EXHIBIT 10.1

 

[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

AMENDMENT

 

Made as of June 11, 2013.

 

By and between,

 

IRONWOOD PHARMACEUTICALS, INC., a company organised and existing pursuant to the
Laws of Delaware, and having its principal offices at 301 Binney Street,
Cambridge, MA 02142 USA (hereinafter, referred to as “Ironwood”).

 

and

 

ALMIRALL, S.A., a company organised and existing pursuant to the Laws of Spain,
and having its principal offices at Rda. General Mitre, 151, 08022 - Barcelona,
Spain (hereinafter, referred to as “Partner”).

 

WITNESSETH

 

WHEREAS Partner (formerly, Laboratorios Almirall, S.A.) and Ironwood are parties
to a License Agreement dated April 30, 2009 (hereinafter, referred to as the
“Agreement”), related to the Product (as such term is defined in the Agreement).

 

WHEREAS the Parties have agreed to amend the Agreement in particular with
respect to certain aspects related to the consideration payable by Partner to
Ironwood.

 

NOW, THEREFORE, the Parties hereby agree as follows:

 

Article 1 — Definitions

 

1.1.         Unless otherwise stated herein, all the definitions contained in
Section 1 of the Agreement shall remain valid and applicable to this Amendment.

 

1.2.         Additionally, the following terms as used hereinafter in this
Amendment shall have the meaning set forth in this Article and shall be deemed
included and added to the defined terms listed in Section 1 of the Agreement:

 

“1.121           “First Wave Countries” means each of Germany, Spain and the
United Kingdom.

 

1.122                 “Reimbursed Price Reference” means the first final
reimbursement amount approved by the relevant Regulatory Authority in a First
Wave Country.”

 

Article 2 — Commercial Diligence

 

Section 3.4.4 of the Agreement shall be deemed supplemented by the following
wording to be included at the end of the current wording:

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

“In the event Partner does not perform the Commercial Launch of the Product in
[**] when such Commercial Launch is due in accordance with the above, then 
Ironwood, in addition to any other remedy, shall be entitled to terminate the
Agreement for [**] and, thereafter, to Commercialize the Product (directly or
through any Third Party) in [**], and (I) the effects of such termination for
[**] shall be as set forth in Section 8.2.3 of the Agreement, but [**] and
(II) Partner’s annual minimum royalty obligation set forth in Section 4.3.1 of
the Agreement shall be reduced by $[**], starting on the date of such
termination; provided, however, that in the event such Commercialization is
performed by any Third Party in [**] (other than through a Third Party service
provider that is compensated for Commercializing the Product on a
fee-for-service basis) instead of Ironwood, such Third Party will be subject to
(x) the same Commercial Launch milestone obligation for [**] as Partner would
be, immediately preceding such termination, had such termination not occurred,
and (y) a minimum annual royalty of $[**], as the case may be, commencing with
the fourth full Year following the Year in which such Third Party has first
achieved Commercial Launch of the Product in [**] and ending in (and including)
the last Year in which there is at least one Valid Claim included in the
Ironwood Patent Rights covering the manufacture, use or sale of the Product in
[**].”

 

Article 3 — Milestones

 

Section 4.2 of the Agreement shall be deemed replaced by the following:

 

“4.2 Milestones. As additional consideration for the rights granted to Partner
pursuant to Section 2.1, Partner will pay to Ironwood the following one-time
milestone payments within thirty (30) days of the occurrence of the following
events:

 

4.2.1          $20,000,000 upon the earlier of (i) Successful Phase III, or
(ii) the filing of an NDA for a Product in any country in the Territory;

 

4.2.2          If Partner seeks pricing and reimbursement approval from the
relevant Regulatory Authority in a First Wave Country and the Reimbursed Price
Reference contained in the first pricing and reimbursement approval in such
First Wave Country is [**] (or, in the case of United Kingdom, the Reimbursed
Price Reference corresponds to an amount in pound sterlings that is [**] on the
date of such Reimbursed Price Reference determination), $[**] for such First
Wave Country upon the later of (i) first Commercial Launch that occurs in such
First Wave Country and (ii) the date of such Reimbursed Price Reference
determination; provided that, (a) if Partner does not seek pricing and
reimbursement approval from the relevant Regulatory Authority in a First Wave
Country, then Partner shall pay to Ironwood $[**] upon the first Commercial
Launch that occurs in such First Wave Country and (b) if Partner does seek
pricing and reimbursement approval from the relevant Regulatory Authority in a
First Wave Country and the Reimbursed Price Reference contained in the first
pricing and reimbursement approval is [**] (or, in the case of United

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Kingdom, the Reimbursed Price Reference corresponds to an amount in pound
sterlings that is [**] on the date of such Reimbursed Price Reference
determination), then Partner shall pay to Ironwood $[**] upon the later of
(i) the first Commercial Launch that occurs in such First Wave Country and
(ii) the date of such Reimbursed Price Reference determination.

