Document:

exv10w23

 

Exhibit 10.23

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

SUPPLY AGREEMENT

     THIS SUPPLY AGREEMENT is made as of October 29, 2004, by and among Sucampo Pharmaceuticals,
Inc., a Delaware corporation having its principal place of business at 4733 Bethesda Avenue, Suite
450, Bethesda, Maryland 20814 USA (“SPI”), Takeda Pharmaceutical Company Limited, a corporation
organized under the laws of Japan having its principal place of business at 1-1, Doshomachi
4-chome, Chuo-ku, Osaka 540-8645, JAPAN (“Takeda”) and R-Tech Ueno, Ltd., a corporation organized
under the laws of Japan having its principal place of business at 10F, Yamato Life Insurance Bldg.,
1-1-7 Uchisaiwaicho, Chiyoda-ku, Tokyo 100-0011, JAPAN (“RTU”) (this “Agreement”). SPI, Takeda
and RTU are sometimes referred to herein individually as a “Party” and collectively as the
“Parties.”

Recitals

     WHEREAS, SPI is a United States based pharmaceutical company;

     WHEREAS, Takeda is a multinational health care company with research, development,
manufacturing and marketing activities worldwide;

     WHEREAS, RTU is a Japanese pharmaceutical company with research, development, manufacturing
and marketing activities;

     WHEREAS, Takeda has obtained from SPI an exclusive license to co-develop, use, sell, promote,
offer for sale, import and distribute the Product (hereinafter defined) for the gastroenterology
indications in the United States and Canada under the Licensed Trademarks (hereinafter defined)
under a collaboration and license agreement of even date herewith (the “Collaboration and License
Agreement”);

     WHEREAS, prior to the grant of such license from SPI to Takeda, SPI has appointed RTU as the
exclusive contract manufacturer to manufacture and supply the Product for clinical and commercial
purposes in the United States and Canada;

     WHEREAS, each Party desires to define in this Agreement certain parameters of their business
relationship regarding each Party’s rights and obligations to or in manufacturing and supply of the
Compound (hereinafter defined) and Product;

     NOW THEREFORE, in consideration of the premises and the mutual covenants hereinafter set
forth, the Parties hereto have agreed as follows:

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Article 1 INTRODUCTORY PROVISIONS

1.1 Defined Terms. The following terms, when used in capitalized form in this
Agreement, shall have the meanings set forth below:

“Additional Indication(s)” shall mean all Initial Indications, other than Constipation and
Constipation-predominant Irritable Bowel Syndrome (“C-IBS”).

“Affiliate” shall mean, in relation to a Party, any corporation or entity that, directly or
indirectly, controls, is controlled by or is under common control with such Party. For purposes of
this definition, the term “control” shall mean the ownership, directly or indirectly, of fifty
percent (50%) or more of the voting interest in, or fifty percent (50%) or more of the equity of or
the right to appoint fifty percent (50%) or more of the directors or managers of that corporation
or other business entity or the power to direct or cause the direction of the management and
policies of such corporation or entity, whether pursuant to the ownership of voting securities, by
contract or otherwise.

“Applicable Regulations” means all statutes, laws and regulations applicable to the development,
manufacture and testing of pharmaceutical materials in effect at a particular time and promulgated
by the FDA or any other Regulatory Authority, including without limitation current good laboratory
practices (“cGLP”), current good clinical practices (“cGCP”), current good manufacturing and
control practices (“cGMP”) and quality system regulations (“QSR”), and any successor or replacement
statues, laws and regulations.

“Best Efforts” shall mean those efforts that would be made by a reasonably prudent business person
acting in good faith and in the exercise of reasonable commercial judgment based on acceptable
practice, process and speed found in the pharmaceutical industry and taking into account the
potential commercial market for the applicable product in the Initial Territory.

“Chief Officer” shall mean chief executive officer in the case of SPI, chief operating officer in
the case of Takeda and Representative Director in the case of RTU.

“Collaboration and License Agreement” shall have the meaning set forth in the Recital.

“Commercial Launch” shall mean the date of first sale of a Product in any country of the Initial
Territory for any indication.

“Commercialization” or “Commercialize” shall mean all activities undertaken pursuant to an approved
commercialization plan relating to the import, promotion, marketing, detail, storage, handling,
offering for sale and sale of a Product for the Initial Indications and, if applicable, Additional
Indications and/or New Formulations in the Initial Territory.

“Compound” shall mean the active pharmaceutical ingredient known as SPI-0211 or by the USAN name
Lubiprostone, as further described in Exhibit A.

“Confidential Information” shall mean all information, including but not limited to any information
on the markets, customers, suppliers, patents or patent applications, inventions, products,
procedures, designs, formulas, business plans, financial projections, organizations,

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employees, consultants or any other similar aspects of a Party’s present or future business, the
secrecy of which confers a competitive advantage upon that Party. Confidential Information shall
include the terms of this Agreement and the Proprietary Product Information.

“Development” or “Develop” shall mean all activities undertaken pursuant to an approved development
plan to obtain Regulatory Approval for a Product for the Initial Indications and, if applicable,
Additional Indications and/or New Formulations in the Initial Territory. This includes preclinical
studies, including but not limited to toxicology, pharmacology, chemistry manufacturing and control
of bulk and finished product and any clinical studies as well as all the process and procedures
necessary to obtain Regulatory Approval, including preparation and submission of an NDA and other
regulatory application(s).

“Drug Approval Application” shall mean an application for Regulatory Approval, such as an NDA,
required to be approved before commercial sale or use of a Product as a drug in a regulatory
jurisdiction.

“Effective Date” shall mean the date first above written.

“Exchange Rate” shall mean the rate of One United States dollars equals to One Hundred Ten JPY
(US$1.00 = JPY110.00); provided, however, that, if the exchange rate between United States and JPY
as of the Effective Date, as reported by the Wall Street Journal, fluctuates from the
above-mentioned rate (i.e., US$1.00 = JPY110.00) by Four JPY (JPY4.00) or more, then the Exchange
Rate shall be the medium of the rate of US$1.00 = JPY110.00 and the rate so reported by the Wall
Street Journal. By way of example, if the exchange rate so reported by the Wall Street Journal at
the Effective Date is US$1.00 = JPY105.00, then the Exchange Rate shall be US$1.00 = JPY107.50
(instead of US$1.00 = JPY110.00).

“FDA” shall mean the United States Food and Drug Administration or any successor entity thereto.

“Force Majeure” shall mean any event, not existing as of the Effective Date and not reasonably
within the control of the Parties as of such date, which, in whole or in material part, prevents or
makes commercially unreasonable one Party’s performance of its obligations (except payment
obligations) under this Agreement. Force Majeure shall include, without limitation: fire, storm,
earthquake, flood, acts of State or other governmental action, war or civil unrest, strikes, and
prolonged shortage of energy or any other supplies.

“GAAP” shall mean generally accepted accounting principles current in the United States.

“ICC” shall have the meaning set forth in Section 12.3.

“Initial Indications” shall mean all gastroenterology indications, including but not limited to,
Constipation and C-IBS for the Product.

“Initial Territory” shall mean the United States and Canada.

“JPY” shall mean Japanese Yen.

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“Liability” shall have the meaning set forth in Section 7.1.

“Licensed Trademarks” shall mean the trademark(s) and tradename(s) selected by SPI for use in
connection with the Products.

“Manufacturing and Supply Agreement” shall have the meaning set forth in Article 2.

“Manufacturing Specification(s)” shall mean the commercial specification for the manufacturing,
quality control, packaging, labeling, shipping, delivery and storage of the Product as set forth in
a Drug Approval Application and/or in the specification agreed upon in accordance with this
Agreement and/or the Supply and Purchase Agreement.

“Marketing Authorization” shall mean (a) for the United States, the approval of an NDA and (b) for
Canada, the approval from the relevant Regulatory Authority to necessary market and sell the
Product in Canada, including, without limitation, all applicable pricing and government
reimbursement approvals.

“NDA” shall mean a new drug license application or supplemental application filed with the FDA or
any comparable application filed with a Regulatory Authority in or for Canada to obtain Marketing
Authorization for a pharmaceutical product in or for Canada.

“Net Sales Revenue” shall mean the gross invoiced sales of the Product by Takeda, Takeda Affiliates
and/or its sub-licensee to a third party, less a deduction for any amounts actually incurred by
Takeda, Takeda Affiliates and/or its sub-licensee for any of the following items to the extent such
items specifically relate to sale of the Product and are incurred by Takeda, Takeda Affiliates
and/or its sub-licensee in the normal course of business, provided that the total deductions for
any particular sale shall not exceed [**] percent ([**]%) of the gross invoiced amount of such sale
of the Product:

	 	(a)	 	credits, price adjustments or allowances for damaged products, returns
or rejections of the Product;
	 
	 	(b)	 	normal and customary trade, cash and quantity discounts, allowances and
credits;
	 
	 	(c)	 	chargeback payments and rebates granted to group purchasing
organizations, managed health care organizations or to federal, state/provincial,
local and other governments, including their agencies;
	 
	 	(d)	 	sales, excise taxes (to the extend not refundable in accordance with
applicable law) and other taxes directly related to the sale (but not including
taxes assessed against the income derived from such sale); and
	 
	 	(e)	 	any freight charges, including postage, shipping, insurance and transportation.

     Such amounts shall be determined from the books and records of Takeda maintained in accordance
with GAAP consistently applied.

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“New Formulation(s)” shall mean any formulation of the Product other than the Initial Formulation.

“Party” or “Parties” shall have the meaning set forth in the introductory paragraph.

“Product” shall mean any and all pharmaceutical preparation for human use that contains the
Compound, a chemical equivalent, a salt, or a prodrug thereof as an active ingredient.

