Exhibit 10.10

 

 

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 ([**]).

 

 

 

Execution Version

 

 

 

LICENSE AND COLLABORATION AGREEMENT

 

BETWEEN

 

ALKERMES PHARMA IRELAND LIMITED

 

AND

 

BIOGEN SWISS MANUFACTURING GMBH

NOVEMBER 27, 2017

 

 

 

--------------------------------------------------------------------------------

 

 

TABLE OF CONTENTS

 

 

 

 

Page

ARTICLE 1 DEFINITIONS

1

1.1.Defined Terms

1

1.2.Additional Definitions

12

1.3.Interpretation

13

ARTICLE 2 MANAGEMENT OF THE COLLABORATION

14

2.1.Joint Steering Committee

14

2.2.Alkermes’ Participation in the JSC

16

2.3.Disbandment of the JSC

16

ARTICLE 3 DEVELOPMENT

17

3.1.Development Team

17

3.2.Development Responsibilities and Rights

19

3.3.Regulatory Filings

22

3.4.Regulatory Meetings and Communications

24

3.5.Debarment Limitations

25

3.6.Compliance

25

3.7.Safety Reporting

25

3.8.Development Costs

26

3.9.Initial Development Plan Budget

26

ARTICLE 4 COMMERCIALIZATION

27

4.1.Commercialization Rights

27

4.2.Commercialization Efforts

27

4.3.Commercialization Costs

27

4.4.Compliance

27

ARTICLE 5 MANUFACTURE AND SUPPLY

27

5.1.Supply and Quality Agreements

27

5.2.Supply Team

29

ARTICLE 6 LICENSE GRANTS

29

6.1.Patent and Know-How License Grant

29

6.2.Patent Update

30

-i-

 

--------------------------------------------------------------------------------

 

Table of Contents

(continued)

 

 

 

 

Page

6.3.Termination of License to Contested Patent Rights

30

6.4.Non-Suit

30

6.5.Non-Interference

31

6.6.Exclusivity

31

ARTICLE 7 INTELLECTUAL PROPERTY RIGHTS

32

7.1.Ownership of Intellectual Property

32

7.2.Disclosure of Inventions

33

7.3.Patent Committee

33

7.4.Patent Filings

33

7.5.Enforcement Rights

35

7.6.Infringement Defense

36

7.7.Patent Marking

37

7.8.Orange Book Listings

37

7.9.Trademark Infringement

38

ARTICLE 8 CONFIDENTIALITY; PUBLICITY

38

8.1.Confidentiality

38

8.2.Authorized Use and Disclosure

39

8.3.Disclosure to Investors

40

8.4.Survival

40

8.5.Publications or Presentations

40

ARTICLE 9 PAYMENTS

41

9.1.Up-Front Payment

41

9.2.Option Payment

41

9.3.NDA Approval Payment

41

9.4.Development Milestones for Products other than the Alkermes 8700 Product

41

9.5.Royalties

42

9.6.Reporting and Paying Net Sales

44

9.7.Records and Reporting; Audits

45

9.8.Manner of Payments

46

-ii-

 

--------------------------------------------------------------------------------

 

Table of Contents

(continued)

 

 

 

 

Page

9.9.Interest on Late Payments

46

9.10.Currency of Payments/Exchange Rates

46

9.11.Taxes

46

ARTICLE 10 REPRESENTATIONS AND WARRANTIES; COVENANTS; DISCLAIMER

47

10.1.Disclaimer

47

10.2.Mutual Representations, Warranties and Covenants

48

10.3.Alkermes Representations and Warranties

48

10.4.Biogen Representations and Warranties

51

10.5.Responsibility for Government Approvals

51

ARTICLE 11 LIABILITY

51

11.1.Limitation of Liability

51

11.2.Biogen Indemnification

52

11.3.Alkermes Indemnification

52

11.4.Indemnification Procedures

53

11.5.Cooperation

53

11.6.Insurance

53

ARTICLE 12 DISPUTE RESOLUTION

54

12.1.Disputes

54

12.2.Jurisdiction

55

12.3.Determination of Disputes Relating to Patents

55

12.4.Equitable Relief

55

ARTICLE 13 TERM AND TERMINATION

56

13.1.Term

56

13.2.Right to Terminate for Government Prohibition

56

13.3.Biogen’s Right to Terminate for Convenience

56

13.4.Right to Terminate Upon Bankruptcy

56

13.5.Effects of Termination

56

13.6.Bankruptcy

59

13.7.Survival of Certain Provisions

60

-iii-

 

--------------------------------------------------------------------------------

 

Table of Contents

(continued)

 

 

 

 

Page

ARTICLE 14 GENERAL PROVISIONS

60

14.1.Notices

60

14.2.Governing Law

61

14.3.Entire Agreement; Amendment

61

14.4.Binding Effect and Assignment

61

14.5.Waiver

62

14.6.Severability

62

14.7.Counterparts and Signatures

62

14.8.Force Majeure

62

14.9.Ambiguities

62

14.10.Headings

62

14.11.No Partnership

62

14.12.No Third Party Beneficiaries

63

14.13.Performance by an Affiliate

63

14.14.Further Assurances

63

 

 

 

-iv-

 

--------------------------------------------------------------------------------

 

 

LICENSE AND COLLABORATION AGREEMENT

This License And Collaboration Agreement (the “Agreement”) is entered into
effective as of November 27, 2017 (the “Effective Date”) by and between Alkermes
Pharma Ireland Limited, a private limited company incorporated in Ireland
(registered number 448848) whose registered address is Connaught House, 1
Burlington Road, Dublin 4, Ireland (“Alkermes”), and Biogen Swiss
Manufacturing GmbH, a Swiss limited liability company with its principal office
at Landis & Gyr Strasse 3, CHR-6300 Zug, Switzerland (“Biogen”).

Recitals:

Whereas, Alkermes is developing the Alkermes 8700 Product for the treatment of
MS;

Whereas, Biogen has experience and expertise in the development and
commercialization of pharmaceutical products;

Whereas, Alkermes will continue the development of the Alkermes 8700 Product in
the U.S. for the treatment of MS through the Transfer Completion Date pursuant
to the terms of this Agreement;

Whereas, Alkermes will manufacture and supply to Biogen Clinical Supplies of the
Alkermes 8700 Product and potentially other Products pursuant to the terms of a
Clinical Supply Agreement;

Whereas, on all of the terms and subject to the conditions set forth in this
Agreement Biogen desires to appoint Alkermes as the toll manufacturer for
Commercial Supplies of the Alkermes 8700 Product in the Territory at a site
outside of the United States, and Alkermes is willing to accept such
appointment, subject to the terms of a supply agreement to be negotiated by the
Parties; and

Whereas, Alkermes wishes to grant to Biogen, and Biogen wishes to obtain, an
exclusive license to Exploit the Products in the Field in the Territory, all on
the terms and subject to the conditions set forth in this Agreement.

Now, Therefore, in consideration of the premises and the mutual covenants and
agreements set forth herein, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties agree as
follows:

Article 1

Definitions

1.1.Defined Terms.  When used in this Agreement, each of the following terms
shall have the meanings set forth in this Article 1:

1.1.1.“Affiliate” with respect to any Party, means any entity that, directly or
indirectly, controls, is controlled by, or is under common control with such
Party, but only for so long as such control continues.  For these purposes,
“control” will refer to: (i) the

1

--------------------------------------------------------------------------------

 

 

possession, directly or indirectly, of the power to direct the management or
policies of an entity, whether through ownership of voting securities, by
contract or otherwise or (ii) the ownership, directly or indirectly, of at least
fifty percent (50%) of the equity securities of the entity entitled to vote in
the election of directors (or, in the case of an entity that is not a
corporation, at least fifty percent (50%) of the equity securities of the entity
entitled to vote in the election of the corresponding managing authority or
entitled to direct the management and policies of such entity).

1.1.2.“Alkermes 8700 Product” means the oral Product in Development by Alkermes
as of the Effective Date and containing as its active ingredient the compound
having the structure set forth in Exhibit A.

1.1.3.“Alkermes 8700 Product 505(b)(2) NDA” means the NDA for the Alkermes 8700
Product in the Initial Indication to be submitted by Alkermes to the FDA in the
U.S. pursuant to (a) the 505(b)(2) regulatory pathway, as set forth in the
Initial Development Plan or (b) the 505(b)(1) regulatory pathway, solely in the
event that Biogen grants to Alkermes the right of reference in accordance with
Section 3.3.2.  

1.1.4.“Alkermes Collaboration Know-How” means Collaboration Know-How invented
solely by Alkermes’ or its Affiliates’ employees, agents or independent
contractors in the performance of activities under the Initial Development Plan
during the Term.

1.1.5.“Alkermes Collaboration Patents” means all Collaboration Patents that
Cover Alkermes Collaboration Know-How.

1.1.6.“Allocable Overhead” means [**].

1.1.7.“Applicable Law” means all applicable laws, statutes, rules, regulations,
ordinances and other pronouncements having the binding effect of law of any
applicable Governmental Authority, including any rules, regulations, guidelines
or other requirements of the Regulatory Authorities, that may be in effect from
time to time in the Territory.

1.1.8.“Bankruptcy Code” means Title 11, U.S. Code, or analogous provisions of
Applicable Law outside the U.S.

1.1.9.“Biogen Collaboration Know-How” means Collaboration Know-How invented
solely by Biogen’s or its Affiliates’ or Sublicensees’ employees, agents or
independent contractors in the performance of activities under the Initial
Development Plan during the Term.

1.1.10.“Biogen Collaboration Patents” means all Collaboration Patents that Cover
Biogen Collaboration Know-How.

1.1.11.  “Business Day” means a day on which banking institutions in Cambridge,
Massachusetts, Zug, Switzerland and Dublin, Ireland are open for business.

2

--------------------------------------------------------------------------------

 

 

1.1.12.“Calendar Quarter” means each three (3)-month period of January through
March, April through June, July through September and October through December.

1.1.13.“Calendar Year” means each annual twelve (12)-month period starting on
January 1 and ending on December 31.

1.1.14.“Change of Control” means, with respect to a Party, (i) an acquisition,
reorganization, merger or consolidation of such Party with a Third Party in
which the holders of the voting securities of such Party outstanding immediately
prior thereto cease to beneficially own at least fifty percent (50%) of the
combined voting power of the surviving entity, directly or indirectly,
immediately after such acquisition, reorganization, merger or consolidation,
(ii) a transaction or series of related transactions in which a Third Party,
together with its Affiliates (if applicable), becomes the beneficial owner of
fifty percent (50%) or more of the combined voting power of the outstanding
securities of such Party, or (iii) the sale or other transfer to a Third Party
of all or substantially all of such Party’s assets.

1.1.15.“Clinical Supplies” means supplies of a Product and Placebo to be used
for the conduct of pre-clinical studies, Post-Marketing Commitments or Clinical
Trials of a Product in the Field in the Territory pursuant to this Agreement.

1.1.16.“Clinical Supply Agreement” means a supply agreement between the Parties
for the Manufacture by Alkermes of Clinical Supplies.

1.1.17.“Clinical Trials” means human studies designed to measure the safety or
efficacy of a Product. 

1.1.18.“Code” means the Code on Interactions with Healthcare Professionals
promulgated by the Pharmaceutical Research and Manufacturers of America (PhRMA)
and the American Medical Association (AMA) Guidelines on Gifts to Physicians
from Industry.

1.1.19.“Collaboration Know-How” means any Know-How invented during the Term by a
Party’s or its Affiliates’, licensees’ or Sublicensees’ employees, agents or
independent contractors, either alone or jointly with the other Party’s or its
Affiliates’, licensees’ or Sublicensees’ employees, agents or independent
contractors, in the performance of activities under the Initial Development Plan
during the Term.

1.1.20.“Collaboration Patents” means any Patent Rights invented by a Party’s or
its Affiliates’, licensees’ or Sublicensees’ employees, agents or independent
contractors, either alone or jointly with the other Party’s or its Affiliates’,
licensees’ or Sublicensees’ employees, agents or independent contractors, in the
performance of activities under the Initial Development Plan during the Term
that Cover any Collaboration Know-How.

1.1.21.“Collaboration Technology” means the Collaboration Know-How and the
Collaboration Patents.

1.1.22.“Combination Product” means any single product in finished form
containing as active ingredients both (i) a Product and (ii) one or more other
pharmaceutically active compounds or substances that are not Products, whether
co-formulated or co-packaged

3

--------------------------------------------------------------------------------

 

 

(i.e., within a single box or sales unit); (such pharmaceutically active
compounds or substances, the “Other Components”).

1.1.23.“Commercial Supplies” or “Commercial Supply” means supplies of a Product
for commercial sale or as promotional samples, or for use in Post-Marketing
Clinical Trials.

1.1.24.“Commercialization” means the performance of any and all activities
directed to promoting, marketing, importing, exporting, distributing, selling or
offering to sell a Product following or in expectation of receipt of Regulatory
Approval (but excluding Development and Manufacture).  When used as a verb,
“Commercialize” means to engage in Commercialization.

1.1.25.“Commercially Reasonable Efforts”  [**].

1.1.26.“Complete GI Tolerability Data Package” means, with respect to Part B of
the GI Tolerability Clinical Trial and the Long-Term Safety Clinical Trial, in
each case, full demographic and patient-level data for all patients enrolled in
each such trial (including, for the Long-Term Safety Clinical Trial, a breakdown
of those patients that were previously enrolled in the GI Tolerability Clinical
Trial and those patients not previously enrolled in such trial) and a complete
set of all data and results available for each such trial, including all data
and results that would fall into the categories set forth on Schedule 1.1.26 for
each of Part B of the GI Tolerability Clinical Trial and the Long-Term Safety
Clinical Trial. 

1.1.27.“Confidentiality Agreements” means (i) the Mutual Confidentiality
Agreement dated September 9, 2015 by and between Alkermes and Biogen, Inc., as
reinstated, amended and extended on September 15, 2017 and (ii) the
Confidentiality Agreement dated April 8, 2013 between Alkermes, Inc. and Biogen,
Inc. (formerly known as Biogen Idec Inc.).

1.1.28.“Controlled” means, with respect to Patent Rights or Know-How, that the
applicable Party, in whole or in part, owns or has a license to such Patent
Rights or Know-How (but without taking into account any rights granted by one
Party to the other Party pursuant to this Agreement) and has the ability to
grant a license or a sublicense, as applicable, or to otherwise disclose
proprietary or trade secret information, to such other Party, without
misappropriating the proprietary or trade secret information of a Third Party or
violating the terms of any agreement or other arrangement with any Third Party
existing and in effect at the time such Party would be required hereunder to
grant the other Party such license or sublicensee; provided, however, that if a
Party is acquired pursuant to a Change of Control, the acquired Party will not
be deemed to Control any Know-How, Patent Rights or other intellectual property
rights owned or controlled prior to such Change of Control by any entities that
were not Affiliates of the acquired Party prior to such Change of Control and
become Affiliates of the acquired Party in connection with such Change of
Control.

1.1.29.“Cover” means, as to a particular subject matter at issue and a claim of
a relevant Patent Right, that, in the absence of a license granted under, or
ownership of, such Patent Right, the making, using, selling, offering for sale
or importation of such subject

4

--------------------------------------------------------------------------------

 

 

matter would infringe such Patent Right or, as to a pending claim included in
such Patent Right, the making, using, selling, offering for sale or importation
of such subject matter would infringe such pending claim if such claim were to
issue in an issued patent without modification.

1.1.30.“Development” means the performance of any and all activities relating to
preparation, submission, obtaining, supporting or maintaining Regulatory
Approval of a Product in the Field in the Territory and to maintaining,
supporting or expanding such Regulatory Approval, including pre-clinical
studies, pharmacokinetic studies, toxicology studies, formulation, test method
development, assay development and stability testing, manufacturing process
development, manufacturing technical support, biomarker development, validation
and scale-up (including bulk compound production), Manufacturing of Clinical
Supplies and activities relating to developing the ability to Manufacture and to
continue to Manufacture the Product, quality assurance and quality control for
formulations of a Product, design and conduct of Clinical Trials or studies
(including all Post-Marketing Commitments), report writing, statistical analysis
and regulatory affairs including regulatory legal services. When used as a verb,
“Develop” means to engage in Development.

1.1.31.“Development Costs” means all costs incurred (i.e., paid or accrued) by
either Party or each such Party’s Affiliates or licensees or Sublicensees (as
applicable), in each case, in accordance with GAAP applied on a consistent
basis, to the extent attributable to Development of the Alkermes 8700 Product in
the Initial Indication for the purpose of obtaining, supporting or maintaining
Regulatory Approval of the Alkermes 8700 Product in the U.S. (including the
performance of all Post-Marketing Commitments) or fulfilling such Party’s
responsibilities under the Initial Development Plan in accordance therewith and
with this Agreement.  Such costs shall include:

(i)costs of research or Development, including costs of studies on the
toxicological, pharmacokinetic, metabolic or clinical aspects of the Alkermes
8700 Product in the Initial Indication conducted internally or by individual
investigators or consultants, necessary or desirable for the purpose of
obtaining, supporting or maintaining Regulatory Approval of the Alkermes 8700
Product in the Initial Indication in the U.S. and for conducting Post-Marketing
Commitments to support or maintain such Regulatory Approval, including the costs
of personnel engaged in the foregoing activities at the applicable Development
FTE Rate;

(ii)Fully Burdened Manufacturing Costs of Clinical Supplies;

(iii)costs of manufacturing process development, validations, scale-up, quality
assurance and quality control for the Alkermes 8700 Product pursued by the
Parties under the Initial Development Plan, to the extent not included in the
Fully Burdened Manufacturing Costs of Clinical Supplies;

(iv)costs of preparing and reviewing data or information for the purpose of
submitting the Alkermes 8700 Product 505(b)(2) NDA to the FDA;

(v)costs of communications and meetings with the FDA, and exchange of
information and assistance related thereto, in each case, until the earlier of
(a)

5

--------------------------------------------------------------------------------

 

 

Regulatory Approval of the Alkermes 8700 Product 505(b)(2) NDA and completion of
all associated Post-Marketing Commitments or (b) the date of an Alkermes
Approval Failure; and

(vi)costs incurred in connection with receiving, investigating, recording,
reviewing, communicating and exchanging adverse events and other reportable
information, in each case, as provided in any safety data exchange agreement
entered into between the Parties to the extent relating to the Development of
the Alkermes 8700 Product in the Initial Indication in the U.S.

For clarity, any Development Cost incurred by a Party or its Affiliates or
licensees or Sublicensees (as applicable) under this Agreement or any Supply
Agreement shall be charged only once.

1.1.32.“Development FTE Rate” means initially an amount equal to [**] U.S.
Dollars (US$[**])  per FTE per year; on January 1, 2019, and annually
thereafter, such amount shall be adjusted to reflect any increase, since the
prior adjustment (or the initial rate, as applicable), based on the most recent
monthly index available as of the adjustment date set forth in the Bureau of
Labor Statistics Consumer Price Index for Urban Wage Earners and Clerical
Workers (CPI-W), Size Class A, all items less energy, which, for clarity, was
266.558 in June 2017.

1.1.33.“Distributor” means, with respect to a country, any Third Party that
purchases its requirements for Products in such country from Biogen or its
Affiliates or Sublicensees and is appointed as a distributor to distribute,
market and resell such Product in such country, even if such Third Party is
granted ancillary rights to develop, package or obtain Regulatory Approval of
such Product in order to distribute, market or sell such Product in such
country.

1.1.34.“DMF” means dimethyl fumarate.

1.1.35.“EMA” means the European Medicines Agency or any successor agency.

1.1.36.“Exploit” means to perform Medical Activities, Develop, Manufacture and
Commercialize, including to make, have made, use, sell, offer for sale, import
and export.

1.1.37.“FDA” means the U.S. Food and Drug Administration or any successor
agency.

1.1.38.“Field” means the treatment, prevention or diagnosis of any human
disease, disorder or condition.

1.1.39.“First Commercial Sale” means, with respect to a Product in a country in
the Territory, the first sale for use or consumption by the general public of
such Product by Biogen or an Affiliate or Sublicensee to a Third Party in such
country after such Product has been granted Regulatory Approval by the
appropriate Regulatory Authority(ies) in such country. Any transfer of a Product
as part of an expanded access program, compassionate

6

--------------------------------------------------------------------------------

 

 

sales or use program, an indigent program, as bona fide samples, as donations,
for the performance of Clinical Trials or for similar bona fide business
purposes in accordance with Applicable Law shall not constitute a “First
Commercial Sale” hereunder.

1.1.40.“First FDA Approval” means the FDA’s approval of an NDA for the Alkermes
8700 Product in the Initial Indication in the U.S.

1.1.41.“FTE” means the equivalent of one (1) person who is employed by a Party
or its Affiliates, or (solely with respect to technical personnel) hired as an
independent contractor by a Party or its Affiliates in lieu of such Party’s own
employees, who is qualified to perform the tasks assigned to such person.  For
FTEs performing Development activities pursuant to the Initial Development Plan,
one (1) FTE shall perform a total of [**] hours of work per Calendar Year.  Any
FTE who devotes less or more than and [**] hours of work per Calendar Year to
such work shall be treated as an FTE on a pro-rata basis calculated by dividing
the actual number of hours spent on such work during such Calendar Year by and
[**].  Such FTEs shall be charged at an hourly rate hereunder by the Parties. 

1.1.42.“Fully Burdened Manufacturing Cost” means the costs incurred (i.e., paid
or accrued) by a Party, its Affiliates or agents in the Manufacture (including
shipping or storage costs) of a Product or Placebo, as applicable, which shall
be the sum of direct labor, direct material and Allocable Overhead incurred in
the Manufacture of such Product or Placebo as determined in accordance with GAAP
as consistently applied by such Party or its Affiliates. Notwithstanding the
foregoing, Fully Burdened Manufacturing Costs exclude (i) all payments
(including upfront fees, milestones and royalties) to any Third Party to obtain
rights (whether by acquisition, license or otherwise) to any intellectual
property that is necessary or useful to Manufacture Clinical Supplies or
Commercial Supplies in any country and (ii) any and all costs and expenses
incurred in connection with the acquisition of any such rights.

1.1.43.“Fumaderm®” means Biogen’s oral fumaric acid ester pharmaceutical
product.

1.1.44.“GAAP” means U.S. Generally Accepted Accounting Principles.

1.1.45.“GI” means gastrointestinal.

1.1.46.“GI Event” means any one or more of nausea, vomiting, diarrhea, abdominal
pain, upper abdominal pain or lower abdominal pain, in any case, experienced by
a patient in a Clinical Trial.

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 (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

7

--------------------------------------------------------------------------------

 

 

agree in writing not to conduct Part B of the GI Tolerability Clinical Trial,
then GI Inferiority will 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 jointly agree otherwise in writing, GI Inferiority will
not be deemed to exist.  

1.1.48.“GI Tolerability Clinical Trial” means the Clinical Trial sponsored by
Alkermes, Inc., an Affiliate of Alkermes, with ClinicalTrials.gov identifier
NCT03093324.

1.1.49.“Governmental Approvals” means all applications, notices, petitions,
filings, ruling requests, and other documents and obtaining all consents,
waivers, licenses, orders, registrations, approvals, permits, rulings,
authorizations and clearances necessary or advisable to be obtained from any
Governmental Authority in order to consummate the transactions contemplated by
this Agreement.

1.1.50.“Governmental Authority” means any court, tribunal, agency, department,
legislative body, commission or other instrumentality of any supra-national,
national, state, county, city or other political subdivision in the world.

1.1.51.“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976
and the rules and regulations thereunder, each as amended.

1.1.52.“IND” means an Investigational New Drug Application, as defined in the
Federal Food, Drug, and Cosmetic Act, as amended or similar application or
submission that is required to be filed with any Regulatory Authority before
beginning Clinical Trials of a pharmaceutical product.

1.1.53.“Initial GI Tolerability Data Package” means (a) with respect to Part A
of the GI Tolerability Clinical Trial, full demographic and patient-level data
for all patients enrolled therein and those elements set forth on Schedule
1.1.26 and (b) with respect to the Long-Term Safety Clinical Trial, full
demographic and patient-level data for all patients enrolled in such trial
(including a breakdown of those patients that were previously enrolled in the GI
Tolerability Clinical Trial and those patients not previously enrolled in such
trial) and a complete set of all data and results available for such trial,
including all data and results that would fall into the categories set forth on
Schedule 1.1.26,  provided that the information set forth in clause (b) will
only be provided as of the date that the information set forth in the foregoing
clause (a) of this definition is available. 

1.1.54.“Initial Indication” means the treatment of MS.

1.1.55.“Know-How” means all non-public, proprietary data and results, technical
information, know-how, inventions, discoveries, trade secrets, processes,
procedures, techniques, new developments, compositions, products, compounds,
material, methods, formulas, formulation, improvements, protocol, result of
experimentation or testing, technology, ideas or other proprietary information
and documentation thereof (including related papers, invention disclosures,
blueprints, drawings, flowcharts, diagrams, diaries, notebooks, specifications,

8

--------------------------------------------------------------------------------

 

 

methods of Manufacture, methods of service, data processing techniques,
compilations of information, customer and supplier lists, pricing and cost
information, and business and marketing plans and proposals), design or other
know-how, whether or not patentable or copyrightable.  Know-How shall not
include any Patent Rights with respect thereto.

1.1.56.“Knowledge” means, with respect to Alkermes, the actual knowledge of [**]
based on such individuals’ good faith understanding of the facts and information
in their possession or control following reasonable inquiry and investigation of
Alkermes personnel and [**], in each case, with relevant functional
responsibilities with respect to such facts and information.

1.1.57.“Licensed Know-How” means (i) any Know-How Controlled by Alkermes or its
Affiliates on the Effective Date or during the Term that (a) is or was used in
the Development or Manufacture of Products, (b) is or was embodied in Products
or (c) is necessary to Exploit the Products in the Field in the Territory, (ii)
all Alkermes Collaboration Know-How and (iii) Alkermes’ interest in the Joint
Collaboration Know-How. 

