Confidential Materials omitted and
filed separately with the
Securities and Exchange Commission.
Asterisks denote omissions.
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.”
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
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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.
(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.
(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
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