caused or alleged to be
caused by defects in the Manufacturing process of the Licensed Product (other
than Secondary Packaging)) then, in each of the foregoing cases, such access
shall be provided as promptly as possible, subject to Takeda’s customary rules
and restrictions with respect to site visits by non-Takeda personnel.  Takeda
will co-operate with Sucampo’s representatives for all of these purposes, and
shall use Commercially Reasonable Efforts to promptly correct any reasonable
deficiencies noted during the audits. All information from the audit will be
considered the Confidential Information of Takeda.
 
 
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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 or to
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., Japan or 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 five (5) Business Days, if
possible, prior to the date of such disclosure);
 
(c)  made to an applicable Regulatory Authority in any country in the Territory
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)  reasonably necessary in filing or prosecuting of Sucampo Patent Rights
directed to the Compound or the Licensed Product in the applicable country in
the Territory or (ii) reasonably necessary in defending litigation related to
Sucampo Patent Rights in the applicable country or jurisdiction in the Territory
if such litigation relates to this Agreement, provided that the other Party is
informed and consulted at least thirty (30) days prior to the disclosure where
possible; and
 
(e)  to the extent necessary, and subject to sublicensing and subcontracting
provisions set forth in this Agreement, to its Affiliates and Sublicensees, and
its and their directors, officers, employees, consultants, contractors or
subcontractors, 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.
 
 
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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) 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
in the applicable country in the Territory concerning the confidentiality or
protection of patient identifiable information and other patient protected
health information.
 
10.3  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 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.
 
10.4  Press Releases; Publications; Use of Name and Disclosure of Terms
 
10.4.1  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, subject to the terms of this Agreement. For subsequent press
releases relating to this Agreement or the Parties' relationship hereunder, each
Party (or its Affiliate) shall use Commercially Reasonable Efforts to submit to
the other Party a draft of such press release for review and comment by the
other Party at least five (5) Business Days prior to the date on which such
Party plans to issue such press release ("Proposed Disclosure"), and shall
review and consider in good faith any comments provided by the other Party.
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, subject to the terms of this Agreement. 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 and its
Affiliates’ and Sublicensees’ 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)
disclosure of the terms of this Agreement by either Party 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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10.4.2  Publications.  All publications, abstracts, manuscripts and
presentations (including information to be presented verbally) that disclose
results of Clinical Studies or Post-Approval Marketing Studies for a Licensed
Product in the Field in the applicable country in the Territory shall be
reviewed and approved by each Party.  Each Party shall provide to the other
Party the opportunity to review each of the submitting Party’s proposed
abstracts, manuscripts or presentations (including information to be presented
verbally) in the applicable country in the Territory that relate to any
Development activities or otherwise with respect to the Licensed Product for use
in the Field in such applicable country in the Territory, at least thirty (30)
days prior to its intended presentation or submission for publication and each
Party agrees, upon written request from  the other Party given within such
thirty (30)-day period, not to submit such abstract or manuscript for
publication or to make such presentation until Sucampo is given up to thirty
(30) days 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 each Party, 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
Licensed Product in the Field in the applicable country 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 Section 10.4.2
shall not limit or restrict Sucampo’s ability to publish or present publicly
available information for Other Indications within the applicable country in the
Territory (except to the extent that Takeda has exercised its right of refusal
for a particular Other Indication in such country in the Territory 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 Takeda’s Confidential Information.
 
 
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ARTICLE 11
INTELLECTUAL PROPERTY RIGHTS
 
11.1  Sucampo Intellectual Property Rights.  As between the Parties, Sucampo
shall have sole and exclusive ownership of the Compound and Licensed Product
(and any improvements, modifications or derivative works to such Compound and
Licensed Product) and all right, title and interest (subject to the licenses
granted in this Agreement) in and to any and all Sucampo Patent Rights, Sucampo
Background Technology and Product Trademarks and all Technology in connection
with the Compound and Licensed Product (and any improvements modifications or
derivative works to such Compound and Licensed Product) anywhere in the world,
including  all Pre-Clinical Data, Clinical Data, CMC Data and other Data in
connection with the Licensed Product, and any improvements, modifications or
derivative works to any of the foregoing
 
11.2  Patent Filing, Prosecution and Maintenance.  Sucampo and its Affiliates,
acting through patent counsel of its choice, and in reasonable consultation with
Takeda solely during the Term, shall be responsible for the preparation, filing,
prosecution and maintenance of the Sucampo Patent Rights in the applicable
country in the Territory.  During the Term, Sucampo shall diligently prosecute
all filed patent applications included in the Sucampo Patent Rights and maintain
all issued patents included in the Sucampo Patent Rights, except as otherwise
set forth below. During the Term, Sucampo shall use Commercially Reasonable
Efforts to notify Takeda within thirty (30) days in the event  (however not
later than ninety (90) days before any relevant patent deadline date for filing
documents, paying fees or any required action) that Sucampo or its
Affiliates decide not to prepare, file, prosecute and/or maintain any of the
Sucampo Patent Rights in the Field in any country in the Territory and, upon the
receipt of such notice, Takeda shall then have the right and option to do so in
such country at its own expense, except for the Sucampo Patent Rights mentioned
in EXHIBIT N, for which Sucampo shall solely bear all fees and costs Takeda has
paid to prosecute and maintain such Sucampo Patent Rights.  Any Sucampo Patent
Right for which Takeda assumes the responsibility to prepare, file, prosecute
and/or maintain pursuant to this Section 11.2 shall remain part of the Sucampo
Patent Rights and shall be solely and exclusively owned by Sucampo and Sucampo
shall grant to Takeda a non-exclusive, royalty free, perpetual license for any
such Sucampo Patent Right outside the Field. In the event Takeda has made the
final decision to not Commercialize in a country of the Territory, the Parties
shall discuss in good faith whether Sucampo shall  be further obliged to
prosecute and maintain the Sucampo Patent Rights in such country of the
Territory.
 
11.3  Information and Cooperation.  During the Term, Sucampo shall (a) provide
Takeda with copies of all patent applications filed with respect to the Sucampo
Patent Rights and other material submissions and correspondence with  any patent
office in the applicable country in the Territory relating thereto, in
sufficient time to allow for reasonable review and comment by Takeda, (b)
provide Takeda and its patent counsel with an opportunity to consult with
Sucampo and its patent counsel regarding the filing and
 
 
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contents of any such application, amendment, submission or response with respect
to the Sucampo Patent Rights in such country and (c) provide notice of filing of
new Sucampo Patent Rights to Takeda in any country in the Territory within ten
(10) Business Days of such filing.  Sucampo hereby agrees that the advice and
suggestions of Takeda 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. For […***…], Takeda shall be invited to briefing
teleconferences with Sucampo’s counsel to discuss case strategy at least […***…]
([…***…]) month before […***…]. In case […***…] or thereof is refused by the
relevant […***…], Sucampo shall use Commercially Reasonable Efforts to (a)
appeal the decision through […***…] and (b) […***…].
 
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 at its own cost and expense for the
filing, prosecution, defense, maintenance and renewal before all Trademark
offices in the relevant country in the Territory of all Product Trademarks and
shall use Commercially Reasonable Efforts to ensure Product Trademarks exist in
such country in the Territory, and that any registered Product Trademarks are
maintained during the Term.
 
11.4.1  Sucampo shall keep Takeda promptly informed of all filings made for
Product Trademarks including sending Takeda a copy of any such filing and
otherwise shall keep Takeda informed of all material developments in relation to
the Product Trademarks.
 
11.4.2  Neither Sucampo nor any Affiliate of Sucampo shall use the Product
Trademark in the Territory or grant a license to a third party under the Product
Trademark in the Territory during the Term.
 
11.4.3  Takeda shall not reproduce or use (or authorize the reproduction or use
of) the Product Trademarks or Sucampo’s Corporate Name in any manner whatsoever
other than as expressly authorized by this Agreement.
 
11.4.4  During the Term and after any expiration or termination of this
Agreement, Takeda shall not use as its own any service mark, service name, trade
name, trademark, design or logo(s) confusingly similar to (i) any Product
Trademarks or Sucampo’s Corporate Name, including without limitation any mark,
word or design that incorporates the word “AMITIZA”, “Sucampo”, “Sucampo AG”, or
“Sucampo Pharmaceuticals, Inc.” or any Product Trademarks on Exhibit C of the
License Agreement, or any mark, word or design confusingly similar thereto.
 
 
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11.4.5  Takeda shall not challenge the validity of the Product Trademarks or
Sucampo’s Corporate Name, nor shall Takeda challenge Sucampo’s or Sucampo’s
Affiliates’ ownership of the Product Trademarks or Sucampo’s Corporate Name or
the enforceability of Sucampo’s or Sucampo’s Affiliates’ rights therein,
anywhere in the world.
 
11.4.6  In the event of a determination by final court decision or under a
definitive settlement by Sucampo that the Commercialization of Product in the
Territory, on account of the use of a Product Trademark, infringes the trademark
rights of a third party in the Territory, then, Sucampo shall: (a) indemnify and
hold Takeda harmless against any such third party claim or proceeding above
brought against Takeda, including damages and reasonable attorney’s fees;
provided, however, that any obligation to indemnify shall be excluded if Takeda
fails to promptly notify Sucampo of the assertion of any such claims; (b) At
Sucampo’s option, finance the re-packaging operation or, if necessary, replace,
free of charge, all Licensed Products in stock at Takeda that are no longer
saleable on account of the infringement of a third party trademark.
 
