Exhibit 10.12

 

A complete version of this Exhibit has been filed separately with the Securities
and Exchange Commission pursuant to an application requesting confidential
treatment pursuant to Rule 24b-2 promulgated under the Securities Act of 1934,
as amended. Certain confidential portions of this Exhibit were omitted and
replaced with double asterisks ([**]).

 

FIRST AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT BETWEEN ALKERMES
PHARMA IRELAND LIMITED AND BIOGEN SWISS MANUFACTURING GMBH

 

WHEREAS, the parties desire to amend the License and Collaboration Agreement
dated November 27, 2017 between Alkermes Pharma Ireland Limited and Biogen Swiss
Manufacturing GMBH (the “Agreement”) such that GI Inferiority for Part B of the
GI Tolerability Clinical Trial shall be revised in consideration for a
commitment from Alkermes around the expenditure of efforts to make available
topline data from said Trial as soon as reasonably practicable.

 

Now, therefore, the Parties agree to amend the Agreement, effective October 3,
2018 (the “Effective Date”), as follows:

 

 

1)

Sections 1.1.47 and 1.1.48 of the Agreement shall be stricken in their entirety
and replaced with the following (with that text that is new to the definitions
underlined):

 

1.1.47. “GI Inferiority” will be deemed to exist if (i) the [**] of patients not
previously enrolled in the GI Tolerability Clinical Trial or otherwise exposed
to a fumarate that discontinue participation in the Long-Term Safety Clinical
Trial due to a GI Event is greater than [**]; or if both of the following in
(ii) and (iii) occur: (ii) the percentage of patients who discontinue
participation in the ALKS 8700 arm of Part B of the GI Tolerability Clinical
Trial due to a GI Event is greater than the percentage of patients who
discontinue participation in the Tecfidera® arm of Part B of the GI Tolerability
Clinical Trial due to a GI Event, in all cases as set forth in the Complete GI
Tolerability Data Package, provided that, if the rate of discontinuations due to
a GI Event in Part A of the GI Tolerability Clinical Trial is lower in the
Tecfidera® arm of such trial and the Parties jointly agree in writing not to
conduct Part B of the GI Tolerability Clinical Trial, then GI Inferiority will
be deemed to exist; and (iii) Part B of the GI Tolerability Clinical Trial
demonstrates the Tecfidera® arm as [**] to the ALKS 8700 arm [**] on the primary
endpoint, which is defined as [**]. For clarity, unless subsections (ii) and
(iii) above are both met, GI Inferiority will not be deemed to exist.  If the
Parties jointly agree in writing not to conduct Part B of the GI Tolerability
Clinical Trial for reasons other than because the rate of discontinuations due
to a GI Event in Part A of the GI Tolerability Clinical Trial is lower in the
Tecfidera® arm of such trial, then, unless the Parties agree otherwise in
writing, GI Inferiority will not be deemed to exist.

 

1.1.48. “GI Tolerability Clinical Trial” means the Clinical Study Protocol
ALK8700-A302 Amendment 2.0, as such may be further amended from time to time.

 

 

2)

Section 3.2, Development Responsibilities and Rights, is amended by adding the
following paragraph at the end of Section 3.2.1:

 

In addition, Alkermes agrees that it shall use best efforts to make available to
Biogen an abstract and the supporting Topline Data report (consisting of the
tables and graphs for the data supporting the abstract)  based upon the Topline
Data (as defined below) from Part B of the GI Tolerability Clinical Trial no
later than [**] with said abstract to be of the caliber that meets industry
standard.  For purposes of this Section 3.2.1, “Topline Data” shall mean the
results of the primary and pre-specified secondary analyses and all key safety
information available as of the date of such primary and pre-specified secondary
analyses (consisting, at a minimum, of baseline demographics, subject
disposition, adverse events, serious adverse events, and discontinuations) for
Part B of the GI Tolerability Clinical Trial.

 

 

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3)

Section 3.8.1, Development Costs Incurred by Alkermes, is amended by adding the
following at the end of Section 3.8.1:

 

[**]

 

 

4)

Pursuant to, and in satisfaction of, the authority delegated to the Parties’
respective JSC members under Section 2.1.2 of the Agreement, Alkermes and Biogen
hereby approve an increase in the Initial Development Plan budget of [**] U.S.
Dollars (US$[**]).

 

 

5)

Reference in this Amendment to terms written in upper case in shall have the
meaning as set out in the Agreement.

 

 

6)

In all other respects, the Agreement shall remain in full force and effect.

[Signature page follows]

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Whereas, each of the Parties has caused this First Amendment to be executed and
delivered by its duly authorized representatives to be effective as of the
Effective Date.

 

ALKERMES PHARMA IRELAND LIMITED

 

BIOGEN SWISS MANUFACTURING GMBH

 

 

 

By:

/s/ Shane Cooke

 

By:

/s/ Frederick Lawson

 

 

 

 

 

Name:

Shane Cooke

 

Name:

Frederick Lawson

 

 

 

 

 

Title:

Director

 

Title:

Senior Director

 

 

 

 

 

Date:

3 October 2018

 

Date:

4-10-2018

 

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