Document:

exv10w25

 

Exhibit 10.25

Confidential
Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

SUPPLEMENTAL AGREEMENT

     THIS SUPPLEMENTAL AGREEMENT (the “Supplemental Agreement”) is made as of February 1, 2006, by
and between Sucampo Pharmaceuticals, Inc., a corporation organized under the laws of Delaware,
having its principal place of business at 4733 Bethesda Avenue, Suite 450, Bethesda, Maryland 20814
USA (“SPI”), and 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”). SPI and Takeda are sometimes referred to herein individually as a “Party” and
collectively as the “Parties.”

     WHEREAS, the Parties entered into a Collaboration and License Agreement dated October 29,
2004 (the “Original Agreement”), whereby the Parties agreed, among other things, to collaborate on
the development and commercialization of a compound known as SPI-0211 (“Lubiprostone”) in
accordance with the terms and conditions set forth therein; and

     WHEREAS, Takeda Pharmaceuticals North America, Inc. is a sub-licensee of Takeda and has
performed and will perform certain of Takeda’s obligations under the Original Agreement and this
Supplemental Agreement; and

     WHEREAS, the Parties desire to enter into this Supplemental Agreement to supplement the
Original Agreement by providing additional details and other terms regarding certain activities to
be performed by the Parties pursuant to the Original Agreement;

     NOW THEREFORE, in consideration of the premises and the mutual covenants set forth herein and
in a Settlement Agreement dated as of January 31, 2006, by and between SPI and Takeda (the
“Settlement Agreement”), the Parties have agreed as follows:

Article 1 DEFINITIONS

     Capitalized terms not defined herein shall have the meanings ascribed to them in the Original
Agreement.

     The following terms shall have the meanings set forth below:

     “External Costs” means reasonable and customary expenses charged by a third party to a Party
to this Supplemental Agreement, and do not include a Party’s internal expenses, such as labor,
administrative, or overhead costs.

     “Medical and Scientific Affairs (“M&SA”)” and “Medical Marketing Activities” collectively mean
the activities set forth in Annex 3 hereto.

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     “Phase IV Marketing Support Studies” means Phase IV Studies to the extent the data from such
studies is not intended for the primary purpose of Regulatory Required Studies, Labeling Changes,
Additional Indications or New Formulations.

			
	Article 2	 	STANDARD OPERATING PROCEDURES RELATING TO CONFIDENTIAL INFORMATION

     2.1 Standard Operating Procedures. For the protection of all Confidential Information
(including, inter alia, Proprietary Product Information) that may be obtained or used in the course
of the Commercialization of the Product, the Parties agree to comply, and to cause their Affiliates
and sub-licensees to comply, with the standard operating procedures (“SOPs”) set forth in Annexes 1
and 2 hereto, which SOPs are incorporated by reference herein.

			
	Article 3	 	M&SA ACTIVITIES, MEDICAL MARKETING, KEY OPINION LEADER DEVELOPMENT AND OTHER ACTIVITIES

     3.1 M&SA and Medical Marketing Activities.

          (a) The Parties agree that, with respect to Medical and Scientific Affairs (“M&SA”) and
Medical Marketing Activities, SPI and Takeda shall cooperate and collaborate with each other to
manage and coordinate such activities. For M&SA and Medical Marketing Activities conducted after
the execution of this Supplemental Agreement, the Parties shall fulfill their roles and
responsibilities as set forth in greater detail in Annex 3 hereto (the “RACI Chart”), which is
incorporated by reference herein. For purposes of the RACI Chart, the following terms have the
meanings set forth below:

          (i) the Party “responsible” for an activity shall mean the Party carrying out and conducting
the listed activity;

          (ii) the Party “accountable” for an activity shall mean the Party with ultimate
decision-making authority for the listed activity;

          (iii) the Party to be “consulted” about an activity shall mean the Party with whom issues and
concepts about a given activity will be discussed and negotiated in good faith; and

          (iv) the Party to be “informed” about an activity shall mean the Party who will be advised
about a given activity, including the results of the activity.

          (b) For M&SA and Medical Marketing Activities conducted by SPI after the execution of this
Supplemental Agreement, Takeda shall reimburse SPI for all documented External Costs incurred,
provided that such External Costs have been pre-approved by the “Article 3 Working Group” and are
documented by third-party invoices. For purposes of this Article 3, the term “Article 3 Working
Group” shall mean a working group consisting of two (2) members, with each Party designating one
(1) member of the working group. For the avoidance of doubt, Takeda shall not be required to
reimburse any External Costs the Article 3 Working Group has not pre-approved in writing prior to
such External Costs being incurred.

          (c) For M&SA and Medical Marketing Activities conducted by SPI prior to the execution of this
Supplemental Agreement, Takeda shall reimburse SPI for all documented External Costs incurred for
the following four activities, but in no event in an amount greater

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than [**] Dollars and [**] Cents ($[**]) for the four activities combined: (i) Telluride
Advisory Board; (ii) Chicago Advisory Board; (iii) February Advisory Board; and (iv) [**] percent
([**]%) cancellation fee for DDW. For the avoidance of doubt, the total amount to be paid by
Takeda under this Section 3.1(c) shall not exceed the lesser of (i) the actual External Costs
incurred by SPI relating to the four activities or (ii) [**] Dollars and [**] Cents ($[**]). SPI
shall not be entitled to any additional reimbursement from Takeda for activities conducted prior to
execution of this Supplemental Agreement.

          (d) Takeda will retain overall responsibility for managing and coordinating M&SA and Medical
Marketing Activities, and SPI shall fully cooperate and coordinate with Takeda in order to allow
Takeda to manage such activities. Takeda will not be reimbursed by SPI for managing M&SA and
Medical Marketing Activities.

          (e) To the extent there are disagreements concerning any of the matters set forth in this
Section 3.1, including any questions or disagreements concerning the meaning of, or
responsibilities assigned or permitted by, the RACI Chart, or the absence of consensus between the
members of the Article 3 Working Group regarding reimbursable External Costs, any such
disagreements shall be presented to the Joint Commercialization Committee (“JCC”) and resolved
pursuant to the provisions of the Original Agreement, including Section 3.1 of the Original
Agreement. SPI shall submit to Takeda invoices for all amounts entitled to reimbursement under
Section 3.1(b) of this Supplemental Agreement, along with documentation reasonably satisfactory to
Takeda, including applicable invoices from third-party vendors, and Takeda shall make payment to
SPI for External Costs incurred in compliance with this Section 3.1 within thirty (30) days after
receipt of such invoice. SPI shall be responsible for making all payments to such third-party
vendors.

     3.2 Publication and Other Activities. In addition to the respective roles and
responsibilities of the Parties set forth in the RACI Chart, the Parties hereby agree as follows:

     (a) Publications, Abstracts and Manuscripts.

     (i) During the [**] period following [**] (the “PDUFA Date”), SPI shall be responsible for the
development of all publications, abstracts and manuscripts (collectively, “publications”) directed
primarily to a scientific audience, to the extent such publications refer to clinical trial or
other study data on the Product; provided that each proposal for a publication shall be discussed
in advance with Takeda, that Takeda’s right to review, approve and/or comment on such publications
prior to submission shall be governed by the SOPs set forth in Annex 2, and that publications shall
be consistent with the overall publication plan approved by the JCC. Any disputes concerning
publication plans shall be presented to the JCC and resolved pursuant to the provisions of the
Original Agreement, including Section 3.1 of the Original Agreement. Takeda shall reimburse SPI
for all documented External Costs in connection with the following two publications, but in no
event shall such reimbursement exceed [**] Dollars ($[**]) per publication: Long-Term Safety of
Lubiprostone in Patients with Occasional Constipation: Results of a 48-Week, Prospective,
Multicenter, Open-Label, Safety Trial and Multicenter, Double-Blind, Randomized, Placebo-Controlled
Trial of Lubiprostone in Patients With Occasional Constipation. Takeda will also reimburse SPI for
all documented External Costs incurred by SPI during such [**] period in connection with future
publications to the extent

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agreed in advance in writing by Takeda, with the specific amount of reimbursement to be agreed
in advance as to each proposed publication.

     (ii) As between SPI and Takeda, SPI shall own all intellectual property rights associated with
publications developed by SPI pursuant to this Section 3.2(a), including but not limited to
copyrights, patent rights and rights of authorship with respect to publications and their subject
matter. SPI shall have approval rights regarding the author(s) to be listed in the publications it
develops but shall consider in good faith Takeda’s recommendations with respect to such authorship
issues.

     (iii) SPI shall submit to Takeda invoices for all amounts entitled to reimbursement under this
Section 3.2(a) along with documentation reasonably satisfactory to Takeda, including applicable
invoices from third-party vendors, and Takeda shall make payment to SPI for expenses incurred in
compliance with this Section 3.2(a) within [**] after receipt of such invoice. SPI shall be
responsible for making all payments to such third-party vendors.

     (iv) Nothing in this Section 3.2(a) shall prohibit Takeda from developing publications
primarily concerning general disease states or quality-of-life issues rather than data derived from
the Product’s clinical development program, provided that such publications are developed in
accordance with the SOPs set forth in Annex 2, and are subject to SPI’s right to review, approve
and/or comment on such publications prior to submission as set forth in Annex 2. Any dispute
relating thereto shall be presented to the JCC and resolved pursuant to the provisions of the
Original Agreement, including Section 3.1 of the Original Agreement.

     (v) After the expiration of the [**] period following the PDUFA Date, Takeda shall be
primarily responsible for the development of publications described in Section 3.2(a)(i) above
pursuant to the Original Agreement, provided that such publications are developed in accordance
with the SOPs set forth in Annex 2.

     (vi) Nothing in this Section 3.2, nor any publication, shall alter in any way SPI’s ownership
of the intellectual property rights associated with the Product.

     (b) Continuing Medical Education (“CME”) and Investigator Initiated Trials. Takeda will be
responsible for planning and managing all CME strategies and programs, in consultation with SPI.
Takeda shall provide all funding relating to CME programs, grants and investigator initiated trials
relating to the Product. SPI shall be recognized as a co-sponsor of such activities. Any disputes
relating to CME strategies and programs shall be presented to the JCC and resolved pursuant to the
provisions of the Original Agreement, including Section 3.1 of the Original Agreement.

     (c) Medical/Regulatory/Legal Review. Takeda shall have approval authority for all
promotional, sales training and related materials to be used by either Party, regardless of their
format or intended use. SPI will be provided an opportunity to review and comment on all such
materials in accordance with the SOPs set forth in Annex 4, with which the Parties agree to comply
and which are incorporated by reference herein.

     (d) Speaker Bureaus. Takeda shall have responsibility for managing and conducting all
speaker bureau programs. Takeda will consult with SPI regarding strategies and plans for such
programs. Any disputes regarding such strategies shall be presented to the JCC and resolved

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pursuant to the provisions of the Original Agreement, including Section 3.1 of the Original
Agreement.

     (e) Press Releases. The Parties agree to comply, and to cause their Affiliates and
sub-licensees to comply, with the SOPs relating to press releases, which SOPs are set forth in
Annex 5 hereto and are incorporated herein by reference.

			
	Article 4	 	SAFETY MONITORING AND POST-MARKETING SURVEILLANCE

     4.1 Safety Monitoring.

     (a) Safety monitoring and Post-Marketing Surveillance activities relating to the Product shall
be conducted as follows: [**] shall be utilized as the telephone call center for the Product at
the expense, and under the management, of Takeda. [**], doing business as [**], shall be utilized
as the vendor for purposes of adverse event reporting to the FDA, under the management of SPI. All
calls, including safety-related calls, Product-related calls, or any other general calls, shall
first be received by [**] (or, if applicable, forwarded to [**] by Takeda and/or SPI) and
categorized by [**]. All safety-related calls shall be forwarded to [**], using an adverse-event
form developed by SPI and [**] and approved by Takeda. Product complaint requests shall be sent to
SPI for resolution. SPI shall have the right to access all records of calls received by [**]
related to the Product, regardless of whether or not the call is safety-related.

     (b) The Parties agree to comply with the SOPs set forth in Annex 6, and incorporated by
reference herein, relating to safety monitoring, safety data, postmarketing activities, and
clinical trial activities.

     (c) In connection with the performance of SPI’s obligations under Section 4.1 of this
Supplemental Agreement, Takeda shall reimburse SPI for amounts due to [**], provided that such
costs are reasonable, customary, documented, and consistent with this Section 4.1, and provided
further that SPI shall not be entitled to reimbursement for [**] start-up and implementation costs,
such as costs relating to equipment and other infrastructure. The terms of any agreement between
SPI and [**] entered into before the date of this Supplemental Agreement, including fees,
discounts, rebates and other charges, if any, shall be disclosed to Takeda. The terms of any other
agreement between SPI and [**] entered into during the term of this Supplemental Agreement shall be
disclosed to Takeda and shall be subject to Takeda’s prior, written approval, which approval shall
not unreasonably be withheld. Any and all amounts due to SPI from Takeda pursuant to this Section
4.1 shall be invoiced by SPI and shall be paid by Takeda within thirty (30) days of invoice
receipt. In the event that Takeda disputes any portion of an invoice, Takeda shall promptly notify
SPI in writing and both Parties shall cooperate and negotiate in good faith to resolve the matter
promptly. To the extent there are any changes to the invoiced amount, SPI shall send a revised
invoice to Takeda, which shall be paid by Takeda within thirty (30) days of the receipt thereof.

			
	Article 5	 	PHASE IV MARKETING SUPPORT STUDIES AND NON-CLINICAL RESEARCH STUDIES

     5.1 Management of Phase IV Marketing Support Studies. The JCC shall be responsible
for the overall strategic direction of all Phase IV Marketing Support Studies (excluding studies
proposed, conducted and managed by an investigator for which an entity other

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than SPI, Takeda, or their agents is the study sponsor (“Investigator Initiated Trials”)). SPI
or Takeda shall first propose a study synopsis, business rationale, budget and timeline of Phase IV
Marketing Support Studies to the JCC, and the JCC, after evaluating such information, shall decide
whether the proposed Phase IV Marketing Support Studies shall be conducted pursuant to Section
5.1(c) of the Original Agreement. If a study is approved by the JCC, then SPI or Takeda, as the
case may be, shall propose a draft protocol to the JDC, and the JDC shall evaluate and finalize the
draft protocol. With respect to any such protocol approved by the JDC, Takeda may, in its sole
discretion, designate SPI or other entities, including Takeda Global Research and Development
Center, Inc., to carry out the related Phase IV Marketing Support Studies. In accordance with
Section 4.2(b)(vi) of the Original Agreement, Takeda shall fund all costs for Phase IV Marketing
Support Studies approved by the JCC and the JDC. Any disputes concerning Phase IV Marketing
Support Studies shall be presented to the JCC and resolved pursuant to the provisions of the
Original Agreement, including Section 3.1 of the Original Agreement.

     For the avoidance of doubt, any studies falling under the categories of Regulatory Required
Studies, Labeling Changes, Additional Indications or New Formulations shall be managed in
accordance with Section 4.2 of the Original Agreement, subject to go/no-go decisions by the JCC
pursuant to Section 5.1(c) of the Original Agreement with regard to Labeling Changes, Additional
Indications and New Formulations.

     5.2 Non-Clinical Research Studies. SPI shall be responsible for the management of all
SPI-initiated non-clinical research studies, excluding Investigator Initiated Trials as defined in
Section 5.1 above, subject to review and approval of study proposals by the JCC. Takeda shall
reimburse SPI for all documented External Costs (net of discounts and rebates) and reasonable and
customary Development costs incurred by SPI in connection with the research studies set forth in
Annex 7 hereto. In addition, Takeda shall reimburse SPI for all External Costs and reasonable and
customary Development costs incurred by SPI in connection with other non-clinical research studies,
provided such studies involve the Initial Indications and have been approved for reimbursement by
the JCC after submission by SPI of a study synopsis, business rationale, budget and timeline. For
purposes of this Section 5.2, reimbursement of Development costs shall be determined in accordance
with Annex 8 hereto. Provided that there is no dispute as to the amounts contained therein, Takeda
shall pay SPI within thirty (30) business days after its receipt of invoices from SPI, including
supporting documentation reasonably satisfactory to Takeda. Any disputes concerning non-clinical
research studies shall be presented to the JCC and resolved pursuant to the provisions of the
Original Agreement, including Section 3.1 of the Original Agreement.

     5.3 Phase IV Marketing Studies and Non-Clinical Research Studies SOPs. The Parties
shall comply with the SOPs set forth in Annex 9 hereto relating to the management of Phase IV
Marketing Support Studies and non-clinical research studies, which SOPs are hereby incorporated by
reference herein.

Article 6 SALES FORCE STRUCTURE AND REIMBURSEMENT

     6.1 Takeda Sales Force. Takeda shall retain or employ a dedicated sales force
of two hundred (200) persons (subject to customary and normal vacancies) whose primary sales
activities shall be to target high-prescribing gastroenterologists and primary care physicians for

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the promotion of the Product. Takeda also agrees to utilize the five hundred (500)-person PSS
sales force that is currently promoting the product Rozerem, or a sales force of comparable effort
(“Takeda Supplemental Sales Force”), to promote the Product in the secondary position. If a
Negative Event has occurred, the Parties shall negotiate the effects, if any, of the Negative Event
on the obligations in this Section 6.1, taking into account all relevant market circumstances,
including without limitation actual initial sales of the Product, sales potential, Product
acceptance by healthcare professionals and availability of competing products. Any disagreements
concerning the effect of the Negative Event shall be presented to the JCC and resolved pursuant to
the provisions of the Original Agreement, including Section 3.1 of the Original Agreement. If a
Negative Event occurs during the [**] immediately following the execution of this Supplemental
Agreement, Takeda’s obligations with respect to the Takeda Supplemental Sales Force shall continue
and shall not terminate at least until the expiration of the [**] period. Nothing in this Section
6.1 or any other provision of this Supplemental Agreement shall affect in any manner the Parties’
rights under Section 5.3(h) of the Original Agreement, and such rights are expressly preserved.
Takeda shall bear the costs of the sales activities described in this Section 6.1.

     6.2 SPI Sales Force.

     (a) SPI shall employ a sales force of approximately thirty-eight (38) representatives (the
“Supplemental Sales Force”) to supplement Takeda’s sales activities, which Supplemental Sales Force
must be deployed exclusively to institutional customers (hospitals/Veterans Administration
facilities/long-term care facilities), unless otherwise agreed by the Parties in writing. Should
SPI use the Supplemental Sales Force for any products other than the Product, the Product must
always be in the primary position, and no more than one additional product may be detailed. SPI,
at its cost, shall be responsible for any customized promotional materials for use with
institutional customers. Detailed plans, strategies and arrangements for the SPI sales activities
shall be presented to the JCC for approval, and any disputes regarding such plans, strategies and
arrangements shall be resolved pursuant to the provisions of the Original Agreement, including
Section 3.1 of the Original Agreement.

     (b) In lieu of the payments set forth in Section 5.4 of the Original Agreement, Takeda shall
pay SPI [**] Dollars [**] ($[**]) per representative per day (the “Reimbursement Amount”) for the
sales activities set forth in Section 6.2(a) above. Reconciliation will be conducted on a monthly
basis. Takeda’s reimbursement of SPI for such sales activities will be based on the number of
representatives utilized by SPI each day and under no circumstances will such reimbursement exceed
[**] Dollars ($[**]) per month, nor exceed [**] Dollars ($[**]) per twelve (12)-month period
following the first date that SPI deploys sales representatives in the field. Takeda’s
reimbursement of SPI for sales activities pursuant to Section 6.2(a) above, and pursuant to the
Reimbursement Amount and limits set forth in this Section 6.2(b), shall continue for sixty (60)
months following the first date that SPI deploys sales representatives in the field. Subject to
the conditions specified in this Section 6.2, Takeda shall reimburse SPI on a monthly basis within
[**] after receipt of invoices from SPI. Reimbursement will be calculated based on a
representative’s actual working days in the field (i.e., excluding vacation, holidays, and days in
training or meetings), which must be documented. For the avoidance of doubt, and by way of
example, if SPI were to deploy only twenty-five (25) representatives in the field on a given day,
reimbursement for that day would be $[**] (25 x $[**]); if SPI were to deploy a given

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representative in the field for only fifteen days in a particular month, reimbursement for
that representative for the month would be $[**] (15 x $[**]).

     (c) SPI may increase the number of representatives beyond the thirty-eight (38) referred to in
Section 6.2(a) above only if the JCC unanimously approves of such expansion. Should the JCC
approve of such expansion, the additional sales representatives (“Additional Sales Force”) will be
reimbursed at a rate of [**] Dollars ($[**]) per PDE pursuant to the Original Agreement, provided,
however, that if the Additional Sales Force is deployed to institutional customers (as defined in
Section 6.2(a), above), reimbursement will be at the rate of [**] Dollars [**] ($[**]) per actual
working day in the field, as defined in Section 6.2(b) above. In no event may the total
reimbursement for the Additional Sales Force exceed [**] Dollars ($[**]) per twelve (12)-month
period.

     (d) Takeda will reimburse SPI for samples for institutional customers, but only to the extent
that the cost of such samples together with the amount of reimbursement of SPI’s Supplemental Sales
Force does not exceed [**] Dollars ($[**]) for the twelve (12)-month period following the first
date that SPI deploys sales representatives in the field and for each successive twelve (12)-month
period. At the conclusion of the twenty-four (24) month period following the first date that SPI
deploys sales representatives in the field, the Parties may consider renegotiating the provisions
in this Section 6.2(d) regarding the cost of samples for institutional customers. Reimbursement
for samples for any SPI sales activities unrelated to institutional customers (to the extent such
activities are approved by the JCC) will be governed by the Original Agreement.

     (e) Takeda’s total payments to SPI for SPI sales activities, including reimbursement for SPI’s
Supplemental Sales Force and Additional Sales Force sales force for institutional and any other
customers, and the cost of samples, shall not exceed [**] Dollars ($[**]) for the [**] period
following the first date that SPI deploys sales representatives in the field and for each
successive [**] period thereafter, throughout the term of the Original Agreement.

     (f) At the conclusion of sixty (60) months following the first date that SPI deploys sales
representatives in the field, if the Parties, after negotiation, have failed to agree on an
extension to the terms in Section 6.2(a) to (e) above, SPI’s co-promotion rights shall revert to
the terms in the Original Agreement.

     (g) Notwithstanding any other provision in this Section 6.2, if a Negative Event has occurred,
the Parties’ obligations under this Section 6.2 shall terminate [**] after execution of this
Supplemental Agreement. During such [**] period, the Parties shall negotiate the effects, if any,
of the Negative Event on the obligations in this Section 6.2, taking into account all relevant
market circumstances, including without limitation actual initial sales of the Product, sales
potential, Product acceptance by healthcare professionals and availability of competing products.
Any disagreements concerning the effect of the Negative Event shall be presented to the JCC and
resolved pursuant to the provisions of the Original Agreement, including Section 3.1 of the
Original Agreement.

     6.3 Promotional Compliance. Each of SPI and Takeda may only use promotional and
sales training and related materials that have been approved in accordance with Section 3.2(c)
above. The Parties further agree that in promoting the Products they will comply with any

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laws and regulations applicable to the marketing, sale and promotion of pharmaceutical
products (including without limitation the Prescription Drug Marketing Act, Federal Health Care
Program Anti-Kickback Law (42 U.S.C. §1320a-7b) and the Health Insurance Portability and
Accountability Act of 1996), the Code on Interactions with Healthcare Professionals promulgated by
the Pharmaceutical Research and Manufacturers of America and the American Medical Association
Guidelines on Gifts to Physicians, as any of the foregoing may be amended, and the terms of the
Original Agreement and this Supplemental Agreement. No Party shall be required to undertake any
obligation, or incur any cost or reimbursement obligation, in connection with any activity under
this Supplemental Agreement that such Party believes, in good faith, may violate any applicable
law, regulation code or guidance. Consistent with recent guidance in the pharmaceutical industry
promulgated by the Office of Inspector General of the Health and Human Services Department on April
28, 2003, each Party agrees to maintain a compliance program with respect to its promotional and
sales activities pursuant to this Supplemental Agreement containing all of the elements described
in such guidance document.

Article 7 TERM

     7.1 Term. The term of this Supplemental Agreement shall be coextensive with the term
of the Original Agreement and shall terminate automatically without further action by either Party
upon the termination of the Original Agreement.

Article 8 MISCELLANEOUS

     8.1 Affiliates.

     (a) The Parties agree that Takeda, directly or through its sub-licensee Takeda
Pharmaceuticals North America, Inc. (“TPNA”), may contract with Takeda Pharmaceuticals America,
Inc. (“TPA”), Takeda Global Research and Development Center, Inc. (“TGRD Inc.”), Takeda Global
Research and Development Centre, Ltd. (“TGRD Ltd.”), and, subject to the prior written approval of
SPI, any other Affiliate of Takeda, for the performance of any of its obligations under, or the
activities contemplated in, the Original Agreement or this Supplemental Agreement, including the
Annexes hereto, or any activities related thereto, provided (1) that each such Affiliate (including
TPA, TGRD Inc. and TGRD Ltd.) shall first consent in writing to comply with the provisions of the
Original Agreement and this Supplemental Agreement, including the Annexes hereto, and including the
confidentiality obligations and provisions of Section 11.3 of the Original Agreement; (2) that any
such contracting by Takeda shall not relieve Takeda’s duty to perform, either directly or through
Affiliates, the obligations and the activities contemplated in the Original Agreement and this
Supplemental Agreement, including the Annexes hereto, and any activities related thereto; and (3)
that each such Affiliate (including TPA, TGRD Inc. and TGRD Ltd.) shall comply with the provisions
of Article 7.6 of the Original Agreement. SPI shall be entitled to a financial audit, to be
conducted by an independent certified public accountant pursuant to Section 7.6 of the Original
Agreement mutatis mutandis, of TPNA, TPA, TGRD Inc., TGRD Ltd., and any other Affiliate of Takeda
with whom Takeda proposes to contract for the performance of any of its obligations under, or the
activities contemplated in, the Original Agreement or this Supplemental Agreement, including the
Annexes hereto, or any activities related thereto, which audit shall be limited in scope to (a)
establishing the good standing of Takeda’s Affiliates and (b) establishing and understanding the
entity structure and revenue flow among Takeda and its Affiliates as such structure and revenue
flow pertains to the

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computation of Net Sales Revenue. The financial audit authorized by this Section 8.1 shall be
in addition to any audit authorized by Section 7.6 of the Original Agreement.

     (b) Takeda represents and warrants (1) that each of TPNA, TPA, TGRD Inc. and TGRD Ltd. is a
direct or indirect wholly-owned subsidiary of Takeda; (2) that Takeda shall ensure that each of the
Affiliates with whom it contracts, including, but not limited to, TPNA, TPA, TGRD Inc. and TGRD
Ltd., shall be informed of, agree to comply with, and will comply with the provisions of the
Original Agreement and this Supplemental Agreement, including the Annexes hereto, and including the
confidentiality obligations and provisions of Section 11.3 of the Original Agreement; and (3) that
each of the Affiliates with whom it contracts, including, but not limited to, TPNA, TPA, TGRD Inc.
and TGRD Ltd., 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 in which failure to have such would prevent it from performing its obligations, or the
activities contemplated in, the Original Agreement or this Supplemental Agreement, including the
Annexes hereto, or any activities related thereto.

     8.2 Entire Agreement. This Supplemental Agreement, including the Annexes attached
hereto and incorporated as an integral part of this Supplemental Agreement, and the Settlement
Agreement, constitute the entire agreement of the Parties solely with respect to the specific
undertakings contained in the Supplemental Agreement, including the Annexes, and the Settlement
Agreement, and supersede all previous agreements by and between the Parties as well as all
proposals, oral or written, and all prior or contemporaneous negotiations, conversations or
discussions between the Parties with respect to the specific undertakings contained in the
Supplemental Agreement, including the Annexes, and the Settlement Agreement.

     8.3 Limited in Scope. This Supplemental Agreement is limited as specified and shall
not constitute modification, acceptance or waiver of any provision of the Original Agreement except
as explicitly and specifically stated herein. Any aspect of Commercialization not specifically set
forth in this Supplemental Agreement shall continue to be governed by the JCC as specified in the
Original Agreement, including resolution of disputes pursuant to Section 3.1 of the Original
Agreement. To the extent there are inconsistencies between the specific undertakings contained in
this Supplemental Agreement and the terms of the Original Agreement, the specific undertakings
contained in this Supplemental Agreement shall govern. The Original Agreement shall continue in
full force and effect, except to the extent modified by specific undertakings agreed to herein.
For the avoidance of doubt, all terms in the Original Agreement relating to a Negative Event remain
in full force and effect and are not modified by this Supplemental Agreement.

     8.4 Assignment. Except as provided in Section 8.1, neither Party shall have the right
to assign or otherwise transfer its rights and obligations under this Supplemental Agreement except
with the prior written consent of the other Party. This Supplemental Agreement shall inure to the
benefit of the Parties hereto and any permitted assignees. Any prohibited assignment shall be null
and void.

     8.5 Notices; Language. Except as may be otherwise provided in this Supplemental
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)

10

 

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 in writing. 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
	 
	 	 	 	 
	 

	 	 	 	Facsimile: 81-6-6204-2328
	 

	 	 	 	Attention: General Manager, Licensing Department
	 
	 	 	 	 
	 

	 	 	 	and
	 
	 	 	 	 
	 

	 	 	 	Takeda Pharmaceuticals North America, Inc.
	 