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 of any Sucampo
Patent Rights or Sucampo Background Technology relating to the Licensed Product
or any Product Trademark in the Field in the applicable country in the
Territory, (b) either Party becomes aware of the submission by any Third Party
of regulatory filing in the applicable country in the Territory for a product
that seeks approval to sell the Compound in the 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
applicable country in the Territory against any Sucampo Patent Right that
relates to the Development, Manufacture, or Commercialization by a Third Party
of a Licensed Product in the Field in the applicable country in the Territory,
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, or Commercialization of any Licensed
Product in the Field in the applicable country 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 reasonable steps in
good faith regarding such Infringement in reasonable consultation with Takeda.
Sucampo shall use Commercially Reasonable Efforts to inform and consult with
Takeda at least sixty (60) days in advance of any due dates, such that Takeda is
able to reasonably comment on the enforcement or defense strategy, and Sucampo
shall reasonably consider Takeda’s comments and suggestions to the strategy;
provided, however, Sucampo and its Affiliates shall make the final decision as
to the enforcement or defense strategy. If Sucampo and its Affiliates do not
take or initiate reasonable steps in good faith to initiate legal proceedings or
take other actions regarding the Infringement within thirty (30) days from any
Infringement Notice, then Takeda and its Affiliates shall have the right and
option to do so at their own expense.
 
 
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11.5.3  No Settlement and Allocation of Damages.  Neither Party shall settle any
Infringement claim nor proceeding under this Section 11.5 without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld, conditioned or delayed.  If either Takeda 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 gross margin, any additional amounts
collected shall be payable to each Party equal to their respective share of lost
gross margin, as demonstrated by written records. To the extent that any such
award of damages does not represent lost gross margin or there are damages
remaining after the allocation based on lost gross margin, any additional
amounts collected shall be allocated based the Party’s respective effort to
collect any settlement or judgment.
 
11.5.4  Right to Representation.  In addition to Takeda’s right and option to
initiate legal proceedings or take other actions regarding the Infringement
pursuant to Section 11.5.2 above, Takeda 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 a
country-by country basis (within the Territory) on the fourteenth (14th)
anniversary of the date of First Commercial Sale in a country in the Territory
(the “Term”).  The Term shall be renewable upon the mutual agreement of both
Parties.
 
12.2  Termination
 
12.2.1  Termination for Material Breach.
 
 
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(a)  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.
 
(b)  In the event of a material breach by any of the Parties of anti-bribery and
anti-corruption obligations defined in Sections 15.2.2 and 15.2.3, the
non-breaching Party shall have the right to terminate this Agreement in its
entirety with immediate effect.
 
12.2.2  Partial Termination by Takeda.  Notwithstanding the provisions of
Section 12.2.1(a) above, Takeda shall have the right to terminate this Agreement
by giving thirty (30) days prior written notice on a Licensed
Product-by-Licensed Product basis and country-by-country basis in the Territory
for the following circumstance:
 
(a)  In the event Sucampo fails to cure a supply shortage of the Licensed
Product in the Field in the applicable country in the Territory within […***…]
days ([…***…]) days of Sucampo’s prior written notice of such shortage to Takeda
pursuant to Section 9.3 (other than a supply shortage due to Force Majeure as
set forth in Section 9.3), then Takeda shall have the right to terminate this
Agreement with respect to such Licensed Product for which there is a supply
shortage and in such country where the supply shortage occurs, or
 
(b)  Upon written notice to Sucampo, Takeda using Commercially Reasonable
Efforts advised that Takeda will not Develop and Commercialize the Licensed
Product in the Field in the country in the Territory. The non-Development or
non-Commercialization of the Licensed Product shall not be considered as
constituting a material breach of this Agreement
 
12.2.3  Termination for Insolvency.  Notwithstanding the provisions of Section
12.2.1(a) 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 Material Adverse Event.  In the event  that either of
the Parties has a reasonable health and safety concern, including due to any
Adverse Event or Serious Adverse Event, with respect to the Compound or Licensed
Product, then either Party may terminate this Agreement on a product-by-product
basis effective immediately upon written notice to the other Party.
 
 
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12.2.5  For the avoidance of doubt, the termination of this Agreement with
respect to a Licensed Product in any applicable country in the Territory in
accordance with Sections 12.2.1(a) or 12.2.2 (“Terminated Licensed Product”)
shall not affect the rights and obligations of the Parties with respect to any
remaining Licensed Product in such country and this Agreement shall remain in
full force and effect with respect to such remaining Licensed Product.  In
addition, the termination of this Agreement with respect to a country in the
Territory in accordance with Sections 12.2.1(a) or 12.2.2 (“Terminated Country”)
shall not affect the rights and obligations of the Parties with respect to the
remaining countries in the Territory and this Agreement shall remain in full
force and effect with respect to such remaining countries.
 
12.3  Consequences of Partial Termination.  Upon the partial termination of this
Agreement with respect to any Terminated Licensed Product in any country in the
Territory or Terminated Country, in each of the foregoing cases, pursuant to
Sections 12.2.1(a) or 12.2.2 or above, the following shall apply with respect to
such Terminated Licensed Product or Terminated Country, as applicable:
 
(a)  all rights and licenses granted by Sucampo to Takeda with respect to the
Terminated Licensed Product and Terminated Country under this Agreement and the
Ancillary Agreements, including under Sections 2.1.1, 2.1.2, 2.1.3 and 2.1.4 of
this Agreement, shall automatically terminate;
 
(b)  all Sublicense Agreements and all written agreements with Subcontractors
for any Terminated Licensed Product and in any Terminated Country shall
automatically terminate;
 
(c)  all Development and Commercialization activities with respect to the
Terminated Licensed Product in the applicable country in the Territory and/or
any Licensed Product in the Terminated Country under this Agreement shall, in
each of the foregoing cases, promptly cease to the extent permitted by
Applicable Law but in no case shall Sucampo be required to purchase the
inventory of the Licensed Product, provided however that Takeda may elect to
continue selling the inventory Licensed Product until depletion (the “Inventory
Sale Period”). It is agreed by the Parties that the licenses granted to Takeda
under Sections 2.1.1 and 2.1.3 shall continue during the Inventory Sale Period;
 
(d)  Takeda shall cease all use of, and shall cause its Affiliate and other
Sublicensees and subcontractors to cease all use of, the Sucampo Background
Technology, Sucampo Patent Rights (except for the term of the Inventory Sale
Period), Promotional Materials provided by Sucampo to Takeda according to
Section 7.4, Product Trademarks (except for the term of the Inventory Sale
Period) , 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 for the Terminated Licensed Product and Terminated Country
and, at the request of Sucampo, shall return or destroy, and thereafter upon
request provide to Sucampo written confirmation of such destruction, all data,
files, records and other materials in its possession or control relating to any
of the foregoing or embodiments of any of the foregoing, or containing or
comprising Sucampo Confidential Information, provided that Takeda may keep one
(1) copy of each relevant document until ten (10) years following expiry of the
batch with the latest expiry or, if longer, for the term required by Applicable
Law for the purpose of complying with record keeping obligations under
Applicable Law;
 
 
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(e)  Takeda, its Subcontractors or Distributors as applicable, shall provide to
Sucampo: (i) one (1) copy of all Regulatory Filings for the Terminated Licensed
Product and/or in the Terminated Country (including, without limitation, all
Regulatory Approvals and other documents necessary to Develop, Promote and
Commercialize the Terminated Licensed Product and/or all Regulatory Approvals in
the Terminated Country, as applicable, as they exist as of the date of such
termination with respect to such Terminated Licensed Product and/or Terminated
Country) and (ii) all Data, documents and support for such Regulatory Filings,
including all documents and filings contained in or referenced in any of the
foregoing, and all raw and summarized Data for any Clinical Studies and
Post-Approval Marketing Studies in the Field in the applicable country in the
Territory (and where reasonably available, electronic copies thereof).  To the
maximum extent permitted by Applicable Law, Takeda, its Subcontractors or
Distibutors as applicable, 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 Takeda’s obligations referenced in this Section
12.2.5 and/or, in the event of failure to obtain an assignment, Takeda hereby
consents and grants to Sucampo the right to access and reference (without any
further action required on the part of Takeda, 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, Takeda will provide written confirmation
to the Regulatory Authority for such grant or assignment.  In each case such
assignment (or access) shall be made within thirty (30) days after such
expiration or termination; and
 
(f)  Unless otherwise expressly and specifically agreed in an Ancillary
Agreement, all Ancillary Agreements with respect to such Terminated Licensed
Product and Terminated Country shall automatically and simultaneously terminate.
 
12.4  Consequences of Expiration or Termination of Agreement.  Upon the
expiration or termination of this Agreement in its entirety, the following shall
apply to all countries in the Territory:
 
(a)  all rights and licenses granted by Sucampo to Takeda under this Agreement
and the Ancillary Agreements shall automatically terminate;
 
(b)  all Development and Commercialization activities under this Agreement shall
promptly cease to the extent permitted by Applicable Law, but in no case shall
Sucampo be required to purchase the inventory of the Licensed Product, provided
however that Takeda may elect to continue selling the inventory Licensed Product
until depletion. It is agreed by the Parties that the licenses granted to Takeda
under Sections 2.1.1 and 2.1.3 shall continue during the Inventory Sale Period;
 
 
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(c)  Takeda shall cease all use of, and shall cause its Affiliate and other
Sublicensees and Subcontractors to cease all use of, the Sucampo Background
Technology, Sucampo Patent Rights (except for the Inventory Sale period),
Promotional Materials provided by Sucampo to Takeda according to Section 7.4,
Product Trademarks except for the Inventory Sale period), Sucampo 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 upon
request provide to the other Party written confirmation of 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; provided that notwithstanding the foregoing, and
subject to ARTICLE 10 of this Agreement, Sucampo shall have the right to
continue to use any of Takeda Confidential Information incorporated into,
necessary or useful for the exercise of its rights under this Agreement in
respect of, or otherwise in connection with the use, disposition or
commercialization and exploitation of any of the Data, Developed Technology,
Developed Patent Rights, the Compound, the Licensed Product or the Promotional
Materials or to the extent Sucampo may retain rights to such Confidential
Information under this Agreement or any of the Ancillary Agreements and provided
that provided that Takeda may keep one (1) copy of each relevant document until
ten (10) years following expiry of the batch with the latest expiry or, if
longer, for the term required by Applicable Law for the purpose of complying
with record keeping obligations under Applicable Law;
 
(d)  Takeda shall provide to Sucampo: (i) one (1) copy of all Regulatory Filings
(including, without limitation, all Regulatory Approvals and other documents
necessary to Develop and Commercialize the Licensed Product, as they exist as of
the date of such expiration or termination) and (ii) all Data, documents and
support for such Regulatory Filings, including all documents and filings
contained in or referenced in any of the foregoing, and all raw and summarized
Data for any Clinical Studies and Post-Approval Marketing Studies in the Field
in the applicable country in the Territory (and where reasonably available,
electronic copies thereof).  To the maximum extent permitted by Applicable Law,
Takeda 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 Takeda’s obligations referenced in this Section 12.4 and/or, in
the event of failure to obtain an assignment, Takeda hereby consents and grants
to Sucampo the right to access and reference (without any further action
required on the part of Takeda, 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, Takeda will provide written confirmation to the Regulatory
Authority for such grant or assignment.  In each case such assignment (or
access) shall be made within thirty (30) days after such expiration or
termination.
 