1.1.58.“Licensed Patents” means (i) the Patent Rights set forth on Exhibit B,
(ii) any Patent Rights Controlled by Alkermes or its Affiliates issuing from or
claiming priority directly or indirectly to Patent Rights listed on Exhibit B,
(iii) the Alkermes Collaboration Patents, (iv) Alkermes’ interest in the Joint
Collaboration Patents and (v) any Patent Rights Controlled by Alkermes or its
Affiliates on the Effective Date or during the Term that Cover Licensed Know-How
or that are necessary to Exploit any compound or product Covered by any Patent
Rights set forth in the foregoing clauses (i) through (iv), in each case, in the
Field in the Territory. The Licensed Patents as of the Effective Date are listed
on Exhibit B,  provided that any Patent Right that is not listed on Exhibit B,
but is otherwise described in this Section 1.1.58, shall still be considered a
Licensed Patent hereunder.

1.1.59.“Long-Term Safety Clinical Trial” means the Clinical Trial sponsored by
Alkermes, Inc., an Affiliate of Alkermes, with ClinicalTrials.gov identifier
NCT02634307.

1.1.60.“Manufacturing” means the performance of any or all activities directed
to producing, manufacturing, validating, scaling up, processing, filling,
finishing, quality control, quality assurance, testing and release, shipping and
warehousing of a Product or Placebo. When used as a verb, “Manufacture” means to
engage in Manufacturing.

1.1.61.“Medical Activities” means any and all activities directed to the
formulation and performance of (i) Post-Marketing Clinical Trials; (ii) market
and key opinion leader plans for the development of the Products, including
plans to support continuing medical education; (iii) publication plans for the
Products; (iv) plans to ensure appropriate medical information responses with
respect to the Products; (v) safety monitoring plans for the Products; (vi)
plans and expected activities for field based medical affairs personnel for the
Products; and (vii) other comparable medical affairs activities.

1.1.62.“MMF” means monomethyl fumarate.

1.1.63.“MS” means multiple sclerosis.

9

--------------------------------------------------------------------------------

 

 

1.1.64.“NDA” means a New Drug Application filed with the FDA as described in 21
C.F.R. § 314 or any equivalent or corresponding application for Regulatory
Approval (including pricing and reimbursement approval required by Applicable
Law prior to sale of a pharmaceutical product) in any country or regulatory
jurisdiction other than the U.S.

1.1.65. “Net Sales” means, with respect to any Product, the amount billed in
arm’s-length transactions by a Party, an Affiliate of such Party, or any
permitted Sublicensee [**].

1.1.66.“OIG Guidance” means the Office of Inspector General of the Department of
Health and Human Services Compliance Program Guidance for Pharmaceutical
Manufacturers.

1.1.67.“Party” means Biogen or Alkermes and, when used in the plural, will mean
both Biogen and Alkermes.

1.1.68.“Patent Rights” means any and all of the following: (i) patent
applications (including provisional patent applications) and patents (including
the inventor’s certificates); (ii) any substitution, extension (including patent
term extensions, patent term adjustments, supplementary protection certificates
and pediatric exclusivity periods), registration, confirmation, reissue,
continuation, divisional, continuation-in-part, reexamination, renewal, patent
of addition or the like thereof or thereto; and (iii) all foreign counterparts
of any of the foregoing, including PCT applications.

1.1.69.“Person” means any individual, firm, corporation, partnership, trust,
business trust, joint venture, limited liability company, Governmental
Authority, association or other entity.

1.1.70.“Placebo” means an inactive substitute for a Product.

1.1.71.“Post-Marketing Clinical Trial” means a clinical trial of a Product in
human patients (including investigator-initiated trials) that is conducted for a
purpose other than to obtain, support or maintain Regulatory Approval.

1.1.72.“Post-Marketing Commitments” means any and all items, tasks, activities,
studies, trials or other commitments the completion of which is recommended or
required by the FDA in connection with the initial grant of Regulatory Approval
for the Alkermes 8700 Product in the Initial Indication in the U.S. or to
support or maintain such Regulatory Approval. 

1.1.73.“Product” means any product that is Covered by a Valid Claim of a
Licensed Patent; provided,  however, that, if any Product ceases to meet the
preceding definition in a country due to the expiration of the last Valid Claim
of a Licensed Patent Covering such product in such country, then such product
shall continue to constitute a “Product” under this Agreement.

1.1.74.“Regulatory Approval” means all approvals necessary for the
Commercialization of a pharmaceutical product for one or more indications in a
country or

10

--------------------------------------------------------------------------------

 

 

regulatory jurisdiction, which may include satisfaction of applicable regulatory
and notification requirements and, where required by Applicable Law, separate
pricing and reimbursement approvals prior to sale of a pharmaceutical product.

1.1.75.“Regulatory Authority” means any applicable supranational, national,
regional, state or local regulatory agency, department, bureau, commission,
council, or other government entity involved in regulating Development and
granting Regulatory Approval for a pharmaceutical product in a regulatory
jurisdiction within the Territory, including the FDA and the EMA.

1.1.76.“Serious Failure to Supply” shall mean that in a given Calendar Year, for
reasons other than a Force Majeure Delay or a default of Biogen, Alkermes fails
on at least [**] occasions to supply Biogen with those quantities of Product
forecasted and ordered in accordance with the terms of the applicable Supply
Agreement, and the cumulative shortfall for such Calendar Year attributable to
such failure(s) is at least [**] of the aggregate amount so forecasted and
ordered from Alkermes for delivery in such Calendar Year.

1.1.77.“Sublicense Agreement” means a written, definitive agreement for a
sublicense between Biogen and a Sublicensee.

1.1.78.“Sublicensee” means any Third Party, other than a Distributor, to whom
rights are granted under any of the rights licensed to Biogen by Alkermes under
Section 6.1 with respect to any Product, including through any license,
sublicense, co-development, co-discovery, co-promotion, distribution, joint
venture, Development and Commercialization collaboration or similar transaction
between Biogen (or an Affiliate of Biogen) and such Third Party. 

1.1.79.“Supply Agreement” means the Clinical Supply Agreement or any supply
agreement entered into between the Parties for the toll manufacture by Alkermes
of Commercial Supplies.

1.1.80.“Tecfidera®” means Biogen’s oral DMF pharmaceutical product.

1.1.81.“Tecfidera® Competing Product” means any pharmaceutical product of any
Third Party which contains the same active pharmaceutical ingredient as
Tecfidera®, and is approved in reliance, in whole or in part, on a prior
Regulatory Approval of Tecfidera®,  provided that Tecfidera® Competing Product
shall not include such pharmaceutical product of a Third Party where Biogen
licenses or sublicenses rights to such Third Party to commercialize such
pharmaceutical product (whether directly or by license, covenant not to sue,
settlement agreement, release or any other arrangement or means).

1.1.82.“Tecfidera® Competition” means, with respect to a given Calendar Year in
the U.S., that during such Calendar Year, the aggregate net revenue earned by
Biogen and its Affiliates and their respective sublicensees and licensees from
sales of Tecfidera® and the Alkermes 8700 Product, in each case in the U.S. in
such Calendar Year, is less than [**] of the aggregate net revenue earned by
Biogen and its Affiliates and their respective sublicensees and licensees from
sales of Tecfidera® and the Alkermes 8700 Product, in each case, in the U.S. in

11

--------------------------------------------------------------------------------

 

 

the last full Calendar Year prior to the Calendar Year in which a Tecfidera®
Competing Product is first sold in the U.S.  

1.1.83.“Territory” means all countries of the world.

1.1.84.“Third Party” means any Person other than the Parties or their respective
Affiliates.

1.1.85.“U.S.” means the United States of America.

1.1.86.“U.S. Dollars” or “US$” means United States Dollars.

1.1.87.“Valid Claim” means a claim of an issued and unexpired Patent Right or
pending claim of a patent application, which claim or pending claim has not been
revoked or held unenforceable, unallowable, unpatentable or invalid by a
decision of a court or other Governmental Authority of competent jurisdiction,
which claim or pending claim is not appealable or has not been appealed within
the time allowed for appeal, and which claim or pending claim has not been
cancelled, withdrawn from consideration, abandoned, disclaimed, denied or
admitted to be invalid or unenforceable through reissue, re-examination, inter
partes review, post-grant review or disclaimer, opposition procedure, nullity
suit, or otherwise; provided, however, that if the holding of such court or
Governmental Authority is later reversed by a court or Governmental Authority
with overriding authority, the claim shall be reinstated as a Valid Claim with
respect to Net Sales made after the date of such reversal; and provided,
further, that a claim of a patent application pending for more than [**] years
([**]) years from the earliest date from which such patent application claims
priority shall not be considered to be a Valid Claim for purposes of this
Agreement unless and until a patent with respect to such application issues with
such claim, in which case such claim will be reinstated and be deemed to be a
Valid Claim, but only as of the date of issuance of such patent.

1.2.Additional Definitions.  The following terms have the meanings set forth in
the corresponding Sections of this Agreement:

 

 

Terms

Section

Agreement

Preamble

Alkermes

Preamble

Alkermes Approval Failure

3.3.1

Alkermes Indemnified Party

11.2

Alkermes Manufacturing Know-How

3.2.3(iv)

ANDA

7.5.2(ii)

Auditing Party

9.7.2

Biogen

Preamble

Biogen Indemnified Party

11.3

Claim

11.2

Complaining Party

12.1.2

Confidential Information

8.1

CPR Rules

12.1.3

Dispute

12.1.1

12

--------------------------------------------------------------------------------

 

 

 

 

Terms

Section

Dispute Notice

12.1.2

DT

3.1.1

Effective Date

Preamble

Force Majeure Delay

14.8

GI Tolerability Data Package Notice

3.2.5(i)

Hatch-Waxman Act

7.5.1

Indemnitee

11.4

Infringement

7.5.1

Infringement Claim

7.6.1

Initial Development Plan

3.1.2

IP

13.6.1

Joint Collaboration Know-How

7.1.2(i)

Joint Collaboration Patents

7.1.2(i)

Joint Collaboration Technology

7.1.2(i)

JSC

2.1.1

Losses

11.2

Minimum Annual Payment(s)

9.5.1(ii)

Minimum Annual Payment Term

9.5.1(ii)

Minimum Payment Commencement Date

9.5.1(ii)

Option Payment

9.2

Other Component

1.1.22

Patent Action

6.3

Patent Committee

7.3

Product Trademarks

7.6.1

Prosecution

7.4.1(i)

Protection

7.4.1(ii)

Quality Agreement

3.3.1

Recording Party

9.7.1

Related Party

1.1.65

Response

12.1.2

Royalty Term

9.5.3

Senior Management

12.1.2

ST

5.2

Sued Party

7.6.1

Surviving Sublicensee

13.5.4

Team Leader

3.1.1

Term

13.1

Transfer Completion Date

3.3.1

Transition Plan

3.2.3(iii)

Up-Front Payment

9.1

VAT

9.11.4

 

1.3.Interpretation.  Except where the context expressly requires otherwise in
this Agreement, (a) the use of any gender herein shall be deemed to encompass
references to either or

13

--------------------------------------------------------------------------------

 

 

both genders, and the use of the singular shall be deemed to include the plural
(and vice versa); (b) the words “include,” “includes,” and “including” shall be
deemed to be followed by the phrase “without limitation” and shall not be
interpreted to limit the provision to which it relates; (c) the word “will”
shall be construed to have the same meaning and effect as the word “shall”; (d)
any definition of or reference to any agreement, instrument or other document
herein shall be construed as referring to such agreement, instrument or other
document as from time to time amended, supplemented or otherwise modified
(subject to any restrictions on such amendments, supplements or modifications
set forth herein); (e) any reference herein to any Person shall be construed to
include the Person’s successors and assigns to the extent not prohibited by this
Agreement; (f) the words “herein,” “hereof,” and “hereunder,” and words of
similar import, shall be construed to refer to this Agreement in its entirety,
as the context requires, and not to any particular provision hereof; (g) all
references herein to Sections, Articles, Exhibits, or Schedules shall be
construed to refer to Sections, Articles, Exhibits, or Schedules of this
Agreement, and references to this Agreement include all Schedules and Exhibits
hereto; (h) the word “notice” means notice in writing (whether or not
specifically stated) and shall include notices, consents, approvals and other
written communications contemplated under this Agreement; (i) provisions that
require that a Party, the Parties or any committee hereunder “agree,” “consent,”
or “approve” or the like shall require that such agreement, consent or approval
be specific and in writing, whether by written agreement, letter, approved
minutes or otherwise (but excluding e-mail and instant messaging); (j)
references to any specific law, rule or regulation, or article, Section or other
division thereof, shall be deemed to include the then-current amendments thereto
or any replacement or successor law, rule or regulation thereof; (k) the term
“or” shall be interpreted in the inclusive sense commonly associated with the
term “and/or”; (l) references to a particular statute or regulation include all
rules and regulations thereunder and any predecessor or successor statute, rules
or regulations, in each case, as amended or otherwise modified from time to
time; and (m) whenever this Agreement refers to a number of days, such number
shall refer to calendar days unless Business Days are specified.

Article 2

MANAGEMENT OF THE COLLABORATION

2.1.Joint Steering Committee.    

2.1.1.Establishment of the JSC.  Within thirty (30) days after the Effective
Date, the Parties shall establish the joint steering committee (the “JSC”),
which will have overall responsibility for the collaboration between the Parties
with respect to the Development of the Alkermes 8700 Product in the Initial
Indication in the U.S. as contemplated by this Agreement.  The JSC will comprise
two (2) representatives of each Party, who will be appointed (and may be
replaced at any time) by each Party upon notice to the other Party in accordance
with this Agreement.  Such representatives will include individuals of each
Party with decision-making authority with respect to the matters within the
authority of the JSC.  To conduct the activities described in Section 2.1.2
below, the JSC will meet at least once each Calendar Quarter until disbandment
of the JSC pursuant to Section 2.2, or more frequently if agreed by the JSC.

14

--------------------------------------------------------------------------------

 

 

2.1.2.JSC Responsibilities.  The JSC will perform the following functions:

(i)for the Alkermes 8700 Product in the Initial Indication in the U.S., review
and, in its discretion, approve amendments to the Initial Development Plan,
including the applicable annual budget or the regulatory strategy, in each case,
as set forth therein; 

(ii)review reports received from the ST (the supply team established pursuant to
Section 5.2) and provide direction to the ST regarding the performance of its
responsibilities under the Clinical Supply Agreement;

(iii)serve as the first forum for the settlement of disputes or disagreements
between the Parties arising in the DT (the development team established pursuant
to Section 3.1.1) or the ST; and

(iv)perform such other functions as appropriate to further the purposes of this
Agreement as determined by mutual agreement of the Parties.

2.1.3.JSC Chairperson; Procedures.  For a one (1)-year period commencing on the
Effective Date, a Biogen representative to the JSC will serve as the chairperson
of the JSC.  For each subsequent one (1)-year period, JSC representatives of the
Parties will alternate as the chairperson of the JSC.  The chairperson will
establish the timing and agenda for all JSC meetings and will send notice of
such meetings, including the agenda therefor, to all JSC members; provided,
however, that either Party may request that specific items be included in the
agenda and may request that additional meetings be scheduled as needed.  The
location of each regularly scheduled JSC meeting will be agreed upon by the
Parties.  Meetings may also be held telephonically or by videoconference.  A
quorum of at least one (1) JSC representative appointed by each Party shall be
present at or shall otherwise participate in each JSC meeting.  If mutually
agreed by the Parties on a case-by-case basis, the JSC may invite other
non-members to participate in the discussions and meetings of the JSC, provided
that the presence of such participants shall not be considered in determining
whether there is a quorum at the JSC.  The chairperson shall appoint one (1)
person (who need not be a member of the JSC) to attend each meeting and record
the minutes of such meeting in writing.  Such minutes shall be circulated to the
Parties promptly following each meeting for review, comment and approval.  If no
comments are received from a Party within thirty (30) days after receipt of the
minutes by such Party, then such minutes shall be deemed to be approved by such
Party.

2.1.4.JSC Decision Making.  As a general principle, the JSC will operate by
consensus, with the JSC representatives of each Party collectively having one
(1) vote, respectively.  In the event that the JSC members do not reach
consensus with respect to a matter that is within the JSC’s decision-making
authority within twenty (20) days after they have met and attempted to reach
such consensus, such matter may be escalated to resolution by Senior Management
by the written request of either Party.  If Senior Management is unable to
resolve such matter within ten (10) days of such written request, then:

15

--------------------------------------------------------------------------------

 

 

(i)Alkermes shall have the final decision-making authority if such matter
relates to (a) the contents of the Alkermes 8700 Product 505(b)(2) NDA or the
conduct of any Clinical Trial of the Alkermes 8700 Product in the Initial
Indication conducted by or on behalf of Alkermes pursuant to the Initial
Development Plan, including the decision to remove Development activities (other
than the GI Tolerability Clinical Trial) not required by the FDA for approval of
the Alkermes 8700 Product 505(b)(2) NDA; (b) subject to Section 3.2.4(iv),  the
design and conduct of Part B of the GI Tolerability Clinical Trial (but,  not
whether to discontinue such trial); (c) the Manufacture of Clinical Supplies of
the Alkermes 8700 Product, subject to the terms of the Clinical Supply
Agreement; and (d) prior to the Transfer Completion Date, Regulatory Authority
interactions, regulatory strategy (provided that Alkermes may not deviate from
pursuit of obtaining Regulatory Approval of the Alkermes 8700 Product in the
Initial Indication via the 505(b)(2) regulatory pathway unless the right of
reference is granted to Alkermes in accordance with Section 3.3.2),
communications, and activities related to the Alkermes 8700 Product in the
Initial Indication and regulatory filings for, and Regulatory Approval of, the
Alkermes 8700 Product in the Initial Indication in the U.S.;

(ii)with respect to any amendments to the Initial Development Plan to add one
(1) or more Development activities, Alkermes shall have final decision-making
authority with respect to the design and execution of such Development
activities and Biogen shall have final decision-making authority with respect to
any increase in the Initial Development Plan budget associated with such
Development activities; and 

(iii)Biogen shall have the final decision-making authority with respect to any
other matter not set forth in Section 2.1.4(i) and Section 2.1.4(ii).

Notwithstanding anything to the contrary, to the extent any matters are required
by Applicable Law or due to safety concerns with respect to a Product to be
resolved within a shorter period of time than the periods set forth in this
Section 2.1.4, the periods set forth in this Section 2.1.4 will be shortened as
appropriate to permit the resolution of such matters within the required period.

2.2.Alkermes’ Participation in the JSC.  The Parties agree that participation in
the JSC is a right rather than an obligation of Alkermes, and Alkermes may elect
at any time or from time to time not to participate in the JSC or any other
committee, subcommittee, team or subteam contemplated hereunder. Accordingly,
the Parties also agree that Alkermes’ decision not to participate in the JSC or
any other committee, subcommittee, team or subteam contemplated hereunder will
not constitute a breach of Alkermes’ material obligations hereunder.  During any
period that Alkermes has elected not to participate in the JSC or any other
committee, subcommittee, team or subteam contemplated hereunder, each Party
shall have the obligation to provide and the right to continue to receive the
information it would otherwise be required to provide and entitled to receive
under this Agreement and to participate directly with the other Party in
discussions, reviews and approvals currently allocated to the JSC or such other
committee, subcommittee, team or subteam pursuant to this Agreement.

2.3.Disbandment of the JSC.  The JSC will automatically disband on the earlier
of (a) the mutual written agreement of the Parties and (b) the Transfer
Completion Date.  Thereafter,

16

--------------------------------------------------------------------------------

 

 

Biogen shall have the sole decision-making authority over all matters that were
within the authority of the JSC prior to such disbandment.

Article 3

DEVELOPMENT

3.1.Development Team.    

3.1.1.Establishment of Development Team.  Within thirty (30) days after the
Effective Date, the Parties shall establish the development team (the “DT”) to
coordinate and implement all activities for the Development of the Alkermes 8700
Product in the Initial Indication in the United States, within the annual
budgets included in the Initial Development Plan.  One (1) representative from
each Party shall be designated as that Party’s “Team Leader” to act as the
primary DT contact for that Party.  Unless otherwise agreed by the Parties, the
DT shall comprise an equal number of representatives of each Party as is
reasonably necessary to accomplish the goals of the DT hereunder.  Such
representatives will include individuals with expertise and responsibilities in
the areas of clinical development, process sciences, quality control, quality
assurance, regulatory affairs and product development.  Either Party may replace
any or all of its DT representatives, including its Team Leader, at any time
upon notice to the other Party in accordance with this Agreement.

3.1.2.Development Team Responsibilities.  The DT will perform the following
functions: 

(i)for the Alkermes 8700 Product in the Initial Indication in the U.S.,
formulating amendments to the Initial Development Plan, including, in each case,
the applicable annual budget or the regulatory strategy, in each case, set forth
therein;

(ii)coordinating implementation of all Development activities for the Alkermes
8700 Product in the Initial Indication in the U.S. pursuant to the Initial
Development Plan;

(iii)generating forecasts of supply requirements for the Alkermes 8700 Product
and Placebo pursuant to the Initial Development Plan and delivering such
forecasts to the ST;

(iv)exchanging information and facilitating cooperation and coordination between
the Parties as they exercise their respective rights and meet their respective
obligations under the Initial Development Plan;

(v)providing status updates to the JSC regarding Development activities for the
Alkermes 8700 Product in the Initial Indication in the U.S. pursuant to the
Initial Development Plan, including progress towards achieving key milestone
events and Development Cost expenditures; and

(vi)performing such other functions as appropriate to further the purposes of
this Agreement as determined by mutual agreement of the Parties.

17

--------------------------------------------------------------------------------

 

 

In addition, the DT may designate subteams as appropriate to facilitate
coordination and cooperation in key areas.  The development plan for the
Alkermes 8700 Product in the Initial Indication in the U.S. and the accompanying
budget are attached hereto as Exhibit C (as amended from time to time in
accordance with this Agreement, the “Initial Development Plan”). This Initial
Development Plan shall be deemed to have been reviewed and approved by the
JSC.  The Initial Development Plan attached hereto as Exhibit C covers
Development activities for the Alkermes 8700 Product in the Initial Indication
in the U.S. through the filing of the Alkermes 8700 Product 505(b)(2) NDA
(including the regulatory strategy for obtaining, supporting or maintaining
Regulatory Approval of the Alkermes 8700 Product in the Initial Indication in
the U.S.). The Initial Development Plan may be amended upon the written
agreement of each Party to include additional Development activities for the
Alkermes 8700 Product in the Initial Indication in the U.S. but, notwithstanding
anything to the contrary set forth under this Agreement, will not include any
Post-Marketing Commitments or Post-Marketing Clinical Trials for the Alkermes
8700 Product.  The DT may formulate amendments to the Initial Development Plan
at any time and submit such amendments to the JSC for review and approval in
accordance with Section 2.1.2(i).  

3.1.3.Development Team Procedures.  For a one (1)-year period beginning on the
Effective Date, the Team Leader of Alkermes shall serve as the chairperson of
the DT.  Thereafter, the Team Leader of Biogen shall serve as the chairperson of
the DT.  The chairperson shall establish the timing and agenda for all DT
meetings and shall send notice of such meetings, including the agenda therefor,
to all DT members; provided, however, that either Party may request that
specific items be included in the agenda and may request that additional
meetings be scheduled as needed.  The DT will meet at least once each month or
as agreed by the DT, until the disbandment of the DT pursuant to Section
3.1.5.  The first DT meeting shall be held at Alkermes’ offices.  Thereafter,
the location of regularly scheduled DT meetings shall alternate between the
offices of the Parties, unless otherwise agreed.  Meetings may be held
telephonically or by videoconference.  A quorum of at least two (2) DT members
appointed by each Party shall be present at or shall otherwise participate in
each DT meeting.  If mutually agreed by the Parties on a case-by-case basis, the
DT may invite other non-members to participate in the discussions and meetings
of the DT, provided that the presence of such participants shall not be
considered in determining whether there is a quorum at the DT.  The chairperson
shall appoint one (1) person (who need not be a member of the DT) to attend each
meeting and record the minutes of such meeting in writing.  Such minutes shall
be circulated to the Parties promptly following the meeting for review, comment
and approval.  If no comments are received from a Party within ten (10) Business
Days after receipt of the minutes by such Party, such minutes shall be deemed to
be approved by such Party.

3.1.4.Development Team Decision Making.  As a general principle, the DT will
operate by consensus, with the DT representatives of each Party collectively
having one (1) vote, respectively.  In the event that the DT members do not
reach consensus with respect to a matter that is within the purview of the DT
within twenty (20) days after they have met and attempted to reach such
consensus, such matter shall be presented to the JSC for resolution.

3.1.5.Disbandment of the DT.  The DT will automatically disband on the earlier
of (i) the mutual written agreement of the Parties and (ii) the Transfer
Completion

18

--------------------------------------------------------------------------------

 

 

Date.  Thereafter, Biogen shall have the sole decision-making authority over all
matters that were within the authority of the DT prior to such disbandment.

3.2.Development Responsibilities and Rights. 

3.2.1.Development Responsibilities of Alkermes.  During the Term, Alkermes shall
use commercially reasonable efforts to perform all activities allocated to
Alkermes in the Initial Development Plan. During the Term, until the earlier of
the Transfer Completion Date or an Alkermes Approval Failure, Alkermes shall be
responsible for any and all interactions with the FDA in relation to the Initial
Development Plan, activities conducted thereunder and the Alkermes 8700 Product
505(b)(2) NDA (other than in connection with any Post-Marketing Commitments, for
which Biogen shall be responsible), including any required modifications to such
Alkermes 8700 Product 505(b)(2) NDA. In addition, and without limiting the
generality of the foregoing, during the Term, until the earlier of the Transfer
Completion Date or an Alkermes Approval Failure,  Alkermes shall use reasonable
efforts to pursue and obtain Regulatory Approval of the Alkermes 8700 Product in
the Initial Indication in the U.S. If Alkermes desires to perform any tasks,
obligations or support that Alkermes is required to perform or provide hereunder
through any of its Affiliates, contractors or agents, then Alkermes may engage
such Affiliates, contractors or agents to perform such tasks, obligations or
support, but Alkermes shall remain responsible for performance of its
obligations hereunder. 