 

However, (x) in the case of [**], Partner will pay to Ironwood $[**] upon the
first Commercial Launch that occurs in [**], and if the Reimbursed Price
Reference contained in the first pricing and reimbursement approval from the
relevant Regulatory Authority in [**] is [**], then Partner will pay to Ironwood
$[**] on the date of such Reimbursed Price Reference determination; and (y) in
the case of [**], if the Reimbursed Price Reference is [**], then, in lieu of
the abovementioned amount of $[**], Partner will pay to Ironwood the amount of
$[**].

 

4.2.3          $[**] upon the first time that Net Sales achieved in each of the
First Wave Countries exceed the amount of €[**] in any Year in each such First
Wave Country, totaling up to a maximum of $[**];

 

4.2.4          $[**] upon the first time that Net Sales achieved in all the
Major Countries, in aggregate, exceed the amount of €[**] in any Year;

 

4.2.5          $[**] upon the first time that Net Sales achieved in all the
Major Countries, in aggregate, exceed the amount of €[**] in any Year; and

 

4.2.6          $[**] upon the first time that Net Sales achieved in all the
Major Countries, in aggregate, exceed the amount of €[**] in any Year.

 

Once Partner has made any particular milestone payment under Sections 4.2.1,
4.2.2, 4.2.3, 4.2.4, 4.2.5 or 4.2.6, Partner will not be obligated to make any
payment with respect to the re-occurrence of the same milestone.  For the sake
of clarity, if during any particular Year, the Net Sales achieved exceed the Net
Sales milestone set forth in Sections 4.2.4 and 4.2.5 , then Partner will be
obligated to make in such Year the milestone payment set forth in Section 4.2.5
in addition to the milestone payment set forth in Section 4.2.4 upon such
occurrence. In the same way, if during any particular Year, the Net Sales
achieved exceed the Net Sales milestone set forth in Sections 4.2.5 and 4.2.6,
then Partner will be obligated to make in such Year the milestone payment set
forth in Section 4.2.6 in addition to the milestone payments set forth in
Section 4.2.5 upon such occurrence.

 

If Partner pays to Ironwood for any of the First Wave Countries as Commercial
Launch/reimbursement milestones the amount of $[**] as provided in Section 4.2.2
above, Partner will have the right to compensate such payments with the Net
Sales milestone set forth in Section 4.2.3 for such First Wave Country.”

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

For the sake of clarity, the Parties confirm that the milestone payment of
Section 4.2.1 has already been paid by Partner as of the date of this Amendment.

 

Article 4 —Royalties

 

Section 4.3.1 of the Agreement shall be deemed replaced by the following:

 

“4.3.1.       Minimum Annual Royalty. Commencing with the fourth full Year
following the earlier of (i) the Year in which Partner has first achieved
Commercial Launch of the Product in three Major Countries or (ii) the second
Year following the Year in which Partner has first achieved Commercial Launch of
the Product in any Major Country and ending in (and including) the last Year in
which there is at least one Valid Claim included in the Ironwood Patent Rights
covering the manufacture, use or sale of the Product in the Territory, Partner
will pay to Ironwood annual minimum royalties of $[**], which payments will be
made no later than February 15th of each year for the preceding year and which
amounts will be fully creditable against royalties owed to Ironwood pursuant to
Section 4.3.2 for the preceding Year.