 
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12.5  Surviving Provisions.  The rights and obligations set forth in this
Agreement shall extend beyond the Term or termination of this Agreement only to
the extent expressly and specifically provided for in this Agreement.  Without
limiting the generality of the foregoing, it is agreed that the provisions of
Sections 2.1.3, 2.1.4, 2.2, 4.4.3, 4.5, 4.6, 7.4 (but only with respect to the
last 6 sentences only), 8.6, 8.7, 8.10, 9.5, 11.1, 11.4 (to the extent set forth
therein), 11.5, 12.2.5, 12.4 , 12.5, 12.6, , 15.7 and 15.10 and those of ARTICLE
10 and ARTICLE 17 and, to the extent applicable, all other Sections or Articles
referenced in any such Section or Article and including ARTICLE 1, shall survive
such expiration or termination.
 
12.6  Continued Obligations.  Upon expiration or termination of this Agreement,
in whole or in part, for any reason, nothing herein shall be construed to
release either Party from any accrued rights or obligations that matured prior
to the effective date of such expiration or termination, nor preclude either
Party from pursuing any right or remedy it may have hereunder or at law or in
equity with respect to any breach of this Agreement.
 
 
ARTICLE 13
TRANSITION PERIOD
 
13.1  The Parties acknowledge and agree that certain transition activities and
obligations (“Transition Activities”) are required in connection with the
transition of the Licensed Products in Switzerland and United Kingdom to ensure
that Takeda and/or its Affiliates can effectively Commercialize the Licensed
Product in Switzerland and United Kingdom after the Effective Date until the
Existing Regulatory Approvals have been successfully transferred to Takeda or a
Third Party designated by Takeda (hereinafter referred to as the “Transition
Period”).  Each of Takeda and Sucampo shall perform or otherwise comply with the
terms and conditions of the Transition Activities. Each Party shall carry its
internal costs. The Parties shall prepare a Transition Plan within thirty (30)
days after the Effective Date to set forth the responsibilities of each Party
during the Transition Period.
 
13.2  Use of Sucampo Corporate Name. During the Transition Period, and subject
to the terms and conditions of this Agreement, Sucampo hereby grants to Takeda a
non-exclusive right and license, with a right to sublicense to Sublicensees, to
use Sucampo Corporate Names in the Territory to solely perform its Transition
Activities during the Transition Period. Takeda shall not use the Sucampo
Corporate Names other than for the purpose expressly and specifically set forth
in this Section 13.2 and in Section 2.1.3.
 
13.3  Transition Activities.
 
13.3.1  Without limitation to the generality of the foregoing, Takeda is
authorized to Commercialize the Licensed Product under the Existing Regulatory
Approvals in Switzerland and United Kingdom. Sucampo acknowledges that as part
of Takeda’s Commercialization activities in Switzerland and United Kingdom
during the Transition Period, Takeda or its Subcontractors will perform the
following Transition Activities: marketing activities, collection of orders,
 invoicing, distribution of the Licensed Product, and booking of sales.
 
 
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13.3.2  During the Transition Period, Sucampo shall provide Takeda with all
information and support for the Commercialization of the Licensed Product in
Switzerland and in United Kingdom. Sucampo shall provide Takeda with any and all
relevant information, including but not limited to pharmacovigilance relevant
data, promotional materials, and prices of the Licensed Product. Sucampo shall
continue to maintain the Existing Regulatory Approvals in Switzerland and United
Kingdom until completion of the transfer of the Existing Regulatory Approvals to
Takeda, at Takeda’s sole cost and expense. Sucampo shall invoice Takeda these
regulatory fees within thirty (30) days of incurring such fees and Takeda shall
pay such invoice within sixty (60) days of the receipt of such invoice. During
the Transition Period, Sucampo shall be responsible for the Transition
Activities which are all activities and obligations as the Marketing
Authorization holder for the Licensed Product, including but not limited to
customer support, medical support,  pharmacovigilance activities, complaint
handling, local batch release and approval of promotional materials.  Sucampo
shall invoice Takeda the external costs associated with its Transaction
Activities within thirty (30) days of incurring such fees and Takeda shall pay
such invoice within sixty (60) days of the receipt of such invoice.
 
13.4  Inventory Purchase.  During the Transition Period, the inventory to be
made available to Takeda for sale is the inventory set forth on Exhibit P
(“Inventory”). The supply of the Inventory to Takeda shall be subject to the
relevant Sections under ARTICLE 9 : 9.1 (except for 9.1.3(d)), 9.4, 9.5, 9.7,
9.8). Such Inventory shall be housed and maintained by Sucampo, at Sucampo’s
expense, at a facility(ies) owned or Controlled by Sucampo and has been or,
promptly after the date hereof, will be segregated and marked as Takeda
inventory. After review of the Inventory as soon as practicable after the
Effective Date, Takeda will place an order for the amount of Inventory it has
determined in its sole discretion to purchase, at the Supply Price specified in
EXHIBIT H. Takeda may, at its sole discretion, purchase inventory that does not
meet the Agreed Quality under Section 9.1.3. Upon receipt of the such order,
Sucampo shall invoice Takeda and Takeda shall pay such invoice within sixty (60)
days of receipt of such invoice. Title shall pass to Takeda upon delivery of the
Inventory.
 
Once Takeda has determined that it can accept orders from the customers for the
Licensed Product, Takeda shall notify Sucampo in writing of the carrier which
will take delivery of the Inventory. Sucampo shall deliver the Inventory FCA at
the Alloga (Dubendorf, Switzerland) or Alliance Healthcare (Normanton, UK)
(Incoterms 2010) in accordance with Takeda’s order, subject to the release of
the Inventory in accordance with Section 9.4.  Takeda shall designate to Sucampo
the carrier which will take delivery of the Inventory.  Sucampo shall contact
such carrier when the Inventory is ready for shipping and shall arrange for
collection, and transportation of the Inventory.  Sucampo shall inform Takeda
two (2) Business Days prior to pick-up by the carrier.  Takeda shall bear the
costs for transport of the Inventory and will be invoiced directly by the
carrier.  Delivery documents shall include purchase order number, quantity, copy
of the certificate of analysis, items codes and description, lot number,
manufacturing date of the Inventory, number of shippers, weight, number of
pallets, and any other documents in accordance with the terms of the Quality
Agreement under Section 13.6.  Sucampo shall deliver all Inventory in conformity
with the Agreed Quality (except for Section 9.1.3 (d)). In the event that the
Inventory is not sold by December 31, 2014, Sucampo shall at its sole discretion
either buy back the remaining Inventory at the Supply Price in EXHIBIT H or have
it destroyed at Sucampo’s costs, being agreed that in the event of destruction
Sucampo shall reimburse the amount paid by Takeda to purchase the Inventory.

 
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13.5  Additional Product Supplied During the Transition Period. During the
Transition Period, the Licensed Product supplied by Sucampo to Takeda shall
include Secondary Packaging with Sucampo’s dress. Such Licensed Product shall be
subject to ARTICLE 9, including conforming to the Agreed Quality except for the
incoterm specified in Section 9.2 as delivery of the licensed Product ordered
during the Transition Period shall occur CIP at Catalent Pharma Solutions Ltd.,
Frankland Road, Blagrove, Swindon, Wiltshire, SN5 8YG, UK .
 
13.6  Other Ancillary Agreements related to the Transition Period. The Parties
shall use their best efforts to agree on the terms of a Quality Agreement and of
a Pharmacovigilance Agreement effective during the Transition Period.

13.7  Unused Promotional Materials. Promptly after the expiration of the
Transition Period, Sucampo shall return to Takeda or destroy or cause to be
destroyed, at Takeda’s discretion, any and all unused sales materials related to
the Licensed Product in Switzerland and the United Kingdom.
 
ARTICLE 14
EMPLOYEES
 
 
The Parties have considered the possibility of whether TUPE is triggered by this
Agreement, and have agreed as follows:
 
14.1  For purposes of this Section 14:
 
14.1.1  “Unexpected Employee” has the meaning set forth in Section 14.4.
 
14.1.2  “Unexpected Employee Liability” has the meaning set forth in Section
14.5.
 
 
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14.1.3  “TUPE” means, as appropriate, (a) the European Union’s Acquired Rights
Directives Nos. 77/187/EEC and/or 01/23/EC; (b) the Transfer of Undertakings
(Protection of Employment) Regulations 2006; (c) the legislation enacted in any
Member State of the European Union, or in any State within the European Economic
Area which is not a Member State of the European Union, giving effect to the
said Directives; and (d) any similar legislation in those or any other
jurisdiction; as amended, updated, re-enacted or extended from time-to-time.
 
14.1.4  “Successor Provider” means any third party (including without limitation
any Affiliate of TAKEDA) who, at any time after the Effective Date, will provide
similar services to those provided, or carries out tasks which were undertaken,
by Sucampo (itself and/or using a third party) before the Effective Date.
 
14.1.5  “Protected Unexpected Employee” means any Unexpected Employee who cannot
be dismissed and remains employed with or is reinstated by Takeda or a Successor
Provider, for the reasons set out in Section 14.5.5.
 
14.1.6  “Dismissed Employee” means any employee of Takeda or a Successor
Provider who is dismissed because a Protected Unexpected Employee cannot be
dismissed, or is reinstated, for the reasons set out in Section 14.5.5.
 