3.2.2.Development Rights of Biogen.

(i)Following the Transfer Completion Date, Biogen shall have the unilateral
right, itself or through its Affiliates, Sublicensees, subcontractors or
Distributors, to conduct Development of the Alkermes 8700 Product in the Initial
Indication in the U.S., and to perform Medical Activities, in each case, in its
sole discretion (unless otherwise agreed by the Parties).

(ii)During the Term, Biogen shall have the unilateral right, itself or through
its Affiliates, Sublicensees, subcontractors or Distributors, to conduct
Development of, and perform Medical Activities with respect to, Products
throughout the Territory, other than the Alkermes 8700 Product in the Initial
Indication in the U.S. (which is covered in Section 3.2.2(i)), in each case, in
its sole discretion. 

(iii)Subject to Section 3.3.4, following receipt of Regulatory Approval for the
Alkermes 8700 Product 505(b)(2) NDA, Biogen shall use Commercially Reasonable
Efforts to conduct any Post-Marketing Commitments for the Alkermes 8700 Product
in the Initial Indication in the U.S. required in connection with such
Regulatory Approval.

3.2.3.Transfer of Data and Technology.    

(i)As of the Effective Date. Promptly following the Effective Date, but in any
event no later than sixty (60) days thereafter, Alkermes shall transfer to
Biogen, at Biogen’s sole cost and expense [**] and thereafter at Alkermes’ cost,
a true and complete copy of (a) all data and results generated from any
Development activities conducted by or on behalf of Alkermes with respect to any
Product prior to the Effective Date (as evidenced by all completed pre-clinical
study reports and completed clinical study reports for Clinical Trials of

19

--------------------------------------------------------------------------------

 

 

the Alkermes 8700 Product in the Initial Indication) and (b) all Trial Master
Files (including any Trial Master File plans, tables of contents or indices and
any evidence or certification of related quality checks) or equivalents thereof,
for all completed or ongoing Clinical Trials of any Product conducted by or on
behalf of Alkermes. If Biogen requests other tangible embodiments of the
Licensed Know-How or additional data or results or any other documentation
relating to such data or results in respect of Development activities conducted
by or on behalf of Alkermes prior to the Effective Date, where the applicable
pre-clinical study report or clinical study report for such activities has not
yet been completed, then Alkermes shall attempt in good faith to provide such
requested embodiments, data or results or other documentation related thereto to
Biogen.

(ii)During the Term. Thereafter, on a quarterly basis until Alkermes’ completion
of all of its obligations under the Initial Development Plan in accordance with
Section 3.2.1, or more frequently as (a) new data and results with respect to
the Products or (b) new or updated Trial Master Files,  in each case ((a) and
(b)), come into Alkermes’ possession or Control, and in any event sufficiently
prior to the date of the First FDA Approval such that the transfer of the
Alkermes 8700 Product 505(b)(2) NDA pursuant to Section 3.3.1 can occur
immediately following the First FDA Approval, Alkermes shall transfer to Biogen,
at Biogen’s sole cost and expense, a true and complete copy of any such new data
and results (including all elements set forth on Schedule 1.1.26) generated from
any Development activities conducted by or on behalf of Alkermes with respect to
any Product for all ongoing Clinical Trials conducted by or on behalf of
Alkermes (including the Long-Term Safety Clinical Trial and the GI Tolerability
Clinical Trial), as evidenced by all completed pre-clinical study reports and
completed clinical study reports for other Clinical Trials of the Alkermes 8700
Product in the Initial Indication, or new or updated Trial Master Files or new
tangible embodiments of the Licensed Know-How. Without limiting the foregoing,
Alkermes shall, prior to the Transfer Completion Date, transfer or have
transferred to Biogen true and complete copies of (1) all data and results
generated from any Development activities conducted by or on behalf of Alkermes
with respect to the Products for all completed Clinical Trials conducted by or
on behalf of Alkermes (including all pre-clinical studies and Clinical Trials of
the Alkermes 8700 Product in the Initial Indication) and (2) all Trial Master
Files (including any Trial Master File plans, tables of contents or indices and
any evidence or certification of related quality checks) or equivalents thereof,
for all completed Clinical Trials of the Alkermes 8700 Product conducted by or
on behalf of Alkermes. Any transfer under this Section 3.2.3 shall be in such
format as mutually agreed by the Parties, provided that upon Biogen’s request,
Alkermes agrees to transfer such materials in electronic form. If Biogen
requests other tangible embodiments of the Licensed Know-How or additional data
or results or any other documentation relating to such data or results in
respect of Development activities conducted by or on behalf of Alkermes under
the Initial Development Plan, where the applicable pre-clinical study report or
clinical study report for such activities has not yet been completed, then
Alkermes shall attempt in good faith to provide such requested embodiments, data
or results or other documentation related thereto to Biogen.

(iii)Transition Plan. Following the completion of Alkermes’ obligations under
the Initial Development Plan in accordance with Section 3.2.1, the Parties shall
cooperate with each other to ensure a smooth transition to Biogen or Biogen’s
designee of ongoing Development activities related to the Alkermes 8700 Product
in the Initial Indication,

20

--------------------------------------------------------------------------------

 

 

including taking the actions specified in a  transition plan that may be entered
into between the Parties after the Effective Date by written agreement of the
Parties, as such plan may be updated from time to time upon written agreement of
the Parties (the “Transition Plan”).  If there is any inconsistency between the
Transition Plan and this Agreement, the terms of this Agreement shall prevail.

(iv)Manufacturing Technology Transfer. Upon Biogen’s written request, Alkermes
will promptly make available to Biogen all Licensed Know-How (including all
historical process or analytical information (i.e., all experimentally or
literature-derived data used to Manufacture any Product)) to enable the
Manufacture of all Products by or on behalf of Biogen (the “Alkermes
Manufacturing Know-How”), by providing copies or samples of relevant
documentation, materials and other embodiments of such Licensed Know-How,
including data within reports, notebooks and electronic files. Alkermes will
perform services reasonably requested by Biogen to facilitate the technology
transfer described in this Section 3.2.3(iv) in a professional and workmanlike
manner in accordance with Biogen’s reasonable instructions, and Biogen will
reimburse Alkermes at the Development FTE Rate for all internal costs incurred
in connection with the performance of such services performed and for all
external expenses directly related thereto. Any materials provided by Alkermes
in connection with the transfer of the Alkermes Manufacturing Know-How will
remain the sole property of Alkermes. 

3.2.4.Initial GI Tolerability Data Package Transfer. 

(i)Initial GI Tolerability Data Package. Within a reasonable time period
following the completion of the last visit for the last patient of Part A of the
GI Tolerability Clinical Trial (including the two (2) week safety follow-up
period for such last patient), Alkermes will provide written notice to Biogen
(such notice, a “GI Tolerability Data Package Notice”) that includes:

(A)The Initial GI Tolerability Data Package; and

(B)Wire transfer instructions for payment of the Option Payment pursuant to
Section 9.2 of this Agreement.

(ii)Incomplete Initial GI Tolerability Data Package.  Following receipt of the
Initial GI Tolerability Data Package Notice as set forth under Section 3.2.4(i),
Biogen will have fifteen (15) days to notify Alkermes if the GI Tolerability
Data Package included therein is missing any information related to Part A of
the GI Tolerability Clinical Trial set forth in clause (a) of the definition of
Initial GI Tolerability Data Package, which notice will describe the information
that is missing from such Initial GI Tolerability Data Package.  Alkermes will
provide Biogen with such missing information identified in such notice, to the
extent such information is Controlled by Alkermes, as soon as reasonably
practicable. 

(iii)Extension of the Initial GI Tolerability Data Package Period.  If Alkermes
provides any information to Biogen following the receipt of the GI Tolerability
Data Package Notice pursuant to Section 3.2.4(i) and such information is, in
Biogen’s reasonable discretion, material information that was not previously
provided to Biogen, then upon written notice from Biogen to Alkermes,
the [**]-day period within which Biogen would be obligated to

21

--------------------------------------------------------------------------------

 

 

make the Option Payment in accordance with Section 9.2 will be extended such
that there is at least [**] days between Biogen’s receipt of such information
and the date on which Biogen would be obligated to make such Option Payment
under Section 9.2.    

(iv)Discussion Regarding Part B. Following receipt of the GI Tolerability Data
Package Notice as set forth under Section 3.2.4(i),  (a)  the Parties will
discuss in good faith whether to conduct Part B of the GI Tolerability Clinical
Trial and (b) unless the Parties have agreed not to conduct such Part B of the
GI Tolerability Clinical Trial, Alkermes will use commercially reasonable
efforts to develop and provide to Biogen no later than thirty (30) days after
the delivery of the GI Tolerability Data Package  (1) a plan for Part B of such
trial that is reasonably designed and powered to sufficiently differentiate
between the Alkermes 8700 Product and Tecfidera® with respect to GI Events and
(2)  a proposed budget for the conduct of activities under such plan for Part B
of the GI Tolerability Clinical Trial.   Thereafter, at Biogen’s request, the
Parties will discuss in good faith such plan and associated budget and if Biogen
wishes to make any changes to the plan (including to increase the scope or power
of such trial) in a manner that increases the associated budget therefor, then
the Parties would discuss such proposed changes in good faith and attempt to
reach agreement on such expanded scope or power and associated increase in
budget. If the Parties mutually agree in writing with respect to the plan for
the conduct of Part B of the GI Tolerability Clinical Trial and the associated
budget for the Development activities to be conducted under such plan, then (A)
the DT will amend the Initial Development Plan to include the conduct of Part B
of the GI Tolerability Clinical Trial in accordance with the agreed-to plan and
the agreed-to budget associated with such Development activities in accordance
with Section 3.1.2 and (B) Alkermes will conduct Part B of the GI Tolerability
Clinical Trial materially in accordance with such agreed-to plan, unless
otherwise jointly agreed in writing by the Parties.

3.2.5.Complete GI Tolerability Data Package Transfer. 

(i) Complete GI Tolerability Data Package.  Within a reasonable time period
following the completion of the last visit for the last patient of Part B of the
GI Tolerability Clinical Trial (including any applicable safety follow-up period
for such last patient), Alkermes will provide to Biogen the Complete GI
Tolerability Data Package.

(ii) Incomplete Complete GI Tolerability Data Package.  Following receipt of the
Complete GI Tolerability Data Package, Biogen will have fifteen (15) days to
notify Alkermes if the Complete GI Tolerability Data Package is missing any
information, which notice will describe the information that is missing from
such Complete GI Tolerability Data Package.  Alkermes will provide Biogen with
such missing information identified in such notice, to the extent such
information is Controlled by Alkermes, as soon as reasonably practicable.    

3.3.Regulatory Filings. 

3.3.1.Alkermes 8700 Product in the Initial Indication in the U.S.  Until the
Transfer Completion Date, Alkermes shall be responsible for making all
regulatory filings with the FDA in respect of the Alkermes 8700 Product in the
Initial Indication, including the Alkermes 8700 Product 505(b)(2) NDA. Alkermes
shall use commercially reasonable efforts to submit all such regulatory filings
in accordance with the Initial Development Plan. All such

22

--------------------------------------------------------------------------------

 

 

filings and Regulatory Approval (if granted) for the Alkermes 8700 Product
505(b)(2) NDA shall initially be held by and in the name of Alkermes until
assignment thereof to Biogen pursuant to this Section 3.3.1.  Alkermes will (A)
send a letter to the FDA to transfer and assign to Biogen Alkermes’ entire
right, title and interest in and to all regulatory filings related to the
Alkermes 8700 Product in the Initial Indication, including the Alkermes 8700
Product 505(b)(2) NDA and (B) transfer to Biogen a complete copy of the approved
Alkermes 8700 Product 505(b)(2) NDA and all regulatory filings, regulatory
documentation and other supplements and records related to such NDA that are
required to be kept under 21 C.F.R. § 314.81, in each case, within one (1)
Business Day following:

(i)receipt of Regulatory Approval of the Alkermes 8700 Product 505(b)(2) NDA; or

(ii)Biogen’s request, if (a) Alkermes receives a complete response letter from
the FDA in connection with the Alkermes 8700 Product 505(b)(2) NDA failing to
grant Regulatory Approval for the Alkermes 8700 Product in the Initial
Indication in the U.S. that suggests additional Development activities or other
requirements, (b) after using reasonable efforts to discuss with the FDA,
Alkermes is not able to narrow or eliminate such suggested additional
Development activities or such other requirements and (c) even if Alkermes were
to perform such additional Development activities or comply with such other
requirements (including through the grant from Biogen of the right of reference
in accordance with Section 3.3.2),  there could be no reasonable expectation
that the 8700 Product 505(b)(2) NDA could receive Regulatory Approval by
December 31, 2021 (the occurrence of the events set forth in the foregoing
clauses ((a) through (c)), an “Alkermes Approval Failure”);

The date on which Alkermes completes its obligations set forth in clauses (A)
and (B) of this Section 3.3.1 shall be deemed the “Transfer Completion Date.”

3.3.2.Right of Reference. If, subsequent to filing the Alkermes 8700 Product
505(b)(2) NDA, (i) Alkermes receives feedback from the FDA, whether through a
complete response letter or otherwise, that the FDA requires access to certain
additional data to determine whether to grant approval for the Alkermes 8700
Product in the Initial Indication in the U.S. and (ii) the Parties, working in
good faith, agree that such information is included in the U.S. Regulatory
Approvals for Tecfidera® or related submissions filed with the FDA and should be
included in the Alkermes 8700 Product 505(b)(2) NDA, then, until the earliest of
the date of (a) approval of the Alkermes 8700 Product 505(b)(2) NDA, (b) an
Alkermes Approval Failure or (c) any notice of termination of this Agreement,
Biogen will, within two (2) Business Days of the occurrence of the events set
forth in the foregoing clauses (i)  and (ii), grant to Alkermes a fully paid-up
and royalty-free right of reference to such U.S. Regulatory Approvals for
Tecfidera® and related submissions filed with the FDA, for the sole purpose of
obtaining Regulatory Approval of the Alkermes 8700 Product 505(b)(2) NDA.  
 Upon such grant of a right of reference, Biogen will take such actions as may
be reasonably requested by Alkermes to give effect to the intent and benefit of
such right of reference as set forth in this Section 3.3.2.

3.3.3.Other Products.  Biogen shall have the unilateral right, in its sole
discretion and at its own cost and expense, to submit any regulatory filings,
including INDs and NDAs for, and seek Regulatory Approval of, any Products in
the Field in the Territory, other

23

--------------------------------------------------------------------------------

 

 

than the Alkermes 8700 Product in the Initial Indication in the U.S., prior to
the date of the Alkermes Approval Failure.

3.3.4.Alkermes Approval Failure. Notwithstanding anything else in this
Agreement, in the event of an Alkermes Approval Failure, Biogen shall have no
obligation to Exploit (including, for clarity, to seek Regulatory Approval for)
the Alkermes 8700 Product. In addition, in the event of such an Alkermes
Approval Failure, upon written agreement of the Parties, Alkermes may conduct
additional Development of the Alkermes 8700 Product in the Initial Indication in
the U.S. at its own cost and expense, including Clinical Trials (and, for
clarity, the costs of such Development activities will not be treated as
Development Costs for purposes of this Agreement unless otherwise agreed by the
Parties).

3.4.Regulatory Meetings and Communications.    

3.4.1.Responsibilities for the Alkermes 8700 Product in the Initial Indication
in the U.S.  Until the Transfer Completion Date, Alkermes shall be primarily
responsible for conducting meetings and discussions with the FDA related to the
Alkermes 8700 Product in the Initial Indication, subject to Section 3.4.3.

3.4.2.Responsibilities for Other Products.  Biogen shall have the unilateral
right, itself or through its Affiliates, Sublicensees, subcontractors or
Distributors, to conduct meetings and discussions with Regulatory Authorities in
the Territory related to Products in the Field, other than, prior to the
Transfer Completion Date, discussions with the FDA related to the Alkermes 8700
Product in the Initial Indication, in its sole discretion.

3.4.3.Regulatory Authority Communications by Alkermes.    

(i)Alkermes shall give Biogen reasonable advance notice of meetings and
discussions, including meetings or discussions that take place via
teleconference or videoconference, with the FDA related to the Alkermes 8700
Product in the Initial Indication, and Biogen shall have the right to send one
(1) representative of its regulatory department with expertise in matters
related to interactions with Regulatory Authorities to participate in person at
all such meetings and discussions.    

(ii)If Alkermes has written communications with the FDA (other than
administrative correspondence) relating to the Alkermes 8700 Product in the
Initial Indication, then Alkermes shall notify Biogen and, (a) as soon as
practicable, but in no case later than forty-eight (48) hours following receipt
of any such written communication from the FDA, provide a copy to Biogen of such
communication(s) and (b) no later than twenty-four (24) hours in advance of
sending any written communication to the FDA in response to such FDA
communication, provide an advance copy to Biogen of any such written
communication.  Alkermes shall provide to Biogen substantive drafts of the NDA
for the Alkermes 8700 Product in the Initial Indication prior to its submission,
(a) following completion of material modules of such NDA or (b) at the request
of Biogen. Alkermes shall consider in good faith any comments received from
Biogen’s representative related to the draft NDA for the Alkermes 8700 Product
in the Initial Indication, communications with the FDA as set forth in this
Section 3.4.3(ii) and any Post-Marketing Commitments, in each case, as described
in this Section 3.4. In the event that, at

24

--------------------------------------------------------------------------------

 

 

any time prior to the Transfer Completion Date, Biogen receives any written
communication from the FDA relating to the Alkermes 8700 Product in the Initial
Indication, Biogen shall notify Alkermes and provide a copy to Alkermes of any
such written communication promptly following such communication’s
receipt.  Prior to the Transfer Completion Date, Biogen shall not respond to any
such communication but shall permit Alkermes to respond on Biogen’s behalf;
provided, however, that Biogen shall have the right to respond to communications
from the FDA to the extent reasonably required to comply with Applicable Laws. 

(iii)In the event that, at any time during the Term, Alkermes receives any
written communication from any Regulatory Authority relating to any Product,
other than any such communication from the FDA relating to the Alkermes 8700
Product in the Initial Indication prior to the Transfer Completion Date,
Alkermes shall notify Biogen and provide a copy to Biogen of any such written
communication promptly following receipt of such communication.  Alkermes shall
not respond to any such communication and instead shall permit Biogen to respond
on Alkermes’ behalf; provided, however, that during any period in which Alkermes
is responsible for Manufacturing any Product, Alkermes shall have the right to
respond to communications from the FDA or other Regulatory Authority to the
extent solely related to the Manufacture of a Product by or on behalf of
Alkermes or its Affiliate or reasonably required to comply with Applicable Laws.

3.5.Debarment Limitations.  In the course of Development of the Products in the
Territory by or on behalf of a Party, each Party shall not knowingly use any
employee or consultant who is or has been debarred by the FDA or any other
Regulatory Authority, or, to the best of such Party’s knowledge, who is or has
been the subject of debarment proceedings by the FDA or any such Regulatory
Authority.  Such Party shall promptly notify the other Party of, and provide the
other Party with a copy of, any correspondence or other reports that such Party
receives from any Third Party with respect to any use of a debarred employee or
consultant in connection with such Party’s performance of its obligations under
this Agreement.

3.6.Compliance.  Each Party shall conduct its Development activities under this
Agreement in compliance with all Applicable Laws and the terms and conditions
set forth in this Agreement.

3.7.Safety Reporting.  Within sixty (60) days after the Effective Date, the
Parties shall enter into a mutually acceptable safety data exchange agreement,
setting forth guidelines and procedures for the receipt, investigation,
recordation, review, communication, and exchange (as between the Parties) of
adverse event reports, pregnancy reports, technical complaints and any other
information concerning the safety of the Products, as well as safety governance
and decision-making roles.  Such guidelines and procedures shall be in
accordance with, and enable the Parties and their Affiliates to fulfill,
reporting obligations to the FDA or any other Regulatory
Authority.  Furthermore, such guidelines and procedures shall be consistent with
relevant International Council on Harmonization (ICH) guidelines, except where
said guidelines may conflict with reporting requirements of local Regulatory
Authorities, in which case local reporting requirements shall prevail.  The
Parties’ costs incurred in connection with receiving, investigating, recording,
reviewing, communicating and exchanging adverse events and other reportable
information as provided in such safety data exchange agreement shall be included
as an element of Development Costs (to the extent relating to the Development of
a Product).

25

--------------------------------------------------------------------------------

 

 

3.8.Development Costs. 

3.8.1.Development Costs Incurred by Alkermes. Biogen shall be responsible for
fifty percent (50%) of all Development Costs in excess of the first Fifty-Six
Million U.S. Dollars (US$56,000,000) incurred by Alkermes in the conduct of the
activities under the Initial Development Plan during Calendar Year
2017.  Starting with Calendar Year 2018 and thereafter until the completion of
the activities allocated to Alkermes under the Initial Development Plan, Biogen
shall be responsible for all Development Costs incurred by Alkermes in the
conduct of its activities in the Initial Development Plan, to the extent such
Development Costs do not exceed [**] percent ([**]%) of the aggregate costs and
expenses set forth in the annual budget for the Initial Development Plan for
each such Calendar Year. Subject to the last sentence of Section 3.9, (a) to the
extent Alkermes incurs any Development Costs that exceed [**] percent ([**]%) of
the aggregate costs and expenses set forth in the annual budget for the Initial
Development Plan for such Calendar Year, each Party shall be responsible for
[**] percent ([**]%) of such excess amounts, up to an amount equal to [**]
percent ([**]%) of the aggregate costs and expenses set forth in the annual
budget for the Initial Development Plan for such Calendar Year and (b) to the
extent Alkermes incurs any Development Costs that exceed [**] percent ([**]%) of
the aggregate costs and expenses set forth in the annual budget for the Initial
Development Plan for such Calendar Year, Alkermes shall be responsible for such
excess amounts; provided that, if the Alkermes 8700 Product 505(b)(2) NDA
receives Regulatory Approval from the FDA prior to December 31, 2021, then
Biogen will reimburse Alkermes for [**] percent ([**]%) of all such Development
Costs in excess of [**] percent ([**]%) of the aggregate costs and expenses set
forth in the annual budget for the Initial Development Plan for such Calendar
Year to the extent that such Development Costs are incurred in the performance
of activities that generate data and results that are submitted as part of such
approved Alkermes 8700 Product 505(b)(2) NDA. 

3.8.2.Development Costs Incurred by Biogen. Biogen shall be solely responsible
for all Development Costs incurred by Biogen.

3.8.3.Development Costs Payments.  Biogen will, within forty-five (45) days
after the end of Calendar Year 2017, pay Alkermes the Development Costs due
under Section 3.8.1 for such Calendar Year. Starting with Calendar Year 2018 and
thereafter, for each Calendar Quarter for which Development Costs are payable by
Biogen to Alkermes pursuant to Section 3.8.1, Biogen will, within forty-five
(45) days after the receipt of an invoice from Alkermes for such Development
Costs, pay Alkermes the amount due for such Calendar Quarter. 

3.9.Initial Development Plan Budget.   Responsibility for amendments to the
Initial Development Plan budget shall rest with the DT, subject to review and
approval by the JSC.  Updates to such budget will be prepared on an annual basis
as set forth in Section 3.1.2. In addition, if Alkermes identifies a potential
overage of greater than [**] percent ([**]%) of the aggregate costs and expenses
expected to be incurred in performing Development activities pursuant to the
Initial Development Plan for a given Calendar Year, then Alkermes shall notify
Biogen of such potential overage (through the DT). Following such notice, the DT
shall discuss in good faith at its next meeting whether to make any amendment to
the Initial Development Plan budget to account for such potential overage, which
amendment, if applicable, shall be presented to the JSC for its review and
approval.  Notwithstanding anything to the contrary set

26

--------------------------------------------------------------------------------

 

 

forth in this Agreement, Biogen shall not be responsible for bearing its share
of any Development Costs that exceed [**] percent ([**]%) of the amounts set
forth in the annual budget under the Initial Development Plan in accordance with
Section 3.8.1 to the extent that such excess Development Costs are incurred as a
result of (i) Alkermes’ failure to perform its Development obligations in
accordance with the Initial Development Plan or this Agreement, or (ii) a delay
in Development of the Alkermes 8700 Product due to the gross negligence or
willful misconduct of Alkermes.

Article 4

COMMERCIALIZATION

4.1.Commercialization Rights.  During the Term, Biogen shall have the unilateral
right, itself or through its Affiliates, Sublicensees, subcontractors or
Distributors, to Commercialize the Products in the Field in the Territory in its
sole discretion. 

4.2.Commercialization Efforts.   Subject to Section 3.3.4, following (i) receipt
of Regulatory Approval for the Alkermes 8700 Product in the Initial Indication
in the U.S.,  (ii) the Transfer Completion Date and (iii) the completion of any
Post-Marketing Commitments that the FDA requires be completed prior to the
commencement of Commercialization activities, Biogen shall use Commercially
Reasonable Efforts to Commercialize the Alkermes 8700 Product in the Initial
Indication in the U.S. 

4.3.Commercialization Costs.   Biogen shall be responsible for all costs of
conducting Commercialization of Products.    

4.4.Compliance.  Biogen shall Commercialize the Products in the Field in the
Territory in compliance with all Applicable Laws, the Code, the OIG Guidance and
the terms and conditions set forth in this Agreement.

Article 5

MANUFACTURE AND SUPPLY

5.1.Supply and Quality Agreements.    