“Proprietary Product Information” shall mean (a) all information and data now or hereafter
contained in any Drug Approval Application or otherwise submitted in support of any Regulatory
Approval to which either Party shall have the right under applicable law, regulations and
administrative decisions to refer to, to authorize third parties to refer to and to prohibit third
parties from referring to the Initial Indications and, if applicable, Additional Indications and/or
New Formulations in the Initial Territory; (b) all data concerning any serious or unexpected
adverse events, side effects and contra-indications of the Product which may come to the attention
of either Party, its Affiliates or any sublicensee; (c) all data and information in the possession
of either Party or any permitted sublicensee of a Party relating to (i) the pharmacological or
toxicological properties of a Product, (ii) pre-clinical or clinical testing and experience in
relation to a Product which is not included in any Drug Approval Application and (iii) to the
extent reasonably required for purposes of any application for Drug Approval Application, the
chemical composition, manufacturing processes and quality control testing of a Product and (d) all
other information and data now or hereafter in existence and not in the public domain, which is in
the possession of either Party and its Affiliates and which relates in any way to the Development,
testing, manufacture, marketing, use or sale of the Products, including, without limitation, all
such information or data that is developed as a result of the Development and/or Commercialization
of the Products hereunder. Notwithstanding the foregoing, any data and information developed or
obtained by a Party or its Affiliates or any sublicensee that not based upon the other Party’s
confidential or proprietary information shall not be deemed to be Proprietary Product Information.

“Regulatory Approval(s)” shall mean any approvals (including pricing and reimbursement approvals),
product and/or establishment licenses, registrations or authorizations of any federal, state or
local regulatory agency, department, bureau or other governmental entity, necessary for the
manufacture, use, storage, importation, marketing, export, transport or sale of a Product for the
Initial Indications and, if applicable, Additional Indications and/or New Formulations in a
regulatory jurisdiction of the Initial Territory.

“Regulatory Authority” shall mean, in respect of any country, any agency responsible for the
issuance of Regulatory Approvals for pharmaceutical products marketed in that country.

“SPI and/or RTU” shall mean both SPI and RTU jointly or, either SPI or RTU as decided mutually
between SPI and RTU.

“Supply and Purchase Agreement” shall have the meaning set forth in Article 2.

“Takeda Affiliates” shall mean those Affiliates of Takeda listed on Exhibit B; provided that
Exhibit B may be modified from time to time during the term of this Agreement by mutual

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written agreement of SPI and Takeda.

“TPDHC” shall mean the Therapeutic Products Directorate of Health Canada.

1.2 Other Rules of Interpretation. Unless the context clearly indicates otherwise,
the following rules shall govern the interpretation of this Agreement:

          (a) The definitions of all terms defined herein shall apply equally to the singular, plural,
and possessive forms of such terms.

          (b) All references to “Sections,” or “Exhibits” shall mean the corresponding Sections of and
Exhibits to this Agreement.

Article 2 ACKNOWLEDGEMENTS

     RTU hereby acknowledges that SPI and Takeda have agreed to enter into the Collaboration and
License Agreement for the Product as of the date hereof in which Takeda has obtained from SPI an
exclusive license to co-develop, use, sell, promote, offer for sale, import and distribute the
Product for the Initial Indications in the Initial Territories.

     Takeda hereby acknowledges that SPI has appointed RTU, under the exclusive manufacturing and
supply agreement by and between SPI and RTU (the “Manufacturing and Supply Agreement”), as the
exclusive contract manufacturer to manufacture and supply the Product for clinical and commercial
purposes for the Initial Indications in the Initial Territory, provided, however, that SPI retains
the license to manufacture the Product in the Initial Territory. Further, Takeda hereby
acknowledges and agrees that neither it, Takeda Affiliates nor its sub-licensee(s) are granted any
right or license to manufacture the Product under the Collaboration and License Agreement.

     The Parties further acknowledge and agree that the Parties shall enter into a definitive
supply and purchase agreement (the “Supply and Purchase Agreement”) among SPI, Takeda (or, if
applicable, Takeda Affiliates or its sub-licensee(s)) and RTU for the purpose of determining more
detailed terms and conditions for the manufacturing and supply of the Product to Takeda, or if
applicable, Takeda Affiliates or its sub-licensee(s), including, but not limited to: the
Manufacturing Specification, ordering processes, supply of forecast requirements,
acceptance/rejection of the Product, provision regarding cGMP inspection, and any other terms and
conditions not covered by this Agreement. The Parties shall discuss in good faith the above terms
and conditions and to execute Manufacturing and Supply Agreement as soon as practicable after the
execution of this Agreement. The Parties acknowledge and agree that SPI may allow RTU to directly
supply the Product to Takeda, or if applicable, Takeda Affiliates or its sub-licensee(s) under such
Supply and Purchase Agreement.

Article 3 SUPPLY PRICE OF THE PRODUCT

     Under the Supply and Purchase Agreement to be separately established among SPI, Takeda and RTU
pursuant to Article 2, SPI shall supply Takeda, or if applicable, Takeda Affiliates or its
sub-licensee(s) with the Product at the following supply prices:

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     (a) Until the earlier of (i) the [**] anniversary of the first Commercial Launch by Takeda, or
if applicable, Takeda Affiliates or its sub-licensee(s) of any Product for the Initial Indications
in the Initial Territory or (ii) such time as the cumulative quantity of the Product supplied to
Takeda, or if applicable, Takeda Affiliates or its sub-licensee(s) for commercial purposes (but
excluding samples of the Product for promotion and samples of the Product for the Development)
reaches [**] capsules, the supply price for the Product payable by Takeda, or if applicable, Takeda
Affiliates or its sub-licensee(s) shall be the following:

          (i) US$[**] of the total quantity and JPY equivalent of US$[**] using the Exchange Rate for
the remaining [**] of the total quantity in case NDA approval for the Product is for BID (i.e.,
[**] intake per day) only;

          (ii) US$[**] of the total quantity and JPY equivalent of US$[**] using the Exchange Rate for
the remaining [**] of the total quantity in case NDA approval for the Product is for QD (i.e., [**]
intake per day); and

          (iii) such price as shall be determined within the ranges of US$[**] and US$[**] of the total
quantity and of JPY equivalent of thus determined price using the Exchange Rate for the remaining
[**] of the total quantity, taking into due consideration the ratio of BID and QD supplied to
Takeda (or, if applicable, Takeda Affiliates or its sub-licensee(s)) hereunder and/or under the
Supply and Purchase Agreement, in case that NDA approvals for the Product are for both BID and QD.

     (b) Immediately after the earlier of (i) the [**] anniversary of the first Commercial Launch
by Takeda, or if applicable, Takeda Affiliates or its sub-licensee(s) of any Product for the
Initial Indications in the Initial Territory or (ii) such time as the cumulative quantity of the
Product supplied to Takeda, or if applicable, Takeda Affiliates, or its sub-licensee(s) for
commercial purposes (but excluding samples of the Product for promotion and samples of the Product
for the Development) reaches [**] capsules, the supply price shall be [**] percent ([**]%) of the
Net Sales Revenue of the Product, provided, however, that, if only QD dosage (and nothing else) is
Commercialized for the Initial Indications, then the supply price for the Product payable by
Takeda, or if applicable, Takeda Affiliates or its sub-licensee(s) shall not exceed US$[**]. In
case there is a significant change in economic conditions beyond reasonable expectation and
assumption, including those with regard to the Net Sales Revenue price of the Product, of the
Parties as of the Effective Date, the Parties shall meet and discuss in good faith about the
possibility of modifying the supply price.

     (c) Notwithstanding the above, (i) samples of the Products for Development use shall be
supplied at a price of US$[**], and (ii) samples of the Product for promotional use shall be
supplied at a price of US$[**], provided that Takeda shall pay the costs of packaging the samples
of the Product for promotional purposes.

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Article 4 PAYMENT

     The payment by Takeda to SPI for the supply of the Product shall be made as follows:

     (a) With regard to the Product supplied to Takeda at the prices set forth in Section 3(a) and
with regard to the samples of the Product for promotional purposes, the payment shall be made
against an invoice submitted to Takeda by SPI, within [**] from the date of receipt of such
invoice.

     (b) With regard to the Product supplied to Takeda at the prices set forth in Section 3(b),
Takeda shall pay to SPI a provisional price to be mutually and separately agreed upon by SPI and
Takeda on a monthly basis, and, once every calendar quarter, SPI and Takeda shall make an
adjustment between thus paid provisional price and the actual price to be paid by Takeda based on
the Net Sales Revenue received during such calendar quarter.

Article 5 SECURE OF SUPPLY

     SPI and/or RTU shall supply the entire requirement of the Product of Takeda, or if applicable
Takeda Affiliates or its sub-licensee(s) in a timely manner and shall maintain 6-month supply
inventory of the Compound and 6-month supply inventory of the intermediate product, shall also use
its Best Efforts to cause its contract manufacturer to maintain sufficient level of inventories
corresponding to the above inventory level.

Article 6 REPRESENTATIONS AND WARRANTIES

6.1 Mutual Representations. Each Party represents and warrants to the other Parties that:

     (a) Due Organization. Such Party is a corporation duly organized, validly existing
and is in good standing under the laws of the jurisdiction of its incorporation and is qualified to
do business in each jurisdiction in which the conduct of its business or the ownership of its
properties requires such qualification and failure to have such would prevent it from performing
its obligations under this Agreement.

     (b) Due Execution. The execution, delivery and performance by such Party of this
Agreement have been duly authorized by all necessary corporate action and do not and will not (i)
require any consent or approval of its stockholders; (ii) violate any provision of any law, rule,
regulation, order, writ, judgment, injunction, decree, determination or award presently in effect
having applicability to it or any provision of its charter or bylaws; or (iii) conflict with or
constitute a default under any other agreement to which such Party is a party.

     (c) Binding Agreement. This Agreement is a legal, valid and binding obligation of
such Party, enforceable against it in accordance with the terms and conditions hereof (except as
enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or
similar laws affecting the enforcement of creditor’s rights generally, and by general principles of
equity and by limitation imposed by law and public policy on indemnification or exculpation).

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     (d) Present Authorizations. Such Party has obtained 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 otherwise perform such Party’s obligations under
this Agreement.

     (e) Conflicting Agreements. Neither such Party nor any of its Affiliates are a party
to, or are otherwise bound by, any oral or written contract that will result in any person or
entity obtaining any interest in, or that would give to any third party any right to assert any
claim in or with respect to, any of such Party’s or the other Parties rights under this Agreement
nor will either Party undertake any such obligation during the Term.

