Exhibit 10.37

 

AMENDMENT 1 TO THE LICENSE, DEVELOPMENT, COMMERCIALIZATION AND SUPPLY AGREEMENT

FOR LUBIPROSTONE

 

This Amendment 1 is entered into as of 18 November 2015 (the “Effective Date”)
by and between Sucampo AG, a corporation organized under the laws of Switzerland
with principal offices at Baarerstrasse 22, CH-6300, Zug, Switzerland
(“Sucampo”) and Takeda Pharmaceuticals International AG (formerly registered as
Takeda Pharmaceuticals International GmbH), a corporation organized under the
laws of Switzerland with principal offices at Thurgauerstrasse 130, 8152
Glattpark-Opfikon, Zurich, Switzerland (“Takeda”). Each of Takeda and Sucampo is
referred to individually herein as a “Party” and collectively as the “Parties”.

 

WHEREAS, Sucampo and Takeda entered into License, Development, Commercialization
and Supply Agreement for Lubiprostone dated October 17, 2014 (the “Agreement”);
and

 

WHEREAS, Sucampo and Takeda have reviewed the conditions of delivery of the
Licensed Product for Commercialization and Development purposes and have agreed
to amend the Agreement accordingly.

 

NOW, THEREFORE, for the mutual covenants contained herein, and other good and
valuable consideration set forth herein, the receipt and sufficiency of which
hereby acknowledge, the Parties agree as follows:

 

1.Capitalized terms used, but not defined herein, shall have the same meanings
given in the Agreement.

 

2.Modification of the Agreement

 

The Parties have agreed that Section 9.2 of the Agreement shall be deleted and
replaced with the following provision:

 

“9.2            Delivery. Sucampo shall deliver the Licensed Product EXW,
[…***…], […***…], […***…] (Incoterms® 2010), subject to the release of the
relevant Licensed Product as per Section 9.4. In the event either Party decides
to change its packaging site — which, upon the Effective Date, is […***…],
[…***…], […***…] for both Parties — the Parties shall discuss the modification
of the conditions of delivery of the Licensed Product, including the incoterm,
in order to avoid any increase of the other Party’s costs that may result from
such change of packaging site. Delivery documents shall include purchase order
number, quantity, copy of the certificate of analysis, items codes and
description, lot number, manufacturing dates of the Licensed Product (i.e.,
manufacturing date of the premix, as well as the date of encapsulation), number
of shippers, weight, number of pallets, and any other documents in accordance
with the terms of the Quality Agreement. Title and ownership shall pass to
Takeda or its Affiliate, as applicable, upon delivery of the Licensed Product in
accordance with this Section 9.2.”

 

 

Confidential and Proprietary 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 
 

 

3.Purchase and Supply of Placebo and Licensed Product for Development.

 

The Parties have agreed to add a new Section 9.2a to the Agreement, immediately
following Section 9.2, as follows:

 

“9.2a.          Delivery of Licensed Product and Placebo for Development. The
Parties agree that the Licensed Product and placebo used by Takeda for
Development activities required for Regulatory Approvals in the Territory will
be purchased from Sucampo directly by its Affiliate Takeda Development Centre
Europe Ltd ([…***…], […***…], […***…], […***…]) (hereinafter “TDC Europe”).
Notwithstanding the terms of delivery agreed in Section 9.2 above, the Parties
agree that the delivery of Licensed Product and placebo for Development
activities purchased by TDC Europe will occur EXW, packaging site of Sucampo in
the USA (Incoterms® 2010), it being understood that Sucampo shall provide Takeda
with reasonably requested information necessary to obtain the export clearance
for such goods. Title and ownership of such Licensed Product and placebo will be
transferred to TDC Europe upon delivery in accordance with this Section 9.2a.
The Parties have agreed on a Supply Price for the placebo, as specified in
Exhibit H of this Agreement.”

 

4.Amendment to Exhibit H.

 

The Parties have agreed to amend and restate, in its entirety, Exhibit H of the
Agreement by replacing the current Exhibit H with the version attached as an
Annex to this Amendment 1.

 

5.This Amendment 1 shall become effective as of the Effective Date.

 

6.Except as amended herein, all the other conditions and provisions of the
Agreement shall remain unchanged.

 

IN WITNESS WHEREOF, the Parties have caused this Amendment 1 to be executed by
their duly authorized representatives.

 

SUCAMPO AG   Takeda Pharmaceuticals International AG                            
    By:     By:     Date:     Date:                                            
By:           Date:    

 

 

 

Confidential and Proprietary 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 
 

ANNEX

 

EXHIBIT H

 

1 - FORM OF THE LICENSED PRODUCT AND PLACEBO

 

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

 

·For Development activities:

[…***…] in […***…]

[…***…] in […***…]

[…***…] in […***…], or […***…]

 

·For Commercialization activities

[…***…] in […***…]

[…***…] in […***…]

[…***…] in […***…], or […***…]

 

·For Commercialization activities during the Transition Period

[…***…] in […***…] or […***…] and […***…]

 

 

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

 

·Supply Price of Licensed Product in connection with Development:

 

[…***…] of the […***…] in […***…] or […***…]

 

·Supply Price of Licensed Product in connection with Commercialization:

 

[…***…] of the […***…] in […***…] or […***…]

[…***…] of the […***…] in […***…]

 

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

 

[…***…] of the […***…] in […***…] for […***…]

[…***…] of the […***…] in […***…] for […***…]

 

3 - SUPPLY PRICE FOR THE PLACEBO

 

·Supply Price of placebo in connection with Development

 

[…***…] of […***…] in […***…] or […***…]

 

 

 

Confidential and Proprietary 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.