	 	 	 	475 Half Day Road
	 

	 	 	 	Lincolnshire, Illinois 60069
	 

	 	 	 	Facsimile: 847-383-3481
	 

	 	 	 	Attention: General Counsel
	 
	 	 	 	 
	 

	 	If to SPI:
	 	Sucampo Pharmaceuticals, Inc.
	 

	 	 	 	4733 Bethesda Avenue, Suite 450
	 

	 	 	 	Bethesda, Maryland 20814
	 

	 	 	 	United States
	 
	 	 	 	 
	 

	 	 	 	Facsimile: 301-961-3440
	 

	 	 	 	Attention: Chief Executive Officer

     8.6 Governing Law. This Supplemental 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.

     8.7 Amendment. This Supplemental Agreement may not be modified or amended, in whole
or in part, except by written agreement signed by both Parties.

     8.8 Severability. If one or more of the provisions of this Supplemental Agreement is
subsequently declared invalid or unenforceable, this Supplemental Agreement shall be treated as
though that provision were not in this Supplemental Agreement, and this shall not affect the
validity or enforceability of the remaining provisions of this Supplemental Agreement (unless those
provisions that are invalidated or unenforceable are clearly material and inseparable from the
other provisions). The Supplemental 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.

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

11

 

     8.10 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.

     8.11 No Limitation of Damages. No payments or agreements to pay under this
Supplemental Agreement shall in any way preclude or limit the rights of either Party to seek the
full recovery of its damages, or to seek equitable relief, for breach of this Supplemental
Agreement or the Original Agreement by the other Party, except to the extent that the claim under
which the Party seeks damages or equitable relief has been specifically released pursuant to the
Settlement Agreement.

     8.12 Right of Audit Relating to Invoices. If there are disputes concerning amounts
invoiced by SPI to Takeda, Takeda shall have the right to audit and inspect any and all SPI
documentation specifically pertinent to and necessary for the auditing of such invoiced amounts,
including, but not limited to, documentation relating to services provided by third parties.
Takeda shall bear costs relating to such audit. For the avoidance of doubt, nothing in this Section
8.12 shall limit the scope or frequency of Takeda’s right to audit or otherwise inspect records of
SPI or Sentrx relating to safety monitoring pursuant to Annex 5 hereto.

*   *   *

     IN WITNESS WHEREOF, the Parties have caused this Supplemental Agreement to be executed as of
the date 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	 	 

12

 

ANNEX 1: IP and Confidential Information Disclosure SOPs

TITLE: Standard Operating Procedure (“SOP”) regarding Disclosure and Handling of Confidential
Information (including Proprietary Product Information) between Sucampo Pharmaceuticals, Inc.
(“SPI”), Takeda Pharmaceuticals Company Limited (“TPC”) and its Affiliates, including Takeda
Pharmaceuticals North America, Inc. (“TPNA”) (TPC and its Affiliates, collectively “Takeda”)

Effective Date: January 31, 2006

Supersedes: N/A

VERSION: 1

PURPOSE: To establish the procedures between SPI and Takeda for the handling and disclosure to
third parties of Confidential Information (including Proprietary Product Information) under the
Collaboration and License Agreement between SPI and Takeda dated October 29, 2004 (“Collaboration
and License Agreement”). Nothing contained in this SOP shall be deemed to modify or amend any
provision of the Collaboration and License Agreement or the Agreement among SPI, Takeda and SAG
dated October 29, 2004.

RESPONSIBILITIES: Each company is responsible for ensuring that its own employees who have access
to Confidential Information, and the employees of its Affiliates who have access to Confidential
Information, read, understand and comply with this SOP.

PROCEDURES

Prior to entering into an agreement with third parties pursuant to which Confidential Information
of the other Party will be disclosed to such third parties (which disclosure shall be subject to
Article 11 of the Collaboration and License Agreement), Takeda or SPI, as applicable, shall notify
the other Party regarding the purpose of such agreement and the nature of the Confidential
Information to be disclosed. Such third parties shall include but are not limited to vendors,
consultants, Key Opinion leaders (KOLs) and medical writers. Such third parties shall not

 

 

include Affiliates of a Party that are engaged in activities related to satisfying such Party’s obligations
under the Collaboration and License Agreement, subject to, in the case where such entity does not
meet the definition of “Affiliate” in the Collaboration and License Agreement, the existence (and
disclosure to the other Party) of an agreement between the Party and Affiliate containing
appropriate confidentiality obligations. In the case where an Affiliate of a Party shall perform
any obligations of such Party under the Collaboration and License Agreement, such Affiliate shall
first consent in writing to comply with the SOP described herein prior to the performance of such
obligations.

Within 5 business days of receipt of such information regarding such third party, Takeda or SPI, as
applicable, shall notify the other Party in writing of any concerns or questions relating to the
proposed disclosure of Confidential Information to such third party and the reasons for such
concerns or questions.

If, within such 5-day period, Takeda or SPI, as applicable, does not notify the other Party of any
concerns or questions relating to the proposed disclosure of Confidential Information to such third
party, then Takeda or SPI, as applicable, will be free to disclose to such Third Party the
Confidential Information under the terms of standard confidentiality provisions.

If, within such 5-day period, Takeda or SPI, as applicable, notifies the other Party of its
concerns or questions relating to the proposed disclosure of Confidential Information to such third
party, then the Parties shall promptly discuss such concerns or questions and seek a reasonable
solution. If the Parties are unable to agree on a solution within 3 business days of such
discussion, then the matter shall be discussed and negotiated in good faith by the CEO of TPNA and
the CEO of SPI. If the CEOs after one business day remain unable to resolve the dispute, then the
matter shall be resolved by a neutral arbitrator from a JAMS panel selected by the Parties, or by
JAMS if the Parties are unable to agree on the selection. The Parties shall brief the arbitrator
on the background of the relevant agreements in advance, and the arbitrator shall decide any such
disputes, which decision shall be final and binding, within 3 business days following a failure of
the CEOs to reach an agreement. For purposes of this paragraph 4, the issues to be decided in any
dispute over a proposed disclosure are (1) whether the scope of the Confidential Information to be
disclosed exceeds what is necessary for the performance of the vendor’s duties and (2) whether the
need to disclose the Confidential Information is outweighed by the need to protect Intellectual
property rights; in no event may an objection to disclosure be based on general dissatisfaction
with the vendor’s services.

 

 

It shall be further noted that under no circumstance shall Takeda disclose the entire New Drug
Application (NDA) to any third party without SPI’s prior written consent.

In cases where the same Confidential Information is to be disclosed to multiple third parties
performing substantially the same activity, the procedures outlined above shall be followed and
completed with respect to each such third party Following the completion of such procedures, Takeda
or SPI, as applicable, shall provide prior notification to the other Party of each third party to
whom the same Confidential Information is to be disclosed in connection with the performance of
substantially the same activity, and Takeda or SPI, as applicable, shall be free to disclose to
such Third Party the Confidential Information under the terms of standard confidentiality
provisions.

 

 

DEFINITIONS

     Confidential Information: Confidential Information shall have the same meaning as set forth
in Article 1 of the Collaboration and License Agreement, subject to the provisions of Article 11 of
the Collaboration and License Agreement.

     Proprietary Product Information: Proprietary Product Information shall have the same meaning
as set forth in Article 1 of the Collaboration and License Agreement. For the avoidance of doubt,
Proprietary Product Information includes, with respect to a Product, New Drug Application (NDA).
Investigational Drug Application (IND), Drug Master File (DMF), Investigator Brochure (IB) and any
Product information contained in SPI pending, non-published patent applications.

     Other: Any capitalized terms not defined in this SOP shall have the same meaning as set forth
in Article 1 of the Collaboration and License Agreement.

 

 

ANNEX 2: Publication SOPs

TITLE: Standard Operating Procedure (“SOP”) regarding publications, abstract and manuscript
development between Sucampo Pharmaceuticals, Inc. (“SPI”), Takeda Pharmaceutical Company Limited
(“TPC”) and TPC’s Affiliates, including Takeda Pharmaceuticals North America, Inc. (“TPNA”) (TPC
and its Affiliates, collectively “Takeda”)

Effective Date: January 31, 2006

Supersedes: N/A

VERSION: 1

 

 

PURPOSE: To establish the procedures between SPI and Takeda regarding the development of
publications, abstracts and manuscripts and maintaining the confidentiality of Confidential
Information (including Proprietary Product Information) under the Collaboration and License
Agreement between SPI and Takeda dated October 29, 2004 (“Collaboration and License Agreement”).
Nothing contained in this SOP shall be deemed to modify or amend any provision of the Collaboration
and License Agreement or the Agreement among SPI, Takeda and SAG dated October 29, 2004.

RESPONSIBILITIES: Each company is responsible for ensuring that its own employees who have access
to Confidential Information, and the employees of its Affiliates who have access to Confidential
Information, read, understand and comply with this SOP.

PROCEDURES:

SPI and Takeda, as applicable, will prepare and/or oversee draft publications, abstracts and
manuscripts in collaboration with consultants, Key Opinion Leaders (KOLs) and vendors in accordance
with the requirements of the Commercialization Plan, subject to Section 3.2 of the Supplemental
Agreement between SPI and Takeda dated January 31,2006 (“Supplemental Agreement”).

Takeda will submit drafts it prepares and/or oversees to SPI for IP review prior to circulation to
any third party other than an outside author or such vendor as may be assisting Takeda in the
preparation of the draft. Such review will be completed within 5 business days after receipt of
such drafts. In addition, SPI will review drafts it prepares and/or oversees for IP review prior
to circulation to any third party other than an outside author.

The Party that prepared the initial draft (the “Drafting Party”) will then submit such drafts to
the other Party for content review, which review shall be completed within 7 business days after
receipt of such drafts.

The Drafting Party will discuss the comments of the other Party with the other Party and shall
incorporate the comments from the other Party, as appropriate, into a revised draft. The revised
draft shall then be submitted to any outside author(s) for content review. Such outside author(s)
shall provide comments within 7 business days.

 

 

The Drafting Party shall incorporate the comments from the outside author(s), as appropriate, into
a final draft. The Drafting Party will then circulate the final draft to the other Party for
review, which review will be completed within 5 business days of receipt of such final draft.

With respect to final drafts prepared by SPI, Takeda shall approve the final draft in writing
unless Takeda reasonably determines that the final draft, if published, would be significantly
detrimental to the commercialization strategies and messages approved by the JCC. With respect to
final drafts prepared by Takeda, SPI shall approve the final draft unless SPI’s Chief Scientific
Officer reasonably determines that approval should be withheld on scientific grounds in light of
generally accepted medical and/or scientific publication practices.

In the event approval is withheld, the Party declining approval shall provide comments and
suggested modifications to the Drafting Party, and shall discuss the reasons for withholding
approval and the suggested modifications and comments with the Drafting Party. The Drafting Party
may then submit a revised final draft for review and approval in accordance with step 5.

No Party shall submit draft publications, abstracts or manuscripts for publication without the
other Party’s approval. In the case of drafts prepared by Takeda, the approval must be in writing
from SPI’s Chief Scientific Officer or his designee (provided such designation is made in writing
by SPI’s Chief Scientific Officer). For the avoidance of doubt, no information in a publication,
abstract or manuscript that has received such final written approval and has been published (i.e.,
in the public domain) shall be considered to contain Confidential Information.

The Drafting Party will submit approved publications, abstracts and manuscripts to relevant
congresses and journals in accordance with the requirements of the Commercialization Plan, subject
to Section 3.2 of the Supplemental Agreement.

Investigator initiated trials (IITs) will receive only study drug and/or funding and will not
receive any Confidential Information (including Proprietary Product Information). Therefore, such
publications will not be subject to the procedures outlined in this SOP; provided, however, a
party’s contract for an IIT shall contain provisions providing for prior review of proposed
publications to identify and protect any Confidential Information and/or intellectual property of a
party.

In the event that an Affiliate of a Party shall perform any obligations of such Party under the
Collaboration and License Agreement relating to the subject matter described herein, such

 

 

Affiliate shall first consent in writing to comply with the SOP described herein prior to the performance of
such obligations.

DEFINITIONS

     Confidential Information: Confidential Information shall have the same meaning as set forth
in Article I of the Collaboration and License Agreement, subject to the provisions of Article 11 of
the Collaboration and License Agreement.

     Proprietary Product Information: Proprietary Product Information shall have the same meaning
as set forth in Article 1 of the Collaboration and License Agreement. For the avoidance of doubt,
Proprietary Product Information includes, with respect to a Product, New Drug Application (NDA),
Investigational Drug Application (IND), Drug Master File (DMF), Investigator Brochure (IB) and any
Product information contained in SPI pending, non-published patent applications.

     Other: Any capitalized terms not defined in this SOP shall have the same meaning as set forth
in Article 1 of the Collaboration and License Agreement.

 

 

ANNEX 3: RACI Chart

 

 

DRAFT for DISCUSSION ONLY

Amitiza RACI

 

 

Purpose of this Document

	•	 	Identify roles and responsibilities of Sucampo (SPI) and
Takeda (TPNA) for Amitiza marketing activities

	•	 	Define efficient and effective strategies and processes
that maximize Amitiza’s market potential

	•	 	Leverage knowledge and experience of Sucampo and Takeda

	•	 	Consider resource constraints of each company

	•	 	Consider efficiency of the implementation

 

 

Activity and RACIS Defined

	•	 	For all activities, responsibilities are described based on the RACIS framework:

	 	•	 	(R)esponsible: Party carrying out the activities, the “do-er”
	 
	 	•	 	(A)ccountable: Party deciding on the activities, with final decision making authority
	 
	 	•	 	(C)onsulted: Party consulted with and verifies concepts
	 
	 	•	 	(I)nformed: Party informed about the results of the activity

	•	 	A company can have multiple responsibilities

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	Sample Activity

	 	A/R
	 	C

 

 

Activity Description

	•	 	Each activity is defined by its Strategy and Execution.

	•	 	Roles and responsibilities are assigned for each

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	•
	 	Activities as
	 	•
	 	Joint decision making
	 	•
	 	Activities described
	 

	 	 	 	described
	 	 	 	as outlined before	 	 	 	 

 

 

Activities Included (1 of 3)

	•	 	Message Development

	•	 	KOL Identification

	•	 	National Ad Boards to Support Commercial Activities

	•	 	Regional Ad Boards to Support Commercial Activities

	•	 	Speaker Bureau (for Peer-to-Peer Promotion)

	•	 	Clinical Publications (during first 12 months post PDUFA*)

	•	 	Non-Clinical Publications

	•	 	Disease State / QoL Publications

	•	 	Exploratory Studies*

	•	 	FDA Required Studies*

	•	 	Post Marketing Studies*

	•	 	Medical Conventions and Association Meetings

 

 

Activities Included (2 of 3)

	•	 	Association Support

	•	 	RSM Management

	•	 	RSM Hiring & Staffing

	•	 	RSM Training

	•	 	Medical Information: Unsolicited Requests and Patient Inquiries

	•	 	Medical Information: Product Complaints

	•	 	Medical Information — Pharmacovigilance

	•	 	CME

	•	 	Educational Grants

	•	 	IIT — Support of Life Cycle Management

	•	 	IIT — Exploratory / Outside of LCM

	•	 	Health Outcomes / Quality of Life Research

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Activities
Included (3 of 3)

	•	 	Label Negotiations

	•	 	Med / Reg / Legal Review

	•	 	DDMAC Review and Submissions

 

 

Message Development

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	Strategy Definition
	 	 	 	 
	Market Research

	 	C
	 	A/R
	Message Development

	 	C
	 	A/R
	Execution
	 	 	 	 
	Message Testing and Fine-Tuning

	 	C
	 	A/R
	Marketing Material Creation

	 	C
	 	A/R
	ROI Assessment for Market Material

	 	C
	 	A/R

 

 

KOL Identification

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	Strategy Definition
	 	 	 	 
	Develop KOL plan

	 	C
	 	A/R
	Execution
	 	 	 	 
	Develop KOL database

	 	C
	 	A/R
	Establish selection criterion for national, regional and
local KOLs

	 	C
	 	A/R
	Conduct search to identify national and regional influencers

	 	C
	 	A/R
	Develop key messages for contacts

	 	C
	 	A/R
	Update KOL plan & database

	 	C
	 	A/R
	Develop and manage KOL website

	 	C
	 	A/R
	Management of official communication to National KOLs
regarding commercial activities

	 	C
	 	A/R
	Management of official communication to Regional & Local
KOLs regarding commercial activities

	 	C
	 	A/R

 

 

National Ad Boards to Support Commercial Activities

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop Ad board plan including timing, messages, and attendants
	 	C	 	A/R
	Define roles and responsibilities for contacting ad board members
	 	C	 	A/R
	Execution
	 	 	 	 
	Development of scientific content for meetings
	 	R	 	A/R
	Manage Ad board logistics including meeting space, timing and vendor selection
	 	C	 	A/R
	KOL logistics including invitations, consulting agreements and travel
	 	C	 	A/R
	Content preparation including objectives, agenda and slide development
	 	C	 	A/R
	Execution of ad board including identification and management of vendors
	 	C	 	A/R
	Follow up with faculty members and other participants
	 	C	 	A/R

 

 

Regional Ad Boards to Support Commercial Activities

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop Ad board plan including timing, messages, and attendants
	 	C	 	A/R
	Define roles and responsibilities for contacting ad board members
	 	C	 	A/R
	Execution
	 	 	 	 
	Manage Ad board logistics including meeting space, timing and vendor selection
	 	C	 	A/R
	KOL logistics including invitations, consulting agreements and travel
	 	I	 	A/R
	Content preparation including objectives, agenda and slide development
	 	I	 	A/R
	Execution of ad board including identification and management of vendors
	 	C	 	A/R
	Follow up with faculty members and other participants
	 	I	 	A/R

 

 

Speaker Bureau (for Peer-to-Peer Promotion)

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Identification and recruitment of potential speakers
	 	C	 	A/R
	Execution
	 	 	 	 
	Speaker slide development
	 	C	 	A/R
	Conduct speaker training, including content development, meeting logistics and ancillary events
	 	I	 	A/R
	Determine the frequency, reach and scope of speaker programs
	 	I	 	A/R
	Manage speaker bureau logistics
	 	I	 	A/R
	Rep speaker recruitment logistics including nomination forms
	 	I	 	A/R
	Develop speaker portal to manage interactions with KOLs
	 	I	 	A/R

 

 

Clinical Publications (during first 12 months post PDUFA*)

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop commercial publication plan
	 	R	 	A
	Execution**
	 	 	 	 
	Determine commercial messages
	 	C	 	A/R
	Determine scientific content
	 	A/R	 	C
	Identify authors
	 	A/R	 	C
	Draft outline and publication
	 	A/R	 	C
	Publication review
	 	A/R	 	R
	Submit publication
	 	A/R	 	C
	Management & administration of publication vendor
	 	A/R	 	R

 

			
	*	 	PDUFA date is [**]
	 
	**	 	Roles and responsibilities for execution of non clinical publications are subject to Annex 2
in Supplemental Agreement

 

 

Non-Clinical Publications (during first 12 months post PDUFA*)

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop commercial publication plan
	 	R	 	A
	Execution**
	 	 	 	 
	Determine commercial messages
	 	C	 	A/R
	Determine scientific data
	 	A/R	 	C
	Identify authors
	 	A/R	 	C
	Draft outline and publication
	 	A/R	 	C
	Publication review
	 	A/R	 	R
	Submit publication
	 	A/R	 	C
	Management & administration of publication vendor
	 	A/R	 	R

 

			
	*	 	PDUFA date is [**]
	 
	**	 	Roles and responsibilities for execution of non clinical publications are subject to Annex 2
in Supplemental Agreement

 

 

Disease State / QoL Publications

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop commercial publication plan
	 	C	 	A/R
	Execution*
	 	 	 	 
	Determine messages
	 	C	 	A/R
	Solicit studies (if necessary)
	 	I	 	A/R
	Identify authors
	 	I	 	A/R
	Draft outline and publication
	 	I	 	A/R
	Publication review
	 	C	 	A/R
	Submit publication
	 	I	 	A/R
	Management & administration of publication vendor
	 	C	 	A/R

 

			
	*	 	Roles and responsibilities for execution of non clinical publications are subject to Annex 2
in Supplemental Agreement

 

 

Exploratory Studies*

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop plan for exploratory studies
	 	C	 	A/R
	Prepare plan
	 	A/R	 	R
	Execution
	 	 	 	 
	Develop protocols and study designs
	 	A/R	 	C
	Develop and initiate studies
	 	A/R	 	C
	Manage studies
	 	A/R	 	C
	Analyze study results
	 	A/R	 	C
	Publish study results
	 	R	 	A

 

			
	*	 	Studies include those that explore a new indication or formulation other than those
identified in the contract. These include, but are not limited to, preclinical to studies and
proof of concept studies.

 

 

FDA Required Studies*

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definitions
	 	 	 	 
	Develop study plans
	 	C	 	A/R
	NPV and market assessment
	 	C	 	A/R
	Prepare plan
	 	C	 	A/R
	Execution
	 	 	 	 
	Develop protocols and study designs
	 	A/R	 	C
	Develop and initiate studies
	 	A/R	 	C
	Manage studies
	 	A/R	 	C
	Analyze study results
	 	A/R	 	C
	Publish study results
	 	A/R	 	C

 

			
	*	 	Studies include all those required by the FDA to support approval and marketability of
Amitiza. These include, but are not limited to, drug interaction studies, renal and hepatic
studies.

 

 

Post Marketing Studies*

	 	 	 	 	 
	 	 	TPNA
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop post-marketing study plan

	 	C
	 	A/R
	NPV and market assessment

	 	C
	 	A/R
	Prepare plan

	 	C
	 	A/R
	Execution
	 	 	 	 
	Develop protocols and study designs	 	Responsibilities will be in accordance with the
SOPs developed for Phase IV Marketing Support
Studies and Publications
	Develop and initiate study
	 
	Manage studies
	 
	Analyze study results
	 
	Publish study results
	 

 

			
	*	 	Studies include all those deemed necessary to support the commercial success of Amitiza.
These include, but are not limited to, long term efficacy studies, QD dosing studies, and
studies to bolster elderly claim.

 

 

Medical Conventions and Association Meetings

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definitions
	 	 	 	 
	Determine convention plan
	 	C	 	A/R
	Execution
	 	 	 	 
	Determine key messages
	 	C	 	A/R
	Develop exhibit material, publications and presentations, including PR
	 	C	 	A/R
	Plan and execute convention logistics
	 	I	 	A/R
	Staff medical booths
	 	C	 	A/R
	Conventions follow-up
	 	C	 	A/R

 

 

Association Support

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Determine appropriate associations and level of support
	 	C	 	A/R
	Execution
	 	 	 	 
	Manage relationships
	 	C	 	A/R
	Manage grant and funding requests from associations
	 	I	 	A/R

 

 

RSM Management

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Alignment of commercial messages and RSM activities
	 	C	 	A/R
	Execution
	 	 	 	 
	Ongoing RSM management and administration
	 	I	 	A/R
	Assignment of territory deployment
	 	I	 	A/R

 

 

RSM Hiring & Staffing

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	RSM resource development (group size, territories, etc.)
	 	C	 	A/R
	RSM hiring
	 	I	 	A/R
	Execution
	 	 	 	 
	RSM slide set development
	 	C	 	A/R
	Thought leader development
	 	C	 	A/R
	Support internal education
	 	I	 	A/R
	Support grants and CME
	 	I	 	A/R
	Support IIT
	 	C	 	A/R
	Support medical meetings
	 	C	 	A/R
	Support managed markets activities
	 	I	 	A/R
	Support speaking training
	 	C	 	A/R
	Support sales training
	 	I	 	A/R

 

 

RSM Training

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	RSM training definition
	 	C	 	A/R
	Execution
	 	 	 	 
	RSM training
	 	C	 	A/R

 

 

Medical Information: Unsolicited Requests and Patient Inquiries

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Call center structuring and contracting
	 	I	 	A/R
	Infrastructure development (staffing, CRM, content management)
	 	I	 	A/R
	Execution
	 	 	 	 
	Define FAQs and standard response letters
	 	C	 	A/R
	Patient inquiries scripts
	 	C	 	A/R
	Managed Markets support & AMCP dossier preparation
	 	I	 	A/R
	Medical Information operations / contractor management
	 	I	 	A/R
	Infrastructure maintenance
	 	I	 	A/R
	Custom responses
	 	C	 	A/R
	Suspected Adverse Events data collection
	 	I	 	A/R
	PIR analysis and report out
	 	I	 	A/R

 

 

Medical Information: Product Complaints

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Process and infrastructure development
	 	A/R	 	C
	Execution
	 	 	 	 
	Call handling procedures
	 	C	 	A/R
	Contractor management
	 	A/R	 	C
	Product Complaints follow up
	 	A/R	 	C
	Intercompany product complaint / activity reporting/QA
	 	A/R	 	C

 

 

Medical Information – Pharmacovigilance

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Process and SOP definition
	 	A/R	 	C
	Execution
	 	 	 	 
	Call handling procedures
	 	C	 	A/R
	Adverse Event follow up and adjudication
	 	A/R	 	C
	AE database and reporting
	 	A/R	 	C
	FDA response and interface
	 	A/R	 	C
	Intercompany pharmacovigilance reporting
	 	A/R	 	C

 

 

CME

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop educational strategy
	 	C	 	A/R
	Evaluate new / innovative opportunities
	 	C	 	A/R
	Execution
	 	 	 	 
	Identify, select and manage CME vendor
	 	C	 	A/R
	Gap analysis
	 	C	 	A/R
	Request and evaluate proposals from providers
	 	C	 	A/R
	Manage interactions with providers and monitor compliance
	 	I	 	A/R
	Manage delivery process and budget compliance
	 	I	 	A/R
	Evaluate summary and outcomes
	 	C	 	A/R

 

 

Educational Grants

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Develop educational strategy
	 	C	 	A/R
	Execution
	 	 	 	 
	Ensure that educational strategy is aligned with KOL strategy
	 	C	 	A/R
	Gap analysis
	 	I	 	A/R
	Evaluate grant proposals
	 	I	 	A/R
	Manage delivery process and budget compliance
	 	I	 	A/R
	Evaluate summary and outcomes
	 	I	 	A/R

 

 

IIT – Support of Life Cycle Management

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Define IIT process
	 	C	 	A/R
	Define IIT strategy
	 	C	 	A/R
	Ensure IIT strategy is aligned with LCM strategy
	 	C	 	A/R
	Execution
	 	 	 	 
	Gap analysis
	 	C	 	A/R
	Review and decide on proposals*
	 	C	 	A/R
	Manage and monitor approved studies
	 	C	 	A/R
	Review study results and publications
	 	C	 	A/R
	Ensure drug supply is delivered to participating sites
	 	A/R	 	C

 

			
	*	 	SPI a role on the IIT committee will be similar to that of TPNA commercial representative and
medical director

 

 

IIT – Exploratory / Outside of LCM

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Define IIT process
	 	A/R	 	R
	Define IIT strategy
	 	A/R	 	R
	Execution
	 	 	 	 
	Gap analysis
	 	A/R	 	C
	Review and evaluate proposals
	 	A/R	 	C
	Manage and monitor approved studies
	 	A/R	 	I
	Review study results and publications
	 	A/R	 	I

 

 

Health Outcomes / Quality of Life Research

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Identify outcomes research needs
	 	C	 	A/R
	Outcomes publication plan
	 	C	 	A/R
	Execution
	 	 	 	 
	Solicit study investigators (if necessary)
	 	C	 	A/R
	Data mining
	 	C	 	A/R
	AMCP dossier (with budget impact model) preparation
	 	I	 	A/R
	Patient reported outcomes instrumentation (HRQoL)
	 	I	 	A/R
	Patient registry
	 	I	 	A/R
	Cost-effectiveness Pharmacoeconomic model
	 	I	 	A/R
	Burden of illness analysis
	 	I	 	A/R

 

 

Label Negotiations

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Label defense preparation
	 	A/R	 	C
	Execution
	 	 	 	 
	Label defense training
	 	A/R	 	C
	Label negotiations
	 	A/R	 	C
	Contingency planning for label
	 	A/R	 	C
	Risk management program development
	 	A/R	 	C
	Development of risk management program (if required)
	 	??	 	??

 

 

Med / Reg / Legal Review

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Process definition
	 	 	 	 
	Prioritization guidelines definition
	 	 	 	 
	Document planning / inventory
	 	 	 	 
	Define PI requirements
	 	 	 	 
	Execution
	 	 	 	 
	Manage review priorities and calendar
	 	 	 	 
	Execute review process
	 	 	 	 
	Proofread promotional material (accuracy, grammar, consistency, references)
	 	 	 	 
	Med / Reg / Legal review of promotional material (content, risk analysis, next steps or approval)
	 	 	 	 
	Track PI versions, create promotional PI and brief summaries
	 	 	 	 
	Track projects and releases
	 	 	 	 

NOTE: SOPs being developed to identify roles and responsibilities for each of these
activities

 

 

DDMAC Review and Submissions

	 	 	 	 	 
	Activity	 	SPI	 	TPNA
	 
	Strategy Definition
	 	 	 	 
	Define DDMAC process
	 	 	 	 
	Define DDMAC requirements
	 	 	 	 
	Execution
	 	 	 	 
	Interface with internal clients (Sales / Marketing / etc.)
	 	 	 	 