     (f) No Debarment. Neither Party will employ any personnel, and will knowingly use a
contractor or consultant, debarred (or a similar sanction) by a Regulatory Authority in the Initial
Territory, or who is subject of an FDA or TPDHC debarment investigation or proceeding (or similar
proceeding of a regulatory authority in the Initial Territory), in connection with the Development,
Commercialization or manufacturing of the Products or the Compound.

     (g) Future Authorizations. Unless expressly stated otherwise in this Agreement, all
Parties shall obtain all authorizations, consent and approvals, government or otherwise, necessary
for such Party to perform its obligations under this Agreement.

     (h) Product Liability Insurance. Each Party shall use its Best Efforts to purchase
product liability insurance which sufficiently covers the possible damages and losses of such
Party.

6.2 Additional Representations by SPI and RTU. SPI and RTU jointly and severally represent
and warrant to Takeda that:

     (a) Shelf Life. Products manufactured or supplied by SPI and/or RTU shall have an
approved shelf life at the date of dispatch from a manufacturing facility;

     (b) Defects. Products shall be free from defects in materials and workmanship, and
shall not be adulterated or misbranded and is not an article which may not be introduced into
interstate commerce;

     (c) Manufacturing Specifications. Products shall be manufactured and supplied in
accordance with the Manufacturing Specifications and Applicable Regulations;

     (d) Compliance with Applicable Regulations. The ownership and operation of the
manufacturing facilities of the Product shall be in material compliance with Applicable
Regulations; and

     (e) Infringement. As of the Effective Date, to SPI’s or RTU’s knowledge, the
manufacture and supply of the Products for promotion and sale in the Initial Territory does not
infringe any third party patents or proprietary rights.

     (f) Commercial Feasibility. As of the Effective Date, to SPI’s or RTU’s knowledge,
the scale up to commercial supply of Product in accordance with this Agreement and/or the Supply
and Purchase Agreement is commercially feasible.

     (g) Disclosure. SPI and/or RTU have provided and shall provide to Takeda all

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pertinent information in their possession relative to physical, environmental and human health
hazards involving the Compound and/or the Product.

     (h) No Debarred Individuals. As of the Effective Date, SPI and/or RTU
have not employed and, to their knowledge, have not used a contractor or consultant that has
employed, any individual or entity debarred by the U.S. or TPDHC, or, to the knowledge of SPI
and/or RTU, any individual who or entity which is the subject of a debarment investigation or
proceeding (or similar proceeding) of the FDA or TPDHC.

6.3 Takeda Warranties. Takeda hereby represents and warrants to SPI and RTU that:

     (a) Affiliate and sub-licensee Compliance. All Takeda Affiliates and sub-licensee(s)
who obtain a sublicense as permitted hereunder will comply with the terms of this Agreement in
connection, and Takeda shall remain responsible for and be a guarantor of the compliance of all
Takeda Affiliates and sub-licensee(s).

     (b) Maximizing Net Sales Revenue. Takeda shall use its Best Efforts to maximize the
Net Sales Revenue for the Products in the Initial Territory.

     (c) No Debarred Individuals. As of the Effective Date, Takeda has not employed and,
to its knowledge, has not used a contractor or consultant that has employed, any individual or
entity debarred by the U.S. or TPDHC, or, to the knowledge of Takeda, any individual who or entity
which is the subject of a debarment investigation or proceeding (or similar proceeding) of the FDA
or TPDHC.

Article 7 INDEMNIFICATION

     7.1 Indemnification by Takeda. Takeda shall indemnify, defend and hold harmless SPI
and RTU from and against any and all liabilities, damages, losses, costs or expenses (including
reasonable attorneys’ and professional fees and other expenses of litigation and/or arbitration)
(the “Liability”) resulting from a claim, suit or proceeding made or brought by a third party
against SPI, RTU or its Affiliates arising from or occurring as a result of (i) any breach of the
representations and warranties made by Takeda (and, if applicable Takeda Affiliates or its
sub-licensee(s)) in Article 6; (ii) negligence of Takeda (and, if applicable, Takeda Affiliates or
its sub-licensee(s)) in conducting any research, development, if conducted by Takeda, Takeda
Affiliates or its sub-licensee(s), testing, importation, use, offer for sale, sale or other
distribution of any Product by Takeda (or, if applicable Takeda Affiliates or its sub-licensee(s))
(including without limitation, product liability claims), (iii) the Commercialization by Takeda
(and, if applicable Takeda Affiliates or its sub-licensee(s)), despite SPI’s good faith proposal to
change the commercialization plan or the Commercialization because of the possible illegality of
the sales and marketing practice, or as a result of unfair practice or unfair competition which is
not within industry standard by Takeda (and, if applicable Takeda Affiliates or its
sub-licensee(s)), or (iv) failure of Takeda (and, if applicable Takeda Affiliates or its
sub-licensee(s)) to comply with any provision of this Agreement, or with any applicable laws,
regulations and/or administrative decisions relating to the Products, except in each case to the
extent caused by the negligence or willful misconduct of SPI, RTU or its Affiliates.

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     7.2 Indemnification by SPI. SPI shall indemnify, defend and hold harmless Takeda
(and, if applicable, Takeda Affiliates and its sub-licensee(s)) and RTU from any Liability
resulting from a claim, suit or proceeding made or brought by a third party against Takeda (and, if
applicable, Takeda Affiliates and its sub-licensee(s)) and/or RTU arising from or occurring as a
result of (i) any breach of the representations and warranties made by SPI in Article 6; (ii)
negligence of SPI in conducting any research, development, testing, manufacture, importation, use,
offer for sale, sale or other distribution of any Product by SPI, contract manufacturers or
sub-licensees (including without limitation, product liability claims) or (iii) failure of SPI,
contract manufacturers or sub-licenses to comply with any provision of this Agreement, or with any
applicable laws, regulations and/or administrative decisions relating to the Products, except in
each case to the extent caused by the negligence or willful misconduct of Takeda, Takeda
Affiliates, its sub-licensee(s) or RTU.

     7.3 Indemnification by RTU. Notwithstanding anything contained in Section 7.1 and
7.2, RTU shall indemnify, defend and hold harmless SPI and Takeda (and, if applicable, Takeda
Affiliates and its sub-licensee(s)) from any Liability resulting from a claim, suit or proceeding
made or brought by a third party against SPI and/or Takeda (and, if applicable, Takeda Affiliates
and its sub-licensee(s)) arising from or occurring as a result of (a) any breach of the
representations and warranties made by RTU in Article 6; or (b) any manufacture of any Product by
RTU (including without limitation, product liability claims arising from a manufacturing defect of
the Product), except in each case to the extent caused by the actions or inactions of SPI, Takeda,
Takeda Affiliates or its sub-licensee(s). In the event of recall of the Product due to
manufacturing defect of the Product, the cost and expenses for the recall shall be borne by RTU.

     7.4 The matters not covered by any of Section 7.1, 7.2 or 7.3. If a product liability
claim is made or brought by a third party against either or both Parties but is not covered by
Section 7.1, 7.2 or 7.3, the SPI and Takeda (or, if applicable, Takeda Affiliates or its
sub-licensee(s)) shall share any damage, loss and cost incurred by either or both Parties in
connection with such product liability claim, in accordance with the Collaboration and License
Agreement.

     7.5 Indemnification Process. In the event that any Party (the “Indemnified Party”)
intends to claim indemnification against any other Party hereto (the “Indemnifying Party”) under
this Article 7, it shall promptly notify the Indemnifying Party in writing of such alleged claim in
reasonable details. The Indemnifying Party shall have the sole right to control the defense and
settlement thereof. The Indemnified Party shall cooperate with the Indemnifying Party and its
legal representatives in the investigation of the Liability subject to the alleged claim covered by
this Article 7. The Indemnified Party shall not, except at its own cost, voluntarily make any
payment or incur any expense with respect to any claim or suit without the prior written consent of
the Indemnifying Party, which the Indemnifying Party shall not be required to give. In addition,
the Indemnifying Party shall be subrogated to the rights of the Indemnified Party against any third
party, and such Indemnified Party hereby assigns to the Indemnifying Party all claims, causes of
action and other rights which the Indemnified Party may then have against any third party,
including Affiliates and sublicensees and, in the case of SPI, against any contract manufacturer of
Product, with respect to the claim, suit or proceeding. Conversely, and without in any way
limiting the obligation of either Party to indemnify the other Party (or Parties) as

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herein provided, to the extent that any Party fails to perform its indemnification obligations
under this Article 7, such Party owing a duty of indemnification hereby assigns to the other Party
all claims, cause of action and other rights which the Party owing such duty may then have against
any third party, including Affiliates and sublicensees and, in the case of SPI and/or RTU, against
any contract manufacturer of the Compound, Product and any intermediate product thereof, with
respect to the claim, suit or proceeding. For the avoidance of doubt, in relation to the
indemnification, SPI and RTU shall be jointly and severally responsible to Takeda.

Article 8 CONFIDENTIALITY

     8.1 Non-Use and Non-Disclosure. Each Party acknowledges and agrees that all the other
Party’s Confidential Information is confidential and proprietary to the disclosing Party. Each
Party shall not use or disclose to any third party the other Party’s Confidential Information for
any purpose other than as permitted or required hereunder. Each Party shall take the same
reasonable measures necessary to prevent any disclosure by its employees, agents, contractors, or
consultants of the other Party’s Confidential Information as it applies to the protection of its
own Confidential Information.

     8.2 Exclusions. Information shall not be considered Confidential Information
hereunder if it:

          (a) was already in the possession of the receiving Party prior to its receipt from the
disclosing Party, as shown by the receiving Party’s books and records;

          (b) is, or becomes, part of the public knowledge or literature through no fault, act or
omission of the receiving Party, provided, Proprietary Product Information shall not be deemed to
have entered the public domain by reason of its having been filed with any Regulatory Authority;

          (c) is, or becomes, available to the receiving Party from a source other than the disclosing
Party, which source has rightfully obtained the same information and has no obligation of
confidentiality to the disclosing Party with respect to it;

          (d) is made available on an unrestricted basis by the disclosing Party to a third party
unaffiliated with the disclosing Party; or

          (e) is required to be revealed pursuant to law, provided, however, the receiving Party which
is under any such requirement of law shall give reasonable notice to the disclosing Party of such
requirement and shall cooperate with the disclosing Party in reasonable legal efforts to limit or
mitigate any such revelation so as to preserve the proprietary nature of any Confidential
Information contained therein.