14.2  The Parties believe that there is neither the transfer of an economic
entity, nor the transfer of an activity, by which this Agreement triggers the
application of TUPE.
 
14.3  Strictly without prejudice to and without limiting Sucampo’s obligations
under the Agreement, Sucampo shall ensure that neither the employment of any
person, nor any liabilities relating thereto, shall transfer by operation of
TUPE from Sucampo and/or any subcontractor (of whatever tier) of Sucampo to
Takeda or any Successor Provider, as a consequence of the execution of this
Agreement.
 
14.4  It is agreed that in the event that any person (an “Unexpected Employee”)
alleges or establishes that his/her employment with Sucampo or any subcontractor
(of whatever tier), or any liabilities or obligations relating to his employment
or its termination, transfers to Takeda or any Successor Provider, by virtue of
the application of TUPE, upon the Effective Date:
 
14.4.1  where either Party becomes aware of such allegation or finding, that
Party will notify the other Party as soon as reasonably practicable;
 
14.4.2  Takeda will then allow Sucampo or any subcontractor (of whatever tier)
21 calendar days either to offer employment to the Unexpected Employee or take
other steps so as to effect a written withdrawal of that such settlement
requires Takeda to be a party for it to validly settle claims against Takeda,
Takeda will co-operate with this and Sucampo indemnifies Takeda for Takeda's
liabilities under such settlement agreement);
 
 
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14.4.3  if at the end of such 21-day period the Unexpected Employee is or still
alleges to be an employee of Takeda or any Successor Provider, then within 14
(fourteen) calendar days of the end of such twenty-one (21)-day period Takeda or
the Successor Provider (as appropriate) shall elect in writing to Sucampo to
follow either (a) or (b) below:
 
(a)  If Takeda or the Successor Provider (as appropriate) elects option (a), it
shall thereafter employ the Unexpected Employee; and notwithstanding the
definition of Unexpected Employee Liability set out below, no costs, claims,
losses, damages, liabilities, reasonable expenses, payments made under
reasonable settlement agreements, statutory redundancy pay, contractual
redundancy pay or entitlements (such as pension-related entitlements) triggered
by redundancy, which relate to the period after the date of the written election
of this option (a), shall constitute Unexpected Employee Liabilities.
 
(b)  If Takeda or the Successor Provider (as appropriate) elects option (b),
then TAKEDA shall, or shall procure that any Successor Provider (as appropriate)
shall, dismiss the Unexpected Employee, as follows. During the twenty-first (21)
days after such written election, Sucampo may upon notification to Takeda
conduct (on Takeda's or the Successor Provider's behalf, and with reasonable
co-operation by Takeda or the Successor Provider, including in the provision of
appropriate information to Sucampo) any process in relation to such dismissal as
it reasonably considers necessary to reduce the chances of legal action by the
Unexpected Employee in relation to his/her dismissal. After such 21 day period
(or earlier if notified in writing by Sucampo) Takeda (or the Successor
Provider, as appropriate) shall dismiss the Unexpected Employee.
 
14.5  For purposes of this Section 14, “Unexpected Employee Liability” means any
costs (including without limitation all salary, benefit, pension and other
employment costs), claims, losses, damages, liabilities, reasonable expenses
(including without limitation all legal and court costs), payments made under
reasonable settlement agreements, statutory redundancy pay, contractual
redundancy pay, and any entitlements (such as pension-related entitlements)
triggered by redundancy, relating to:
 
14.5.1  any Unexpected Employee (other than any Protected Unexpected Employee)
being employed by Takeda or a Successor Provider;
 
14.5.2  any Protected Unexpected Employee being employed by Takeda or a
Successor Provider up to the date of the dismissal of his or her corresponding
Dismissed Employee;
 
 
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14.5.3  any Unexpected Employee’s dismissal by Takeda or a Successor Provider in
accordance with Section 14.4.3(b);
 
14.5.4  Sucampo's conduct of any process under Section 14.4.3(b);
 
14.5.5  Takeda’s (or a Successor Provider’s, as appropriate) dismissal of any
other employee in the event that an Unexpected Employee cannot be dismissed, and
remains or is reinstated as a Takeda (or a Successor Provider's) employee,
because of national laws which set an order of social selection for dismissal or
which otherwise prevent (as opposed to merely rendering unlawful) the dismissal
of the Unexpected Employee;
 
14.5.6  any Unexpected Employee’s allegations or claims relating to periods
prior to the alleged transfer of undertaking; and/or
 
14.5.7  information and consultation obligations generally under TUPE in respect
of the TUPE transfer or potential transfer of which the Unexpected Employee
claims to be a part.
 
14.6  Sucampo shall fully indemnify, keep indemnified and, within thirty (30)
calendar days of invoice, evidence from TAKEDA or the Successor Provider (as
applicable) for such Unexpected Employee Liabilities having been incurred.
 
 
ARTICLE 15
REPRESENTATIONS AND WARRANTIES
 
15.1  Mutual Representations and Warranties.  Sucampo and Takeda represent and
warrant to the other, as of the Effective Date, as follows:
 
15.1.1  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 power and authority to enter into this Agreement and to
perform its obligations hereunder, and it has full corporate power and authority
and the legal right to own and operate its property and assets and to carry on
its business as it is now being conducted and as it is contemplated to be
conducted by this Agreement.
 
15.1.2  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.
 
15.1.3  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.
 
 
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15.1.4  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.
 
15.2  Compliance with Applicable Law
 
15.2.1  Sucampo and Takeda 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.
 
15.2.2  Takeda 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 15.2, and such representations and warranties are incorporated by
reference into this Agreement and made a part hereof.  Takeda shall comply with
each of the covenants set forth in EXHIBIT K as if each such covenant were set
forth in this Section 15.2, and such covenants are incorporated by reference
into this Agreement and made a part hereof. Takeda may update any provision of
EXHIBIT K at any time, and from time to time, upon written notice to Sucampo 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.
 
15.2.3  Sucampo and Takeda acknowledge and agree that there are anti-bribery and
anti-corruption laws to which Sucampo and Takeda 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 Takeda, (b) to help Sucampo or Takeda obtain or retain any
business, or (c) to otherwise improperly benefit Sucampo’s or Takeda’s business
activities, and such laws prohibit Sucampo and Takeda 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 above, breach of this Section 15.2 by either
Party shall entitle the other Party to terminate this Agreement with immediate
effect to the extent legally and clinically possible.
 
15.2.4  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.
 
 
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15.3  Intellectual Property
 
15.3.1  Ownership. Sucampo represents and warrants that Sucampo and its
Affiliates have the right to grant the licenses granted to Takeda herein
(whether through ownership or otherwise) with respect to all Sucampo Background
Technology, Sucampo Patent Rights, Sucampo Know-How and Product Trademarks,
Corporate Names, Trademarks and Other Intellectual Property Rights that are
licensed to Takeda pursuant to the terms and conditions of this Agreement or
that are necessary for Sucampo and Takeda to perform their obligations pursuant
to the terms of this Agreement and the Ancillary Agreements (all such rights,
collectively, the "Sucampo Rights").
 
15.3.2  To the knowledge of Sucampo, Sucampo represents and warrants to Takeda
that Sucampo or an affiliate thereof have obtained from the inventors of Sucampo
Background Technology and Sucampo Patent Rights valid and enforceable agreements
assigning to Sucampo or an affiliate thereof each such inventor’s entire right,
title and interest in and to all such technology or has claimed such right,
title and interest under the applicable employee invention law
 
15.3.3  To the knowledge of Sucampo, Sucampo represents and warrants to Takeda
that, as of the Effective Date, neither Sucampo nor any of its Affiliates
(including Sucampo Pharmaceuticals, Inc.) has received any letters or oral
communication by a Third Party relating to the claimed infringement of such
Third Party's intellectual property rights by the import, use, manufacture or
sale of the Compound or Licensed Product in the Field in the Territory.
 
15.3.4  To the knowledge of Sucampo, Sucampo represents and warrants to Takeda
that neither Sucampo nor any of its Affiliates nor Takeda has infringed, is
infringing or will infringe, in connection with the license of Sucampo Rights or
the Manufacture (by Sucampo or third party manufacturer contracted by Sucampo
anywhere in the world) and sale of the Licensed Product to Takeda for the
Commercialization of the Licensed Product by Takeda in the Territory and the
import, Manufacture (Secondary Packaging) and export of the Licensed Product in
any material respect the rights of any third party with regard to any of such
third party's intellectual property.
 
15.3.5  To the knowledge of Sucampo, Sucampo represents and warrants to Takeda
that as of the Effective Date, no material claims by any Third Party are
pending, or to the knowledge of Sucampo, threatened with regard to the ownership
or licensing by Sucampo of the Sucampo Rights.
 
15.3.6  To the knowledge of Sucampo, Sucampo represents and warrants to Takeda
that as of the Effective Date, no material claims by any Third Party are
pending, or to the knowledge of Sucampo, threatened with regard to the
infringement of such Third Party’s intellectual property rights by Sucampo or
any of its Affiliates.
 
 
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15.3.7  To the knowledge of Sucampo, Sucampo represents and warrants to Takeda
that all Sucampo Patent Rights have been duly registered and/or filed with or
issued by each appropriate Regulatory Authority in each applicable jurisdiction
in the Territory, all necessary affidavits of continuing use have been timely
filed and all necessary maintenance fees have been timely paid to continue all
such Sucampo Patent Rights in effect. None of the Sucampo Patent Rights have
expired or been declared invalid, in whole or in part, by any Regulatory
Authority. There are no ongoing material interferences, oppositions, reissues,
reexaminations or other proceedings involving any of the Sucampo Rights in any
patent office or similar administrative agency, apart from the following:
 
 
-
Appeal No. OA/42/2012/PT/CH, Patent No. 224855 (Patent application No.
IN/PCT/2002/516/CHE) in India

 
 
-
IPAB Case No. SR.NO.278/2011/PT/CH, Patent No. 223147 (Patent application No.
460/CHENO/2003) in India

 
 
-
Appeal to Brazilian Patent application No. PI 0014869-5

 
 
-
Appeal to Brazilian Patent application No. PI0114042-6)

 
 
-
Case No. 89121423N01, Patent No. I 281918 (Patent application No. 89121423) in
Taiwan

 
15.3.8  To the knowledge of Sucampo, as of the Effective Date, there are no
inquiries, actions, investigations or other proceedings pending before or
threatened by any Regulatory Authority in any country in the Territory with
respect to the Licensed Product or any facility where the Licensed Product is
Manufactured, and Sucampo, to its knowledge, has not received written notice
threatening any such inquiry, action, investigations or other proceeding.
 