	Interface with external clients (DDMAC)**
	 	 	 	 

NOTE: SOPs being developed to identify roles and responsibilities for each of these
activities

 

 

ANNEX 4: Med/Reg/Legal Review SOPs

TITLE: Standard Operating Procedure (“SOP”) regarding review and approval of promotional,
sales training or other related materials between Sucampo Pharmaceuticals, Inc. (“SPI”), Takeda
Pharmaceutical Company Limited (“TPC”) and TPC’s Affiliates, including Takeda Pharmaceuticals North
America, Inc. (“TPNA”) (TPC and its Affiliates, collectively “Takeda”)

Effective Date: January 31, 2006

Supersedes: N/A

VERSION: 1

PURPOSE: To establish the procedures between SPI and Takeda regarding the review and approval of
promotional, sales training or other related materials to be utilized in the commercialization of
Lubiprostone (“Promotional Piece”) under the Collaboration and License Agreement between SPI and
Takeda dated October 29, 2004 (“Collaboration and License Agreement”). Nothing contained in this
SOP shall be deemed to modify or amend any provision of the Collaboration and License Agreement or
the Agreement among SPI, Takeda and SAG dated October 29, 2004.

RESPONSIBILITIES: Each company is responsible for ensuring that its own employees who are involved
in the review and approval of Promotional Pieces, and the employees of its Affiliates who are
involved in the review and approval of Promotional Pieces, have read, understood and comply with
this SOP. Takeda will be responsible for the preparation, review and approval of any Promotional
Piece.

PROCEDURES:

Takeda and SPI will comply with all applicable laws, rules and regulations relating to the
promotion of pharmaceutical products.

Takeda will prepare (or oversee the preparation by its vendors of) each Promotional Piece and
submit each such Promotional Piece to Takeda’s Med/Reg/Legal Review Committee for approval.

Following initial review by Takeda’s Med/Reg/Legal Review Committee, Takeda will submit (or cause
its vendors to submit) to SPI for SPI’s Med/Reg/Legal review and comment Promotional Pieces that
include any major new messages, claims or campaigns not already reviewed by SPI and approved by
Takeda’s Med/Reg/Legal Review Committee. Takeda also will provide a summary of the outcome of such
initial review, noting any changes and the rationale for such changes. Promotional Pieces will be
sent to SPI’s contact person identified in item 8 below by email, facsimile or mail, as
appropriate. For the avoidance of doubt, once a major, new Promotional Piece has been approved by
Takeda’s Med/Reg/Legal Review in accordance with

 

 

this SOP, any supplemental Promotional Pieces repeating the same already approved message, claim or
campaign will not require further SPI Med/Reg/Legal review.

Within four (4) business days after receipt of such Promotional Piece, SPI will provide Takeda with
SPI’s comments and related rationale or notify Takeda that SPI has no comments. If SPI does not
contact Takeda and/or provide SPI’s comments and related rationale within such 4-day period, then
SPI shall be deemed to have accepted the Promotional Piece. SPI shall provide its comments and
related rationale orally to the contact person identified in item 8 below.

Takeda’s contact person shall communicate SPI’s comments and related rationale to the other members
of Takeda’s Med/Reg/Legal Review Committee. To the extent Takeda’s Med/Reg/Legal Review Committee
disagrees with any of SPI’s comments, Takeda’s representatives from its Med/Reg/Legal Review
Committee shall discuss such comment(s) with his/her counterpart on SPI’s Med/Reg/Legal Review
Committee.

Takeda, in good faith, will take into consideration any SPI comments and related
rationale during Takeda’s final Med/Reg/Legal review for such Promotional Piece; provided, however,
Takeda shall have final approval authority for all Promotional Pieces to be used by either Takeda
or SPI. In any event, Takeda will provide a summary of the outcome of such final review noting any
changes and the rationale for such changes.

Takeda will provide SPI with the final version of each Promotional Piece once the Med/Reg/Legal
review is completed.

The primary contacts for communications under this SOP shall be:

	 	 	 	 	 	 	 
	 

	 	For Takeda:
	 	For SPI:
	 	Robert Cormack
	 

	 	to be determined no later than
	 	 	 	Regulatory Manager
	 

	 	February 15, 2006
	 	 	 	 r.cormack@sucampo.com
	 

	 	 	 	 	 	Tel (301) 961-3400 x163
	 

	 	 	 	 	 	Fax (301) 961-3440

Either Takeda or SPI may change its contact person at any time upon written notice to the other.

 

 

Takeda will be responsible for all communications with DDMAC, pre-clearance submissions with DDMAC
and preparing and filing FDA form 2253 with DDMAC for each Promotional Piece. Prior to the filing
of the first of such FDA forms 2253, SPI shall provide written notification to the FDA authorizing
Takeda as SPI’s designee for interactions relating to Promotional Pieces. Takeda will
send to SPI via e-mail a scanned signed copy of FDA Form 2253 at time of submission to DDMAC.

Any dispute relating to this SOP shall be referred to the JCC for discussion and resolution. If
the JCC is unable to agree on a solution, then the matter shall be handled under the dispute
resolution provisions of the Collaboration and License Agreement, including Section 3.1.

DEFINITIONS

     Any capitalized terms not defined in this SOP shall have the same meaning as set forth in
Article 1 of the Collaboration and License Agreement.

 

 

ANNEX 5: Press Releases

TITLE: Standard Operating Procedure (“SOP”) regarding development and approval of
Press Materials and Media Relations Activities (both as defined below) development
between Sucampo Pharmaceuticals, Inc. (“SPI”), Takeda Pharmaceutical Company
Limited (“TPC”) and TPC’s Affiliates, including Takeda Pharmaceuticals North America,
Inc. (“TPNA”) (TPC and its Affiliates collectively “Takeda”)

Effective Date: January 31, 2006

Supersedes: N/A

VERSION: 1

PURPOSE: To establish the procedures between SPI and Takeda regarding the development and approval
of Press Materials (as defined below) and Media Relations Activities (as defined below) and
maintenance of the confidentiality of Confidential Information (including Proprietary Product
Information) under the Collaboration and License Agreement between SPI and Takeda dated October 29,
2004 (“Collaboration and License Agreement’). Nothing contained in this SOP shall be deemed to
modify or amend any provision of the Collaboration and License Agreement or the Agreement among
SPI, Takeda and Sucampo AG dated October 29, 2004.

RESPONSIBILITIES: Each company is responsible for ensuring that its own employees who are involved
in developing Press Materials and participating in Media Relations Activities, and the employees of
its Affiliates who are involved in developing Press Materials and participating in Media Relations
Activities, read, understand and comply with this SOP.

PROCEDURES:

Any Press Materials and/or materials for Media Relations Activities prepared by either SPI or
Takeda shall be submitted to the other party for review and comment prior to any public release
thereof.

The party reviewing the Press Materials and/or materials for Media Relations Activities shall
provide comments encompassing all relevant internal reviews on such materials as soon as reasonably
practical but no later than 8 business days after receipt of such materials. In the event of an
emergency, crisis, time-sensitive issue or time-sensitive media request that requires same day or
immediate response, responsive materials will be developed, reviewed and approved by both parties
via electronic mail within 2 hours.

In the case of review of such materials by SPI, SPI shall determine whether Sucampo AG IP review is
necessary and, if so, shall also obtain and provide to Takeda comments from Sucampo AG within the
applicable review period.

 

 

In the case of review of press releases by Takeda, Takeda shall obtain and provide to SPI comments
from TPC within the applicable review period.

The party preparing the Press Materials and/or materials for Media Relations Activities shall
consider in good faith any comments received by the reviewing party and, if necessary, discuss with
the other party appropriate revisions to such materials taking into account relevant circumstances.
If SPI provides comments relating to marketing or promotional issues, Takeda shall be required to
submit such comments through the Med/Reg/Legal review process outlined in the SOP agreed by SPI and
Takeda dated January 31, 2006 titled “Med/Reg/Legal Review Process” to the extent the issues relate
to such SOP.

The party preparing the Press Materials and/or materials for Media Relations Activities shall
provide the other party with a copy of the final version of such materials.

The primary contacts for communications under this SOP shall be:

	 	 	 	 	 
	 

	 	For Takeda:
	 	For SPI:

	 	 	 	 	 
	 

	 	Jocelyn Gerst
	 	Kei Tolliver
	 

	 	Manager, Product Public Relations
	 	Director, Legal and BD
	 

	 	Tel: 847-383-3696
	 	Tel: 301-961-3400
	 

	 	Cell: 847-769-6889
	 	Fax: 301-961-3440
	 

	 	jgerst@tpna.com
	 	k.tolliver@sucampo.com

     Either Takeda or SPI may change their respective contact person at any time upon written
notice to the other.

All press releases shall identify both parties and shall include, for both parties, media contact
information, quotes (where appropriate) and a company description. As an example, Sucampo and
Takeda’s current company description are attached in Exhibit 1 hereto.

Press Materials shall be distributed as follows: press releases and media alerts will be
distributed, at a minimum, via the paid newswires PR Newswire, EurekAlert, MarketWire and Newswise.

Each party shall be entitled to respond to any press inquiry based on approved Press Materials
and/or approved materials for Media Relations Activities.

Any dispute relating to this SOP shall be referred to the JCC for discussion and resolution. If
the JCC is unable to agree on a solution, then the matter shall be handled under the dispute
resolution provisions of the Collaboration and License Agreement, including Section 3.1.

DEFINITIONS

     Confidential Information: Confidential Information shall have the same meaning as set forth
in Article I of the Collaboration and License Agreement, subject to the provisions of Article 11 of
the Collaboration and License Agreement.

 

 

     Media Relations Activities: Media Relations Activities shall mean media efforts in response
to inquiries or proactive outreach, medical meeting data or publications support, and other
communications programs that are developed in support of the Development or Commercialization of the Product. For the avoidance of doubt, Press Materials does not
include publications, abstracts and manuscripts covered by other SOPs between SPI and Takeda.

     Press Materials: Press Materials shall mean information prepared for the purpose of
communicating in support of the Development or Commercialization of the Product that is intended to
be disclosed primarily to news media and investors, and may include press releases, media alerts,
media standby statements, FAQs (frequently asked questions), background information and other
supporting materials. For the avoidance of doubt, Press Materials does not include publications,
abstracts and manuscripts covered by other SOPs between SPI and Takeda.

     Proprietary Product Information: Proprietary Product Information shall have the same meaning
as set forth in Article 1 of the Collaboration and License Agreement. For the avoidance of doubt,
Proprietary Product Information includes, with respect to a Product, New Drug Application (NDA),
Investigational Drug Application (IND), Drug Master File (DMF), Investigator Brochure (IB) and any
Product information contained in SPI pending, non-published patent applications.

     Other: Any capitalized terms not defined in this SOP shall have the same meaning as set forth
in Article 1 of the Collaboration and License Agreement.

 

 

EXHIBIT 1

AMITIZATM is developed by Sucampo Pharmaceuticals, Inc. and will be jointly marketed
in the United States by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America,
Inc. and will be available to patients in Spring 2006.

Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is a science-driven pharmaceutical company, based in Bethesda, Md.,
focusing on gastrointestinal and specialty diseases. Sucampo has concentrated on developing and
commercializing drugs from its proprietary prostone technology platform, which was created by Ryuji
Ueno, M.D., Ph.D., Ph.D., Co-Founder, Executive Chair and Chief Scientific Officer of the company.
Prostones are a new class of functional fatty acid with a variety of physiological and
pharmacological activities. The first commercial prostone product, RESCULA®, was
launched in 1994 in Japan, and later approved in more than 40 other countries for the treatment of
glaucoma. AMITIZATM is Dr. Ueno’s second prostone product to be marketed in the United
States, and the first selective chloride channel activator for therapeutic use. To learn more
about the company and its products, visit www.sucampo.com.

In October 2004, Sucampo entered into an agreement with Takeda Pharmaceutical Company Limited
(Osaka, Japan) to jointly market AMITIZATM in the United States and Canada. Takeda
Pharmaceuticals America, Inc. and Takeda Pharmaceuticals North America, Inc. are US subsidiary
companies of Takeda. To learn more about Takeda, visit www.takeda.co.ip and
www.tpna.com

Takeda Pharmaceuticals North America, Inc.

Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned
subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.
In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol lowering and
gastroenterology treatments, and through the Takeda Global Research & Development Center, Inc. the
company has a robust pipeline with compounds in development for diabetes, cardiovascular disease
and other conditions. Takeda is committed to striving toward better health for individuals and
progress in medicine by developing superior pharmaceutical products. To learn more about the
company and its products, visit www.tpna.com.

 

 

ANNEX 6: Safety Data, Postmarketing Activities, and

Clinical Trial Activities SOPs

TITLE: Standard Operating Procedure (SOP) for Management of Safety Information On
Lubiprostone between Sucampo Pharmaceuticals, Inc. (“SPI”), Takeda Pharmaceutical Company Limited
(“TPC”) and TPC’s Affiliates, including Takeda Pharmaceuticals North America (“TPNA”) (TPC and its
Affiliates, collectively “Takeda”)

Effective Date: January 31, 2006

Supersedes: N/A

VERSION: 1

Attachments

	1.	 	Responsible Persons and Contact Persons
	 
	2.	 	Agreed Causal Relationship between an AE and a Marketed Drug at SPI
	 
	3.	 	Causal Relationship between an AE and a Marketed Drug
	 
	4.	 	Agreed Relationship between Causality Assessment and Reportability

 

 

Standard Operating Procedure (SOP)

For Management of Safety Information

On Lubiprostone

Scope

Sucampo Pharmaceuticals, Inc (hereinafter “SPI”) and Takeda Pharmaceuticals Company, Limited
(“TPC”) and TPC’s Affiliates, including Takeda Pharmaceuticals North America, Inc. (“TPNA”)
(TPC and its Affiliates, including TPNA, collectively “Takeda”) should make the greatest
effort to ensure the safety of Lubiprostone and to fully comply with all regulatory
requirements through the close exchange of information and mutual cooperation as set forth
below.

This SOP describes the procedures and timeframes and defines the responsibilities of SPI and
Takeda to assure compliance with all applicable laws and regulations pertaining to safety
reporting.

All parties commit to following the ICH harmonized tripartite guidelines.

Definitions

Takeda

Takeda means Takeda Pharmaceutical Company, Limited (“TPC”) and its Affiliates, including
Takeda Pharmaceuticals North America, Inc. (“TPNA”).

SPI

SPI means Sucampo Pharmaceuticals, Inc. SPI is the holder of Marketing Authorization (MAH).

SPI Affiliate

SPI Affiliate means by any company that markets Lubiprostone under a license granted by SPI.
However, SPI Affiliate does not mean Takeda.

Designee

Designee means any company, business, organization, or other person that performs the
duties, functions, operations or activities that are the responsibilities of either SPI or
Takeda as defined by this SOP. “SPI’s Designee” does not mean Takeda.

 

 

[**], doing business as (“[**]”) is SPI’s worldwide Designee, including U.S. regulatory and safety
reporting.

Adverse Event (AE)

Adverse event (hereinafter AE) means all untoward medical occurrences with a marketed
product or in a trial subject treated with a medicinal product and not necessarily only
those in which the causal relationship to the medicinal product is clear.

AEs include all untoward or unintended signs (including abnormalities in laboratory test
values), symptoms or illness that occurs in association with the administration of a
medicinal product.

Adverse Drug Reaction (ADR)

With respect to pre-approval clinical trials with an investigational drug (including a trial
for obtaining approval for additional indication(s)), adverse drug reaction (hereinafter
ADR) means all noxious and unintended responses to a medicinal product at any dose. As used
in the previous sentence, the phrase “response to a medicinal product” means that a causal
relationship between the medicinal product and the AE is at least a reasonable possibility,
i.e., a relationship cannot be ruled out.

Regarding a marketed drug, ADR means a noxious and unintended response to a medicinal
product used for prophylaxis, diagnosis or therapy of disease or for modification of
physiological function.

Serious Adverse Event (SAE)

The term SAE means any untoward medical event that at any dose:

Results in death,

Is life-threatening,

 

 

Note: The term “life-threatening” in the definition of “SAE” refers to an event in which
the patient was at risk of death at the time of event; it does not refer to an event which
hypothetically might have caused the death if it were more severe.

Requires inpatient hospitalization or prolongation of present hospitalization.

Results in persistent or significant disability/incapacity,

Is a congenital anomaly/birth defect, or

Is an important medical event that may not be immediately life-threatening or result in death or
hospitalization but may jeopardize the health of the patient or may require intervention to prevent
one of the above (1) — (5).

Note: The term “severe” is often used to describe the intensity (severity) of a specific
event (as in mild, moderate or severe myocardial infarction); the event itself however may
be of relatively minor medical significance (such as a severe headache). This is not the
same as “serious,” which is based on patient/event outcome or action criteria usually
associated with events that pose a threat to a patient’s life or functioning. Seriousness
(not severity) serves as a guide for defining regulatory reporting obligations.

Non-Serious AE

The term non-serious AE means an AE which cannot be categorized as an SAE.

Expected/Unexpected ADR/AE

If the nature, severity, specificity and outcome of an ADR in the case of a marketed drug
are consistent with the information listed in the current package insert or on product label
in the country concerned, the ADR is deemed to be expected. In the case of an
investigational drug, the criteria for determining whether an ADR is expected or unexpected
are the same, except that the reference information is the investigator’s brochure in the
country concerned. If an ADR is not listed in the specified reference information or the
nature, severity, specificity or outcome of the ADR is not consistent with the description
in the aforesaid information, the ADR is deemed to be unexpected.

 

 

Expedited Report

Expedited report means an AE/ ADR report which an IND/NDA holder in a specific country is
required to submit to the regulatory authorities immediately or at latest within a specified
number of days in accordance with the regulations of the country concerned. The specified
number of days and the criteria used to determine whether or not an expedited report must be
submitted vary from country to country.

Time-Clock-Start-Point

Time-clock-start-point means the date when SPI or Takeda personnel, including any clinical
research organization working on behalf of SPI or Takeda, have obtained the minimum
information which is necessary for transmission of an AE case report. For example, the
clock will start upon the receipt of a valid report. For the purpose of data exchange, the
time-clock starts at this point as day zero; however, in cases where the information is such
as that shown in Section 5.2, the time-clock starts at the time when SPI or Takeda has
obtained any such information. This applies to both initial and follow-up information.

Health Care Professionals and Non-Health Care Professionals

Health Care Professionals (hereinafter HCPs) are physicians, dentists, pharmacists, nurses,
physician’s assistants (PAs) and coroners. Non-Health Care Professionals are all people
other than HCPs, such as consumers and attorneys.

Company Core Data Sheet (CCDS)

The Company Core Data Sheet (hereinafter CCDS) is a document that is the responsibility of
SPI and [**], to prepare, which contains, in addition to safety

 

 

information, material related to indications, dosing, pharmacology and other information concerning the product
for which has Marketing Authorization (hereinafter MA).

Company Core Safety Information (CCSI)

Company Core Safety Information (hereinafter CCSI) means all relevant safety information
contained in the CCDS and which SPI shall make the effort to have the CCSI listed worldwide.

Listed/Unlisted AE

If the nature, severity, specificity and outcome of an ADR are consistent with the
descriptions in the CCSI, the ADR is regarded as “Listed,” and if they are not consistent
with the descriptions, the ADR is regarded as “Unlisted,” The terms listed and unlisted
apply only to preparation of the Periodic Safety Update Report (hereinafter PSUR)

International Birth Date (IBD)

The International Birth Date (hereinafter IBD) is the date of the first marketing
authorization for a new medicinal product granted to any company in any country. Regarding
Lubiprostone, January 31, 2006 is designated as the IBD.

Data Lock-Point (data cut-off date)

The data lock-point is the date designated as the cut-off date for data to be included in a
PSR. It is based on the IBD and should usually be in increments of six months.

Periodic Safety Report (“PSR”)

The PSR, based on the ICH-E2C guidelines, is a document which the MAH is required to submit
to the U.S. regulatory authorities according to the relevant regulations. The PSR is an
overall evaluation of safety information on the marketed drug for a period of every three
(3) months for the first three (3) years counted from the IBD, and every six (6)

 

 

months for the following two (2) years. Subsequent reporting will be in compliance with the
regulations and laws in effect at that time.

Phase IV Marketing Support Studies

Phase IV Marketing Support Studies means Phase IV Studies to the extent the data from such
studies is not intended for the primary purpose of Regulatory Required Studies, Labeling
Changes, Additional Indications or New Formulations.

Safety Reporter means SPI, the Party that is the holder of the IND and NDA. SPI has sole
responsibility for reporting AEs and submitting all safety reports and updates to regulatory
authorities under this SOP. SPI’s Designee for worldwide safety reporting is [**].

Capitalized terms used herein but not otherwise defined shall have the meanings ascribed to them in
the Collaboration and License Agreement, dated October 29, 2004, between SPI and TPC.

Responsible Organizationl Persons and Contact Persons

To ensure effective communication and exchange of questions and opinions on safety
information and measures to be taken, both Takeda and SPI shall designate a person to be
responsible for exchange of safety information after marketing approval (as per Attachment
1). In the case of any change in the responsible personnel at Takeda or SPI, the other
party shall be notified of the change immediately so that this information is always up to
date (Attachment I can be amended as personnel changes etc. necessitated). SPI shall, in
addition to identifying its own personnel, also identify one senior medical doctor contact
at [**].

Common Language

English shall be used as the common language for the exchange of information, the
transmission of individual AE case reports, periodic AE reports and the contents of package
inserts as well as the exchange of other important safety information between Takeda and
SPI.

Collection of Safety Information

SPI shall inform Takeda of all reports on Lubiprostone from the sources identified in
Section 5.1 or reports relating to the information described in Section 5.2, and their
subparts, and to clarify the source of information obtained each time. These obligations
apply to U.S. and worldwide sources of information.

AE Case Reports

Spontaneous Reports

 

 

	•	 	Spontaneous reports from HCPs

	•	 	Spontaneous reports from non-health care professionals, such as
attorneys and consumers (non-medically confirmed)

	•	 	Spontaneous reports where Lubiprostone is identified as a
concomitant or co-suspect medication

Regulatory Authorities Registries Reports

Case reports obtained indirectly though the regulatory authorities or regional
pharmacovigilance centers.

Medical Literature and Academic Conference Information

Case reports on Lubiprostone published in medical/pharmaceutical journals or proceedings of
academic conferences, etc.

Post-Marketing Investigations/Epidemiological Studies

Case reports obtained from post-marketing investigations/epidemiological studies which are
not carried out under Good Clinical Practice (hereinafter GCP).

Post-Marketing Clinical Trials

Case reports obtained from clinical trials conducted in compliance with GCP to investigate
the efficacy and safety of a marketed drug.

Pre-Approved Clinical Trials with an Investigational Drug

Case reports obtained from clinical trials carried out for the purpose of obtaining a
supplemental approval for additional indications, dosage forms, administration routes, etc.

Other Important Safety Information

Urgent and Important Information Related to Measures Taken, for Safety Reasons, by Regulatory
Authorities, by Takeda or by SPI

	•	 	Information related to post-marketing withdrawal of or a change in marketing authorization that may lead to a recall of
Lubiprostone or discontinuation of or restrictions on the marketing of Lubiprostone

	•	 	Information on any changes in indication, dosage, usage or administration

 

 

	•	 	Issuance of a “Dear Doctor Letter” or revision of the “Contraindications” or “Warnings” section of PIs /Labeling

Revision of Any Safety-Related Sections in PIs/Labeling

Information on revision of any safety-related sections in any PI/Labeling

An Increase in the Incidence of ADRs

Findings suggesting an increase in the incidence of expected serious ADRs to a clinically
important extent.

Lack of Efficacy, Exposing Patients to a Significant Hazard

Findings suggesting exposure of patients to a significant hazard, such as lack of efficacy
in a drug used for a life threatening disease

Results from Non-Clinical Studies Suggesting a Significant Hazard to Humans

Of the findings obtained from such non-clinical studies as mutagenicity, carcinogenicity or
teratogenicity studies conducted by internal or external research institutes, those results
suggesting a significant hazard to humans

Safety-Related Information Obtained from Mass Media or Consumer Organizations

Safety information on Lubiprostone, obtained from mass media, consumer organizations’
publications/internet sites, etc.

Notes:

The following information should be exchanged between SPI and Takeda in the same manner as
that for AE case reports (See Section 7).

	•	 	Pregnancy: Any case in which a patient is found to be pregnant during treatment with Lubiprostone and of which SPI or
Takeda becomes aware, regardless of whether an AE results or not.

	•	 	Overdose: Accidental or intentional overdose regardless of whether an AE results or not.

	•	 	Misuse or Abuse: All information on misuse or abuse regardless of whether an AE results or not

 

 

Responsibility for Safety Information

SPI, as the holder of the IND and NDA, shall have sole responsibility as Safety Reporter to report
any and all AEs in connection with and arising out of, in any manner whatsoever, post marketing
drug experience.

SPI, as the holder of the IND and NDA, shall have sale responsibility as Safety Reporter to report
any and all AEs in connection with and arising out of, in any manner whatsoever, any
studies falling under the categories of Regulatory Required Studies, Labeling Changes, Additional
Indications or New Formulations.

SPI, as the holder of the IND and NDA, shall have responsibility as Safety Reporter to submit
reports for any and all AEs in connection with and arising out of, in any manner whatsoever, any
studies falling under the categories of Phase IV Marketing Support Studies not conducted by SPI.
The report shall be generated as per the requirements of Section 8.3 below.

SPI’s Designee, [**], shall fulfill SPI’s responsibilities for world-wide safety reporting,
including safety reporting required by U.S. Federal and state law or regulation. Additionally,
[**] shall, as SPI’s Designee, also have the duty to fulfill all of SPl’s duties and obligations as
defined by this SOP.

Notwithstanding any other provision of this Section 6 of this SOP or any other agreement between
the Parties, if Takeda, in its sole discretion believes that SPI, SPI’s Designee, SPI’s Affiliate,
and/or [**] has failed to make a report required by U.S. Federal or state law or regulation, or the
laws or regulations of any other country in which Takeda sells or promotes Lubiprostone, or has
made an inaccurate or incorrect report, or has made a report that is not in the best interests of
the safety and health of patients taking Lubiprostone, Takeda shall first contact SPI and discuss
such issue with SPI’s Medical Directors, including whether or not the matter in question must be
reported. If SPI’s assessment differs from the assessment of Takeda, SPI and Takeda shall exchange
opinions in an effort to agree on one opinion. However, if SPI and Takeda cannot agree, Takeda may
make its own report to the affected governmental regulatory authorities after having brought the
error, deficiency, defect, and/or failure to the attention of SPI or [**], and SPI or [**] either
expressly declines to take proper corrective action, which declination is confirmed by a writing,
or fails to take proper corrective action on a timely basis.

Assessment of Safety Information by Takeda and SPI

An individual AE case report received by Takeda or SPI shall be reviewed by [**] to confirm
whether or not the contents of the case report meet the minimum requirements listed below.
If the contents meet the requirements, [**] shall make an assessment of the case report. If
the contents do not meet the requirements, [**] shall make a reasonable effort to obtain the
information which is lacking.

 

 

Minimum Requirements for Information Reporting

An AE case report must contain the following 4 items at the minimum to be considered
reportable:

An identifiable patient (e.g. patient initials, sex, age),

An identifiable reporter,

An event that can be identified and

A specifiable suspect drug.

Identification Number

SPI or [**] shall assign a unique identification number to each AE case report. Cases
arising from Takeda’s Phase IV Marketing Support Studies shall receive a unique Takeda
identification number when entered into Takeda’s database. SPI or [**] shall also assign a
unique identification number, in addition to Takeda’s number, when such an AE case report is
sent to either of them.

Assessment of AEs

SPI or SPI’s Designee shall assess the following points for all AE case reports.

	 	•	 	Seriousness
	 
	 	•	 	Causal relationship to the medical product

Assessment of Seriousness

Seriousness should be assessed by a specialist who is well experienced in clinical matters,
and the judgment of the reporter in cases where the reporter is a medical specialist shall
be prioritized, in principle. Regardless of whether the reporter is a medical specialist or
not, if a case which has been assessed as non-serious by a reporter is judged as serious in
accordance with the ICH criteria by [**], the case will be handled as a serious case. On
the other hand, if a case which has been assessed as serious by the reporter, is judged by

 

 

[**] as non-serious, [**] shall consult with the reporter, and, only in the event that the
reporter’s written consent is obtained, the case will be handled as a non-serious case.
Such written consent shall be kept with the MedWatch and/or CIOMS file.

Assessment of Causal Relationship

The causal relationship between an AE and Lubiprostone shall be assessed according to Safety
Reporter’s criteria for determining the causal relationship, which shall be
consistent with best clinical and/or safety practices, and communicated in writing to
Takeda.

As to the relationship between an AE and a medicinal product, the causal relationship is
classified as one of five (5) or one of three (3) categories as shown in Attachment 2 and
Attachment 3, respectively. The relationship for causality assessment between SPI’s system,
[**]’s system and Takeda’s system is shown in Attachment 4.