 

However, in the event that Partner seeks pricing and reimbursement approval from
the relevant Regulatory Authority in one of the following First Wave Countries
and the Reimbursed Price Reference for such First Wave Country is [**] (or, in
the case of [**], [**]), then the above-described annual minimum royalty
obligation shall thereafter be reduced by the following amount (corresponding to
such First Wave Country):

 

Major Country

 

Minimum Royalty

 

[**]

 

$

[**]

 

[**]

 

$

[**]

 

Total:

 

$

[**]

 

 

Section 4.3.2 of the Agreement shall be deemed replaced by the following:

 

4.3.2       Royalty. Partner will pay to Ironwood royalties based on the
aggregate annual Net Sales of Products sold by Partner or its Affiliates in the
Field in the Territory at the rates set forth in the tables below (as
applicable):

 

(I) During the first 48 months of the Commercial Launch of the Product in the
Territory:

 

Aggregate annual Net Sales in the Territory

 

Royalty rate

 

 

 

 

 

Euros 0 to 60,000,000

 

[**]

%

Euros 60,000,001 to 100,000,000

 

[**]

%

Euros 100,000,001 to 250,000,000

 

[**]

%

Euros 250,000,001 to 500,000,000

 

[**]

%

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

Euros 500,000,001 to 750,000,000

 

[**]

%

Euros 750,000,001 and above

 

[**]

%

 

(II) After the first 48 months of the Commercial Launch of the Product in the
Territory:

 

Aggregate annual Net Sales in the Territory

 

Royalty rate

 

Euros 0 to 100,000,000

 

[**]

%

Euros 100,000,001 to 250,000,000

 

[**]

%

Euros 250,000,001 and above

 

[**]

%

 

For the avoidance of doubt, the above rates are incremental rates that apply to
the Net Sales indicated for each applicable rate only. For example, if Partner
receives Euro 40 million of Net Sales of Products in each Calendar Quarter in a
given Year within the first 48 months immediately following the Commercial
Launch, then Partner will pay a royalty of Euro [**] ([**]% of 40 million) in
the first Calendar Quarter, a royalty of Euro [**] ([**]% of 20 million plus
[**]% of 20 million) in the second Calendar Quarter, a royalty of Euro [**]
([**]% of 20 million plus [**]% of 20 million) in the third Calendar Quarter,
and a royalty of Euro [**] ([**]% of 40 million) in the fourth Calendar Quarter.
In the Year which includes the 4th anniversary of the First Commercial Sale, the
royalties payable shall be calculated as the average royalty payable in
accordance with the tables in paragraphs (I) and (II) above in proportion to the
number of days during such Year in which each of such tables should apply.

 

Article 5 — [**]

 

[**].

 

Article 6 — Term and Termination

 

The first sentence of Section 8.3 of the Agreement shall be deemed replaced by
the following:

 

“Termination for Convenience. By Partner effective upon at least [**] days prior
written notice to Ironwood, this Agreement may be terminated for any reason by
Partner (a) in its entirety, prior to the expiration of the Agreement, or
(b) with respect to [**] only, prior to the Commercial Launch of the Product in
[**].  If Partner terminates this Agreement with respect to [**] only pursuant
to (b) in the preceding sentence, Ironwood shall be entitled to Commercialize
the Product (directly or through any Third Party) in [**], and (I) the effects
of such termination for [**] shall be as set forth in Section 8.2.3 of the
Agreement, but [**] and (II) Partner’s annual minimum royalty obligation set
forth in Section 4.3.1 of the Agreement shall be reduced by $[**], starting on
the date of such termination; provided, however, that in the event such
Commercialization is performed by any Third Party in [**] (other than through a
Third Party service provider that is compensated for Commercializing the Product
on a fee-

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

for-service basis) instead of Ironwood, such Third Party will be subject to
(x) the same Commercial Launch milestone obligation for [**] as Partner would
be, immediately preceding such termination, had such termination not occurred,
and (y) a minimum annual royalty of $[**], as the case may be, commencing with
the fourth full Year following the Year in which such Third Party has first
achieved Commercial Launch of the Product in [**] and ending in (and including)
the last Year in which there is at least one Valid Claim included in the
Ironwood Patent Rights covering the manufacture, use or sale of the Product in
[**].”

 

Article 7 — Extent of the present Amendment

 

This Amendment constitutes an integral part of the Agreement. It is expressly
understood that the terms and conditions of the Agreement shall remain fully
enforceable except where directly and expressly modified by this Amendment.

 

[Remainder of Page Intentionally Left Blank]

 

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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the Commission.

 

IN WITNESS WHEREOF, the parties have executed this Amendment as of the day and
year first above written.

 

IRONWOOD PHARMACEUTICALS, INC.

 

ALMIRALL S.A.

 

 

 

 

 

 

/s/ Michael J. Higgins

 

/s/ M. Zambrini          /s/ J. Sabé

By:

Michael J. Higgins

 

By: M. Zambrini     –     J. Sabé

Title:

Chief Operating Officer

 

Title: Proxies

 

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