Exhibit 10.10.3

 

In accordance with Item 601(b)(2)(ii) of Regulation S-K,
certain information (indicated by “[**]”) has been excluded from this exhibit
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

 

THIRD AMENDMENT TO LICENSE AND COLLABORATION AGREEMENT

 

THIS THIRD AMENDMENT (the “Amendment”) is made and entered into as of October
30, 2019 (the “Amendment Effective Date”) to amend that certain License and
Collaboration Agreement dated November 27, 2017, as amended (the “Agreement”),
by and between ALKERMES PHARMA IRELAND LIMITED (“Alkermes”) and BIOGEN SWISS
MANUFACTURING GMBH (“Biogen”). Unless explicitly noted otherwise, capitalized
terms used but not defined herein shall have the meanings set forth in the
Agreement.

 

RECITALS:

 

WHEREAS, Alkermes and Biogen have entered into the Agreement;

 

WHEREAS, Alkermes and Biogen now wish to amend the Agreement to effect the
transfer of Manufacturing of Clinical Supplies and up to one-hundred percent
(100%) of Commercial Supplies of the Alkermes 8700 Product from Alkermes to
Biogen;

 

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

 

1.

Section 1.1 of the Agreement is hereby amended to add the following new defined
terms:

 

“Commercial Supply Agreement” means that certain Commercial Supply Agreement
dated October 30, 2019, as may be amended, by and among Biogen, Biogen
International GmbH and Alkermes.

 

“Equipment” means Existing Equipment and New Equipment as such terms are defined
in the Commercial Supply Agreement.

 

“Exclusive Manufacturing End Date” means the earlier of (i) the date of [**] and
(ii) [**] after the date of [**].

 

“Technology Transfer” means the transfer from Alkermes to Biogen or its designee
of all technology Controlled by Alkermes that is necessary to enable Manufacture
of the Alkermes 8700 Product and other then-existing Products in accordance with
Section 3.2.3(iv) of the Agreement. For the avoidance of doubt, the term
“technology” as used in this definition shall not include Equipment.

 

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2.

A new Section 4.5 is hereby added to the Agreement with the following text:

 

4.5. Forecasting.  For the Alkermes 8700 Product, Biogen will provide Alkermes
with (a) a [**] written forecast of Biogen’s anticipated product demand, in
units, broken down on a country-by-country basis for each month of such period,
which forecast will be updated by Biogen [**] and provided to Alkermes no later
than [**]; (b) an [**] good faith [**] written forecast in respect of Biogen’s
anticipated product demand, in units, broken down by U.S., Europe and
rest-of-world, which forecast will be updated by Biogen [**] and provided to
Alkermes no later than [**]; and (c) a quarterly inventory report providing
inventory levels for work in progress (including, but not limited to, active
pharmaceutical ingredients and drug product) and finished goods, which will be
updated by Biogen and provided to Alkermes on a quarterly basis.

 

3.

Section 5.1.2 of the Agreement is deleted in its entirety and replaced with the
following text:

 

5.1.2 Commercial Supplies.   Pursuant to this Agreement, Biogen has the right to
Manufacture or have Manufactured Commercial Supplies. Biogen has considered in
good faith, and hereby appoints, Alkermes as the toll manufacturer for such
Commercial Supplies for Commercialization in the Territory at a site outside of
the United States, and Biogen and its Affiliates and Sublicensees will purchase
Commercial Supplies exclusively from Alkermes; provided that, (A) with respect
to the Alkermes 8700 Product only and subject to the Manufacturing transition
plan referenced in this Section 5.1.2, Biogen’s appointment of Alkermes as toll
manufacturer, Alkermes’ obligation to Manufacture, and the obligations of Biogen
and its Affiliates and Sublicensees to purchase Clinical Supplies and Commercial
Supplies exclusively from Alkermes will each expire on the Exclusive
Manufacturing End Date and (B) for Products other than the Alkermes 8700
Product, Biogen may qualify to Manufacture, or engage and qualify a Third Party
to Manufacture, Commercial Supplies as a back-up manufacturer so long as such
Third Party Manufacturer does not Manufacture more than [**] percent ([**]%) of
Commercial Supplies in the aggregate in any Calendar Year, except in the event
of a Force Majeure Delay or a Serious Failure to Supply.

 

Upon Biogen’s written request, Alkermes and Biogen shall work in good faith to
(a) enter into a technology transfer plan pursuant to which Alkermes will
undertake a Technology Transfer in accordance with Section 3.2.3(iv) of the
Agreement, including the reimbursement provisions therein, as promptly as
reasonably practicable and, in any event, to be completed no later than [**]
after Biogen’s written request to transition manufacturing and enter into a
technology transfer plan, and (b) enter into a Manufacturing transition plan
([**]) to ensure the orderly transition after the Exclusive Manufacturing End
Date to Biogen or its designee of Manufacturing responsibility for Clinical
Supplies and Commercial

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Supplies of the Alkermes 8700 Product in an effort to prevent any interruption
in the supply of such product.