Follow-Up Investigation

Whenever an AE case report is received from a non-health care professional [**] shall ask a
health care professional for validation of the case report. If the first report received
does not have necessary data, or when Takeda, [**] or SPI requests additional information,
[**] shall make reasonable efforts to obtain the requested information. SPI and [**] have
the duty to obtain additional and sufficient information from the reporter so that the case
can be assessed.

Management of “Blinded” Clinical Trial Cases

All reports of serious AEs from blinded clinical trials shall be assessed, regardless of
whether the blind for the individual case has been broken or not. If the blind has not been
broken, this shall be clearly stated in the information which is exchanged, and when the

 

 

blind is eventually broken, a follow-up report including therapy unblinding information
shall be sent within three (3) working days.

AE/ ADR Terminology

Takeda and SPI shall use the latest version of MedDRA as AE/ADR terminology.

Assessment of Other Important Safety Information

As regards safety information, other than individual case reports, as shown in Section 5.2.1
to 5.2.5, the Safety Reporter shall evaluate the information to determine, in its
opinion, what influence it could have on the risk/benefit profile of Lubiprostone and shall
notify Takeda of its opinions in addition to relevant safety information.

Exchange of Safety Information

The Parties shall work together to develop processes and training to ensure that all Takeda and SPI
Designees, employees and contractors are aware of the need to and methods for submitting AEs to the
Safety Reporter.

Transmission of AE Case Reports

Transmission of Serious AE Case Reports Arising out of Post-Marketing, and Clinical Trials That Are
Not Phase IV Marketing Support Studies, or Conducted by Takeda or its Designee

SPI and/or [**] shall conduct the medical review of all Adverse Events and shall make the
determination as to whether the Adverse Event is an expedited SAE. When SPI and/or [**]
assesses an AE case report categorized as “serious,” regardless of whether or not it is an
expected AE or whether or not the case has been unblinded in the case of a double-blind
clinical study/trial, the regulatory submission shall be timely filed within the appropriate
time frame as shown below (Refer to Section 2.12 Time-Clock-Start-Point), and the full
regulatory submission shall be transmitted to Takeda by facsimile or e-mail within three
days from the date that the regulatory submission was made.

Fatal or Life-Threatening AE Case Reports:

SPI and/or [**] shall transmit preliminary information to Takeda
by facsimile or e-mail as soon as practicable for the

 

 

protection of the health and safety of clinical trial subjects, and patients
taking Lubiprostone. SPI and/or [**] shall transmit the
regulatory submission, and any other relevant or material
information applicable to the safety and efficacy of Lubiprostone
to Takeda within three (3) days after the Safety Reporter’s
regulatory submission, or sooner if practicable.

Other Serious AE Case Reports:

The full regulatory submission shall be transmitted to Takeda by
facsimile or e-mail within three (3) days from the date that the
regulatory submission was made.

Analysis and IND Safety Letters for SAEs Requiring Expedited Reporting (“Expedited SAE”), Including
Serious Unexpected and Related:

For expedited SAEs, which includes Serious Unexpected and Related
SAEs, SPI and [**], through a Safety physician, will review all
source documents, conduct a literature review, and provide the
assessment of causality, expectedness and relatedness, and
narrative description which shall be reported to the regulatory
authorities. SPI and [**] will also develop and search the
preferred search terms and will review the entire Lubiprostone
safety database (clinical and post-marketing), to conduct an
Analysis of Similar Events which shall be submitted to the
regulatory authorities with the assessment of causality,
expectedness and relatedness (MedWatch and/or CIOMS) prepared by
[**] and SPI. Based on the medical review and the narrative
description and Analysis of Similar Events, [**] will draft an
IND Safety Letter and send the draft letter to Takeda for its
review.. Takeda shall have the right to comment on the draft IND
Safety Letter prepared by SPI or [**]. If SPI’s assessment
differs from the assessment of Takeda, SPI and Takeda shall
exchange opinions in an effort to agree on one opinion. However,
if the companies cannot agree, the more serious assessment shall
be taken as the final assessment and the final IND Safety Letter
will be distributed to all investigators, including investigators
for clinical trials conducted by Takeda or its designees, within
the regulatory required timeframes. SPI will be responsible for
the submission of the expedited safety report in MedWatch and/or
CIOMS format to the FDA (U.S. regulatory authority).

 

 

Transmission of Non-Serious AE Case Reports

With respect to case reports that SPI and/or [**] assess as “non-serious,” Takeda will have
the right to audit pursuant to Section 8.5 of this SOP.

Non-Serious Case Reports Obtained from Information Sources other than Clinical Trials/Studies:

With respect to case reports that SPI and/or [**] assess as
“nonserious,” Takeda will have the right to audit pursuant to
Section 8.5 of this SOP.

Non-Serious Case Reports Obtained from Clinical Trials/Studies:

SPI and/or [**] shall transmit the clinical trial report or CTR
to Takeda within fifteen (15) business days of completion of the
clinical trial report. SPI and/or [**] shall share the clinical
trial data with Takeda or its Designee upon request.

Formats

SAE reports should be made using MedWatch and/or CIOMS forms. The forms shall be sent
together with a “communication letter” which includes a section for confirmation of receipt.

The scope, timeframe, format and contents for the AE case reports are outlined in Attachment
6. (The parties will develop a mutually agreeable Attachment 6)

For Phase IV Marketing Support Studies conducted by Takeda

SAEs Requiring Expedited Reporting, Including Serious Unexpected and Related:

Takeda or its designee shall conduct the medical review of all Adverse Events and shall make
the determination as to whether the Adverse Event is an expedited SAE. For expedited SAEs,
Takeda or its Designee, through a Safety physician, will review all source documents,
conduct a literature review, and provide the assessment of causality, expectedness and
relatedness, and narrative description to [**], and which SPI shall report to the regulatory
authorities. Takeda or its Designee will also provide [**] with the preferred search terms
and [**] will review the entire Lubiprostone safety database (clinical and post-marketing)
to conduct an Analysis of Similar Events. Based on the medical review, narrative
description and Analysis of Similar Events [**] will draft an IND Safety Letter for the
approval of Takeda or its Designee, and send the approved

 

 

letter to all investigators,
including investigators for clinical trials conducted by Takeda or its Designee, within
regulatory required timeframes. Takeda shall have the right to comment on the draft IND
Safety Letter . If SPI’s assessment differs from the assessment of Takeda, SPI and Takeda
shall exchange opinions in an effort to agree on one opinion. However, if the companies
cannot agree, Takeda’s or its Designee’s assessment shall be taken as the final assessment.
[**] will be responsible for the submission of the expedited safety report in MedWatch
and/or CIOMS format to the FDA (U.S. regulatory authority).

SAEs That are Not Expedited, SAEs That are Expected and/or Not Related:

SAEs that are not expedited, SAEs that are expected and/or related, will remain in Takeda’s
database until the end of the trial at which time such SAEs will be shared with SPI and/or
[**] for the conduct of pharmacovigilance activities. Clinical trial data will be provided
to SPI and/or [**] within fifteen (15) business days of the delivery to SPI of the clinical
trial report or CTR.

Non-Serious AE Case Reports:

Non-serious AE cases will remain in Takeda’s database until the end of the trial at which
time such AEs will be shared with SPI and/or [**] for the conduct of pharmacovigilance
activities. Clinical trial data will be provided to SPI and/or [**] within fifteen (15)
business days of the delivery to SPI of the clinical trial report or CTR.

Transmission of Other Important Safety Information

As regards safety information other than AE case reports, SPI or [**] shall transmit to
Takeda, or Takeda shall transmit to [**], the information by facsimile or e-mail within the
appropriate timeframe below. As respects SPI, SPI’s Designee and/or [**], these companies
shall have proper policies, procedures and programs to become timely aware of such safety
information. As respects Takeda, Takeda will transmit the information of which it becomes
aware.

Urgent and Important Information Related to Measures taken, for Safety Reasons, by Regulatory
Authorities, by SPI or by Takeda

 

 

Whenever Takeda, SPI, SPI’s Designee, SPI’s Affiliate, or [**] receives such emergency
information as that mentioned in Section 5.2.1, Takeda, SPI, or [**] shall transmit the
information as required by Section 8.4 within three (3) business days of its receipt.

Revision of the Safety-Related Sections in Package Inserts/Labeling/SPC

Whenever Takeda, SPI, SPI’s Designee, SPI’s Affiliate, or [**] receives a regulatory
authority’s instructions to revise any safety-related section of a Package Insert, or
intends to submit a spontaneous revision to a regulatory authority, as shown in Item 5.2.2,
SPI and/or [**] shall transmit the information to Takeda prior to taking any official action
and within one (1) business day in the case of a regulatory authority’s instructions or
fifteen (15) business days prior to submission of the revision to the authority in the case
of a spontaneous revision to be made by SPI. SPI will transmit such information related to
any revision of a safety-related section of Package Insert by SPI, SPI Affiliate or [**] to
Takeda within three (3) business days after its receipt. Takeda’s responsibility to transmit
all such information governed by Section 8.4.2 shall be to transmit such information to
[**].

Important Findings Suggesting a Significant Hazard to Humans

Whenever Takeda, SPI, SPI’s Designee, SPI’s Affiliate, or [**] obtains important findings
suggesting a significant hazard to humans as shown in Section 5.2.3, 5.2.4 and 5.2.5, that
company shall transmit the information to the other, as required by Section 8.4, within
three (3) business days after receipt of it.

Other Important Safety-Related Information

Whenever Takeda, SPI, SPI’s Designee, SPI’s Affiliate, or [**] receives such information as
that shown in Section 5.2.6, that company shall transmit the information of importance to
the other Party within three (3) business days after receipt of it by Takeda or SPI.

Information of Post-Marketing Non-Clinical Studies or Clinical Trials Targeting Safety Issues

When SPI, SPI’s Designee, or SPI’s Affiliate performs a post-marketing non-clinical study or
clinical trial targeting safety issues spontaneously or as per the instructions of the
regulatory authorities, Takeda shall be notified of the protocol while in its draft form, of

 

 

any material changes thereto, and of the final protocol and/or any material changes thereto,
and Takeda shall be permitted to provide its comments and expertise thereon. Upon completion
of the study or trial SPI shall provide Takeda the final clinical trial report or CTR within
fifteen (15) business days of completion of the clinical trial report. SPI and/or [**] shall
share the clinical trial data with Takeda or its Designee upon request.

Audit

Notwithstanding any provisions contained in this SOP or any other Agreement to the contrary,
Takeda, or Takeda’s Designee, and SPI, or SPI’s Designee, shall have the right to audit the
performance of any and all aspects of safety reporting related to Lubiprostone. The right to
audit shall be fulfilled by full access and recourse to any and all regulatory reports and
submissions, source documents, data, policies, procedures,
BOPs, SOPs, documents, information and materials, medical records, case report forms,
clinical trial documents and information, files, databases and things, etc., of whatever
kind, form or nature, including any and all electronic or computerized regulatory reports
and submissions, source documents, data, policies, procedures, BOPs, SOPs, documents,
information and materials, medical records, case report forms, clinical trial documents and
information, files, databases and things, that form the basis for, or are related to, any
duty or obligation of SPI, SPI’s Designee, [**], Takeda, or Takeda’s Designee under this
SOP, or under any law, regulation, and/or convention as it relates to the submission of
safety and efficacy information to any U.S. Federal or state governmental authority or
agency.

 

 

The right to audit may be exercised as frequently as Takeda or SPI deems to be necessary.
The Party to be audited will be provided with at least fifteen (15) days advance notice of
its intent to exercise its audit rights.
Takeda and SPI, or their respective Designees will communicate preliminary audit results to
one another, and provide each other with an opportunity to respond prior to the audit report
becoming final. Takeda and SPI, or their respective Designees will communicate the final
audit report to one another to ensure the accuracy and integrity of the Parties reports and
reporting obligations.
Takeda, or its Designee, shall bear the full costs and expenses of any audit it requests.
SPI, or its Designee, shall bear the full costs and expenses of any audit it requests.

Measures to be Taken for Regulatory Requirements

Literature Monitoring

[**] and/or SPI, assumes the responsibility for literature monitoring.

[**], on SPI’s behalf, shall monitor medical and pharmaceutical journals and screen
databases such as MEDLINE and EMBASE.

Any medical or pharmaceutical journal article information that contains a serious AE report
shall be exchanged between Takeda and SPI in the same manner as that for AE case reports
with a copy of the original article being attached. In addition, both Parties shall transmit
to the other any journal article, and/or information, of which they become aware that
contains a non-serious AE case report in the same manner. SPI and/or [**], shall where
applicable, perform the requirements of Sections 8.4, 8.4.1, and 8.4.2 for such serious AEs.

Also, SPI and/or [**] shall transmit to Takeda serious AE case reports which were retrieved
from literature databases other than EMBASE, and SPI and/or [**] shall transmit to Takeda
serious AE case reports which were retrieved from any database, including EMBASE, and were
reported to the relevant regulatory authority in a country where SPI, an SPI Designee, or an
SPI Affiliate, has MA. SPI and/or [**] shall, where applicable, perform the requirements of
Sections 8.4, 8.4.1, and 8.4.2 for such serious AEs.

 

 

Submission of PSRs

SPI shall take responsibility for submission of the PSRs to the U.S. regulatory authorities.
[**] is responsible for preparing the draft document. Takeda shall have the opportunity to
review and comment on the draft PSR and provide to [**] comments on the draft PSR no later
than ten (10) days after database lock, and Takeda shall be permitted five (5) business days
to submit comments to SPI. If SPI’s assessment differs from the assessment of Takeda, SPI
and Takeda shall exchange opinions in an effort to agree on one opinion. However, if SPI and
Takeda cannot agree, the more serious assessment shall be taken as the final assessment.

After the PSR has been submitted to the regulatory authorities, SPI and/or [**] shall notify
Takeda of the submission date immediately, and provide Takeda with three (3) copies of the
PSR within three (3) business days.

Measures Taken to Comply with Instructions from Regulatory Authorities

When SPI, SPI Designee, SPI Affiliate, or [**] receives such instructions from the
regulatory authorities in any country in which Lubiprostone is marketed, sold prescribed or
administered as shown in Section 5.2.1, SPI, SPI Affiliate, or [**] shall send a preliminary
notification to Takeda to obtain necessary advice and cooperation. SPI, SPI Designee, SPI
Affiliate, or [**] shall provide to Takeda such instructions from regulatory authorities
within five (5) business days of its receipt of same, and Takeda shall have the opportunity
to provide to SPI, SPI Affiliate, or [**] comment regarding appropriate safety measures in
any country in which Takeda sells, markets and/or promotes Lubiprostone.

 

 

Actions and Measures to be Taken when any Safety-Related Emergency Arises

When such an emergency situation as that shown in Section 5.2.1 that could lead to
discontinuation of the sale or marketing of Lubiprostone arises, Takeda or SPI shall notify
the other within the time frames stipulated in Section 8.4.1 and each Party shall continue
to promptly provide the other with subsequent information on the situation as it is obtained
through intensive collection of related information.

Preparation and Revision of Packet Insert by SPI, SPI Designee, and/or SPI Affiliates

SPI, SPI Designee, and/or SPI Affiliates shall take responsibility for the preparation and
revision of the package inserts for Lubiprostone in any country where they have MA on the
basis of the CCDS/CCSI. When a package insert is newly prepared or revised spontaneously or
as per the instructions of the regulatory authorities in a way that deviates from the
CCDS/CCSI, SPI, SPI Designee, and/or SPI Affiliates shall notify Takeda within three (3)
business days, and Takeda shall have the right to comment regarding the revisions to the
Package Insert, and any requirement for a change to the U.S. package insert.

Preparation and Update of CCDS/CCSI

The draft of the initial CCDS/CCSI, and any amendment thereto, will be prepared by SPI.
Takeda shall have the opportunity to review and comment on the draft CCDS/CCSI and provide
to SPI comments on the draft CCDS/CCSI within a reasonable timeframe. If SPI’s assessment
differs from the assessment of Takeda, SPI and Takeda shall exchange opinions in an effort
to agree on one opinion. However, SPI and Takeda cannot agree, SPI’s assessment will be
used. SPI shall make an effort to have one unique CCDS/CCSI worldwide.

The CCDS/CCSI will be developed, or amended, by SPI based on the close exchange of opinions
between SPI and Takeda in writing.

Amendment of the CCSI should not only be based only on the number of collected AEs but also
on the global judgment of the seriousness of the events and quality of the case reports,
referring to the literature and the pharmacological factors as well.

SPI will provide Takeda with its SOPs for the development of the CCDS/CCSI.

Storage of Original Information

Original information obtained by Takeda, SPI, SPI Affiliates, SPI Designees or [**] shall be
kept and stored by SPI or [**] in accordance with the regulations in the country concerned.

 

 

SPI shall provide to SPI’s Affiliates and Designees, and to [**] this SOP, and SPI shall require
from its Affiliates and Designees, and [**] their written acknowledgement of this SOP and written
commitment to adhere thereto. SPI shall provide such written acknowledgements and commitments to
Takeda within fifteen (15) days of SPI’s receipt of same.

Amendment

This SOP may only be amended by a written Agreement signed by Takeda and SPI. The
requirement of Section 13 shall govern any amendments. SPI and Takeda agree to address any
requested amendments that are reasonably required to comply with laws, and/or for the safety
and health of patients and clinical trial subjects.

 

 

Attachment 1

     Responsible Person and Contact Persons

	 	 	 	 	 	 	 
	 	 	SPI	 	[**]	 	TAKEDA
	Responsible
	 	 	 	 	 	 
	Person:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Contact Persons
	 	1. Safety	 	1. Safety	 	1. Safety
	 
	 	Information:	 	Information:	 	Information:
	 
	 	2. General Matters,	 	2. General Matters,	 	2. General Matters,
	 
	 	Labeling and SOP:	 	Labeling and SOP:	 	Labeling and SOP:

 

 

Attachment 2

     Agreed Causal Relationship between an AE and a Marketed Drug at SPI and [**]

Definite

An AE that follows a reasonable temporal sequence from administration of a marketed drug
(including the course after withdrawal of the drug) and that satisfies any of the following:

	•	 	Reappearance of a similar reaction by repeated exposure (rechallenge)
	 
	•	 	Positive results in drug sensitivity tests (skin test, etc.)
	 
	•	 	Toxic level of the drug revealed by measurement of drug concentrations in blood or
another bodily fluid

Probable

An AE that follows a reasonable temporal sequence from administration of the drug (including
the course after withdrawal of the drug) and for which involvement of factors other than the
drug, such as underlying diseases, complications, concomitant drugs or concurrent
treatments, can reasonably be excluded.

Possible

An AE that follows a reasonable temporal sequence from administration of the drug (including
the course after withdrawal of the drug) and for which possible involvement of the drug can
be argued*, although factors other than the drug, such as underlying diseases,
complications, concomitant drugs or concurrent treatments, may also be responsible.

 

*     For example, there have been similar reports in the past, including reports on its
analogues, or the occurrence of the event could be predicted from the pharmacological
actions/chemical structure of the drug.

Not related

An AE that does not follow a reasonable temporal sequence from administration of the drug or
that can be reasonably explained by other factors, including underlying diseases,
complications, concomitant drugs or concurrent treatments.

Lack of data

Lack of data, such as temporal sequence of an AE from administration of the drug (including
the course after withdrawal of the drug), underlying diseases, complications, concomitant
drugs or concurrent treatments, considered necessary for evaluation.

As regards the causal relationship between an investigational drug and an adverse event,
assessment shall be made using a four-category (Definite, Probable, Possible or Not Related)
system.

 

 

Attachment 3

Causal Relationship

Between an AE and a Marketed Drug

YES

Terms such as possibly, probably, definitely, or most likely will be interpreted and reported as
“possibly related.”

NO

Terms such as remotely, unlikely, doubtfully related, will be interpreted and reported as “not
related.”

Unassessed (or Unknown)

The reporter’s assessment is actively sought in each case, however, where not provided, or unknown,
the general principle of suspected causality by the reporter is adopted for all spontaneous reports
in line with the ICH guidelines.

 

 

Attachment 4

Agreed Relationship between

Causality Assessment and Reportability

	 	 	 
	Category
	 	Reportability
	Definite
	 	 
	Probable
	 	Yes
	Possible
	 	 
	Not related
	 	No
	Lack of data
	 	Unassessed (Unknown)

It is stipulated in this criterion for assessment that all AEs other than those assessed as
“Not-related” or “No” in the Table above are to be handled as ADRs.

 

 

ANNEX 7: Approved Research Studies

Summary of Research Grants

	 	 	 	 	 	 	 	 	 
	 	 	Principle	 	 	 	 	 
	Title of Study	 	Investigator	 	Institution	 	Budget	 
	The Mechanism of
Action of Lubiprostone
on Single ENaC, CFTR and
CIC2 Channels
	 	[**]	 	[**]	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 
	The Role of Lubiprostone
in Maintaining
Epithelial Barrier
Function
	 	[**]	 	[**]	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 
	Role of CIC-2 in
duodenal bicarbonate
secretion
	 	[**]	 	[**]	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 
	Role of CIC-2 in
protecting against
bacterial translocation
in colitis
	 	[**]	 	[**]	 	(both projects)
	 
	 	 	 	 	 	 	 	 
	Mechanism of
Lubiprostone protection
during epithelial injury
	 	[**]	 	[**]	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 
	Mechanism of
Lubiprostone-stimulated
intestinal secretion
	 	[**]	 	[**]	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 
	Actions of Lubiprostone
in the Mammalian
Intestinal Tract
	 	[**]	 	[**]	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 
	Plus 3 additional studies
	 	 	 	 	 	$	[**]each

 

 

ANNEX 8: Development Costs

     “Development costs” shall mean all internal costs based on the fixed hourly rate of each
individual engaged in the Development project. The amount of internal costs to be billed for each
individual is calculated as follows: Hourly Rate x [**] Hours x Percentage of Day Dedicated to the
Development Project x Number of Days Worked. (For example, if person A is assigned to two projects
(one of which is the subject Development project), is dedicating equal amount of his time on each
project, and worked for [**] days, the payment for that individual for the month would be Hourly
Rate x [**] Hours x [**]% x [**]). The work sheet showing the calculation of the internal costs
shall be provided with the relevant invoice.

 

 

ANNEX 9: SOPs Relating to Phase IV Marketing Support Studies

and Non-Clinical Research Studies

 

 

TITLE: Standard Operating Procedure (“SOP”) regarding the management of Phase IV Marketing
Support Studies between Sucampo Pharmaceuticals, Inc. (“SPI”), Takeda Pharmaceutical Company
Limited (“TPC”) and TPC’s Affiliates, including Takeda Pharmaceutical North America, Inc. (“TPNA”)
(TPC and its Affiliates, collectively “Takeda”)

Effective Date: January 31, 2006

Supersedes: N/A

VERSION: 1

CONFIDENTIAL AND PROPRIETARY

			
	 	Page 1 of 4	Effective Date:
	 	 	Print Date: 02/02/06

 

 

PURPOSE: To establish the procedures between SPI and Takeda regarding the management of Phase IV
Marketing Support Studies (as defined in the Supplemental Agreement between SPI and TPC dated
January 31, 2006 (“Supplemental Agreement”)) and maintenance of the confidentiality of Confidential
Information (including Proprietary Product Information) relating to such studies under the
Collaboration and License Agreement between SPI and Takeda dated October 29, 2004 (“Collaboration
and License Agreement”). Nothing contained in this SOP shall be deemed to modify or amend any
provision of the Collaboration and License Agreement or the Agreement among SPI, Takeda and SAG
dated October 29, 2004.

RESPONSIBILITIES: Each company is responsible for ensuring that its own employees who are involved
in the management of Phase IV Marketing Support Studies, and the employees of its Affiliates who
are involved in the management of Phase IV Marketing Support Studies, read, understand and comply
with this SOP.

PROCEDURES:

If a Party identifies any commercial issues or questions related to the Product that it believes
need to be addressed by the conduct of a Phase IV Marketing Support Study, such Party will present
a study concept (i.e., a brief synopsis of the study, including key endpoints to address such
commercial issues or questions), business rationale, approximate budget and timeline of such Phase
IV Marketing Support Studies to the JCC. Takeda and SPI will agree on a proposal template so that
proposal formats will be consistent.

Within 15 calendar days following the receipt of such information, the JCC will notify the parties
whether it approves moving forward with development of a Phase IV Marketing Support Study or study
plan to address the commercial issues or questions identified. In the event that the JCC deems it
appropriate to hold discussions with the proposing Party regarding the proposed Phase IV Marketing
Support Study concept, business rationale, budget or timeline before making a go/no-go decision of
a proposed study, the JCC shall hold and complete such discussions within ten business days from
the receipt of the related information from a Party.

Upon JCC approval of moving forward with such a Phase IV Marketing Support Study. Takeda will
request from both its Affiliate, Takeda Global Research & Development Center, Inc. (“TGRD”), and
from SPI a proposal for the conduct of such a Phase IV Marketing Support Study. Each proposal
shall include a study synopsis (i.e., draft protocol), more concrete budget estimate, timeline,
study populations, study assessments, endpoints, key outcomes and any proposed use of outside
vendors. Such proposals shall be submitted to Takeda within 30 calendar days following Takeda’s
request. Takeda and SPI will agree on a proposal template so that proposal formats will be
consistent.

Within 15 calendar days of receipt of such proposals, Takeda shall evaluate the responses and
either (a) select the proposal it believes to be the most appropriate to execute, based on
budget, timing, ability to address the identified commercial issues or questions and any other
relevant

CONFIDENTIAL AND PROPRIETARY

			
	 	Page 2 of 4	Effective Date:
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factors, or (b) require TGRD and SPI to repeat step 3 in order to respond to questions or
objections raised by Takeda.

The selected proposal will be submitted to Sucampo AG for IP review and comment prior to initiation
of protocol development. Within five (5) business days of receipt of such proposal, Sucampo AG
will provide its comments to Takeda and the entity (SPI or TGRD) selected to move forward with the
Phase IV Marketing Support Study proposal.

SPI or TGRD, whichever is selected to conduct the Phase IV Marketing Support Study, will prepare a
draft protocol (taking into account IP comments provided by SAG) and submit it to the JDC for its
review and approval. Within 10 days of receipt of such protocol, the JDC will notify Takeda and
SPI or TGRD, whichever is selected to conduct the Phase IV Marketing Support Study, in writing
whether it approves moving forward with such protocol.

Prior to the execution of any contract with, or the disclosure of any Confidential Information to,
a vendor or investigator in connection with the development or conduct of such Phase IV Marketing
Support Study, SPI, Takeda and/or TGRD shall follow the SOP agreed by SPI and Takeda dated January
31, 2006 titled “IP and Confidential Information Disclosure.”

Regulatory submission of protocols for Phase IV Marketing Support Studies will be done under SPI’s
IND, with concurrent submission of notification of such protocols to the NDA. Such submissions
will be made by SPI if it is the entity conducting the Phase IV Marketing Support Study (with a
copy to Takeda) or by Takeda and/or TGRD with cooperation from SPI if TGRD is the entity conducting
the Phase IV Marketing Support Study.

The entity conducting a Phase IV Marketing Support Study will provide monthly progress updates to
SPI or TGRD, as the case may be. Such updates shall include the number of sites participating in
the study, the number of patients enrolled, costs incurred, timelines and any known study
results and shall be provided in the same format as the spreadsheet attached as Exhibit 1 hereto.

Following completion of a Phase IV Marketing Support Study, the entity conducting a Phase IV
Marketing Support Study will provide SPI or TGRD, as the case may be, with Flash Results of the
study within 1 week of their availability.

A draft final report shall be prepared by the entity conducting the Phase IV Marketing
Support Study and provided to (i) SPI or TGRD, as the case may be, for a review and comment and
(ii) to Sucampo AG for IP review and comment. The reviewing entity shall provide its comments
within 10 days of receipt of such draft report and Sucampo AG will provide its comments within 5
business days of receipt of such draft report.

Following receipt of such comment, the party preparing the final report shall have up to 10
business days to conduct a quality assurance review of the report for the purpose of validating the
integrity and accuracy of the data.

CONFIDENTIAL AND PROPRIETARY

			
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Following the consideration and incorporation, if applicable, of such comments into the final
report,

if SPI conducted the Phase IV Marketing Support Study and prepared the study report, within 15
calendar days after receipt of such comments SPI shall provide Takeda with a copy of the final
report and either (1) confirm to Takeda in writing that SPI has incorporated Takeda’s comments and
given final authorization of the study report, or (2) SPI shall submit another draft of the final
report to Takeda in accordance with the same procedures as set forth above in this subsection (a)
until both parties agree on the final draft of the final report

if TGRD conducted the Phase IV Marketing Support Study and prepared the study report, within 15
calendar days after receipt of such comments Takeda shall submit the final report to SPI and,
within 3 business days thereafter, SPI shall either (1) confirm to Takeda in writing that SPI gives
its final authorization of the study report or (2) SPI shall provide additional comments to the
study report, in which case TGRD shall submit another draft of the final report to SPI in
accordance with the same procedures as set forth above in this subsection (b) until both parties
agree on the final draft of the final report.

Any decision by either party to decline to approve a final draft shall be based on
reasonable grounds in light of generally accepted medical and/or scientific publication
practices.

A final report will be submitted to the regulatory authority if applicable. Such submission will
be made by SPI if it is the entity conducting the Phase IV Marketing Support Study (with a copy to
Takeda) or by Takeda and/or TGRD with cooperation from SPI if TGRD is the entity conducting the
Phase IV Marketing Support Study.