15.3.9  To the knowledge of Sucampo, as of the Effective Date, the Manufacture
(other than Secondary Packaging) of the Licensed Product has been conducted by
Sucampo, its Affiliates and subcontractors, to the extent necessary, in
compliance in all material respects with Applicable Law.
 
15.3.10  Right to Grant Licenses and Assignments.  Sucampo represents and
warrants to Takeda that it has the right to grant to Takeda 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,
warrants and covenants that it will not enter into an agreement that is
inconsistent with the rights, licenses and assignments granted to Takeda in this
Agreement.
 
 
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15.3.11  No Existing Claims.  Sucampo represents and warrants to Takeda that
there is, to Sucampo’s knowledge, as of the Effective Date, no claim or demand
of any Person in writing pertaining to, or any proceeding which is pending or
threatened that challenges Sucampo’s interest in the Sucampo Rights in the
applicable country in the Territory or makes any adverse claim of ownership
thereof.  Sucampo represents and warrants to Takeda that, as of the Effective
Date, none of the relevant Sucampo Rights are the subject of any pending or
threatened, adverse claim, judgment, injunction, order, decree or agreement
restricting its use for the Licensed Product in the Field in the applicable
country in the Territory.
 
15.3.12  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 Takeda 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.
 
15.3.13  Maintaining Existing Licenses and Rights.  Subject to Section 11.2
above, Sucampo represents, warrants and covenants that Sucampo shall use
Commercially Reasonable Efforts to maintain all rights and licenses executed by
Sucampo that materially affect Takeda’s rights with respect to the  Licensed
Product in the Field in the applicable country 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 ensure Product Trademarks
are registered and maintained in the applicable country in the Territory for the
Licensed Product in the Field during the Term.
 
15.3.14  Future Authorizations.  Each Party shall use Commercially Reasonable
Efforts to 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.
 
15.3.15  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 and Commercialization of the
Licensed Product in the Field in the applicable country in the Territory, and
such Party has received no written claims relating to any such infringement or
misappropriation.
 
15.4  Secondary Packaging by Takeda.  Takeda represents and warrants that the
Secondary Packaging of the Licensed Product performed by Takeda shall: (a) be in
accordance and in compliance with Applicable Law in the countries in the
Territory where such Licensed Product in the Field is to be Commercialized,
including cGMP; (b) be in accordance with the applicable Regulatory Filings and
Regulatory Approvals in the countries in the Territory where such Licensed
Product in the Field is to be Commercialized; and (c) be in compliance with
applicable Specifications for the Secondary Packaging of such Licensed Product.
 
 
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15.5  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 (including, in the case of Takeda, any
Subcontractor) 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 sanctioned, suspended, excluded or otherwise declared ineligible from any
Regulatory Authority 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.  Notwithstanding Section 12.2 above, 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.
 
15.6  No Litigation.  As of the Effective Date, Sucampo represents and warrants
that there is no pending, settled or, to its knowledge, threatened litigation
with respect to the Compound or the Licensed Product in the applicable country
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.
 
15.7  Affiliate and other Sublicensee and Subcontractor Compliance.  Either
Party represents and warrants that it shall remain responsible for any breach of
its obligations hereunder by any of its Affiliates, Sublicensees and
Subcontractors as applicable.
 
15.8  When any representation, warranty, covenant or agreement contained in this
Agreement is expressly qualified by reference “to the knowledge of Sucampo” or
words of similar, then Sucampo shall be deemed to have knowledge if any of its
employees or any of its Affiliates employees (including but not limited to
Sucampo Pharmaceuticals, Inc.) at the time of the execution of this Agreement
has actual knowledge, or ought reasonably to have knowledge, given their
particular position and responsibilities.
 
15.9  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 COMPOUND, THE LICENSED
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.
 
 
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15.10  Limited Liability.  NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE
CONTRARY, EXCEPT IN CIRCUMSTANCES OF WILFUL MISCONDUCT BY A PARTY OR ITS
AFFILIATES, OR WITH RESPECT TO EACH PARTY’S INDEMNIFICATION OBLIGATIONS SET
FORTH IN ARTICLE 16 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 LOST
PROFITS OF ANY KIND OR FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, INCLUDING, LOST PROFITS OR LOST REVENUES, OR COST/EXPENSE
OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES, WHETHER UNDER ANY
CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE
THEORY.
 
 
ARTICLE 16
INDEMNIFICATION; INSURANCE
 
16.1  Indemnification by Takeda.  Takeda 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 other expenses of litigation and/or arbitration)
(collectively, “Losses”) resulting from a claim, suit or proceeding made or
brought by a Third Party against Sucampo or its Affiliates (collectively, a
“Third Party Claim”) arising out of or resulting from:
 
(a)  Any breach of representations or warranties made by Takeda (and if
applicable Takeda’s Affiliate or Sublicensees) in ARTICLE 15;
 
(b)  Negligence of Takeda (and if applicable Takeda’s Affiliate or Sublicensees)
in conducting any Development of the Licensed Product, if conducted by Takeda,
Takeda’s Affiliates or Sublicensees;
 
(c)  The Commercialization by Takeda (or, if applicable Takeda’s Affiliates or
its Sublicensee(s)) (including without limitation, product liability claims);
 
 
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(d)  The failure of Takeda (and, if applicable Takeda’s Affiliates or its
sub-licensee(s) or subcontractors) to comply with any provision of this
Agreement, or with any Applicable Law, regulations and/or administrative
decisions relating to any Licensed Product,
 
except in each case to the extent caused by the negligence or wilful misconduct
of Sucampo or its Affiliates.
 
16.2  Indemnification by Sucampo.  Sucampo agrees to indemnify, defend and hold
harmless Takeda and its Affiliates and their respective employees, agents,
officers, directors and permitted assigns (“Takeda Indemnitees”) from and
against any and all Losses resulting from a Third Party Claim arising out of or
resulting from the following:
 
(a)  Any breach of representations or warranties made by Sucampo (and if
applicable Sucampo’s Affiliate) in ARTICLE 15;
 
(b)  The Manufacturing (excluding Secondary Packaging) and the supply of the
Licensed Product by Sucampo, Sucampo’s Affiliates or its subcontractors or other
parties for whom Sucampo is responsible;
 
(c)  Any product liability claim in the applicable country in the Territory to
the extent resulting from any Latent Defect or Patent Defect of the Licensed
Product;
 
(d)  Infringement, misappropriation or violation of any Patent Rights, any
rights, title and interests in Trademarks, Other Intellectual Property Rights,
publicity, privacy or other intellectual property or other proprietary rights of
any Third Party (other than each Party’s Affiliates), in each of the foregoing
cases, solely in the Field in the applicable country ;
 
The failure of Sucampo (and, if applicable Sucampo’s Affiliates or its
subcontractors or other parties for whom Sucampo is responsible) to comply with
any provision of this Agreement, Ancillary Agreement or with any Applicable Law,
regulations and/or administrative decisions relating to any Licensed Product,
except in each case to the extent caused by the negligence or wilful misconduct
of Takeda or its Affiliates.
 
16.3  Procedures for Indemnification. The obligations of an indemnifying Party
under Section 16.1 and Section 16.2 shall be governed by and contingent upon the
following:
 
16.3.1  Notice of Claim.  Each Party shall give the other Party prompt written
notice of any Third Party Claim (an “Indemnification Claim Notice”).  Each
Indemnification Claim Notice shall contain a description of the claim and the
nature and amount of the Loss claimed (to the extent that the nature and amount
of such Loss is known at such time).  The indemnified Party shall furnish
promptly to the indemnifying Party copies of all material 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 relieve 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.
 
 
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16.3.2  Assumption of Defense.  At its option, the indemnifying Party may assume
the defense of any Third Party Claim by giving written notice to the indemnified
Party within fourteen (14) days after the indemnifying Party’s receipt of an
Indemnification Claim Notice or sooner if necessary.  The assumption of the
defense of a Third Party Claim by the indemnifying Party shall not be construed
as an acknowledgement that the indemnifying Party is liable to indemnify any
Takeda Indemnitees or Sucampo Indemnitees (as applicable) in respect of such
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.
 
16.3.3  Control of the Defense.  Upon the assumption of the defense of a Third
Party Claim by the indemnifying Party:
 
(a)         the indemnifying Party may appoint as lead counsel in the defense of
the Third Party Claim any legal counsel selected by the indemnifying Party,
which shall be reasonably acceptable to the indemnified Party;

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

(c)         the indemnifying Party shall not be liable to the indemnified Party
for any legal expenses subsequently incurred by such indemnified Party or any
Takeda 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.

16.3.4  Right to Participate in the Defense.  Without limiting Section 16.3.2 or
Section 16.3.3, any Takeda 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
16.3.2 (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.
 
 
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16.3.5  Settlement.  The indemnifying 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 indemnified
Party (which consent shall not be unreasonably withheld, conditioned or
delayed).  The indemnifying Party shall not be liable for any settlement or
other disposition of a Third Party Claim by an indemnified Party that is reached
without the prior written consent of the indemnifying Party.  Regardless of
whether the indemnifying Party chooses to defend or prosecute any Third Party
Claim, no indemnified Party shall admit any liability with respect to, or
settle, compromise or discharge, any Third Party Claim without the prior written
consent of the indemnifying Party, such consent not to be unreasonably withheld,
conditioned or delayed.
 