     8.3 Authorized Disclosures. Each Party may disclose Confidential Information
hereunder to the extent such disclosure is reasonably necessary in filing or prosecuting patent
applications, prosecuting or defending litigation, complying with applicable governmental
regulations, obtaining financing from third parties or conducting pre-clinical or clinical trials,
provided that if a Party is required by law or regulation to make any such disclosures of the other
Party’s Confidential Information it will, except where impracticable for necessary disclosures,

-12-

 

for example in the event of medical emergency, give reasonable advance notice to the other
Party of such disclosure requirement and, except to the extent inappropriate in the case of patent
applications, will use its reasonable efforts to secure confidential treatment of such Confidential
Information required to be disclosed. In addition, and with prior notice to the other Party of
each third party with whom a confidential disclosure agreement is being entered into, each Party
shall be entitled to disclose, under a binder of confidentiality containing provisions as
protective as those of this Article 8 to any third party for the purpose of carrying out the
purposes of this Agreement

     8.4 Duration; Surviving Obligation. Each Party’s obligations of non-use and
non-disclosure of the other Party’s Confidential Information shall apply during the term of this
Agreement and shall also survive for a period of ten (10) years after its termination for any
reason, provided, however, that this Agreement is terminated earlier than the term set forth in
Section 10.1, each Party’s obligations shall survive ten (10) years after the expiration of the
last valid Licensed Patent.

Article 9 FORCE MAJEURE

     9.1 Notice. A Party affected by an event of Force Majeure shall promptly provide the
other Parties with written notice describing the event, its cause and foreseeable duration, and its
possible consequences upon performance under this Agreement.

     9.2 Suspension of Performance. After an affected Party has given notice under Section
9.1, that Party shall be relieved of any liability under this Agreement, except for the obligation
to pay amounts due and owing, but only to the extent and only for so long as the Force Majeure
prevents performance, provided, however, that the Party so affected shall use reasonable efforts to
avoid or remove such causes on non performance. The other Parties may likewise suspend the
performance of all or part of its obligations, except for the obligation to pay any amounts due and
owing, to the extent that such suspension is commercially reasonable.

     9.3 Termination. If the period of Force Majeure continues for more than one (1) year,
the Parties shall meet and discuss whether the Agreement shall be amended or terminated.

Article 10 TERM AND TERMINATION.

     (a) The term of this Agreement shall commence on the Effective Date and shall continue in full
force and effect until December 31, 2020. RTU hereby acknowledges and accepts that this Agreement
may be terminated earlier than said termination date in case Collaboration and License Agreement
terminates, in that case which SPI and Takeda shall use commercially reasonable effort to give RTU
a prior notice about such early termination. RTU shall accept such early termination upon
receiving the notice from SPI and Takeda.

     (b) The Parties’ respective rights and obligations under Article 4 (Payment), 7
(Indemnification), 11 (Limitation of Liability), 12 (Dispute Resolution) and 13 (Miscellaneous)
shall survive termination or expiration of this Agreement. The Parties’ respective rights and
obligations under Article 8 (Confidentiality) shall survive termination or expiration of this
Agreement for the period stated therein.

-13-

 

Article 11 LIMITATION OF LIABILITY

     EXCEPT FOR ANY BREACH OF ARTICLE 8 (CONFIDENTIALITY), IN NO EVENT SHALL EITHER PARTY BE LIABLE
TO THE OTHER PARTIES HEREUNDER FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR
SIMILAR LOSSES OR DAMAGES, EVEN IF SUCH PARTIES SHALL HAVE BEEN ADVISED IN ADVANCE OF THE
POSSIBILITY OF SUCH POTENTIAL LOSS OR DAMAGE. IN ADDITION, SPI AND ITS AFFILIATES SHALL NOT BE
LIABLE TO TAKEDA AND RTU IN THE EVENT THAT AN NDA IS NEVER ISSUED OR GRANTED OR NET SALES REVENUE
ARE NEVER ACHIEVED.

Article 12 DISPUTE RESOLUTION

     12.1 Negotiation. The Parties agree to consult and negotiate in good faith to try to
resolve any dispute, controversy or claim that arises out of or relates to this Agreement. Except
as provided in Section 12.2, no formal dispute resolution shall be used by either Party unless and
until the Chief Officer of each Party shall have attempted to meet in person to achieve such an
amicable resolution.

     12.2 Reservation for Litigation. Notwithstanding Section 12.3 below, each Party
expressly reserves the right to seek judicial relief from a court of competent jurisdiction if the
other Party is or appears to be in violation of such other Party’s obligations of non-use and
non-disclosure under Article 8 above, including, without limitation, any injunction or other
preliminary relief; PROVIDED, HOWEVER, THAT EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY WAIVES
ANY RIGHTS THAT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION UNDER THIS SECTION
12.2.

     12.3 Arbitration. Subject to the reservation of the Parties under Section 12.2
above, any dispute, controversy or claim that arises out of or relates to this Agreement that is
not resolved between or among the Parties hereto under Section 12.1 shall be settled by final and
binding arbitration in accordance with the Rules of Arbitration of the International Chamber of
Commerce (“ICC”) in effect on the Effective Date, as modified by Section 12.4 below. Judgment upon
the award rendered by the arbitrators may be entered in any court of competent jurisdiction. The
place of arbitration shall be New York, New York, U.S.A. The arbitration shall be conducted in the
English language by three (3) neutral arbitrators selected as follows: (i) if the arbitration is
held between two (2) of the Parties, one (1) of the arbitrators will be selected by one (1) of the
relevant two (2) Parties, one of the arbitrators will be selected by the remaining one (1) of the
relevant two(2) Parties, and the other will be selected by mutual agreement of the two(2)
arbitrators thus selected by the relevant two (2) Parties or, if that is not possible within thirty
(30) days of the initial demand for such arbitration, by the ICC; and (ii) if the arbitration is
held among all of the Parties, one (1) of the arbitrators will be selected by SPI and RTU, one of
the arbitrators will be selected by Takeda, and the other will be selected by mutual agreement of
the two(2) arbitrators thus selected by the Parties or, if that is not possible within thirty (30)
days of the initial demand for such arbitration, by the ICC. At least one (1) arbitrator shall
have knowledge of and experience in the pharmaceutical industry, and at least one (1) arbitrator
shall have knowledge of and experience in international law and technology licensing.
Notwithstanding anything to the contrary contained herein, if an arbitration is held only between

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two (2) of the Parties, the rights and obligations of the remaining one (1) Party under this
Agreement and/or Supply and Purchase Agreement shall not be modified, changed or influenced in any
way.

     12.4 Special Rules. Notwithstanding any provision to the contrary in the Rules of
Arbitration of the “ICC”, the Parties hereby stipulate that any arbitration hereunder shall be
subject to the following special rules: (a) the arbitrators may not award or assess punitive
damages against either Party; and (b) relevant Parties among SPI, Takeda and/or RTU shall bear
their own costs and expenses of the arbitration and shall equally share the fees and costs of the
arbitrators, subject to the power of the arbitrators, in their sole discretion, to award all such
reasonable costs, expenses and fees to the prevailing Party (or Parties).

     12.5 Survival. The duty of the Parties to arbitrate any dispute, controversy or
claim under this Article 12 shall survive the termination of this Agreement for any reason.

Article 13 MISCELLANEOUS

     13.1 Entire Agreement. This Agreement, including Exhibits attached hereto and
incorporated as an integral part of this Agreement constitute the entire agreement of the Parties
with respect to the subject matter hereof, and supersede all previous agreements by and among the
Parties as well as all proposals, oral or written, and all prior or contemporaneous negotiations,
conversations or discussions among the Parties related to this Agreement.

     13.2 Relationship. The Parties are independent contractors and shall not be deemed to
have formed any partnership, joint venture or other relationship. Neither Party shall make, or
represent to any other person that it has the power or authority to make, any financial or other
commitment on behalf of the other Party.

     13.3 Assignment. Neither Party shall have the right to assign or otherwise transfer
its rights and obligations under this Agreement except with the prior written consent of the other
Party. This Agreement shall inure to the benefit of the Parties hereto and any permitted
assignees. Any prohibited assignment shall be null and void.

     13.4 Notices; Language. Except as may be otherwise provided in this Agreement, any
notice, demand or request given, made or required to be made shall be in writing and shall be
effective, unless otherwise provided herein, when received after delivery by (a) registered air
mail, postage prepaid; (b) facsimile with electronic confirmation of receipt; or (c) a reputable
international courier such as Federal Express or DHL at the addresses set forth below or to any
other address that a Party specifies pursuant hereto. All reports, notices and communications
required or permitted hereunder shall be in the English language.

	 	 	 	 	 
	 

	 	If to Takeda:
	 	Takeda Pharmaceutical Company Limited.
	 

	 	 	 	1-1, Doshomachi 4-chome
	 

	 	 	 	Chuo-ku, Osaka 540-8645 Japan

-15-

 

	 	 	 	 	 
	 

	 	 	 	Facsimile: 81-6-6204-2328
	 

	 	 	 	Attention: General Manager, Licensing Department
	 
	 	 	 	 
	 

	 	If to SPI:
	 	Sucampo Pharmaceuticals, Inc.
	 

	 	 	 	4733 Bethesda Avenue, Suite 450
	 

	 	 	 	Bethesda, Maryland 20814
	 

	 	 	 	United States
	 
	 	 	 	 
	 

	 	 	 	Facsimile: 1-301-961-3440
	 

	 	 	 	Attention: Dr. Sachiko Kuno, Chief Executive Officer
	 
	 	 	 	 
	 

	 	If to RTU:
	 	R-Tech Ueno, Ltd.
	 