Any publication of Phase IV Marketing Support Study results will be in accordance with the SOP
agreed by SPI and Takeda dated January ___, 2006 titled “Publications.”

DEFINITIONS

     Confidential Information: Confidential Information shall have the same meaning as set forth
in Article I of the Collaboration and License Agreement, subject to the provisions of Article 11 of
the Collaboration and License Agreement.

     Flash Results: Flash Results shall mean preliminary study data analysis prior to statistical
validation and review.

     Party: Party shall mean SPI or Takeda (as defined above).

     Proprietary Product Information: Proprietary Product Information shall have the same meaning
as set forth in Article 1 of the Collaboration and License Agreement. For the avoidance of the
doubt, Proprietary Product Information includes, with respect to a Product, New Drug

CONFIDENTIAL AND PROPRIETARY

			
	 	Page 4 of 4	Effective Date:
	 	 	Print Date: 02/02/06

 

 

Application (NDA), Investigational Drug Application (IND), Drug Master File (DMF),
Investigator Brochure (IB) any Product information contained in SPI pending, non-published patent
applications.

     Other: Any capitalized terms not defined in this SOP shall have the same meaning as set forth in
Article 1 of the Collaboration and License Agreement.

CONFIDENTIAL AND PROPRIETARY

			
	 	Page 5 of 4	Effective Date:
	 	 	Print Date: 02/02/06

 

 

	 	 	 	 	 
	 

	 	Phase IV Study Activity Report as of October 31, 2005
	 	2/2/2006

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	ENROLLMENT	 	STUDY MILESTONES
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	PLAN	 	ACTUAL	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	ACTUAL	 	PLANNED	 	% to	 	 	 	 	 	 	 	 	 	 	 	 	 	PLANNED	 	ACTUAL	 	FINAL	 	FINAL	 	REG	 	REG
	 	 	 	 	PROTOCOL	 	 	 	MARKETING	 	PLANNED	 	TO	 	TO	 	planned	 	PLANNED	 	ACTUAL	 	PLANNED	 	ACTUAL	 	PLANNED	 	ACTUAL	 	FLASH	 	FLASH	 	REPORT	 	REPORT	 	FILING	 	FILING
	COMPOUND	 	PHASE	 	NUMBER	 	DESCRIPTION	 	NAME	 	TOTAL	 	DATE	 	DATE	 	to date	 	FSI	 	FSI	 	LSI	 	LSI	 	LSO	 	LSO	 	RESULTS	 	RESULTS	 	REG	 	REG	 	PLANNED	 	ACTUAL
	Lublprostone

Preclinical

	 	PI

PI

PI

PI
	 	###

###

###

###
	 	XXX

XXX

XXX

XXX
	 	XXX

XXX

XXX

XXX	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Lublprostone

CC

	 	PI

PII

PIIIA

PIV
	 	###

###

###

###
	 	XXX

XXX

XXX

XXX
	 	XXX

XXX

XXX

XXX	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Lublprostone

IBS

	 	PIIIA
	 	SPI021131B-

0431
	 	12-week
multicenter, double
blind randomized
efficacy and safety
study of
Lublprostone in
subjects with IBS-C
	 	XXX	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	PIIIB
	 	SPI021131B-

0432
	 	12-week
multicenter, double
blind randomized
efficacy and safety
study of
Lublprostone in
subjects with IBS-C	 	XXX	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	PIVB
	 	###
	 	Open Label

Extension
	 	XXX	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	 	 	 	 	 
	Study Font Color

	 	 	 	On target to achieve milestone
	Study X

	 	Ongoing
	 	Milestone at risk of being delayed
	Study X

	 	Planned
	 	Milestone delayed
	Study X

	 	Completed
	 	Milestone acceleratedexv10w26

 

	 	 	 	 	 
	 

	 	Confidential Materials omitted and filed separately with the
	 	Exhibit 10.26
	 

	 	Securities and Exchange Commission. Asterisks denote omissions.	 	 

SERVICE AGREEMENT

     This agreement (the “Agreement”) is made as of February 9, 2006 (the “Effective Date”) by and
between VENTIV COMMERCIAL SERVICES, LLC, a New Jersey limited liability company (“Ventiv”); and
SUCAMPO PHARMACEUTICALS, INC., a Delaware corporation (“Client”). Ventiv and Client may each be
referred to herein as a “Party” and collectively as the “Parties”.

     1. The Services — In consideration for the compensation and schedule provided in
Exhibit A, Ventiv shall provide Client with a field force of Ventiv employees that shall consist of
thirty-eight (38) hospital medical center representatives (the “Ventiv Medical Center
Representatives”) who shall exclusively market and promote Client’s Product (as defined in Section
3 below). Ventiv shall provide candidates for Ventiv Medical Center Representatives and Client
shall participate in the recruitment, interview and hiring process; although the Parties understand
and agree that all decisions regarding hiring and firing shall be made by Ventiv. The Ventiv
Medical Center Representatives shall work on a full-time basis (i.e., [**] days per year in
the field) on the Client’s account. The Ventiv Medical Center Representatives shall be managed by
one shared Project Manager and one shared Team Leader, each of whom shall be an employee of Ventiv
and shall assist in the provision of the Services (as defined below) to Client on a non-exclusive
basis (i.e. the shared Project Manager and shared Team Leader, expressly subject to Section
1 (f) (iv) below, shall perform services for other Ventiv clients during the Term hereof). The
shared Project Manager, shared Team Leader and Ventiv Medical Center Representatives shall
collectively be referred to herein as the “Project Team”. The primary Client contact for the
Ventiv Project Team shall be Client’s Director of Marketing and National Sales Director (the
“Primary Client Contacts”). The Primary Client Contacts shall provide field direction for the
Project Team in connection with the marketing and promotion of Client’s Product, as such term is
defined below. Ventiv shall perform the services and obligations specified in this Section 1 of
the Agreement (collectively, the “Services”):

     (a) Implementation — With respect to Client’s Product and in addition to the
recruitment and employment of the Project Team, Ventiv shall:

          (i) train the Ventiv Medical Center Representatives on compliance with applicable heath care
laws and regulations including OIG Guidance, the PhRMA Code on Interactions with Healthcare
Professionals, the Federal Food, Drug and Cosmetic Act (“FDCA”) and the Medicare/Medicaid
anti-kickback statute. Ventiv shall also provide the Ventiv Medical Center Representatives with
training on selling skills (using Ventiv’s proprietary selling skills program, Rx Advantage), and
human resource policies and procedures. As set forth in Section 4 below, Client shall provide all
training concerning the Product. The aforementioned training shall consist of [**] of home study
with respect to only Client’s Product and [**] of in-person initial training provided by Ventiv.
All training shall be conducted utilizing informative materials prepared by Client and provided to
the Ventiv Medical Center Representatives and shall occur prior to Deployment (as defined in
Section 1(b) below);

Service Agreement

Page 1 of 19

 

 

          (ii) with Client, develop marketing and promotion program procedures, and administer as
directed by Client;

          (iii) with Client, customize marketing and promotion program processes, and administer as
directed by Client; and

          (iv) with Client, establish marketing and promotion program performance parameters, goals and
metrics, and administer as directed by Client.

          (v) provide [**] Rapid Recall market research surveys at no additional charge.

In all cases relating to (i) through (iv) above, Ventiv shall provide Client, promptly after
creation by Ventiv and prior to use by Ventiv, with a complete copy of all training materials
developed by Ventiv and/or used for the benefit of Client. Ownership of all such materials shall
remain with the originator of such materials, as set forth more fully in Section 7 (b) below.
Notwithstanding the foregoing, in the event Ventiv incorporates Client’s material (including
Product information, data, technology, business strategies, historical business cases, projections,
and/or other information generally related to Client’s products or business practices) (the “Client
Material”) as an integral part of any such training materials developed by Ventiv in connection
with the Services (the “Combined Training Material”), Ventiv agrees that the Client Material and
Combined Training Material shall be treated as Confidential Information pursuant to Section 7 of
this Agreement and that Ventiv will use such Combined Training Material only for the benefit of
Client.

     (b) Deployment — Under direction of Primary Client Contacts, Ventiv shall deploy the
Ventiv Medical Center Representatives throughout the Territory (as defined below in Section 1(h))
and provide each with all compensation and all support necessary for the Ventiv Medical Center
Representatives to maximize their promotion and marketing efforts solely for the benefit of Client.
Deployment shall include but not be limited to:

          (i) the administration, payment and/or provision by Ventiv to the Ventiv Medical Center
Representatives of all salary and benefits;

          (ii) timely provision, administration and maintenance of all appropriately-featured handheld
PDAs, laptops (including Target Software sales force automation software) and printers;

          (iii) timely provision, administration and maintenance of fleet automobiles for use by the
Ventiv Medical Center Representatives; and

          (iv) administration and payment of bonuses as determined by prior written mutual agreement of
the parties.

Service Agreement

Page 2 of 19

 

 

The shared Project Manager and shared Team Leader shall assist the Primary Client Contacts in
providing management of the Ventiv Medical Center Representatives. As employees of Ventiv, Ventiv
shall provide the Project Manager and Team Leader with salary and benefits. Ventiv shall also
provide turnover recruiting and training of the Project Team and administer office
costs/operational supplies in addition to the pass-through expenses associated with this Agreement.
As set forth in this Agreement, “Deployment” or “Deployment Date” means the date the Ventiv
Medical Center Representatives commence the marketing and promotion of the Client’s Product
pursuant to this Agreement. The Deployment Date is April 17, 2006.

     (c) Meetings — All meetings between Client and Project Team shall be on the dates,
times and places as determined by Client pursuant to written direction from Primary Client Contact
to Project Team, with Client paying for any travel cost and expense of Project Team to be present
at such meetings, so long as Client has pre-approved such travel cost and expense prior to being
incurred by Ventiv and any of its employees or affiliates.

     (d) Reports —

          (i) Ventiv shall provide Client with standard data activities and reports in accordance with
Exhibit B attached hereto.

          (ii) Any customized or “non-standard” data activities or reports (i.e., data
activities or reports requiring material changes in the nature of the data or formatting)
requested in writing by Primary Client Contact to Ventiv in accordance with Exhibit B herein shall
be prepared by Ventiv for Client after Ventiv has first provided Client with a written scope of
work and maximum cost/charge for Ventiv to prepare such customized or “non-standard” activity or
report, with Primary Client Contact being required to approve in writing each such scope of work
and maximum cost/charge prior to Ventiv commencing any work related thereto. Client shall pay
Ventiv [**] Dollars ($[**]) per hour in increments of one-quarter hour for the actual preparation
of such customized or “non-standard” reports, up to the maximum number of hours and cost/charge set
forth in the written scope of work therefor, as pre-approved in writing by Client.

          (iii) Ventiv represents and warrants that Ventiv’s standard operating procedures for producing
such reports (attached hereto as Exhibit B, Section 2) will govern all reports produced for Client.
At its sole cost and expense, Client or Client’s agent (subject to appropriate confidentiality
restrictions approved in advance by Ventiv) shall have the right (up to once per year during the
Term) to conduct an audit or investigation to ensure that the reports produced in accordance with
this Agreement are in compliance with Ventiv standard operating procedures solely for purposes of
verifying report quality as it relates to this Agreement. Client shall provide at least seven days
prior written notice of its desire to conduct an audit pursuant hereto and any audit shall be
conducted by Client in such a manner so as to not interfere with Ventiv’s business operations.
Provided however that should any audit conducted pursuant to this paragraph (d) reveal material
errors in the reports or that such reports have not been produced in accordance with Ventiv
standard operating procedures, Client may perform another audit during

Service Agreement

Page 3 of 19

 

 

the same one year period.

     (e) Sample Accountability — On Client’s behalf, Ventiv shall implement and maintain a
sample accountability program in accordance with Exhibit C Attachment 1. The sample accountability
program shall be in compliance with applicable federal and state laws, regulations, and guidelines,
including but not limited to the Prescription Drug Marketing Act and its implementing regulations
(“PDMA”). The fees of the sampling program are set forth in Exhibit A, and the terms of the
sampling program are set forth more fully in Exhibit C attached hereto. Ventiv, through it
affiliate, Promotech Research Associates, Inc. (“Promotech”), shall be responsible for shipment of
Product samples and Product literature to the Ventiv Medical Center Representatives in accordance
with PDMA guidelines, and confirming all returned samples. Client is responsible for taking all
action required or suggested by the Food and Drug Administration (“FDA”), including but not limited
to reporting of adverse events, and, where applicable, notifying the FDA, and all supplemental
communications with respect to any of the above activities by Client.

     (f) Product Literature; Promotion — In strict accordance with Section 2 below, Ventiv
shall be responsible for:

          (i) ensuring that only the Product and Product literature approved by Client are distributed
by the Ventiv Medical Center Representatives;

          (ii) promoting and marketing the Product in a manner that complies with applicable federal and
state law, including but not limited to, the Federal Food, Drug and Cosmetic Act (“FDCA”) and PDMA;

          (iii) cooperating with Client, at Client’s expense, to conduct any necessary recalls of the
Product and/or Product literature; and

          (iv) ensuring that during the Term, the Ventiv Medical Center Representatives, Team Leader and
Project Manager do not promote or market a product from a third party which competes with the
Product.

     (g) Physician Validation — Within fourteen days of its receipt from Client of a list
of Targets (as defined below) who are physicians to be contacted and personally visited by the
Ventiv Medical Center Representatives to promote the use of Client’s Product in accordance with
Section 2 below, Ventiv shall provide license verification services which shall consist of
validation of all such physicians against a current list of state license numbers in order to
confirm that such physicians are holders of current state medical licenses. All additions, changes
and off-list potential Targets shall be validated in advance by Ventiv. Fees for this service are
set forth in the Exhibit A, Item 6.

     (h) The territory where the Product will be promoted, marketed and sold by the Ventiv Medical
Center Representatives will be the United States (the “Territory”). The Ventiv

Service Agreement

Page 4 of 19

 

 

Medical Center Representatives shall contact, personally visit, solicit, and provide details
of the Product to physicians, hospitals, teaching hospitals, VA hospitals, medical schools and long
term care facilities to whom and where the Product has a reasonable likelihood of being prescribed,
purchased and/or used (each a “Target” and collectively, the “Targets”) located in the Territory
pursuant to Client’s territory alignment.

     (i) Ventiv shall provide to Client, during the Term hereof, the warehousing services and
product sample and distribution services (collectively, the “Promotech Services” as more fully
described in Exhibit C. Ventiv agrees that during the first six month period of the Term hereof,
pricing for the Promotech Services shall be Ventiv’s cost therefor [**] and that during the
remainder of the Term hereof, pricing for the Promotech Services shall be Ventiv’s cost therefor
[**].

     (j) Notwithstanding anything herein to the contrary, neither Ventiv nor Ventiv Project Team
members shall at any time promote Client Product for any indications not approved by the FDA.
Client shall ensure that none of its regional managers, Primary Client Contacts and other Client
employees requests that any member of the Project Team promote the Product for any indication not
approved by the FDA.

       2. Compliance with Applicable Requirements —

     (a) Ventiv shall comply with all applicable laws; regulations; guidance provided by the FDA,
the Department of Health and Human Services or other governmental agency; and policies and
procedures of Client with respect to the marketing of the Product, communications with healthcare
providers, and the distribution of samples. In particular, and without limiting the foregoing:

          (i) Ventiv shall ensure that promotional messages are consistent with approved product
labeling, shall adhere to standards no less rigorous than those set forth in Client policies and
procedures for communications with and courtesies provided to healthcare professionals (a copy of
which is attached hereto as Exhibit D) that do not create a conflict of interest, and shall meet
all applicable requirements for the distribution of samples to healthcare providers (including but
not limited to all requirements in 21 CFR Part 203, except requirements pertaining to the labeling
of samples and the reporting of any information to FDA, which shall be the responsibilities of
Client).

          (ii) Ventiv shall ensure that all such laws, regulations, guidance, policies and procedures
are followed by its employees, agents, affiliates, contractors, subcontractors, and all persons
through whom it undertakes the responsibilities in this Agreement.

          (iii) Ventiv shall assume full responsibility for accounting for, storing, handling, and
maintaining records for all samples upon receipt of such samples by Ventiv from Client.

Service Agreement

Page 5 of 19

 

 

          (iv) Ventiv shall not alter, modify or otherwise change any label, labeling, advertisement,
sample, promotional material or other materials provided to it by Client without Client’s express
written permission.

     (b) Ventiv shall immediately notify Client of any falsification of drug sample requests,
receipts or records; any diversion of drug samples; any loss or theft or sale of samples; any legal
action against any of its employees relating to pharmaceutical manufacture or marketing (including
any conviction of any representative of any law involving the sale, purchase or trade of any drug
sample or the offer to sell, purchase or trade a drug sample); any alteration of any materials
provided by Client; any request for information on unapproved uses of the Product; any
communication with FDA or other governmental agency about the activities covered by this Agreement;
and any other matter that may relate to an actual or potential violation of such laws, regulations,
guidance, policies or procedures.

     (c) At Client’s sole cost and expense, once per year or more frequently where extraordinary
circumstances exist, during the Term, Client shall have the right to conduct an audit or
investigation to ensure that the activities covered by this Agreement are in compliance with laws,
regulations, guidance, policies or procedures. Any such audit shall be conducted by Client or
Client’s designated third-party auditor (subject to appropriate confidentiality restrictions
approved in advance by Ventiv) in such a manner so as to ensure there is no interference with
Ventiv’s business operations. Subject to Section 7 hereof and compliance with laws and court or
regulatory orders, Ventiv shall cooperate with Client in any such audit or investigation, and
Client shall have access to all relevant facilities, records and employees of Ventiv. In any
interaction with or investigation by any governmental agency regarding the activities covered by
this Agreement, Ventiv shall take no action on its own, but shall coordinate with Client and follow
Client’s directions with respect to communications with such agencies, subject to compliance with
laws and court or regulatory orders. Provided however that should any audit conducted pursuant to
this paragraph (c) reveal significant compliance issues relating to the Services, Client may
perform another audit during the same one year period.

     (d) Ventiv hereby warrants and represents that it shall not hire employees that are or have
been debarred or convicted of any violation of law involving the sale, purchase, or trade of any
drug sample.

     (e) Warranties:

          (i) Ventiv represents and warrants that it is under no obligation or restriction nor will it
assume any such obligation or restriction which would in any way interfere or be inconsistent with,
or present a conflict of interest concerning, the Services to be furnished by Ventiv or the
obligations undertaken by the Ventiv pursuant to this Agreement.

          (ii) Ventiv represents and warrants that written materials and documents to be prepared by
Ventiv and submitted to Client pursuant to this Agreement do not violate any copyright or other
intellectual property right of any third party.

Service Agreement

Page 6 of 19

 

 

          (iii) Ventiv represents and warrants that the Services will be performed in a professional
manner consistent with generally accepted industry standards.

          (iv) Ventiv warrants that to the best of its knowledge, no deliverable provided pursuant
hereto which is delivered in electronic format will contain any virus or computer software code,
routines or devices designed to disable, damage, impair, erase, deactivate, or electronically
repossess such deliverable or other software or data.

          (v) Client represents and warrants, that its Product training (including all Client provided
training materials), as well as the program pursuant to which Ventiv shall provide Services
hereunder, complies with all applicable state and federal laws as well as all statutes, laws,
ordinances, rules and regulations of all governmental and regulatory authorities.

          (vi) Client represents and warrants that the trademarks, trade names and trade dress and the
promotion of the Product by Ventiv does not infringe on any intellectual property or product
marketing rights of any other person or entity.

     3. The Product; Right to Promote; Market — Client’s Product (or the “Product”) is
Amitiza 24 microgram soft gelatin capsule. Such Product shall be marketed by the Ventiv Medical
Center Representatives strictly in accordance with FDA-approved labeling. All pricing decisions
relating to the Product shall be made by Client. Client retains the right to promote and market
the Product to supplement Ventiv’s Services, and retains the right to accompany Ventiv employees
when promoting and marketing Product. All promotion other than promotion conducted by the Project
Team, including but not limited to advertising and website hosting, are Client activities. Client
retains the right to establish and amend all messaging guidelines. The Product shall be promoted by
Ventiv under trademarks owned by or licensed to Client and is a product which is either owned by
Client or which Client has all lawful authority (state and federal) necessary to market and sell
such Product in the Territory. This Agreement does not constitute a grant to Ventiv of any
property right or interest in the Product or the trademarks owned by or licensed to Client and/or
any other intellectual property rights which Client owns now or in the future. Ventiv recognizes
the validity of and the title to all of Client’s owned or licensed trademarks, trade names and
trade dress in any country in connection with the Product, whether registered or not.

     4. Client Responsibilities — Client is responsible for: (i) identification of a list
of Targets and a Territory alignment (with assistance from Ventiv) and has provided such to Ventiv,
(ii) employing a certain number of regional managers to provide field direction, management and
marketing communications to the Ventiv Medical Center Representatives, (iii) production of Product
samples and Product literature, (iv) sending Product samples and product literature to Promotech
for distribution to the Ventiv Medical Center Representatives, (v) all Product-specific training,
and (vi) all communications with the FDA concerning the Products.

     5. Additional Services —

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     (a) To support the Services
to be performed by Ventiv (as set forth in Section 1 hereof),
Client hereby appoints Ventiv as its exclusive provider of the following services (the “Supporting
Services”) to be performed by Ventiv for the benefit of Client’s employees with regard to the
Product:

          (i) Fleet Management — See Exhibit E

          (ii) Sales Force Automation — See Exhibit F

     (b) Ventiv shall also be
Client’s primary provider of recruiting services (as set forth in
Exhibit G attached hereto).

     (c) To the extent any
provisions or terms set forth in an exhibit conflict with the terms set
forth in the body of this Agreement, the terms set forth in the exhibit shall govern and control.

       6. Ventiv
Compensation and Accounting Records — In accordance with the terms in this
Section 6, Ventiv shall receive compensation from Client for performance of the Services and
Supporting Services provided hereunder as set forth in Exhibit A attached hereto and made a part
hereof.

     (a) Billing
Terms —

         
 (i) Client will be invoiced monthly in arrears for all fees, unless otherwise set forth herein
or with other terms approved in writing by Client and Ventiv prior to invoicing. For Client’s
reconciliation purposes, all invoices relating to this Agreement will reference this Agreement
regardless of vendor producing invoice. Invoices are due within [**] days of receipt by
Client. If not paid within [**] days of receipt by Client, there will be a finance
charge of 1.5% monthly, applied to the outstanding balance due.

         
 (ii) Pass-through Costs will be invoiced to Client at actual cost as incurred by Ventiv. With
the exception of meetings planned by Ventiv on Client’s behalf (and expenses associated therewith),
Ventiv shall send Client invoices for Pass-through Costs within [**] days following
receipt of documentation of such Pass-through Costs and shall include appropriate documentation to
support such expenses. With respect to meetings planned by Ventiv on Client’s behalf (and expenses
associated therewith), Ventiv shall submit to Client an estimate of such costs prior to
commencement of the meeting. Ventiv will update the estimate for any Client requests outside the
scope of the original assumptions used for the estimate. Ventiv will bill actual costs for the
meeting (and expenses associated therewith) upon receipt of all documentation of expenses incurred
for such meeting.

         
 (iii) If Client disputes any portion of an invoice, Client shall promptly notify Ventiv in a
writing setting forth in detail the nature and extent of such dispute (a “Dispute Notice”) and both
parties shall work in good faith to resolve the matter quickly. Undisputed

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portions of an invoice shall be paid in accordance with the terms hereof. If needed, Ventiv
will re-invoice the charges at which point Client shall pay the corrected invoice unless Client
continues to dispute the revised invoice. Within twenty (20) business days of delivery to Ventiv
of the Dispute Notice, management representatives from both Parties shall meet to resolve any
dispute regarding an invoice. The Parties agree that disputes regarding invoices shall be resolved
by the Parties within a commercially reasonable period of time.

     (b) Accounting Records

     Ventiv will maintain true and complete financial records relating to the Services performed
under this Agreement, including pass-through expenses and labor hours applied in connection with
the Services. At Client’s sole cost (up to once per year during the Term and for two years
thereafter) Client or Client’s authorized agent (subject to appropriate confidentiality
restrictions) will have the right to audit, at any reasonable time during normal business hours and
upon at least ten (10) business days prior written notice to Ventiv, on a confidential basis, such
records for the purpose of verifying the amounts charged under this Agreement. Any such audit
shall be conducted by Client in such a manner so as to ensure no interference with Ventiv’s
business operations. Provided however that should any audit conducted pursuant to this paragraph
(b) reveal material discrepancies in the financial records relating to the Services, Client may
perform another audit during the same one year period.

       7. Confidentiality; Ownership of Property —

     (a) During the performance of the Services contemplated by this Agreement, each Party may
learn confidential, proprietary, and/or trade secret information of the other Party. The Party
disclosing Confidential Information shall be referred to as the “Disclosing Party” and the Party
receiving Confidential Information shall be referred to as the “Receiving Party.”

     “Confidential Information” shall mean any information, unknown to the general public, which is
disclosed by the Disclosing Party to the Receiving Party under this Agreement and shall include,
without limitation, technical, trade secret, commercial and financial information about either
Party’s (i) research or development; (ii) marketing plans or techniques, contacts or customers;
(iii) organization or operations; (iv) business development plans (i.e., licensing, supply,
acquisitions, divestitures or combined marketing); (v) Product, licenses, trademarks, patents,
other types of intellectual property or any other contractual rights or interests (including
without limitation processes, procedures and business practices involving trade secrets or special
know-how) and (vi) in the case of Ventiv, the names and work assignments of the members of the
Project Team, provided, however, that all Data (as defined in Section 8 below) and information
concerning the results of the Services provided hereunder which are compiled by Ventiv (including
but not limited to the Ventiv Medical Center Representatives) in performing the Services hereunder
shall be deemed to be the exclusive Confidential Information of Client. The Receiving Party shall
neither use or disclose Confidential Information from the Disclosing Party for any purpose other
than is specifically allowed by this Agreement.

     Upon the expiration or termination of this Agreement, the Receiving Party shall return to

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the Disclosing Party all tangible forms of Confidential Information, including any and all copies
and/or derivatives of Confidential Information made by either Party or their employees as well as
any writings, drawings, specifications, manuals or other printed or electronically stored material
based on or derived from Confidential Information. Any material or media not subject to return
must be destroyed and certified as such by the destroying Party to the other Party. The Receiving
Party shall not disclose to third parties nor use anything related to any Confidential Information
of the Disclosing Party or any reports, recommendations, conclusions or other results of work
relating to the Confidential Information of the Disclosing Party under this Agreement without prior
consent of an officer of the Disclosing Party. The obligations set forth in this Section 7,
including the obligations of confidentiality and non-use shall be continuing and shall survive the
expiration or termination of this Agreement and will continue for a period of five (5) years.

     The obligations of confidentiality and non-use set forth herein shall not apply to the
following: (i) Confidential Information at or after such time that it is or becomes publicly
available through no fault of the Receiving Party; (ii) Confidential Information that is already
independently known to the Receiving Party as shown by prior written records; (iii) Confidential
Information at or after such time that it is disclosed to the Receiving Party by a third party with
the legal right to do so; (iv) Confidential Information required to be disclosed pursuant to
judicial process, court order or administrative request, provided that the Receiving Party shall so
notify the Disclosing Party sufficiently prior to disclosing such Confidential Information as to
permit the Disclosing Party to seek a protective order.

     (b) All materials and documents supplied to either Party during the Term of this Agreement,
including but not limited to sales force automation software, report designs, and sales training
materials shall be the sole and exclusive property of the originator of those materials and
developments (“Ventiv Property” or “Client Property” as applicable), provided, however, that all
Data (as defined in Section 8 below) and information concerning the results of the Services
provided hereunder which are compiled by Ventiv and/or the Ventiv Medical Center Representatives in
performing the Services hereunder shall be deemed to be the exclusive Confidential Information of
Client. Each Party agrees to hold all such property and developments confidential in accordance
with this Section 7 of the Agreement.

       8. Disposition of Computer Files and Client Materials — Ventiv will take reasonable
and customary precautions, including periodic backup of computer files, to prevent the loss or
alteration of Client Property, Data (as defined hereafter) and documentation. “Data” means all
information submitted by Client, Ventiv and/or the Project Team to be processed for the benefit of
Client, as contemplated by this Agreement, wherever residing, in all media and in any form,
including raw data, compilations, analyses and summaries of such information. Data shall include,
but not be limited to, information about clients, physicians and medical entities and all reports
and compilations prepared by Client, Ventiv and/or the Project Team in connection therewith. Both
Parties recognize that Ventiv cannot guarantee against any such loss or alteration, however, Client
shall not be liable for any expenses related to Ventiv’s loss or alteration of Client Property
and/or Data. Client will be notified immediately in writing of such

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loss or alteration of Client Property and/or Data, and all reasonable efforts shall be made by
Ventiv and Ventiv third-party vendors under this Agreement to recover such loss or alteration.
Upon termination of this Agreement and as directed by Client, Ventiv will dispose of Client
computer-stored files and study materials according to Ventiv’s internal standard operating
procedures. Client may communicate any special request for the disposition of Client Property
and/or Data in writing to Ventiv. Client shall bear all costs incurred by Ventiv in complying with
any such written instructions furnished by Client. Ventiv will provide a written estimate to
Client, and Client will provide written approval, of all such costs prior to any action by Ventiv.

