Exhibit 10.9.1

 

AMENDMENT NO. 2 TO COLLABORATION AGREEMENT

 

This AMENDMENT NO. 2 TO THE COLLABORATION AGREEMENT (the “Amendment”) is entered
into and effective on this 8th day of January, 2013 (the “Second Amendment
Effective Date”), by and between Ironwood Pharmaceuticals, Inc. a Delaware
corporation (formerly Microbia, Inc.) (“Ironwood”) and Forest Laboratories, Inc.
(“Forest”).  Ironwood and Forest may each be referred to herein individually as
a “Party” and collectively as the “Parties.”

 

BACKGROUND

 

Ironwood and Forest entered into a Collaboration Agreement dated as of
September 12, 2007 and an Amendment No. 1 to Collaboration Agreement dated as of
November 3, 2009 (as amended, the “Agreement”).

 

Ironwood and Forest now desire to further amend the Agreement to reflect the
transfer of ownership of the global safety database from Forest to Ironwood as
of the Second Amendment Effective Date, under the terms and conditions set forth
herein.

 

AGREEMENT

 

NOW THEREFORE, in consideration of the mutual promises and covenants set forth
below and other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the Parties agree as follows:

 

1.              Adverse Events.  The text of Section 4.3 is hereby deleted in
its entirety and replaced with the following:

 

“Adverse Events.  The Parties have entered into an amended and restated
pharmacovigilance agreement, which is attached as an exhibit hereto and hereby
incorporated into this Agreement by reference (the “Pharmacovigilance
Agreement”).  The Parties will comply with the provisions of such
Pharmacovigilance Agreement.  Ironwood will maintain and will be the recognized
holder of the global safety database for Adverse Event reports related to the
Collaboration Compound and Product received by either Party.  Forest or its
sublicensees may request from Ironwood safety data or reports included in, or
generated from, the global safety database, and Ironwood shall deliver such
safety data and/or reports to Forest in a reasonably prompt manner to enable
Forest and its sublicensees to timely comply with all Applicable Laws.  Forest
will respond, or will cause its sublicensees to, respond to safety inquiries
regarding the Product in the Field in the Territory.  Seventy-five percent (75%)
of all costs incurred by Ironwood and, if applicable, one hundred percent (100%)
of all costs incurred by Forest, in maintaining the global safety database will
be included as Development Expenses; provided, however, that with respect to
costs incurred by Ironwood, upon either Party’s request (but not more frequently
than annually), the Parties will adjust the applicable percentage to

 

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reflect the percentage of safety reports processed in the global safety database
that originated in the Territory during the prior year (as compared to the total
number of safety reports that originated in any country worldwide during such
year) and, if necessary, reconcile costs for such prior year (for example, if
such percentage of safety reports that originated in the Territory is less than
75% then the percentage of the costs incurred by Ironwood will be reduced to
equal such lower percentage, and if such percentage of safety reports that
originated in the Territory is more than 75% then the percentage of the costs
incurred by Ironwood will be increased to equal such higher percentage).  In
addition, all other costs incurred by each Party in performing its respective
obligations under the Pharmacovigilance Agreement will be included as
Development Expenses.”

 

2.              General.

 

A.                                    Except as amended by this Amendment, the
Agreement shall remain in full force and effect in accordance with the terms
thereof.  Amendments made pursuant to this Amendment shall be effective as of
the Second Amendment Effective Date.

 

B.                                    This Amendment may be executed in any
number of counterparts, each of which shall be deemed an original and all of
which taken together shall be deemed to constitute one and the same instrument. 
An executed signature page of this Amendment delivered by PDF facsimile
transmission shall be as effective as an original executed signature page.

 

(The remainder of this page has been intentionally left blank.  The signature
page follows.)

 

2

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IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly
executed this Amendment to be effective as of the Second Amendment Effective
Date.

 

FOREST LABORATORIES, INC.

IRONWOOD PHARMACEUTICALS, INC.

 

 

 

 

By

/s/ M. Boerstoel

 

By

/s/ Jim DeTore

 

 

 

Name: M. Boerstoel

Name: Jim DeTore

Title: CSO, VP Global Drug Safety

Title: VP, Finance and Administration

 

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