16.3.6  Cooperation.  Regardless of whether the indemnifying Party chooses to
defend or prosecute any Third Party Claim, the indemnified Party shall, and
shall cause each Indemnitee to, cooperate in the defense or prosecution thereof
and shall furnish such records, information and testimony, provide such
witnesses and attend such conferences, discovery proceedings, hearings, trials
and appeals as may be reasonably requested in connection therewith.  Such
cooperation shall include access during normal business hours afforded to
indemnifying Party to, and reasonable retention by the indemnified Party of,
records and information that are reasonably relevant to such Third Party Claim,
and making itself and its employees and agents and other Indemnitees 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.
 
16.4  Insurance.  Each Party shall obtain and carry in full force and effect the
minimum insurance requirements set forth herein, which shall protect Indemnitees
with respect to events covered by Section 16.1 and Section 16.2.  Such insurance
(a) shall be primary insurance with respect to each Party’s own participation
under this Agreement, and (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.  The types of insurance, and minimum limits shall be
General liability insurance with a minimum limit of […***…] United States
Dollars (USD […***…]) per occurrence and […***…] United States Dollars (USD
[…***…]) in aggregate.  General liability insurance or other insurances (such as
Clinical Trial Insurance) shall include, at a minimum, Clinical Trial Insurance
and, beginning at least thirty (30) days prior to First Commercial Sale of any
Licensed Product, product liability insurance.  Upon request by a Party, the
other Party shall provide Certificates of Insurance evidencing compliance with
this Section 16.4.   The insurance policies shall be under claims made form.
Either Party shall use its Commercially Reasonable Efforts to continue to
maintain such insurance after the expiration or termination of this Agreement
for period of five (5) years from the date of last sale under this
Agreement.  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 17
MISCELLANEOUS
 
17.1  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 the State of
New York ]without regard to conflict of laws principles, except that (a)
questions affecting the construction and effect of any Patent Rights shall be
determined by the Applicable Law in the country in which the Patent Rights shall
have been granted; (b) matters related to Regulatory Filings and Regulatory
Approval shall be governed by the Applicable Law in the applicable country in
the Territory; and (c) any matters not subject to being construed, governed,
interpreted and applied in accordance with the substantive laws of the State of
New York or required by Applicable Law to be exclusively resolved pursuant to
the Applicable Law in the applicable country in the Territory, shall be resolved
by the Applicable Law in such applicable country.  The Parties hereby exclude
the United Nations Convention on Contracts for the International Sale of Goods
from this Agreement.
 
17.2  Arbitration.  In the event of any dispute, difference or question arising
out of or relating this Agreement, the construction thereof, or the rights,
duties or liabilities of either Party hereunder the Parties shall initiate an
arbitration proceeding to be conducted in accordance with the procedures set
forth in EXHIBIT G.
 
17.3  Notices
 
17.3.1  Notice Requirements.  Any notice, request, demand, waiver, consent,
approval or other communication permitted or required under this Agreement shall
be in writing and in 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 17.3.2, or to such other address as
the Party to whom notice is to be given may have been provided in writing to the
other Party, in accordance with this Section 17.3.  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 17.3 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.
 
 
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17.3.2 Addresses for Notice
 
For Takeda:
For Sucampo:
   
Takeda Pharmaceuticals International GmbH
Thurgauerstrasse 130
8152 Glattpark-Opfikon
Zurich, Switzerland
Fax:
Attention: Head of Legal
Sucampo AG
Baarerstrasse 22
CH-3600
Zug
Switzerland
Fax:
Attention: Secretary & Director
     
With a copy to:
     
Sucampo Pharmaceuticals, Inc.
4520 East West Highway
Bethesda, MD 20814
Fax: 301-961-3440
Attention: Commercial Officer
     
With a copy to: Executive Vice President, Chief Legal Officer & Corporate
Secretary

 
17.4  Equitable Relief. The Parties acknowledge and agree that the restrictions
set forth in Sections 2.1.4, 2.1.6 and 7.5, 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, 2.1.6 and 7.5, and 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, 2.1.6 and 7.5,  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 17.4 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.
 
 
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17.5  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
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.
 
17.6  No Third Party Beneficiaries.  Except as set forth in Section 16.1 and
Section 16.2, 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.
 
17.7  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
under any of the Ancillary Agreements, 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
applicable country in the Territory.
 
17.8  Assignment and Successors.  This Agreement is personal to both Parties and
neither Party shall sell, transfer, assign, delegate, pledge or otherwise
dispose – other than Takeda’s right to sublicense its rights as and to the
extent expressly and specifically permitted under Sections 2.1.1, 2.1.2 and
2.1.3 or subcontract the performance of its obligations as and to the extent
expressly and specifically permitted under Section 2.1.2 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, change of control or otherwise,
in whole or in part without the prior written consent of the other Party, except
that either Party may, on providing written notice to the other, assign this
Agreement and its rights, obligations and interests hereunder, in whole or in
part, without the written consent of the other Party to any of its Affiliates or
to any purchaser of all or substantially all of its assets and/or all or
substantially all of its assets to which this Agreement relates or to any
successor corporation resulting from any merger or consolidation of such
assigning Party with or into such corporation.  Any permitted assignee of all of
a Party’s rights under this Agreement shall be deemed to be a party to this
Agreement as though named herein. Any attempted assignment or delegation in
violation of this Section 17.8 shall be void.
 
 
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17.9   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.
 
17.10  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 then, notwithstanding
Section 12.2 above, the unaffected Party may terminate this Agreement upon
written notice to the affected Party (such termination may be on a
country-by-country or Licensed Product-by-Licensed Product basis).
 
17.11  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.
 
17.12  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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17.13  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.
 
17.14  Entire Agreement.  This Agreement and the Ancillary Agreements constitute
the entire agreement between the Parties with respect to the subject matter of
the Agreement.  This Agreement and the Ancillary Agreements supersede 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,
and expressly disclaims reliance on, any representations, warranties or
covenants of the other Party except as specifically set out in this Agreement or
any of the Ancillary Agreements.  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 or any of the Ancillary
Agreements, the terms and conditions of this Agreement shall govern, except that
in case of discrepancy between any provision of the Agreement and the Quality
Agreement or the Pharmacovigilance Agreement, then (i) as to matters related to
quality the provisions of the Quality Agreement shall prevail or related to
pharmacovigilance the provisions of the Pharmacovigilance Agreement shall
prevail and (ii) as to all other matters the Agreement shall control.
 
17.15  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.  Signatures to this
Agreement transmitted by facsimile transmission, by electronic mail in “portable
document format” (“.pdf”) form, or by any other electronic means intended to
preserve the original graphic and pictorial appearance of a document, will have
the same effect as physical delivery of the paper document bearing the original
signature.
 
 
88

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17.16  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.
 
17.17  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.
 
[Remainder of page intentionally left blank.]
 
 
 
 
89

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

SUCAMPO AG
TAKEDA PHARMACEUTICALS INTERNATIONAL GMBH
 
 
 
 
    By:     By:       (Signature)     (Signature)                          
(Printed Name) Peter Greenleaf
 
(Printed Name)
                         
(Title) President & Director.
 
(Title)
                                            By:            
(Signature)
                               
(Printed Name)
                               
(Title)
             

 
 
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EXHIBIT A
COMPOUND, ISOMERS AND TAUTOMERS

 Chemical Name:
 […***…]

Code Name:       SPI-0211, SPL-0211, RU-0211
CAS Number:    333963-40-9
Monocyclic Tautomer
CAS Number:  136790-76-6
 
 
*Confidential Treatment Requested
 
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EXHIBIT B
EXISTING REGULATORY APPROVALS

 

Japan       MA holder: Sucampo Pharma Ltd., Osaka     MA number: 22400AMX
0073300     MA date:
29 June 2012
    Tradename:
Amitiza
    Strength:
soft capsule 24 mcg
    Indication: chronic constipation, excluding constipation caused by organic
diseases
                    Switzerland     MA holder:
Sucampo AG, Zug
    MA number:
59‘275
    MA date:
16 November 2009, renewed 22 May 2014
    Tradename: Amitiza     Strength:
soft capsule 24 mcg
    Indication:
chronic idiopathic constipation (16 November 2009)
   
Opioid-induced constipation (30 June 2014)
                    United Kingdom     MA holder: Sucampo Pharma Europe Ltd.,
Abingdon     MA number:
PL21341-0003
    MA date:
10 September 2012
    Tradename:
Amitiza
    Strength:
soft capsule 24 mcg
    Indication:
chronic idiopathic constipation
   

      

 
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United States of America
    MA holder: Sucampo Pharma Americas LLC, Bethesda     MA number: NDA 21908  
  MA date:
31 January 2006
    Tradename:
Amitiza
    Strength:
soft capsule 24 mcg and 8 mcg
    Indication: chronic idiopathic constipation (24 mcg; 31 January 2006)
Irritable bowel syndrome with constipation (8 mcg; 29 April 2008)
     
Opioid-induced constipation (24 mcg; 19 April 2013)
   

 
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EXHIBIT C
PRODUCT TRADEMARKS
 
 
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  EXHIBIT D
SUCAMPO PATENT RIGHTS
 
 
 
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EXHIBITS E & F
 
INTENTIONALLY LEFT BLANK
 
 
 
 
 
 
 
 
 

 
 

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EXHIBIT G
ALTERNATIVE DISPUTE RESOLUTION

The Parties recognize that from time to time there may be a disputes arising out
of or relating to either Party’s rights or obligations under this Agreement
(“Dispute”).  The Parties agree that any such Dispute shall be resolved by the
Alternative Dispute Resolution provisions set forth in this Exhibit, the result
of which shall be binding, upon the Parties.

To begin the Alternative Dispute Resolution process, 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 twenty-eight
(28) days after such notice is received (all references to “days” in this
Alternative Dispute Resolution provision are to calendar days).  If the matter
has not been resolved within twenty-eight (28) days of the notice of dispute, or
if the Parties fail to meet within such twenty-eight (28) days, either Party may
initiate an Arbitration proceeding as provided herein.  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 Rules of Arbitration of the International Chamber of Commerce.  There
will be three (3) arbitrators, one nominated by the initiating party in the
request for arbitration, the second nominated by the other party within 30 days
of receipt of the request for arbitration, and the third, who shall act as
presiding arbitrator, nominated by the two party-nominated arbitrators within 30
days of the appointment of the second arbitrator.  If any arbitrators are not
nominated within these periods, the President of the ICC International Court of
Arbitration shall make the appointment(s).
 