5.1.1.Clinical Supplies. Within ninety (90) days after the Effective Date, the
Parties will negotiate in good faith and execute a Clinical Supply Agreement
pursuant to which Alkermes will Manufacture or have Manufactured, and Biogen and
its Affiliates and Sublicensees will purchase exclusively from Alkermes,
Clinical Supplies (provided that Biogen may qualify to Manufacture, or engage
and qualify a Third Party to Manufacture, Clinical Supplies as a back-up
manufacturer in the event of a Force Majeure Delay or a Serious Failure to
Supply). The Clinical Supply Agreement will reflect the terms and conditions
included in Exhibit D and such other commercially reasonable and customary terms
and conditions, satisfactory in form and substance to the Parties and their
legal advisors, as are necessary or appropriate for transactions of this type
and that will allow Biogen to be supplied with Product in a manner appropriate
to meet its obligations and exercise its rights under this Agreement, subject to
both Parties’ compliance with the terms and conditions of such Clinical Supply
Agreement.

27

--------------------------------------------------------------------------------

 

 

Notwithstanding anything to the contrary set forth in this Agreement or the
Clinical Supply Agreement, the Fully Burdened Manufacturing Costs of Clinical
Supplies will be included in the Development Costs under this Agreement and will
not be charged to Biogen under the Clinical Supply Agreement. Within one hundred
and twenty (120) days after the Effective Date, the Parties will negotiate in
good faith and execute a technical and quality agreement, which will be appended
to the Clinical Supply Agreement and which will specify certain quality
assurance and quality control requirements relating to the Manufacture of such
Clinical Supplies. Notwithstanding anything to the contrary set forth in this
Section 5.1.1, if (i) Alkermes foregoes its exclusive right to Manufacture or
have Manufactured Clinical Supplies or (ii) there is a Serious Failure to
Supply, then, in any case ((i) – (ii)), (a) Biogen and its Affiliates and
Sublicensees shall have no further obligation to purchase Clinical Supplies from
Alkermes, (b) Biogen shall have the exclusive right to Manufacture or to have
Manufactured Clinical Supplies and (c) Alkermes shall promptly conduct a
transfer of Manufacturing technology to Biogen or its designee to enable Biogen
or such designee to Manufacture Clinical 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
Clinical Supplies, Biogen may Manufacture itself or have Manufactured by its
back-up manufacturer, all Clinical Supplies for which Alkermes is unable to meet
Biogen’s demand.

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 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). This appointment is subject to the Parties
negotiating in good faith and entering into a commercial supply agreement
pursuant to which Biogen would engage Alkermes on a toll manufacturing basis to
Manufacture Commercial Supplies and Biogen would purchase such Commercial
Supplies in accordance with the terms and conditions included in Exhibit E and
such other commercially reasonable and customary terms and conditions,
satisfactory in form and substance to the Parties and their legal advisors, as
are necessary or appropriate for transactions of this type and that will allow
Biogen to be supplied with Product in a manner appropriate to meet its
obligations and exercise its rights under this Agreement, subject to both
Parties’ compliance with the terms and conditions of such commercial supply
agreement.  In connection with such commercial supply agreement, the Parties
will also negotiate in good faith and execute a technical and quality agreement,
which will be appended to the commercial supply agreement and which will specify
certain quality assurance and quality control requirements relating to the
Manufacture of such Commercial Supplies.  If, following the use of good faith
efforts, the Parties are unable to reach agreement on the terms of a commercial
supply agreement within a period of six (6) months from the commencement of
negotiations, then Biogen shall have the right (in its sole discretion) to
Manufacture or have Manufactured Commercial Supplies. 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

28

--------------------------------------------------------------------------------

 

 

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 shall have no further obligation to exclusively purchase Commercial
Supplies from Alkermes, (b) Biogen shall have the exclusive right to Manufacture
or to have Manufactured Commercial Supplies and (c) Alkermes shall promptly
conduct a transfer of 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 which
Alkermes is unable to meet Biogen’s demand.

5.2.Supply Team.  The Parties will establish a supply team (the “ST”) pursuant
to the provisions of the Clinical Supply Agreement.  The ST will report to the
JSC.

Article 6

LICENSE GRANTS

6.1.Patent and Know-How License Grant.    

6.1.1.Grant to Biogen.  Subject to the terms and conditions of this Agreement,
Alkermes hereby grants to Biogen an exclusive (even as to Alkermes and its
Affiliates, except as expressly set forth in Section 6.1.4), royalty-bearing,
worldwide license, with the right to sublicense through multiple tiers pursuant
to Section 6.1.2, under the Licensed Patents and the Licensed Know-How to
Exploit the Products in the Field in the Territory.

6.1.2.Sublicenses.  Biogen will have the right to grant sublicenses through
multiple tiers to Affiliates and Third Parties of the rights granted to Biogen
under this Agreement in accordance with the terms and conditions of this Section
6.1.2. The grant of any such sublicense will not relieve Biogen of its
obligations under this Agreement (including its financial obligations).  In
addition, such sublicense will be consistent in all respects with all applicable
terms and conditions of this Agreement.  With respect to any sublicense with a
Sublicensee other than an Affiliate, Biogen shall provide Alkermes with a copy
of such sublicense, and any modification or termination thereof, promptly after
execution of such sublicense, modification or termination (and in any event
within thirty (30) days after such sublicense has been fully executed or
modified or termination of such sublicense has occurred); provided that any such
copy may be redacted to remove any confidential, proprietary or competitive
information of Biogen or its Sublicensee, and any other information not
necessary for Alkermes to assess Biogen’s compliance with the terms of this
Section 6.1.2.

6.1.3.No Implied Licenses; Negative Covenant.  Except as expressly granted
herein, neither Party grants to the other Party any right or license under any
intellectual property rights Controlled by such first Party. 

6.1.4.Alkermes Reservation of Rights. The license granted in Section 6.1.1 is
subject to a reserved non-exclusive, non-transferable, and, except as necessary
or

29

--------------------------------------------------------------------------------

 

 

useful for Alkermes to Manufacture Clinical Supplies and Commercial Supplies in
accordance with this Agreement and the applicable Supply Agreements,
non-sublicenseable right of Alkermes under the Licensed Patents and Licensed
Know-How solely to exercise its rights and perform its obligations under this
Agreement and any Supply Agreement.

6.2.Patent Update.  At least once annually, Alkermes will provide to Biogen an
update to the list of Licensed Patents set forth on Exhibit B, and Exhibit B
shall automatically be modified to include such updates.  Notwithstanding the
foregoing, and for the avoidance of doubt, any Patent Right that satisfies the
definition of a “Licensed Patent” under Section 1.1.58 shall automatically
constitute a Licensed Patent under this Agreement, notwithstanding any failure
or delay in including such Patent Right on the list of Licensed Patents set
forth on Exhibit B.

6.3.Termination of License to Contested Patent Rights.  If Biogen or any of its
Affiliates or Sublicensees initiates or provides financial support (other than
equity funding) or information to a Third Party for purposes of initiating any
action or proceeding in any forum of competent jurisdiction in the Territory
(including a court, a patent office or an arbitral tribunal, and whether in the
form of petitions for declaratory relief, claims, counterclaims, defenses,
interferences, petitions for reexamination, inter partes review, post-grant
review, or otherwise, but excluding any action that may be necessary or
reasonably required in response to a subpoena or court or administrative law
request or order) that any Patent Right (or any claim thereof) within the
Licensed Patents is unpatentable, invalid, unenforceable, or not infringed (any
such action or proceeding, a “Patent Action”) and a final, non-appealable order
is made in any such forum that such Patent Right or claim thereof is patentable,
valid, enforceable or infringed, as applicable, then Alkermes, as the licensor
of the Licensed Patents under this Agreement, may at its discretion, (a) invoice
Biogen for all expenses incurred by Alkermes in such Patent Action, including
reasonable attorneys’ fees, experts’ fees and other costs of investigation or
defense, court costs and other litigation expenses, and Biogen shall pay all
undisputed amounts set forth in such invoice within sixty (60) days after
receipt of such invoice, (b) terminate its license to Biogen pursuant to this
Article 6 to such Patent Right, whereupon such Patent Right will no longer be
deemed to be within the Licensed Patents or (c) take both actions outlined in
clauses (a) and (b) of this sentence.  Notwithstanding the foregoing, (1) if any
Affiliate of Biogen that becomes an Affiliate of Biogen through a Change of
Control of Biogen is engaged in a Patent Action at the time of such Change of
Control, the provisions of this Section 6.3 shall not be deemed to apply as a
result of such Patent Action by such Affiliate of Biogen, (2) Biogen shall have
the right to defend itself against any action or proceeding in any forum of
competent jurisdiction in the Territory brought by Alkermes or any of its
Affiliates or Sublicensees alleging infringement of any Patent Right and (3) in
the case of a Patent Action by a Sublicensee, Alkermes shall not have the right
to take the actions described in the preceding sentence unless Biogen fails to
either terminate the applicable sublicense or cause the Sublicensee to cease
pursuing such Patent Action within sixty (60) days of the date that Biogen
becomes aware of such Patent Action.

6.4.Non-Suit.  During the Term until the Transfer Completion Date, Biogen, on
behalf of itself and of any Affiliates, Sublicensees, successors and assigns,
agrees on a worldwide basis not to file or maintain any lawsuit, cause of action
or other legal action against Alkermes or its Affiliates under any Patent Rights
Controlled by Biogen that Cover the Alkermes 8700 Product solely for purposes of
Exploiting the Alkermes 8700 Product in accordance with

30

--------------------------------------------------------------------------------

 

 

this Agreement. Biogen shall cause all of its Affiliates,  Sublicensees,
successors and assigns to be bound by the obligations of this Section 6.4. 

6.5.Non-Interference.  During the Term until the Transfer Completion Date,
Biogen and its Affiliates, Sublicensees, successors and assigns shall not, and
shall not cause or provide support to any Third Party to, initiate or otherwise
undertake any of the following actions against the Alkermes 8700 Product:
interfering with efforts to obtain and maintain Regulatory Approval of the
Alkermes 8700 Product in the U.S., or advocating for non-approval or limited
Regulatory Approval of the Alkermes 8700 Product in the U.S., including the
filing of a lawsuit against the FDA or the filing or submission of any Citizen
Petitions, correspondence or other written submissions with the FDA.  Biogen
shall cause all of its Affiliates,  Sublicensees, successors and assigns to be
bound by these obligations.    

6.6.Exclusivity.  During the Term, neither Party nor any of such Party’s
Affiliates, or Sublicensees (who are granted research and Development rights
under this Agreement), shall (i) directly or indirectly research, develop or
commercialize any pro-drug or salt of MMF or DMF or (ii) acquire any right,
title or interest from a Third Party in any pro-drug or salt of MMF or DMF,
except, in each case (i) or (ii), with respect to the conduct of such activities
by Biogen or its Affiliates with respect to Tecfidera® and Fumaderm® (in each
case, using the same active pharmaceutical ingredient(s) included in Tecfidera®
or Fumaderm®, as applicable, as of the Effective Date, in any form, formulation,
combination, administration, dosage or delivery mechanism (but not including any
pro-drug or salt of DMF or MMF (other than DMF))) or any Product.
Notwithstanding anything to the contrary in this Agreement, upon a finding of GI
Inferiority of the Alkermes 8700 Product, (a) if Biogen has Commercialized the
Alkermes 8700 Product, then the exclusivity obligations of Alkermes and its
Affiliates set forth in this Section 6.6 shall remain in effect, and the
exclusivity obligations of Biogen and its Affiliates and Sublicensees (who are
granted research and Development rights under this Agreement) set forth in this
Section 6.6 shall automatically terminate or (b) if Biogen has not
Commercialized the Alkermes 8700 Product in the U.S. within six (6) months after
the receipt of Regulatory Approval for the Alkermes 8700 Product in the Initial
Indication in the U.S. and the completion of any Post-Marketing Commitments that
the FDA requires be completed prior to the commencement of Commercialization
activities, then the exclusivity obligations of Alkermes and Biogen and their
respective Affiliates, and with respect to Biogen, Sublicensees (who are granted
research and Development rights under this Agreement), set forth in this Section
6.6 shall automatically terminate.  In the event that a Party or its Affiliate,
or Sublicensee (who is granted research and development rights under this
Agreement), obtains, whether through acquisition, merger or other similar
transaction, control of any entity that is engaging in any activities that would
cause such Party to breach this Section 6.6, then such Party shall not be deemed
in breach of this Section 6.6 if (1) such Party or its Affiliate or, with
respect to Biogen, Sublicensee, or the applicable entity divests such rights
(through sale, exclusive license or other transfer) within six (6) months from
the date such rights are obtained and (2) all activities by such Party or its
Affiliate or Sublicensee with respect to the applicable competitive compound or
product during such six (6)-month period are conducted independently of the
activities conducted by such Party or its Affiliates or Sublicensees pursuant to
this Agreement with customary firewall separations, and no intellectual property
of such Party or its Affiliates or the other Party or its Affiliates relating to
any Product is used in the conduct of such activities.  Notwithstanding anything
to the contrary in this Section 6.6, if a Party or its Affiliate or

31

--------------------------------------------------------------------------------

 

 

Sublicensee undergoes a Change of Control (in the case of a Sublicensee,
applying that term as if such Sublicensee were a Party) in which the acquirer or
its Affiliate (in each case, that was not an Affiliate of such Party prior to
such Change of Control) is engaging in any activities that would cause such
Party to breach this Section 6.6, such Party shall not be deemed to be in breach
of this Section 6.6 as a result of such Change of Control, provided that, during
the period in which such Party is subject to exclusivity obligations under this
Section 6.6, all activities by such Party or its Affiliate or Sublicensee with
respect to the applicable competitive compound or product are conducted
independently of the activities conducted pursuant to this Agreement with
customary firewall separations, and no intellectual property of such Party or
its Affiliates or the other Party or its Affiliates relating to any Product is
used in the conduct of such activities.

Article 7

INTELLECTUAL PROPERTY RIGHTS

7.1.Ownership of Intellectual Property.    

7.1.1.Product Trademarks.  Biogen may, in its sole discretion, select any
trademarks, trade dress, designs, logos or slogans to be used in connection with
the Exploitation of the Products in the Field in the Territory (collectively,
the “Product Trademarks”) and will own all such Product Trademarks.  Neither
Alkermes nor its Affiliates shall use or seek to register, anywhere in the
world, any trademarks that are confusingly similar to any Product Trademark. 

7.1.2.Collaboration Technology.

(i)Ownership.  Alkermes shall own all rights, title and interests in and to any
and all Alkermes Collaboration Know-How and Alkermes Collaboration
Patents.  Biogen shall own all rights, title and interests in and to any and all
Biogen Collaboration Know-How and Biogen Collaboration Patents.  The Parties
shall jointly own any and all Collaboration Know-How invented jointly by a
Party’s or its Affiliates’ employees, agents or independent contractors, on the
one hand, and the other Party’s or its Affiliates’ employees, agents or
independent contractors, on the other hand, in the performance of activities
under the Initial Development Plan during the Term (“Joint Collaboration
Know-How”), and any and all Collaboration Patents Covering such Collaboration
Know-How (“Joint Collaboration Patents” and, collectively with the Joint
Collaboration Know-How, the “Joint Collaboration Technology”). Subject to
Section 6.6 and the licenses granted under this Agreement, each Party shall be
free to exploit, either itself or through the grant of licenses to Third Parties
(which Third Party licenses may be further sublicensable), its rights in and to
the Joint Collaboration Technology, throughout the world without restriction,
without the need to obtain further consent from the other Party, and without any
duty to account or payment of any compensation to the other Party; provided,
however, that if either Party disclaims in writing its ownership interest in any
Joint Collaboration Technology, then such Joint Collaboration Technology shall
become solely owned by the other Party and such disclaiming Party will and
hereby does assign to the other Party its rights, title and interests in and to
such disclaimed Collaboration Technology.  Inventorship of any Collaboration
Technology shall be determined in accordance with United States patent laws. 

32

--------------------------------------------------------------------------------

 

 

(ii)Assignment of Inventions. To the extent either Party or any of its
Affiliates obtains any rights, title or interests in or to any Collaboration
Technology of the other Party, such first Party, on behalf of itself and its
Affiliates, hereby assigns to the other Party all such rights, title and
interests to the extent necessary to effectuate the allocation of ownership set
forth in Section 7.1.2(i). Each employee, agent or independent contractor
(including all subcontractors) of a Party or its respective Affiliates
performing work under this Agreement shall, prior to commencing such work, be
bound by invention assignment obligations, including: (a) promptly reporting any
invention, discovery, process or other intellectual property right; (b)
presently assigning to the applicable Party or Affiliate all of his or her
right, title and interest in and to any invention, discovery, process or other
intellectual property; (c) cooperating in the preparation, filing, prosecution,
maintenance and enforcement of any patent or patent application; and (d)
performing all acts and signing, executing, acknowledging and delivering any and
all documents required for effecting the obligations and purposes of this
Agreement.  It is understood and agreed that such invention assignment agreement
need not reference or be specific to this Agreement.

7.2.Disclosure of Inventions.  During the Term, each Party will promptly (but no
later than sixty (60) days following such Party’s receipt of an invention
disclosure) provide to the other Party any invention disclosure submitted to
such Party that discloses any Collaboration Technology.

7.3.Patent Committee.  Each Party will appoint one (1) representative with
patent and intellectual property expertise no later than forty-five (45) days
after the Effective Date.  Such representatives (the “Patent Committee”) will
meet (in person, by telephone or videoconference) upon request by either Party
during the Term to coordinate, discuss, and review strategies with respect to
Prosecuting and enforcing the Licensed Patents and the Joint Collaboration
Patents. 

7.4.Patent Filings.    

7.4.1.Prosecution.    

(i)By Alkermes.  Alkermes will have the first right, at its own cost and expense
and using patent counsel of its choosing, to prepare, file, prosecute and
maintain the Licensed Patents and the Joint Collaboration Patents, including any
appeal proceeding made at the applicable patent office following such patent
office’s failure to issue any such patent (collectively, “Prosecution” and when
used as a verb, “Prosecute” means to engage in Prosecution).  Alkermes will
provide Biogen with copies of all material documents and correspondence relating
to the Prosecution of the Licensed Patents and the Joint Collaboration Patents
(a) promptly after receipt, with respect to communications from applicable
patent authorities and (b) a reasonable time in advance of filing, for documents
to be filed by Alkermes, in each case (a) and (b), to allow Biogen time to
review such materials and comment thereon.  Alkermes will reasonably consider
Biogen’s reasonable comments on the documents filed, but Alkermes will not be
obligated to implement such comments. Biogen will provide Alkermes all
reasonable assistance in the Prosecution of such Licensed Patents and Joint
Collaboration Patents, including by making its employees, agents and consultants
reasonably available to Alkermes (or

33

--------------------------------------------------------------------------------

 

 

Alkermes’ authorized attorneys, agents or representatives), to the extent
reasonably necessary to enable Alkermes to undertake Prosecution as contemplated
by this Agreement. 

(ii)By Biogen.  If Alkermes elects to halt Prosecution of any patents or patent
applications within the Licensed Patents or the Joint Collaboration Patents in
any country in the Territory, then Alkermes will notify Biogen in a timely
manner to permit the preservation of any rights in such country with respect to
such Licensed Patents or Joint Collaboration Patents.  Following written
notification from Biogen to Alkermes that Biogen wishes to assume Prosecution of
such Licensed Patents or Joint Collaboration Patents in such country, Alkermes
will permit Biogen to so assume Prosecution of such Licensed Patents or Joint
Collaboration Patents (as applicable), at its own cost and expense and using
patent counsel of its choosing. In addition, and notwithstanding anything to the
contrary set forth in this Agreement, Biogen will have the first right, at its
sole cost and expense and using patent counsel of its choosing, to direct and
control any patent interferences, reexaminations, inter partes reviews,
reissuances, revocations, oppositions and appeals from any such proceedings of
the Licensed Patents and the Joint Collaboration Patents (collectively,
“Protection”). Alkermes will provide Biogen reasonable assistance in the
Prosecution and Protection of such Licensed Patents or Joint Collaboration
Patents, including by making its employees, agents and consultants reasonably
available to Biogen (or Biogen’s authorized attorneys, agents or
representatives), to the extent reasonably necessary to enable Biogen to
undertake Prosecution and Protection as contemplated by this Agreement. If
Biogen elects to halt Protection of any patents or patent applications within
the Licensed Patents or the Joint Collaboration Patents in any country in the
Territory, then Biogen will notify Alkermes in a timely manner to permit the
preservation of any rights in such country with respect to such Licensed Patents
or Joint Collaboration Patents.  Following written notification from Alkermes to
Biogen that Alkermes wishes to assume Protection of such Licensed Patents or
Joint Collaboration Patents in such country, Biogen will permit Alkermes to so
assume Protection of such Licensed Patents or Joint Collaboration Patents (as
applicable) at its own cost and expense and using patent counsel of its
choosing. Biogen will provide reasonable assistance in the Protection of such
Licensed Patents or Joint Collaboration Patents, including by making its
employees, agents and consultants reasonably available to Alkermes (or Alkermes’
authorized attorneys, agents or representatives), to the extent reasonably
necessary to enable Alkermes to undertake Protection as contemplated by this
Agreement. Notwithstanding the foregoing, Biogen shall forfeit its right to
control Protection of any Licensed Patents and Joint Collaboration Patents that
are or become subject to a Patent Action under Section 6.3.

(iii)Other Patent Rights.  Except as expressly provided in this Section 7.4.1,
each Party shall have the sole right, in its sole discretion, to conduct
Prosecution of any Patent Rights owned by such Party.

7.4.2.Common Interest.  All information exchanged between the Parties or between
the Parties’ outside patent counsel regarding Prosecution of the Licensed
Patents, and the Joint Collaboration Patents shall be deemed Confidential
Information of the prosecuting Party subject to Article 8.  In addition, the
Parties acknowledge and agree that, with regard to Prosecution of the Licensed
Patents and the Joint Collaboration Patents, the interests of the Parties as
licensor and licensee are aligned and are legal in nature.  The Parties agree
and acknowledge that they have not waived, and nothing in this Agreement
constitutes a waiver of,

34

--------------------------------------------------------------------------------

 

 

any legal privilege concerning the Licensed Patents or the Joint Collaboration
Patents, including privilege under the common interest doctrine and similar or
related doctrines.

7.4.3.Patent Term Extensions.  The Parties will use reasonable efforts and
cooperate with one another to obtain all available supplementary protection
certificates, patent term restorations and other patent extensions with respect
to the Products, and to make any filings with respect thereto. Alkermes will
cooperate with Biogen with respect to any such filings, including by executing
such authorizations and other documents and taking such other actions as may be
reasonably requested by Biogen to obtain such extensions.    

7.5.Enforcement Rights. 

7.5.1.Notification of Infringement. If either Party learns of any actual or
threatened infringement by a Third Party of a Licensed Patent or Collaboration
Patent in the Territory or, other than Prosecution-related matters, any attack
by a Third Party on the validity or enforceability of a Licensed Patent or
Collaboration Patent in the Territory, including any certification received by
such Party under the U.S. Drug Price Competition and Patent Term Restoration Act
of 1984 (Public Law 98-417, as amended, the “Hatch-Waxman Act”), with respect to
a Licensed Patent or Collaboration Patent and a Product in the Field (each, an
“Infringement”), such Party will promptly, and in any event within five (5)
days, notify the other Party and will provide the other Party with available
evidence of such events. 

7.5.2.Enforcement of Licensed Patents and Joint Collaboration Patents.    

(i)Biogen shall have the first right, but not the obligation, at its own cost
and expense and using counsel of its choosing, to institute any action, suit or
proceeding against any Infringement of a Licensed Patent or Joint Collaboration
Patent.  Biogen shall have the right to cause Alkermes to join Biogen as a party
plaintiff to any such action, suit or proceeding, at Biogen’s sole
expense.  Biogen will keep Alkermes reasonably informed regarding such action,
suit or proceeding and will reasonably consider Alkermes’ input regarding such
action, suit or proceeding.    

(ii)If, after sixty (60) days following the date of notice given pursuant to
Section 7.5.1 (or at least twenty (20) days before the expiration of any time
limit set forth under 21 U.S.C. §355), Biogen has not provided written
notification to Alkermes that Biogen will institute an action, suit or
proceeding against the applicable Infringement or provided Alkermes with
information and arguments demonstrating that there is insufficient basis for the
allegation of such Infringement, then Alkermes shall have the right, but not the
obligation, at its own cost and expense and using counsel of its choosing, to
institute any action, suit or proceeding against such Infringement, provided
that, if Biogen provides notice to Alkermes that Biogen has determined, for
reasons related to the benefit of the Alkermes 8700 Product in the aggregate not
to institute an action, suit or proceeding against such Infringement, Alkermes
shall not have the right to institute an action, suit or proceeding against such
Infringement. Notwithstanding the foregoing provisions of this Section
7.5.2(ii), if Biogen forms a good faith belief that instituting an action, suit
or proceeding against such Infringement would not benefit the Alkermes 8700
Product in the aggregate, then Biogen shall consult with Alkermes in

35

--------------------------------------------------------------------------------

 

 

reasonable detail regarding Biogen’s reasonable good faith rationale for such
determination, and if after such consultation with Alkermes, Biogen maintains
such belief in good faith, then Alkermes shall agree to a reasonable request
from Biogen not to institute any such action, suit or proceeding against such
Infringement;  provided that, if the Parties disagree as to whether any such
request from Biogen not to institute any such action, suit or proceeding against
such Infringement is reasonable, then Alkermes will not institute any such
action, suit or proceeding against such Infringement unless and until (a) in the
case of an abbreviated new drug application (“ANDA”) under the Hatch-Waxman Act,
Senior Management has attempted in good faith to discuss and resolve such
disagreement at least five (5) days before the expiration of any time limit set
forth under 21 U.S.C. §355 (and each Party agrees that it will use its best
efforts to make its respective Senior Management available for such discussion
within such timeframes) and (b) other than in the case of an ANDA, such request
by Biogen is determined not to be reasonable in accordance with the Senior
Management escalation and dispute resolution procedure set forth in Section
12.1.2 and, if such dispute remains unresolved after such procedure, then in
accordance with the procedure set forth in Section 12.1.3, which escalation and
dispute resolution procedures shall be conducted in an expedited manner so as to
allow Alkermes to proceed with an action, suit or proceeding against such
Infringement if such request by Biogen is determined not to be reasonable. In
connection with any action, suit or proceeding pursuant to this Section 7.5.2,
the Parties will cooperate with and assist each other in all reasonable
respects.