 

Notwithstanding anything to the contrary set forth in this Section 5.1.2, if (i)
Alkermes foregoes its exclusive right to Manufacture or have Manufactured
Commercial Supplies, (ii) Alkermes undergoes a Change of Control in which the
acquirer is a competitor of Biogen set forth on Schedule 5.1 or a Third Party
toll manufacturer that Manufactures a competing fumarate product or (iii) there
is a Serious Failure to Supply, then in any case ((i)-(iii)), (a) Biogen and its
Affiliates and Sublicensees will have no further obligation to exclusively
purchase Commercial Supplies from Alkermes, (b) Biogen will have the exclusive
right to Manufacture or have Manufactured Commercial Supplies and (c) Alkermes
will promptly conduct a transfer (to the extent not already conducted pursuant
to any Technology Transfer) of all necessary Manufacturing technology to Biogen
or its designee to enable Biogen or such designee to Manufacture Commercial
Supplies.  In addition, in the event of a Force Majeure Delay (and for the
duration thereof), until such time as Alkermes is able to resume sufficient
Manufacturing to meet Biogen’s demand for Commercial Supplies, Biogen may
Manufacture itself or have Manufactured by its back-up manufacturer, all
Commercial Supplies for so long as Alkermes is unable to meet Biogen’s demand.

 

4.

Section 9.4 of the Agreement is hereby deleted in its entirety and replaced with
the following text:

 

 

9.4

Milestone Payments.  

 

 

9.4.1

Commercial Milestones for the Alkermes 8700 Product. As further consideration of
the grant of the licenses set forth in Section 6.1 and the performance of
Alkermes’ other obligations hereunder, Biogen will pay to Alkermes the amounts
set forth below no later than [**] days after the earliest date on which the
corresponding milestone event has first been achieved:

 

Commercial Milestone Event

Amount

Parties’ execution of amendments to the Commercial Supply Agreement and the
Clinical Supply Agreement reflecting the transition of Manufacturing of Clinical
Supplies and up to 100% of Commercial Supplies of the Alkermes 8700 Product to
Biogen

$5,000,000

Exclusive Manufacturing End Date

$5,000,000

 

 

9.4.2

Development Milestones for Products other than the Alkermes 8700 Product. As
further consideration of the grant of the licenses set forth in Section 6.1 and
the performance of Alkermes’ other obligations

3

 

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hereunder, Biogen will pay to Alkermes the amounts set forth below no later than
[**] days after the earliest date on which the corresponding milestone event has
first been achieved with respect to the first two Products other than the
Alkermes 8700 Product:

 

Development Milestone Event

Amount

The first administration to the first patient in a Clinical Trial of such
Product.

$[**]

The first administration of such Product to the first patient in a phase 3
Clinical Trial.

$[**]

Receipt of Regulatory Approval of an NDA from the FDA in the U.S. for such
Product.

$[**]

 

The milestone payments set forth in this Section 9.4.2 will be paid on a
Product-by-Product basis on the first occurrence of each such applicable
milestone for each of the first two Products other than the Alkermes 8700
Product.

 

5.

Section 9.5.1(i) of the Agreement is hereby deleted in its entirety and replaced
with a new Section 9.5.1(i)(A) and a new Section 9.5.1(i)(B) with the following
text:

 

 

(i)

(A) Royalty Percentages for Alkermes 8700 Product Manufactured by Alkermes. As
further consideration of the grant of the licenses set forth in Section 6.1 and
the performance of Alkermes’ other obligations hereunder for Alkermes 8700
Product Manufactured by Alkermes, Biogen will pay to Alkermes royalty payments
on Net Sales of the Alkermes 8700 Product in the Territory on a
country-by-country basis during the applicable Royalty Term at the rate of
fifteen percent (15%) of Net Sales. Notwithstanding the foregoing, in the event
of a determination of GI Inferiority, then the royalty rate during each Royalty
Term for the Alkermes 8700 Product in each country in the Territory will be [**]
percent ([**]%) of Net Sales until such time as the aggregate royalty payments
paid to Alkermes across all countries equal Fifty Million U.S. Dollars
($50,000,000), after which time such royalty rate will return to its prior
level, before the determination of GI Inferiority that resulted in such royalty
rate of [**] percent ([**]%) (but subject in any event to Section 9.5.5, Section
9.5.6 and Section 9.5.7).