	 	 	 	10F Yamato Life Insurance Bldg.,
	 

	 	 	 	1-1-7 Uchisaiwaicho
	 

	 	 	 	Chiyoda-ku, Tokyo 100-0011 Japan
	 
	 	 	 	 
	 

	 	 	 	Facsimile: 81-3-3596-8023
	 

	 	 	 	Attention: Ms. Yukiko Hashitera, Representative Director

     13.5 Governing Law. This Agreement shall be governed by, and interpreted and
construed in accordance with, the law of the State of New York, USA, excluding its choice of law
rules and the U.N. Convention on the International Sale of Goods.

     13.6 Amendment. This Agreement may not be modified or amended, in whole or in part,
except by written agreement signed by all the Parties hereto.

     13.7 Severability. If one or more of the provisions of this Agreement is subsequently
declared invalid or unenforceable, this Agreement shall be treated as though that provision were
not in this Agreement, and this shall not affect the validity or enforceability of the remaining
provisions of this Agreement (unless those provisions that are invalidated or unenforceable are
clearly material and inseparable from the other provisions). The Agreement as modified shall be
applied and construed to reflect substantially the good faith intent of the Parties and to achieve
the economic effects originally intended by the terms hereof.

     13.8 Counterparts. This Agreement shall be executed in three or more counterparts,
and each such counterpart shall be deemed an original hereof.

     13.9 Waiver. No failure by either Party to take any action or assert any right
hereunder shall be deemed to be a waiver of such right in the event of the continuation or
repetition of the circumstances giving rise to such right.

     13.10 No limitation of damages. No payments or agreements to pay under this Agreement
shall in any way preclude or limit the rights of either Party to seek the full recovery of its
damages (subject to the limitations stated in this Agreement), or to seek equitable relief, for
breach of this Agreement by the other Party.

     13.11 License Status in Bankruptcy. All rights and licensed granted under or

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pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the United States Bankruptcy Code (“the Bankruptcy Code”), licenses of any rights
to “intellectual property” as that term is defined under Section 101(35A) of the Bankruptcy Code.
Upon the bankruptcy of any Party or Affiliate thereof, the non-bankrupt Party shall further be
entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual
property and all embodiments thereof, and the same, if not already in its possession, shall be
promptly delivered to the non-bankrupt Party upon written request therefor, unless the bankrupt
Party elects to continue, and continues, to perform all of its obligations under this Agreement.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the day first above
written,

	 	 	 	 	 	 	 	 	 
	Takeda Pharmaceutical Company Limited	 	 	 	Sucampo Pharmaceuticals, Inc.
	 
	 	 	 	 	 	 	 	 
	By

	 	/s/ Yasuchika Hasegawa
	 	 	 	By
	 	/s/ Sachiko Kuno
	 

	 	 
	 	 	 	 	 	 
	Name:

	 	Yasuchika Hasegawa
	 	 	 	Name:
	 	Sachiko Kuno, PhD
	Title:

	 	President and Chief Operating Officer
	 	 	 	Title:
	 	President and Chief Executive Officer
	 
	 	 	 	 	 	 	 	 
	R-Tech Ueno, Ltd.	 	 	 	 	 	 
	 
	By

	 	/s/ Mitsunaga Tada	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 
	Name:

	 	Mitsunaga Tada	 	 	 	 	 	 
	Title:

	 	President and Representative Director	 	 	 	 	 	 

-17-

 

EXHIBITS

	A.	 	Description of Compound
	 
	B.	 	Takeda Affiliate

-18-

 

EXHIBIT A

Description of Compound

	 	 	 
	Generic Name:

	 	lubiprostone
	 
	Chemical Names:

	 	[**]
	 
	Code Name:

	 	SPI-0211
	 
	CAS No:

	 	136790-76-6

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EXHIBIT B

Takeda Affiliate

Takeda Pharmaceuticals North America, Inc.

-20-exv10w24

 

Confidential
Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

Exhibit 10.24

SUPPLY AND PURCHASE AGREEMENT

THIS SUPPLY AND PURCHASE AGREEMENT is made as of January 25, 2006, by and among Sucampo
Pharmaceuticals, Inc., a Delaware corporation having its principal place of business at 4733
Bethesda Avenue, Suite 450, Bethesda, Maryland 20814 USA (“SPI”), Takeda Pharmaceutical Company
Limited, a corporation organized under the laws of Japan having its principal place of business at
1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645, JAPAN (“Takeda”) and R-Tech Ueno, Ltd., a
corporation organized under the laws of Japan having its principal place of business at 10F, Yamato
Life Insurance Bldg., 1-1-7 Uchisaiwaicho, Chiyoda-ku, Tokyo 100-0011, JAPAN (“RTU”) (this
“Agreement”). SPI, Takeda and RTU are sometimes referred to herein individually as a “Party” and
collectively as the “Parties.”

Recitals

WHEREAS, Takeda has obtained from SPI an exclusive license to co-develop, use, sell, promote, offer
for sale, import and distribute the Product (hereinafter defined) for the gastroenterology
indications in the United States and Canada under a collaboration and license agreement as of
October 29, 2004 (the “Collaboration and License Agreement”) and Takeda has the right to execute
its rights and duties under the Collaboration and License Agreement through Takeda Affiliates
and/or its sublicensees;

WHEREAS, SPI, Takeda and RTU have entered into a supply agreement as of October 29, 2004 (the
“Supply Agreement”) pursuant to which the Parties acknowledged and agreed (i) Takeda has the right
to execute its rights and duties under the Supply Agreement through Takeda Affiliates and/or its
sublicensees and (ii) to enter into a definitive supply and purchase agreement for the purpose of
determining more detailed terms and conditions for the manufacturing and supply of the Product to
Takeda;

NOW THEREFORE, in consideration of the premises and the mutual covenants hereinafter set forth, the
Parties hereto have agreed as follows:

Article 1 INTRODUCTORY PROVISIONS

1.1 Defined Terms. The following terms, when used in capitalized form in this
Agreement, shall have the meanings assigned to them in this Article. The terms when used in
capitalized form in this Agreement and not defined in this Agreement shall have the same meanings
as defined in the Supply Agreement.

“Binding Forecasts” shall have the meaning ascribed to such term in Section 6.2 hereof.

“JPY Equivalent” shall mean JPY one hundred seven point ninety-two (107.92).

“Manufacturing” means the compounding, component preparation, testing, and other procedures, or any
part thereof, involved in manufacturing the Products in accordance with

1

 

the Manufacturing Specifications. The terms “Manufacture,” “Manufactured” and “Manufacturing” in
this Agreement shall have the identical meaning.

“Manufacturing Specification(s)” shall mean the commercial specification for the manufacturing,
quality control, packaging, labeling, shipping, delivery and storage of the Product and Samples to
be agreed upon between the Parties but which at least satisfies specifications approved by FDA and
TPDHC.

“Non-Conformity/Non-Conforming” shall have the meaning ascribed to such term in Section 7.1 hereof.

“Packaging” means the procedures of filling, inspecting, labeling, packaging and packing of the
Products or any part thereof in accordance with the Manufacturing Specifications. The terms
“Package,” “Packaged” and “Packaging” in this Agreement shall have the identical meaning.

“Product” shall mean any and all pharmaceutical preparations for human use that contains the
Compound, a chemical equivalent, a salt, or a prodrug thereof as an active ingredient, in finished
package form suitable for distribution to end users.

“RTU Contractor” shall mean a third party under contract with RTU in accordance with Section 2.3 of
this Agreement to conduct any portion of Manufacturing and/or Packaging for which RTU is
responsible under this Agreement.

“Sample(s)” shall mean the samples of the Product for promotional use.

Article 2 SUPPLY AND PURCHASE OBLIGATIONS OF THE PARTIES

2.1 Supply and Purchase Obligations. During the term of this Agreement, Takeda agrees to
purchase all its demand on the Product exclusively from RTU, Takeda’s requirements for the Product
and Samples for the Initial Territory in accordance with the terms and conditions set forth in this
Agreement.

2.2 Product. Subject to the terms and conditions of this Agreement, RTU shall Manufacture,
Package and supply Takeda with entire requirement of the Product and Samples of Takeda, or if
applicable Takeda Affiliates or its sub-licensee(s), in a timely manner according to forecasted
demands of Takeda in the Initial Territory. Except as provided in Article 8, Takeda agrees to
purchase its requirements for the Product and Samples exclusively from RTU at the prices described
in Article 3.

2.3 Subcontracts. RTU shall be responsible for Manufacturing and Packaging the Product and
Sample at RTU’s own premises or by use of contractors selected by RTU. Any and all RTU Contractors
shall have sufficient knowledge and expertise to carry out the Manufacture and/or Packaging, as the
case may be, of the Product and Samples and sufficient capacity to meet the requirements of Takeda
for the Product and Samples. Any such Manufacturing and/or Packaging by an RTU Contractor,
however, shall not relieve RTU from

2

 

any of its obligations or covenants under this Agreement and/or the Supply Agreement. RTU shall
inform Takeda and SPI of its contractor promptly after RTU’s appointment of its contractor.

2.4 Development Product. The Parties acknowledge that any Product to be used in connection
with the conduct of clinical studies shall be provided to Takeda pursuant to the Collaboration and
License Agreement.

Article 3 PRICE AND PAYMENT

3.1 Price for Product. The prices for the Manufacture, Packaging and supply of Product
shall be:

     (a) the prices set forth in subsections 3.1(a)(i), (ii) and(iii), as applicable, until the
earlier of (i) the [**] anniversary of the first Commercial Launch by Takeda (or, if applicable,
Takeda Affiliates or its sub-licensee(s)) of any Product for the Initial Indications in the Initial
Territory, or (ii) such time as the cumulative quantity of the Product (other than Samples and
Product used for clinical studies) supplied to Takeda (or, if applicable, Takeda Affiliates or its
sub-licensee(s)) reaches [**] capsules.