7.5.3.Recoveries.  In the event that either Party exercises the rights conferred
in Section 7.5.2 and recovers any damages or other sums in such action, suit or
proceeding or in settlement thereof, such damages or other sums recovered shall
first be applied to all reasonable out-of-pocket costs and expenses incurred by
the Parties in connection therewith, including attorneys’ fees.  If such
recovery is insufficient to cover all such costs and expenses of both Parties,
it shall be shared pro rata in proportion to the total of such costs and
expenses incurred by each Party.  If, after such reimbursement, any funds shall
remain from such damages or other sums recovered, and (i) if Biogen institutes
the action, suit or proceeding pursuant to Section 7.5.2(i) that results in such
damages or other sums recovered, then Biogen shall pay Alkermes a payment
calculated by multiplying the applicable royalty rate for the Alkermes 8700
Product (that Biogen would have paid to Alkermes if such damages or other sums
recovered were treated as Net Sales hereunder) by the amount of such damages or
other sums recovered and Biogen shall retain the remainder or (ii) if Alkermes
institutes the action, suit or proceeding pursuant to Section 7.5.2(ii) that
results in such damages or other sums recovered, then Alkermes shall pay Biogen
a payment calculated by multiplying the applicable royalty rate for the Alkermes
8700 Product (that Biogen would have paid to Alkermes if such damages or other
sums recovered were treated as Net Sales hereunder) by the amount of such
damages or other sums recovered and Alkermes shall retain the remainder.

7.5.4.Other Patent Rights.  Except as expressly provided in Section 7.5.2, each
Party shall have the sole right, in its sole discretion, to institute any
action, suit or proceeding against any actual or threatened infringement by a
Third Party of any Patent Right owned by such Party.

7.6.Infringement Defense. 

36

--------------------------------------------------------------------------------

 

 

7.6.1.Notice.  In the event that a Third Party at any time provides written
notice of a claim to, or brings an action, suit or proceeding against, either
Party, or any of their respective Affiliates or sublicensees (each Person so
sued being referred to herein as a “Sued Party”), claiming infringement of such
Third Party’s Patent Rights or unauthorized use or misappropriation of its
Know-How based upon an assertion or claim arising out of the Exploitation of a
Product in the Field in the Territory (“Infringement Claim”), such Party shall
promptly notify the other Party of the Infringement Claim or the commencement of
such action, suit or proceeding, enclosing a copy of the Infringement Claim and
all papers served.    

7.6.2.Right to Defend.  If the Sued Party with respect to any Infringement Claim
is entitled to indemnification under Article 11 with respect to such
Infringement Claim, then the terms and conditions of Article 11 and not this
Section 7.6.2 shall apply to such Infringement Claim. In all other cases, Biogen
shall have the right, but not the obligation, at its own cost and expense and
using counsel of its choosing, to defend against any Infringement Claim brought
against Biogen or its Affiliates or Sublicensees and Alkermes shall have the
right, but not the obligation, at its own cost and expense and using counsel of
its choosing, to defend against any Infringement Claim brought against Alkermes
or its Affiliates or sublicensees.  The Sued Party shall keep the other Party
reasonably informed of all material developments in connection with any such
suit and shall not, without the other Party’s prior written consent, enter into
any settlement or consent decree that requires any payment by or admits or
imparts any other liability to the other Party.  The other Party shall make
available to the Sued Party its advice and counsel regarding any Infringement
Claim and shall offer reasonable assistance in connection with any Infringement
Claim to the Sued Party, at the Sued Party’s cost and expense.

7.7.Patent Marking.  Biogen agrees to mark, and to require any of its Affiliates
or Sublicensees to mark, any Products (or their containers or labels) made,
sold, or otherwise distributed by it or them with any notice of Patent Rights
required under Applicable Law to enable such Patent Rights to be enforced to
their full extent in any country where Products are made, used, sold, or offered
for sale.

7.8.Orange Book Listings.  With respect to patent listings in the FDA Orange
Book for issued patents for the Alkermes 8700 Product in the Initial Indication,
the Parties shall determine by mutual agreement which patents to list in the FDA
Orange Book (a) prior to the submission of the Alkermes 8700 Product 505(b)(2)
NDA, or any other NDA for the Alkermes 8700 Product submitted to the FDA and (b)
within twenty (20) days after the receipt of Regulatory Approval for the
Alkermes 8700 Product in the Initial Indication. If the Parties are unable to
reach agreement on any such listings within twenty (20) days before submission
of the Alkermes 8700 Product 505(b)(2) NDA, or any other NDA for the Alkermes
8700 Product submitted to the FDA or within twenty (20) days after receipt of
Regulatory Approval for the Alkermes 8700 Product in the Initial Indication in
the U.S. prior to the Transfer Completion Date, then Alkermes will have the
right to make the determination with respect to which patents to list in the FDA
Orange Book.  After the Transfer Completion Date, Biogen shall have the sole
right, in its sole discretion, to determine which patents to list in the FDA
Orange Book (or its foreign equivalent in any country in the Territory) for the
Alkermes 8700 Product.  With respect to patent listings in the FDA Orange Book
(or its foreign equivalent in any country in the Territory) for issued patents
for any other Product or for the Alkermes 8700 Product in any other indication

37

--------------------------------------------------------------------------------

 

 

than the Initial Indication in the Field, in each case, Biogen shall have the
sole right, in its sole discretion, to determine which patents to list. 

7.9.Trademark Infringement. 

7.9.1.Notification of Infringement.  If Alkermes learns that a Third Party is
infringing any Product Trademark in the Territory, Alkermes will promptly notify
Biogen.

7.9.2.Infringement Action.  Biogen will have the sole right, at its own cost and
expense and in its sole discretion, to take any action with respect to any
infringement of a Product Trademark in the Territory, with counsel of its own
choice.  Any recovery from any settlement or judgment from such action will be
retained by Biogen. 

Article 8

CONFIDENTIALITY; PUBLICITY

8.1.Confidentiality.  Except to the extent authorized by this Agreement or
otherwise agreed upon in writing, the Parties agree that the receiving Party
will keep confidential and will not publish or otherwise disclose or use for any
purpose, any proprietary and confidential information and materials furnished to
it by the disclosing Party pursuant to this Agreement or the Confidentiality
Agreements (collectively, “Confidential Information”), except to the extent that
it can be established by the receiving Party that such Confidential Information:

8.1.1.was already known to the receiving Party or its Affiliates, as
demonstrated by competent written records, other than under an obligation of
confidentiality, at the time of disclosure by the disclosing Party;

8.1.2.was generally available to the public or otherwise part of the public
domain at the time of its disclosure by the disclosing Party;

8.1.3.became generally available to the public or otherwise part of the public
domain after its disclosure by the disclosing Party and other than through any
act or omission of the receiving Party or its Affiliates in breach of this
Agreement;

8.1.4.was disclosed to the receiving Party or its Affiliates, other than under
an obligation of confidentiality, by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others; or

8.1.5.was subsequently developed by the receiving Party or its Affiliates
without use of or reference to the Confidential Information of the disclosing
Party as demonstrated by competent written records.

Licensed Know-How and unpublished Licensed Patents (to the extent that such
Licensed Know-How or unpublished Licensed Patents are not subject to any of the
foregoing exceptions set forth under this Section 8.1) will be considered
Confidential Information of Alkermes, provided that Biogen may use or disclose
such Licensed Know-How and Licensed Patents in

38

--------------------------------------------------------------------------------

 

 

accordance with Article 8. Notwithstanding anything to the contrary set forth in
this Agreement, during the Term Alkermes will use at least the same degree of
care to protect the secrecy of such Licensed Know-How and unpublished Licensed
Patents that it uses to prevent the disclosure of its own other confidential
information of similar importance and in any event a reasonable duty of care.

8.2.Authorized Use and Disclosure.  Each Party will maintain the Confidential
Information of the other Party in confidence and may use the Confidential
Information of the other Party only in performance of its obligations under this
Agreement and any Supply Agreement.  Each Party may disclose such Confidential
Information to its employees, Affiliates, sublicensees, agents, consultants or
other Third Parties who need to know such Confidential Information in connection
with the performance of such Party’s obligations under this Agreement or any
Supply Agreement and who are bound by obligations of confidentiality and non-use
at least substantially equivalent to the obligations of this Article 8.  Each
Party will be liable for any unauthorized use or disclosure of Confidential
Information by its employees, Affiliates, sublicensees, agents, consultants or
other Third Parties to which it has disclosed or transferred such Confidential
Information.

Without limiting the generality of the foregoing paragraph, a Party may disclose
Confidential Information of the other Party to the extent that such disclosure
is reasonably necessary in connection with:

8.2.1.filing or prosecuting patent or trademark applications relating to the
Products;

8.2.2.prosecuting or defending litigation relating to the Products;

8.2.3.Exploiting the Products;

8.2.4.seeking Regulatory Approval of a Product, including Regulatory Approval of
a Manufacturing facility for a Product;

8.2.5.seeking reimbursement or pricing approvals for a Product from Governmental
Authorities;

8.2.6.complying with Applicable Laws, including securities laws and the rules of
any securities exchange or market on which a Party’s or its Affiliates’
securities are listed or traded; or

8.2.7.complying with subpoenas or requests for information from Governmental
Authorities.

In making any disclosures set forth in Section 8.2.1 through Section 8.2.7
above, the disclosing Party will, except where impracticable for necessary
disclosures (as in the event of medical emergency), give such advance notice to
the other Party of such disclosure requirement as is reasonable under the
circumstances and, except to the extent inappropriate (as in the case of patent
applications), use its reasonable efforts to cooperate with the other Party in
order to secure confidential treatment of such Confidential Information required
to be disclosed, except to the

39

--------------------------------------------------------------------------------

 

 

extent that the disclosing Party receives advice from its legal counsel or
independent registered public accounting firm that such information is required
to be disclosed under Applicable Laws, including securities laws and the rules
of any securities exchange or market on which a Party’s or its Affiliates’
securities are listed or traded.

8.3.Disclosure to Investors.  The Parties acknowledge that each Party may, from
time to time, engage or have engaged in fundraising or other business
activities. The Parties may disclose a copy of this Agreement, under terms of
confidentiality no less strict than those contained in this Agreement, to their
respective actual or bona fide potential investors or business partners (and to
their respective bankers, lawyers, accountants and agents);  provided that any
such copy may be redacted to remove any confidential, proprietary or competitive
information of the disclosing Party and any other information not necessary in
connection with their evaluation of such potential or actual investment.

8.4.Survival.  This Article 8 will survive the termination or expiration of this
Agreement for a period of [**] years.

8.5.Publications or Presentations.  

8.5.1.General.  Biogen shall have the sole right, in its sole discretion, to
present at symposia, national or regional professional meetings and to publish
in journals regarding the Products and any activities under this Agreement,
provided that any such presentation or publication shall not include any
Confidential Information of Alkermes.  Alkermes shall have no right to present
at symposia, national or regional professional meetings or to publish in
journals regarding the Products or any activities under this Agreement.

8.5.2.Publicity.  A joint press release approved by each Party announcing this
Agreement is attached hereto as Exhibit F. Biogen retains the right to make
publications about its activities under the Agreement (i) prior to the Transfer
Completion Date and with respect to the Alkermes 8700 Product, with the consent
of Alkermes, which consent shall not be unreasonably withheld or delayed, and
(ii) (a) with respect to any Product other than the Alkermes 8700 Product and,
(b) following the Transfer Completion Date, with respect to the Alkermes 8700
Product, in each case (a) and (b), without the consent of Alkermes. Neither
Party shall be required to seek the permission of the other Party to repeat any
information regarding the terms of this Agreement or the arrangements hereunder
to the extent the same has already been publicly disclosed by such Party or by
the other Party; provided that such information remains true, correct and
consistent with the most recent information related thereto that has been
publically disclosed. Routine references to this Agreement and the arrangements
hereunder in the context of disclosures or publications regarding a Party’s
business in general will be allowed in the usual course of a Party’s business,
including the use of other Party’s name.  Each Party may use the other Party’s
corporate logo(s) or Product Trademarks only with the prior written consent of
the other Party.

40

--------------------------------------------------------------------------------

 

 

Article 9

PAYMENTS

9.1.Up-Front Payment.  Within ten (10) Business Days after the Effective Date,
as an upfront, one-time, nonrefundable and non-creditable fee in consideration
of the grant of the licenses set forth in Section 6.1, Biogen will pay to
Alkermes the amount of Twenty Eight Million U.S. Dollars (US$28,000,000) (the
“Up-Front Payment”).

9.2.Option Payment.  Within [**] days after Biogen’s receipt from Alkermes of
the Initial GI Tolerability Data Package in accordance with Section 3.2.4(i),
subject to any extension pursuant to Section 3.2.4(iii), Biogen will make a
one-time, nonrefundable and non-creditable payment to Alkermes in the amount of
Fifty Million U.S. Dollars (US$50,000,000) (the “Option Payment”), unless,
following the Parties’ discussions as set forth in Section 3.2.4(iv),  the
Parties jointly agree in writing not to conduct Part B of the GI Tolerability
Clinical Trial 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 (in which case GI Inferiority will be deemed to exist and Biogen will not
be obligated to make the Option Payment). If Biogen does not make the Option
Payment in accordance with this Section 9.2 for any reason other than the
Parties jointly agreeing in writing not to conduct Part B of the GI Tolerability
Clinical Trial 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, and Biogen fails to make such Option Payment within five (5) Business
Days following written notice from Alkermes of such failure, then Biogen will be
deemed to have given notice of termination for convenience in accordance with
Section 13.3. 

9.3.NDA Approval Payment.  If the Alkermes 8700 Product 505(b)(2) NDA approval
is obtained on or prior to December 31, 2021, then within [**] days after the
Transfer Completion Date, Biogen will make a one-time, nonrefundable and
non-creditable payment to Alkermes in the amount of One Hundred Fifty Million
U.S. Dollars (US$150,000,000). 

9.4.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 hereunder, Biogen shall 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.

[**]

 

41

--------------------------------------------------------------------------------

 

 

The milestone payments set forth in this Section 9.4 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).

9.5.Royalties.    

9.5.1.Royalty Payments for Alkermes 8700 Product.    

(i)Royalty Percentages.  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 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 [**] percent ([**]%) of Net Sales.
 Notwithstanding the foregoing, in the event of a determination of GI
Inferiority, if Biogen has made the Option Payment to Alkermes, then the royalty
rate during each Royalty Term for the Alkermes 8700 Product in each country in
the Territory shall 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 shall
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). 

(ii)Minimum Annual Payments.  As further consideration for the grant of the
licenses set forth in Section 6.1 and the performance of Alkermes’ other
obligations hereunder, Biogen will pay Alkermes a minimum aggregate royalty
payment during each twelve (12)-month period (each, a “Minimum Annual Payment”
and together, the “Minimum Annual Payments”) in the amounts set forth in the
table below, commencing on the first day of the first month following the date
of the First FDA Approval (such first day of such first month, the “Minimum
Payment Commencement Date”) and continuing for a period of five (5) years,
unless earlier terminated as set forth in Section 9.5.1(iii) (the “Minimum
Annual Payment Term”). 

42

--------------------------------------------------------------------------------

 

 

For clarity, for each twelve (12)-month period during the Minimum Annual Payment
Term in which the aggregate amount payable to Alkermes as royalties under
Section 9.5.1(i) is less than the applicable Minimum Annual Payment, Biogen
shall pay Alkermes an amount equal to the applicable Minimum Annual Payment for
such twelve (12)-month period, minus the aggregate amount already paid to
Alkermes as royalties under Section 9.5.1(i) for such twelve (12)-month period.

 

 

Twelve (12)-Month Period

Minimum Annual Payment

First twelve (12)-month period following the Minimum Payment Commencement Date

[**]

Second twelve (12)-month period following the Minimum Payment Commencement Date

[**]

Third twelve (12)-month period following the Minimum Payment Commencement Date

[**]

Fourth twelve (12)-month period following the Minimum Payment Commencement Date

[**]

Fifth twelve (12)-month period following the Minimum Payment Commencement Date

[**]

 

(iii)Termination of Minimum Annual Payments.  Notwithstanding anything to the
contrary in Section 9.5.1(ii), the Minimum Annual Payment Term shall immediately
terminate, and no further Minimum Annual Payments shall be payable under this
Agreement, if any of the following conditions is met: 

(A)(i) [**] and (ii) [**];

(B)[**]; or

(C)[**].

Notwithstanding anything to the contrary, if any of the foregoing conditions in
clauses (A) through (C) exist prior to the Minimum Payment Commencement Date,
then the Minimum Annual Payment Term shall be deemed not to commence and no
Minimum Annual Payments shall be payable under this Agreement.

9.5.2.Royalty Payments 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 hereunder, Biogen will pay to
Alkermes tiered royalty payments on annual aggregate worldwide Net Sales of
Products, other than the Alkermes 8700 Product, on a Product-by-Product basis
during the applicable Royalty Term as follows: (i) for Net Sales less than or
equal to [**] U.S. Dollars (US$[**]), [**] percent ([**]%) of such Net Sales and
(ii) for Net Sales greater than [**] U.S. Dollars (US$[**]), [**] percent
([**]%) of such Net Sales.

9.5.3.Duration of Royalty Payments. Biogen will pay royalties to Alkermes, as
set forth in Section 9.5.1(i) and Section 9.5.2, on a country-by-country and

43

--------------------------------------------------------------------------------

 

 

Product-by-Product basis, during the period commencing on the First Commercial
Sale of a Product in a country and ending on the later of (i) the expiration of
all Valid Claims of the Joint Collaboration Patents and Licensed Patents that
Cover the use or sale of such Product in such country and (ii) [**] years after
the First Commercial Sale of such Product in such country (any such period, a
“Royalty Term”).  Following expiration of the Royalty Term for any Product in a
country, no further royalties shall be payable in respect of sales of such
Product in such country and, thereafter, the license granted to Biogen under
Section 6.1.1 with respect to such Product in such country shall be
non-exclusive, fully paid-up, perpetual, irrevocable and royalty-free.

9.5.4.Cumulative Royalties.  The obligation to pay royalties under this
Agreement shall be imposed only once with respect to a single unit of a Product
regardless of how many Valid Claims of the Licensed Patents Cover the use or
sale of such Product in the applicable country.

9.5.5.No Valid Claim.  On a country-by-country and Product-by-Product basis, in
any country in which a Product is Commercialized and there are no remaining
Valid Claims of the Licensed Patents that Cover the use or sale of such Product
in such country, the royalties payable to Alkermes on Net Sales of such Product
pursuant to (i) Section 9.5.1(i) will be reduced to [**] percent ([**]%) of such
Net Sales for the Alkermes 8700 Product and (ii) Section 9.5.2 will be reduced
to [**] percent ([**]%) of the applicable royalty rate for any Product (other
than the Alkermes 8700 Product).    

9.5.6.Third Party Payment Obligations. If Biogen or its Affiliates or
Sublicensees are required to make any payments (including upfront fees,
milestones or royalties) to a Third Party to obtain rights to any intellectual
property that is necessary to Exploit a Product in the Field in any country,
then Biogen may deduct up to [**] percent ([**]%) of such Third Party payments
as and when incurred from any royalty payment or Minimum Annual Payment due to
Alkermes under Section 9.5.1 or Section 9.5.2 with respect to such Product and
such country; provided that Biogen may not deduct from any payments due to
Alkermes hereunder any such Third Party payments due under any arrangement
entered into prior to the Effective Date. 

9.5.7.Royalty Floor. Notwithstanding anything to the contrary herein, in no
event shall the royalty payments or Minimum Annual Payments due to Alkermes
under Section 9.5.1 or Section 9.5.2 for any Product in a given Calendar Quarter
be reduced as a result of the application of the reductions and offsets
described in this Section 9.5 below [**] percent ([**]%) of the amounts
otherwise payable to Alkermes under Section 9.5.1 or Section 9.5.2 with respect
to such Product.  Any reductions or offsets that are not used to reduce payments
under Section 9.5.1 or Section 9.5.2 in a given Calendar Quarter as a result of
the foregoing limitations may be carried over to reduce payments due under
Section 9.5.1 and Section 9.5.2 in subsequent Calendar Quarters. 

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 non-binding 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,

44

--------------------------------------------------------------------------------

 

 

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.  In addition, within
forty-five (45) days of 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 of the Minimum Annual Payment Term. Each report delivered hereunder shall
be considered Confidential Information of Biogen, subject to the terms and
conditions of Article 8 hereof. Any payments due hereunder for less than a full
Calendar Quarter will be prorated.

9.7.Records and Reporting; Audits. 

9.7.1.Records and Reporting.  Each Party shall keep, and shall cause its
Affiliates and Sublicensees to keep, such accurate and complete records of Net
Sales and its Development Costs as are necessary to determine the amounts due to
Alkermes under this Agreement, including time records.  Records of Net Sales and
Development Costs shall be retained by each Party or any of its Affiliates and
Sublicensees (in such capacity, the “Recording Party”) for three (3) years
following the end of the Calendar Year to which they pertain.

9.7.2.Audits.  During normal business hours and with reasonable advance notice
to the Recording Party, such records shall be made available for inspection,
review and audit, at the request and expense of the other Party (the “Auditing
Party”), by an independent certified public accountant, appointed by such
Auditing Party and reasonably acceptable to the Recording Party, for the sole
purpose of verifying the accuracy of the Recording Party’s accounting reports
and payments made or to be made pursuant to this Agreement or any Supply
Agreement; provided, however, that such audits may not be performed by the
Auditing Party more than once per Calendar Year, that such audits may only cover
records pertaining to any period commencing not more than two (2) Calendar Years
prior to the date of such audit, and that such Auditing Party shall not be
permitted to audit the same period of time more than once.  Such accountants,
prior to any review hereunder, shall have entered into an appropriate
confidentiality agreement with the Recording Party on mutually acceptable terms
and shall have been instructed not to reveal to the Auditing Party the details
of their review, except for (i) such information as is required to be disclosed
under this Agreement and (ii) such information presented in a summary fashion as
is necessary to report the accountants’ conclusions to the Auditing Party.  The
report prepared by such accountants shall be sent or otherwise provided to the
Recording Party by such accountants at the same time it is sent or otherwise
provided to the Auditing Party.  All costs and expenses incurred in connection
with performing any such audit shall be paid by the Auditing Party unless the
audit uncovers a net underpayment of amounts owed or overreporting of expenses
by a Recording Party of five percent (5%) of total amounts owed or expenses
reported by such Recording Party for any Calendar Year period covered by the
audit, in which case the Recording Party will bear the full cost of such
audit.  If either Party is found to have been underpaid any amounts payable to
such

45

--------------------------------------------------------------------------------

 

 

Party hereunder or to have overpaid to the other Party any amounts payable
hereunder, such first Party will be entitled to recover any undisputed
discrepancy, plus interest calculated in accordance with Section 9.9, within
forty-five (45) days after receipt of such audit report.  If either Party
disagrees with any discrepancy identified during the course of any audit
conducted pursuant to this Section 9.7.2, then either Party may submit the issue
for resolution in accordance with Article 12.  

9.8.Manner of Payments.  All sums due to Alkermes or Biogen under this Agreement
shall be payable in U.S. Dollars by bank wire transfer in immediately available
funds to such bank account(s) as Alkermes and Biogen, respectively, shall
designate from time to time.  Each Party shall endeavor to notify the other
Party as to the date and amount of any such wire transfer to the other Party at
least two (2) Business Days prior to such transfer, but in no event later than
the Business Day of such transfer.

9.9.Interest on Late Payments.  Without limitation on other available rights or
remedies, any payments or portions thereof due hereunder that are not paid at
the latest five (5) days following the date such payments are due under this
Agreement will bear interest at the lower of (i) the Prime Rate as determined by
Bank of America in effect on the due date, or (ii) the maximum rate permitted by
Applicable Law, calculated on the number of days such payment is delinquent. 

9.10.Currency of Payments/Exchange Rates.  All payments to be made under this
Agreement will be made in U.S. Dollars.  The royalty due on Net Sales and the
price for any applicable Product sold in the Territory (other than in the U.S.)
will be calculated on the basis of the local currency sales figures translated
into U.S. Dollars according to Biogen’s standard currency translation
methodology. As of Effective Date, Biogen converts revenue in local currency
using the average FX rates for the month downloaded from the Bloomberg end of
day rates on the second last business day of the month.   The methodology
employed by Biogen will be that methodology used by Biogen from time to time in
the translation of its foreign currency operating results for external reporting
and will be consistent with GAAP, and in any event will not be impacted by
Biogen’s hedging program.

9.11.Taxes.    

9.11.1.Withholding.  Biogen will make all payments to Alkermes under this
Agreement without deduction or withholding except to the extent that any such
deduction or withholding is required by Applicable Law.  It is the intention of
the Parties that all payments will be made by Biogen hereunder from its offices
in Zug, Switzerland.  No such payments will be made by Biogen hereunder from any
other jurisdiction, unless Biogen and Alkermes agree in advance that such
payments would not adversely affect the withholding tax position of such
payments. In the event of Biogen’s breach of this Section 9.11.1 resulting in an
adverse effect on Alkermes’ withholding tax position of such payments, Biogen
shall make true-up payments to Alkermes as compensation for such adverse effect.

9.11.2.Payment of Taxes.  Any tax required to be withheld by Applicable Law on
amounts payable under this Agreement will promptly be paid by Biogen on behalf
of Alkermes or Alkermes on behalf of Biogen, as applicable, to the appropriate
Governmental

46

--------------------------------------------------------------------------------

 

 

Authority, and the Party making such payment will furnish the other Party with
proof of payment of such tax within one (1) calendar month of such payment.  The
Party making tax payments hereunder will give ten (10) days’ advance notice of
its intention to begin withholding any such tax in advance of such withholding.