       9. Independent Contractors — Ventiv and its directors, officers, and the persons
providing services under this Agreement, including the Ventiv Medical Center Representatives, are
at all times independent contractors with respect to Client. Persons provided by Ventiv to
perform Services shall be deemed to be employees of Ventiv and shall not be deemed to be employees
of Client. Client shall not be responsible for Ventiv’s acts or the acts of its officers, agents,
employees and the Ventiv Medical Center Representatives while such persons are performing the
Services, whether present on Client premises or elsewhere.

     Ventiv shall not be responsible for any cost, however, attributable to: (i) any actions by
Client that caused a person provided by Ventiv to perform services under this Agreement to be
reclassified as an employee of Client, (ii) any unlawful or discriminatory acts of Client, and
(iii) any language in any Client employee benefit plan (as such term is defined Section 3(3) of
ERISA), and any other incentive compensation, stock option, stock purchase, incentive, deferred
compensation, supplemental retirement, severance and other similar fringe or employee benefit
plans, programs or arrangements that may be sponsored at any time by Client or any of its
affiliates that cause any Ventiv employee to be reclassified by a governmental or regulatory agency
or a court as an employee of Client.

       10. Ventiv Personnel —

     (a) Except as otherwise set forth in Section 10(b) below, Client may not employ or retain any
member of the Project Team during the Term of this Agreement or within one (1) year after the
termination of this Agreement without the prior written approval of Ventiv, which may be withheld
by Ventiv in its sole and absolute discretion; provided, however, that nothing in this Agreement
shall restrict Client from employing any member of the Project Team who terminates his or her
employment with Ventiv without any assistance, encouragement or solicitation by Client (provided
further that such member of the Project Team may not be employed or otherwise retained by Client
until the three (3) month anniversary of the termination or expiration of this Agreement).

     (b) Conversion — Client may solicit, employ or retain at any one time, any or all of
the Ventiv Medical Center Representatives performing Services hereunder (a “Conversion”) provided
that: (i) such hiring may not occur prior to the first anniversary of the Deployment Date and (ii)
Client provides at least ninety (90) days’ prior written notice to Ventiv of any proposed
Conversion. In the event Client wishes to implement a Conversion, Client shall pay Ventiv a fee of
$[**] per Ventiv Medical Center Representative (in the event the Conversion

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occurs after one year anniversary of the Deployment Date and prior to the two year anniversary
of the Deployment Date) and $[**] per Ventiv Medical Center Representative (in the event the
Conversion occurs on or after two year anniversary of the Deployment Date). Client understands and
agrees that the decision to accept employment with Client pursuant to the terms hereof, rests
solely with each Ventiv Medical Center Representative.

     (c) Notwithstanding anything to the contrary set forth herein, Client agrees during the Term
of this Agreement and for one (1) year thereafter not: (i) to provide information (i.e.,
name, address, phone number or e-mail address) concerning any member of the Project Team to any
third party that provides or proposes to provide contract sales services to Client or (ii) to
assist actively in any other way such a third party in employing or retaining a member of the
Project Team. Client shall pay or cause the third party to pay Ventiv $[**] for each Ventiv
employee so employed or retained as liquidated damages for breach of this section.

       11. Indemnification —  For the purposes of this Section 11, “Liability” shall mean
losses, liabilities, costs, expenses (including reasonable attorneys’ fees), claims (including
without limitation, claims for bodily or personal injury or property damage), penalties, judgments
and/or other damages. The Parties agree to follow the procedures set forth in Section 11(c) below.

     (a) Ventiv shall defend, at its own cost and expense, and indemnify and hold harmless Client,
its officers, directors, agents and employees (“Client Indemnified Parties”) from and against any
third party Liability which results from (i) any reckless, negligent or willful acts or omissions
by Ventiv, its agents, directors, officers, or employees, including but not limited to the Ventiv
Medical Center Representatives, (ii) acts or omissions outside the scope of the Services to be
provided by the Project Team pursuant to this Agreement, or (iii) any material breach of this
Agreement by Ventiv, its agents, directors, officers or employees, including but not limited to the
Ventiv Medical Center Representatives. In the event of any such claim against Client Indemnified
Parties by any third party, Client shall promptly notify Ventiv in writing of the claim and Ventiv
shall manage and control, at its sole cost and expense, the defense of the claim and its
settlement. Client’s failure to provide such notice to Ventiv shall constitute a waiver of
Ventiv’s indemnification obligations under this Section 11(a) if, and only if, Ventiv is materially
damaged by such failure. Client Indemnified Parties shall cooperate with Ventiv and may, at their
option and expense, be represented in any such action or proceeding. Ventiv shall not be liable
for any litigation costs or expenses incurred by Client Indemnified Parties without Ventiv’s prior
written authorization. Notwithstanding anything to the contrary set forth herein, Ventiv shall not
be responsible for the indemnification or defense of any Client Indemnified Party arising from any
act or omission requiring Client to indemnify Ventiv pursuant to Section 11(b) below.

     (b) Client shall defend, at its own cost and expense, and indemnify and hold harmless Ventiv,
its officers, directors, agents, and employees (“Ventiv Indemnified Parties”) from and against any
third party Liability which result from (i) any reckless, negligent or willful acts or omissions by
Client, its agents, directors, officers or employees, (ii) any material breach of this

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Agreement by Client, its agents, directors, officers, or employees, or (iii) any products liability
warranty or negligence claim relating to the Product. In the event of any such claim against the
Ventiv Indemnified Parties by any third party, Ventiv shall promptly notify Client in writing of
the claim and Client shall manage and control, at its sole cost and expense, the defense of the
claim and its settlement. Ventiv’s failure to provide such notice to Client shall constitute a
waiver of Client’s indemnification obligations under this Section 11(b) if and only if Client is
materially damaged by such failure. Ventiv Indemnified Parties shall cooperate with Client and
may, at their option and expense, be represented in any such action or proceeding. Client shall
not be liable for any litigation costs or expenses incurred by the Ventiv Indemnified Parties
without Client’s prior written authorization. Notwithstanding anything to the contrary set forth
herein, Client shall not be responsible for the indemnification or defense of any Ventiv
Indemnified Party arising from any act or omission requiring Ventiv to indemnify Client pursuant to
Section 11(a) above.

     (c) Indemnification Procedure —

          (i) Each indemnified Party agrees to give the indemnifying Party written notice, as soon as is
practicable, but in any event within thirty (30) days if possible, of any Liability or the
discovery of fact upon which such indemnified party intends to base a request for indemnification
under Section 11(a) or 11(b).

          (ii) Each Party shall furnish promptly to the other Party (upon written request from such
Party) copies of all papers and official documents received in respect of any Liability. The
indemnified Party shall cooperate with the indemnifying Party, at the indemnifying Party’s expense,
in providing witnesses and records necessary in the defense against any Liability.

          (iii) With respect to any settlement of Liability relating solely to the payment of money
damages (i.e., such settlement will not result in the indemnified Party’s becoming subject to
injunctive or other relief, will not contain an admission of guilt and otherwise will not adversely
and materially affect the business of the indemnified party in any manner), and as to which
settlement the indemnifying Party shall have acknowledged in writing the obligation to indemnify
the indemnified Party hereunder, the indemnifying Party shall have the sole right to defend,
settle, or otherwise dispose of such claim, on such terms as the indemnifying Party, in its sole
discretion, shall deem appropriate.

          (iv) With respect to all other settlements of Liability, the indemnifying Party shall obtain
the written consent of the indemnified Party, which shall not be unreasonably withheld, prior to
ceasing to defend, settling, or otherwise disposing thereof.

          (v) The indemnifying Party shall not be liable for any settlement or other disposition of a
loss by the indemnified Party that is reached without the written consent of the indemnifying
Party.

       12. Term — This Agreement shall be in effect as of the Effective Date and shall
remain in effect through March 29, 2008 (the “Term”); provided, however, that either Party may

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terminate this Agreement prior to that time as provided in Section 13. The period from March
30, 2006 until March 29, 2007 shall be referred to herein as “Year One” and the period from March
30, 2007 until March 29, 2008 shall be referred to herein as “Year Two”. Unless earlier terminated
as provided under Section 13, this Agreement will renew for additional periods of one year each
(each an “Additional Term”), upon written agreement by the Parties to be executed at least sixty
(60) days prior to the end of the Term. The compensation to Ventiv, as set forth in Exhibit A, for
any Additional Term must be agreed upon and set forth in the written agreement between the Parties
to be executed at least sixty (60) days prior to the end of the Term.

       13. Termination —

     (a) Notwithstanding anything else contained in this Agreement to the contrary, this Agreement
may be terminated by Ventiv or Client upon giving written notice as follows:

          (i) by Ventiv, if payment to Ventiv by Client is not made when due and such payment is still
not made within thirty (30) days from the date of notice to Client of such nonpayment, provided
such payment is not being handled as in accordance with Section 6(a)(iii) or

          (ii) by either Party, in the event that the other Party has committed a material breach of
this Agreement and such breach has not been cured within sixty (60) days of receipt of written
notice from the non-breaching Party specifying in detail the nature and extent of such breach; or

          (iii) by Client, without cause, upon ninety (90) days prior written notice to Ventiv;
provided, however, that the actual termination date shall not be prior to the one year anniversary
of the Deployment Date; or

          (iv) by either Party, in the event that the other Party has become insolvent or has been
dissolved or liquidated, filed or has filed against it, a petition in bankruptcy and such petition
is not dismissed within sixty (60) days of the filing, makes a general assignment for the benefit
of creditors; or has a receiver appointed for a substantial portion of its assets.

     (b) In the case of any termination of this Agreement during Year One by Client or Ventiv under
Section 13 of this Agreement, Client shall (in addition to all other payment obligations under this
Agreement) promptly pay (or if paid by Ventiv, promptly reimburse Ventiv): the amount due any
lessor or rental agent of the equipment provided by Ventiv to members of the Project Team pursuant
hereto (i.e., laptop computers, handheld PDA’s, and fleet automobiles (collectively, the
“Equipment”)), for any early termination of the lease or rental agreement. In addition, Client may
elect to either: (i) in the event the Equipment is owned by Ventiv, accept transfer of the
Equipment from Ventiv and pay an amount equal to the net book value (if any) of the Equipment on
the books of Ventiv at the time of the transfer, or in the event the Equipment is subject to a
lease or finance lease, and to the extent allowed by the governing lease documents, seek transfer
of the Equipment to Client from Ventiv (subject to the last sentence of this Section 13 (b) and
Client shall assume the responsibility for all further payments

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due (including costs associated with the transfer), or (ii) pay Ventiv the net loss to Ventiv
on such Equipment determined by the difference between the net book value of such Equipment and the
actual net price received by Ventiv for the disposal of such Equipment, plus any costs associated
with the disposal of said Equipment. Any proposed transfer of Equipment shall be subject to Client
establishing its own relationship and credit with the entity that Ventiv contracted with to lease
or rent such Equipment.

     (c) Upon the effective date of such termination, the Parties shall have no further obligation
to each other (other than those set forth in Sections 6 (“Ventiv Compensation and Accounting
Records”), 7 (“Confidentiality; Ownership of Property”), 8 (“Disposition of Computer Files and
Client Materials”), 10 (“Ventiv Personnel”), 11 (“Indemnification”), 13 (c) (this provision), 14
(“Publicity; Press Releases”) and 15 (“Miscellaneous”), except that Client shall pay the amounts
set forth or provided for in all of the exhibits attached hereto through the actual date of
termination, and Ventiv shall continue to provide all Services through the actual date of
termination.

       14. Publicity; Press Releases — 

Nothing contained in this Agreement shall be construed as conferring any rights to use in
advertising, publicity or other marketing activities any trade name or trademark owned or used
under license to Client or Ventiv, as case may be, or other designation of Client or Ventiv,
including any contraction, abbreviation, or simulation of any of the foregoing, and disclosing
party agrees not to use the existence of this Agreement in any promotional activity without the
express written approval of the other party and with regard to Ventiv’s promotional activity the
signature of Client’s Chief Executive Officer and Client’s IP Committee in each instance.

Neither party shall disclose the terms, conditions or subject matter of this Agreement without
the prior written consent of the other unless, in the judgment of the disclosing party, such
disclosure is:

     (a) In response to a valid order of a court or other governmental body of the United States or
any political subdivision thereof; provided, however, that Ventiv shall first have made a
reasonable effort to obtain a protective order requiring that the information or documents so
disclosed be used only for the purposes for which the order was issues; or

     (b) As may be required by law; or,

     (c) As may be necessary to establish its rights under this Agreement.

Notwithstanding anything to the contrary stated in this section, upon Client’s receipt of
written consent from Ventiv (which shall not be unreasonably withheld or delayed), Client may
disclose certain terms and conditions of this Agreement to third parties that are providing
services to Client, provided: (i) such information shall be used by third party solely in
connection with Client’s business operations; (ii) Client shall limit the disclosure to only such
information as is required or necessary to be disclosed; and (iii) Client has an agreement with
such third party that

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obligates the third party to hold the disclosed terms and conditions of this Agreement
confidential.

       15. Miscellaneous

     (a) Each Party represents to the other that the execution, delivery and performance of this
Agreement by such Party has been duly authorized by all requisite corporate action; that the
Agreement constitutes the legal, valid, and binding obligation of such Party, enforceable in
accordance with its terms (except to the extent enforcement is limited by bankruptcy, insolvency,
reorganization or other laws affecting creditors’ rights generally and by general principles of
equity); and that this Agreement and performance hereunder does not violate or constitute a breach
under any organizational document of such Party or any contract, other form of agreement, or
judgment or order to which such Party is a party or by which it is bound.

     (b) In addition to the insurance set forth in Exhibit E (“Fleet Management Services”), each
Party shall have and maintain such type and amount of insurance covering the development,
manufacture, promotion, supply, use, and sale, (as applicable to such Party) of Product as is
normal and customary in the pharmaceutical industry generally for parties similarly situated in
commercially reasonable amounts with carriers with a Best rating of A-XII or better and include
contractual liability, including in the case of Client product liability insurance in the amount of
at least $25 million. Additionally, Ventiv shall be named as an additional insured on such product
liability insurance. If carried under claims made form, this insurance shall be carried by each
Party for a minimum of ten (10) years following the termination of this Agreement. In addition,
upon written request, each Party will provide the other with a copy of its policies of insurance or
a certificate of insurance in that regard, along with any material amendments and revisions
thereto. Additional insurance requirements in connection with certain of the Additional Services
are set forth in the exhibits attached hereto.

     (c) Neither Ventiv nor Client may assign this Agreement or any of its rights, duties or
obligations hereunder without the other Party’s prior written consent; provided, however, that
either Ventiv or Client may assign its rights, duties and obligations as part of an acquisition of
Ventiv or Client, as the case may be, so long as the acquirer (i) is a financially capable business
entity with financial resources and business capabilities that are at least as extensive as the
Party being acquired, and so long as the acquired Party remains financially liable (i.e. not liable
for performance) under this Agreement in addition to the acquirer, and (ii) expressly assumes in
writing those rights, duties and obligations under this Agreement and this Agreement itself.

     (d) This Agreement supersedes all prior arrangements and understandings between parties
related to the subject matter of this Agreement.

     (e) Noncompliance with the obligations of this Agreement due to a state of force majeure, the
laws or regulations of any government, regulatory or judicial authority, war, civil commotion,
destruction of facilities and materials, fire, flood, earthquake or storm, labor strikes organized
by a national labor union, shortage of materials or failure of public utilities or common

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carriers due to the preceding conditions, and any other causes beyond the reasonable control
of the applicable Party, shall not constitute a breach of contract.

     (f) If any provision of this Agreement is finally declared or found to be illegal or
unenforceable by a court of competent jurisdiction, both parties shall be relieved of all
obligations arising under such provision, but, if capable of performance, the remainder of this
Agreement shall not be affected by such declaration or finding.

     (g) This Agreement, including any attachments or exhibits entered into hereunder, contains all
of the terms and conditions of the agreement between the parties and constitutes the complete
understanding of the parties with respect thereto. No modification, extension or release from any
provision hereof shall be affected by mutual agreement, acknowledgment, acceptance of contract
documents, or otherwise, unless the same shall be in writing signed by the other Party and
specifically described as an amendment or extension of this Agreement.

     (h) This Agreement shall be construed according to the laws of the State of New York and any
action brought by either Ventiv or Client in connection with this Agreement shall be brought in the
state or federal courts located in the State of New York.

     (i) This Agreement may be executed in any number of counterparts, each of which, when
executed, shall be deemed to be an original and all of which together shall constitute one and the
same document.

     (j) Any notices required or permitted under this Agreement shall be given in person or sent by
first class, certified mail to:

Ventiv:

Ventiv Commercial Services, LLC

200 Cottontail Lane

Somerset, New Jersey 08873

Attention: Terrell G. Herring, President and Chief Executive Officer

with a copy to:

David Blatteis, Esq.

Norris, McLaughlin & Marcus, P.A.

721 Route 202-206

P.O. Box 1018

Somerville, New Jersey 08876-1018

Client:

Sucampo Pharmaceuticals, Inc.

4733 Bethesda Avenue, Suite 450

Bethesda, MD 20814

Attention: Director, Legal Department

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or to such other address or to such other person as may be designated by written notice given from
time to time during the term of this Agreement by one Party to the other.

     (k) In no event, except as expressly provided herein, will either Party be liable to the other
Party on a claim of any kind for special, indirect, incidental or consequential damages, including
without limitation, loss of anticipated profits, damage to business reputation, costs of preparing
claims, costs of tooling or equipment, arising with respect to Services terminated pursuant to the
terms hereof or this Agreement.

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     WHEREFORE, the parties hereto have caused this Agreement to be executed by their duly
authorized representatives.

	 	 	 	 	 
	 	VENTIV COMMERCIAL SERVICES, LLC

 	 
	 	By:  	/s/ Terrell G. Herring
 	 
	 	 	Name:  	Terrell G. Herring 	 
	 	 	Title:  	President & CEO 	 
	 

	 	 	 	 	 
	 	SUCAMPO PHARMACEUTICALS, INC.

 	 
	 	By:  	/s/ Sachiko Kuno, Ph.D.
 	 
	 	 	Name:  	Sachiko Kuno, Ph.D. 	 
	 	 	Title:  	President & CEO 	 
	 

List of Attached Exhibits

	 	 	 
	Exhibit A

	 	“Ventiv Compensation — Fees, Incentives and Pass-through
Compensation”
	 
	 	 
	  Attachment
1 to Exhibit A

	 	“Promotech Pricing”
	 
	 	 
	Exhibit B

	 	“Database Activity, Sales Reports and Analysis, Standard
Operating Procedures”
	 
	 	 
	Exhibit C

	 	“Product Sample and Product Literature Warehousing and
Distribution (Promotech Services)”
	 
	 	 
	  Attachment
1 to Exhibit C

	 	“Sampling and Sample Accountability Policies and Procedures”
	 
	 	 
	Exhibit D

	 	“Sucampo Pharmaceuticals, Inc. Compliance Program on
Communications to Healthcare Professionals and Promotional
Activities”
	 
	 	 
	Exhibit E

	 	“Fleet Management Services for Client Employees”
	 
	 	 
	Exhibit F

	 	“Sales Force Automation Software Services”
	 
	 	 
	Exhibit G

	 	“Recruiting Services”

Service Agreement

Page 19 of 19

 

 

EXHIBIT A

VENTIV COMPENSATION — FEES, INCENTIVES AND PASS-THROUGH COMPENSATION

1. Ventiv Monthly Management Fee (Fixed Fee)

“Monthly Management Fee” includes fixed fees for Services provided in accordance with Agreement
Sections 1(a), 1(b), 1(d)(i), 1(e), and 1(f).

Commencing March 30, 2006, the first date of hire of Ventiv Medical Center Representatives, Ventiv
shall invoice Client and Client shall pay Ventiv a Fixed Monthly Fee in accordance with the
following:

	 	 	 
	Period	 	Monthly Fee 
	March 30, 2006 - March 29, 2007

	 	$[**]
	(Year One)
	 	 
	 
	 	 
	March 30, 2007 - March 29, 2008

	 	$[**]
	(Year Two)
	 	 

 

*     For March 30, 2006 through April 17, 2007, Client shall receive a credit of $[**] per Ventiv
Medical Center Representative per day in the event Ventiv has hired less than 38 Ventiv Medical
Center Representatives.

2. Pass-Through Costs 

     In addition to the fixed fees, certain expenses will be charged to Client on a pass-through
basis. These expenses will be billed to Client at actual cost incurred by Ventiv. Pass through
expenses approved by Client shall include:

— Ventiv Medical Center Representative bonuses (including employer portion of taxes)

— Shared Team Leader bonus (including employer portion of taxes) up to [**] of the total
annual bonus

— All Project Team travel associated with this Agreement

— All costs associated with National Training Meeting and POA Meetings

— Third Party data acquisition costs

Exhibit A

Page 1 of 6

 

 

— DME funds

— Phone and internet provider costs in excess of $[**] per Ventiv Medical Center
Representative per month. These pass-through costs will not exceed $[**] per Ventiv Medical
Center Representative per month.

     Additional pass-through costs associated with a particular service to be provided by Ventiv
are set forth in this Exhibit A.

3. Ventiv Incentive Fees

     (a) Ventiv Incentive Fees represent a pool of money which will be paid to Ventiv by Client on
the achievement of certain goals as set forth below. [**] percent ([**]%) of the incentive pool in
Year One (i.e. $[**]) will be paid upon Ventiv’s recruitment, hiring and training of the Ventiv
Medical Center Representatives as set forth in detail below and [**] ([**]%) of the incentive pool
in Year One (i.e. $[**]) shall be paid based upon maintenance in the field of a certain number of
Ventiv Medical Center Representatives in certain time periods, as set forth in detail below. [**]
percent of the incentive pool in Year Two (i.e. $[**]) shall be paid based upon maintenance in the
field of a certain number of Ventiv Medical Center Representatives in certain time periods, as set
forth in detail below.

	 	 	 
	Period	 	Incentive Pool Amount
	March 30, 2006 – March 29, 2007
	 	$[**]
	(Year One)

	 	 
	 
	 	 
	March 30, 2007 – March 29, 2008
	 	$[**]
	(Year Two)

	 	 

     (b) Pursuant to Ventiv achieving the goals according to the terms in the table below, Ventiv
shall invoice Client and Client shall pay Ventiv (in accordance with Agreement Section 5), the
Ventiv Incentive Fees. Such Ventiv Incentive Fees will be achieved, reconciled and paid as
follows:

Exhibit A

Page 2 of 6

 

 

	 	 	 	 	 	 	 
	 	 	 	 	Performance Period	 	 
	 	 	 	 	and Reconciliation	 	 
	Goal	 	Achievement Measure	 	Date	 	Payment Terms
	$[**]

	 	Recruitment and
hiring of [**] or
more Ventiv Medical
Center
Representatives by
March 30, 2006
	 	February 9, 2006 -
April 16, 2006
	 	Within thirty (30)
days of April 17,
2006
	 
	 
	 	OR	 	 
	 	 
	 
	 
	 	Recruitment, hiring
and training of
thirty-eight (38)
or more Ventiv
Medical Center
Representatives by
April 17, 2006
	 	 
	 	 
	 
	 	 	 	 	 	 
	$[**]

	 	Ventiv Medical
Center
Representatives
working in the
field at least [**]
days in Performance
Period
	 	April 17, 2006 -
June 30, 2006
	 	$[**] — Within
thirty (30) days of
invoice
	 
	 	 	 	 	 	 
	 

	 	Ventiv Medical
Center
Representatives
working in the
field at least
[**] days in
Performance Period
	 	July 1, 2006 -
September 30, 2006
	 	$[**] — Within
thirty (30) days of
invoice
	 
	 	 	 	 	 	 
	 

	 	Ventiv Medical
Center
Representatives
working in the
field at least [**]
days in Performance
Period
	 	October 1, 2006 -
December 31, 2006
	 	$[**] — Within
thirty (30) days of
invoice
	 
	 	 	 	 	 	 
	 

	 	Ventiv Medical
Center
Representatives
working in the
field at least [**]
days in Performance
Period
	 	January 1, 2007
- March 29, 2007
	 	$[**] — Within
thirty (30) days of
invoice
	 
	 	 	 	 	 	 
	$[**]

	 	Ventiv Medical
Center
Representatives
working in the
field at least [**]
days in Performance
Period
	 	March 30, 2007 -
June 30, 2007
	 	$[**] — Within
thirty (30) days of
invoice
	 
	 	 	 	 	 	 
	 

	 	Ventiv Medical
Center
Representatives
working in the
field at least [**]
days in Performance
Period
	 	July 1, 2007 -
September 30, 2007
	 	$[**] — Within
thirty (30) days of
invoice
	 
	 	 	 	 	 	 
	 

	 	Ventiv Medical
Center
Representatives
working in the
field at least [**]
days in Performance
Period
	 	October 1, 2007 -
December 31, 2008
	 	$[**] — Within
thirty (30) days of
invoice
	 
	 	 	 	 	 	 
	 

	 	Ventiv Medical
Center
Representatives
working in the
field at least [**]
days in Performance
Period
	 	January 1, 2008 -
March 29, 2008
	 	$[**] — Within
thirty (30) days of
invoice

     As used in the chart above “working in the field” shall mean days in the field performing

Exhibit A

Page 3 of 6

 

 

services as well as days attending training meetings, POA meetings or other meetings as
requested by Client. Number of days “working in the field” was calculated as follows: Number of
Ventiv Medical Center Representatives (38) x number of expected days in the field per performance
period x [**]%.

     The number of days “working in the field” set forth in the above chart shall be adjusted as
agreed to by the Parties to address POA meetings, convention attendance and additional
administrative time spent on activities other than providing details of the Product to Targets.

4. Early Termination Fee

     In the event the Agreement is terminated for any reason prior to the last day of Year One,
then Client shall pay Ventiv an early termination fee in an amount equal to $[**] times the number
of months remaining in Year One. This early termination fee may be prorated in the event of
termination prior to the last day in any given month of Year One.

5. Reporting Fees

Outside of standard reports included in Monthly Management Fee, “non-standard” reports will be
provided in compliance with Agreement Section 1(d)(ii) and (iii), and at the prices set forth in
Exhibit B, Item 1, Table B.

6. Physician Validation Services

Ventiv shall invoice Client and Client shall pay Ventiv [**] dollars ($[**]) to provide validation
of [**] physicians against a current list of state license numbers. Validation of additional
physicians, if requested in writing in advance by Client, shall be performed by Ventiv and invoiced
at a cost of $[**] for each additional physician validation performed.

7. Fees and Costs for Fleet Management Services for Client Employees

In consideration for the performance of the services set forth on Exhibit E attached hereto by
Ventiv, Client shall pay Ventiv as follows:

     (a) Monthly fee per the following chart:

Exhibit A

Page 4 of 6

 

 

	 	 	 	 	 	 	 
	 	 	Model	 	 	 	Monthly
	Current Selections	 	Year	 	VIN	 	Total
	 
	Chrysler Pacifica Touring 4DR AWD SUV
	 	2006	 	[**]	 	$[**]
	 
	 	 	 	 	 	 
	Ford Freestyle SEL FWD 4DR Wagon
	 	2006	 	[**]	 	$[**]
	 
	 	 	 	 	 	 
	Saab 9-3 Aero 4DR Sedan
	 	2006	 	[**]	 	$[**]
	 
	 	 	 	 	 	 
	Saab 9-3 2.0T 4DR Sedan
	 	2006	 	[**]	 	$[**]
	 
	 	 	 	 	 	 
	Ford Explorer 4WD XLT 4.0L V6 4DR SUV
	 	2006	 	[**]	 	$[**]
	 
	 	 	 	 	 	 
	Ford Explorer 4WD XLT 4.0L V6 4DR SUV
	 	2006	 	[**]	 	$[**]

     (b) Pass through costs associated with Exhibit E services:

	 	a.	 	costs associated with gas as incurred through Ventiv provided
gas cards
	 
	 	b.	 	costs associated with maintenance as incurred by Ventiv in
connection with its maintenance program
	 
	 	c.	 	rental costs associated with bridge rentals
	 
	 	d.	 	training travel and expenses
	 
	 	e.	 	vehicle storage and rentals (if necessary)

     (c) Pricing for services performed by Ventiv as set forth in Exhibit E is subject to change
after prior written notice to Client in the event any vehicle is replaced.

     (d) The fees set forth above assume the autos are purchased directly from the manufacturer.
Purchases from a dealer lot will require a recalculation of the fees.

     (e) Fleet and safety training is available for a fee of $[**] per session in Year One and
$[**] in Year Two (up to [**] Client attendees), plus facilitator’s travel and expenses.

     (f) Ventiv Standard Driver Safety Manuals can be provided for a fee of $[**] per manual.

8. Promotech Services

In consideration for the performance of the services set forth on Exhibit C attached hereto by
Ventiv, Client shall pay Ventiv as set forth on Exhibit A — Attachment 1 attached hereto.