          (i) in the event NDA approval for the Product provides for BID dosing (i.e., intake twice
daily) only, US$[**] (or US$[**] per capsule) for [**] of the total quantity of Product purchased
by Takeda and JPY Equivalent of US$[**] (or US$[**] per capsule) for the remaining [**] of such
total quantity;

          (ii) in the event NDA approval for the Product provides for QD dosing (i.e., intake once
daily) only, US$[**] (or US$[**] per capsule) for [**] of the total quantity of Product purchased
by Takeda and JPY Equivalent of US$[**] (or US$[**] per capsule) for the remaining [**] of such
total quantity; and

          (iii) in the event NDA approval for the Product provides for both BID and QD dosing, then the
price shall be determined by mutual agreement of the Parties (based on the ratio of BID and QD
supplied to Takeda (or, if applicable, Takeda Affiliates or its sub-licensee(s)) within the range
of US$[**] and US$[**] for [**] of the total quantity of Product purchased by Takeda and the JPY
Equivalent of such determined price for the remaining [**] of such total quantity.

     (b) the price set forth in this subsection 3.1(b) after the earlier of (i) the [**]
anniversary of the first Commercial Launch by Takeda (or, if applicable, Takeda Affiliates or its
sub-licensee(s)) of any Product for the Initial Indications in the Initial Territory, or (ii) such
time as the cumulative quantity of the Product (other than Samples and Product used for clinical
studies) supplied to Takeda (or, if applicable, Takeda Affiliates or its sub-licensee(s)) reaches
[**] capsules. Immediately following the occurrence of the applicable triggering event described
in the prior sentence, the price shall be [**] percent ([**]%) of the Net Sales Revenue of the
Product; provided, however, if only the QD dosage form (and nothing else) is Commercialized for the
Initial Indications, then the price shall not exceed US$[**] (or US$[**] per capsule). In case
there is a significant change in economic conditions beyond

3

 

the reasonable expectation and assumption, including those with regard to the Net Sales Revenue
price of the Product, of the Parties as of the Effective Date, the Parties shall meet and discuss
in good faith about the possibility of modifying such price.

3.2 Price for Samples.

     (a) The price for the Manufacturing and supply of Samples shall be US$[**], excluding
Packaging costs. Takeda shall pay all reasonable direct costs (excluding any mark up) to Package
the Samples.

     (b) RTU shall keep complete and accurate records of its Packaging costs for Sample in
accordance with generally accepted accounting principles in Japan. Such records shall be
maintained by RTU for a period of five (5) years. Not more frequently than once each year, Takeda,
at its expense, shall have the right to conduct an examination or audit of said records of RTU in
order to verify that amounts paid to RTU for Samples hereunder are correct. RTU shall cooperate
fully with the auditor and to provide all reasonable access to records and employees necessary to
promptly complete this audit. In the event any examination or audit of the records of RTU discloses
an under- or overpayment hereunder, written notice of such fact, specifying the amount and basis of
the under- or overpayment shall promptly be furnished to both parties by the auditor. In the event
of an overpayment the amount thereof shall be credited against future amounts owed to RTU
hereunder, or if there will be no such future amounts, RTU shall refund the overpayment to Takeda
within [**] of such notice. In the event of an underpayment, Takeda shall pay the amount thereof
to RTU within [**] after such disclosure.

3.3 Payment.

     (a) RTU shall submit invoices to Takeda for each shipment of Product and/or Samples shipped to
Takeda (or, if applicable, Takeda Affiliates and/or its sublicensees). Such invoices shall be paid
by Takeda within [**] after the date the relevant invoice is received or the date of shipment,
whichever is later.

     (b) With regard to Product supplied at the price set forth in Section 3.1(b), Takeda shall pay
to RTU each month a provisional price to be mutually and separately agreed upon by SPI and Takeda
not later than [**] following the occurrence of the applicable triggering event described in
subsection 3.1(b). If the Parties are unable to reach agreement on such provisional price, then
the provisional price shall be [**]% of the Net Sales Revenue of the latest six months divided by
6. Within ninety (90) days following each calendar year beginning with the calendar year in which
the price set forth in Section 3.1(b) becomes effective, Takeda shall submit to SPI and RTU a
report stating its Net Sales Revenue for such calendar year (or for the portion of such year for
which the price set forth in Section 3.1(b) is applicable) and the amount equal to [**] percent
([**]%) of such Net Sales Revenue. If Takeda’s payments of such provisional price for such
calendar year (i) are less than [**]% of Net Sales Revenue, Takeda shall pay RTU the shortfall
within fifteen (15) days of submitting such report, or (ii) exceed [**]% of Net Sales Revenue, RTU
shall pay Takeda the excess amount within fifteen (15) days of receiving such report.

     (c) All payments hereunder shall be made as follows:

4

 

     (i) Payments for the Product whose prices are set forth in subsections 3.1(a) shall be made in
United States Dollars for [**] of the quantity of the Product purchased by Takeda and in JPY for
the remaining [**] of such total quantity whose price is calculated by using JPY Equivalent.

     (ii) Payments for the Product whose prices are set forth in subsection 3.1(b) and the Samples
shall be made in United States Dollars. The exchange rates from local currency to United States
Dollars shall be the exchange rates (buying rates of United States Dollars) at the time of each
shipment published in The Wall Street Journal (or any substitute source mutually agreed to by the
Parties).

3.4 Development Product. Pursuant to Section 4.2(b)(vii) of the Collaboration and License
Agreement, the costs for any Product and/or placebo used in connection with the conduct of clinical
studies shall be deemed to be included within Development costs and any such costs therefore shall
be paid by SPI or Takeda as provided in the Collaboration and License Agreement. The Parties
acknowledge the price [**] of such Product is U.S.$[**]. The price for any placebo [**] supplied
by RTU for use in connection with the conduct of clinical studies shall be US $[**] equal to [**]
percent ([**]%) of Product). RTU shall supply and Takeda and SPI shall purchase their entire
requirements for the Product from RTU in the standard order quantities of standard case lots (i.e.
[**] per lot). RTU shall keep the Product and placebo in appropriate condition until the Product
and placebo are required for use.

Article 4 MANUFACTURING AND QUALITY

4.1 RTU manufacturing. RTU shall be responsible for Manufacturing, Packaging, storing and
shipping the Product, Samples and placebo to be supplied to Takeda and/or SPI hereunder. The
Product, Samples and placebo shall be Manufactured, Packaged, stored and shipped in accordance with
the Manufacturing Specifications, Applicable Regulations and Market Authorizations. Each batch of
the Product, Samples and placebo shipped to Takeda and/or SPI will include (i) a certificate of
analysis confirming that the Product, Samples and/or placebo meets the then-current Manufacturing
Specifications; and (ii) a certificate of release approval stating that the Product, Samples and/or
placebo were Manufactured and/or Packaged in accordance with current good manufacturing and control
practices.

4.2 Modifications. In case RTU wishes to modify its Manufacturing or Packaging processes
and procedures and/or to change the facilities and/or site where the Product, Samples or Compound
are Manufactured and/or Packaged, RTU shall provide to Takeda and SPI in writing the information
and the reason therefore sufficiently in advance. RTU shall ensure that any such approved
modifications or changes are in compliance with Applicable Regulations and the Market
Authorizations, and that such changes do not affect the Manufacturing Specifications or do not
result in any interruption of supply of Product and Samples to Takeda and SPI (or, if applicable,
Takeda Affiliates and/or its sublicensees). If any such changes are made or are to be made that
are substantial or will require an amendment to the Market Authorizations, RTU shall be
responsible, at its expense, for obtaining any necessary or advisable amendments to the Market
Authorizations.

5

 

4.3 Quality Control and Audit.

     (a) Testing. RTU shall perform quality control tests, assays and final release
testing on Compound, Products and Samples in accordance with the Manufacturing Specifications and
Applicable Regulations. Results of such tests and assays will be submitted to Takeda and SPI
promptly upon request. Takeda shall have the right to reject any lot or batch of the Products not
later than thirty (30) days after the date on which results of the tests and assays are received if
there is any non-conformity of the results with the Manufacturing Specifications or Applicable
Regulations.

     (b) Retention Samples. RTU shall retain, for at least one (1) year after the
expiration date of the applicable lot or batch of Products, a file sample properly stored from each
lot or batch of Products Manufactured or Packaged of sufficient quantity to perform each quality
control test specified in the Manufacturing Specifications at least two (2) times.

     (c) Nonconformance. In the event a material quality issue arises at any RTU facility
or RTU Contractor facility relating to the Product or Samples, RTU shall promptly provide Takeda
and SPI written notice of such issue, its impact on the supply of Product and/or Samples, and the
corrective measures to be utilized. For purposes of this Section 4.3(c), a material quality issue
shall include: foreign product mix-up, contamination; failure to meet stability and/or release
specifications; incorrect labeling material used in Packaging; and missing or incorrect lot number
or expiration date on Packaging.

     (d) Audits. Takeda and SPI shall have the right to conduct or to have a designated
third party conduct quality assurance audits at any and all facilities (whether operated by RTU or
RTU Contractors) in the presence of RTU, where Manufacturing, Packaging, storage, testing or other
related activities are carried out on the Product and/or Samples for the purpose of verifying
conformance to the Manufacturing Specifications and Applicable Regulations in an interval of not
more than once a year in the normal course. Takeda’s, SPI’s or designated third party’s auditors
shall have the right to review any and all relevant documents related to the Product, Samples
and/or facility operations related to their Manufacturing, Packaging, storage, testing (including
without limitation test results, batch records, investigations by Regulatory Authorities) and may
take copies of relevant documents with RTU’s and, if applicable, RTU Contractor’s approval. Such
audits shall be conducted following at least thirty days (30 days) notice during normal business
hours and shall be limited to those operations that are directly related to the Compound, Product
or Samples. Not withstanding the foregoing, in the emergency situation including without limitation
the event of Product quality complaints, Takeda and SPI shall have the right to conduct such audits
on a needed basis with shorter notice and RTU shall fully cooperate with such audit.

4.4 Regulatory Inspections. In the event any Party receives a notification of inspection or
other communication (including the reporting of adverse drug experiences or field alerts) from the
Regulatory Authorities relating to the Product, or Samples and/or a facility at which they are
Manufactured, Packaged, stored or tested, the Party receiving such notice will notify the other
Parties within three (3) days. RTU, Takeda and SPI agree to notify each other in advance of any
response to agency observations. The Party so inspected or communicated

6

 

with shall provide the other Parties with a report on the outcome of the inspection or
communication.