9.11.3.Cooperation and Documentation.  Biogen and Alkermes will cooperate (i) in
all respects necessary to take advantage of any double taxation agreements or
similar agreements as may, from time to time, be available in order for the
payments under this Agreement to be made without any deduction or withholding
and (ii) with respect to producing all documentation required by any
Governmental Authority including an IRS Form W-8BEN-E with respect to taxes or
as reasonably requested by Biogen or Alkermes, as applicable, to secure a
reduction in the rate of applicable withholding taxes or to secure a credit or
refund for withheld taxes.  Alkermes shall prepare and deliver to Biogen a
complete, accurate IRS Form W-8BEN-E for the Up-Front Payment within three (3)
days after the Effective Date.

9.11.4.Value Added Tax. All payments to Alkermes under this Agreement are
exclusive of any applicable value added tax (“VAT”), for which, if applicable,
Biogen will be responsible; provided that Alkermes will issue an appropriate VAT
invoice to Biogen. 

9.11.5.Pharmaceutical Excise Taxes. Biogen may invoice Alkermes each Calendar
Quarter for its pro rata share of any pharmaceutical excise taxes (based on the
applicable Product royalty rate(s) in effect at the time of such Product sales
to which the tax applies) imposed by the United States Patient Protection and
Affordable Care Act of 2010 due with respect to sales of the Products in the
U.S. at the time Biogen accrues such taxes in accordance with GAAP. Biogen will
provide a summary of the amount invoiced and a roll-forward of the accrual
balance. Alkermes will, within forty-five (45) days after the receipt of an
invoice from Biogen for such pharmaceutical excise taxes, pay Biogen the
undisputed amounts set forth in such invoice. Alkermes will notify Biogen of any
disputed amounts within ten (10) days of receipt of any such invoice and will
work with Biogen to resolve such issues on a timely basis. If such issue cannot
be resolved by the Parties, then such matter will be resolved in accordance with
the dispute resolution process set forth in Article 12. If the amount of such
pharmaceutical excise taxes owed by Biogen differs from the amount accrued by
Biogen in respect of such taxes for the applicable period, then Biogen will
reflect such differences in Alkermes’ next accrual payment.

Article 10

REPRESENTATIONS AND WARRANTIES; COVENANTS; DISCLAIMER

10.1.Disclaimer.  EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, EACH PARTY
DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
WARRANTIES OF COMMERCIAL UTILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, VALIDITY OR SCOPE OF PATENT RIGHTS OR NON-INFRINGEMENT OF THIRD PARTY
INTELLECTUAL PROPERTY RIGHTS.  Each Party acknowledges and agrees that nothing
in this Agreement will be construed as representing any estimate or projection
of (a) the successful Development or

47

--------------------------------------------------------------------------------

 

 

Commercialization of any Product under this Agreement, (b) the number of
Products that will or may be successfully Developed or Commercialized under this
Agreement, (c) anticipated sales or the actual value of any Products that may be
successfully Developed or Commercialized under this Agreement or (d) the
damages, if any, that may be payable if this Agreement is terminated for any
reason. Without limiting the foregoing, Biogen makes no representation, warranty
or covenant, either express or implied, that (i) it will successfully Develop,
Manufacture, Commercialize or continue to Commercialize any Product in any
country, (ii) if Commercialized, that any Product will achieve any particular
sales level, whether in any individual country or cumulatively throughout the
Territory or (iii) other than is expressly required under Section 4.2, that it
will devote, or cause to be devoted, any level of diligence or resources to
Developing or Commercializing any Product in any country, or in the Territory in
general.

10.2.Mutual Representations, Warranties and Covenants.  Each Party represents,
warrants and covenants to the other as of the Effective Date as follows:

10.2.1.this Agreement has been duly executed and delivered by such Party and
constitutes the valid and binding obligation of such Party, enforceable against
such Party in accordance with its terms, except as enforceability may be limited
by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and
other Applicable Laws relating to or affecting creditors’ rights generally and
by general equitable principles;

10.2.2.such Party has the full right, power and authority to execute, deliver
and perform this Agreement;

10.2.3.the execution, delivery and performance of this Agreement have been duly
authorized by all necessary action on the part of such Party and its officers
and directors;

10.2.4.the execution, delivery and performance of this Agreement do not breach,
violate, contravene or constitute a default under any contracts, arrangements or
commitments to which such Party is a party or by which it is bound nor do the
execution, delivery and performance of this Agreement by such Party violate any
order or Applicable Law of any court or Governmental Authority having authority
over it; and

10.2.5.such Party will not enter into any contract, arrangement or commitment in
the future that conflicts with or violates any term or provision of this
Agreement.

10.3.Alkermes Representations and Warranties.  Alkermes further represents and
warrants to Biogen as of the Effective Date as follows: 

10.3.1.Exhibit B contains a complete and correct list of all Patent Rights
Controlled by Alkermes or its Affiliates as of the Effective Date that (i) are
necessary for the Exploitation of the Alkermes 8700 Product in the Field in the
Territory or (ii) Cover any Know-How Controlled by Alkermes or its Affiliates on
the Effective Date that (a) is or was used in the Development or Manufacture of
Products or (b) is or was embodied in Products;

48

--------------------------------------------------------------------------------

 

 

10.3.2.Alkermes has and will have the full right, power and authority to grant,
and is not required to obtain the consent of any Third Party to grant, the
rights and licenses granted to Biogen under Article 6;

10.3.3.Except as set forth in Schedule 10.3.3, Alkermes owns the entire right,
title and interest in and to the Licensed Patents and the Licensed Know-How,
free of any encumbrance, lien, charge, license grant, option grant or other
burden, and any such encumbrance, lien, charge, license grant, option grant or
other burden set forth in Schedule 10.3.3 will not negatively affect Alkermes’
right to grant the license to Biogen pursuant to Article 6;

10.3.4.the polymorph used by Alkermes in the Alkermes 8700 Product was disclosed
in WO2014/152494, which published September 25, 2014 and is owned or otherwise
Controlled by Alkermes, as compound (14) of Example 1, and which is further
characterized in Example 7 and Figure 7 therein; 

10.3.5.the data provided by Alkermes to Biogen that characterizes the polymorph
used by Alkermes in the Alkermes 8700 Product, including the x-ray powder
diffraction data, is true and complete and correct in all material respects;

10.3.6.Alkermes has complied in all material respects with all Applicable Laws
in connection with the Prosecution of the Licensed Patents, including, with
respect to any issued patents and pending patent applications, any disclosure
requirements of the United States Patent and Trademark Office or any other
Governmental Authority and has timely paid all filing and renewal fees payable
with respect thereto;

10.3.7.Alkermes has obtained, or caused its Affiliates, as applicable, to
obtain, assignments from the inventors of all inventorship rights to the
Licensed Patents, and all such assignments are valid and enforceable, and the
inventorship of the Licensed Patents is properly identified on each patent or
patent application;

10.3.8.to Alkermes’ Knowledge, no Third Party is infringing any Licensed Patent;

10.3.9.to Alkermes’ Knowledge, the Exploitation of the Alkermes 8700 Product in
the Field in the Territory does not infringe any issued Patent Right of any
Third Party and Alkermes has disclosed to Biogen, to Alkermes’ Knowledge, any
pending Patent Rights that, if issued, may be infringed by the Exploitation of
the Alkermes 8700 Product in the Field in the Territory;

10.3.10.Alkermes has not received notice of any claims, and there are no
judgments or settlements against or owed by Alkermes or, to Alkermes’ Knowledge,
any pending or threatened claims or litigation, in each case, claiming that a
Patent Right owned by such Third Party would be infringed by Exploitation of the
Products in the Field in the Territory;

10.3.11.to Alkermes’ Knowledge, Alkermes has the right to use, and to permit
Biogen, Biogen’s Affiliates and Biogen’s Sublicensees to use, the Licensed
Know-How for all permitted purposes under this Agreement;

49

--------------------------------------------------------------------------------

 

 

10.3.12.to Alkermes’ Knowledge, the Manufacture of the Alkermes 8700 Product as
conducted or as currently planned to be conducted (including for Commercial
Supplies), in each case, as of the Effective Date does not and will not infringe
any Patent Right of any Third Party or misappropriate any Know-How of any Third
Party (for clarity, this provision applies to Patent Rights and Know-How of
Third Parties that Cover the process of manufacturing the Alkermes 8700
Product);

10.3.13.Alkermes and its Affiliates have taken commercially reasonable measures
consistent with industry practices to protect the secrecy, confidentiality and
value of all Licensed Know-How that constitutes trade secrets under Applicable
Law (including requiring all employees, consultants and independent contractors
to execute binding and enforceable agreements requiring all such employees,
consultants and independent contractors to maintain the confidentiality of such
Licensed Know-How) and, to Alkermes’ Knowledge, such Licensed Know-How has not
been used, disclosed to or discovered by any Third Party except pursuant to such
confidentiality agreements and there has not been a breach by any party to such
confidentiality agreements;

10.3.14.the Licensed Patents are, to Alkermes’ Knowledge, valid and enforceable,
and no Third Party has made any claim made against Alkermes or its Affiliates
asserting the invalidity, unenforceability or non-infringement of any Licensed
Patents (including, by way of example, through the institution or written threat
of institution of interference, nullity, opposition, inter partes or post-grant
review or similar invalidity proceedings before the United States Patent and
Trademark Office or any analogous foreign Governmental Authority);

10.3.15.Except as set forth in Schedule 10.3.3, the Licensed Patents and
Licensed Know-How are not subject to any funding agreement with any Governmental
Authority or any other Third Party, and are not subject to the requirements of
the Bayh-Dole Act or any similar provision of any Applicable Law;

10.3.16.neither Alkermes nor any of its Affiliates (i) are subject to any
obligation to or with any Third Party that causes Alkermes or its Affiliates not
to Control (or otherwise not have rights to) any Patent Right or Know-How that
would, but for such obligation, be included in the Licensed Patents or the
Licensed Know-How or (ii) hold for use or otherwise have rights to, but do not
Control, any Patent Rights or Know-How that would otherwise be included in the
Licensed Patents or Licensed Know-How if such Patent Rights or Know-How were
Controlled by Alkermes or an Affiliate;

10.3.17.there is no action, claim, demand, suit, proceeding, arbitration,
grievance, citation, summons, subpoena, inquiry or investigation of any nature,
civil, criminal, regulatory or otherwise, in law or in equity, pending or, to
Alkermes’ Knowledge, threatened, with any judicial or arbitrative body against
Alkermes or any of its Affiliates in connection with the Licensed Patents, the
Licensed Know-How or the Products;

10.3.18.the Development and Manufacture of the Alkermes 8700 Product have been
conducted in all material respects in accordance with Applicable Law;

50

--------------------------------------------------------------------------------

 

 

10.3.19.in the Development and Manufacture of the Alkermes 8700 Product,
Alkermes is not, as of the Effective Date, using any employee who is debarred by
the FDA or any other Regulatory Authority, or who is the subject of debarment
proceedings by the FDA or any such Regulatory Authority;

10.3.20.to Alkermes’ Knowledge, in the Development and Manufacture of the
Alkermes 8700 Product, Alkermes has not previously used any employee and has not
previously used, and is not currently using, any consultant, in each case, who
is or has been debarred by the FDA or any other Regulatory Authority, or, to
Alkermes’ Knowledge, who is or has been the subject of debarment proceedings by
the FDA or any such Regulatory Authority; and

10.3.21.Alkermes has not knowingly withheld from Biogen information relating to
the Licensed Patents, the Licensed Know-How and the Alkermes 8700 Product, in
each case, that Alkermes reasonably believes would be material to Biogen’s
decision to enter into this Agreement and undertake the commitments and
obligations set forth herein.

10.4.Biogen Representations and Warranties.   Biogen further represents and
warrants to Alkermes that, as of the Effective Date, Biogen has undertaken an
assessment of the reportability of the transactions contemplated by this
Agreement under the HSR Act, and following such assessment, Biogen has concluded
that pursuant to 16 CFR 801.10, a filing under the HSR Act is not required as of
the Effective Date.

10.5.Responsibility for Government Approvals.   Biogen, as the acquirer of the
licenses granted in Article 6, shall determine, control and direct strategy
regarding requesting Governmental Approvals in connection with the transactions
contemplated by this Agreement, including with respect to determining the
necessity of requesting Governmental Approvals for the transactions contemplated
by this Agreement by any Governmental Authority, and if applicable, all matters
relating to any review by any Governmental Authority, or any litigation by, or
negotiations with, any Governmental Authority related thereto, and will take the
lead in all meetings, discussions, and communications, if any, with any
Governmental Authority relating to requesting or obtaining all Governmental
Approvals for the transactions contemplated by this Agreement (provided that
this Section 10.5 shall not apply to any Regulatory Approvals that may be
required to Exploit the Alkermes 8700 Product prior to the Transfer Completion
Date). 

Article 11

LIABILITY

11.1.Limitation of Liability.  EXCEPT FOR (i) LIABILITY FOR EITHER PARTY’S
BREACH OF ARTICLE 8, (ii) THE PARTIES’ INDEMNIFICATION OBLIGATIONS PURSUANT TO
SECTIONS 11.2 AND 11.3 OR (iii) ANY LIABILITY ARISING FROM A PARTY’S FRAUD OR
WILLFUL MISCONDUCT, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY OR ANY OF
SUCH OTHER PARTY’S REPRESENTATIVES OR STOCKHOLDERS FOR ANY INDIRECT, INCIDENTAL,
SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES OR LOST PROFITS OR LOST
REVENUES ARISING OUT OF OR RESULTING FROM THIS

51

--------------------------------------------------------------------------------

 

 

AGREEMENT, REGARDLESS OF WHETHER IT HAS BEEN INFORMED OF THE POSSIBILITY OR
LIKELIHOOD OF SUCH DAMAGES OR THE TYPE OF CLAIM, CONTRACT OR TORT (INCLUDING
NEGLIGENCE).

11.2.Biogen Indemnification.  Biogen will indemnify, defend and hold harmless
Alkermes and its Affiliates and their respective directors, officers, employees
and agents (each an “Alkermes Indemnified Party”) from and against all costs,
losses, liabilities, expenses (including reasonable attorneys’ fees, experts’
fees and other costs of investigation or defense at any stage of the
proceedings) and damages (collectively, “Losses”) to the extent relating to a
claim, action or demand (“Claim”) by a Third Party or Governmental Authority
arising out of or resulting from:

11.2.1.any breach of this Agreement by Biogen;

11.2.2.the violation of any Applicable Law by or on behalf of Biogen, its
Affiliates or its Sublicensees;

11.2.3.Development or Commercialization of any Product in the Field in the
Territory by or on behalf of Biogen, its Affiliates or its Sublicensees,
including use of the Products by Third Parties;

11.2.4.a trademark infringement action pursuant to Section 7.9.2; or

11.2.5.the gross negligence or willful misconduct of any Biogen Indemnified
Party;

except to the extent such Claim is subject to an indemnification, defense or
hold harmless obligation of Alkermes set forth in Section 11.3 or in any Supply
Agreement.

11.3.Alkermes Indemnification.  Alkermes will indemnify, defend and hold
harmless Biogen and its Affiliates and their respective directors, officers,
employees and agents (each a “Biogen Indemnified Party”) from and against all
Losses relating to a Claim by a Third Party or Governmental Authority to the
extent arising out of or resulting from:

11.3.1.any breach of this Agreement by Alkermes;

11.3.2.the violation of any Applicable Law by or on behalf of Alkermes or its
Affiliates;  

11.3.3.Development of any Product in the Field in the Territory by or on behalf
of Alkermes or its Affiliates; 

11.3.4.Development or Commercialization of the Alkermes 8700 Product by or on
behalf of Alkermes or its Affiliates after the effective date of termination of
this Agreement with respect to the Alkermes 8700 Product or in its entirety; or

11.3.5.the gross negligence or willful misconduct of any Alkermes Indemnified
Party;

52

--------------------------------------------------------------------------------

 

 

except to the extent such Claim is subject to an indemnification, defense or
hold harmless obligation of Biogen set forth in Section 11.2 or in any Supply
Agreement.

11.4.Indemnification Procedures.  In the event of any Claim by a Third Party or
Governmental Authority against any Alkermes Indemnified Party or Biogen
Indemnified Party (individually, an “Indemnitee”), the indemnified Party shall
promptly notify the other Party in writing of the Claim and the indemnifying
Party shall manage and control, at its sole expense, the defense of the Claim
and any settlement thereof.  The Indemnitee shall cooperate with the
indemnifying Party and may, at its option and expense, be represented in any
such action or proceeding.  The indemnifying Party shall not be liable for any
settlements, litigation costs or expenses incurred by any Indemnitee without the
indemnifying Party’s prior written authorization.  Notwithstanding the
foregoing, if the indemnifying Party believes that any of the exceptions to its
obligation of indemnification of the Indemnitees set forth in Sections 11.2 or
11.3, as applicable, may apply, the indemnifying Party shall promptly notify the
Indemnitees, which may be represented in any such action or proceeding by
separate counsel at their expense; provided, however, that the indemnifying
Party shall be responsible for payment of such expenses if the Indemnitees are
ultimately determined to be entitled to indemnification from the indemnifying
Party.  Notwithstanding any other provision of this Article 11 to the contrary,
no Indemnitee under this Agreement shall be required to waive a conflict of
interest under any applicable rules of professional ethics or responsibility if
such waiver would be required for a single law firm to defend both the
indemnifying Party and one or more Indemnitees.  In such case, the indemnifying
Party shall provide a defense of the affected Indemnitees through a separate law
firm reasonably acceptable to the affected Indemnitees at the indemnifying
Party’s expense.  Except with the approval of an Indemnitee, which approval will
not be unreasonably withheld or delayed, the indemnifying Party will not consent
to entry of any judgment or enter into any settlement that would admit any
wrongdoing by, or result in injunctive or other relief being imposed against, an
Indemnitee.

11.5.Cooperation.  The indemnified Party and each Indemnitee will cooperate in
the defense or prosecution of any action or proceeding with respect to which it
is being indemnified and will furnish such records, information and testimony,
provide such witnesses and attend such conferences, discovery proceedings,
hearings, trials and appeals as may be reasonably requested by the indemnifying
Party in connection with such action or proceeding.  Such cooperation will
include access during normal business hours afforded to the indemnifying Party
to, and reasonable retention by the indemnified Party and the Indemnitee of,
records and information that are reasonably relevant to such action or
proceeding, and making Indemnitees and other employees and agents available on a
mutually convenient basis to provide additional information and explanation of
any material provided hereunder, and the indemnifying Party will reimburse the
indemnified Party for all its reasonable out-of-pocket expenses incurred in
connection with such cooperation.

11.6.Insurance.  As of the Effective Date each Party shall procure and maintain,
at its sole cost and expense, commercial general liability insurance and
products liability coverage in amounts not less than Ten Million U.S. Dollars
(US$10,000,000) per incident and Twenty Million U.S. Dollars (US$20,000,000)
annual aggregate.  In the event of an indemnification claim pursuant to Sections
11.2 or 11.3 above, such insurance will be primary to any insurance owned,
secured or put in place by the Indemnitee.  All such policies will be written by
insurance

53

--------------------------------------------------------------------------------

 

 

companies with an A.M. Best’s rating (or its equivalent) of A-VII or higher.  In
the event that any of these policies are written on a claims-made basis, then
such policies shall be maintained during the Term and until the later of (i)
three (3) years after expiration of Term or (ii) sixty (60) days following
expiration of all applicable statutes of limitation for any potential Claims
that may be indemnified Losses pursuant to Sections 11.2 or 11.3, as applicable.
 Upon written request, each Party will provide the other Party with a
certificate of insurance attesting to such coverage.  The minimum amounts of
insurance coverage required under this Section 11.6 shall not be construed to
create a limit of either Party’s liability with respect to its indemnification
obligation under Sections 11.2 or 11.3 above, as applicable.  Notwithstanding
the foregoing, Biogen and Alkermes may self-insure to the extent that such Party
self-insures for its other products.

Article 12

DISPUTE RESOLUTION

12.1.Disputes.    

12.1.1.Objective.  The Parties recognize that disputes, controversies or claims
arising out of or relating to this Agreement or any Supply Agreement, or the
interpretation, breach, termination or invalidity hereof or thereof (each a
“Dispute”), may from time to time occur during the Term.  It is the objective of
the Parties to establish procedures to facilitate the resolution of Disputes
occurring with respect to this Agreement or any Supply Agreement, in an
expedient manner by mutual cooperation and without resorting to litigation.  To
accomplish this objective, the Parties agree to follow the procedures set forth
in this Article 12 if and when a Dispute occurs with respect to this Agreement
or any Supply Agreement. Notwithstanding the foregoing or anything to the
contrary in this Agreement, with respect to any matter under this Agreement, (a)
if such matter is within the scope of the JSC’s authority, the dispute
resolution provisions of Section 2.1.4 and not this Article 12 shall apply with
respect to such matter and (b) if this Agreement expressly provides that such
matter is subject to a Party’s sole discretion or to a Party’s sole or final
decision-making authority, such matter shall not be subject to dispute
resolution under this Article 12, but may be finally determined by such Party in
accordance with the terms of this Agreement.

12.1.2.Escalation.  With respect to any Dispute under this Agreement, other than
any Dispute relating to the scope, validity or enforceability of a Licensed
Patent or a Collaboration Patent (which may only be determined in accordance
with Section 12.3 hereof), either Party (the “Complaining Party”) may present
such Dispute for resolution by senior management of each of Alkermes and Biogen
(in the case of Alkermes, its Chief Executive Officer or a designee, and in the
case of Biogen, its Chief Executive Officer or a designee) (collectively,
“Senior Management”) by providing a dispute notice (the “Dispute Notice”) to
Senior Management and the other Party.  The Dispute Notice will concisely set
forth the Dispute, the Parties’ respective positions, and the specific relief
requested.  Within ten (10) days after receipt of a Dispute Notice, the Party
receiving the Dispute Notice will provide a concise written response (the
“Response”) to such Dispute Notice to Senior Management and the Complaining
Party. Senior Management will attempt to resolve such Dispute within ten (10)
days after receipt by Senior Management of the Response. In the event that
Senior Management cannot resolve a

54

--------------------------------------------------------------------------------

 

 

Dispute within the ten (10)-day period, unless otherwise agreed by the Parties,
such Dispute may be referred by either Party to arbitration in accordance with
Section 12.1.3 upon written notice to the other Party.    

12.1.3.Arbitration.  The Parties agree that any Dispute referred for arbitration
by a Party pursuant to Section 12.1 will be resolved through binding arbitration
in accordance with the CPR International Institute for Conflict Prevention and
Resolution Rules for Non-Administered Arbitration, as amended from time to time
(the “CPR Rules”).  If either Party receives a Dispute Notice, then any
associated time to cure will be stayed pending the resolution of the issue
pursuant to this Section 12.1.3.  Any Dispute in which either Party seeks in
excess of Twenty Million U.S. Dollars (US$20,000,000) in damages will be
resolved by an arbitral tribunal consisting of three (3) arbitrators, one (1) of
whom will be designated by each Party in accordance with the CPR Rules, and a
third arbitrator who will chair the tribunal and who will be selected as
provided in the CPR Rules.  Any other Dispute, aside from those seeking
equitable relief, will be submitted to a sole arbitrator, appointed pursuant to
the CPR Rules.  Any suit seeking equitable relief shall be heard by a court of
competent jurisdiction pursuant to Section 12.2.  The arbitrator(s) will render
a written opinion setting forth findings of fact and conclusions of law with the
reasons therefor stated.  Arbitration pursuant to this Section 12.1.3 will be
governed by the Federal Arbitration Act, 9 U.S.C. §§ 1-16, and judgment upon the
award rendered by the arbitrators may be entered by any court having
jurisdiction thereof.  The arbitration proceedings for all Disputes will be
conducted in New York, New York in English and will be confidential in
nature.  Each Party will continue to perform its obligations under the Agreement
pending final resolution of any Dispute unless to do so would be impossible or
impracticable under the circumstances.  The Parties agree that they will share
equally the cost of the arbitration filing and hearing fees, and the cost of the
arbitrators.  Each Party must bear its own attorneys’ fees and associated costs
and expenses. 

12.2.Jurisdiction.  The Parties agree to the exclusive jurisdiction of the
federal courts located in the State of New York for the purposes of enforcing
awards entered pursuant to this Article 12 and for enforcing the agreements
reflected in this Article 12.  

12.3.Determination of Disputes Relating to Patents.  Notwithstanding anything to
the contrary herein, any Dispute relating to the determination of scope,
validity or enforceability of a Licensed Patent or Collaboration Patent will be
submitted exclusively to the national court or other tribunal having
jurisdiction over the disputed patent.

12.4.Equitable Relief.  The Parties agree that irreparable harm may occur in the
event any of the provisions of Article 6,  Article 7,  Article 8, in each case,
are not performed in accordance with the terms of this Agreement or are
otherwise breached and that money damages may not be a sufficient remedy for
such a breach of this Agreement.  Therefore, in addition to, and not in
limitation of, any other remedy available to either Party, a Party will be
entitled to seek, at its sole expense, injunctive relief or other equitable
relief in the event of any such breach or threatened breach of this Agreement by
the other Party from a court of competent jurisdiction, and such an action may
be filed and maintained notwithstanding any ongoing arbitration
proceeding.  Such remedies, and all other remedies provided for in this
Agreement, shall be cumulative and not exclusive and will be in addition to any
other remedies a Party may have under Applicable Law or in equity or otherwise.

55

--------------------------------------------------------------------------------

 

 

 

Article 13

TERM AND TERMINATION

13.1.Term.  This Agreement will commence as of the Effective Date and, unless
sooner terminated as provided in this Article 13, will continue in effect until
the expiration of the last Royalty Term as set forth in Section 9.5.3 (such
period, the “Term”). 

13.2.Right to Terminate for Government Prohibition.  Either Party will have the
right to terminate this Agreement effective immediately upon written notice to
the other Party, following the issuance of any order, decree or judgment by any
Governmental Authority that makes illegal, enjoins or prohibits the transactions
effected by this Agreement.