Exhibit A

Page 5 of 6

 

 

9. Fees and Costs for Sales Force Automation Services for Client Employees

     In consideration for the performance of the services set forth on Exhibit F attached hereto by
Ventiv Client shall pay Ventiv the following fees:

     (i) Service Fees — Client shall pay Ventiv a monthly service fee (which includes the
license and maintenance fees) (collectively, the “Monthly Fee”) based on the number of Client
managers using the SFA:

	 	 	 
	 	 	Monthly Fee Per 
	Period	 	Client Employee
	 
	Year One

	 	$[**]
	Year Two

	 	$[**]

	 	(ii)	 	Pass through costs associated with Exhibit B services:

	 	i.	 	training travel and expense

	 
	 	ii.	 	shipping and postage costs

10. Billing Terms

     Ventiv shall provide invoices to Client and shall pay such invoices in accordance with Section
6 of the Agreement.

Exhibit A

Page 6 of 6

 

 

			
	 	 	 
	“PROMOTECH PRICE”
	 	Exhibit A
	 
	 	Attachment 1

PROMOTECH

a division of ventiv commercial services

			
	 	 	 
	Field Force Fulfillment
	 	4/19/2006
	 
	 	Version 2

Scope of Work:

PROMOTECH will provide field force fulfillment of samples and literature on behalf of Sucampo. PROMOTECH will design a custom order web site which will include thumbnails of the materials,
product description, min/max quantities and shopping cart application for ordering.

Representatives will be provided an initial password (which they can then change) to place a quarterly order of materials and samples. Pricing is provided for the following shipping options
regarding samples:

	 	1.	 	Samples to be sent via ground — signature required
	 
	 	2.	 	Samples sent via 3 day air 10:30 a.m. delivery
	 
	 	3.	 	Samples sent via ground freight wilt 2 hour window delivery

All literature will be shipped via UPS ground no signature required.

All samples will be shipped in full cases. All literature will be custom pick/packed in pre-bundled quantities — defined by Sucampo.
It is possible that overpack of the samples will be required — pricing for this step has been included.

Ventiv will provide the updated field rosters and PROMOTECH will communicate all lot/sku information for loading into the iPAQ.
Ventiv/Franklin Group will handle all reconciliations and sample accountability.

PROMOTECH will provide monthly reporting to indude: inventory (receipts/shipments/quarantine), usage, ordering history and low point inventory notification.

It is assumed there is one (1) RX products with a total of one (1) SKU and thirty (30) SKUs of promotional literature and materials.

Pallet Count Monthly:

20 — Samples

40 — Literature

Start-up and PROMOTECH services provided
from March 30, 2006, through September 30, 2006, will be billed at cost [**].
PROMOTECH services provided October 1, 2006, through contract term will be billed cost [**].

Program Assumptions:

	 	 	 	 	 	 	 
	Program Duration (in months):

	 	 	12	 	 	 
	Total Medical Center Representatives:

	 	 	38	 	 	 
	Total Regional Managers:

	 	 	4	 	 	 
	Total Representative Shipments:

	 	 	152	 	 	Quarterly
	Total Manager Shipments:

	 	 	12	 	 	(1 piece of each sku — no drug)
	Total cases shipped:

	 	 	3,040	 	 	(20 per quarter of samples)

PROMOTECH SERVICES

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Start-up (one-time fee)	 	Quantity	 	Promotech Cost	 	Cost [**]	 	Cost [**]	 	Total Price
	Project Start-up Fee (includes website set-up)
	 	 	1	 	 	$	[**]	 	 	$	[**]	 	 	 	 	 	 	$	[**]	 
	Total Estimated Start-up Fee
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	$	[**]	 

 

 

			
	 	 	 
	“PROMOTECH PRICE”
	 	Exhibit A
	 
	 	Attachment 1

PROMOTECH

a division of ventiv commercial services

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Operations	 	Quantity	 	Promotech Cost	 	Cost [**]	 	Cost [**]	 	Total Price
	Project Management
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Data Systems Management Fee, monthly
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Additional Computer Programming due to Client Changes, hourly
	 	 	 	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	 	—	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Total Estimated Operations
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Warehouse Services	 	Quantity	 	Promotech Cost	 	Cost [**]	 	Cost [**]	 	Total Price
	Receiving, hourly (assumes 10 hours quarterly)
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Inventory Management/Compliance, monthly
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Inventory Storage, Drug, per pallet (assumes average 30 pallets per month)
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Inventory Storage, Literature, per pallet (assumes average 30 pallets per month)
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Fulfillment, Drug, per case (assumes wholes cases)
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Expedite: Fulfillment, Drug, per case (assumes wholes cases)
	 	 	 	 	 	 	 	 	 	 	—	 	 	$	[**]	 	 	 	—	 
	Overpack Fee, per box
	 	 	 	 	 	 	 	 	 	 	—	 	 	$	[**]	 	 	 	—	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Fulfillment Literature, hourly (assumes .5 hours per rep per shipment
+ 6 hours per drop ship)
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Expedite: Fulfillment, Literature, hourly (assumes .5 hours per rep per shipment)
	 	 	 	 	 	 	 	 	 	 	—	 	 	$	[**]	 	 	 	—	 
	Drop Ship Staging Fee, each (assumes 1 monthly)
	 	 	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 	 	$	[**]	 
	Returns, hourly
	 	 	 	 	 	 	 	 	 	 	—	 	 	$	[**]	 	 	 	—	 
	Destruction, hourly (does not includes 3rd party services)
	 	 	 	 	 	 	 	 	 	 	—	 	 	$	[**]	 	 	 	—	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Total Estimated Warehouse Services
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TOTAL ESTIMATED PROMOTECH SERVICES
	 	$	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	OTHER EXPENSES FOR CONSIDERATION
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 
	 	Quantity	 	 	 	 	 	 	 	 	 	Price	 	Total Price
	Literature Freight, UPS Residential Ground, each (assumes 5 per rep
per shipment © 20 lbs each)
	 	 	[**]	 	 	 	 	 	 	 	 	 	 	$	[**]	 	 	$	[**]	 
	Boxes and Packing Materials, each
	 	 	[**]	 	 	 	 	 	 	 	 	 	 	$	[**]	 	 	$	[**]	 
	Drug Freight, UPS Residential Ground, delivery signature required, each
(assumes 6 lbs per case)
	 	 	[**]	 	 	 	 	 	 	 	 	 	 	$	[**]	 	 	$	[**]	 
	Drug Freight, UPS 2nd Day Air Early AM, delivery signature required,
each (assumes 6 lbs per case)
	 	 	[**]	 	 	 	 	 	 	 	 	 	 	$	[**]	 	 	$	[**]	 
	Drug Freight, 4-7 Deferred Business Ground with 2-hour delivery window,
each rep shipment (up to 175 lbs)
	 	 	[**]	 	 	 	 	 	 	 	 	 	 	$	[**]	 	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Total Estimated Operations
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	$	[**]	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	TOTAL ESTIMATED PROGRAM FEES
	 	$	[**]	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

The
above information is only an estimate, changes in scope may result in
changes to the estimated costs.

As is customary in the Fulfillment and Teleservices industry, Long Distance Charges, Freight and Postage will be billed at cost.

This estimate does not include Scope of Work changes and these will be estimated separately.

The above represents expected volume based on the SOW as defined to date. Client will be billed actual activity.

 

 

EXHIBIT B

DATABASE ACTIVITY, SALES REPORTS AND ANALYSIS, STANDARD OPERATING PROCEDURES

1. Database Activity, Sales Reports and Analysis

     In compliance with Section 1(d) of the Agreement and the standard operating procedures set
forth below, Ventiv shall produce the reports set forth in the table below. For non-standard
activities authorized in writing by the Primary Client Contacts, Ventiv shall invoice Client and
Client shall pay Ventiv (in accordance with Section 6 of the Agreement) the prices set forth in the
table below.

Work to be performed/requested

Table A
— Database Activity Table

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	Required
	Standard	 	 	 	 	 	Standard	 	 	 	Turnaround
	or Non-	 	 	 	Base	 	Annual	 	Standard	 	from Data
	Standard*	 	Database Activity	 	assumptions	 	Frequency**	 	Timing**	 	Provision
	 
	Standard

	 	Initial Data Loads
	 	Data provided from
one source in basic
Ventiv provided
layout
	 	 	1	 	 	3-6 weeks prior to
deployment
	 	5 business days
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Universe Deletions
	 	Data provided from
one source in basic
Ventiv provided
layout
	 	 	4	 	 	quarterly
	 	5 business days
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Universe Merges
	 	Data provided from
one source in basic
Ventiv provided
layout
	 	 	4	 	 	quarterly
	 	5 business days
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Universe Additions
	 	Data provided from
one source in basic
Ventiv provided
layout
	 	 	4	 	 	quarterly
	 	5 business days
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Universe Zip/Terr
Changes
	 	Standard (zip code :from
territory : to
territory)
format
	 	 	4	 	 	quarterly
	 	5 business days

EXHIBIT B
Page 1 of 5

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	Required
	Standard	 	 	 	 	 	Standard	 	 	 	Turnaround
	or Non-	 	 	 	Base	 	Annual	 	Standard	 	from Data
	Standard*	 	Database Activity	 	assumptions	 	Frequency**	 	Timing**	 	Provision
	 
	Standard

	 	Major realignments
(more than 25% of
universe changes)
	 	Standard (zip
code: from territory: to
territory) format
	 	 	1	 	 	annually
	 	10 Business Days
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Minor realignments
(less than 25% of
universe changes)
	 	Standard (zip
code: from territory: to
territory) format
	 	 	4	 	 	quarterly
	 	10 Business Days
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Universe matches to
third party
	 	Matchable unique
identifiers
	 	 	N/A	 	 	N/A
	 	5 business days
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Target changes
	 	 	 	 	4	 	 	quarterly
	 	5 business days
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Data Extracts
	 	standard format-no
charge for setup
	 	 	 	 	 	 	 	10 days for initial
set up/ run/qc time
thereafter
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Data Extracts to
third party vendors
	 	standard format-no
charge for
setup-per run
charge (TBD with
complexity.
	 	 	 	 	 	 	 	10 days for initial
set up/ run/qc time
thereafter
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Non -Standard

	 	Data Set-up for
third party data	 	 	 	 	 	 	 	 	 	 

Table B
— Reports Table

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Standard	 	 	 	 	 	 	 	 	 	 
	or Non-	 	 	 	Base	 	Standard	 	Standard	 	 
	Standard	 	Reports Type	 	assumptions	 	Frequency	 	Timing	 	Customizable*
	 
	Standard

	 	Call Activity
	 	Standard Format
	 	 	n/a	 	 	daily sweep of
communicated data
	 	No
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Standard

	 	Territory Summary
	 	Customized to
specific activity
measurements within
set up matrix
(calls, targets
only, reach,
frequency, sample
distribution)
	 	 	12	 	 	monthly (Within 10
business days of
close of the month)
	 	yes

EXHIBIT B
Page 2 of 5

 

 

	 	 	 	 	 	 	 	 	 	 	 	 	 
	Standard	 	 	 	 	 	 	 	 	 	 
	or Non-	 	 	 	Base	 	Standard	 	Standard	 	 
	Standard	 	Reports Type	 	assumptions	 	Frequency	 	Timing	 	Customizable*
	 
	Non-standard

	 	Call Planning
	 	$[**] per quarter
hour
	 	as requested by
Primary Client
Contacts
	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Non-standard

	 	Alignments
	 	$[**] per quarter
hour
	 	as requested by
Primary Client
Contacts
	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Non-standard

	 	Incentive
Compensation
	 	$[**] per quarter
hour
	 	as requested by
Primary Client
Contacts
	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Non-standard

	 	Ad hoc/Customized
Reporting
	 	$[**] per quarter
hour
	 	as requested by
Primary Client
Contacts
	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Non-standard

	 	Web Portal
Customizations
	 	$[**] per quarter
hour
	 	as requested by
Primary Client
Contacts
	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Non-standard

	 	Data Extract Set Up
and Modifications
	 	$[**] per quarter
hour
	 	as requested by
Primary Client
Contacts
	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 

 

			
	*	 	For purposes of this table, “Standard” is any activity included in the Ventiv Monthly
Management Fee and “Non-Standard” will charged to the Client as a pass-through Cost in accordance
with Agreement Section 6.
	 
	**	 	Customizations, expedited timeframes not due to Ventiv error, and/or increases to standard
frequency of tasks will be performed at $[**] per hour, to be charged on the quarter-hour.

EXHIBIT B
Page 3 of 5

 

 

	2.	 	Sales Reports And Analysis Production Standard Operating Procedures
	 
	A.	 	Data QC

          1. Script

	 	i.	 	Import raw data to copy of project workspace.
	 
	 	ii.	 	Verify Data file against check control numbers
	 
	 	iii.	 	Check market data for new products (Verify any
product adds with client).
	 
	 	iv.	 	Process data using market load procedure into market
data table (one data set for each market).
	 
	 	v.	 	Verify and Update market period table
	 
	 	vi.	 	Copy tables to production database and set applicable
keys.
	 
	 	vii.	 	Check imported raw data to processed market data.
	 
	 	viii.	 	Check Data in CAST DB
	 
	 	ix.	 	Load SFA (Sales Force Automation) device.
	 
	 	x.	 	Verify Data in SFA device.
	 
	 	xi.	 	Submit Change control to EDM (Electronic Data
Management) to Download Market data.

          2. Data loads

	 	xii.	 	Update or load Zip_Terr (Zip to Territory File).
	 
	 	xiii.	 	Load raw data.
	 
	 	xiv.	 	Verify professional information

	 	1.	 	Check all unique identifiers — no 2
professionals share an identifier.

	 	a.	 	If multiple identifiers cross-reference
for uniqueness.

	 	2.	 	Verify name, degree & specialty for each record.
	 
	 	3.	 	Check addresses for p. o. boxes.
	 
	 	4.	 	Verify addresses against Zip _Terr.
	 
	 	5.	 	Make sure only one primary address per
professional.
	 
	 	6.	 	Verify all target segments and frequencies.

	 	xv.	 	Load data load file into Ventiv formatted file.
	 
	 	xvi.	 	Run Data Verification procedure and fix all
applicable discrepancies.
	 
	 	xvii.	 	Execute Data Load procedure to load call plan.
	 
	 	xviii.	 	Execute QC procedure to ensure correct load.
	 
	 	xix.	 	Run database check to ensure database integrity.
	 
	 	xx.	 	Load SFA device to check territory.
	 
	 	xxi.	 	Check CAST for territory loaded in device.
	 
	 	xxii.	 	Send commands to load professionals into SFA
device.

	B.	 	Reports QC

          1.Activity reports

Exhibit B

Page 4 of 5

 

 

	 	i.	 	Territory summary/ Manager summary

	 	1.	 	Replicate production database
	 
	 	2.	 	Run activity reports.
	 
	 	3.	 	Verify all data and calculations on all reporting
levels.
	 
	 	4.	 	Investigate and rectify all deviations.
	 
	 	5.	 	E-mail /distribute to client/reps

          2.Script reports

	 	i.	 	After script data is loaded into device, run
procedures for Activity Productivity and Competitive
Analysis

	 	6.	 	Replicate production database
	 
	 	7.	 	Run script reports
	 
	 	8.	 	Verify all data and calculations on all reporting
levels.
	 
	 	9.	 	Investigate and rectify all deviations.
	 
	 	10.	 	E-mail /distribute to client/reps

	C.	 	Extracts

          1.Call and professional extracts

	 	1.	 	Replicate production database
	 
	 	2.	 	Process data extracts
	 
	 	3.	 	Verify all data and calculations on all reporting
levels.
	 
	 	4.	 	Investigate and rectify all deviations.
	 
	 	5.	 	E-mail /distribute to client/reps

Exhibit B

Page 5 of 5

 

 

EXHIBIT C

PRODUCT SAMPLE AND PRODUCT LITERATURE WAREHOUSING AND

DISTRIBUTION

(PROMOTECH SERVICES)

1. GENERAL PROVISION.

     1.1 Services. Promotech shall perform warehouse and fulfillment services for Client.
Client shall pay Promotech in accordance with Exhibit A-Item 8 the fees set forth in Exhibit
A-Attachment 1 for performance by Promotech of such Services.

     1.2 Product(s). The Services shall be performed with respect to Client’s product
Amitiza (the “Product”) and promotional materials.

2. WAREHOUSE AND FULFILLMENT SERVICES.

     2.1 Description of Services. Promotech shall provide Client with warehouse and
fulfillment services (the “Fulfillment Services”) as more fully set forth herein. All Fulfillment
Services shall be consistent with the terms of and meet the requirements of Promotech’s Standard
Operating Procedures concerning the Fulfillment Services (the “SOPs”).

     2.2 Receiving and Storage.

     (a) Upon receipt of inbound Products, Promotech on behalf of Ventiv, will make a visual
inspection of each inbound Product shipment, and will notify Client with reasonable promptness
(consistent with regulations of the U.S. Food and Drug Administration (“FDA”) under the
Prescription Drug Marketing Act (“PDMA”) whenever Products do not substantially conform to
specifications designated by Client, provided such nonconformity is apparent upon a visual
inspection. Neither Promotech nor Ventiv will dispose of any nonconforming Products without
prior written authorization and instructions from an authorized representative of Client.

     (b) Promotech will comply with the requirements of local, state and federal governments and
agencies having jurisdiction over the Products, their storage in the Promotech premises, and their
distribution as part of the Fulfillment Services, including but not limited to, the FDA, DEA and
the Colorado State Board of Pharmacy.

     (c) Promotech will maintain written documentation conforming to the Standard Operating
Procedures as part of a shipment receipt verification system in conformation with the PDMA
regulations.

     (d) Promotech shall store the Products in locations and under conditions, including light and
temperature, consistent with requirements set forth on the Product label.

     2.3 Shipment.

     (a) Sample orders shall be processed in adherence with established operating procedures and
shall include a packing list with a description of the shipment including a product description,
quantity and lot number. Each packing list is uniquely numbered and shall be

Exhibit C

Page 1 of 3

 

 

specifically referenced by the Ventiv Sales Representatives when acknowledging receipt of
their shipments with their handheld PDAs. The packing list shall be retained by the Ventiv Sales
Representative for a period consistent with Client’ record retention policy. In the event the
packing list cannot be located, the Ventiv Sales Representative shall use an Acknowledgment of
Delivery Form provided by Ventiv and retained accordingly. In cases where, PDMA requirements are
being violated, Ventiv Sales Representatives will not receive sample shipments, if there are two
outstanding acknowledgment receipts through the PDA. Ventiv will cause Promotech to pick, pack and
ship in accordance with the SOPs and in all cases in compliance with all applicable laws and
regulations. All literature and sample orders will be placed by representatives through a custom
website designed by Promotech. Representatives may order quantities, as determined by client, for
materials. All materials will be shipped via a common carrier (ground freight) signature required
for samples, no signature required for literature. Client may change shipping method with
notification in writing. Any expenses related to shipping change will be passed to Client.

     (b) Promotech will prepare a standard packing list for each shipment.

     (c) Promotech will ship samples and literature on a quarterly schedule (prepared by Client) to
the Ventiv Sales Representatives requesting samples through the custom order website. The order
quantities are determined by the inventory in CAST. Upon prior written request from Client, Ventiv
will cause Promotech to ship more frequently or on a more expedited basis upon payment of agreed to
additional fees by Client.

     2.4 Records and reports. Ventiv and Promotech will operate in accordance with the
SOP’s.

     2.5 Notification of Client and Authorities. Upon Ventiv’ discovery that any Product
samples have been lost or stolen or that a diversion of a sample or a falsification of a sample
record by a properly licensed practitioner or Ventiv Sales Representative has occurred, Ventiv
shall (either directly or through Promotech), within twenty-four (24) hours, report such theft or
loss to the Principal Contact Person of Client. Client will be responsible for determining whether
a “theft” or a “significant loss” has occurred under the PDMA and the regulations of the FDA.
Client shall also be responsible for determining whether there is “reason to believe” that a
diversion of a sample or falsification of a sample record by a licensed practitioner has occurred.
Client shall then be responsible for reporting the theft or loss or the diversion or falsification
to the FDA (including both the 5 day telephone notice and 30-day full report requirements) and, if
a controlled substance is involved, to the DEA.

     2.6 Other duties.

     (a) Upon two business days advance notice, Ventiv and Promotech will allow Client’s personnel,
designated agent, or the personnel of Ventiv to perform physical inventory audits of Products in
Promotech’s custody, possession or control at any time during normal business hours. Ventiv
reserves the right to charge an overtime fee.

     (b) Ventiv will cause Promotech to accept returned Products from Ventiv Sales Representatives
and such returned Products will be placed in Quarantine at Promotech.

Exhibit C

Page 2 of 3

 

 

Promotech shall advise Client and await direction from Client with respect to the proper
disposition of such returned Products.

     (c) Promotech shall maintain required permits; licenses and registrations required to store
and distribute Products.

3. CLIENT RESPONSIBILITIES.

     3.1 Client will be solely responsible for reviewing and approving all direct mail pieces,
packaging, letterhead, samples, promotional items and inserts.

     3.2 Products Identification. Client shall notify Ventiv and Promotech of the lot
numbers of Products being shipped by Client in advance of shipment and provide an ASN (Advanced
Shipping Notice) prior to all samples and literature materials arriving at Promotech.

     3.3 Noninfringement. Client represents and warrants that Client has all rights
necessary to ship, store, repackage, distribute and sell the Products.

4. CHANGES.

     4.1 Notice of Requested Changes. Client may request changes to the Services, in
writing addressed to Ventiv reasonably in advance of the date on which a change is to be effective.

     4.2 Agreement to Changed Fees. Client shall pay any additional fees for any change to
the Services as determined by Ventiv promptly after receipt of Client’s written request to change
the Services. Client may in writing cancel any change in the Services requested, if Client finds
the additional fees are not acceptable, subject to reimbursing Ventiv for any costs incurred in
preparing to provide the changed Services.

Exhibit C

Page 3 of 3

 

 

EXHIBIT C — ATTACHMENT 1

SAMPLING AND SAMPLE ACCOUNTABILITY

POLICIES AND PROCEDURES

General

     Ventiv shall cause the Sales Representatives to distribute samples of the Products to Targets
(and to non-Targets as permitted under the terms of the Agreement) as part of the detailing
activity of the Ventiv Sales Representatives, under a sampling program which complies in all
respects with applicable Federal and State law and regulations, including the Federal Prescription
Drug Marketing Act, as amended (“PDMA”) and regulations and guidelines promulgated thereunder. The
sampling program will be reviewed and approved by Client prior to implementation. In connection
with the foregoing Client expressly authorizes Ventiv to distribute the Product samples during the
Term of the Agreement.

     Since the Agreement to which this Exhibit is attached provides for the shipment of Product
samples from Client to Promotech for distribution to the Ventiv Sales Representative (and
thereafter to Targets), Ventiv shall ensure Promotech stores the samples of the Products and
distributes the samples to the Ventiv Sales Representatives in compliance with all applicable legal
requirements, including, without limitation, the PDMA. Notwithstanding anything herein which may
be interpreted to the contrary, Client shall retain all risk of loss with respect to Product
samples and shall at all times maintain its own insurance with respect to their loss, damage or
destruction.

Responsibility for Sample Distribution and Storage

     Client shall be responsible for initial storage of samples in the aggregate and for
distribution of samples to Promotech. Promotech shall be responsible for storage and distribution
of the Product samples to the Ventiv Sales Representatives. Ventiv shall be accountable for
samples received by the Ventiv Sales Representatives (including any storage of samples by the
Ventiv Sales Representatives).

State License Number for Targets

     The Call Plan shall include a list of Targets utilized by the Ventiv Sales Representatives who
have been validated against a current list of state license numbers provided by IMS or other
recognized vendor.

Sample Accountability Records

     Ventiv shall utilize a security and audit program that includes allowance for all of: random,
for cause and periodic physical inventories of samples delivered to the Sales Representatives
consistent with the PDMA and applicable regulations of the FDA (including those adopted under the
FDA Modernization Act of 1997). In the course of utilizing that program, Ventiv will generate
Inventory Records, Reconciliation Reports and Summary Report as required by the regulations of the
FDA.

Exhibit C — Attachment 1

Page 1 of 4

 

 

Written Accountability Policies

     Ventiv will prepare written policies, provide instruction and testing concerning those
policies and (with the cooperation of Client) gather all required information concerning Sample
Accountability issues to assure that Ventiv is in compliance with the requirements of the
regulations of the FDA covering the sampling services (if any) provided by Ventiv. Those written
policies and procedures will address: (i) the inventory process, (ii) an inventory schedule, (iii)
the audit standards for detecting falsified and incomplete records, (iv) what is a significant loss
and how it is to be identified, (v) responsibility for notifying the FDA, (vi) system for
monitoring samples to identify the loss or theft of samples and (vii) the standards for storage of
samples. Those written policies and procedures shall be provided to and accepted in writing by
Client. In addition, Client shall prepare written policies and procedures covering shipping of
samples by Client and return of samples, as applicable. Client shall provide Ventiv with a written
copy of Client’s written policies and procedures.

Audit Services

     Ventiv will develop audit procedures including random selection audits, operational
guidelines, proposed timelines and checklists to demonstrate PDMA compliance to performance
requirements regarding security functions. These procedures will include random and for-cause
audit criteria, on-site inventory, inspection of sample storage locations, interviews of Ventiv
Sales Representatives and reconciliation services and reports. The on-site inventory of the
samples in the possession of a Ventiv Sales Representative and related reconciliation services and
report shall constitute a “physical audit”. In addition to any other physical audits, performed by
either Client or Ventiv, required by the PDMA and/or regulations thereunder and/or by the
applicable written policies and procedures for the sample accountability program, a physical audit
shall be conducted on each Ventiv Sales Representative upon termination of employment by Ventiv.
Random signature audits will be performed by Ventiv and the results reported to Client.

Shipment of samples

     Ventiv, through Promotech, is responsible for shipping Product samples directly to the Ventiv
Sales Representatives, including use of appropriate delivery verification system and confirmation
documentation. Ventiv shall provide Client with a written description of that delivery
verification system and copies of the conformation documentation forms. Ventiv shall provide
Client with all PDMA-related information concerning shipped samples as required by FDA regulations
(including lot numbers). Upon written request from Client, this information may be delivered
either electronically or on paper but in either case within 24 hours of the shipment of the
samples. Upon written request from Client, Ventiv shall also provide all information reasonably
necessary to allow Client to verify the receipt of shipped samples.

     Ventiv will receive a copy of all documents confirming shipments of samples to the Ventiv
Sales Representatives. Ventiv will, in all cases, reconcile the receipt of samples by each Ventiv
Sales Representative with the samples shipped to that Ventiv Sales Representative, based upon the
shipping records provided to it and acknowledged of delivery provided by the Ventiv Sales
Representatives. All discrepancies between the sample shipping records and the

Exhibit C — Attachment 1

Page 2 of 4

 

 

acknowledgment of delivery by the Ventiv Sales Representatives shall be identified by Ventiv.
All loss of product and potential loss of product during shipment to the Ventiv Sales
Representatives shall be investigated by Promotech and the Ventiv Sales Representatives. All loss
of product as a loss in transit shall be and reported to Client within [**] days of confirmation
discovery. Client shall determine the significant loss threshold for loss in transit and be
responsible to report such loss to the FDA. All loss of Product samples or potential loss of
Product samples shall be investigated by Client.

Returns

     Promotech shall be responsible for confirming all returns of Product samples by Ventiv and the
Ventiv Sales Representatives. Promotech will provide Ventiv with written confirmation of sample
returns within [**] business days after confirming the receipt by Promotech of the returned sample.
The Parties recognize that Ventiv will reconcile sample data and account for samples based (in
part) on the return confirmations provided by Promotech. Client shall not remove, destroy or
otherwise impair the availability of the returned samples until identified discrepancies of
returned quantities have been resolved by Ventiv.

Access to Records

     Ventiv shall provide Client access in less than [**].

Notification of Client: of FDA

     Upon Ventiv’s discovery that any Product samples have been lost or stolen, Ventiv shall,
within [**], report such theft or loss to Client. In addition, Ventiv shall instruct the Ventiv
Sales Representatives to obtain a police report regarding such theft. Client shall be responsible
for defining the significant loss threshold for each product, and the rationale for such
determination. Client will be responsible for determining whether a “theft” or a “significant
loss” has occurred under the PDMA and the regulations of the FDA. Client shall also be responsible
for determining whether there is “reason to believe” that a diversion of a sample or falsification
of a sample record by a Ventiv Sales Representative has occurred. Client is responsible for
reporting the theft or loss to the FDA.

Prescription Sample Identification

     Promotech shall provide to Ventiv a report referred to as a Shipping Report, inclusive of the
complete product description, lot number, quantity and expiration date by representative for
shipments being made by Promotech to the Ventiv Sales Representatives. The report shall be
provided in a format consistent with Ventiv’s needs and within [**] of the date of shipment to the
Ventiv Sales Representatives. Client shall notify Ventiv of the lot numbers of prescription
samples being shipped by Client to Promotech in advance of shipment; such notice shall be given at
least [**] prior to delivery to the Ventiv Sales Representatives. Ventiv will in all cases require
the Ventiv Sales Representatives to keep written records by lot number of all prescription samples
distributed to licensed practitioners. Ventiv will reconcile sample data according to product
code.

Exhibit C — Attachment 1

Page 3 of 4

 

 

Recalls

     Ventiv shall maintain such traceability records at the product code level on samples of the
Products as may be necessary to permit a recall or field correction of the Product. The decision
to conduct and the right to control a recall shall be solely Client’s. Ventiv shall cooperate
fully with Client in connection with any recall efforts affecting the Product.