 

(B) Royalty Percentages for Alkermes 8700 Product Manufactured by Biogen. As
further consideration of the grant of the licenses set forth in Section 6.1 and
the performance of Alkermes’ other obligations hereunder with respect to the
Alkermes 8700 Product Manufactured by Biogen or its designee, Biogen will pay to
Alkermes royalty payments on Net Sales of the Alkermes 8700 Product in the
Territory on a country-by-country basis

4

 

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during the applicable Royalty Term at the rate of [**] percent ([**]%) of Net
Sales.  Notwithstanding the foregoing, in the event of a determination of GI
Inferiority, then the royalty rate during the Royalty Term for the Alkermes 8700
Product in each country in the Territory will be [**] percent ([**]%) of Net
Sales until such time as the aggregate royalty payments paid to Alkermes across
all countries equal Fifty Million U.S. Dollars ($50,000,000), after which time
such royalty rate will return to its prior level, before the determination of GI
Inferiority that resulted in such royalty rate of [**] percent ([**]%) (but
subject in any event to Section 9.5.5, Section 9.5.6 and Section 9.5.7).

 

6.

Section 9.6 of the Agreement is hereby deleted in its entirety and replaced with
a new Section 9.6 with the following text:

 

9.6. Reporting and Paying Net Sales. For each Calendar Quarter for which
royalties are payable by Biogen to Alkermes pursuant to Section 9.5.1(i) or
Section 9.5.2, Biogen will (i) deliver to Alkermes, within five (5) days after
the end of each such Calendar Quarter, a nonbinding estimated report prepared in
good faith, (ii) deliver to Alkermes, within forty-five (45) days after the end
of each such Calendar Quarter a true and accurate report, in each case of (i)
and (ii), providing in reasonable detail (A) an accounting of all Net Sales made
on a country-by-country and Product-by-Product basis in the Territory during
such Calendar Quarter, including the amount of gross sales of Products and the
aggregate allowable deductions therefrom, (B) the number of units of Products
sold, (C) the currency conversion rates used, (D) the U.S. Dollar-equivalent of
such Net Sales during such Calendar Quarter and (E) a calculation of the amount
of royalty payment due on such Net Sales, and (iii) within forty-five (45) days
after the end of each such Calendar Quarter, pay Alkermes the royalties due
under Section 9.5.1(i) and Section 9.5.2 with respect to such Calendar Quarter
as provided for in the report delivered under (ii) above. Each of the reports
set forth in (i) and (ii) of this Section 9.6 will be organized to distinguish
whether the Alkermes 8700 Product was Manufactured by Alkermes or Biogen or
their respective designees and, in the case of the report set forth in (ii), the
amount of Alkermes 8700 Product in inventory as of the end of the Calendar
Quarter to which the report relates. In addition, within forty-five (45) days
after the end of the first Calendar Quarter following each twelve (12)-month
period during the Minimum Annual Payment Term, Biogen shall pay Alkermes any
amount due under Section 9.5.1(ii) for such twelve (12)-month period. Each
report delivered hereunder shall be considered Confidential Information of
Biogen, subject to the terms and conditions of Article 8. Any payments due
hereunder for less than a full Calendar Quarter will be prorated.

 

7.

The Parties agree that all terms relating to the Manufacture of Commercial
Supplies of the Alkermes 8700 Product are set forth in the Commercial Supply
Agreement and that the terms set forth in Exhibit E of the Agreement do not
apply to the Manufacture of Commercial Supplies of the Alkermes 8700 Product.

5

 

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8.

Governing Law.  This Amendment shall be governed by and construed in accordance
with the laws of the State of New York without regard to its conflict of law
provisions.

 

9.

Integration.  Except as expressly provided in this Amendment, all other terms,
conditions and provisions of the Agreement shall continue in full force and
effect as provided therein.  The Agreement (as amended by this Amendment), this
Amendment, the Clinical Supply Agreement and the Commercial Supply Agreement
constitute the entire agreement between the parties hereto and thereto relating
to the subject matter hereof and thereof and supersede all prior and
contemporaneous negotiations, agreements, representations, understandings and
commitments with respect thereto.

 

 

 

[Signature page follows]

6

 

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IN WITNESS WHEREOF, Alkermes and Biogen have executed and delivered this
Amendment effective as of the Amendment Effective Date.

 

ALKERMES PHARMA IRELAND LIMITED

 

By: /s/ Kevin Brady

Name: Kevin Brady

Title:  Director

 

BIOGEN SWISS MANUFACTURING GMBH

 

By:/s/ Peter Puype

Name: Peter Puype

Title: VP, Global Supply Chain

 

 

 

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