13.3.Biogen’s Right to Terminate for Convenience.   Biogen may terminate this
Agreement, on a Product-by-Product basis or in its entirety, for any reason or
for no reason, upon fifteen (15) days’ prior written notice to Alkermes;
provided that, from and after the date of the First FDA Approval, Biogen may
only terminate this Agreement, with respect to the Alkermes 8700 Product or in
its entirety, upon one hundred and eighty (180) days’ prior written notice to
Alkermes.   Notwithstanding anything to the contrary set forth in this
Agreement, from and after any notice of termination provided by Biogen to
Alkermes under this Section 13.3 that terminates the Agreement with respect to
the Alkermes 8700 Product or in its entirety, Biogen will not be obligated to
make any further Minimum Annual Payments.

13.4.Right to Terminate Upon Bankruptcy.  Either Party may, in addition to any
other remedies available to it under Applicable Law or in equity, terminate this
Agreement, effective immediately upon written notice to the other Party in the
event (i) the other Party has made an assignment for the benefit of its
creditors; (ii) there has been appointed an administrator, trustee or receiver
for the other Party or for all or a substantial part of its property; or (iii)
any case or proceeding has been commenced or other action taken by or against
the other Party in bankruptcy or seeking reorganization, liquidation,
dissolution, winding-up, arrangement, composition or readjustment of its debts
or any other relief under any bankruptcy, insolvency, reorganization or other
similar act or Applicable Law of any jurisdiction now or hereafter in effect,
and any such event has continued for sixty (60) days undismissed.

13.5.Effects of Termination.    

13.5.1.Termination of License Grants. Upon any termination (but not expiration)
of this Agreement in its entirety, except for the licenses and rights granted
under Sections 13.5.2 and 13.5.3, all other licenses and rights granted by a
Party to the other Party hereunder will terminate. Upon any termination of this
Agreement with respect to a Product pursuant to Section 13.3, except for the
licenses and rights granted under Sections 13.5.2 and 13.5.3, all other licenses
and rights granted by a Party to the other Party hereunder with respect to such
Product(s) (as applicable) shall terminate.

13.5.2.Alkermes 8700 Product Rights. In the event of a termination (but not
expiration) of this Agreement with respect to the Alkermes 8700 Product or in
its entirety, so

56

--------------------------------------------------------------------------------

 

 

long as at such time (1) GI Inferiority does not exist or GI Inferiority exists
and Biogen has Commercialized the Alkermes 8700 Product, and (2) Alkermes is not
then in breach of its obligations under this Agreement (unless such breach is
curable and has been cured no later than sixty (60) days after written notice
from Biogen to Alkermes requesting cure of such breach), then at Alkermes’
written request, Biogen shall:

(i)within a reasonable time period, transfer to Alkermes all ongoing Clinical
Trials being conducted by the Parties for the Alkermes 8700 Product as of the
effective date of such termination of this Agreement, if permitted by Applicable
Law and the applicable Regulatory Authorities (or any data monitoring review
board or internal safety review board), and provide cooperation reasonably
requested by Alkermes in connection with such transfer;

(ii)if such termination occurs after the Transfer Completion Date, then no later
than one (1) Business Day following the effective date of such termination, (a)
send a letter to the FDA to transfer and assign to Alkermes all Regulatory
Approvals and regulatory filings related to the Alkermes 8700 Product, including
the Alkermes 8700 Product 505(b)(2) NDA and (b) transfer to Alkermes a complete
copy of the Alkermes 8700 Product 505(b)(2) NDA and any other application for
Regulatory Approval of the Alkermes 8700 Product and all regulatory filings,
regulatory documentation and other supplements and records related to such NDA
and applications that are required to be kept under 21 C.F.R. § 314.81, in each
case, in Biogen’s possession and Control as of the effective date of such
termination of this Agreement;

(iii)no later than one (1) Business Day following the effective date of such
termination, transfer to Alkermes a true and complete copy of (a) all data and
results generated from any Development activities conducted by or on behalf of
Biogen with respect to the Alkermes 8700 Product prior to the effective date of
such termination of this Agreement, (b) all Trial Master Files (including any
Trial Master File plans, tables of contents or indices and any evidence or
certification of related quality checks) or equivalents thereof, for all
completed or ongoing Clinical Trials of the Alkermes 8700 Product conducted by
or on behalf of Biogen and (c) all other tangible embodiments of the
Collaboration Know-How, in each case, in Biogen’s possession and Control as of
the effective date of such termination of this Agreement;

(iv)as of the effective date of such termination, grant to Alkermes an exclusive
(even as to Biogen and its Affiliates), fully paid-up, perpetual, irrevocable
and royalty-free, worldwide license, with the right to grant sublicenses through
multiple tiers, under Biogen Collaboration Know-How and Biogen Collaboration
Patents to Exploit the Alkermes 8700 Product in the Initial Indication in the
Territory; and

(v)as of the effective date of such termination, grant to Alkermes a
non-exclusive, fully paid-up, perpetual, irrevocable and royalty-free, worldwide
license, with the right to grant sublicenses through multiple tiers, under any
Know-How and Patent Rights that (a) are Controlled by Biogen or its Affiliates
as of the effective date of such termination, (b) are invented after the
Effective Date and prior to the effective date of such termination in the course
of performance of activities by Biogen or its Affiliates or Sublicensees under
this Agreement and (c) relate to (with respect to Know-How) or Cover (with
respect to Patent Rights) the Alkermes 8700 Product in the form such product
exists as of the effective date of such termination to

57

--------------------------------------------------------------------------------

 

 

Exploit the Alkermes 8700 Product in the form such product exists as of the
effective date of such termination in the Initial Indication in the Territory.

13.5.3.License to Biogen Know-How and Biogen Patents. In the event of a
termination (but not expiration) of this Agreement with respect to the Alkermes
8700 Product or in its entirety, so long as at such time (i) GI Inferiority does
not exist or GI Inferiority exists and Biogen has Commercialized the applicable
Product and (ii) Alkermes is not then in breach of its obligations under this
Agreement (unless such breach is curable and has been cured no later than sixty
(60) days after written notice from Biogen to Alkermes requesting cure of such
breach), then at Alkermes’ written request, the Parties will negotiate in good
faith the terms and conditions of the grant of a license to Alkermes under
Know-How and Patent Rights Controlled by Biogen prior to the Effective Date that
Cover the Alkermes 8700 Product and that are not licensed to Alkermes pursuant
to Sections 13.5.2(iv) or Section 13.5.2(v).  

13.5.4.Costs of Product Reversion to Alkermes. Alkermes shall be responsible for
all costs and expenses incurred [**] in connection with the activities set forth
in Section 13.5.2, and thereafter Biogen shall be responsible for all such costs
and expenses incurred.

13.5.5.Surviving Sublicensee.  Following the effective date of any termination
of this Agreement, at the request of any Sublicensee with a market
capitalization (or other independent valuation) of at least Ten Billion U.S.
Dollars (US$10,000,000,000), and who is not then in breach of its Sublicense
Agreement and is otherwise in good standing, subject to Alkermes’ receipt of a
copy from such Sublicensee of the Sublicense Agreement with such
Sublicensee  (together with all modifications or amendments); provided that any
such copy may be redacted to remove any confidential, proprietary or competitive
information of Biogen, Alkermes will enter into, without any assistance by
Biogen, a direct license agreement with such Sublicensee under the Licensed
Know-How and Licensed Patents that are sublicensed to such Sublicensee on
substantially the same terms, i.e., provides Sublicensee and Alkermes (as a
substitute thereunder for Biogen) the same rights and obligations, as set forth
in such Sublicense Agreement between Biogen and such Sublicensee effective as of
the date of termination of the Sublicense Agreement granted to Sublicensee by
Biogen; provided,  however, that (a) such direct license agreement would not
impose on Alkermes any obligations over and above its obligations under this
Agreement and would not impose on any such Sublicensee any obligations over and
above its obligations under the applicable Sublicense Agreement, and (b) as
consideration for such direct license, the direct license agreement would
require Sublicensee to pay Alkermes the same amount as Alkermes would have
received from Biogen (had this Agreement survived) as a result of the
Sublicensee’s performance under such Sublicense Agreement. During the pendency
of any negotiation of a direct license agreement between Alkermes and the
applicable Sublicensee in accordance with this Section 13.5.5, so as to ensure
no disruption in the rights granted to such Sublicensee, such Sublicensee is
hereby licensed to continue to exercise its rights and will continue to perform
its obligations, in each case, as set forth under such Sublicense Agreement and
the applicable terms under such Sublicense Agreement will apply mutatis mutandis
to Alkermes rather than Biogen, except that Alkermes will not have any
obligations over and above its obligations under this Agreement. As provided in
this Section 13.5.5, in the event of any termination of this Agreement, Alkermes
will not have the right to terminate or otherwise restrict any rights granted to
a Sublicensee that is not also in breach of this Agreement

58

--------------------------------------------------------------------------------

 

 

or the applicable Sublicense Agreement. For any Sublicensee with a market
capitalization (or other independent valuation) of less than Ten Billion U.S.
Dollars (US$10,000,000,000) and who is not then in breach of its Sublicense
Agreement and is otherwise in good standing, Alkermes agrees to discuss in good
faith with such Sublicensee a direct license agreement with such Sublicensee
under the Licensed Know-How and Licensed Patents that are sublicensed to such
Sublicensee.

13.6.Bankruptcy. 

13.6.1.All rights and licenses granted under or pursuant to this Agreement are,
and shall otherwise be deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code or analogous provisions of Applicable Law outside the U.S.,
licenses of right to “intellectual property” as defined under Section 101 of the
Bankruptcy Code or analogous provisions of Applicable Law outside the U.S.
(hereinafter “IP”).  The Parties agree that the licensee of any such rights
under this Agreement shall retain and may fully exercise all of its rights and
elections under the Bankruptcy Code or any other provisions of Applicable Law
outside the U.S. that provide similar protection for IP.  The license-granting
Party shall, during the Term, create and maintain current copies of all IP
licensed to the other Party under this Agreement.  Upon the bankruptcy of a
Party, the other Party shall further be entitled to a complete duplicate of (or
complete access to, as appropriate) any such IP, and such IP, if not already in
such other Party’s possession, shall be promptly delivered to such other
Party.  Each Party acknowledges and agrees that “embodiments” of such IP within
the meaning of Section 365(n) include, without limitation, laboratory notebooks,
product samples and inventory, research studies and data, all Regulatory
Approvals and rights of reference therein, and all embodiments of any Licensed
Know-How.  If (a) a case under the Bankruptcy Code is commenced by or against a
license-granting Party, (b) this Agreement is rejected as provided in the
Bankruptcy Code, and (c) the other Party elects to retain its rights hereunder
as provided in Section 365(n) of the Bankruptcy Code, the license-granting Party
(in any capacity, including debtor-in-possession) and its successors and assigns
(including a trustee) shall:

(i)provide to the other Party all such IP (including all embodiments thereof) in
such license-granting Party’s possession on terms agreed by the Parties,
promptly upon the other Party’s written request; and 

(ii)not interfere with the other Party’s rights under this Agreement, or any
agreement supplemental hereto, to such IP (including such embodiments),
including any right to obtain such IP (or such embodiments) from another entity,
to the extent provided in Section 365(n) of the Bankruptcy Code.

13.6.2.All rights, powers and remedies provided herein are in addition to and
not in substitution for any and all other rights, powers and remedies now or
hereafter existing at law or in equity (including the Bankruptcy Code) in the
event of the commencement of a case under the Bankruptcy Code with respect to
either Party.  The Parties agree that they intend the following rights to extend
to the maximum extent permitted by law, and to be enforceable under Bankruptcy
Code Section 365(n) upon any rejection of this Agreement: (a) the right of
access to any IP (including all embodiments thereof) of the license-granting
Party or any Third Party with whom the license-granting Party contracts to
perform any of its obligations

59

--------------------------------------------------------------------------------

 

 

under this Agreement; and (b) the right to contract directly with any such Third
Party to complete the contracted work.

13.7.Survival of Certain Provisions.  Termination of this Agreement for any
reason or expiration of this Agreement will not release either Party from any
obligation arising prior to the date of expiration or termination.  The rights
and obligations under Section 3.8.1 and Section 3.8.3 (in each case solely with
respect to amounts accruing prior to the effective date of termination or
expiration of this Agreement and record-keeping and audits with respect to such
amounts), Section 6.1.3,  Section 7.1,  Section 10.1, Section 13.5 and this
Section 13.7 and Article 1 (solely to the extent necessary to give effect to the
other surviving provisions), Article 8,  Article 9 (solely with respect to
amounts accruing prior to the effective date of termination or expiration of
this Agreement, and record-keeping and audits with respect to such
amounts), Article 11,  Article 12 and Article 14, in each case, only in the
event and to the extent applicable, and subject to the terms and conditions
stated therein, will survive any expiration or termination of this
Agreement.  Any right to terminate this Agreement, and any rights a Party has
under Section 13.5, as applicable, shall be cumulative and not exclusive and
will be in addition to any other rights or remedies that the Party giving notice
of termination may have under Applicable Law or in equity or otherwise. 

Article 14

GENERAL PROVISIONS

14.1.Notices.  All notices, reports, requests or demands required or permitted
under this Agreement will be sent by hand or overnight courier, properly
addressed to the respective Parties as follows:

If to Alkermes:
Alkermes Pharma Ireland Limited
Connaught House
1 Burlington Road
Dublin 4, Ireland
Attention:  President

With a copy to:

Alkermes Public Limited Company

Connaught House

1 Burlington Road

Dublin 4, Ireland

Attention: Chief Legal Officer

 

If to Biogen:
Biogen MA Inc.

225 Binney Street

Cambridge, MA 02142

Attention: Executive Vice President, Head of R&D

60

--------------------------------------------------------------------------------

 

 

With a copy to:

Biogen MA Inc.

225 Binney Street

Cambridge, MA 02142

Attention: Chief Legal Officer

and

Ropes & Gray LLP

Prudential Tower, 800 Boylston Street

Boston, MA 02199-3600

Attention: Susan Galli, Esq.

or to such address or addresses as the Parties hereto may designate for such
purposes during the Term.  Notices will be deemed to have been sufficiently
given or made: (i) if by hand, when delivered, and (ii) if by overnight courier,
upon receipt by the applicable Party.

14.2.Governing Law.  This Agreement and all questions regarding the existence,
validity, interpretation, breach or performance of this Agreement will be
governed by and construed in accordance with the laws of the State of New York
(other than its choice of law principles).

14.3.Entire Agreement; Amendment.  This Agreement, together with the Exhibits
hereto, represent the entire agreement between the Parties regarding the subject
matter hereof, and supersedes all prior or contemporaneous written or oral
promises or representations relating such subject matter not incorporated herein
(including the Confidentiality Agreements).  The Parties are not relying, and
have not relied, on any representations or warranties whatsoever regarding the
subject matter of this Agreement, express or implied, except for the
representations and warranties set forth in this Agreement.  No amendment or
modification of the terms and conditions of this Agreement will be binding on
either Party unless reduced to writing referencing this Agreement and signed by
a duly authorized officer of each Party. 

14.4.Binding Effect and Assignment.  This Agreement will be binding upon and
inure to the benefit of the Parties hereto and their respective successors and
permitted assigns.  This Agreement will not be assignable by either Party
without the other Party’s prior written consent; provided, however, that either
Party may assign its rights or obligations under this Agreement (in whole or in
part), without the other Party’s written consent but with notice to the other
Party, to an Affiliate.  If any Affiliate to which a Party has assigned its
rights or obligations under this Agreement thereafter ceases to be an Affiliate
of such Party, then such assignment will be deemed to require the consent of the
other Party pursuant to this Section 14.4.   To the extent that the assigning
Party survives as a legal entity, the assigning Party shall remain responsible
for the performance by its assignee of this Agreement or any obligations
hereunder so assigned to such assignee.  Either Party may also assign this
Agreement (in whole or in part) without the other Party’s written consent, but
with notice to the other Party, to any successor pursuant to a Change of
Control, and Biogen may assign this Agreement (in whole or in part), without
Alkermes’ written consent but with notice to Alkermes in connection with the
sale or other

61

--------------------------------------------------------------------------------

 

 

transfer to a Third Party of all or substantially all of Biogen’s assets to
which this Agreement relates (i.e., Tecfidera®, Fumaderm® and any Product).    

14.5.Waiver.  No provision of this Agreement shall be waived by any act,
omission or knowledge of a Party or its agents or employees except by an
instrument in writing expressly waiving such provision and signed by a duly
authorized officer of the waiving Party.  A waiver by either Party of any of the
terms and conditions of this Agreement in any instance will not be deemed or
construed to be a waiver of such term or condition for the future, or of any
other term or condition hereof.  All rights, remedies, undertakings, obligations
and agreements contained in this Agreement will be cumulative and none of them
will be in limitation of any other remedy, right, undertaking, obligation or
agreement of either Party.

14.6.Severability.  If any part of this Agreement will be found to be invalid,
illegal or unenforceable under Applicable Law in any jurisdiction, such part
will be ineffective only to the extent of such invalidity, illegality or
unenforceability in such jurisdiction, without in any way affecting the
remaining parts of this Agreement in that jurisdiction or the validity, legality
or enforceability of the Agreement as a whole in any other jurisdiction.  In
addition, the part that is ineffective will be reformed in a mutually agreeable
manner so as to as nearly approximate the intent of the Parties as possible.

14.7.Counterparts and Signatures.  This Agreement may be executed in two or more
counterparts, each of which will be deemed an original for all purposes, but all
of which together will constitute one and the same instrument.  Signatures
provided by facsimile transmission or in Adobe™ Portable Document Format (PDF)
sent by electronic mail shall be deemed to be original signatures.

14.8.Force Majeure.  Neither Party will be held liable or responsible to the
other Party or be deemed to have breached or defaulted under this Agreement for
failure or delay in performing its obligations hereunder (except for payment of
money) to the extent, and as long as, such failure or delay is caused by or
results from causes beyond the reasonable control of the affected Party (a
“Force Majeure Delay”), including fire, floods, embargoes, war, civil
commotions, terrorism, strikes, lockouts or other labor disturbances, acts of
God, acts of a Governmental Authority or judicial orders or decrees.  In the
event of a Force Majeure Delay, the affected Party will give prompt notice
thereof to the other Party (to the extent possible), will use commercially
reasonable efforts to mitigate the adverse consequences thereof and will resume
performance hereunder with dispatch whenever the consequences of the Force
Majeure Delay have been mitigated.

14.9.Ambiguities.  Ambiguities, if any, in this Agreement will not be construed
against any Party, irrespective of which Party may be deemed to have authored
the ambiguous provision.

14.10.Headings.  Headings are for the convenience of reference only and will not
control the construction or interpretation of any of the provisions of this
Agreement.

14.11.No Partnership.  Nothing in this Agreement is intended or will be deemed
to constitute a partnership, agency, or joint venture relationship between the
Parties. 

62

--------------------------------------------------------------------------------

 

 

Notwithstanding any of the provisions of this Agreement, neither Party will at
any time enter into, incur, or hold itself out to Third Parties as having
authority to enter into or incur, on behalf of the other Party, any commitment,
expense, or liability whatsoever.

14.12.No Third Party Beneficiaries.  No Person other than Alkermes, Biogen and
their respective successors and permitted assigns shall be deemed an intended
beneficiary hereunder or have any right to enforce any provision of this
Agreement.

14.13.Performance by an Affiliate.  Each of Biogen and Alkermes acknowledges
that obligations under this Agreement may be performed by Affiliates of Biogen
and Alkermes.  Each of Biogen and Alkermes will remain responsible for any
obligations of such Party under this Agreement undertaken by one or more of its
Affiliates.

14.14.Further Assurances.  Each Party agrees to do and perform all such further
acts and things and shall execute and deliver such other agreements,
certificates, instruments and documents necessary or that the other Party may
deem advisable in order to carry out the intent and accomplish the purposes of
this Agreement and to evidence, perfect or otherwise confirm its rights
hereunder.

[Signature page follows]

 

63

--------------------------------------------------------------------------------

 

 

In Witness Whereof, each of the Parties has caused this Agreement 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/ Fred Lawson

Name:

Shane Cooke

 

Name:

F. Lawson

Title:

Director

 

Title:

Director

Date:

November 27, 2017

 

Date:

26/11/2017

 

 

 

Signature Page to License and Collaboration Agreement

--------------------------------------------------------------------------------

 

 

EXHIBIT A

Alkermes 8700 Chemical Structure

The chemical structure of the active ingredient in the Alkermes 8700 Product:

 

Picture 1 [alks20171231ex10103cf86001.jpg]

 

 

 

A-1

--------------------------------------------------------------------------------

 

 

EXHIBIT B

Licensed Patents

 

 

B-1

--------------------------------------------------------------------------------

 

 

Picture 1 [alks20171231ex10103cf86002.jpg]

B-2

--------------------------------------------------------------------------------

 

 

Picture 2 [alks20171231ex10103cf86003.jpg]

B-3

--------------------------------------------------------------------------------

 

 

Picture 3 [alks20171231ex10103cf86004.jpg]

B-4

--------------------------------------------------------------------------------

 

 

EXHIBIT C

Initial Development Plan

 

 

C-1

--------------------------------------------------------------------------------

 

 

 

ALKS 8700 Product High‐Level Development Plan

 

* The activities that are allocated to Alkermes, unless otherwise agreed in writing by the Parties, are (1) all activities prior to the  

 
Transfer Completion Date and (2) transition of the P3 Long‐Term Safety Study (‐A301) to Biogen following the Transfer
 

  Completion Date.

 

   [**]

 

 

C-2

--------------------------------------------------------------------------------

 

 

Detailed ALKS 8700 Product Plan – Multiple Sclerosis (505b2)

 

[**]

 

* The activities that are allocated to Alkermes, unless otherwise agreed in writing by the Parties, are (1) all activities prior to the Transfer Completion Date and (2) transition of the P3 Long‐Term Safety Study (‐ A301) to Biogen following the Transfer Completion Date.

 

 

 

C-3

--------------------------------------------------------------------------------

 

 

ALKS 8700 Development Plan Budget – Multiple Sclerosis

 

Spend in $M

FY'17

FY'17

FY'17

FY'17

FY'17

FY'18

FY'18

FY'18

FY'18

FY'18

FY'19

FY'19

FY'19

FY'19

FY'19

Total

Q1

Q2

Q3

Q4

Total

Q1

Q2

Q3

Q4

Total

Q1

Q2

Q3

Q4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Base ALKS 8700 Development (FY16 - FY'21)

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

Clinical

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Phase 1 PK and Clinical Pharmacology Studies

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

ALKS 8700 FIH Study (-001)

[**]

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 MAD / FE Study (-A102)

[**]

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 Relative BA Study Fasted Condition (-A103)

[**]

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 Relative BA Study Fed (HF) Condition (-A104)

[**]

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 Mass Balance Study (-A105)

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 Alcohol Dose Dumping Study (-A106)

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 DDI Study (-A107)

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 Renal Study (-A108)

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 Additional Food Effect Study (-A109)

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

 

 

 

 

 

 

ALKS 8700 Potential tQT Study

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

 

[**]

 

 

 

 

Phase 3 Long-term Safety Study (-A301)

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

Phase 3 Tolerability Study (-A302)

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

Clinical CRO Credits

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

Translational Medicine

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

[**]

 

 

 

 

Non-Clinical

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2-Yr Rat Study

[**]

[**]

 

[**]

[**]

[**]

[**]

 

 

 

[**]

 

 

 

 

Mouse Carci Studies

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

 

[**]

 

 

 

 

Additional Non-Clinical Studies/Activities

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

[**]

 

 

 

 

CMC

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

API & Drug Product Development, Manufacturing, and Supply

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

Medical Affairs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PRO Development & Additional Medical Affairs Activities

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

NDA Submission Fee & supporting preparation spend

[**]

 

 

 

 

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

 

Other – All

[**]

 

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

Pediatric Plan Activities

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

Non-clinical Studies

[**]

 

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

 

 

 

Adult PK Sprinkling Study

[**]

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

Pediatric PK Study

[**]

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

Pediatric Extension

[**]

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

ALKS 8700 External Spend Projection

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

ALKS 8700 Internal Spend Projection

[**]

 

 

 

 

[**]

[**]

[**]

[**]

 

 

Total R&D

[**]

 

 

 

 

[**]

 

 

 

 

[**]

 

 

 

 

 

 

 

C-4

--------------------------------------------------------------------------------

 

 

Phase 3 Long‐Term Safety Study (‐A301)

 

Name of Sponsor/ Company: Alkermes, Inc.

Name of Investigational Product: ALKS 8700

Name of Active Ingredient: ALKS 8700

Title of study: A Phase 3 Open Label Study to Evaluate the Long-term Safety and
Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis

Investigators: This study will be conducted at approximately 125 sites in North
America and Europe.

Study Period:

Estimated date of first subject’s consent: Q4 2015

Estimated date of last subject’s last visit: Q4 2020

Phase of Development:  3

Objectives:

•    Evaluate the long-term safety and tolerability of ALKS 8700 for up to 96
weeks of treatment in adult subjects with relapsing remitting multiple sclerosis
(RRMS)

•    Evaluate treatment effect over time in adult subjects with RRMS treated
with ALKS 8700

Methodology:

[**]

 

C-5

--------------------------------------------------------------------------------

 

 

Study Design Schematic

[**]

 

Number of Subjects Planned: [**]

Main Criteria for Inclusion:

[**]

 

Investigational Product, Dosage, Duration and Mode of Administration:

[**]

 

Reference Therapy, Dosage, Duration and Mode of Administration:

[**]

 

Duration of Study:

[**]

 

 

C-6

--------------------------------------------------------------------------------

 

 

Criteria for Evaluation:

Safety and Tolerability:

[**]

 

 

Efficacy:

[**]

 

 

Pharmacokinetics:

[**]

 

Statistical Methods: [**]

 

 

Study Populations: [**]

 

 

C-7

--------------------------------------------------------------------------------

 

 

Safety: [**]

 

 

Efficacy: [**]

 

 

Pharmacokinetics: [**]

 

 

Sample Size Considerations: [**]

 

 

C-8

--------------------------------------------------------------------------------

 

 

Phase 3 Tolerability Study (‐A302)

 

Name of Sponsor/ Company: Alkermes, Inc.