Accountability Training

     The Parties recognize that such a sampling program will require incremental training in sample
accountability. Ventiv, with the assistance of Client, will provide, as part of the training, all
Ventiv Sales Representatives and Managers training which addresses sampling matters. Ventiv will
consult with Client to assure that the Ventiv Sales Representatives will use detail bags and report
forms which are acceptable to Client. Should Ventiv and/or Client determine that follow-on
training is necessary in the future, Client will be responsible for the reasonable costs associated
with such follow-on training.

Exhibit C — Attachment 1

Page 4 of 4

 

 

EXHIBIT D

SUCAMPO PHARMACEUTICALS, INC.

COMPLIANCE PROGRAM

ON

COMMUNICATIONS TO HEALTHCARE PROFESSIONALS

AND PROMOTIONAL ACTIVITIES

1.1 General Policy

It is the policy of Sucampo Pharmaceuticals, Inc. to (i) promote our products in full compliance
with law, (ii) to foster scientific research and education in medical fields relating to our
products, and (iv) to ensure that our relationships with Healthcare Professionals involve no
communications or remuneration that is inconsistent with laws or regulations regarding the
promotion of pharmaceutical products. All Sucampo Field Representatives who interact with
Healthcare Professionals or engage in promotional activities are expected to carry out both the
letter and the spirit of this policy.

Field Representatives are expected to promote the products at all times in a manner consistent with
the Federal Food, Drug, and Cosmetic Act and FDA regulations governing labeling and advertising of
prescription drug products; relevant FDA guidance (including Guidance for Industry on
Industry-Supported Scientific and Educational Activities (Nov. 1997)); the PhRMA Code on
Interactions with Healthcare Professionals (July 1, 2002); the Department of Health and Human
Services (DHHS) Office of the Inspector General (OIG) Compliance Program Guidance for
Pharmaceutical Manufacturers (68 Fed. Reg. 23731, May 5, 2003) (and related anti-kickback statutes
and regulations); California Health and Safety Code §119402; and other statutes and regulations as
applicable.

This policy applies to communications to Healthcare Professionals and promotional activities that
take place in, or are related to, the Company’s products in the United States.

1.2 Definitions

“The Company” refers to Sucampo Pharmaceuticals, Inc.

“Field Representatives” refers to Company employees, subcontractors, or agents involved in
marketing or promoting the Company’s products.

“Healthcare Professionals” refers to physicians, nurses and other medical professionals involved in
patient care, and any other persons who purchase, dispense, recommend, use, arrange for the
purchase of, or prescribe Company products. This would also include scientists or others who,

Exhibit D

Page 1 of 3

 

 

because of their professional reputations, may have an influence on clinical opinions even though
they may not actually prescribe the products.

1.3 Unapproved Drugs

Field Representatives shall not engage in promotional activities for “unapproved drugs,” which term
shall include:

	 	•	 	drugs that are not the subject of an approved new drug application (NDA) (or other
lawful marketing authority), or
	 
	 	•	 	an unapproved indication or condition of use for an approved drug.

1.4 Approved Drugs

For a drug that is approved (that is, where the product and its intended use are covered by an NDA
or other marketing authority), information provided by the Field Representatives must be consistent
with the approved labeling.

Promotional activities shall consist of communications about an approved drug that are consistent
with the approved labeling. Promotional activities shall not include communications about
unapproved drugs.

Acceptable promotional activities by Field Representatives shall be truthful and not misleading,
shall include a fairly balanced discussion of the benefits and risks of the drug, and may consist
of:

	 	•	 	Meetings and other communications with Healthcare Professionals in which a drug is
discussed consistently with approved labeling. At such meetings, disclosure shall be made
to participants that the meeting or communication is sponsored by Company. If such meeting
is offered in connection with a meal (a “Business Meal”), the location for the meal must be
conducive to informational communication/discussion. Business Meals occurring outside the
Healthcare Professional’s office or institution are specifically limited to restaurants.
No entertainment or recreational events are allowed in connection with Business Meals.
Business Meals shall not be offered to the same Healthcare Professional or group of
Healthcare Professionals on more than an occasional basis and shall be modest in value by
local standards. Meals shall not be conditioned on any explicit or implicit agreement or
understanding to use, purchase, order, recommend, arrange or provide formulary status for,
prescribe or dispense any Company product. No meals may be provided to reward past
purchases or past recommendations or past prescriptions to use Company products or to
reward the potential for future purchases or future recommendations or future prescriptions
to use Company products.
	 
	 	•	 	Use of sales aids provided to Field Representatives for dissemination to Healthcare
Professionals. Field Representatives may only use such sales aids provided by Company that
have been approved for dissemination via the Company review process. Field Representatives
must not use homemade sales aids, including any type of handwritten or printed materials
addressing claims, uses or benefits of Company products, or

Exhibit D

Page 2 of 3

 

 

	 	 	 	comparisons to competitive products. Field Representatives must not make enhancements to
approved sales aids, including but not limited to modification by way of highlighting and/or
underlining. Such enhancements may violate the FDA’s fair balance requirements.
	 
	 	•	 	Provision of drug samples to healthcare providers licensed to prescribe such drugs or,
at the request of a licensed practitioner, to pharmacies of hospitals or other healthcare
entities in a manner that meets all requirements of the Prescription Drug Marketing Act
(PDMA), including any related regulations. In doing so, Field Representatives shall not
condition sample provision on any explicit or implicit agreement or understanding to use,
purchase, order, recommend, arrange or provide formulary status for, prescribe or dispense
any Company product. No sample may be provided to reward past purchases or past
recommendations or past prescriptions to use Company products or to reward the potential
for future purchases or future recommendations or future prescriptions to use Company
products. Field Representatives are in no case permitted to provide samples in exchange
for any category of remuneration, goods or services.
	 
	 	•	 	Provision of gifts which are restricted to $25 per person per event, with an aggregate
of $100 per person per year unless further restricted by any applicable regulations. Gifts
shall be limited to those that primarily benefit a Healthcare Professional’s patients;
relate to the Healthcare Professional’s practice; serve a genuine educational function; or
that prominently display Company name and logo. Gifts shall not be given on more than an
occasional basis. Gifts shall not be conditioned on any explicit or implicit agreement or
understanding to use, purchase, order, recommend, arrange or provide formulary status for,
prescribe or dispense any Company product. No gift may be given to reward past purchases
or past recommendations or past prescriptions to use Company products or to reward the
potential for future purchases or future recommendations or future prescriptions to use
Company products. In no case shall the Field Representative accept gifts or gratuities.

Exhibit D

Page 3 of 3

 

 

EXHIBIT E

FLEET MANAGEMENT SERVICES

Ventiv shall provide [**] Client managers (the “Client Employees”) with use of a fleet automobile
in accordance with the terms and conditions set forth in this Exhibit E.

1. Ventiv will provide the following fleet services (“Fleet Services”) for Client Employees:

     (a) Vehicle specifications and costing of vehicles for Client selection. The vehicles are
listed in Section 8 below. Client and Ventiv agree that no changes may be made to the list of
vehicles set forth in Section 8 below, without Ventiv having obtained the prior written consent of
Wheels, Inc. (hereinafter the “Leasing Company”)

     (b) Ordering of company vehicles

     (c) Vehicle administration and registration

     (d) Presentation of fleet policies including video on defensive driving

     (e) Managing daily inquiries from field

     (f) Vehicle tracking and high mileage replacement

     (g) Arranging for short term “bridge” rentals in advance of delivery of fleet vehicle, if
applicable

     (h) Provision of gas cards

     (i) Management of Ventiv fleet maintenance program

     (j) Sublease of vehicles from Leasing Company

2. Client Responsibilities

     (a) Secure insurance in accordance with the Section 3 below, entitled, “Insurance Provisions”

     (b) Maintain fleet arrangement with Ventiv for any vehicle deployed for a minimum term of one
year from date of vehicle deployment

     (c) Ensure that any Client Employee who fails a background check does not have access to or
use of any fleet vehicle.

     (d) Ensure the vehicles are driven only by those Client Employees as provided in this
Agreement, and only for the purposes set forth in this Agreement.

     (e) Tax compliance (employee fleet deductions, and reporting on personal use of vehicle)

Exhibit E

Page 1 of 4

 

 

     (f) Costs associated with gas as incurred through Ventiv provided gas cards

     (g) Costs associated with maintenance as incurred by Ventiv in connection with its maintenance
program.

     (h) Payment of fees and costs as set forth below

     (i) Settlement costs associated disposing of the vehicles (See Termination Expense below)

     (j) Client understands and agrees that Leasing Company is an express third party beneficiary
of the services provided by Ventiv pursuant to this Exhibit E.

     (k) Rental costs associated with bridge rentals

     (l) Providing mechanism for Ventiv to receive accident reports regarding fleet automobiles.

3. Insurance Provisions.

     Client shall be responsible for obtaining the appropriate insurance as set forth below and
ensuring compliance with the following:

     (a) Provider to be rated A-VII or better.

     (b) Coverage shall include commercial automobile liability insurance on an “occurrence” basis
with a combined single limit of not less than $1,000,000 per occurrence and $2,000,000 in the
aggregate against bodily injury and third party property damage liability.

     (c) Coverage should extend to first party physical damage coverage with a limit of actual cash
value, subject to a comprehensive and collision deductible.

     (d) Client to also obtain commercial umbrella insurance coverage of not less than $2,000,000
per occurrence/aggregate with the above stated policies as an underlying coverage.

     (e) Coverage should extend to use of rental automobiles (in case such use is necessary).

     (f) Policies to contain agreements by the insurers that such policies shall not be cancelled
except upon thirty (30) days prior written notice to each named insured and each additional
insured.

     (g) Prior to delivery of the automobiles to Client Employees, Client to provide Ventiv with
evidence of insurance coverage in compliance with the above.

4. Indemnification

     (a) Client shall indemnify, defend and hold harmless (collectively, the “Obligations”) Ventiv
and Leasing Company, and each of its respective officers, directors,

Exhibit E

Page 2 of 4

 

 

agents and employees, from and against any and all actual or alleged liabilities, losses,
actions, damages, personal injury claims, property damage claims, death, any other claims of third
parties or claims by Client’s employees, or expenses and costs of any kind (including reasonable
attorneys’ fees) (collectively, “Damages”), any of which are directly or indirectly related to
Client’s (or its employees, agents or independent contractors) use or misuse of the automobiles
provided by Ventiv to Client pursuant hereto. The Obligations shall include but shall not be
limited to, Damages directly or indirectly related to a driver’s possession and use of the vehicle
and any traffic violations in which said vehicles may be involved. The Obligations are absolute
and unconditional and apply without consideration of fault (comparative or otherwise).

     (b) Client’s obligation to indemnify, defend and hold harmless Ventiv and Leasing Company (and
each of its respective officers, directors, agents and employees) shall depend upon Ventiv
providing notice to the Client of any claim or lawsuit giving rise to the indemnity obligation;
however, failure to comply with this notice requirement shall not reduce the Client’s
indemnification obligation except to the extent that Client is clearly prejudiced as a result.
Thereafter, the Client shall have control over the handling of the claim or lawsuit, provided,
however, that: (i) Ventiv shall have the right to participate in the defense of the claim at its
own expense through counsel of its choice (control of the defense will remain with the Client),
(ii) Client shall not consent to the entry of any judgment or enter into any settlement that would
require any act or forbearance on the part of the Ventiv or Leasing Company or which does not
unconditionally release Ventiv and Leasing Company from all liability in respect of the claim
without the prior written consent of Ventiv, and (iii) Ventiv may undertake the defense of the
claim, at the Client’s expense, if Client fails promptly to assume and diligently to prosecute the
defense.

5. No Warranty.

     Client understands and agrees that: there are no warranties or other rights provided by
Ventiv or Leasing Company (other than the automobile manufacturer’s warranties which have been
assigned to Ventiv). Neither Ventiv nor Leasing Company makes any representation or warranty of
any kind, express or implied, with respect to any vehicle, including its design, operation or
condition, merchantability, or its fitness for a particular purpose. Neither Ventiv nor Leasing
Company shall have any liability to Client or its customers or third parties for any direct,
indirect, special or consequential damages of any kind or nature directly or indirectly arising out
of Ventiv’s lease with Leasing Company or any vehicle provided to Client hereunder or any damages
based on strict or absolute tort liability or negligence. Client acknowledges that neither Ventiv
nor Leasing Company is the manufacturer, designer or distributor of the vehicle and neither Ventiv
nor Client has any ownership rights with respect to the vehicles. Ventiv and the Leasing Company
shall have no liability whatsoever for any failure of or delay in delivery of the vehicle or for
the breach of any representation or warranty made by the manufacturer.

6. Security Interest.

     Client acknowledges and agrees that the interest of Client in the vehicles is limited to a
sublessee’s interest and is subject to and subordinate to the lease agreement (the “Lease”) between
Ventiv and Leasing Company. Client acknowledges and agrees that it has no ownership interest in the
vehicles and that the Lease is a true lease, that Leasing Company is the owner of

Exhibit E

Page 3 of 4

 

 

the vehicles, that the interest of Client in the vehicles is subject to and subordinate to the
ownership interest of Leasing Company. In the event that, for any reason, the Lease is deemed not
to be a true lease, Client acknowledges and agrees that the interest of Client in the vehicles is
subject to and subordinate to the security interest and lien of Leasing Company. In the event of a
default by Ventiv under the Lease, Client agrees that Leasing Company shall have all rights
provided in the Lease, including, but not limited to, the right to repossess the vehicles from
Client; provided, however, that Lessor will take no action to disturb Client’s quiet enjoyment of
the vehicles so long as Client is not in default under this Agreement or under this Exhibit E.

7. Termination Expense.

     In the case of any termination of the Agreement by Client or Ventiv, or at the end of Term (or
any Additional Term), Client shall (in addition to all other payment obligations under this
Agreement) promptly pay (or if paid by Ventiv, promptly reimburse Ventiv): the amount due any
lessor or rental agent of the automobiles provided to Client’s employees, for any early termination
of the lease or rental agreement. In addition, Client may elect to either: (i) subject to the
consent from Leasing Company, transfer the automobiles and the related lease or rental obligations
to Client, and pay an amount equal to the net book value (if any) of the automobiles on the books
of Ventiv at the time of the transfer event, and further in the case of any lease or finance lease,
Client shall assume the responsibility for all further payments due or (ii) pay Ventiv the net loss
to Ventiv on such automobiles determined by the difference between the net book value of each
automobile and net price received by Ventiv for the disposal of such automobile, plus any amounts
due by Ventiv in connection with the lease or rental termination (inclusive of any prepaid taxes).
Any proposed transfer of the automobiles shall be subject to Client establishing its own
relationship and credit with the entity that Ventiv contracted with to lease or rent the
automobiles.

8. List of Vehicles.

     Client and Ventiv agree that, with respect to the vehicles set forth below: (i) Client will
utilize no Leasing Company fleet number other than the Leasing Company fleet number assigned to
Client, and (ii) the vehicles may not be transferred to any other Leasing Company fleet number
unless Leasing Company otherwise agrees in writing.

	 	 	 	 	 	 	 	 	 	 	 
	Leasing	 	 	 	 	 	 	 	 
	Company	 	 	 	 	 	 	 	 
	Unit No.	 	Year	 	Make	 	Model	 	VIN
	 
	922KW

	 	 	2006	 	 	Chrysler
	 	Pacifica Tourig 4dr AWD SUV
	 	[**]
	032KX

	 	 	2006	 	 	Ford
	 	Freestyle SEL FWD 4DR Wagon
	 	[**]
	332KT

	 	 	2006	 	 	Saab
	 	9-3 Aero 4DR Sedan
	 	[**]
	501KT

	 	 	2006	 	 	Saab
	 	9-3 2.0T 4DR Sedan
	 	[**]
	500KX

	 	 	2006	 	 	Ford
	 	Explorer 4WD XLT4.0L V6
4DR SUV
	 	[**]
	432KX

	 	 	2006	 	 	Ford
	 	Explorer 4WD XLT 4.0L V6
4DR SUV
	 	[**]

Exhibit E

Page 4 of 4

 

 

EXHIBIT F

SALES FORCE AUTOMATION SERVICES

Ventiv shall provide, in accordance with in Exhibit A Item 9, a laptop computer to [**] Client
regional managers, each installed with the following Target Software, Inc. product:

	 	•	 	Target Mobile Web Sales Management Edition

1. Sublicense Grant; Ownership of Intellectual Property Rights; Restrictions.
(a) Client acknowledges that Target Software, Inc. (“Target Software”) is the sole owner of all
rights, title and interest in and to the above referenced software system (the “SFA”) (including
but not limited to all intellectual property contained therein and including without limitation,
all modules and components, and all existing versions and any versions to be developed in the
future in any media now known or hereafter to be developed) and that Ventiv is merely a licensee of
SFA pursuant to that certain License Agreement by and between Target Software and Ventiv (the
“Target Software License”). Client expressly agrees and acknowledges that Client has engaged
Ventiv to perform the Services and that Client shall look solely to Ventiv for any breach by Ventiv
of its performance obligations arising from the performance of said Services.

     (b) Subject to the terms, conditions and restrictions herein set forth, including without
limitation, payment of the monthly service fees set forth below, Ventiv hereby grants, and Client
accepts, a limited, nonsublicensable, nonexclusive, non-transferable, non-assignable sublicense
(the “Sublicense”) to Use SFA in accordance with the terms and conditions herein set forth for the
Term. For purposes of the sublicense herein granted, “Use” means the copying of all or any portion
of SFA from storage units or media for processing and operation, provided that any such use is for
Client’s internal business purposes only and is limited to the purposes for which SFA is designed.
Client acknowledges that it understands and agrees that Ventiv, as a licensee of SFA, is itself
authorized to only use SFA in accordance with the Target Software License, and therefore, the scope
of the license granted to Ventiv is thereby limited. Client agrees and acknowledges that neither
it nor its employees shall, during the Term or at any time thereafter, directly or indirectly,
alone or with any person, use all or any portion of SFA in any manner which is inconsistent with
its intended purpose or in any manner which violates the terms of this Agreement or which is
otherwise inconsistent with the permitted Use. Without limiting the foregoing, Client agrees that
neither it nor its employees shall:

          (i) sell, lease, rent, loan, assign, pledge, encumber, sublicense, distribute, resell or
otherwise transfer all or any part of SFA;

          (ii) transfer, share, disclose, assign, sublicense or otherwise transfer SFA or any
confidential or proprietary information related thereto, to any third party;

          (iii) permit any person to use SFA other than those Client employees who are authorized to use
SFA unless such person is engaged by Client to perform general maintenance and services on Client’s
computer systems and the person has executed a non-disclosure agreement with substantially the same
confidentiality obligations and Use restrictions regarding SFA as are set forth herein;

Exhibit F

Page 1 of 4

 

 

          (iv) decompile, disassemble, reverse engineer or otherwise attempt to discover any source code
or underlying trade secrets of Target Software, Inc. and/or contained in SFA;

          (v) remove, obscure or alter any copyright notice, restricted rights legend or other notice of
proprietary rights that appears or is contained on or in SFA;

          (vi) modify, adapt, alter, or translate SFA;

          (vii) export SFA or the direct product of such software outside the United States except as
authorized by the laws and regulations of the United States and any export permits that may be
required;

          (viii) use SFA in violation of applicable copyright laws, trade secret laws or other
intellectual property laws;

          (ix) merge SFA with any other software to create a new program or library of programs wherein
SFA loses its own identity;

          (x) sublicense or transfer SFA to any third party for a service business, outsourcing or any
other purpose;

          (xi) otherwise use or copy SFA without the express prior written consent of Target Software,
Inc.;

          (xii) Use SFA after the expiration or earlier termination of the Term; or

          (xiii) allow more than the previously agreed upon number of Client managers to use any
server-based or mobile component of SFA in connection with the Services (unless Client agrees to
pay the additional fees as set forth below).

     (c) Client acknowledges that all materials and intellectual property created or generated by
Target Software in connection with the performance of any technical support or related services
hereunder shall be the sole and exclusive property of Target Software, provided that, as between
Ventiv, Client and Target Software, all Data (as defined below) shall be the sole and exclusive
property of Client. Client further acknowledges that Target Software reserves all right, title and
interest in and to SFA, the related documentation (the “Documentation”), and any updates thereto or
new versions thereof, and to materials created or generated by Target Software in connection with
the performance of any services related thereto. Client hereby assigns to Target Software all
rights, titles, and interest in and to any and all derivative works of SFA, the Documentation,
materials created by Target Software. While the foregoing assignment is intended to be
self-executing, without the need for additional written agreement or acknowledgment, Client shall
execute and deliver any additional written agreement evidencing such assignment upon the request of
Target Software. In addition, Client acknowledges that SFA and its structure, organization and
source code constitute valuable trade secrets of Target Software. Nothing in this Agreement shall
be construed to give Client any right, title or interest to Target Software’s proprietary
information, other than the sublicense rights granted by Ventiv hereunder and subject to the terms
and conditions herein set forth. In any event, neither Ventiv nor Target Software shall have any
rights, title or interest in Client’s Data (as hereinafter

Exhibit F

Page 2 of 4

 

 

defined). “Data” means all information submitted by Client to be processed by SFA, as
contemplated by this Agreement, wherever residing, in all media and in any form, including raw
data, compilations, analyses and summaries of such information. Data shall include, but not be
limited to, information about Sales Representatives, clients, physicians and medical entities and
all reports and compilations prepared by Client in connection therewith. Data shall not include
any call reports, call data or related call information.

     (d) Client is aware and acknowledges that Target Software has made no representation, and has
not granted any warranty, express or implied, nor has Target Software otherwise assured that (i)
Client’s use of SFA shall meet Client’s requirements; (ii) operation of SFA shall be uninterrupted
or error free; (iii) SFA shall operate in the combination that may be selected for use by Client;
or (iv) SFA complies with any regulations including CFR Title 21, Parts 11, 203 and 205 (the
“Regulations”) or any other applicable statute, code, law or regulation.

     Notwithstanding the foregoing, the Parties understand that Target Software has no actual
knowledge of any deficiencies and/or defects in SFA as of the date hereof that would prevent
compliance with the Regulations when utilized in accordance with the documentation written by
Target Software in connection with SFA (the “Documentation”) and when configured and Used in
concert with appropriate standard operating procedures (“SOP’s”), which SOP’s are and shall remain
the sole and absolute responsibility of Client and Ventiv. Client and Ventiv hereby agree and
acknowledge that the creation and implementation of such SOP’s, and therefore the Use and
compliance of any results obtained through Use of SFA, are based upon Client’s interpretation of
the Regulations together with any other laws, regulations, ordinances or rules which Client
determines to be applicable to Client’s operations and compliance. Client hereby agrees, affirms,
represents and acknowledges that the ultimate burden of compliance with any law, regulation, rule,
ordinance, statutory scheme or other requirement (including, without limitation, the Regulations)
is and shall remain the sole and absolute responsibility of Client and Ventiv with respect to the
Services, as contemplated by this Agreement.

     (e) Term of Sublicense. The Parties hereto understand and agree that the Sublicense granted
hereunder shall be for a term consistent with the Term and any applicable Additional Term (as
defined in Section 10 of the Agreement). Notwithstanding the foregoing, the Sublicense granted
hereunder shall automatically terminate (without the necessity of any further action by either
Party) upon the first of the following to occur: (i) the expiration or earlier termination of this
Agreement (as set forth in Section 11 of the Agreement); or (ii) the termination of the Target
Software License (a “Termination Event”). Ventiv represents that it has received such approvals
and consents from Target Software as is necessary to enter into this Agreement and provide the SFA
upon the terms and conditions set forth herein.

     (f) Assignment of Sublicense. The Sublicense granted by this Agreement may not be assigned or
transferred by Client without the prior written consent of Target Software and Ventiv, provided,
however, that subject to the provisions of this Section, Client may (without the need for the
consent of Target Software and Ventiv) assign said Sublicense in connection with a corporate
restructuring or acquisition of Client (whether by asset purchase, stock purchase, merger,
consolidation or otherwise) which restructuring or acquisition (i) shall not result in any
significant change in the number or identity of end-users of SFA or the customer base of Client,

Exhibit F

Page 3 of 4

 

 

and (ii) shall not involve a successor entity engaged in business operations directly
competitive with the business operations of either Ventiv or Target Software, and provided, in each
case, that such successor entity and acquirer (if applicable) executes and delivers an agreement,
in form and substance reasonably satisfactory to Ventiv and Target Software, pursuant to which such
assignee assumes all obligations respecting SFA set forth in this Agreement. Any attempt to assign
or transfer the Sublicense set forth in this Agreement in violation of this section shall be void.

     (g) Client understands and acknowledges that Client has contracted hereunder directly with
Ventiv (and not Target Software) for the performance of the Services. Therefore, notwithstanding
Target Software’s consent to the Sublicense and Client’s permitted use of the SFA in connection
with this Agreement, Client shall look solely to Ventiv for any breach by Ventiv of its performance
obligations hereunder.

     (h) Ventiv and Target Software may disclose, on their websites, in press releases, sales
materials and in standard presentations to potential customers, that Client uses the Target SFA and
the scale of usage of such software by Client (i.e., number of users, etc.), only upon receipt of
prior written consent from Client in each instance, in Client’s sole discretion.

2. Limitation of Liability. NEITHER PARTY NOR TARGET SOFTWARE, INC. (“TARGET SOFTWARE”)
SHALL BE LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS EXHIBIT F UNDER ANY CONTRACT, TORT,
NEGLIGENCE, STRICT LIABILITY, BREACH OF WARRANTY (EXPRESS OR IMPLIED) OR OTHER THEORY FOR ANY
INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING
WITHOUT LIMITATION, ANY LOSS OF REVENUES, PROFITS OR DATA OR THE COSTS OF PROCUREMENT OF SUBSTITUTE
PRODUCTS BY CLIENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN ADDITION, THE
COLLECTIVE LIABILITY OF VENTIV AND TARGET SOFTWARE FOR DIRECT DAMAGES RESULTING FROM THE
PERFORMANCE OF THE SERVICES SET FORTH IN THIS EXHIBIT F SHALL BE LIMITED TO THE FEES ACTUALLY PAID
BY CLIENT TO VENTIV FOR THE SIX (6) MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO THE
CLAIM.

Exhibit F

Page 4 of 4

 

 

EXHIBIT G

RECRUITING SERVICES

1. Ventiv shall assist Client with the recruitment of Client’s managers. Client shall pay Ventiv a
recruitment fee in the amount of [**] percent ([**]%) of each new Client manager’s: (i) first year
salary, and (ii) signing bonus (if applicable), and (iii) first year incentive compensation bonus.
If during the first [**] days of employment, the Client manager is discharged by Client for cause
(in accordance with Client’s employment policies and handbook), Ventiv shall find a replacement
free of charge.

2. Additional recruiting services and the applicable fees for such services are set forth in
Section 7 of this Exhibit G. In the event Client desires for Ventiv to conduct additional
recruiting services on its behalf, Client shall provide Ventiv with a written request (an “Open
Position Request”) setting forth all newly opened or recently formed positions to be filled by
Ventiv. Upon receipt of the Open Position Request, Ventiv will contact Client to determine
Client’s preferred candidate profile and interview availability. Within thirty (30) days of
Ventiv’s receipt of an Open Position Request, Ventiv will use commercially reasonable efforts to
provide Client with [**] candidates for each open position, each of whom shall be ranked based upon
such candidate’s qualifications and availability. Each candidate shall be pre-screened by Ventiv
to determine if such candidate meets certain agreed upon criteria. Upon written request, Ventiv
will adopt and implement the screening tools and/or systems utilized by Client.

3. If the [**] candidates provided by Ventiv are unacceptable to Client, Client shall send to
Ventiv, in writing (e-mail is acceptable), a request for additional candidates (who have been
pre-screened by Ventiv) to be produced for interviews until such time as the vacant position(s) is
filled. Ventiv will conduct all communication with external candidates including initial contact,
screening, and notification of rejection.

4. Client and Ventiv understand and agree that Ventiv shall be exclusively responsible for the
performance of background checks on candidates.

5. Ventiv will not discriminate in the referral or acceptance of potential candidates on the basis
of race, color, religion, age, national origin, marital status, sexual orientation, disability or
other protected classification. Ventiv will comply with all applicable Federal, State and local
fair employment laws and regulations in the course of performing its obligations hereunder.

6. Client and Ventiv understand and agree that: (i) Client is solely responsible for all hiring
decisions, and (ii) Ventiv has no responsibility for the acts or omissions of any candidate hired
by Client.

Exhibit G

Page 1 of 2

 

 

7. Types of Recruitment Services and Applicable Fees and Costs.

	 	 	 	 	 	 	 
	Division	 	Service Name	 	Description	 	Price
	 
	Recruitment

Services TM

	 	Background

Investigations
	 	Criminal Felony &
Misdemeanor; Drug
Testing; Education
Report; Employment
Report; MVR; SSN
Trace; Debarment
	 	$[**] per

investigation
	 
	 	 	 	 	 	 
	Recruitment

Services TM

	 	Contingency Search
	 	Review client
needs, develop
profile, provide
screened candidates
meeting Client
profile, charge fee
upon placement
	 	[**]% of base
salary + signing
bonus + first year
incentive comp.
bonus

Exhibit G

Page 2 of 2

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