2.  The seat of the arbitration shall be New York, New York., USA
 
3.  The language of the arbitration shall be 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. The arbitral tribunal may not award or assess punitive or exemplary
damages against either Party.

6.  In addition to any remedy available pursuant to Article 29 of the Rules of
Arbitration of the International Chamber of Commerce (“Emergency Arbitrator”),
prior to the time the arbitral tribunal is constituted, Sucampo and Takeda may
apply to the Specified Court for Provisional Relief.  In the event that Sucampo
or Takeda applies to the Specified Court for Provisional Relief, the decision of
the Specified Court, and not the Emergency Arbitrator, shall prevail.  If
Sucampo or Takeda 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.

 
 

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7.  The Parties unconditionally and irrevocably consent to the exclusive
jurisdiction of the federal or state courts in the State of New York (the
“Specified Court”) in any action, suit or proceeding with respect to 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 Takeda of the arbitration.  The Parties further
agree that any award may be enforced by Sucampo or Takeda against the assets of
the other Party wherever those assets are located (including but not limited to
New York), and that any award may be entered into and enforced by any court or
tribunal of competent jurisdiction.

8.  Sucampo, on the one hand, and Takeda, on the other hand, each hereby
appoints the designated person in Section 17.3 (the “Service Process Agent”) as
its agent for service of process in New York in any Dispute, provided that the
agent named by such Party in Section 17.3 may be replaced by another agent in
New York 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 pursuant to Section 17.3, provided, however that the failure to copy
any Party directly shall not affect the effectiveness of any service of process.

9.  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.

10.  The existence of any 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, unless such
disclosure is (i) made for purposes of a legal proceeding to enforce an arbitral
award or any provision of this Agreement; (ii) required by any governmental
agency; (iii) requested by any of the Parties’ auditors; (iv) made by a Party to
its parent corporation; (v) included as part of a securities filing, to the
extent a Party’s accountants, auditors or other securities advisors conclude
that such information is necessary to a filing;  or (vi) otherwise required to
be disclosed by law.  The Parties agree that they will notify each other in
writing within five (5) business days of the receipt of any subpoena, court
order, or administrative order requiring disclosure of information subject to
this confidentiality provision and provide the other Party with a reasonable
opportunity to object to the same before disclosing such information.
 
 
 

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EXHIBIT H
SUPPLY PRICE AND CONDITIONS

1 - FORM OF THE LICENSED PRODUCT

Sucampo shall supply the Licensed Product to Takeda in the following forms:

·
For Development activities:

Sample capsules in 2 count (ct.) alu-alu blister strips
Capsules in 10 ct. alu-alu blister strips
Capsules in 28 ct., 30 ct., 56 ct., or 60 ct. bottles

·
For Commercialization activities

Samples capsules in 2 count (ct.) alu-alu blister strips
Capsules in 10 ct. alu-alu blister strips
Capsules in 28 ct., 30 ct., 56 ct., or 60 ct. bottles

·
For Commercialization activities during the Transition Period

Capsules in  28 ct. or 56 ct. bottles and secondary packaged

2 - SUPPLY PRICE FOR THE LICENSED PRODUCT (including the samples)

·
Supply Price of Licensed Product in connection with Development:

JPY[…***…] per capsule of the Licensed Product primary packed in alu-alu blister
strip capsules or bottle

·
Supply Price of Licensed Product in connection with Commercialization:

JPY […***…] per capsule of the Licensed Product primary packed in alu-alu
blister strips or bottles
JPY […***…] per capsule of the Licensed Product primary packed in 2 count sample
blister strip

·
Supply Price of Licensed Product in connection with Commercialization during the
Transition Period:

JPY […***…] per capsule of the Licensed Product in secondary packaged form for
56 ct. bottles
JPY […***…] per capsule of the Licensed Product in secondary packaged form for
28 ct. bottles

*Confidential Treatment Requested

 
 

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  EXHIBIT I
PRESS RELEASE
 
 

[sucampo_logo.jpg] [takeda_logo.jpg]

 
 
Takeda and Sucampo Enter Into Global Licensing Agreement for AMITIZA®
(lubiprostone)
 
Takeda Gains Exclusive Rights to AMITIZA Beyond U.S. and Canada for All Markets
Except Japan and China
 
 
BETHESDA, Md., October 21, 2014 and OSAKA, Japan, October 22, 2014 (GLOBE
NEWSWIRE) - Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global
biopharmaceutical company, and Takeda Pharmaceutical Company Limited (Takeda)
today announced that on October 17, 2014, they entered into a global license,
development, commercialization and supply agreement for AMITIZA®
(lubiprostone).  Through this agreement, Takeda expanded its exclusive rights
beyond the United States (U.S.) and Canada to further develop and commercialize
AMITIZA in all global markets, except Japan and the People’s Republic of China.
 
“Takeda is committed to being patient and customer-centric, making quality
health products available to the patients who need them. Through this agreement,
AMITIZA can now be made available to patients worldwide,” said Shinji Honda,
Senior Managing Director and Corporate Strategy Officer. “Takeda forms
partnerships to advance science and to provide innovative treatment options for
patients, and this global agreement is an excellent example. This global
collaboration leverages the expertise we have established through our
gastroenterology portfolio of products.”
 
“The expansion of our collaboration with Takeda represents a critical step
forward with our strategic plan and is the natural evolution of our partnership
with them for North America,” said Peter Greenleaf, Chief Executive Officer of
Sucampo. “This agreement allows Sucampo to remain focused on our strengths in
drug development while allowing us to bring AMITIZA to more patients in need
around the world.  Through the eight years Takeda has marketed AMITIZA in the
U.S., the company has garnered extensive experience with the product.  Combined
with their proven global infrastructure, we are confident that Takeda will build
the brand in new global markets as they have done in the U.S., where AMITIZA
continues to grow steadily.”
 
Under the terms of the agreement, Sucampo will receive an upfront payment of $14
million from Takeda and will also be eligible for up to $35 million in
additional commercial milestones contingent on the achievement of certain net
sales revenue targets.  Additionally, Sucampo will be the exclusive supplier of
AMITIZA to Takeda at an agreed-upon supply price.
 
Takeda will be responsible for all development activities and costs, with
Sucampo assuming responsibility for the first $6 million in development
expenses. In addition, Takeda will become the marketing authorization holder in
each of the countries and will be responsible for all commercialization and
regulatory activities.  The agreement is effective until it expires on a
country-by-country basis on the fourteenth anniversary of the date of first
commercial sale in that country.
 
About AMITIZA (lubiprostone)

AMITIZA (lubiprostone) is a prostone and is a locally acting chloride channel
activator, indicated in the United States for the treatment of chronic
idiopathic constipation (CIC) in adults and opioid-induced constipation (OIC) in
adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in
patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been
established. AMITIZA is also indicated in the U.S. for irritable bowel syndrome
with constipation (IBS-C) (8 mcg twice daily) in women 18 years of age and
older.
 
 
 

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Important Safety Information
 
·
AMITIZA (lubiprostone) is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction. Patients with symptoms suggestive of
mechanical gastrointestinal obstruction should be thoroughly evaluated by the
treating healthcare provider (HCP) to confirm the absence of such an obstruction
prior to initiating AMITIZA treatment.

 
·
Patients taking AMITIZA may experience nausea. If this occurs, concomitant
administration of food with AMITIZA may reduce symptoms of nausea. Patients who
experience severe nausea should inform their HCP.

 
·
AMITIZA should not be prescribed to patients that have severe diarrhea. Patients
should be aware of the possible occurrence of diarrhea during treatment.
Patients should be instructed to discontinue AMITIZA and inform their HCP if
severe diarrhea occurs.

 
·
Patients taking AMITIZA may experience dyspnea within an hour of first dose.
This symptom generally resolves within three hours, but may recur with repeat
dosing. Patients who experience dyspnea should inform their HCP. Some patients
have discontinued therapy because of dyspnea.

 
·
In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316,
respectively) in patients with CIC, the most common adverse reactions (incidence
> 4%) were nausea (29% vs 3%), diarrhea (12% vs 1%), headache (11% vs 5%),
abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6%
vs 2%).

 
·
In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=860 vs N=632,
respectively) in patients with OIC, the most common adverse reactions (incidence
>4%) were nausea (11% vs 5%) and diarrhea (8% vs 2%).

 
·
In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435,
respectively) in patients with IBS-C the most common adverse reactions
(incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain
(5% vs 5%).

 
·
Concomitant use of diphenylheptane opioids (e.g., methadone) may interfere with
the efficacy of AMITIZA.

 
·
The safety of AMITIZA in pregnancy has not been evaluated in humans. Based on
animal data, AMITIZA may cause fetal harm. AMITIZA should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus. Caution should be exercised when AMITIZA is administered to a nursing
woman. Advise nursing women to monitor infants for diarrhea.

 
·
Reduce the dosage in CIC and OIC patients with moderate and severe hepatic
impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

 
 
Please see the Full Prescribing Information here. For further information on
AMITIZA, please visit www.sucampo.com/products.
 
About Sucampo Pharmaceuticals, Inc.
 
Sucampo Pharmaceuticals, Inc. is focused on the development and
commercialization of medicines that meet major unmet medical needs of patients
worldwide. Sucampo has two marketed products – AMITIZA® and RESCULA® – and a
pipeline of product candidates in clinical development. A global company,
Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan,
Switzerland and the United Kingdom. For more information, please visit
www.sucampo.com.
 
 
 

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The Sucampo logo is the registered trademark and the tagline, The Science of
Innovation, is a pending trademark of Sucampo AG. AMITIZA is a registered
trademark of Sucampo AG.  RESCULA is a registered trademark of R-Tech Ueno, Ltd,
and has been licensed to Sucampo AG.
 
Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo
Pharmaceuticals).
TwitterLinkedIn

Sucampo Forward-Looking Statement
 
This press release contains "forward-looking statements" as that term is defined
in the Private Securities Litigation Reform Act of 1995. These statements are
based on management's current expectations and involve risks and uncertainties,
which may cause results to differ materially from those set forth in the
statements. The forward-looking statements may include statements regarding
product development, product potential, future financial and operating results,
and other statements that are not historical facts. The following factors, among
others, could cause actual results to differ from those set forth in the
forward-looking statements: the impact of pharmaceutical industry regulation and
health care legislation; the ability of Sucampo to develop and commercialize
existing and pipeline products; Sucampo's ability to accurately predict future
market conditions; dependence on the effectiveness of Sucampo's patents and
other protections for innovative products; the risk of new and changing
regulation and health policies in the U.S. and internationally; the effects of
competitive products on Sucampo’s products; and the exposure to litigation
and/or regulatory actions.
 
No forward-looking statement can be guaranteed and actual results may differ
materially from those projected. Sucampo undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this presentation
should be evaluated together with the many uncertainties that affect Sucampo's
business, particularly those mentioned in the risk factors and cautionary
statements in Sucampo's most recent Form 10-K as filed with the Securities and
Exchange Commission on March 12, 2014 as well as its filings with the Securities
and Exchange Commission on Form 10-Q and 8-K, which Sucampo incorporates by
reference.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main
focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one
of the global leaders of the industry, Takeda is committed to strive towards
better health for people worldwide through leading innovation in medicine.
Additional information about Takeda is available through its corporate website,
www.takeda.com.

Takeda Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking
statements include statements regarding Takeda's plans, outlook, strategies,
results for the future, and other statements that are not descriptions of
historical facts. Forward-looking statements may be identified by the use of
forward-looking words such as "may," "believe," "will," "expect," "project,"
"estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro
forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or
other similar words or expressions of the negative thereof. Forward-looking
statements are based on estimates and assumptions made by management that are
believed to be reasonable, though they are inherently uncertain and difficult to
predict. Investors are cautioned not to unduly rely on such forward-looking
statements.

Forward-looking statements involve risks and uncertainties that could cause
actual results or experience to differ materially from that expressed or implied
by the forward-looking statements. Some of these risks and uncertainties
include, but are not limited to, (1) the economic circumstances surrounding
Takeda's business, including general economic conditions in Japan, the U.S. and
worldwide; (2) competitive pressures and developments; (3) applicable laws and
regulations; (4) the success or failure of product development programs; (5)
actions of regulatory authorities and the timing thereof; (6) changes in
exchange rates; (7) claims or concerns regarding the safety or efficacy of
marketed products or product candidates in development; and (8) integration
activities with acquired companies.

 
 

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The forward-looking statements contained in this press release speak only as of
the date of this press release, and Takeda undertakes no obligation to revise or
update any forward-looking statements to reflect new information, future events
or circumstances after the date of the forward-looking statement. If Takeda does
update or correct one or more of these statements, investors and others should
not conclude that Takeda will make additional updates or corrections.

Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Communications
1-240-223-3718
staylor@sucampo.com
 

 
Takeda Pharmaceutical Company Limited
Corporate Communications Dept.
Tel: +81-3-3278-2037
 
Jocelyn Gerst
Takeda Pharmaceuticals International, Inc.
Corporate Communications Dept.
Tel: +1 224 554 5542
 
 
# # #
 
 
 
 
 
 
 
 

 
 
 

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EXHIBIT J
TAKEDA’S AFFILIATES
 
 
List of Takeda Affiliates Arizona
  
Country
Legal Name
Registered Office
ARMENIA
The Representative Office of Takeda Austria GmbH in Armenia
0009, Teryan str. 105/1 Yerevan, Armenia
BELARUS
The Representative Office of Takeda Osteuropa Holding GmbH (Austria) in Belarus
4, Svoboda square, 220030 Minsk, Belorus
BRAZIL
Takeda Pharma Ltda.
Rua do Estilo Barroco, nº 721, Santo Amaro, CEP 04709-011, Cidade de São Paulo,
Estado de São Paulo
COLOMBIA
Takeda S.A.S.
Calle 64 #93-11, Barrio Álamos Industrial, Bogotá, DC, Colombia
EGYPT
Takeda Egypt Trading and Distribution Company LLC
Apartment 101, Building No 52, Nady El Says Street, Giza, Egypt
GEORGIA
The Representative Office of Takeda Osteuropa Holding GmbH (Austria) in Gerorgia
3 Nutsubidze str., 0177 Tbilisi, Georgia
INDONESIA
PT Apex Pharma Indonesia
Office 8, 25th Floor, SCBD lot 28, Jl. Jend Sudirman kav 52-53, Jakarta 12190,
Indonesia
ISRAEL
Takeda Israel Ltd.
25 Efal st., P.O. Box 4140, Kiriat Arie, Petach-Tikva, 4951125 Israel
ITALY
Takeda Italia S.p.A.
Via Elio Vittorini  n.129-Rome Italy, REA RM-1365602
KAZAKHSTAN
Takeda Kazakhstan LLP
Begalina street, 136 a, 050010, Kazakhstan, Almaty
KOREA, REPUBLIC OF
Takeda Pharmaceuticals Korea Co. Ltd.
Being established.
LEBANON
Representative Office in Lebanon
Lebanon – legally existing, though not yet operating as entry into the
commercial register is still outstanding
MALAYSIA
Takeda Malaysia Sdn. Bhd.
Jalan Perdana 4/3, Pandan Perdana, YL Consultancy, 12-1A (room A), 55300 Kuala
Lumpur
MEXICO
Takeda México S.A. de C.V.
Avenida Primero de Mayo #130, Colonia Industrial Atoto, C.P. 53519, Naucalpan de
Juárez
PHILIPPINES
Takeda Healthcare Philippines Inc.
17th floor, Zuellig Building, Makati Avenue corner Paseo de Roxas, Makati City,
Metro Manila
RUSSIAN FEDERATION
Takeda Pharmaceuticals LLC
2 Usatcheva Str., Building 1, Moscow, 119048, the Russian Federation
SWITZERLAND
Takeda Pharma AG
Huobstrasse 16, 8808 Pfäffikon SZ

 
 
 
 

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List of Takeda Affiliates Arizona
 
 
THAILAND
Takeda (Thailand) Ltd.
57 Park Ventures Ecoplex Building, 15th floor, Wireless Road, Lumpini, Patumwan
Bangkok 10330
UKRAINE
Takeda Ukraine LLC
55-G, Chervonoarmiyska Str., Kyiv, 03150
UNITED KINGDOM
Takeda UK Ltd.
Takeda House, Mercury Park, Wycombe Lane, Wooburn Green, High Wycombe,
Buckinghamshire, HP10 0HH
UZBEKISTAN
Takeda Osteuropa Holding GmbH (Austria)
Mustakillik 88a street, Mirzo Ulugbekskiy District, Tashkent, Uzbekistan
VENEZUELA, BOLIVARIAN REPUBLIC OF
Takeda S.R.L.
Av. Francisco de Miranda, entre Calle Mohedano y Av. El Parque, Centro
Empresarial Galipán, Torre C Piso 9 Oficina 91C, Urbanización El Rosal 1060,
Caracas

 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 

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EXHIBIT K
 
TAKEDA CODE OF CONDUCT
 
 
 
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EXHIBIT L
 
DEVELOPMENT PLAN
 
[…***…]
 
 
 
 
 
 
 
 
 
 

 
*Confidential Treatment Requested

 
 

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EXHIBIT   M
 
PAEDIATRIC INVESTIGATION PLAN
 
The European Medicines Agency approved the following Paediatric Investigation
Plan (EMEA-000245-PIP01-08-M01):
 
1.           AMITIZA® shall be developed in the paediatric population for the
target indication Functional Constipation and Opioid Induced Constipation.
 
2.           The subsets of paediatric patients will be from 6 years to less
than 18 years of age and from 6 months to less than 6 years.  The Pharmaceutical
forms will be the soft capsule for the older children and adolescents, and an
“age-appropriate oral liquid dosage form” for the young population
 
3.           Studies to be completed are as follows:
 
a.           Study 1 (Quality study):  Development of an age-appropriate oral
liquid dosage form dispensed in a metering pump. (this study has been
completed);
 
b.           Study 2 (Non-Clinical):  Oral Toxicity study (study completed);
 
c.           Study 3 (Clinical):  Multi-center, double-blinded, placebo
controlled study of lubiprostone to evaluate efficacy pharmacokinetic,
pharmacodynamics, in children from 6 years to less than 18 years with functional
constipation, stratified according to patients age. (completion of this study is
deferred);
 
d.           Study 4 (Clinical):  Multi-center, double-blinded placebo
controlled study of lubiprostone to evaluate efficacy pharmacokinetic,
pharmacodynamics in children from 6 months to less than 6 years with functional
constipation, stratified according to patients age.  (completion of this study
is deferred);
 
e.           Study 5 (Clinical):  Multi-Center, open-labeled safety study of
lubiprostone in children from 6 years to less than 18 years with functional
constipation. (completion of this study is deferred);
 
f.           Study 6 (Clinical):  Multi-Center, open-labeled safety study of
lubiprostone in children from 6 months to less than 6 years with functional
constipation. (completion of this study is deferred); and
 
g.           Study 7 (Clinical):  Model-based bridging of clinical data to
children and adolescents from 6 months to less than 18 years of age with opioid
induced constipation. (completion of this study is deferred).
 

 
 

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EXHIBIT N
 
LIST OF PATENTS TO BE PROSECUTED AND MAINTAINED BY SUCAMPO ACCORDING TO SECTION
11.2
 
 
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EXHIBIT O
 
 
 
FORECAST
 
[…***…]
 

 
 
 
 
 
 
 
*Confidential Treatment Requested

 
 

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EXHIBIT P
 
 
 
INVENTORY
 
 […***…]
 
 
 
 
 
 

 

*Confidential Treatment Requested

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