Name of Investigational Product: ALKS 8700

Name of Active Ingredient: ALKS 8700

Title of study: A Phase 3 Study in Subjects with Relapsing Remitting Multiple
Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate

Investigators: This study will be a multicenter study.

Study Period:

Estimated date of first subject’s consent: Q1 2017

Estimated date of last subject’s last visit: [**]

Phase of Development:  3

Objectives:

•    Evaluate the utility of two GI symptom scales (IGISIS and GGISIS) and
endpoints derived from the scales in assessing GI tolerability in adult subjects
with relapsing remitting multiple sclerosis (RRMS) (after administration of ALKS
8700 or DMF in Part A

•    Compare the GI tolerability of ALKS 8700 and DMF in adult subjects with
RRMS using two GI symptom scales (IGISIS and GGISIS) in Part B with endpoints
informed from Part A

•    Evaluate the safety and tolerability of ALKS 8700 in adult subjects with
RRMS in Parts A and B

Methodology (Part A and Part B): [**]

 

 

 

C-9

--------------------------------------------------------------------------------

 

 

Number of Subjects Planned (Part A and Part B): [**]

 

 

Main Criteria for Inclusion (Part A and Part B): [**]

 

 

Investigational Product, Dosage, Duration and Mode of Administration (Part A and
Part B): [**]

 

 

Reference Therapy, Dosage, Duration and Mode of Administration (Part A and Part
B): [**]

 

 

C-10

--------------------------------------------------------------------------------

 

 

Duration of Study (Part A and Part B): [**]

 

Criteria for Evaluation (Part A and Part B):

 

Endpoints:

 

Primary Endpoint: [**]

 

Secondary Endpoints: [**]

 

Safety and Tolerability (Part A and Part B): [**]

 

Exploratory Efficacy (Part A and Part B): [**]

 

Pharmacokinetics (Part A): [**]

 

 

C-11

--------------------------------------------------------------------------------

 

 

Statistical Methods (Part A and Part B): 

Sample Size Considerations (Part A and Part B): [**]

 

Study Populations (Part A and Part B): [**]

 

Safety Analyses (Part A and Part B): [**]

 

GI Tolerability Analyses (Part A and Part B): [**]

 

Exploratory Efficacy Analyses (Part A and Part B): [**]

 

Pharmacokinetics Analyses (Part A): [**]

 

 

C-12

--------------------------------------------------------------------------------

 

 

 

 

[**]

 

 

C-13

--------------------------------------------------------------------------------

 

 

ALKS 8700 Renal Study (‐A108)

 

Name of Sponsor/ Company: Alkermes, Inc.

Name of Investigational Product: ALKS 8700

Name of Active Ingredient: ALKS 8700

Title of study: A Phase 1 Study of the Pharmacokinetics, Safety and Tolerability
of ALKS 8700 in Subjects with Renal Impairment

Investigators: This study will be conducted at multiple centers study in the
United States.

Study Period:

Estimated date of first subject’s consent: Q4 2016

Estimated date of last subject’s last visit: Q2 2017

Phase of Development: 1

Objectives: The objective of this study is to compare the pharmacokinetics (PK),
safety and tolerability of ALKS 8700 in subjects with mild, moderate and severe
renal impairment versus healthy control subjects following single dose
administration.

Methodology: [**]

 

 

C-14

--------------------------------------------------------------------------------

 

 

 

 

Study Design Schematic 

[**]

 

Number of Subjects Planned: [**]

 

Main Criteria for Inclusion: [**]

 

Investigational Product, Dosage, Duration and Mode of Administration: [**]

 

Reference Therapy, Dosage, Duration and Mode of administration: [**]

 

 

C-15

--------------------------------------------------------------------------------

 

 

Duration of Study: [**]

 

Criteria for Evaluation:

Pharmacokinetics: [**]

 

Safety: [**]

 

Statistical Methods: [**]

 

Analyses Populations: [**]

 

Pharmacokinetic Analysis: [**]

 

 

 

C-16

--------------------------------------------------------------------------------

 

 

Safety Analysis: [**]

 

 

Sample Size Considerations: [**]

 

 

C-17

--------------------------------------------------------------------------------

 

 

ALKS 8700 tQT Study (‐A110)

 

Name of Sponsor/ Company: Alkermes, Inc.

Name of Investigational Product: ALKS 8700

Name of Active Ingredient: Monomethyl fumarate

Title of study: A Phase 1 Study to Evaluate the Effect of Multiple Doses of ALKS
8700 on QTc Interval in Healthy Volunteers

Investigator(s): Single center study in the US

Study Period (years):

Estimated date of first patient visit: Q4 2017

Estimated date of last patient completed:  Q1 2018

Phase of Development: 1

Objectives:

Primary:

To evaluate the effects of multiple doses of therapeutic and supratherapeutic
oral dose strengths of ALKS 8700 on the heart rate-corrected QT interval using
Fridericia’s formula (QTcF)

Secondary:

•    To evaluate the effect of ALKS 8700 on other electrocardiogram (ECG)
parameters: heart rate, PR and QRS intervals, and T-wave morphology and U-wave
presence

•    To demonstrate sensitivity of the study to detect a small QT effect using
moxifloxacin as a positive control

•    To evaluate the safety and tolerability of ALKS 8700

•    To evaluate the pharmacokinetic/pharmacodynamic relationship between the
effect of ALKS 8700 on ECG and plasma concentrations of the metabolites
monomethyl fumarate (MMF) and RDC-6567

Methodology:

[**]

 

 

C-18

--------------------------------------------------------------------------------

 

 

Number of Subjects Planned: 

[**]

 

Main Criteria for Inclusion: 

[**]

 

Investigational Product, Dosage, Duration, and Mode of Administration: [**]

 

Reference Therapy, Dosage, Duration, and Mode of Administration:

[**]

 

Duration of Study: [**]

 

Criteria for Evaluation:

Primary Endpoint: [**]

Secondary Endpoints:

[**]

 

 

 

C-19

--------------------------------------------------------------------------------

 

 

Pharmacokinetics/Pharmacodynamics:

[**]

 

Safety: [**]

 

 

 

C-20

--------------------------------------------------------------------------------

 

 

Statistical Methods: [**]

 

Analyses Populations:

[**]

 

Baseline: [**]

 

Safety Analyses: [**]

 

Concentration-Response Analysis: [**]

 

 

 

C-21

--------------------------------------------------------------------------------

 

 

Criteria for Negative QT Assessment: [**]

 

Investigation of Hysteresis: [**]

 

Assessment of Appropriateness of Model: [**]

 

 

C-22

--------------------------------------------------------------------------------

 

 

Assay Sensitivity: [**]

 

By-Time Point Analysis: [**]

 

Categorical Analyses: [**]

 

Safety: [**]

 

Sample Size Considerations: [**]

 

 

C-23

--------------------------------------------------------------------------------

 

 

 

[**]

 

 

C-24

--------------------------------------------------------------------------------

 

 

ALKS 8700 Juvenile Animal Toxicity Study

 

[**]

 

 

 

 

 

 

C-25

--------------------------------------------------------------------------------

 

 

EXHIBIT D

Clinical Supply Agreement Terms

 

Clinical Supply Agreement and Quality Agreement

 

-The Parties will negotiate and execute a Clinical Supply Agreement and an
associated Technical and Quality Agreement (“Clinical Supply Quality Agreement”)
in accordance with Section 5.1.1 of the Agreement.

 

Program of Manufacturing, Forecasts and Delivery of Products

-A detailed program of Manufacture with a rolling Calendar Quarter forecast and
order and delivery mechanisms will be outlined in the Clinical Supply Agreement.

-Biogen to supply Tecfidera® [**].  

-Alkermes shall have no liability as a result of any failure or delay in
Manufacturing Clinical Supplies.

 

Quality Assurance

-Alkermes will Manufacture the Products in accordance with Applicable Law and
cGMPs, the specifications for the Products and the terms and conditions of the
Clinical Supply Agreement and the Clinical Supply Quality Agreement.

-Alkermes will perform and document those tests and checks required to assure
the quality of the Product that are established by the Clinical Supply Quality
Agreement.

-The Clinical Supply Agreement will contain terms establishing standards for the
release, acceptance and rejection of the Products and will establish a minimum
shelf life for the Products.

-In accordance with the terms of the Clinical Supply Agreement and the Clinical
Supply Quality Agreement, Biogen will be entitled to inspect or have inspected
those portions of the facilities that are used by Alkermes in the Manufacture of
the Products as well as the relevant Manufacturing records.

-Validation batches will be treated as Clinical Supplies until such time as they
are utilized in the Commercialization of Product, at which time Biogen will pay
Alkermes the difference between the clinical and commercial supply prices.

 

Supply Price for Clinical Supplies of Products

[**]

 

D-1

--------------------------------------------------------------------------------

 

 

EXHIBIT E

Commercial Supply Agreement Terms

Clinical Supply Agreement and Quality Agreement

-The Parties will negotiate and execute a Commercial Supply Agreement and an
associated Technical and Quality Agreement (“Commercial Supply Quality
Agreement”) in accordance with Section 5.1 of the Agreement.

 

Program of Manufacturing, Forecasts and Delivery of Products

-A detailed program of Manufacture with a rolling Calendar Quarter forecast and
order and delivery mechanisms will be outlined in the Commercial Supply
Agreement.

-Product in the form of “finished goods” to be delivered Ex Works (Incoterms
2010) Athlone, Ireland.

-Biogen to provide (A) 3-year rolling forecasts and (B) 4-quarter rolling
forecasts, the proximate two quarters of which shall be binding and the
subsequent two quarters of which may be increased or decreased by 20% prior to
becoming binding.

 

Quality Assurance

-Alkermes will Manufacture the Products in accordance with Applicable Law and
cGMPs, the specifications for the Products and the terms and conditions of the
Commercial Supply Agreement and the Commercial Supply Quality Agreement.

-Alkermes will perform and document those tests and checks required to assure
the quality of the Products that are established by the Commercial Supply
Quality Agreement.

-The Commercial Supply Agreement will contain terms establishing standards for
the release, acceptance and rejection of the Products and will establish a
minimum shelf life for the Products.

-In accordance with the terms of the Commercial Supply Agreement and the
Commercial Supply Quality Agreement, Biogen will be entitled to inspect or have
inspected those portions of the facilities that are used by Alkermes in the
Manufacture of the Products as well as the relevant Manufacturing records.

 

Supply Price for Commercial Supplies of Products

[**]

Products in Process upon Termination

-For any Product that Alkermes has commenced the Manufacture of, but for which
Manufacture is incomplete on the Commercial Supply Agreement termination date,
Biogen shall either request that Alkermes (i) complete the Manufacture of such
incomplete Product, in which case Biogen shall pay Alkermes [**] or (ii) cease
the

E-1

--------------------------------------------------------------------------------

 

 

Manufacture of such incomplete Product, in which case Biogen shall pay Alkermes
the costs incurred by Alkermes for such incomplete Product, as calculated in
accordance with GAAP.

 

Indemnification and Liability for Manufacture of Commercial Supplies of Products

-Customary toll manufacturer indemnification provisions.

-Limitation of liability equal to one year of amounts paid to Alkermes under the
Commercial Supply Agreement.

-In the event of a Serious Failure to Supply, Alkermes shall transfer to Biogen
or its designee, at Biogen’s cost and expense, the Manufacturing technology to
enable Biogen or its designee to Manufacture Commercial Supplies.

 

 

 

 

E-2

--------------------------------------------------------------------------------

 

 

EXHIBIT F

Press Release 

 

 

 

 

 

 

F-1

--------------------------------------------------------------------------------

 

 

 

 

 

Biogen Contacts:

 

For Investors: Matt Calistri         +1 781 464 2442

 

For Media: Matt Fearer               +1 781 464 3260

 

 

 

 

 

Alkermes Contacts:

 

For Investors: Sandy Coombs     +1 781 609 6377

 

                       Eva Stroynowski +1 781 609 6823

 

For Media:  Jennifer Snyder      +1 781 609 6166

 

 

BIOGEN AND ALKERMES ANNOUNCE LICENSE AND COLLABORATION AGREEMENT TO DEVELOP AND
COMMERCIALIZE ALKS 8700 FOR THE TREATMENT OF MULTIPLE SCLEROSIS

 

–– Novel, Oral, Fumarate Therapy Intended to Provide a Differentiated
Gastrointestinal Tolerability Profile ––

–– Biogen Brings Multiple Sclerosis Expertise to Commercialization of ALKS 8700
––

–– New Drug Application Anticipated for Submission in 2018 ––

 

Cambridge, Mass and Dublin, Ireland., Nov. 27, 2017 —  Biogen (Nasdaq: BIIB) and
Alkermes plc (Nasdaq: ALKS) today announced that they have entered into a global
license and collaboration agreement to develop and commercialize ALKS 8700, a
novel, oral, monomethyl fumarate (MMF) small drug molecule in Phase 3
development for the treatment of relapsing forms of multiple sclerosis (MS).

 

“This partnership is further evidence of Biogen’s ongoing commitment to multiple
sclerosis and builds upon our deep experience in neuroscience and particularly
in MS,” stated Michel Vounatsos, Chief Executive Officer at Biogen. “We aim to
provide patients with a new oral therapy which may bring differentiated
benefits.”

 

“This collaboration has the potential to provide important benefits to patients
with multiple sclerosis and immediately increases the value of ALKS 8700 to
Alkermes,” said Richard Pops, Chief Executive Officer at Alkermes. “Biogen has a
broad product portfolio and a highly experienced commercial team. In Biogen’s
hands, we believe that patients will have broader and more rapid access to this
important medicine. Meanwhile, we will focus our growing commercial capabilities
on our expanding portfolio of medicines in psychiatry, including addiction,
schizophrenia and depression.”

 

Under the terms of the agreement, Biogen will receive an exclusive, worldwide
license to commercialize ALKS 8700 and will pay Alkermes a mid-teens royalty on
worldwide net sales of ALKS 8700.

 

This collaboration aligns the interests of Alkermes and Biogen in the successful
development and commercialization of ALKS 8700 as an important potential
treatment option for patients

F – Press Release

--------------------------------------------------------------------------------

 

 

suffering from MS. Biogen will reimburse Alkermes for fifty percent (50%) of the
2017 ALKS 8700 development costs, with Alkermes receiving an upfront payment of
$28 million representing Biogen’s share of development expenses already incurred
in 2017. Beginning Jan. 1, 2018, Biogen will be responsible for all development
expenses related to ALKS 8700. Alkermes may also receive milestone payments for
ALKS 8700 with a maximum aggregate value of $200 million upon certain clinical
and regulatory achievements. Biogen anticipates the initial milestone payment of
$50 million will be recorded as an expense in 2017.

 

Alkermes will maintain responsibility for regulatory interactions with the U.S.
Food and Drug Administration (FDA) through the potential approval of the New
Drug Application (NDA) for ALKS 8700 for the treatment of MS. Biogen shall be
responsible for all commercialization activities for ALKS 8700.

 

ALKS 8700 is currently in Phase 3 development for MS. Alkermes plans to seek
approval of ALKS 8700 under the 505(b)(2) regulatory pathway referencing
Biogen’s TECFIDERA® (dimethyl fumarate).  The registration package for ALKS 8700
will include pharmacokinetic bridging studies that establish bioequivalence to
TECFIDERA and data from a two-year safety study known as EVOLVE-MS-1. Initial
safety data from EVOLVE-MS-1 were recently presented at MSParis2017, the 7th
Joint Meeting of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in
Multiple Sclerosis (ACTRIMS) in October. Safety data from the first month of the
EVOLVE-MS-1 study (N=580) showed that treatment with ALKS 8700 was associated
with low rates of gastrointestinal (GI) adverse events (AEs) leading to
discontinuation and no occurrence of serious GI AEs. The most common AEs during
the first month of treatment with ALKS 8700 were flushing, pruritus and
diarrhea.

 

Also, currently underway is a head-to-head study (EVOLVE-MS-2) evaluating the GI
tolerability of ALKS 8700 compared to TECFIDERA. Initial data from EVOLVE-MS-2
are expected in the first half of 2018.

 

About the EVOLVE-MS Clinical Development Program

The key components of the EVOLVE-MS (Endeavoring to Advance Treatment for
Patients Living with Multiple Sclerosis) clinical development program of ALKS
8700 include a two-year safety study and pharmacokinetic bridging studies
comparing ALKS 8700 and TECFIDERA. In addition, the program includes an elective
head-to-head study comparing the GI tolerability of ALKS 8700 and TECFIDERA.

 

About ALKS 8700

ALKS 8700 is an oral, novel and proprietary monomethyl fumarate (MMF) prodrug
candidate in development for the treatment of relapsing forms of multiple
sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF
in the body and to offer differentiated features as compared to the currently
marketed dimethyl fumarate, TECFIDERA®.

 

About Multiple Sclerosis

Multiple sclerosis (MS) is an unpredictable, often disabling disease of the
central nervous system (CNS), which interrupts the flow of information within
the brain, and between the brain and

F – Press Release

--------------------------------------------------------------------------------

 

 

body.1 MS symptoms can vary over time and from person to person. Symptoms may
include extreme fatigue, impaired vision, problems with balance and walking,
numbness or pain and other sensory changes, bladder and bowel symptoms, tremors,
problems with memory and concentration and mood changes, among
others.1Approximately 400,000 individuals in the U.S. and 2.5 million people
worldwide have MS, and most are diagnosed between the ages of 15 and 50.2

 

About Alkermes plc

Alkermes plc is a fully integrated, global biopharmaceutical company developing
innovative medicines for the treatment of central nervous system (CNS) diseases.
The company has a diversified commercial product portfolio and a substantial
clinical pipeline of product candidates for chronic diseases that include
schizophrenia, depression, addiction and multiple sclerosis. Headquartered in
Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a
research and manufacturing facility in Athlone, Ireland; and a manufacturing
facility in Wilmington, Ohio. For more information, please visit Alkermes’
website at www.alkermes.com.

 

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen
discovers, develops and delivers worldwide innovative therapies for people
living with serious neurological and neurodegenerative diseases. Founded in 1978
as one of the world’s first global biotechnology companies by Charles Weissman,
Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and
Phillip Sharp, today Biogen has the leading portfolio of medicines to treat
multiple sclerosis; has introduced the first and only approved treatment for
spinal muscular atrophy; and is focused on advancing neuroscience research
programs in Alzheimer’s disease and dementia, neuroimmunology, movement
disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and
acute neurology. Biogen also manufactures and commercializes biosimilars of
advanced biologics.

 

We routinely post information that may be important to investors on our website
at www.biogen.com.  To learn more, please visit www.biogen.com and follow us on
social media Twitter, LinkedIn, Facebook, YouTube.

 

Biogen Safe Harbor

This press release contains forward-looking statements, made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995,
including statements relating to the potential benefits and results, including
financial and operating results, that may be achieved through Biogen’s license
agreement with Alkermes, risks and uncertainties associated with drug
development and commercialization, the potential benefits, safety, efficacy and
clinical effects of ALKS 8700, the timing and status of regulatory filings, and
the potential of Biogen’s commercial business and pipeline programs, including
ALKS 8700. These forward-looking statements may be accompanied by such words as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,”
“intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” and other
words and terms of similar meaning. Drug development and commercialization
involve a high degree of risk, and only a small number of research and
development programs result in commercialization of a product. Results in early
stage clinical trials may not be indicative of full results or results from
later stage or larger scale clinical trials and do not ensure

F – Press Release

--------------------------------------------------------------------------------

 

 

regulatory approval. You should not place undue reliance on these statements or
the scientific data presented.

 

These statements involve risks and uncertainties that could cause actual results
to differ materially from those reflected in such statements, including, without
limitation: uncertainty as to whether the anticipated benefits and potential of
Biogen’s license agreement with Alkermes can be achieved; risks that Biogen
and/or Alkermes may not fully enroll the clinical trials for ALKS 8700 or will
take longer than expected; risks of unexpected costs or delays; uncertainty of
success in the development and potential commercialization of ALKS 8700, which
may be impacted by, among other things, unexpected concerns that may arise from
additional data or analysis, the occurrence of adverse safety events, failure to
obtain regulatory approvals in certain jurisdictions, failure to protect and
enforce Biogen’s data, intellectual property, and other proprietary rights and
uncertainties relating to intellectual property claims and challenges; third
party collaboration risks; and uncertainty of Biogen’s success in developing,
licensing, or acquiring other product candidates or additional indications for
existing products. The foregoing sets forth many, but not all, of the factors
that could cause actual results to differ from Biogen’s expectations in any
forward-looking statement. Investors should consider this cautionary statement,
as well as the risk factors identified in Biogen’s most recent annual or
quarterly report and in other reports Biogen has filed with the U.S. Securities
and Exchange Commission. These statements are based on Biogen’s current beliefs
and expectations and speak only as of the date of this press release. Biogen
does not undertake any obligation to publicly update any forward-looking
statements, whether as a result of new information, future developments or
otherwise.

 

Alkermes Note Regarding Forward-Looking Statements

Certain statements set forth in this press release constitute “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act
of 1995, as amended, including, but not limited to, statements concerning: the
continued expansion of Alkermes’ portfolio of medicines in psychiatry, the
continued clinical development and the potential therapeutic and commercial
value of ALKS 8700 for the treatment of relapsing forms of MS, the number of
patients enrolled in the ALKS 8700 Phase 3 studies, the timing of expected
initial data from EVOLVE-MS-2, the regulatory strategy for filing of an NDA for
ALKS 8700 and the adequacy of the EVOLVE-MS development program for ALKS 8700 to
serve as the basis for an NDA, the timing of the submission of an NDA to the FDA
for ALKS 8700 and the potential financial, commercial and therapeutic benefits
that may be achieved through collaboration with Biogen under the license and
collaboration agreement between Alkermes and Biogen. Alkermes cautions that
forward-looking statements are inherently uncertain. Although Alkermes believes
that such statements are based on reasonable assumptions within the bounds of
its knowledge of its business and operations, the forward-looking statements are
neither promises nor guarantees and they are necessarily subject to a high
degree of uncertainty and risk. Actual performance and results may differ
materially from those expressed or implied in the forward-looking statements due
to various risks and uncertainties. These risks and uncertainties include, among
others: whether the results from the head-to-head study to evaluate the GI
tolerability of ALKS 8700 compared to TECFIDERA will show that ALKS 8700 has
more favorable GI tolerability; whether preclinical and early clinical results
for ALKS 8700 will be predictive of future clinical study results or real-world
results; whether clinical trials for ALKS 8700 will be completed on time or at
all; changes in the cost, scope and duration of the ALKS 8700 clinical trials;
whether

F – Press Release

--------------------------------------------------------------------------------

 

 

ALKS 8700 could be shown ineffective or unsafe during clinical studies, and
whether, in such instances, Alkermes may not be permitted by regulatory
authorities to undertake new or additional clinical studies of ALKS 8700;
whether regulatory submissions for ALKS 8700 will be submitted on time or at
all; whether adverse decisions by regulatory authorities will occur; whether the
pharmacokinetic, Phase 3 and other studies conducted for ALKS 8700 will meet the
FDA’s requirements for approval; whether the potential financial, commercial and
therapeutic benefits of collaboration with Biogen under the license and
collaboration agreement between Alkermes and Biogen will be achieved; and those
risks described in the Alkermes Annual Report on Form 10-K for the fiscal year
ended December 31, 2016, and Quarterly Reports on Form 10-Q for the quarters
ended March 31, 2017 and September 30, 2017 and in subsequent filings made by
Alkermes with the U.S. Securities and Exchange Commission (SEC), which are
available on the SEC’s website at www.sec.gov. Existing and prospective
investors are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Except as required by law,
the company disclaims any intention or responsibility for updating or revising
any forward-looking statements contained in this press release.

 

TECFIDERA® is a registered trademark of Biogen Inc.

 

1 National Multiple Sclerosis Society. Multiple Sclerosis: Just the Facts.
Accessed
from http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-Just-the-Facts.pdf on Nov.
27, 2017.

2 Multiple Sclerosis Association of America. MS Overview. Accessed from
http://mymsaa.org/ms-information/overview/who-gets-ms/ on Nov. 27, 2017.

 

###

 

 

 

 

 

F – Press Release

--------------------------------------------------------------------------------

 

 

Schedule 1.1.26

GI Tolerability Data Package

[**]

 

 

Schedule 1.1.26

--------------------------------------------------------------------------------

 

 

Schedule 5.1

Change of Control - Competitors

[**]

 

 

Schedule 5.1

--------------------------------------------------------------------------------

 

 

 

Schedule 10.3.3

Amended and Restated Credit Agreement, dated as of September 16, 2011, as
amended and restated on September 25, 2012, as further amended by that certain
Amendment No. 2 to Amended and Restated Credit Agreement dated as of February
14, 2013, and as amended by that certain Amendment No. 3 and Waiver to Amended
and Restated Credit Agreement dated as of May 22, 2013 and by that certain
Amendment No. 4 to Amended and Restated Credit Agreement dated as of October 12,
2016, among ALKERMES, INC., a corporation organized under the laws of the
Commonwealth of Pennsylvania, ALKERMES PLC, a company incorporated under the
laws of the Republic of Ireland (registered number 498284) (“Holdings”),
ALKERMES PHARMA IRELAND LIMITED, a private limited company organized under the
laws of the Republic of Ireland (registered number 448848) and a wholly owned
indirect subsidiary of Holdings (the “Intermediate Holdco”), ALKERMES US
HOLDINGS, INC., a Delaware corporation and a wholly owned subsidiary of
Intermediate Holdco, certain other subsidiaries of Holdings, the several banks
and other financial institutions or entities from time to time parties to the
Credit Agreement as lenders, MORGAN STANLEY SENIOR FUNDING, INC., as
administrative agent, MORGAN STANLEY SENIOR FUNDING, INC., Citigroup Global
Markets, Inc. and JPMorgan Chase Bank, N.A. as co-syndication agents, and MORGAN
STANLEY SENIOR FUNDING, INC., as collateral agent.

 

 

Schedule 10.3.3

--------------------------------------------------------------------------------