4.5 Recalls.

     (a) Determination. If SPI or Takeda believes that a voluntary recall of a Product is
necessary, such Party shall notify and consult with the other Party within one (1) working day of
such determination, and SPI and Takeda shall cooperate in good faith to determine if such a recall
is necessary and, if so, to allow such recall to occur under the direction of the JSC. In the
event of a dispute regarding whether or not to recall a Product, the decision of the JSC shall
prevail. SPI or Takeda may recall the Product unilaterally due to an emergency, for example, (a)
relevant Regulatory Authorities instructed, recommended or suggested the recall or (b) in such
Party’s reasonable judgment, non-implementation of recall may constitute a violation of a relevant
law or regulation or (c) non-implementation of recall may court criminal or administrative
punishment under a relevant law or regulation or (d) if the mechanism under the foregoing
provisions of this Section 4.5 is not adequate to address a serious health or safety risk to
consumers.

     (b) Implementation. The conduct of any recall of the Product or Samples from the
market shall be the responsibility of RTU and/or SPI. Takeda shall fully cooperate with RTU and/or
SPI in the event of any recall, field alert or similar event and provide such assistance in
connection therewith as RTU may reasonably request.

     (c) Costs. The cost and expenses for the recall shall be borne by SPI or Takeda or
shared by both SPI and Takeda, respectively, in accordance with the same rules as provided for in
Article 10 of the Collaboration and License Agreement. In the event of recall of the Product due
to manufacturing defect of the Product, the cost and expenses for the recall shall be borne by RTU.

4.6 Product Quality Complaints and Adverse Experience Data.

     (a) Product Quality Complaints. RTU shall be responsible for handling all Product complaints.
Takeda shall forward to RTU any Product complaints received by Takeda five (5) business days after
receipt thereof and shall, at RTU’s cost, provide such assistance in investigating and resolving
such complaints as RTU may reasonably request. RTU shall notify Takeda at least once each calendar
quarter of any Product quality complaints received by RTU or RTU Contractors. RTU’s handling of
complaints shall in no way waive, modify or diminish any of its obligations under this Agreement,
the Supply Agreement or the Collaboration and License Agreement.

     (b) Adverse Experience Data. The Parties shall be responsible for reporting and investigating
Adverse Experience Data in accordance with a separate safety data exchange protocol to be mutually
agreed by SPI and Takeda.

     (c) Annual Reports. The Parties shall be responsible for filing annual safety reports with
the Regulatory Authority in accordance with a separate safety data exchange protocol to be mutually
agreed by SPI and Takeda.

7

 

Article 5 WARRANTIES

In addition to Article 6 of the Supply Agreement, Each Party represents and warrants to the other
Parties that:

5.1 RTU and SPI Warranties. RTU and SPI warrant to Takeda that:

     (a) RTU and SPI have good and marketable title to the Products and Samples delivered to Takeda
hereunder;

     (b) The Products and Samples delivered to Takeda will be Manufactured and Packaged in
compliance with Applicable Regulations and will meet the Manufacturing Specifications;

     (c) The Products and Samples delivered to Takeda will not be adulterated or misbranded within
the meaning of the United States Food, Drug and Cosmetic Act or any regulation thereunder; and

     (d) The Products and Samples delivered to Takeda do not infringe on any currently existing
United States or Canadian patents held by any person or entity.

5.2 Takeda Warranties. Takeda hereby represents and warrants to SPI and RTU that:

	 	(a)	 	Takeda will distribute the Products and Samples in compliance with Applicable
Regulations.
	 
	 	(b)	 	Takeda will not adulterate or misbrand the Products and Samples within the
meaning of the United States Food, Drug and Cosmetic Act or any regulation hereunder.

Article 6 ORDERS AND FORECASTS

6.1 Undertaking.

RTU, directly or through RTU Contractors (subject to receipt of any required approvals of
Regulatory Authorities), will Manufacture, Package and ship the Product and Samples to Takeda,
directly or, if applicable, to Takeda Affiliates and/or its sublicensees, by the delivery dates and
in the quantities specified by Takeda in purchase orders submitted in accordance with this Article
6.

6.2 Forecasts.

At least [**] prior to each calendar quarter, Takeda will provide RTU (and a copy to SPI) with a
written twenty-four (24) month rolling forecast of the quantities of Product and Samples that
Takeda expects to purchase during each of the next twenty-four (24) months (the “Rolling
Forecast”); provided, however, the first Rolling Forecast shall be attached hereto as Exhibit B.
Each Rolling Forecast shall be non-binding except for the first [**] months thereof (the “Binding
Forecast”) which shall be firm and Takeda shall purchase from RTU no less than [**] percent ([**]%)
of the quantities of the Product and the Samples contained in the Binding Forecast. RTU shall be
obliged to fill Takeda’s purchase orders for quantities of the Product and/or Samples up to [**]
percent ([**]%) of the Binding Forecast. RTU will use its commercially reasonable efforts to
supply Product and/or Samples in excess of [**] percent ([**]%) of the Binding Forecast. If, prior
to the delivery of the next Rolling

8

 

Forecast, Takeda shall have cause to revise its purchase projections, Takeda will promptly provide
RTU (and a copy to SPI) with a revised Rolling Forecast. If Takeda’s right to commercialize the
Product is terminated by reason of termination of this Agreement, the Collaboration and License
Agreement or the Supply Agreement, Takeda shall not be obligated to purchase the quantity of the
Product and/or Samples contained in the Binding Forecast.

6.3 Order Size

Takeda shall purchase its requirements for the Product and Samples from RTU in the standard order
quantities of standard case lots (i.e. [**] per lot).

6.4 Shelf life of the Product

Products, when shipped to Takeda, shall not have an expiration date of less than [**] from the date
of delivery; provided, however, that the shelf life approved by relevant Regulatory Authority is
less than [**], such period shall be its shelf life [**], but shall not be less than [**].

6.5 Purchase Orders

Takeda will purchase the Product and Samples solely by written purchase orders (including
non-verbal, electronic format), which must be consistent with Section 6.3 above. Takeda will submit
each such written firm purchase order to RTU at least [**] in advance of the date specified in each
purchase order for delivery of the Product and/or the Samples to Takeda (or, if applicable, to
Takeda Affiliates and/or its sublicensees). Such firm orders shall show clearly (i) the quantity
of the Product and/or the Samples, (ii) the delivery destination, and (iii) the required delivery
date. RTU will provide written notice to Takeda of its receipt of a specific purchase order within
five (5) business days of receipt thereof. The terms and conditions of this Agreement will be
controlling over any conflicting terms and conditions in any such purchase order, RTU’s
acknowledgement form or any other form. Notwithstanding the foregoing, RTU will use its Best
Efforts, but will not be obligated, to (i) meet any request of Takeda for delivery of the Product
or the Samples to Takeda (or, if applicable, to Takeda Affiliates and/or its sublicensees) in less
than [**] from the delivery date specified in purchase orders, and (ii) accommodate any changes
requested by Takeda in delivery schedules for the Product and the Samples following RTU’s receipt
of purchase orders from Takeda. RTU is not entitled to accept verbal orders of any kind for the
supply of the Product or the Samples hereunder.

6.6 Shipment.

The Product and Samples will be shipped to the one (1) location in the Initial Territory designated
by Takeda in its purchase orders. RTU (or RTU Contractors) shall include with each shipment a copy
of the documents required under Section 4.1, the bill of lading, and documents setting forth the
quantity of the Product and Samples shipped, sufficient to allow for an accurate count of the
quantity delivered. The Product and Samples will be shipped in accordance with DDP (INCOTERMS
2000) to the delivery destination designated by Takeda. Title to the Product and Samples shall
pass from RTU to Takeda free and clear of any security interest, other lien or encumbrance at such
time as they have been delivered to the delivery

9

 

destination designated by Takeda, and risk of loss of the Product and Samples shall pass from RTU
to Takeda in accordance with DDP term (INCOTERMS 2000).

6.7 Inventory.

In addition to Article 5 of the Supply Agreement, RTU shall maintain an adequate level of inventory
of the Product in accordance with the following:

     (a) RTU shall maintain an adequate level of inventory of the Product to meet the
requirements of Takeda as estimated in the Rolling Forecasts; provided, however, that Takeda shall
provide RTU (and a copy to SPI) with information, in such format as reasonably requested by RTU,
concerning the inventory of the Product maintained by Takeda (or, if applicable, Takeda Affiliates
and/or its sublicensees) on at least a monthly basis.

     (b) During the initial [**] period following Takeda’s initial sales launch and, if any,
launch of any Product with new therapeutic indication, respectively, RTU shall maintain, at its
expense and at a location mutually agreed by the Parties, a safety stock of both (i) Product and
(ii) Product in the form before final packaging (collectively, the “Safety Stock”). The quantity of
both (i) and (ii) mentioned above shall be at least an amount equal to the quantity for the first
[**] respectively, or, the latest [**] moving average of quantity in total of (i) and (ii) shall be
at least an amount equal to the quantity for the first [**] subject that the quantity of (i) shall
not be less than an amount equal to the quantity for the first [**] as indicated in Takeda’s most
recent Rolling Forecast. If RTU fills Takeda’s purchase orders for quantities of Product and/or
Samples in quantity larger than the Binding Forecast pursuant to Section 6.2 and consequently uses
all or part of the required level of the Safety Stock temporarily, RTU shall use its Best Efforts
to make up for the used quantity and to return the Safety Stock to the required level as soon as
possible. As soon as reasonably practicable after the execution of this Agreement, RTU shall
commence building the Safety Stock.

Article 7 INSPECTION AND REJECTION OF THE PRODUCT

7.1 Non-Conforming Product. Takeda (or, if applicable, Takeda Affiliates and/or its
sublicensees) will visually inspect each shipment of Product and Samples supplied to it (or, if
applicable, Takeda Affiliates and/or its sublicensees) hereunder to (i) determine whether such
Product and/or Samples are damaged, (ii) verify that the quantity of Product and/or Samples
delivered agrees with the invoice and other applicable documentation, and (iii) verify conformance
with the Manufacturing Specifications and Applicable Regulations by reviewing documents included in
the shipment (but Takeda shall have no obligation to test or study the contents of the Products).
If Takeda finds damage, a deficiency in the quantity of the Product and/or Samples, or
non-conformity with the Manufacturing Specifications and/or Applicable Regulations (hereafter
referred to as a “Non-Conformity” or “Non-Conforming”), Takeda will notify RTU in writing within
[**] after receipt of the applicable shipment specifying the details of such Non-Conformity. If
the Non-Conformity of the Product and/or Samples is latent and hidden such that it cannot
reasonably be found by visual inspection, then Takeda shall give notice to RTU regarding such
latent Non-Conformity within [**] after such Non-Conformity comes to the knowledge of Takeda (or,
if applicable, Takeda Affiliates and/or its sublicensees).

10

 

7.2 Replacement or Reimbursement. Upon receipt of any notice of Non-Conformity from
Takeda, RTU shall, at Takeda’s option, either (i) replace, at RTU’s cost, the quantity of such
Non-Conforming Product and/or Samples within the commercially reasonable shortest time, or (ii)
reimburse Takeda for the cost of such Non-Conforming Product and/or Samples. Takeda’s rights set
forth in this Section 7.2 shall not be exclusive of, or prejudicial to, any other rights or
remedies that Takeda may otherwise have on account of such Non-Conformity or RTU’s breach of any of
its obligations hereunder.

7.3 RTU’s Obligations. RTU shall not be subject to the obligations as set forth in this
Article 7 to the extent that any such damage, deficiency or Non-Conformity of the Product and/or
Samples is due to Takeda’s negligence after the receipt of them by Takeda.

Article 8 INABILITY TO SUPPLY

In the event that RTU (directly or through RTU Contractors) is unable for any reason to manufacture
or supply sufficient quantities of the Compound or the Product hereunder to meet Takeda’s, or if
applicable Takeda Affiliate’s and its sub-licensee(s)’s requirements for the Product and/or Samples
in excess of [**] percent ([**]%) of the Binding Forecast in any given quarter, then RTU shall
provide Takeda and SPI with immediate written notice thereof. The Parties shall negotiate in good
faith how to cope with such shortage of supply, including the purchase by RTU of the necessary
materials from third parties and the possibility of Takeda’s Manufacturing of the Product and/or
Samples.

Article 9 TERM AND TERMINATION

The term of this Agreement shall commence on the date first above written and shall continue in
full force and effect until December 31, 2020. RTU hereby acknowledges and accepts that this
Agreement may be terminated earlier than said termination date in case the Collaboration and
License Agreement or the Supply Agreement terminates, in which case SPI and Takeda shall use
commercially reasonable effort to provide RTU with a prior notice of such early termination, but in
no event shall such notice be provided later than three (3) months prior to such termination. RTU
shall accept such early termination upon receiving the notice from SPI and Takeda.

Article 10 MISCELLANEOUS

10.1 Applying the provisions of the Supply Agreement. The Parties hereby acknowledge and
agree that the Supply Agreement shall remain effective, and its terms and conditions shall remain
applicable among the Parties to the extent not particularly changed or amended by this Agreement.

10.2 Notices; Language. Except as may be otherwise provided in this Agreement, any
notice, demand or request given, made or required to be made shall be in writing and shall be
effective, unless otherwise provided herein, when received after delivery by (a) registered air
mail, postage prepaid; (b) facsimile with electronic confirmation of receipt; or (c) a reputable
international courier such as Federal Express or DHL at the addresses
set forth below or to

11

 

any other address that a Party specifies pursuant hereto. All reports, notices and communications
required or permitted hereunder shall be in the English language.

	 	 	 	 	 
	 

	 	If to Takeda:
	 	Takeda Pharmaceutical Company Limited.
	 

	 	 	 	12-10, Nihonbashi 2-chome, Chuo-ku,
	 

	 	 	 	Tokyo 103-8668, Japan
	 
	 	 	 	 
	 

	 	 	 	Facsimile: 81-3-3278-2230
	 

	 	 	 	Attention: Shinji Honda, Senior Manager,
	 

	 	 	 	US Operations, Corporate Strategy & Planning Department
	 
	 	 	 	 
	 

	 	If to SPI:
	 	Sucampo Pharmaceuticals, Inc.

4733 Bethesda Avenue, Suite 450
	 

	 	 	 	Bethesda, Maryland 20814
	 

	 	 	 	United States
	 
	 	 	 	 
	 

	 	 	 	Facsimile: 1-301-961-3440
	 

	 	 	 	Attention: Director of Business Development
	 
	 	 	 	 
	 

	 	If to RTU:
	 	R-Tech Ueno, Ltd.
	 

	 	 	 	10F, Yamato Life Insurance Bldg.,
	 

	 	 	 	1-1-7 Uchisaiwaicho
	 

	 	 	 	Chiyoda-ku, Tokyo 100-0011 Japan
	 
	 	 	 	 
	 

	 	 	 	Facsimile: 81-3-3596-8023
	 

	 	 	 	Attention: Ms. Yukiko Hashitera, Representative Director

10.3 Governing Law. This Agreement shall be governed by, and interpreted and construed in
accordance with, the law of the State of New York, USA, excluding its choice of law rules and the
U.N. Convention on the International Sale of Goods.

10.4 Entire Agreement. This Agreement, including Exhibits attached hereto and incorporated
as an integral part of this Agreement, together with the Supply Agreement constitute the entire
agreement of the Parties with respect to the subject matter hereof, and supersede all previous
agreements by and among the Parties as well as all proposals, oral or written, and all prior or
contemporaneous negotiations, conversations or discussions among the Parties related to this
Agreement. Any differences between the text of certain provisions contained in both this Agreement
and the Supply Agreement are intended for clarification purposes only and not to alter the original
intent of the Parties.

Article 11 LIMITATION OF LIABILITY

EXCEPT FOR ANY BREACH OF CONFIDENTIALITY OBLIGATION, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO
THE OTHER PARTIES HEREUNDER FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR
SIMILAR LOSSES OR DAMAGES, EVEN IF SUCH PARTIES SHALL HAVE BEEN

12

 

ADVISED IN ADVANCE OF THE POSSIBILITY OF SUCH POTENTIAL LOSS OR DAMAGE. IN ADDITION, SPI AND ITS
AFFILIATES SHALL NOT BE LIABLE TO TAKEDA AND RTU IN THE EVENT THAT AN NDA IS NEVER ISSUED OR
GRANTED OR NET SALES REVENUE ARE NEVER ACHIEVED.

NOTWITHSTANDING OF THE PRECEDING SENTENCES, LIMITATION OF LIABILITY PROVIDED FOR IN THIS ARTICLE
SHALL NOT BE APPLICABLE WHERE LOSS OR DAMAGES ARE CAUSED BY WILFUL MISCONDUCT OR GROSS NEGLIGENCE
OF EACH PARTY.

This Article shall supersede, to the extent that liability relating to subject matter of this
Agreement of the Parties is concerned, any provisions concerning limitation of liability in the
Supply Agreement or Collaboration and License Agreement.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the day first above
written,

	 	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	Takeda Pharmaceutical Company Limited	 	 	 	Sucampo Pharmaceuticals, Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By

	 	/s/ Yasuhiko Yamanaka
	 	 	 	By
	 	/s/ Brad E. Fackler	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	Name: Yasuhiko Yamanaka	 	 	 	Name: Brad E. Fackler	 	 
	Title: Corporate Officer	 	 	 	Title: Vice President of Marketing and Sales	 	 
	          General Manager, Corporate Strategy	 	 	 	 	 	 	 	 
	          & Planning Department	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	R-Tech Ueno, Ltd.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By

	 	/s/ Mitsunaga Tada	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	Name: Mitsunaga Tada	 	 	 	 	 	 	 	 
	Title: President and Representative Director	 	 	 	 	 	 	 	 

Exhibits

	 	 	 	 	 
	 

	 	A
	 	Manufacturing Specifications
	 
	 

	 	B
	 	First 24-Month Rolling Forecast

13

 

Exhibit A            Manufacturing Specifications

Confidential
Materials omitted and filed separately with

the Securities and Exchange Commission.

14

 

Exhibit B            First 24-Month Rolling Forecast

	 	 	 	 	 	 	 	 	 
	 	 	Product	 	Product	 	Sample	 	Sample
	 	 	Purchase Pills	 	Purchase Bottles	 	Purchase Pills	 	Boxes
	Mar-06
	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 
	Apr-06
	 	[**]	 	[**]	 	[**]	 	[**]
	May-06
	 	[**]	 	[**]	 	[**]	 	[**]
	Jun-06
	 	[**]	 	[**]	 	[**]	 	[**]
	Jul-06
	 	[**]	 	[**]	 	[**]	 	[**]
	Aug-06
	 	[**]	 	[**]	 	[**]	 	[**]
	Sep-06
	 	[**]	 	[**]	 	[**]	 	[**]
	4-9/06
	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 
	Oct-06
	 	[**]	 	[**]	 	[**]	 	[**]
	Nov-06
	 	[**]	 	[**]	 	[**]	 	[**]
	Dec-06
	 	[**]	 	[**]	 	[**]	 	[**]
	Jan-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Feb-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Mar-07
	 	[**]	 	[**]	 	[**]	 	[**]
	10-3/06
	 	[**]	 	[**]	 	[**]	 	[**]
	2-3/06
	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 
	Apr-07
	 	[**]	 	[**]	 	[**]	 	[**]
	May-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Jun-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Jul-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Aug-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Sep-07
	 	[**]	 	[**]	 	[**]	 	[**]
	4-9/07
	 	[**]	 	[**]	 	[**]	 	[**]
	 
	 	 	 	 	 	 	 	 
	Oct-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Nov-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Dec-07
	 	[**]	 	[**]	 	[**]	 	[**]
	Jan-08
	 	[**]	 	[**]	 	[**]	 	[**]
	Feb-08
	 	[**]	 	[**]	 	[**]	 	[**]
	Mar-08
	 	[**]	 	[**]	 	[**]	 	[**]
	10-3/07
	 	[**]	 	[**]	 	[**]	 	[**]
	4-3/07
	 	[**]	 	[**]	 	[**]	 	[**]

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